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Description: In This Issue: 2018 Natural Industry Forecast, Heart Health, Digestive Health, and Nutritional Beverage

V EX ISIT BO P OT O W US H E AT 3 ST 92 A VRM Media Publication 0 January February 2018 Don t miss a single issue of NIE in 2018... go online to renew your free subscription today JanFeb18 Go to sabinsa for info about this advertiser Go to nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 23 NO. 1 JANUARY FEBRUARY2018 F E A T U R E S 41 Heart Health Maintenance Though the market for heart health supplements is mature improved ingredients and consumers increasing desire for natural preventions may help the category build speed. 44 Digestion Developments As consumers learn more about the importance of digestive health suppliers see to it that natural ingredients are part of their maintenance plan. 44 A L S O I N S I D E 50 2018 Natural Industry Forecast From renewing its focus on science to experiencing an Amazonian market entry to re-thinking natural--the natural products industry forges ahead. C O L U M N S 14 25 33 34 35 62 62 63 63 63 Industry News Ingredient News AHPA Update Science Update Association News Engredea Booth Preview Conventions & Meetings Equipment & Packaging Advertiser Index Industry Events Supplier of the Month 4 First Word 6 Condition Specific 10 Legalities 57 Marketing Innovation 60 Functional Foods 10 64 FREE Subscription (Print Digital or BOTH) & E-newsletter Available Copyright 2018. Nutrition Industry Executive (ISSN 2331-2602) Volume 23 Number 1 January February 2018. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 432-9288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Periodicals Postage Paid at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues & Single Copies For order information contact (732) 432-9600 or info March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive January February 2018 Go to fccproducts for info about this advertiser FirstWord A Resolution to Supplement More ith the beginning of the New Year many of us decide to turn over a new leaf. In a recent survey from YouGov an online polling firm eating better and exercising more top the list of New Year s resolutions along with spending less money--with performing better self-care (such as getting more sleep) coming in fourth place. I totally get the spending less money goal but was intrigued by the resolution of eating better. Although the concept is quite broad it s probably a better goal than say losing weight. That s because defining eating better is fairly simple in my opinion--eat more fruits and vegetables. And isn t focusing on what you can eat more doable than focusing on depriving yourself On the same day I read about the most popular New Year s resolutions I also saw a report in the New York Times about why fiber in foods is so beneficial. We know that a diet high in fiber such as in fruits and vegetables reduces the risk of developing diabetes heart disease and arthritis. Indeed the evidence for fiber s benefits extends beyond any particular ailment. But while the benefits of fiber are clear it s not so clear why fiber is so great. It s an easy question to ask and a hard one to really answer said Fredrik B ckhed PhD a biologist at the University of Gothenburg in Sweden. According to the news report he and other scientists are running experiments that are yielding some important new clues about fiber s role in human health. Their research indicates that fiber doesn t deliver many of its benefits directly to our bodies. Instead the fiber we eat feeds billions of bacteria in our guts according to the article. Keeping them happy means our intestines and immune systems remain in good working order. In order to digest food we need to W bathe it in enzymes that break down its molecules. Those molecular fragments then pass through the gut wall and are absorbed in our intestines. B ckhed and his colleagues carried out an experiment surveying the microbiome in mice as they were switched from fiberrich food to a low-fiber diet. It s basically what you d get at McDonald s B ckhed said. A lot of lard a lot of sugar and 20 percent protein. The scientists focused on the diversity of species that make up the mouse s gut microbiome. Shifting the animals to a low-fiber diet had a dramatic effect they found Many common species became rare and rare species became common. Along with changes to the microbiome the team also observed rapid changes to the mice themselves. Their intestines got smaller and its mucus layer thinner. As a result bacteria wound up much closer to the intestinal wall and that encroachment triggered an immune reaction. B ckhed and his colleagues also fed another group of rodents the high-fat menu along with a modest dose of inulin. The mucus layer in their guts was healthier than in mice that didn t get fiber the scientists found and intestinal bacteria were kept at a safer distance from their intestinal wall. In my feature article on digestive health (see page 44) suppliers discussed the many ways their ingredients for supplements--enzymes prebiotics etc.-- also contribute to the health of intestinal microbiota which is especially beneficial as we age. So rather than lose weight or even eat better I decided that my New Year s resolution for 2018 is to improve my gut bacteria (via fruits vegetables and supplements) to beneficially shift my microbiome --and also to save more money. Publisher Daniel McSweeney Editorial Director DanM Associate Russ Fields Publisher RussF Advertising Gary Pfaff Sales Associate GaryP Editor-in-Chief Janet Poveromo JanetP Managing Editor Shari Barbanel ShariB Associate Editor Nicholas Saraceno NicoS Contributing Writers Anne Cruz James Gormley Matthew Kaplan Orlaigh Mathews Jenna Mills Suzanne Shelton Art Director Robert Certo Production Manager RobertC Production Assistant Bryan Zak Graphic Designer BryanZ Circulation Manager Rosie Brodsky Rosie A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info Website VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and FitnessTrainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues See the Table of Contents page for price and order information. Connect With Us vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive January February 2018 Go to jiaherb for info about this advertiser ConditionSpecific Fighting Inflammation Pain & The pain and inflammation category that was once dominated by Baby Boomers is now attracting a younger demographic--both groups look for proven ingredients. B Y S HARI B ARBANEL P ain is inevitable--it is something we all experience at some point in our lives. In addition inflammation is necessary it is the body s response to injury. However when pain and inflammation become chronic problems it can lessen a person s quality of life and may make doing even the simplest of tasks difficult. The pain and inflammation category continues to grow at a rapid rate said Paul Garrott managing director for Marinova in Australia. Sedentary lifestyles poor diet and an aging population are all contributing to this growth. We are also observing that more consumers take nutritional and dietary supplements alongside prescription medications and we expect that the category will continue to grow but with increasing regulatory pressures. While members of the Baby Boomer generation and those of an advanced age have been the driving forces behind the pain and inflammation market for some time the category has 6 Nutrition Industry Executive begun to widen including athletes weekend warriors and fitness fanatics. The advanced age demographic is the core of the pain and inflammation market but we are noting category growth among fitness enthusiasts who are seeking natural methods to alleviate discomfort and strengthen their joints explained S bastien Bornet vice president of global sales and marketing at Horphag Research in Switzerland. With these drivers the market for joint health supplements is expected to increase to more than 14 billion by the year 2024. Athletes and those who exercise regularly know all too well about the temporary pain and inflammation that often comes with cardio and strength training. To combat these issues New Jerseybased XSTO Solutions recently launched Cuvitus a whole-fruit cucumber extract with scientific evidence supporting reduction in biomarkers related to pain and inflammation. According to said Dan Murray vice president of business development Cuvitus is XSTO s first ingredient specifically addressing the temporary pain and inflammation category. While still in the launch phase we see significant interest in Cuvitus and this growing category he said. According to Nena Dockery technical services manager for Missouri-based Stratum Nutrition while both demographics are looking to find relief from pain and inflammation they are often doing so for very different reasons. For the younger and more active consumer the main interest is in products that help ease pain and inflammation associated with sports and athletics she said. Within this category there is a need for products that target minor acute injuries and a need for products for managing muscle and joint soreness January February 2018 associated with regular exercise or the introduction of a new exercise regimen. These products may also help with muscle recovery following exercise. This type of product will often contain ingredients that have an analgesic effect as well as an anti-inflammatory attribute. Dockery added that for older but still active individuals pain and inflammation in the joints becomes a bigger concern. These consumers will often select products that contain ingredients that have been researched for their benefits in reducing inflammation in and around the joints and products that help protect or even rebuild cartilage tissue that usually begins to lose its ability to regenerate and rebuild after middle age she noted. There is also a large group of individuals mostly older who are interested in products to help manage chronic inflammation Dockery continued. They are often concerned with protecting their cardiovascular health in selecting these products. supposed to make them feel better. Safety of use particularly over time has always been a concern for most people seeking products to help them with pain relief Jackson-Michel explained. In recent years there has been significant issue with adverse events brought on by the chronic use of COX-2 pain relievers for instance. While most Baby Boomers are of the mindset that their pain and inflammation will persist they are not agreeable to complicating their health conditions with side effects. clinically-studied patented curcumin ingredient. In addition the company offers the novel boswellia active core ingredient BosPure. Pain & Inflammation Fighters Products with natural ingredients are often a good alternative for those looking for an option to replace prescription or OTC drugs and the list of ingredients that can offer relief from pain and or inflammation is plentiful. Among them include omega-3s collagen peptides glucosamine and chondroitin sulfate. However while these long-standing ingredients are mainstays in the category other ingredients are pushing their way to the forefront. Going Natural While natural solutions have been available for thousands of years when dealing with pain and inflammation a number of consumers would often reach for over-the-counter (OTC) NSAIDS or prescription medications that were prescribed to them by a doctor. But after learning that many of these medications just mask the symptoms instead of getting to the root of them problem many consumers often go in search of options that do more. Supplement products generally support healthy natural metabolic functions which is why the claims are related to structure and function of a normal healthy person said Murray. Consumers are seeking products that will support their health and active lifestyles. Drugs typically shut down or limit metabolic processes to address symptomatic relief oftentimes not addressing the underlying condition or cause of the problem. Shavon Jackson-Michel ND medical and scientific affairs advisor for DolCas Biotech LLC in New Jersey noted that another consumer concern is how safe a product is for them to use both in the short and long term. Often OTC and prescription medications can cause unwanted side effects and for those already dealing with pain the last thing they probably want to worry about is their body reacting poorly to what is Curcumin and Boswellia Curcumin and boswellia have both been gaining in popularity in the pain and inflammation category for some time. Curcumin which is found in turmeric is a powerful antioxidant and contains anti-inflammatory properties and boswellia which is also known as Indian frankincense is also an effective antiinflammatory. While both curcumin and boswellia are beneficial for addressing pain and inflammation on their own together they can create a one-two punch. Interestingly boswellia and curcumin synergize one another in their action against pain and inflammation said Jackson-Michel. Whereas boswellia is able to interfere with the alternate pathway for pain signaling via lipoxygenase (LOX) inhibition curcumin s complementary action on COX-2 make them a powerful pair. The active core of our BosPure ingredient additionally removes pro-inflammatory boswellic acid while concentrating the 6 core acetylated boswellic acids which have proven anti-inflammatory action. DolCas Biotech s flagship ingredient BCM-95 is a highly bioavailable and NEM In addition to their high-quality curcumin Stratum Nutrition offers NEM brand eggshell membrane that can be used in conjunction. Natural Eggshell Membrane (NEM) is natural source of collagen chondroitin and hyaluronic acid which is beneficial for combating pain and inflammation. Stratum Nutrition s NEM is a foodsourced ingredient demonstrated in multiple clinical trials to help relieve pain and inflammation in and around the joints associated with both exercise-related stress on the joints and age-related wear and tear. Research on this ingredient continues to expand beyond its benefits in reducing joint discomfort and inflammation Dockery said. Most recently both a veterinary study on dogs as well as a human clinical trial have demonstrated that supplementation with NEM can help protect joint cartilage from damage caused by strenuous exercise or wear and tear using measurement of CTX-II a biomarker of cartilage turnover and indicator of potential damage to joint cartilage. NEM is also an ideal ingredient for combining with other ingredients since its researched efficacious dose is a moderate 500 mg. Fucodian Extract While some ingredients are well-known long-standing ingredients in the category others like fucodian extract from seaweed are now getting significant attention in the U.S. For centuries seaweeds have also been used for their dietary and therapeutic properties including well documented anti-inflammatory and pain relieving effects said Garrott. Only recently however has fucoidan been isolated from seaweed and recognized in Western cultures for its anti-inflammatory and pain reduction benefits. Marinova manufactures the unique high-purity Maritech fucoidan extracts from Fucus vesiculosus and Undaria pinnatifida seaweed species. According to Nutrition Industry Executive 7 January February 2018 ConditionSpecific the company the range of ingredients have been well researched for their antiinflammatory properties and are highly sought after for use in nutritional dietary and pharmaceutical applications. ucts contain to not only ensure that they are effective but that they are also high-quality and safe. According XSTO s Murray it is important to have scientific data to demonstrate your inhabitant effect on the appropriate biomarkers related to pain and inflammation. Anecdotal stories do not help establish an efficacious ingredient. Cuvitus has been shown to have a positive benefit for TNF- and other ILs related to temporary pain and inflammation he said. Ingredients with robust scientific evidence will ultimately stand out from competitors. In addition to credibility superior products on the market are those with accreditations that reflect industry standards and a reputable supply chain agreed Garrott. Currently there is high consumer demand for products with non-GMO (genetically modified organism) and certified-organic ingredients as well as clean labels. Consumers are increasingly becoming concerned about where the ingredients in their products are sourced and if the evidence actually exists to support the product claims. It is our experience that many consumers conduct their own research before purchasing a product even to the extent of contacting the ingredient manufacturer to confirm source and quality. To address consumer demand and set their product apart from competitors product manufacturers should be seeking ingredients with traceability industry accreditations and scientific evidence that support the marketing story of their product. inflammatory marker IL-6. Jackson-Michel noted that DolCas Biotech s commitment to providing a safe research-backed ingredient very seriously. In fact BCM-95 has an accomplished dossier of more than 28 published studies and it is one of only two branded curcumin ingredients to have received an FDA (U.S. Food and Drug Administration) No Questions notification for safety. To respond to any concerns about its intake in the concentrated form of BCM-95 we have gone far beyond the basics of an animal safety study she said. We have committed to the rigors of a self-affirmed generally recognized as safe (GRAS) assessment of the ingredient following up that designation with an FDA submission. The FDA concurred with the panel s conclusion of BCM-95 as GRAS in foods at up to 180 mg day and under the supervision of a physician at 1 000 mg day. While doing research and ensuring that you have a top-quality ingredient is vital not educating manufacturers retailers and consumers about these facts is a wasted opportunity. Horphag Research has always made education a priority Bornet said. Part of our responsibility is to proactively ensure retailers and consumers have access to information and content at all stages of the purchasing process including point of purchase in order to make an informed buying decision. As the pain and inflammation category grows beyond the aging population to include a wider demographic barring any future roadblocks the sky seems to be the limit. The category is strong today and could potentially continue to grow concluded Dockery if the FDA and FTC [Federal Trade Commission] don t become too restrictive in what can be claimed about this type of product. NIE Maritech fucoidans are extracted from wild grown macroalgae in the cool pristine waters of Tasmania Nova Scotia Patagonia and Brittany using best practice environmental standards noted Garrott. The seaweed is harvested in line with its seasonal growth cycle to minimize disruption to the environment and ensure sustainable growth. Once harvested the seaweed is immediately sun dried to retain the natural bioactivity of the fucoidan compounds. Pycnogenol Pycnogenol is a natural plant extract derived from French maritime pine bark grown exclusively along the coast of Southwest France. As Horphag Research s flagship ingredient Pycnogenol s basic property is that it acts as a natural antiinflammatory and works to reduce the harmful inflammation in the body. According to the company Pycnogenol has been shown to help reduce joint inflammation associated with osteoarthritis. Pycnogenol is backed by more than 40 years of research and one of its primary mechanisms of action is its anti-inflammatory effects noted Bornet. Pycnogenol naturally inhibits the pro-inflammatory master switch NF-kB by more than 15 percent. Most recently one study found that this super antioxidant s polyphenols are distributed directly into joint synovial fluid--effectively reducing underlying inflammation associated with osteoarthritis. Reference Dr. Helen Fitton Marinova chief scientist elaborated on Marinova s commitment to research and development mentioning a human clinical study in which Maritech fucoidan was shown to decrease the symptoms of osteoarthritis. In this study patients who ingested 1 g of Maritech fucoidan daily over 12 weeks achieved a 52 percent reduction in clinical scores of pain and stiffness she explained. In addition healthy subjects taking either a 100 mg or 1 g daily dose of Maritech fucoidan demonstrated a reduction in the chronic Myers SP O Connor J Fitton JH Brooks L Rolfe M Connellan P et al. A combined phase I and II open label study on the effects of a seaweed extract nutrient complex on osteoarthritis. Biologics. 2010 4 33-44. FORMOREINFORMATION Research & Quality These days many consumers refuse to take things at face value. They research the products they purchase and often investigate the ingredients those prod8 Nutrition Industry Executive DolCas Biotech LLC Horphag Research Marinova Pty Ltd. Stratum Nutrition XSTO Solutions LLC January February 2018 Go to gcinutrients for info about this advertiser Legalities When Supplement Product Advertising Goes Too Far By Anne Cruz and Matthew Kaplan Tucker Ellis LLP W here is the line on what the Federal Trade Commission (FTC) can require of supplement companies to support their advertising claims It s a tough question with still no clear answer. However there are some new lessons learned from a recent federal court decision out of New York. Across the marketing spectrum of websites TV infomercials social media newspapers and magazines Quincy Bioscience advertised its Prevagen supplements as improving cognitive function. Quincy Bioscience advertised Prevagen as a supplement that was clinically shown to improve memory problems related to aging. Despite the use of a doubleblind and placebo controlled study two Federal Trade commissioners initiated the filing of a lawsuit with the 10 Nutrition Industry Executive New York attorney general against Quincy Bioscience related entities and officers alleging false advertising and unfair or deceptive acts and practices under the FTC Act and New York state law. After the lawsuit was filed in January 2017 Quincy Bioscience released the following statement We vehemently disagree with these allegations made by only two FTC commissioners. This case is another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours. This fall the Federal Court dismissed the government s claims. Why Quincy Bioscience based its advertising claims on a study called the Madison Memory Study. This study was designed to determine whether Prevagen improved cognitive function in older adults. It employed what is often considered the gold standard of scientific inquiry a randomized double-blind placebo-controlled study and used objective outcome measures of human cognitive function. The study s overall design was left unscathed through this lawsuit. The FTC s allegations however were based on the fact that there was no statistically significant result across the entire 218-person study population on the measured cognitive tasks. Yet certain subgroups showed statistically significant improvements over those who received placebos in cognitive tasks including measuring memory psychomotor function visual learning among others. The study also showed trends toward significance in a couple of other tasks such January February 2018 Go to kyowa for info about this advertiser Legalities as measuring verbal learning and executive function. The study s researchers concluded that Prevagen demonstrated the ability to improve aspects of cognitive function in older participants in the sub-grounds of those who had normal cognitive function or very mild impairment. Here is where the FTC tried to draw the line on how supplement companies could use subgroup results. The two FTC commissioners pushing the lawsuit reviewed Prevagen s advertising and concluded that the claims were false or misleading based on the assertions that Prevagen clinically shown to improve memory helps with memory problems associated with aging can support healthier brain function a sharper mind and clearer thinking and similar claims. The FTC asserted that there were no statistically significant results observed for the study population as a whole on any of the measured cognitive tasks and that Quincy Bioscience s reliance on results obtained for various subgroups was improper. The FTC further asserted that Quincy Bioscience conducted numerous post hoc analyses of the data broken down by variations of subgroups looking for statistically significant results and that these post hoc analyses greatly increased the risk that the positive subgroup results were merely the result of chance and not Prevagen. The FTC asserted that the Madison Memory Study s few positive findings on specific cognitive tasks for small subgroups of participants was insufficient scientific evidence to substantiate a reliable treatment effect. The Federal Court disagreed. In fact the judge concluded that the FTC and New York attorney general s challenge never proceeds beyond the theoretical. The FTC did not assert that there were in fact any false positives in the subgroup results. It challenged the use of post hoc identification of subgroups that benefitted but failed to explain the nature of any risks associated with use of post hoc analysis or demonstrate that the use of such after the fact analysis of study results affected the subgroups performance in any way or caused any false positive conclusions. The court observed that there were statistically significant results in the subgroups for certain cognitive tests and those results supported the claims in Prevagen s advertising none of which appeared to go beyond what the results in the specific subgroup tasks reflected. Since the subgroup concept is widely used in analyzing information from dietary supplement studies FTC s broad claim that it is a risky practice to Go to somalabs for info about this advertiser use subgroup analysis without any specific basis for demonstrating its use was improper in the Madison Memory Study was insufficient as a matter of law to conclude the advertising was false or misleading. Thus the court dismissed the claims. However the FTC and State of New York have both appealed this decision. For now FTC should draw a lesson from this decision about how far it may rely on its own interpretation and analysis of data after the fact. Mere theoretical or speculative risks about possible issues with subgroup data are not enough to overshadow researchers proper conclusions of measured test results. The subgroup concept remains a reasonable and reliable method of analyzing data obtained in properly designed supplement studies. Assuming statistically significant results in specific areas are obtained a supplement company should be able to use that information as substantiation for well-tailored product claims. Indeed it is critical that advertisers ensure that their claims reflect the support available from any study or other information relied on. Ad copy must distinguish between results shown across an entire study population versus any results applicable to only a subgroup. So when a supplement company advertises its product s great traits it should be particularly mindful of not making statements suggesting that the entire clinical study group showed improved results if those results arise only in certain subgroups. Supplement companies must continue to pay close attention to this difference as the FTC will continue to vigorously pursue cases where proper substantiation is lacking. NIE Anne Swoboda Cruz is a partner in the Mass Tort & Product Liability Group at Tucker Ellis LLP. She can be reached at (213) 430-3314 or anne.cruz Matthew I. Kaplan is a partner in the Food Cosmetics and Nutritional Supplements Group at Tucker Ellis LLP. He can be reached at (213) 430-3309 or matthew.kaplan 12 Nutrition Industry Executive January February 2018 Go to futureceuticals for info about this advertiser IndustryNews Senator Hatch Announces Retirement n January 2 the longest-serving Senate Republican Senator Orrin Hatch of Utah announced that he would not seek re-election for an eighth term. Sen. Hatch who formed and led the Dietary Supplement Caucus in the Senate co-authored the landmark legislation that established a rational framework for regulating dietary supplements the Dietary Supplement Health and Education Act of 1994 (DSHEA). He also played a critical role in passing the Nonprescription Drug & Dietary Supplement Consumer Protection Act of 2006 enacting the Food Safety Modernization Act in 2011 and shepherding the passage of the Designer Anabolic Steroid Control Act of 2014--all of which strengthened consumer confidence in dietary supplements. He used his considerable influence to prod U.S. Food and Drug Administration (FDA) to issue final Current Good Manufacturing Practices regulations O in 2007 and to elevate FDA s Division of Dietary Supplement Programs to Office status in 2016 both of which strengthened FDA s oversight of dietary supplements that nearly 76 percent of Americans turn to for better health and wellness. Of all of Senator Orrin Hatch s achievements his commitment to the dietary supplement consumer will be celebrated most by this industry said Steve Mister president and CEO of the Council for Responsible Nutrition (CRN). Senator Hatch has been a champion of dietary supplements to be sure but his insistence on a common sense approach to legislation and regulation has always managed to strike the important balance between safety and access in pursuit of promoting public health. We ve had the opportunity and privilege to work very closely with Sen. Hatch for more than 40 years. His tenure in the Senate has been one of the most productive in history the significant legislation he has authored or co-authored is remarkable and has touched the lives of Hatch every American added Loren Israelsen president of the United Natural Products Alliance (UNPA). With DSHEA Sen. Hatch worked tirelessly to ensure Americans rights to make their own health care choices through the wide availability of regulated dietary supplements Israelsen continued. Consumers of these products all owe him a debt of gratitude and generations of Americans have benefited from his deep support and commitment to help people find their own pathway to health. DuPont Scientist Philippe Horvath Receives Franklin Institute Science Prize he Specialty Products Division of DowDuPont has announced that Senior Scientist Philippe Horvath has been awarded the Franklin Institute s prestigious 2018 Bower Award and Prize for Achievement in Science. Horvath will be honored for groundbreaking research on CRISPRCas during a ceremony in April 2018 in Philadelphia PA. Horvath s initial article published in Science in 2007 provided the first biological evidence that CRISPR-Cas constitutes an immunity system against viruses in bacteria. Beginning in the early 2000s Horvath and colleagues initially utilized CRISPR for bacterial identiPhilippe fication then for its ability to improve the resistance of starter culture strains against bacteriophage T attack. The discoveries opened new research avenues and laid the groundwork that inspired numerous scientists to pursue the CRISPR field. Based at the DuPont Nutrition & Health site in Dang -Saint-Romain France Horvath already has been honored with three of the world s leading science awards the 2015 Massry Prize the 2016 Warren Alpert Foundation Prize and the 2016 Canada Gairdner International Award. DuPont congratulates Philippe on this wonderful recognition. We are proud of the achievements made by Philippe and the entire CRISPR team at DuPont. It is a great testament to our Horvath company s heritage in scientific innovation and the incredible work that has been done to advance new ideas and solve some of the world s biggest challenges said Alexa Dembek chief technology and sustainability officer for the Specialty Products Division of DowDuPont. The early discoveries made by Philippe and team opened new areas of research and opportunities to use CRISPR-Cas in a range of scientific fields. I am deeply honored to be selected by the Franklin Institute for the pioneering work our team has done said Horvath. Our findings which were focused on the natural CRISPRCas system will continue to have a significant impact in the fight against viral infections during food fermentations and are finding new applications in tools for genome editing including opportunities in plant improvement and gene therapy. For more information visit 14 Nutrition Industry Executive January February 2018 Industry Responds to FDA Proposed Enforcements of Homeopathy n December 18 2017 the U.S. Food and Drug Administration (FDA) proposed a new risk-based enforcement approach to drug products labeled as homeopathic. According to the FDA to protect consumers who choose to use homeopathic products this proposed new approach would update the FDA s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices the agency stated. In recent years we ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions from the common cold to cancer. In many cases people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments or worse--that may cause significant and even irreparable harm because the products are poorly manufactured or contain active ingredients that aren t adequately tested or disclosed to patients said FDA Commissioner Scott Gottlieb MD Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm. The FDA s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Under this approach the agency said many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. The FDA intends to focus its enforcement authorities on the following kinds of products Products with reported safety concerns Products that contain or claim to contain ingredients associated with potentially significant safety concerns O Products for routes of administration other than oral and topical Products intended to be used for the prevention or treatment of serious and or life-threatening diseases and conditions Products for vulnerable populations and Products that do not meet standards of quality strength or purity as required under the law. In response to the FDA s proposal the American Association of Homeopathic Pharmacists (AAHP) Natural Product Association (NPA) Christian DeRivel and Nobel Prize winning physicist Brian D. Josephson released the following statements The American Association of Homeopathic Pharmacists shares the FDA s commitment to protecting public health and applauds the Agency s plan to take quick action against illegal or unsafe homeopathic medicines AAHP wrote. In fact the association encouraged FDA to do just that in its comments at the regulatory body s April 2015 workshop on the topic. The AAHP is confident that the current Compliance Policy Guide provides FDA with ample opportunity to take such action right now. AAHP also notes that the draft guidance would not materially affect the vast majority of homeopathic drug products available in the United States given these products wide margin of safety and manufacturing according to current good manufacturing practices (cGMPs). The association further underscores that the current Compliance Policy Guide 400.400 remains in effect. AAHP looks forward to providing extensive comments to FDA on the new draft guidance during the open comment period. As always AAHP is committed to ensuring that consumers have access to natural safe homeopathic medicines in the United States and throughout the world. Risk based is generally good because it keeps focus on fly-by-nights and scam artists selling junk masquerad- ing as natural products and those criminals should be caught and penalized to the full extent of the law said NPA President and CEO Daniel Fabricant PhD in a statement. So that is a win for consumers and safety and taxpayers. Still homeopathic products have been used safely since the 1700s and we re sure the agency will factor that into any regulatory decisions and balance the risk to benefit with legitimate industry for the millions of Americans looking to those responsible companies for safe alternatives in the marketplace. Some manufacturers took issue with FDA s proposition specifically its comment Until relatively recently homeopathy was a small market ... Over the last decade the homeopathic drug market has grown exponentially resulting in a nearly 3 billion industry ... said Christian DeRivel of California-based Green Pharmaceuticals. The consumers that the FDA wants to protect have already proven with their pocket books the safety and efficacy of these medications. Yes success might produce a few bad apples so the FDA should focus its attention on enforcing already existing policies (serious disease claims adulterated ingredients and GMPs in place for the few dozen U.S. labs manufacturing homeopathic medicine) not updating them or scaring the public with risk-based enforcement priorities to protect the public from potentially harmful unproven homeopathic drugs. We object to the broad accusatory description that lumps together the good (almost 100 replicated experiments over 1 000 published clinical trials and over 10 000 experiments demonstrating hormesis) with a few bad. Josephson emeritus professor of physics at the University of Cambridge added My own experience as an experienced physicist is that it is the people who are against homeopathy who do it on the basis of religious belief more than a scientific one. As I sometimes put it the idea that water can have a memory can be readily refuted by any one of a number of easily understood invalid arguments. Note the following nugget if as commonly (but incorrectly) asserted homeopathic dilutions are such that the alleged remedies can have no effect then a fortiori they can have no harmful effects. For more information visit or Nutrition Industry Executive 15 January February 2018 IndustryNews NOW Celebrates 50 Years n 2018 NOW (Bloomingdale IL)-- the largest independent and familyowned manufacturer of natural products in the U.S. health food store channel--celebrates 50 years as a manufacturer dedicated to its mission of providing products and services that empower people to lead healthier lives. A whole year of anniversary events and programs are planned. NOW will have an array of giveaways special events to thank retailers and will provide special retailer in-store support materials. The company will increase their already substantial philanthropic donations by 50 percent. NOW is creating a variety of themed assets including monthly videos website content and social media posts highlighting key components of their ongoing commitment to such issues as sustainability value advocating for consumer health freedom supporting health quality and philanthropy. Topping all this off will be an exciting consumer instant-win game designed to drive traffic and excitement in retail stores. Details of the program will be announced in January. We feel such gratitude to all the individuals through the decades that have been part of the NOW story from employees to retailers to consumers I who have made NOW a key part of their healthy lifestyles said NOW CEO Jim Emme. The Richard family s continued commitment to the NOW mission and staunch support of the natural channel retailer positions the company for another equally gratifying 50 years. NOW was founded in 1968 by Elwood Richard with the goal of making healthy and quality products accessible and affordable for everyone. Started as a small local operation in the Western suburbs of Chicago IL today NOW is a trusted natural products manufacturer with distribution in more than 60 countries offering more than 1 400 high-quality and affordable products from functional foods and supplements to sports nutrition and health and beauty products and essential oils. NOW s industry-leading quality control and assurance programs which includes conducting more than 16 000 tests each month on raw materials and finished products in their state-of-theart lab complex ensures that what s on the label is in the bottle or package. NOW is still privately owned by the Richard family. According to Dan Richard Elwood s son and vice president of global sales and marketing family is truly the litmus test for the company s vast product portfolio. We only make products we feel good about giving to our own families so we know the products we bring to market meet our high standards. What s more remaining a familyowned independent company is also vital to the company s growth strategy for the next 50 years and even beyond. We are a for-profit company but maintaining our independence enables us to make decisions that are not just profit oriented which could include taking a hit on sales because the product will not be available or even taking a lower margin on sales to make our products more affordable added Richard. Health and wellness shouldn t have a high price tag and we re doing what we do because we re passionate about making good or better health a goal anyone can achieve. For more information visit Plasma Nutrition Expands Research Partnership with USF lorida-based Plasma Nutrition has announced that it has expanded its research partnership with the University of South Florida (USF) and the Florida High Tech Corridor to further investigate the impact of Ingredient Optimization technology on bioavailability with the launch of four more clinical trials. This study will also mark the first clinical trial of Ingredient Optimization technology on a non-protein application. The partnership for continued research builds upon a successful study authored by lead researcher Dr. Bill Campbell and his team at the USF s Performance and Physique Enhancement Laboratory which was presented last June at the Annual Conference of the International Society of Sports Nutrition. The Performance and Physique Enhancement Laboratory research team are excited to be partnering F with Plasma Nutrition to continue to study their uniquely processed protein said Campbell. We will be looking at the bioavailability of the plasma processed protein and it will be a great complement to our first investigation. The upcoming studies will focus on the enhanced bioavailability of Ingredient Optimized nutritional products across multiple applications. In addition to expanding its research on whey protein Plasma Nutrition will also be comparing the bioavailability of ioProtein to a high DH hydrolyzed protein adapting the process to improve plant protein bioavailability and demonstrating the first non-protein application of this patent-pending technology. With these studies we are excited to solidify the ability of our technology to create the highest bioavailability whey protein as well as demonstrate the technology s flexibility not just on plant proteins but other food ingredients as well said Plasma Nutrition s co-founder Steve Motosko. From an environmental and consumers perspective a scalable technology that allows the formulation of supplements with less protein higher bioavailability and fewer calories can make protein production more sustainable and help create truly differentiated products for sports nutrition weight management and clinical nutrition. The commitment of Dr. Campbell s team and the FHTC to rigorous research with great commercial significance aligns closely with our company s mission of creating real consumer value through advanced science and technology said Plasma Nutrition s Co-founder Chris Flynn Rozanski. For more information visit 16 Nutrition Industry Executive January February 2018 FDA Raids Enhanced Athlete Facilities Seizes SARM Products n December 6 2017 the U.S. Food & Drug Administration (FDA) and a few other government organizations executed a search warrant at several facilities of a company associated with Charles Anthony Hughes called Enhanced Athlete (EA) in Sacramento CA. The FDA confiscated raw materials unfinished and finished products such as Ostarine and 2 4-Dinitrophenol (DNP) which contain SARMs (selective androgen receptor modulators). Hughes promotes the sales of EA products via his YouTube personality Dr. Tony Huge. In an email sent to customers EA CEO Scott Cavell said that the company s attorneys are encouraging EA to reconsider its decision to continue business as usual. We feel that freedom of information and choice as long as provided within the context of the law is imperative. This means that we intend to carry on doing what we have always done until told to do otherwise by the proper authorities Cavell wrote. We believe this to be the first time that the FDA s Criminal Investigation Unit has executed a search warrant related to O SARMs Cavell said in the letter. Tony has always believed that SARMs are nearly as powerful as steroids in the correct dosages. This will come to the realization of the FDA and other government authorities eventually if it hasn t already. This means that the window of opportunity is closing on SARMS. SARMs have been on the FDA and the natural product industry s radar for some time. On October 31 Donald D. Ashley JD director of the Office of Compliance in the FDA s Center for Drug Evaluation and Research issued a consumer warning about the use of SARMS. We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients he said. Bodybuilding products that contain selective androgen receptor modulators or SARMs have not been approved by the FDA and are associated with serious safety concerns including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage. We will continue to take action against companies marketing these products to protect the public health. And in early November the American Herbal Products Association (AHPA) the Consumer Healthcare Products Association (CHPA) the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA) the United Natural Products Alliance (UNPA) and the U.S. Anti-Doping Agency (USADA) joined in support of FDA s recent actions to protect consumers from bodybuilding products containing SARMs. We are committed to educate consumers to help protect them from these intolerable fly-by-night companies who are engaging in criminal activity by bringing SARMs to the online marketplace said Duffy MacKay ND CRN s senior vice president scientific & regulatory affairs in a statement. Further we will continue to remind the dietary supplement industry that SARMs should not be used in their products. We have aligned with the U.S. Anti-Doping Agency and other dietary supplement trade associations in support of strict enforcement by FDA to rid the market of SARMs. Go to mackflavor for info about this advertiser January February 2018 Nutrition Industry Executive 17 IndustryNews Cranberry Adulteration Bulletin Released by Botanical Adulterants Program he ABC-AHP-NCNPR Botanical Adulterants Program announced the publication of a new Botanical Adulterants Bulletin (BAB) on cranberry (Vaccinium macrocarpon Ericaceae). Cranberry dietary supplements are widely used for the prevention and adjuvant treatment of recurrent urinary tract infections. Cranberry was the second top-selling botanical dietary supplement ingredient in U.S. mainstream retail outlets in 2016 with an 11.9 percent increase in sales compared to the previous year. There are important differences in the composition of the various cranberry supplements on the market. This is particularly true with regard to the content of proanthocyanidins (PACs) which are the cranberry compounds responsible for preventing bacterial adhesion in the urinary tract. The dried press cake which is the solid material obtained after the fruit juice has been squeezed out contains ca. 0.8 to 1.5 percent PACs. The dried press cake makes up more than 50 percent of the cranberry dietary ingredient supply (i.e. the material sold in bulk for processing into finished cranberry supplements). Other important cranberry ingredients are whole cranberry fruit extracts and blends of cranberry juice extracts with cranberry fruit extracts with 3 to 5 percent PACs as well as pure cranberry juice extracts containing 12 to 24 percent PACs. Ingredients with higher concentrations of PACs are much more expensive. The availability of lower-cost PACs from other plant sources such as peanut (Arachis hypogaea Fabaceae) skin or grape (Vitis vinifera Vitaceae) seed has led some unscrupulous suppliers to dilute or replace cranberry PACs--without labeling such dilution or replacement--for financial gain. Other adulterants include anthocyanin-rich extracts from other lower-cost ingredients such as mulberry (Morus spp. Moraceae) fruit hibiscus (Hibiscus sabdariffa Malvaceae) calyx black bean (Phaseolus vulgaris Fabaceae) skin or black rice (Oryza sativa Poaceae). Anthocyanins have a color ranging from red to blue and anthocyanin-rich extracts are used to mimic the red color found in authentic cranberry extracts. The new bulletin written by ethnob- T otanist and herb industry consultant Thomas Brendler and American Botanical Council (ABC) Chief Science Officer and Botanical Adulterants Program Technical Director Stefan Gafner PhD provides information on the growing range production and market importance of cranberry and its extracts. It also lists the known adulterants potential therapeutic and or safety concerns associated with the adulterated ingredients and laboratory analytical approaches to detect adulterants. Twenty-one expert peer reviewers from academia and industry provided input on the cranberry bulletin. In response to the bulletin Stephen Lukawski director of global sales and product development for Canada-based Fruit d Or Nutraceuticals made the following statement Adulteration has been a concern and now is becoming a serious problem for the credibility and respect of the nutraceuticals industry. Fruit d Or is working hard to combat this epidemic problem not only for the health and safety of consumers but also to make it possible to grow the cranberry industry beyond UTIs. Standardization purity and DNA fingerprinting are essential if we are to conduct credible science linking health outcomes to cranberry biomarkers. The ABC s choice to create the new Botanical Adulterants Bulletin on cranberry validates what Fruit d Or is striving to do by establishing our Cranberry Quality Assurance (CQA) program using state-of-the-art equipment and testing methods is a step in the right direction to debunk the junk. By creating this blueprint to defend against adulteration we re making it more difficult for those who insist on cheating. If you as a manufacturer are quoted a surprisingly low price that s incentive to do your own testing to confirm what you ve purchased is actually cranberry and not an inferior adulterated product. Better yet If the price or promises are too good to be true walk away. Consumers should also do their due diligence. Fruit d Or is conducting a consumer education program teaching the public to read the labels. We re encouraging people to open their cranberry supplement capsules. If the powder is not deep red or if it doesn t taste like a tart cranberry we re advising them to return it. The ABC Bulletin reinforces what we know to be true Not all cranberry is the same. This serious adulteration problem won t go away unless all cranberry and botanical industry stakeholders work together to empower consumers to identify quality cranberry ingredients. At Fruit d Or we encourage growing the cranberry industry and taking it beyond UTI. For more information visit http BAP index. html. BASF Declares Force Majeure for Vitamins A and E and Several Carotenoids n October 31 a fire occurred during the startup of the Citral plant in Ludwigshafen Germany. Consequently BASF had to shut down the plant and had to declare Force Majeure for its Citral and Isoprenol based aroma ingredients. BASF s vitamin A and E plants are currently also shut down for scheduled routine maintenance. The company will only be able to restart these plants once supply of Citral is re-established and the corresponding intermediates for vitamin A and E become available. As the cleaning process follow-up inspection repair and restart of the Citral plant will take several weeks BASF is forced to extend the Force Majeure to vitamin A and E and in consequence to several carotenoid products. The impact of the Force Majeure situation as well as the effects for customers resulting therefrom are being evaluated at the moment. Meanwhile BASF is implementing measures to limit the consequences of the situation. BASF will continuously inform its customers about the development and the details regarding the supply capability of the affected products. For more information visit O 18 Nutrition Industry Executive January February 2018 Nestl Acquires Garden of Life n December 5 Nestl (Switzerland) announced that it agreed to acquire privately held Atrium Innovations a global leader in nutritional health products from a group of investors led by Permira Funds for 2.3 billion in cash. Atrium s 2017 sales are expected to reach almost 700 million. The move supports Nestl s pursuit of growth opportunities in consumer health care to complement the company s focus on its high-growth food and beverage categories. The transaction is expected to close in the first quarter of 2018 following the completion of customary approvals and closing conditions. Upon closing Atrium with its corporate offices in Quebec Canada will become part of Nestl Health Science. Its existing management team will continue to manage the business led by Peter Luther Atrium Innovations president and CEO. We value Atrium s history as a highly successful company and welcome its 1 400 employees to the Nestl family said Greg Behar Nestl Health Science CEO. Their brands are a natural complement to our Consumer Care portfolio which offers nutritional solutions in the areas of healthy aging healthy growing gut health and obesity care. Atrium s portfolio will extend our product range with value-added solutions such as probiotics plant-based protein O nutrition meal replacements and an extensive multivitamin line enabling consumers to address their health and wellness goals. Atrium s established brands are in attractive categories and have the potential for continued strong growth as part of Nestl through category channel and geographic expansion Behar added. It also represents additional offerings in the segment for non-GMO (genetically modified organism) organic and natural supplements a fast-growing consumer trend as well as a new sales channel. Atrium s largest brand Garden of Life is headquartered in Palm Beach Gardens FL manufactures certified organic non-GMO supplements that are sold in more than 14 000 health food stores and online in the U.S. as well as select markets internationally. Pure Encapsulations is a full line of hypoallergenic research-based dietary supplements and is the No. 1 recommended brand in the U.S. practitioner market. Headquartered in Sudbury MA the Pure Encapsulations product line is free from common food allergens GMOs fillers binders and artificial colors and is sold in the U.S. via health care practitioners online as well as in pharmacies in several markets in Europe. Since Atrium was established in 1999 we have been dedicated to providing premium-quality science-based professionally recognized products to consumers and health care practitioners said Luther. We are very pleased to be joining Nestl Health Science as we share a common purpose of helping people lead healthier lives by providing good-for-you products made with the highest standards for quality and efficacy. Nestl will provide Atrium with the resources to accelerate the growth of our brands and reach more people globally. The remainder of the Atrium portfolio includes strong specialty brands like Wobenzym Douglas Laboratories Genestra Brands Orthica AOV Minami Klean Athlete Pharmax and Trophic. For more information visit New Publication Calls for Dietary Reference Intake for Lutein utein is ready to be considered for intake recommendations asserted the authors of a new paper published online in the European Journal of Nutrition. Lutein a carotenoid found in egg yolks colorful fruits and vegetables and dietary supplements has gained attention from the nutrition research community for its potential role in reducing the risk of age-related macular degeneration (AMD) and other eye issues and the paper s authors noted that establishing a recommended dietary reference intake (DRI) value for the bioactive is critically important for advancing and improving public health. AMD is the leading cause of agerelated blindness in industrialized countries said Jim Griffiths PhD vice president of scientific and international affairs for the Council for Responsible L Nutrition International (CRN-I) and one of the paper s six coauthors. Establishing intake guidelines for lutein could encourage the consumption of lutein-containing foods and subsequently decrease the risk of age-related visual degradation and improve overall visual health. We hope policymakers and stakeholders take note of the strong research supporting the benefits of lutein and move forward with setting a DRI. In the paper the authors cited a previously developed set of nine criteria used to determine whether a bioactive is ready to be considered for DRI-like recommendations and illustrate the ways in which lutein satisfies each. These criteria include 1) an accepted definition 2) a reliable analysis method 3) a food database with known amounts of the bioactive 4) cohort studies 5) clinical trials on metabolic processes 6) clinical trials for dose-response and efficacy 7) safety data 8) systematic reviews and or meta-analyses and 9) a plausible biological rationale. Based on the careful review of the literature supporting the criteria the authors concluded that lutein should join the roster of those nutrients that already have DRI recommendations. Establishing a DRI recommendation for lutein would provide the public with yet another reason to eat more of the colorful fruits and vegetables lacking in our diets wrote the co-authors. Many consumers purchase products containing lutein [...] but they may not be aware of the science that supports its role in health or know the appropriate intake level. For more information visit Nutrition Industry Executive 19 January February 2018 IndustryNews U.N.-affiliated Initiative Gets an Assist from Rivkin Radler n December 12 the Island Women Open Network (IWON) created by the Sustainable Energy and Climate Resilience Initiative in partnership with the United Nations Industrial Development Organization (UNIDO) signed an agreement engaging New York and New Jersey-based Rivkin Radler LLP for legal assistance. IWON s main objective is to empower women and children at the grassroots level to transform the sustainableenergy sector of Small Island Developing States (SIDS DOCK) in the Pacific Caribbean Africa and Indian Ocean. A key element of this initiative O focuses on member-states biodiversity and economic development through sustainable natural resources. Rivkin Radler s team--composed of Marc S. Ullman Steven Shapiro Shari Claire Lewis and Nancy Del Pizzo--initially will focus on IWON s Biodiversity Initiative particularly with developing a regulatory framework that will allow member states to sell herbal products dietary supplements and cosmetics into the U.S. market while maintaining compliance with the guidelines set forth by the U.S. Food and Drug Administration and the U.S. Federal Trade Commission. Legal work will also focus on organizing and protecting IWON s intellectual property and cyber security. SIDS DOCK was launched in 2010 to bring about the transformation of the SIDS energy sector which is considered by islands as the most effective and sustainable manner to build resilience to climate change. According to SIDS DOCK the IWON initiative is particularly important as it pertains to the protection conservation and sustainable use of biodiversity resources. For more information visit WHO Rules on CBD fter more than a month of deliberation World Health Organization officials announced their recommendation that CBD should not be considered a drug. On November 6 the World Health Organization announced its recommendation that cannabidiol (CBD) should not be subject to international drug scheduling. After reviewing evidence related to the benefits and risks of CBD the WHO s Expert Committee on Drug Dependence (ECDD) concluded that Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol [THC] for instance). The ECDD therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018 when the committee will undertake a comprehensive review of cannabis and cannabis related substances. For more information visit en . A Frutarom to Acquire Full Ownership of Enzymotec rutarom (Israel) will acquire full ownership of Enzymotec Israel at a net investment of approximately 210 million (U.S.). As of the date of signing Frutarom held approximately 19 percent of Enzymotec s shares at an average price of 9.6 (U.S.) per share. Frutraom will acquire the balance of shares at 11.9 (U.S.) per share. The transaction will be done via full merger of Enzymotec into a subsidiary of Frutarom. Total Enzymotec sales in the 12-month period ended June 2017 at 47 million (U.S.). Enzymotec s nutrition segment sales in the 12-month period ended June 2017 totaled 36.5 million (U.S.) with adjusted EBITDA of 15.7 million (U.S.). In H1 2017 sales of Enzymotec s nutrition segment reached 19.2 million (U.S.) with adjusted EBITDA1 of 9.3 million (U.S.). For more information visit F Ashland Combines Nutrition Business with Pharmachem shland (Wilmington DE) is taking aim at the fast-growing global nutraceuticals market by combining its nutrition business with the ingredients processing expertise of recently acquired Pharmachem. The combined unit which will be called Health and Wellness will continue to report up through Ashland s Specialty Ingredients segment. Our plan is to fulfill the growing needs of a thriving and ever-changing global marketplace for nutraceutical products including dietary supplements food and beverages said David Neuberger group vice president pharmaceutical nutrition and agriculture. We intend to harness the synergy created between Ashland and Pharmachem to help us fully cap- A italize on emerging trends in the nutraceutical marketplace and foodbased supplements. We are combining the expertise and knowledge of two great companies and expanding our functional food platform on a global basis. It will enable us to utilize Ashland s comprehensive food science capabilities along with Pharmachem s advanced ingredient process services expertise to develop innovative new products for the nutra-food and beverage industry he continued. Ashland s technical knowledge of food science will add a valuable new dimension to our ingredient processing capabilities and enable the new division to respond quickly and seamlessly to the needs of brand marketers added Colin MacIntyre Pharmachem executive vice president and general manager. Ashland has helped customers address global trends in food and beverage development--from stabilizing sugar reduced beverages to adapting foods for gluten-free diets. For more information visit or 20 Nutrition Industry Executive January February 2018 DuPont Comments On Plant-based Nutrients and Cardiometabolic Health lobally as well as in the United States poor diet is recognized as a leading risk for illness disability and death. Diets that reduce the burden of chronic disease are becoming a greater focus of research and public health policies. DuPont Nutrition & Health (St. Louis MO) contributed its voice to a recent journal article published in the American Society for Nutrition s Current Developments in Nutrition. The article appears in the November 2017 edition of the publication and presents the latest evidence supporting the role of plant-based sources as part of a healthy dietary pattern for cardiometabolic health. Senior author of the article Penny Kris-Etherton PhD and past member of the Dietary Guidelines Advisory Committee said Today dietary guidance policies are moving away from nutrient-based recommendations and toward dietary pattern-based recommendations. In many countries including the U.S. recommendations have shifted more toward dietary patterns emphasizing plant-based foods such as fruits vegetables legumes whole grains nuts seeds soy products and vegetable oils based on the strong evidence for support of cardiometabolic health that surrounds these sources. A diet that shifts to include more plant sources for support of health can still include moderate amounts of dairy and other animal sources of protein said Ratna Mukherjea technical senior manager DuPont Nutrition & G Health. In fact many countries are recognizing the importance of a variety of high-quality protein sources including seafood lean meats poultry eggs legumes nuts seeds and soy products in dietary guidance policies. Substantial excitement exists in the food industry to deliver foods that support health while meeting consumer expectations for taste. This paper reviews the available evidence that demonstrates improving intake patterns to align with dietary guidelines should be the focus of our efforts collectively. Evidence suggests that higher intake of plant-based foods is associated with lower risk of cardiometabolic disease whereas a higher meat intake increases risk of cardiometabolic disease and replacement of small quantities of animal protein with plant protein is associated with lower risk. Consumers appear to be taking note of dietary recommendations emphasizing plant-based foods. In its PlantBased Eating Trends study published earlier this year Health Focus International reported that 54 percent of consumers surveyed globally indicated they were reducing their consumption of animal-based foods and increasing consumption of plant-based foods. Consumers perception that plant-based foods are healthier than animal-based foods was identified in the study as a key driver of this shift. The evidence presented in this paper reminds us that rather than engaging in debates about whether diets should be exclusively plantbased or include animal the focus should be consumption of foods in recommended amounts to support cardiometabolic disease prevention said Michael Flock PhD Clinical & Translational Sciences Institute University of Pittsburgh. Many foods available in the marketplace are composed of not just a single source of protein of plant or animal origin but rather a blend of proteins. Blending different sources can enable the creation of foods that are advantageous from an amino acid composition or digestibility point-ofview. And food scientists have learned and appreciate that formulating a product with a blend of proteins can lead to a better taste profile. The review was conducted by researchers who are past members of the Dietary Guidelines Advisory Committee their colleagues and scientists with DuPont Nutrition & Health. For more information visit or Ingredion for Emerging Business to Help Start-up Food & Beverage Manufacturers llinois-based Ingredion Incorporated has introduced Ingredion for Emerging Business a new U.S. initiative designed to help emerging food and beverage companies grow efficiently with customer-centric innovative ingredient solutions product development expertise market insights and a new e-commerce platform. Entrepreneurs now can turn their ideas into on-trend scalable foods and beverages more quickly and efficiently with help from a new uniquely qualified Ingredion for Emerging Business team. I We understand that entrepreneurs wear many hats and want to draw on partner resources and capabilities to find the right ingredients solve product and formulation challenges and get to market faster said Evan Hyman director of Emerging Business at Ingredion. Ingredion has the expertise to address many challenges start-ups face and can provide customer and market insights to help emerging businesses develop and bring trend-setting products to market. The new Emerging Business e-com- merce platform accessible at provides food and beverage entrepreneurs across a wide range of applications with a selected portfolio of Ingredion s clean label non-GMO (genetically modified organism) and conventional ingredient solutions including starches fibers pulse proteins and sweeteners. After listening to the needs of emerging businesses we built a small quantity order fulfillment solution to make it easy to purchase ingredients with a credit card said Hyman. Nutrition Industry Executive 21 January February 2018 IndustryNews Kappa Bioscience Expands K2VITAL Presence in the U.S. appa Bioscience AS maker of K2VITAL vitamin K2 MK-7 has announced the appointment of Garnet Pigden and New Jersey-based D2C to head-up the continued development of Kappa s position in the U.S. market. The appointment spans the establishment of strategy infrastructure partnerships and key accounts in support of an overall objective of solidifying vitamin K2 in mainstream U.S. markets and channels. This expansion of Oslo Norwaybased Kappa represents an advancement in the evolution of vitamin K2 from a niche segment to a staple ingredient alongside its peers in the essential vitamins and minerals categories. Garnet and D2C s role will build upon Kappa R&D innovations such as synthesis microencapsulation for stability and pro-vitamin forms to further commercialize K2VITAL in the U.S. using comparisons to vitamin D3 as both a model and benchmark for success. Garnet brings experience from the ingredients and functional foods industries among others including leading multiple supplement companies a K global senior vice president position with DSM Nutritional Products and launching his own brand of supplementenhanced skincare products. The appointment includes the responsibility for the evaluation and U.S. strategy development for K2VITAL and establishment and management of infrastructure inclusive of distributor relationships. Garnet will also secure the U.S. key accounts and partnerships required to fulfill the objective of moving K2 into mainstream product and consumer categories and wide-distribution retail channels. We were delighted to secure a relationship with Garnet and D2C as part of our campaign to expand the footprint of K2VITAL globally said Egil Greve CEO of Kappa Bioscience. The U.S. may represent as much as 50 percent of the growth opportunity for vitamin K2 and top-tier U.S. companies provide the best possibilities for leveraging the innovations from Kappa s extensive science and R&D programs. Through Garnet and D2C we hope to establish the path that will put K2 in every U.S. household in product formats that serve all consumer types--much like D3 today. It s rare to identify a ground-floor opportunity like K2 added Pigden. It s one of only a handful of essential vitamins provides significant bone and heart health benefits and large segments of the U.S. population are likely deficient. While all the important commercial innovations to drive mass-adoption are in place there are still significant opportunities for early-movers to differentiate and secure market-leading positions. Kappa is best-positioned to lead K2 to the next stage and I look forward to a collaboration that will see K2 reach its potential. For more information visit Genysis Labs Sensapure Flavors Announce Spin Offs tah-based Genysis Labs an ISO IEC 17025 2005 accredited contract laboratory providing specialized chemistry and microbiology testing services to the nutraceutical food and beverage industries since 2008 and Sensapure Flavors formerly a division of The Genysis Group announced that they have been spun off from Genysis Group in conjunction with the sale of Genysis Brand Solutions to Nellson Nutraceuticals LLC. Simultaneously Genysis Labs will change its name to Dyad Labs. Dyad Labs will continue to provide testing services to Genysis Brand Solutions as part of the transaction agreement between Genysis Group and Nellson. Additionally within the next few months Dyad Labs will relocate to a nearby facility to accommodate the needs of the growing lab. In 2008 Genysis Labs began as an in-house testing laboratory for Genysis Brand Solutions a large contract manufacturer of nutritional supplements. As Genysis Brand Solutions expanded over the years the lab also grew in size and scope to offer a full range of U chemical and microbiological testing services using state of the art equipment. This increase in capabilities and expertise resulted in the acquisition of additional third-party national and international clients and positioned Dyad Labs to be successful as a standalone laboratory. As part of the agreement with Nellson Sensapure Flavors will continue to provide powdered flavorings to Genysis Brand Solutions. Additionally within the next few months Sensapure Flavors will relocate to a nearby facility to accommodate the needs of the growing business. In preparing to operate as an independent company and to support the anticipated growth of the business Sensapure has hired certified flavor chemists (a first for a Utah-based nutrition company) as well as a team of industry veterans in the nutrition space. The process of creating natural and artificial flavors involves literally thousands of extracts chemicals and oils and then getting those ingredients into a powder form where they can by combined with active ingredi- ents such as protein amino acids and others requires a process called spray drying. The new Sensapure facility located in the Pioneer Square Business Park at the intersection of I-215 and 2100 South in Salt Lake City will have more than 30 000 square feet dedicated to flavor labs flavor manufacturing and offices for the Sensapure team based in Salt Lake City. The flavor labs will consist of a flavor creation lab an applications lab and a sensory lab. The Utah campus will also house Dyad Labs which will have more than 20 000 square feet of laboratory space to allow for the addition of new testing services equipment and staff. An open house of the new facility is scheduled for spring of 2018. In addition to the Utah headquarters Sensapure has secured a location in Southern California for a flavor technology office with the same suite of flavor laboratories. This R&D lab will open in the spring of 2018. For more information visit or 22 Nutrition Industry Executive January February 2018 Mount Franklin Nutritionals Opens New Manufacturing Facility ount Franklin Nutritionals leading provider of gummy nutritional supplements organic gummies and fruit snacks has recently invested more than 10 million in its nutraceutical capabilities with the opening of a new 100 000-square-foot state-ofthe-art nutritionals manufacturing facility in Sumter SC. The facility which can produce 11 million gummies per day was built to deliver top-quality nutritionals for private label and co-manufacturing customers in the U.S. and internationally. Leveraging the expertise of parent company Mount Franklin Foods an award-winning candy and nut manufacturer and distributor Mount Franklin Nutritionals combines the best in gummy manufacturing with a top-quality nutraceutical facility and deeply committed experienced staff the company stated. Our goal is to deliver innovative products that anticipate consumer demand said Gary Ricco president and CEO of Mount Franklin Foods. We help our customers provide nutritionals that will be popular tomorrow versus what was possible yesterday. That innovation combined with our commitment to quality is what sets Mount Franklin Nutritionals apart and ensures our customers maintain a strong competitive edge. Mount Franklin Nutritionals new facility was specifically designed to manufacture nutritionals with a high attention to detail utilizing cutting-edge technology to ensure stringent regulations are met. The facility is SQF Level 3 Certified cGMP (current good manufacturing practice) and CFR111 compliant organic certified and kosher. In addition Mount Franklin Nutritionals is certified through NSF s Certified for Sport Program which includes product testing for 265-plus banned substances label content confirmation formulation and label review production facility and supplier inspections as well as ongoing monitoring in line with substance prohibitive lists allowing athletes coaches dietitians and trainers to make more informed decisions when choosing sports supplements. This is an exciting time for Mount Franklin Foods as we expand our nutritionals business and we re doing it the right way with the right products and the right ingredients Ricco said. We re also tapping the right people having brought in seasoned veterans from the nutraceutical and pharmaceutical industries across our organization--from R&D and quality control to sales and customer service and beyond. For more information visit Lakeview Equity Invests in NutriScience Innovations akeview Equity Partners LLC a Wisconsin-based private equity fund has invested in NutriScience Innovations LLC (Trumbull CT). NutriScience is a current good manufacturing practice (cGMP)-certified global supplier of quality nutritional and functional ingredients to companies that manufacture nutraceutical pharmaceutical food and beverage and dietary products. Lakeview has also acquired the assets of NutriScience s sister company FabriChem Inc. a global pharmaceutical and specialty chemical raw materials supplier. Collectively the companies will operate as a unified market leader and provide a large and diverse portfolio of ingredients to a global customer base. Our investment in NutriScience targets the health and wellness market similar to our investment in UAS Labs of Wausau WI which produces scientifically proven probiotic-based supplements said Joe Cesarz managing director of Lakeview Equity Partners. Dietary supplements sports supplements and nutraceuticals are a huge and growing worldwide market. The NutriScience FabriChem group was established in 1993 by the Pallathra family co-founded by Jacob and Martha Pallathra who will retain an ownership interest. We re excited to partner with the Pallathra s and with Alan Yengoyan a management executive with experience in the sports and performance nutrition industry who will be the new CEO of NutriScience said W. Kent Velde president of Lakeview Equity Partners. The Pallathras have created a unique and robust company and we re confident in Alan s ability to take its operations and marketing to the next level. I m excited to join the team and to have the opportunity to build upon the strong foundation that has been created at NutriScience Yengoyan said. NutriScience has a strong reputation for providing customers with high quality nutritional ingredients exceptional customer service and technical expertise. This along with a specialized portfolio of branded and specialty ingredients and exclusive relationships with suppliers around the globe is a great basis for growth. We are thrilled to have the confidence of Lakeview s investment in NutriScience and we look forward to this new and exciting chapter added NutriScience founder Jacob Pallathra. We feel this investment and partnership will lead us to new heights as we grow our portfolio of specialty nutritional solutions. For more information visit or M L January February 2018 Nutrition Industry Executive 23 IndustryNews In Memoriam James A. Duke PhD ames (Jim) A. Duke PhD a leading authority on herbal medicine who made invaluable contributions to the herbal products community passed away on December 10. Duke helped introduce herbal medicine to countless people through his books research lectures poetry music and his botanical garden The Green Farmacy Garden where the American Herbal Products Association (AHPA) conducts annual HerbWalks. Duke was born in Birmingham AL in 1929 and was a bluegrass fiddler who performed at the Grande Ole Opry. He earned a degree in botany in 1955 and a doctorate in botany in 1961 from the University of North Carolina. He served three years at the Missouri Botanical Garden seven years at the Battelle Memorial Institute in Panama Colombia and Columbus OH as an ecologist. For 27 years he served as an economic botanist at the U.S. Department of Agriculture (USDA) before retiring in 1995. Before leaving USDA Duke published his phytochemical and ethnobotanical databases online at USDA (https phytochem ) which now includes more than 80 000 plant species. It is one of the most frequently visited sites on the USDA website. Throughout his life Duke pursued his personal interest in medicinal plants and helped introduce herbal medicine to mainstream America. He wrote more than 30 books on medicinal plants including the best seller The Green Pharmacy. He also served as a distinguished herbal lecturer at the Maryland University of Integrated Health. Beyond Dr. Duke s invaluable contributions to the herbal industry he was a humble man who personified the Southern gentleman said AHPA President Michael McGuffin. His sincere passion for understanding how humans used plants as medicine to promote health and well-being helped numerous individuals improve their quality of life using herbs and botanicals. Jim s passing will be mourned by the herbal community but his work and legacy will not be forgotten and will help future generations benefit from herbal medicine. You reHired NSF International has appointed Lynne Byers as executive director and David Waddington as director of NSF s pharma biotech services in Europe. In her role Byers oversees consulting auditing and training services for a variety of pharmaceutical operations in Europe. She also provides strategic consulting and training services and assists clients in establishing and implementing remediation plans to address audit findings and regulatory actions. In his new position Waddington s responsibilities include the establishment promotion and growth of NSF International s consulting auditing and training services in Europe. In addition he is the key account manager in the development and maintenance of business relationships. Xsto Solutions LLC (Morristown NJ) has announced the addition of Nathan Wolfinger to the organization as a new sales account manager and Andrew Downey as the company s new marketing manager. Wolfinger based in Atlanta GA will be responsible for expanding East Coast sales through new customer acquisition while servicing and educating existing customers on Xsto s branded innovative supplement ingredients. Downey will oversee the marketing efforts for Xsto s new and existing innovative ingredients. NattoPharma ASA (Oslo Norway and Metuchen NJ) has announced the addition of Elise Kaiser to its U.S. sales team. Prior to joining Nattopharma as senior account manager she was a national key account manager at Aker BioMarine coordinating business development activities and promotion of new products and applications. Texas-based Essential Formulas Incorporated recently promoted Brian Craig to chief executive officer. Craig s new position will include making major corporate decisions managing the company s overall resources and operations as well as communicating with the board of directors management team and setting a course for company strategy. To support further expansion in concentrated market areas OmniActive Health Technologies (Morristown NJ) has hired Ray Bonaventura and Lisa Clark as sales managers with Bonaventura overseeing California and Canada while Clark focuses on the U.S. southeast. Stern-Wywiol Gruppe (Aurora IL) has appointed William Solomon as the new chief operating officer of its U.S. contract manufacturing business SternMaid America. Previous to the Stern-Wywiol Gruppe Solomon has worked as the vice president of manufacturing for innovative food processors director of operations for Grecian Delight Foods Inc. and for multi-nationals such as Ecolab PepsiCo and Procter & Gamble. J Don t miss a single issue of NIE in 2018 ... go online to renew your free subscription today JanFeb18 24 Nutrition Industry Executive January February 2018 IngredientNews Valensa International Secures Two New U.S. Patents Offers New Formula for Licensing he United States Patent and Trademark Office recently awarded Florida-based Valensa International two new patents its 17th and 18th in this area locking down patent protection for the core ingredients related to its commercial blockbusters FlexPro MD and FlexPro ES. In clinical trials these dietary formulations for joint health were shown to be three to five times more effective in relieving joint discomfort than a standard commercial formulation of glucosamine and chondroitin. Subjects from the trial reported being essentially pain-free after the 56-day study. The first of the two patents was granted for Flexuron Plus Valensa s proprietary non-animal derived and highly bioactive formula that features medium-chain hyaluronic acid (which has a lower molecular weight than traditional hyaluronic acid) when used in combination with the powerful antioxidant astaxanthin. Flexuron Plus is now available for licensing as a separate ingredient or finished product. The second patent was granted to Naturex Collaborates With Milne and Olene aturex s (France) Open Innovation Program Ingenium is continuing efforts to bring new sciencebased ingredients to market. Its latest initiative has led to the signing of a collaboration agreement with Washingtonbased Milne Fruit Products Inc. to jointly fund human clinical research utilizing Milne s Concord grape aqueous extract. Concord grape (Vitis labrusca) is a North American fruit whose unique grapes are rich in health-promoting polyphenols. T N Valensa for their bioavailable Zanthin Astaxanthin that has been coupled with phospholipids. The Flexuron Plus blend of Zanthin Astaxanthin (a potent downregulator of pro-inflammatory cytokines) and immunogenic hyaluronic acid enhanced in the presence of phospholipid-based surfactants has been clinically shown to dramatically reduce knee joint discomfort. In recent clinical trials Valensa has demonstrated that this multi-patented blend works fast and has a cumulative beneficial effect over time on maximizing joint comfort. Valensa s joint formulations including FlexPro MD and FlexPro ES are available for multiple distribution channels including retail mass market and specialty health stores. For more information visit Sabinsa s Curcumin C3 Complex and Aspirin Combination Researched in Groundbreaking Colorectal Cancer Study n an extensive efficacy and mechanistic study using transcriptomic analysis using RNA-seq published in the leading journal Biochemical Pharmacology researchers provided the first evidence of chemopreventive effect of a low dose combination of aspirin and New Jerseybased Sabinsa Curcumin C3 Complex. Colorectal cancer (CRC) is one of the major causes of human mortality and morbidity. Colitis-accelerated colon cancer (CAC) is a sub-type of CRC that is also closely associated with inflammatory bowel disease (IBD). Although aspirin has been widely investigated as a chemopreventive agent for CAC and different types of CRC the potential sideeffect of gastrointestinal bleeding has been a concern in long-term high-dose aspirin therapy. In this new study on animals researchers at Rutgers University (New Jersey) discovered that co-administration of Curcumin C3 Complex and aspirin helps to lower the dose of aspirin Traditionally used in food and beverage applications the Concord grape has lacked a corporate champion focused on the nutritional supplement market with the ability to significantly drive its global health message. Naturex and Milne intend to lead this initiative and are currently seeking proposals from interested researchers targeting healthy aging and quality of life with an emphasis on cognitive performance digestive metabolic cardiovascular or immune health. I by 50 percent rendering this therapy feasible without adverse effects. It has been known earlier that Curcumin C3 complex is non-toxic at all tested doses. Additionally aspirin and C3 Complex combination modulated a larger gene sets than the single agent treatment. These genes were involved in several canonical pathways important in the inflammatory network and liver metastasis in CAC. Also this was the first study is first of its kind in an Azoxymethane(AOM) DSS (Dextran sulfate sodium)-induced CAC. The study Mechanisms of colitisaccelerated colon carcinogenesis and its prevention with the combination of aspirin and curcumin Transcriptomic analysis using RNA-seq can be accessed here http 10.1016 j.bcp.2017.02. 021. For more information visit Meanwhile Naturex and India-based Olene are collaborating through Ingenium Naturex s Open Innovation Program to bring Gingest to the global market. Gingest is a new highly standardized ginger extract powder for natural digestive health applications. Gingest was developed using Olene s patented new technology Aqueosome. This solvent-free and safe process makes it possible to obtain ginger oleoresin powder while retaining a high level of standardization of active compounds (greater than 26 percent). For more information visit or Nutrition Industry Executive 25 January February 2018 IngredientNews Aker BioMarine Wins Awards for Work on Health Promotion Receives Third SFP A Rating n October 2017 Aker BioMarine (Norway) took home the Complementary Medicine Innovation Award granted by the Complementary Medicines Australia for its work on omega-3 evangelism in Australia. Last year Aker BioMarine formed the Omega-3 Index Project to bring more attention to omega-3 insufficiency which has become a global health concern. Since the program was extremely well-received in Australia the company launched it on an international level. This concern of omega-3 deficiency is too important to ignore and knowing your Omega-3 Index should be as important as knowing your cholesterol. Having control over your number will help you make important adjustments to your diet which will significantly I reduce your risk of heart disease and other health issues said Matts Johansen Aker BioMarine CEO. As part of this health awareness program 5 000 Australians measured their omega-3 EPA and DHA levels in red blood cells during the past 12 months using the Omega-3 Index Test. With the Omega-3 Index Test everyone has the ability to help identify correct and maintain healthy levels of omega-3s which is essential for good overall health. Also for the third year in a row the krill fishery in the Antarctic received an A rating from The Sustainable Fisheries Partnership (SFP). The Reduction Fisheries SFP Fisheries Sustainability Overview 2017 analyzed 20 of the most significant fisheries used for the production of fishmeal or fish oil and assessed the sustainability of the current management regimes. Similar to the findings in previous years only 2.2 percent of the total catch volume of the reduction fisheries in this analysis came from stocks in very good condition and this corresponds to a single fishery Antarctic krill - Atlantic Southern Ocean. Eighty one percent of the total catch volume comes from stocks that are reasonably well managed an improvement from last year where only 57.4 percent of the fisheries received that rating. For more information visit BI Calls on Industry Participants to Demand Kill Step Validation Study KSM-66 Ashwagandha Normalizes the Level Of Thyroid Hormone C alifornia-based BI has called on industry participants to demand product-specific kill step validation procedures stating that a 5-log reduction on a product that is too numerous to count is still potentially harmful. With the vast proliferation of hospitalizations and deaths that result from foodborne diseases each year BI is emphasizing the urgency on industry participants to be vigilant in the implementation of the U.S. Food and Drug Administration s (FDA) Hazard Analysis and Critical Point (HACCP) plan as well as validation of supply chain testing. Validation of kill step is essential. More importantly the type of validation protocol used should be fit for purpose. BI states that having a 5-log reduction is neither adequate nor safe in protecting consumers from pathogens. A 5-log reduction may be an acceptable kill step validation for almonds or some other food products but not for all botanicals. Some botanicals such as roots have such a high bacterial and pathogen count to begin with that a 5-log reduction may not be sufficient. Also 5-log reduction of targeted known pathogens is not sufficient in botanicals where there is a host of unknown pathogens. According to the FDA an HACCP 26 Nutrition Industry Executive plan when properly implemented will effectively control hazards. BI added that it is critical to ensure the sterilization processes of natural ingredients have a validated kill step in addition to HACCP adherence because of the variance of ingredients found in nature. BI s Protexx HP Green Steam sterilization method remains the industry s only species-specific organic steam sterilization method with a validated kill step. Protexx HP Green Steam utilizes more than 40 settings which control heat moisture time and pressure parameters tailored for each individual species. All products require their own specific combination to provide the maximum reduction in potential contaminants while preserving the color flavor and bioactive attributes. BI has fine-tuned more than 350 product-specific validated protocols across its five steam units that utilize the highest pressure and temperature settings in the industry resulting in shorter treatment times to eliminate pathogens which help maintain the product s characteristics. It also has the only steam unit in the industry validated using the USP (United States Pharmacopeia) method. For more information visit A clinical trial report published in the Journal of Alternative and Complementary Medicine evaluated the effects of KSM-66 Ashwagandha (from California and India-based Ixoreal Biomed Inc.) on thyroid hormone levels. The double-blind randomized placebo-controlled trial had a sample size of 50 subjects. An eight-week supplementation of KSM-66 Ashwagandha significantly improved serum TSH serum T4 and serum T3 levels achieving change toward normalization of 19 percent 45 percent and 21 percent respectively. These findings are noteworthy because they indicate that KSM-66 Ashwagandha can normalize thyroid hormone levels in hypothyroid individuals and also maintain normal thyroid function in healthy people. For more information visit January February 2018 Botanical Liaisons and NaturPro Scientific Complete Authentication of Rhodiolife PLT Health Solutions lantria Algal DHA is Verified Non-GMO otanical Liaisons LLC (Colorado) and NaturPro Scientific LLC (Indiana) announced that the two companies have jointly completed a successful ingredient identity verification program for Rhodiolife Rhodiola rosea L. which is marketed by New Jersey-based PLT Health Solutions. Verification of Rhodiolife identity was based on a comprehensive set of criteria including supplier verification chain of custody review and identity testing using HPLC and DNA testing. The authenticity of rhodiola dietary supplement products has been called into question by the October 2017 publication of Adulteration of Rhodiola (Rhodiola rosea) Rhizome Root and Extracts by the American Botanical Council (ABC). The report authored by top natural products experts outlined that less expensive rhodiola species grown in China may be commonly B added to the intended species resulting in its adulteration. According to Trish Flaster CEO and Founder of Botanical Liaisons who led the review team a spike in demand for rhodiola in the USA and globally may be responsible for quality and identity issues. The global demand for Rhodiola rosea has rapidly increased which has led to shortages of authentic material. Most harvesting comes from alpine regions and forests where supplies can be depleted quickly without replanting and sustainability efforts said Flaster. I applaud PLT Health Solutions for taking the initiative to develop a sustainable supply by building relationships with rural co-ops in the Altai Mountains she added. PLT Health Solutions Inc. also announced that it has received nonGMO (genetically modified organism) verification from the Non-GMO Project company for its lantria Algal DHA line of ingredients. The verification covered raw materials manufacturing processes and logistics. It is the first commercially available algal DHA to have verified non-GMO status in the USA--based on information obtained from the NonGMO Project. Introduced in the U.S. market by PLT in June of 2016 lantria Algal DHA has been shown to be up to four times more stable than conventionally stabilized algal DHA--offering benefits of longer shelf-life as well as improved taste and odor as a result. With this new non-GMO verification lantria Algal DHA ingredients are eligible for inclusion in non-GMO products that industry analysts say will comprise more than 30 percent of the total food market in 2017 and which is growing at nearly 13 percent per year. For more information visit AstaZine Natural Astaxanthin is Now Non-GMO Project Verified NOW Foods Launches AstaZine Product alifornia-based Algae Health Sciences Inc. a subsidiary of BGG announced that its flagship AstaZine Natural Astaxanthin supercritical CO2 oleoresin extracts produced in Germany and whole-food based astaxanthin-rich algae powder have attained NonGMO (genetically modified organism) Project Verified status in conjunction with becoming the world s first organically certified Haematococcus pluvialis microalgae product in March 2016 and bearing the NAXA Verified Seal. In other news Illinois-based natural products manufacturer NOW and Algae Health Sciences announced NOW s launch of astaxanthin capsules containing AstaZine Natural Astaxanthin derived from Organic Haematococcus pluvialis microalgae. The product is being launched in a 4 mg dose with 90 capsules per bottle. The two-piece hardshell capsules feature Capsugel s Vcaps which are organic compliant certified vegan Non-GMO Project Verified halal and kosher. Astaxanthin acts as a free radical scavenger supports healthy immune function and healthy aging. Natreon Expands Global Intellectual Property Portfolio atreon (New Brunsick NJ) has been granted U.S. Chinese and Japanese patents for a new bioactive isolated from Sensoril an aqueous extract of ashwaghanda. These additional domestic and global patents cover the recent discovery of a new class of compounds Indolealkylamino-withasteroid conjugates and their significant acetylcholinesterase inhibitory activity. Additionally Natreon has been granted a U.S. patent for its Ayuric ingredient whose claims support the use of Ayuric a standardized extract of Terminalia bellirica for the treatment of gout uricemia and hyperuricemia. Finally the Canadian patent office issued a patent for Natreon s super antioxidant ingredient Capros a standardized extract of Phyllanthus emblica which covers a composition and method to treat or prevent endothelial dysfunction. These additional issued patents support Natreon s focus on investing in product innovation and clinical studies to support the ingredients it brings to market. They include US 9 750 778 CA 2 810 732 US 9 084 800 and JP 6144688. For more information visit C N This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat cure or prevent any disease. For more information visit or January February 2018 Nutrition Industry Executive 27 IngredientNews Lycored Calls for Focus on Education as Consumers Fail to Spot Bad Cholesterol ost consumers do not know which kind of cholesterol is considered bad for health new research by Lycored (Orange NJ) has shown. The global wellness company surveyed 329 dietary supplement users. More than eight in 10 (82 percent) said they were aware that there are two main forms of cholesterol one considered good and one considered bad. However when they were asked which was considered good 58 percent named LDL rather than HDL. In fact high levels of oxidized-LDL cholesterol in the blood are associated with risk of cardiovascular disease. By contrast HDL is often known as good cholesterol. Lycored believes the findings highlight the responsibility of manufacturers to support consumer education. Zev Ziegler head of global brand and marketing M health at Lycored said Too often nutrition marketing is about making claims for products without considering how much the user really knows. Most consumers understand that there s good cholesterol and bad cholesterol but beyond that things get a bit hazy. Our research highlights the importance of educating consumers--not just selling to them. Cardiomato Lycored s cardio-grade tomato extract has been shown to reduce levels of oxidized LDL. The company has worked with distributors nutritionists and clinicians on initiatives to help educate people on the role of nutrition in cardiovascular health. Earlier this year Lycored launched Lycopedia an interactive educational hub which explains the health benefits of lycopene at different stages of life. Survey of 329 U.K. consumers (160 men and 169 women) carried out online in June 2017. All respondents took dietary supplements at least once a week. For more information visit Introducing Focalis With Cognizin Citicoline ocalis dietary supplement delivers next-level focus free of the common side effects of stimulants. Focalis produced in a partnership between New York-based Focalis and Texas-based Uniwell Laboratories gets its effects via three clinically proven actives each targeting a key aspect of mental performance huperzine A which breaks down the neurotransmitter acetylcholine in a process that the company said helps combat dementia symptoms whole green coffee powder which supplies a steady delivery of caffeine throughout the day and [use AlgaeHealth here] Cognizin a patented form of citicoline manufactured by Kyowa Hakko Bio Company Ltd. Citicoline is critical for healthy brain function and is proven to support alertness as well as boost energy according to Kyowa Hakko Bio. Clinical studies show Cognizin provides vital nutrients that help the brain stimulate electronic impulses maintain healthy neurons and protect them from free radicals. F Nutrition 21 Presents the Effects of Velositol on Exercise-induced Myokines ew York-based Nutrition 21 LLC (Nutrition 21) announced the presentation of new preclinical and clinical study results that support the efficacy of Velositol a modifiedrelease chromium complex combined with a specialized form of amylopectin in increasing the levels of various myokines after exercise. The results entitled The Effects of Velositol on Exercise-induced Myokines were presented to nutrition science researchers clinical nutritionists and other professionals during the American College of Nutrition s (ACN) 58th annual conference in Alexandria VA. They will also be published in the Journal of the American College of Nutrition. Velositol is a novel complex previously shown to accelerate and boost muscle protein synthesis (MPS) when combined with protein. MPS is a prime N component for amplified muscle growth lean body mass and quicker muscle recovery. To investigate if myokines [cytokines musclin and fractalkine released by muscles during exercise that lead to MPS] are affected by Velositol the ingredient was tested in a preclinical study where treatment groups included exercise in control exercise whey protein and exercise whey protein Velositol. All active treatment groups showed significant increases in musclin serum levels as compared to the exercise control group however all groups supplemented with Velositol whey protein had significantly higher musclin levels when compared to whey protein alone results that highly correlated with the increases observed in MPS. For more information visit These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat cure or prevent any disease. For more information visit or ExcelVite s EVNolMax 20% (T) Earns Non-GMO Project Verification Seal E xcelVite (New Jersey) announced that its new tocotrienol product in powder form--EVNolMax 20% (T)--is now Non-GMO (genetically modified organism) Project Verified. Between 2014 and 2015 a range of ExcelVite s palm based tocotrienol and mixed-carotene ingredients have been verified by the Non-GMO 28 Nutrition Industry Executive Project. This latest addition of EVNolMax 20% (T) natural full spectrum palm tocotrienol complex powder adds to the list making a total of nine products that are now permitted to carry the Non-GMO Project Verification Seal. For more information visit January February 2018 Pre-Meal Shot With Whey Protein and Fiber Offers Blood Sugar Control rla Foods Ingredients (Denmark) has developed a high-protein PreMeal Shot concept that highlights the potential for launching innovative products that deliver improved blood sugar control in a natural tasty and convenient way. Millions of people worldwide struggle to maintain healthy blood sugar levels including the 400 million diagnosed with type 1 and type 2 diabetes. Another 300 million people meanwhile are estimated to be pre-diabetic and at high risk of developing diabetes. A Diabetics and pre-diabetics are susceptible to hyperglycaemia prolonged periods when levels of sugar in the blood are too high. Left untreated this can lead to a number of serious health complications. Arla Foods Ingredients new 100 ml Pre-Meal Shot concept is high in fiber and contains 15 g of Lacprodan whey protein. Results of a recent clinical trial demonstrated that consumption of 15 g of whey protein by people with type 2 diabetes before a meal helped to keep their blood sugar levels within the nor- mal glycaemic range following the meal. For more information visit Introducing Instaferm VitaD Premixes FDA Issues GRAS No Objection Letter For BESTEVIA weeGen Inc. a nature-based sweetener company in California and Ingredion Incorporated (Illinois) a global provider of ingredient solutions to diversified industries jointly announced that the U.S. Food and Drug Administration (FDA) issued a GRAS (generally recognized as safe) No Objection Letter for BESTEVIA Rebaudioside D stevia leaf sweetener for use as a general-purpose nonnutritive sweetener for foods and beverages. BESTEVIA Reb D SweeGen s non-caloric high-purity stevia sweetener with a clean sugar-like taste is produced from the stevia leaf. The manufacturing process ingredient composition and other factors were provided to the FDA in GRAS notice No. 715. The FDA acknowledged in a letter dated October 24 2017 that it evaluated the application and has no further questions regarding the conclusion that BESTEVIA Reb D is GRAS under its intended conditions of use. For more information visit or N ovember 2 was Vitamin D Day which aimed to recognize vitamin D deficiency as a global problem. To facilitate bakeries compliance with new nutrition labeling regulations in the U.S. and in Canada Canada-based Lallemand is introducing a new range of Instaferm VitaD Premixes which are simple blends composed of dried VitaD yeast (Saccharomyces cerevisiae) and wheat flour for inclusion in bread rolls and fine bakery products. With the increase in the daily value for vitamin D to 800 IU (20 mcg) and the new serving sizes (Reference Amounts Customarily Consumed) for the bakery products the bakeries that want to continue claiming a vitamin D in their bread will have to review the bread formulations. The use of a premix gives more control and flexibility to bakers when considering the vitamin D enrichment of their bread formula. For more information visit S BENEO Celebrates 10 Years of Connecting Nutrition and Health Launches Prebiotic Logo ENEO (U.S. location in New Jersey) celebrated the company s 10-year anniversary at FiE 2017 in Frankfurt Germany this past November. Originally launched at FiE 2007 in London England BENEO has since focused on delivering its brand promise to contribute to better nutrition and health for people and animals. This year BENEO said it will be exhibiting at FiE once again and will be using the show as an opportunity to celebrate this company milestone together with its customers and busi- B ness partners. Over the 10 years since BENEO was formed by industry players Orafti Palatinit and Remy the company s influence has continually grown. It is now represented in more than 75 countries and has more than 900 employees in seven offices and five production sites. Today the BENEO-Institute and BENEO-Technology Center which were created shortly after BENEO s inception offer customers and the wider industry insights into nutrition science legislation and provide expert advice on application technology. BENEO s continued investment in scientific research substantiates the technical and nutritional effectiveness of its functional ingredients and has resulted in a range of EFSA health claim approvals being awarded. The company also launched a new on-pack logo to further support the promotion of digestive health and wellness achievable through its prebiotic chicory root fibers. For more information visit Nutrition Industry Executive 29 January February 2018 IngredientNews Neumentix Clinical Study Shows Sustained Attention Benefits N ew human clinical trial data presented at the Society for Neuroscience on November 15 showed supplementation with patented Neumentix Phenolic Complex K110-42 supports sustained attention and focus in young healthy individuals. The new study used CNS Vital Signs test to evaluate the effects of Neumentix supplementation on cognitive performance compared to placebo. The CNS test uses a series of computerized neurocognitive tests to assess brain function. Results showed significant improvement in sustained attention after 30 days which lasted through the 90-day study. These results indicate longterm supplementation with Neumentix can improve focus over time. Neumentix is a water-extracted natural dietary ingredient that was selec- tively bred to be high in polyphenols and targeted to support cognitive and physical performance. Previous research suggests key polyphenols in Neumentix support working memory function in the brain through at least four potential mechanisms of action. Polyphenols in Neumentix are suggested to support cognition by reducing oxidative stress increasing acetylcholine supporting the growth of new neurons and protecting existing cells. For more information visit Innophos Acquires NutraGenesis N ew Jersey-based Innophos Holdings Inc. has acquired NutraGenesis a Vermont-based marketer of proprietary branded and science-backed nutraceutical ingredients. Under the terms of the purchase agreement Innophos has acquired all of the outstanding equity interests of NutraGenesis LLC Icon Group LLC and Tradeworks Group Inc. together referred to as NutraGenesis for a total purchase price of 28 million in cash. Innophos has funded the acquisition with borrowings under its existing credit facility. The acquisition is expected to be accretive to Innophos earnings per share in the first year following the close of the transaction. For more information visit or Pomella Obtains Self-GRAS Status ndiana-based Verdure Sciences announces that its Pomella Pomegranate Extract obtained self-affirmed generally recognized as safe (GRAS) status following an extensive and comprehensive evaluation by an independent panel of experts. I Hello HEYLO A Breakthrough No Compromise Sugar Alternative oyal Ingredients LLC (New Jersey) the U.S. Operations of ED&F Man a sugar distributor announced the B2B launch of a breakthrough no compromise sugar alternative called HEYLO. According to the company HEYLO is not a sweetener. It is the first real alternative to sugar as it has no taste texture or gut health trade-off according to the company. The formula is protected by patents in the U.S. and across the world. It is made of only two natural ingredients--water extracted stevia (not chemically extracted) and all-natural dietary fibers from the acacia tree. HEYLO is a prebiotic that is entirely free from artificial sweeteners has no chemicals no hidden sweeteners no diuretic effect zero glycemic index value and zero calories. It is ideal for all those who want to or need to consumer less sugar but still want to enjoy sweet foods and beverages. R HEYLO has been successfully applied in non-carbonated beverages ketchup peanut butters dairy products ice cream chocolate ice cream peanut butter jams ketchup and bakery products. When launched B2C it will be available in three forms Organic Brown Sugar Alternative Natural White Sugar Alternative and Liquid. HEYLO can fully eliminate added sugar and artificial sweeteners from food and drinks. For more information visit Heylo. The self-affirmed GRAS status is yet another indication of the company s commitment to continuously improve its scientific initiatives on its branded ingredients the foundation of which lies in safety and efficacy. Furthermore the GRAS status will allow the company to continue to diversify its positioning. Backed by human clinical substantiation safety and efficacy Pomella Extract is available in a variety of grades from Verdure Sciences. These grades include Pomella FG (food grade) and Pomella Organic. All varieties of Pomella have received self-GRAS status. For more information visit 30 Nutrition Industry Executive January February 2018 Quatrefolic New Food Nutritional Fortification Substance Authorized in China ith an official notification (2017 No. 8) issued on October 20 2017 by the National Health and Family Planning Commission of the PRC (former Ministry of Health of the People s Republic of China) Quatrefolic has been publicly authorized as Food Nutritional Fortification Substance with a specific monograph W that describes its quality (physical chemical and microbiological) requirements. After the first positive assessment made by the China National Center for Food Safety Risk assessment (CFSA) in early 2016 the use of Quatrefolic as Food Nutritional Fortification Substance now enters in force in China. The published monograph defines dosage and intended use of Quatrefolic the 5-MTHF glucosamine salt as a new active ingredient introducing this innovative folate instead of the already known folic acid. For more information visit or MenaQ7 Vitamin K2 Granted New Patents NattoPharma Launches in China attoPharma ASA (New Jersey) announced it has successfully secured patents in Israel the United States and Australia for its nature-identical synthesis creating MenaQ7 PharmaPure Vitamin K2 as MK-7 enriching the company s already robust patent portfolio. Israel On July 31 2017 patent 238199 Process for preparation of MK-7 type of Vitamin K2 was granted. United States On August 28 2017 Notice of Allowance for patent 14 435 260 Process for preparation of MK-7 type vitamin K2 was issued. Furthermore Nattopharma was honored to participate in a launching conference commemorating the first product introduced in China featuring MenaQ7 Vitamin K2 as MK-7. FishBurg a Chinese dietary supplement producer with a strong position in the calcium vitamin D3 (VD3) segment signed a partnership and supply agreement with NattoPharma world leaders in vitamin K2 as MK-7 research and development on November 28 in Guangzhou. During this event FishBurg officially launched its new Blue Hat-registered calcium VD3 MenaQ7 Vitamin K2 supplement for bone health to the Chinese market. For more information visit or Parabel Wins Innovations Award at Food Ingredients Europe arabel (Florida) won the FIE (Food Ingredients Europe) Innovations Award in the Growth Category for the company s Novel LENTEIN Plant Protein. LENTEIN is a plant protein that comes from the world s smallest flowering plant Lemnaceae commonly called the water lentil or duckweed. It grows on top of still water all around the world and has been eaten by animals and humans in East Asia for a long time. Parabel is the first company to develop an open hydroponic system to grow process and commercialize the plant according to the company. Barentz is the global distributor of LENTEIN plant protein. LENTEIN Complete is a whole food ingredient containing 40 to 50 percent protein and 35 percent dietary fibers. Very popular for nutritional beverages such as meal replacements and sports protein powders it also fortifies snacks and bars. Because of its high chlorophyll content it has a mild pleasant green taste and color. The crop is minimally processed without chemicals which maximizes digestibility and bioavailability of the nutrients. LENTEIN protein contains higher levels of essential amino acids and BCAA s than other plant proteins and has an amino acid profile similar to whey protein. The protein is also very digestible with a typical PDCAAS of 0.93. It is free of common food allergens such as soy and gluten. LENTEIN Complete also contains good levels of omega-3 ALA as well as other macro and micronutrients. For more information visit N P Deerland Enzymes & Probiotics Earns Non-GMO Project Verification for Dairylytic and Glutalytic eorgia-based Deerland Enzymes & Probiotics announced that it has earned Non-GMO (genetically modified organism) Project verification for Dairylytic and Glutalytic the company s branded enzyme blends for dairy and gluten digestion. Dairylytic and Glutalytic are the fourth and fifth of Deerland s branded products to earn verification the company s ProHydrolase DE111 probiotic and PreforPro prebiotic were verified earlier this year. G These enzyme-based products hydrolyze wheat and dairy proteins and break them down into smaller protein constituents so they can be more easily managed by the body. Dairylytic is a dual-functioning enzyme blend designed to break down the lactose associated with intolerance as well as make milk proteins that could cause an immune response easier to digest. Glutalytic is a uniquely designed enzyme blend that breaks down gluten proteins faster and more efficiently than DPPIV-only supplements by attacking the internal and external bonds that make up the gluten protein. Clinical studies show Glutalytic s ability to improve a variety of discomforts associated with gluten sensitivity. For more information visit Nutrition Industry Executive 31 January February 2018 IngredientNews Kappa Bioscience Announces Free Vitamin K2 MK-7 Quality Testing Program appa Bioscience (Norway) announced the worldwide launch of a free vitamin K2 MK-7 quality testing program. Testing is open to finished K2 products from any source for testing and verification of the product s K2 label claim. The program supports wider goals of educating markets about K2 stability and advancing K2 science to resolve the question of why unprotected K2 is unstable in mineral formulations. The formal launch opens the program to global participation and now includes website support to facilitate submissions. Testing now includes a process for independent third-party laboratory verification by region. The independent verification process insures credibility of results and provides a model for how the supplements industry can address problems of low-quality ingredients products that don t meet label claims and questionable use of data in marketing. K Stakeholders for vitamin K2 products are invited to submit samples for no-cost MK-7 testing. Tests are conducted using USP (U.S. Pharmacopeia) methods and the confidential results are reported only to the test requestor. The first samples were submitted at CPhI India from brands contract manufacturers and retailers seeking to verify the quality and performance of the K2 in their specific formulations. The testing offer is open to companies with a role in the supply chain for a K2 product or an interest in protecting consumers or other stakeholders. Finished products that contain vitamin K2 MK-7 and minerals particularly calcium or magnesium will be prioritized. Any K2 product however where quality may be in question is eligible for testing such as cis (inactive) vs. trans (active) testing vitamin MK-4 labeled as MK-7 and testing of K2 in ingredient form. For more information visit Salt of the Earth Appoints U.S. Exclusive Distributor alt of the Earth Ltd. (Israel) has appointed New Jersey-based A&B Ingredients Inc. as its exclusive distributor of Mediterranean Umami for the U.S. and Canadian markets. This is the second distribution agreement signed in 2017 as Salt of the Earth builds the global sales infrastructure for its all-natural and clean-label ingredient for reducing salt intake in processed foods. Mediterranean Umami is an all-natural ingredient designed for clean-label sodium reduction and enhancing a great umami flavor profile. Based upon a proprietary blend of vegetable extracts and sea-salt it allows for significantly reduced sodium--up to 45 percent in various food products. With Mediterranean Umami food manufac- S Go to ayushherbs 32 Nutrition Industry Executive turers can eliminate use of MSG and yeast extracts. Being on-trend and highly effective it was recently awarded (in June 2017) an IFT17 Food Expo Innovation Award at the Institute of Food Technologists annual meeting. For more information visit or January February 2018 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Fostering an Environment Where the Herbal Industry Can Thrive T he herbal products industry continued to grow and evolve in 2017 and the industry took proactive steps to meet growing demand for high-quality sustainably produced natural ingredients for an array of products. The American Herbal Products Association (AHPA) continued to capitalize on strategic partnerships to promote industry best practices and advocate common sense changes to current laws and regulations to help the industry ensure quality and meet the growing demand. AHPA addressed a wide variety of issues that impact the herbal community in 2017. The following are just a few highlights. ation clause of the Food Drug and Cosmetic Act (FDCA) and is adulterated if it presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or under ordinary conditions of use. AHPA published a free resource the Good Agricultural Collection Practices and Good Manufacturing Practices (GACP-GMP) for Botanical Materials to provide a template to help growers harvesters and processors implement and document best practices to ensure quality of herbal ingredients. On the Hill AHPA members and staff joined the Council for Responsible Nutrition (CRN) in June to co-produce CRN s 18th annual Day on the Hill. CRN graciously accepted AHPA s request to participate in this growing lobbying event which attracted nearly 100 dietary supplement industry representatives from across the country. The event allows member companies to take an active role in advocating for reasonable regulation and to put a face on the responsible dietary supplement industry. The event also provided an opportunity to recruit congressional members to join the Dietary Supplement Caucus (DSC) the bipartisan group of House and Senate members who work to raise congressional awareness of supplements and the laws and regulations governing the industry. In August Rep. Mia Love R-Utah assumed a new leadership role as a cochair of the Congressional Caucus. Love replaced Rep. Jason Chaffetz formerly a DSC co-chair who retired from the House of Representatives in the summer. AHPA also works with the Consumer Healthcare Products Association (CHPA) the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA) to host regular educational events for the caucus. An event held in June featured U.S. soccer player Christie Pearce who spoke to policymakers about the responsible use of supplements in sport and fitness. Protecting Consumers from SARMs AHPA joined the leading dietary supplement industry s trade associations and the U.S. Anti-Doping Agency (USADA) to support FDA actions to crack down on companies unlawfully manufacturing bodybuilding products containing selective androgen receptor modulators (SARMs) and illegally marketing them as dietary supplements. GACP-GMP AHPA published a free resource the Good Agricultural Collection Practices and Good Manufacturing Practices (GACP-GMP) for Botanical Materials to provide a template to help growers harvesters and processors implement and document best practices to ensure quality of herbal ingredients. The GACP-GMP resource has been endorsed by the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA). Nutritional Outlook also recognized AHPA as a 2017 industry leader for building consensus among its members and providing tools for the good of the industry. Informing Health Research AHPA Chief Information Officer Merle Zimmermann PhD presented at the 2017 Mary Frances Picciano Dietary Supplement Research Practicum an event held by the National Institutes of Health (NIH) Office of Dietary Supplements to provide faculty students and practitioners in health-related disciplines with fundamental knowledge of dietary supplements. Zimmermann provided an overview of the regulated supplement industry s proactive efforts to ensure quality and safety and comply with all relevant laws and regulations. ODI-NDI I presented at a public meeting held by the U.S. Food and Drug Administration (FDA) to discuss the development of a list of pre-DSHEA dietary ingredients and stressed that FDA must make some significant changes to previous positions on new dietary ingredients (NDIs) in order to successfully create an authoritative list of old dietary ingredients (ODIs). AHPA also submitted comments to FDA that note that the NDI provision of the law only establishes that old dietary ingredients are old. It does not establish that every ODI is safe in any quantity for any person. Whether a supplement is made with pre-DSHEA (Dietary Supplement Health and Education Act of 1994) ingredients or NDIs it is held to the same standard under the adulter- Medical Cannabis Standards AHPA and the global standards organization ASTM International announced a Memorandum of Understanding to work together on standards for the cannabis industry. Under the agreement AHPA provides ASTM International with technical and regulatory recommendations to support coordinated development of standards for the cannabis industry. AHPA continues to promote standards and best practices for medical cannabis outlined in our recommendations to regulators. These recommendaNutrition Industry Executive 33 January February 2018 AHPAUpdate tions for states that allow medical cannabis provide a framework for the oversight of cannabis production and distribution practices from seed to the consumer. Modernization Act (FSMA). 2018 AHPA is excited to build on the momentum created in 2017 to further the shared goals of the herbal products industry moving forward. Among other things AHPA will be working to capitalize on opportunities to improve current regulations to reduce unnecessary burdens on the industry. Supporting Herbal Medicine AHPA issued a free guide for qualified practitioners who compound herbal formulations for clients based on one-onone consultations. The Good Herbal Compounding and Dispensing Practices white paper helps acupuncturists herbalists naturopaths and other adequately trained professionals to use best practices when compounding and dispensing herbs and herbal formulations. Pesticide Regulations AHPA submitted comments to the Environmental Protection Agency (EPA) to request the agency reform current regulations in a manner that maintains protections for consumers and the environment and also reduces burdens on food companies that use herbs and spices in their products. AHPA informed EPA that there is a significant disconnect between the occurrence of detectable pesticide residues on foods with no tolerance or a tolerance exemption and the technical requirements of the existing enforcement policies. This discrepancy between the requirements and the reality of widespread pesticide use and trace contamination has been causing problems in the food industry for decades and will increase dramatically with the enforcement of new regulations under the Food Safety Healthy Claims AHPA requested FDA expand the criteria for use of the term healthy beyond nutrient content claims to include claims for other foods including herbs spices and teas that promote healthy eating patterns as recommended by the Dietary Guidelines for Americans. AHPA encouraged FDA to prioritize efforts to amend the current regulation that is inconsistent with the latest nutrition research and expressed support for FDA s current policy to exercise enforcement discretion until the current healthy regulation is updated. Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) ScienceUpdate Omega-6 Fatty Acids Do Not Promote Low-grade Inflammation he higher the serum linoleic acid level the lower the C-reactive protein (CRP) according to a new study from the University of Eastern Finland. Linoleic acid is the most common polyunsaturated omega-6 fatty acid. The findings were published in the European Journal of Clinical Nutrition. It has been speculated that a high intake of omega-6 polyunsaturated fatty acids may increase the risk of several chronic diseases by promoting lowgrade inflammation among other things. The reasoning behind this speculation is that in the human body linoleic acid is converted into arachidonic acid (also an omega-6 fatty acid) which in turn is converted into various inflammation-promoting compounds. CRP levels were measured from 1 287 healthy 42-to-60 year-old men at the onset of the Kuopio Ischaemic Heart Disease Risk Factor Study in 1984-1989 at the University of Eastern Finland. The study found that a low serum linoleic acid level was associated with T higher serum CRP levels. When the study participants were divided into four groups based on their serum linoleic acid levels the probability for an elevated CRP was 53 percent lower in the highest quarter compared to the lowest one. Other serum omega-6 fatty acids such as arachidonic acid gamma-linolenic acid or dihomo-y-linolenic acid were not associated with CRP levels. This research supports earlier findings. Clinical trials have shown that even a very high intake of linoleic acid does not increase inflammatory responses nor has a significant impact on arachidonic acid levels. In the human body linoleic acid is converted into various compounds that alleviate inflammation. It is worth noting that arachidonic acid too is converted into inflammation-alle- viating compounds and not just into inflammation-promoting ones. In the light of these facts it can be concluded that the theory according to which linoleic acid promotes low-grade inflammation by increasing the body s arachidonic acid levels is too simplified. Linoleic acid which is an essential omega-6 fatty acid has been linked with a lower risk of chronic diseases in which low-grade inflammation is a significant risk factor. Examples of such diseases include cardiovascular diseases and type 2 diabetes. The serum linoleic acid level is mainly determined by a person s diet and the main sources of linoleic acid are vegetable oils plant-based spreads nuts and seeds. For more information visit en etusivu. 34 Nutrition Industry Executive January February 2018 AssociationNews Industry Coalition Reminds Consumers Retailers & Product Marketers Dietary Supplements Cannot Claim to Treat Opioid Addiction he dietary supplement industry is aware of growing concerns regarding significant negative health impacts associated with opioid addiction and abuse. The leading trade associations of the industry support the responsible marketing and use of health-promoting vitamins minerals herbs sports nutrition and other dietary supplements. The associations are unaware however of published scientific research that supports the use of any dietary supplement to treat opioid use disorder or to mitigate opioid withdrawal symptoms. Furthermore federal law does not allow dietary supplements to claim to treat or cure any diseases including opioid addiction and the industry trade associations have been consistent in taking strong positions against marketing dietary supplements for treatment or prevention of diseases--whether for anthrax SARS avian flu swine flu Ebola virus--or for treatment of opioid addiction. The American Herbal Products Association (AHPA) the Consumer Healthcare Products Association (CHPA) the Council for Responsible T Nutrition (CRN) the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA) are therefore endorsing the following unified advisory for manufacturers marketers and retailers as well as for consumers of dietary supplements Retailers of dietary supplements including online retail portals should refuse to stock or sell any dietary supplements that claim to treat or cure opioid use disorder or addiction or claim to reduce the symptoms of opioid withdrawal. Manufacturers marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for these conditions. Anyone in need of treatment for opioid abuse or addiction should contact a healthcare professional immediately. The National Institute on Drug Abuse has information on currently available effective medical treatments. Many dietary supplements have much to offer in terms of enhancing general well-being providing essential nutrients and promoting good nutrition. Therapies for the treatment of opioid use disorder or addiction should only be recommended by qualified health care professionals or public health authorities. The organizations supporting this advisory represent the majority of dietary supplement ingredient suppliers manufacturers and product marketers. Each of the associations and its member companies remain committed to providing the American public with high-quality products for supporting personal health and wellness and empowering self-care choices when appropriate. For more information visit or New Book Compiles First Ever List of Pre-DSHEA Dietary Ingredients A new book from the Natural Products Association (NPA) compiles the first ever list of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) dietary ingredients according to the association. The NPA book titled PreDSHEA List of Old Dietary Ingredients is available for sale for members non-members federal agencies and non-governmental organizations (NGOs). It is also available as a searchable database for NPA members only. This book is the first of its kind and should serve as a valuable tool for industry regulatory divisions retailers industry consultants as well as state and federal regulators said Dan Fabricant PhD president and CEO of NPA and one of the book s authors. NPA continues to work with the FDA (U.S. Food and Drug Administration) in their quest to develop a list of its pre-DSHEA (Dietary Supplement Health and Education Act of 1994) dietary ingredients that are exempt from notification. This book represents a considerable investment of NPA s resources and took over two years to develop. We look forward to releasing new editions of the book as we add new independently verified ingredients to this extensive collection. This book written and compiled by Fabricant and Dr. Corey Hilmas alphabetically organizes a list of pre-DSHEA or old dietary ingredients (ODIs) that were marketed and sold prior to October 15 1994 the implementation date for DSHEA. These dietary ingredients would be exempt from filing notifications with FDA as new dietary ingredients (NDIs). The ingredient names contain reference citations to the original printed source material which consists of NPA s own printed magazines and newsletters over the decades. The ingredient listing also includes ingredients submitted as GRAS (generally recognized as safe) notices to FDA with no further comment by the agency. As there has not yet been an authoritative list of ODIs this will be the first pre-DSHEA ODI list to be published and available to the public. For those who are unsure whether a dietary ingredient is grandfathered under DSHEA (pre-DSHEA dietary ingredient or ODI) or is a NDI requiring notification under the Federal Food Drug and Cosmetic Act this book will serve as a useful regulatory guidepost. The book contains an index more than 1 850 ingredients to make searching easier. This dietary ingredient list is available at 2 000 for members and 10 000 for nonmembers. There will be an additional upcharge for industry consultants state and federal regulatory agencies libraries and NGOs. For more information visit Nutrition Industry Executive 35 January February 2018 AssociationNews New Study on SARMs Reaffirms Need for Enforcement Action and Consumer Awareness n November 28 the Journal of the American Medical Association (JAMA) published a study online entitled Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators (SARMs) and Sold Via the Internet. In the study researchers analyzed products that were labeled to be containing SARMs that are marketed on the internet. The researchers found that the chemical analyses of 44 products sold via the internet as selective androgen receptor modulators revealed that only 52 percent contained SARMs and another 39 percent contained another unapproved drug. In addition 25 percent of products contained substances not listed on the label 9 percent did not contain an active substance and 59 percent contained substance amounts that differed from the label. In response to the study the Council O for Responsible Nutrition (CRN) issued the following statement We appreciate the work of the study authors in uncovering incidents of companies who put consumers at risk by illegally marketing products that contain SARMs which are unapproved drugs and are breaking the law by trying to sell them as dietary supplements. As the study authors have indicated and as FDA (U.S. Food and Drug Administration) has previously warned products containing SARMs are not dietary supplements they are adulterated illegal unapproved drugs said Duffy MacKay ND CRN s senior vice president scientific & regulatory affairs. We are committed to educate consumers to help protect them from these intolerable fly-by-night companies who are engaging in criminal activity by bringing SARMs to the online marketplace. Further we will continue to remind the dietary supplement industry that SARMs should not be used in their products. We have aligned with the U.S. Anti-Doping Agency and other dietary supplement trade associations in support of strict enforcement by FDA to rid the market of SARMs. It is important for consumers to understand that products containing SARMs are not dietary supplements and can be life threatening. Building muscle and enhancing athletic performance happens gradually over time and requires a multi-faceted approach including healthy diet and exercise. Sports nutrition dietary supplements can play a beneficial role and we strongly urge consumers to discuss their usage of these supplements with their doctors health care practitioners coaches or trainers in order to identify the best products to fit their needs. For more information visit CRN and CHPA Voice Support for AHPA s GACPs and GMPs for Botanical Material T he American Herbal Product Association s (AHPA) Good Agricultural Collection Practices and Good Manufacturing Practices for Botanical Material (GACP-GMP) has been endorsed by the Consumer Healthcare Products Association (CHPA) and the Council for Responsible Nutrition (CRN). The presidents of both organizations recently issued statements expressing support for AHPA s guidance. According to AHPA the GACP-GMP for Botanical Material provides a template for small and large growers harvesters and processors to implement and document best practices. The guidance and accompanying assessment tools help the industry ensure that herbal raw materials used in consumer products are accurately identified not adulterated with contaminants that may present a public health risk and fully conform to all quality characteristics for which they are represented. CHPA applauds AHPA s new guidelines on Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Material and acknowledges their 36 Nutrition Industry Executive importance in helping to ensure the production and supply of high-quality herbal raw materials said Scott Melville CHPA president and CEO in a statement. Quality consumer products require dependable ingredients sourced from reliable providers and AHPA has filled a critical need by establishing best practices that botanical suppliers and processors of all sizes can easily adapt to improve and standardize the way they cultivate collect and process botanical crops. This type of initiative is a good example of industry leadership and self-regulation that will ultimately benefit suppliers manufacturers and consumers. CRN welcomes AHPA s guidelines on Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Material and recognizes the crucial role they will play in ensuring the production of high-quality herbal raw materials. There has been a need for best practices that are easily adaptable for growers harvesters and processors to improve their operations for the cultivation wild collection and processing of botanical crops and we commend AHPA for filling this gap commented Steve Mister president and CEO of CRN. Creating standards such as these provides companies of all sizes an equal opportunity to succeed in the marketplace and strengthens the overall supply chain. Ultimately adherence to these guidelines will help to assure our consumers of consistently high-quality botanical supplements that deliver on their health benefits every time. CRN is committed to participating in meaningful self-regulatory initiatives. In unanimously adopting this resolution of support CRN s board of directors has given strong consideration as to how the AHPA guidelines might be incorporated into member operations. As the industry continues to grow and innovate we embrace our colleagues efforts to increase adherence to legal ethical and safety standards. AHPA s guidelines are no exception and we look forward to witnessing the positive impact they will have. For more information visit or January February 2018 Supplement Industry and Anti-Doping Agency Warn Consumers on SARMs he dietary supplement industry s leading trade associations and the U.S. Anti-Doping Agency (USADA) have joined in support of the U.S. Food and Drug Administration s (FDA) recent actions to protect consumers from body-building products containing selective androgen receptor modulators (SARMs) illegally marketed as dietary supplements. SARMs are dangerous and illegal and they pose an immediate risk to consumers jeopardize the careers of athletes and have no place in any sports nutrition regimen according to a press release issued by the group. Together the American Herbal Products Association (AHPA) the Consumer Healthcare Products Association (CHPA) the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA) the United Natural Products Alliance (UNPA) and USADA share concerns about these products and are supporting FDA s efforts to crack down on companies unlawfully manufacturing products containing SARMs. As recognized in a recent FDA advisory products containing these ingredients are not dietary supplements they are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness. Prohibited under the S1 Anabolic Agent category of the World AntiDoping Agency (WADA) Prohibited List SARMs have raised serious concerns for FDA USADA and the legitimate dietary supplement industry as they have the potential to be misused for athletic performance enhancement due to their anabolic properties and their ability to stimulate androgen receptors in muscle and bone. SARMs are not approved for human use or consumption in the United States but despite being prohibited SARMs have been found in a number of adulterated products falsely labeled as dietary supplements. Some products list the ingredient as ostarine --one ingredient in the class of SARMs--but the ingredients may also go by an alternative name or be entirely undisclosed on the label. In addition to alerting consumers the five supplement industry trade associations have taken action to remind member companies of the responsibility to ensure that SARMs are not used in their products. USADA issues educational resources on an ongoing basis to warn T athletes and sports organizations of the negative consequences resulting from using products that contain SARMs including sanctions and suspension. The industry groups and USADA are committed to amplifying consumer alerts warnings issued by FDA and to disseminating tips consumers can use to make smart decisions when choosing sports nutrition products. FDA regulates the dietary supplement industry and this advisory puts companies on notice that those failing to comply with the law are subject to strict enforcement actions. Additionally the advisory serves as a reminder to consumers--particularly amateur and elite athletes--to educate themselves on the dangers SARMs-tainted products pose. There are legitimate sports nutrition dietary supplements that are safe bene- ficial and not prohibited by WADA and it is important for all consumers including athletes to engage in due diligence when deciding which products to use and which companies to purchase products from. Further consumers should maintain an open dialogue with health care practitioners and as appropriate trusted coaches and trainers when incorporating products into their training programs or performance goals. Finally consumers would be wise to manage expectations for their sports nutrition supplement products and should not purchase dietary supplements claiming to have drug-like effects. For more information visit or UNPA Signs Joint Memorandum of Understanding With CNHFA n an effort to formalize cooperation and collaboration between the natural health products industries in the United States and China the United Natural Products Alliance (UNPA) and the China Nutrition and Health Food Association (CNHFA) signed a memorandum of understanding (MOU) agreement in a ceremony held at the U.S. Embassy in Beijing. UNPA and CNHFA signed the MOU to promote and exchange research and technology as well to promote cultural exchange and the safe and sustainable development of the natural and health products industry in both countries. The two organizations agreed to mutually communicate about regulations and policies to strengthen Sino-U.S. health products registration regulation market access and other aspects of regulatory policy. We are honored to be working closely with our colleagues at CNHFA to further our mutual interests to responsibly grow the natural health products industries in both countries said Loren Israelsen UNPA president. This MOU agreement will stimulate further collaboration and the exchange of ideas resources delegation visits and developing business opportunities for both sides. We believe the MOU will promote cooperation and communication between both associations and indus- I tries. We hope through information exchange and projects it will encourage industry development and regulatory harmonization added Liu Xuecong secretary-general of CNHFA. Xuecong Bian Zhenjia CNHFA president and former deputy commissioner of the China State Food and Drug Administration and Scott Pozil counselor of the U.S. Embassy in China attended the signing ceremony along with members of the China State Food and Drug Administration International Cooperation Department. UNPA organizes its key objectives and work plans through its MOU partnerships with 13 U.S. and international trade and non-profit organizations academic institutions and other groups that bring expertise influence and trusted reputations. By laying out its joint objectives via an MOU UNPA is able to serve the needs of its members and its industry stakeholders with greatest effect and efficiency. For more information visit Nutrition Industry Executive 37 January February 2018 AssociationNews IPA Submits Proposal For Work on Harmonized Probiotic Guidelines for Use in Foods & Dietary Supplements epresentatives from the International Probiotics Association (IPA) recently announced a proposal for probiotic guidelines pertaining to the food and dietary supplement markets. This important IPA activity took place at the 39th session of the CCNFSDU (Codex Committee on Nutrition and Foods for Special Dietary Uses) meeting in Berlin Germany on December 4-8 2017 which was attended by government representatives observers and experts from 66 member states and 41 international organizations. The IPA introduced the proposal to initiate a dedicated New Work on Harmonized Probiotic Guidelines for Use in Foods and Dietary Supplements on December 6. The IPA delegation was successful in achieving a positive reaction and support to this proposal from many national delegations herewith securing the initiation of this new work on probiotics. The pro- R posal received the support of Argentina which requested to take the lead on the activities and committed to preparing a structured document on the content and scope of the new work on probiotics for the next CCNFSDU meeting next year. The work will include updates to the generally accepted probiotic definition. The current Food and Agriculture Organization of the United Nations World Health Organization (FAO WHO) expert panel definition for probiotics from 2001 2002 is the accepted reference point for the probiotic community. This definition is well respected from not only the probiotic community but also the scientific and regulatory communities since its inception. However it only provides a very general guidance for the recognition of the health benefit and consumer demand for probiotic foods in a world where a global regulatory landscape is not harmonized. Due to the technological and scientific advances within the probiotic industry since the FAO WHO work a broader scope is required to include these advancements into new guidelines. As the activities within Codex are strictly regulated and protocol oriented we expect this work will be long term but the IPA considers it an essential part of the process for the harmonization of the probiotic framework said George Paraskevakos executive director for the IPA. Moreover the new guidelines will provide essential requirements and specifications for probiotics that will not only inform consumers but also ensure fair practices in food trade with the eventual development of a Codex definition and the possible progression into a standard at the Codex level. For more information visit New Options Make it Easier for Companies to Upload Dietary Supplement Labels to the Supplement OWL C ompanies looking to upload their dietary supplement product labels into the Supplement OWL (Online Wellness Library) the dietary supplement product registry now have two additional efficient and affordable options to get their labels into this industry initiative. UL the global independent safety science company responsible for developing and administering the Supplement OWL and the Hamacher Resource Group (HRG) a partner in category management business strategy analytics and brand marketing services focused on consumer health care at retail are each eager to partner with manufacturers for a nominal per label fee to reduce the internal workload and speed up the process. As the Supplement OWL gains traction there s growing energy about the long-term potential for the registry to raise the bar for our industry said Duffy MacKay ND senior vice president scientific & regulatory affairs Council for Responsible Nutrition (CRN). When companies provide feedback the one concern we hear is that they re worried about the staff time involved in the initial upload process. We re grateful to UL and HRG for coming up with a way to cut down on the time involved and provide the manufacturer with a reliable accurate solution. For a nominal per label fee the two companies are offering to populate the required data fields in Tier 1 of the Supplement OWL using information provided by the product manufacturer. Companies will still be involved in the process including sharing edits (as needed) and providing final approval. But now the more tedious elements of the label upload process will be greatly reduced allowing companies to focus on fine-tuning each entry before it is made public and allowing in-house staff to more effectively uti- lize their own time. The Supplement OWL is an industry-wide self-regulatory initiative that will help create a rich and more complete picture of the marketplace for regulators retailers and industry. The Supplement OWL will serve as a resource for these audiences to identify products their ingredients and the companies who market them and permit registry users to examine and evaluate labels and other product information. Taking advantage of the label upload service provided by UL or HRG is a great way for busy companies to get started with the Supplement OWL and ensure their brands are represented said MacKay. CRN member companies will be required as a condition of membership to participate in the Supplement OWL in 2018 and CRN anticipates the number of responsible dietary supplement companies both CRN members and those who are not will also continue to increase as companies voluntarily comply. For more information visit 38 Nutrition Industry Executive January February 2018 CRN Foundation Pledges Additional Funding to NAD Dietary Supplement Advertising Review Program T he Council for Responsible Nutrition Foundation (CRNF) has announced that it has committed an additional 735 000 over a threeyear period to support the National Advertising Division (NAD) program dedicated to the review of dietary supplement advertisements to help ensure they are truthful and non-misleading. With this latest pledge CRNF will have provided grants to NAD totaling more than 2.8 million since the dietary supplement self-regulatory initiative launched in 2006. I m proud that our member companies remain steadfast in their commitment to support the effective self-regulation of this dietary supplement advertising program said CRNF President Steve Mister. By holding companies accountable to accurate advertising and promoting fair play within the business community this program helps protect consumers and foster trust in the marketplace. The CRN NAD self-regulatory initiative which celebrated its tenth anniversary in 2016 has been cited by the Federal Trade Commission (FTC) as a demonstration of ...just how impactful self-regulation can be. Since the program s inception in 2006 the NAD has issued nearly 300 decisions involving dietary supplement advertising. We appreciate the CRN Foundation s ongoing support for this program said C. Lee Peeler president and CEO of the Advertising SelfRegulatory Council (ASRC) which sets the policies and procedures for NAD and executive vice president of the Council of Better Business Bureaus. Through this support we ve been able to build a meaningful sustainable self-regulatory initiative for the dietary supplement industry that the FTC has publicly recognized as a valuable complement to [the agency s] own enforcement efforts to eliminate fraud in [the dietary supplement] industry. In addition to NAD s ongoing monitoring of dietary supplement ads the program provides a process for companies to challenge competitors whose advertisements appear misleading or unsubstantiated. NAD independently reviews the challenged advertisements to ensure that the advertiser has a reasonable basis for the challenged claims. Based on its review of the information submitted by the advertiser NAD makes recommendations as to whether the advertising should be modified or discontinued or determines the advertiser s evidence provides adequate substantiation. The advertising industry has developed a uniquely effective self-regulatory model said Peeler. It s a model that is good for consumers and good for ethical advertisers. According to NAD companies comply with its recommendations at a rate of more than 90 percent of the time. In cases where a company refuses to engage in the process NAD will publicly refer the advertiser to the appropriate government agency often the FTC for review. CRN also files its own challenges with NAD based on ads submitted to the association and reviewed by a voluntary task force of its members. Rend Al-Mondhiry CRN s associate general counsel who oversees the CRN filings advises One of the reasons the CRN NAD program works is that companies appreciate the opportunity to self-correct if there are concerns about their ads. The alternative to self-regulatory programs such as the NAD is more costly onerous litigation or government enforcement action. No company wants to be in that position. As a service to all companies in the dietary supplement industry CRN has developed a searchable compilation of all dietary supplement advertising decisions issued by the NAD available at no charge on CRN s website. The full decisions are available by subscription on ASRC s website. For more information visit self-regulation crnnad-initiative. ABC Welcomes Three New Board of Trustees Members T he American Botanical Council (ABC) has announced the election of three new members to its Board of Trustees Bethany Davis Richard Kingston PharmD and Holly Shimizu. The new trustees bring decades of combined experience in a diverse range of fields related to medicinal plants. Davis Kingston and Shimizu are recognized leaders in dietary supplement industry regulation and environmental sustainability practices clinical toxicology botanical safety and pharmacy and public horticulture and herbal education respectively. ABC is delighted to welcome Bethany Holly and Rick to our Board of Trustees said ABC Founder and Executive Director Mark Blumenthal. Each of these new board members has numerous skills and strengths that will help ABC achieve new successes in the fields of medicinal plant education and research. Now that ABC is in its 30th year and as ABC determines its future growth and direction these new trustees will help empower the board and ABC to fulfill its unique nonprofit educational mission publications and programs. The addition of these three experts brings the total number of ABC Board of Trustees members to 11. In April 2017 longtime ABC trustee Fredi Kronenberg PhD a champion of integrative medicine for women s health died after a long illness. The decision to expand the board was made unanimously at the annual Board of Trustees meeting at ABC s headquarters in November 2017. More information about the eight other board members can be found at http site PageServer pagename Board_of_ Trustees. Nutrition Industry Executive 39 January February 2018 AssociationNews Streamlining Regulations Is Necessary to Keep Consumers Safe NPA Says O n December 7 2018 The Natural Products Association (NPA) asked the U.S. Food and Drug Administration (FDA) to streamline regulations to keep consumers safe as the demand for natural products continues to grow. NPA s comments are in response to President Donald J. Trump s Executive Order to streamline regulations for American businesses. NPA has been the leading voice among the natural product and nutritional supplement trade associations to weigh in publicly with comments to the FDA on this issue. The United States has the safest food and drug supply in the world but that doesn t mean there aren t areas where we could see some improvement said Daniel Fabricant PhD president and CEO of NPA. Booming demand for natural products means that a streamlined and efficient regulatory structure is critical in order to protect consumers and public health. We are pleased to work with the Trump Administration to ensure that health conscious American consumers have access to the products they use every day. The natural organic and healthy consumer products sector is predicted to expand with a compound average growth rate of nearly 9 percent over the next two years to 252 billion by 2019 according to the Nutrition Business Journal. Smart commonsense regulatory reform with a focus on protecting public health will unlock the full potential of our industry and ensure we remain on a level playing field with our overseas competitors added Fabricant. NPA highlighted a number of regulatory issues (final rules codified federal regulations and federal guidance documents) for the Trump Administration to consider including one that would classify dietary supplements under the same category as pharmaceutical drugs Environmental Protection Agency s (EPA) Reclassification of Dietary Supplements as Pharmaceuticals Dietary supplements are regulated under the Dietary Supplement Health and Education Act and the Federal Food Drug and Cosmetic Act (FDCA) by the FDA. Under the FDCA dietary supplements are not classified as pharmaceutical products and therefore should not be included in the definition of hazardous waste pharmaceuticals. By merging two commodities under one definition the proposed rule would contradict the intent of DSHEA (Dietary Supplement Health and Education Act of 1994). Food and Supplement Labeling FDA s Final Rule to Change Nutrition and Supplement Facts NPA has requested a three-year delay in the implementation of these final rules to understand whether FDA possess empirical data to support that these changes are necessary and material and assess their economic impact to small businesses more accurately. Regulation of New Dietary Ingredients (NDIs) NPA has been actively involved in working with the FDA on its draft guidance for NDIs. NPA has requested that the FDA consider the economic impact on small businesses as part of their rewrite of NDI guidance. Small Business Suppliers of Vinpocetine The FDA recently took steps to ban a five-time acknowledged dietary ingredient through issuing an administrative proceeding. The FDA s actions are causing confusion in the industry and NPA has asked the FDA to clarify that the product is not banned by issuing a notice in the Federal Register. NPA s comments including a full list of proposed regulatory reforms can be viewed at document D FDA-2017-N-5093-0001. For more information visit NAXA Files Citizen Petition With FDA to Find ZanthoSyn Adulterated and Misbranded T he Natural Algae Astaxanthin Association (NAXA) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the agency to make the determination that Cardax s (Honolulu HI) ZanthoSyn product is misbranded and adulterated. The petition stated that ZanthoSyn does not meet the definition of a dietary supplement and even if ZanthoSyn is found to meet the definition of dietary supplement NAXA has requested that FDA make the determination that it is a new dietary ingredient (NDI). NAXA has found no evidence that Cardax has submitted an NDI notification and the organization believes ZanthoSyn is not exempt from FDA notification thus causing the product to be adulterated. 40 Nutrition Industry Executive Further NAXA has requested that FDA make a determination that Cardax s ZanthoSyn product is a drug ... because it is intended for use in the cure mitigation treatment or prevention of disease and that ZanthoSyn s synthetic astaxanthin is not generally recognized as safe and effective for its intended uses. We are expecting FDA to take action regarding this matter as NAXA believes Zanthosyn and Cardax s activities may potentially pose a risk to consumers and are a plausible misrepresentation of the status of this product noted NAXA President Scott Steinford. If the FDA determines the product is marketed or sold in violation of the law the agency may take actions including but not limited to requiring that Cardax cease distribution of the product pursuing injunctions against the manufacturers and distributors and seizing violative products. The entire dietary supplement industry and especially single ingredient trade associations have the obligation to selfpolice said Steinford. This filing was action on behalf of a responsible industry to ensure FDA is aware of this important issue. The FDA should provide feedback within 180 days of its acceptance of a citizen petition submission. The complete petition may be accessed at document D FDA-2017-P6631-0001. For more information visit January February 2018 One of the most challenging issues with combination products is being able to include therapeutic levels of key ingredients while keeping the daily serving of tablets or capsules to a minimum -- Marci van der Muelen National Sales Manager Nordic Naturals Though the market for heart health supplements is mature improved ingredients and consumers increasing desire for natural preventions may help the category build speed. By Nicholas Saraceno O lder adults drive the heart health supplement market with good reason. According to Thierry Garrier marketing director supplements for New Jerseybased DSM Consumer sales of supplements targeted to heart health have been growing in the last three years at around half the rate of the total supplements market as the category is more mature than other health benefit areas of the industry (U.S. data source NBJ). The market for ingredients tends to follow retail sales trends he noted. The cardiovascular health supplement market is primarily driven by middle-aged to older consumers. A 2017 DSM proprietary global consumer research with a sample of 750 people in the U.S. showed that cardiac health is of concern to 60 percent of adults 31-50 years of age and 57 percent of adults 51-plus. Younger adults are significantly less worried about their cardiac health Garrier said. With more than 75 million Baby Boomers added Michael I. McBurney PhD FACN vice president of science communications and advocacy with DSM 735 000 Americans have a heart attack each year and one out every four deaths is due to heart disease (according to the Centers for Disease Control and Prevention). People are looking for holistic approaches to health and well being he added. According to Managed Healthcare Executive 88 percent of consumers experience challenges to eating healthy. However Bryan See business developer ExcelVite Sdn. Bhd. (Malaysia) cited a 2017 market research reported published by Global Industry Analysts which projected the global market for ingredients supporting heart health to reach 23 billion (U.S.) by the year 2022. Contributing factors include both an increase in consumers taking more preventative measures and the prevalence of cardiovascular disease. Maintaining adequate heart health is a daunting task which is a detail that ingredient suppliers are aware of. As a result in order to create more effective products manufacturers are attempting to cover all of their bases from the process of trying to prevent heart issues to embracing the active lifestyle for all ages. Prevention has always been a foundation for heart health but it s also shifting to include categories that are increasingly important to consumers--healthy aging and sports performance active lifestyle said Brian Appell marketing manager with OmniActive Health Technologies in New Jersey. Not so much of a concern Nutrition Industry Executive 41 January February 2018 but still relevant the term healthy aging is being thrown around a lot but it is resonating with consumers whose perception about aging is less about anti-aging and more about living an active lifestyle and heart health plays a big role. In sports nutrition vasodilators and nitric oxide boosters have been a staple for bodybuilders but they are trickling down to active lifestyle consumers who find value in supporting heart function. technology to create a concentrated krill oil addresses blood pressure and cholesterol. Krill oil operates differently compared to omega-3 triglycerides the company noted. Omega-3 fatty acids (specifically longchain omega-3s EPA and DHA) are essential for our overall health and play an important role in many processes in our bodies said Dr. Nils Hoem chief scientist at Aker BioMarine. In fact research has shown that long-chain omega-3s support blood pressure cholesterol levels and normal blood clotting processes as well as a regular heartbeat all of which contribute to keeping both the heart and its arteries healthy. Not so much of a concern but still relevant the term healthy aging is being thrown around a lot but it is resonating with consumers whose perception about aging is less about anti-aging and more about living an active lifestyle and heart health plays a big role. -- Brian Appell OmniActive Health Technologies Krill oil an increasingly popular omega-3 option provides EPA and DHA mainly in the form of phospholipids which are structurally different than omega-3 triglycerides found in fish and algal oils or the semi-synthetic free fatty acid and ethyl ester forms found in concentrates. Krill s omega-3s are carried directly into the blood via the phospholipids thereby raising one s omega-3 index more efficiently as compared to other omega-3 oils that are delivered as triglycerides and follow different paths in the body. Jayesh Chaudhari MS CNS director of research and development Prinova Solutions (Illinois) the manufacturer of Oxyjun a stimulant free extract of the Improving Popular Ingredients According to Appell some of the most popular ingredients for heart health supplements include CoQ10 Magnesium Soy L-arginine Fish oil Vitamin C Resveratrol Cocoa In addition OmniActive has found curcumin to be effective to combat heart health via its CucuWin product although it may struggle in the bioavailability department. However the company s use of UltraSOL technology addresses that problem. OmniActive has focused on curcumin since it s such a promising ingredient for heart health said Appell. But the bioavailability of orally administered curcumin is quite poor because of poor solubility low absorption from the gut rapid metabolism and rapid systemic elimination. CurcuWIN uses UltraSOL technology a molecular dispersion process that converts lipophilic nutrients into waterdispersible ingredients to enhance bioavailability and retention greater than standard curcumin. The results of the Jaeger study show that CurcuWIN has 46-times higher relative absorption than standard curcumin. CurcuWIN was also shown to have longer-lasting action with higher serum concentrations after 12 hours. The combination of improved bioavailability and extended retention in the body may explain why CurcuWIN s heart health benefits are observed in a healthy population at a lower dosage. Norway-based Aker BioMarine s SuperBoost product which utilizes new 42 Nutrition Industry Executive Terminalia arjuna tree containing standardized polyphenols that may help to improve endurance further expounded upon Hoem s point. He illustrated that these sorts of ingredients including healthy omega-3 fatty acids Co-Q10 phytosterols vitamin K2 beta glucan vitamin D niacin and polyphenols continue to be in demand due to new research. Clinically speaking most of the nutrient ingredients have exhibited positive findings in minimizing the cardiovascular issues by establishing a healthy-lipid profile he said. For example studies have shown lowered triglycerides and LDL cholesterol increased cellular energy increased antioxidant power (chelate free radicals) and reduction in a building of plaques and inflammation. With increased awareness about health and proactive approach for life extension there has been an increased demand for nutrient ingredients supported by a strong scientific backup and possibly with qualified health claims. That being said well-established trademarked branded ingredients from global corporates capture more market share than traditional ingredients. Germany-based Wacker Chemie AG has also invested in production and technology. According to Rachela Mohr manager of business development the company Received about 3.0 million (about 3.5 million U.S.) from licensing agreements in 2016 Filed 116 patent applications in 2016 Has a portfolio containing about 5 600 active patents worldwide and 1 900 patent applications currently pending. Mohr continued adding that We patented for example the new production method to synthesize nature-identical hydroxytyrosol known under the brand HTEssence. WACKER has also developed a solution for significantly improving the bioavailability of such hydrophobic substances. Our technology of choice here is complexation with the ring-shaped cyclodextrins. Cyclodextrins are hydrophilic on the outside but have a lipophilic interior that can take up other lipophilic molecules. This inclusion compound can improve the solubility of lipophilic substances and thereby significantly improve their bioavailability. ExcelVite also has a focus on bioavailability. In addition to research that supports the efficacy of the ingredients stated See manufacturers should really consider the bioavailability of the ingredi- January February 2018 ents that they use. Oil or fat-soluble ingredients such as vitamin E CoQ10 omega-3s are insoluble at all pose the most challenges in processing and formulating in term of ensuring optimum absorption in the GI (gastroinestinal) tract. Very often these ingredients are poorly absorbed or not absorbed at all. The tocotrienol is one such ingredient because vitamin E is a fat soluble compound he explained. Raz was also reluctant to say one ingredient for heart health was superior than another but noted that lycopene an antioxidant found in Tomato-O-Red and phytosterols have been tested in a variety of preclinical[s] and clinical[s] and for multiple indications. Magnesium Low magnesium levels have serious implications for heart health. The World Health Organization has stated that low magnesium status has been implicated in hypertension and coronary heart disease also noting that up to 80 percent of Americans are deficient in magnesium said Todd Johnson senior director of marketing human nutrition and pharma with Balchem Albion Minerals in Utah. Optimum Efficacy NattoPharma USA Inc. (New Jersey) developers of MenaQ7 (vitamin K2 as MK-7) created a new product based off MenaQ7 with the goal of successfully closing the diet-supplement gap that so often exists for consumers. Natural product consumers recognize that supplementation is required to fill dietary gaps but they want their supplementation as close to natural food sources as possible which inspired us to recently develop and launch MenaQ7 Full Spectrum K2 said Eric Anderson senior vice president of global marketing and business development with the company. The Rotterdam and Prospect studies 1-3 have shown that food-derived vitamin K (such as from aged not processed cheeses) improves long-term cardiovascular health outcomes because it more specifically delivers the long-chain menaquinones MK-6 7 8 and 9. MenaQ7 Full Spectrum provides the vital menaquinone isomers MK-6 7 8 and 9 vital for cardiovascular health for optimum delivery of vitamin K2 with respect to absorption half-life and biological activity. Whatever the ingredient for heart health may be testing through the entire process from formulation to finished product is also important to knowing its effectiveness. The main concern is that once you mix few ingredients together into a formula and you do not test the final formula (finished product) for efficacy you can never say whether the product is effective or not noted Golan Raz PhD head of the global health division at Lycored (New Jersey) who created Tomato-O-Red a carotenoid extract that is derived from tomatoes. The fact that an ingredient was proven to be effective as a standalone isn t saying much about its efficacy once mixed with other ingredients. Therefore the minimum that can be done to move from guessing to knowing is to run the formulation through a relevant and suitable pre-clinical test. This isn t the best practice but it is well better than going straight to the market. The fact that an ingredient was proven to be effective as a standalone isn t saying much about its efficacy once mixed with other ingredients. -- Golan Raz PhD Lycored According to the National Institutes of Health magnesium is a cofactor in over 300 enzyme systems that regulate diverse biochemical reactions in the body including protein synthesis muscle and nerve function blood glucose control and blood pressure regulation. Many studies have shown a significant correlation between people that have low levels of magnesium (either in their diet or in their blood) and a higher incidence of heart attack and stroke. Research also connects magnesium with inflammation. Arteriosclerosis where there are actual blockages in the heart is closely related to inflammation in the vascular system. Balchem offers Albion Magnesium Bisglycinate Chelate which Johnson described as both gentle and highly bioavailable. As the industry heads into the New Year it will see continued improvement. With the breakthrough revolution and disruptive innovation the food and nutrition industry has changed its face radically by offering differentiated products through the use of clinically proven branded ingredients in convenient delivery systems and cutting-edge packaging observed Chaudhari. Constantly shifting trends and educated consumer behavior promotes innovation and the need to meet new requirements such as the use of clean label (natural ingredients) non-GMO (genetically modified organism) gluten free small dosage with more effective small and convenient delivery systems i.e. films spray minitabs. These types of developments have helped the ingredient market become what it has today. Transparency and Quality When it comes to creating products manufacturers must consider that consumers are more aware of where the ingredients are sourced. Companies such as Aker BioMarine are adamant about this. Manufacturers need to consider where their ingredients are coming from when formulating new products recommended Hoem. According to 2016 data from the Natural Marketing Institute (NMI) supplement users are looking more closely at where ingredients are sourced from showing strong preference for natural organic and sustainable sources. Not all omega-3s are created equal or sourced the same. Sustainability is a major factor for Aker BioMarine and something the company takes very seriously on many levels from technology to third-party certification. For the third year in a row Aker BioMarine received an A rating from The Sustainable Fisheries Partnership (SFP) for its operations. Transparency is also very important. Aker BioMarine owns and controls its entire supply chain which means the company can assure secure supply volume product quality and seamless service every time. And by utilizing a GPS tracking system that can pinpoint the exact location of each krill batch processed consumers can use the coordinates on the product bottles to know where the krill was harvested from. Besides transparency Chaudhari added that manufacturers must be adherent to specific criteria such as Effectiveness (effective clinically (Continued on page 59) Nutrition Industry Executive 43 January February 2018 Digestion Developments As consumers learn more about the importance of digestive health suppliers see to it that natural ingredients are part of their maintenance plan. By Janet Poveromo T he American diet might be described as consisting of hamburgers hot dogs meatloaf roast beef fried chicken and soda etc. These foods however are not what Americans eat every day--American cooking is more diverse. In fact the human diet is diverse said Amanda Brown global sales manager with American Laboratories Inc. in Nebraska. And as we are consuming more synthetic foods and ingredients we need some help breaking down the components into absorbable nutrients for the body to use. So it comes as no surprise that consumers are always on the lookout for a good digestive aid she noted. There are a multitude of digestive issues that a person could encounter from having trouble digesting gluten to or having lactose intolerance and not being able to properly break down milk. 44 Nutrition Industry Executive As we are learning many health problems can be traced to the gut added Dr. John Deaton vice president of science and technology with Deerland Enzymes & Probiotics in Georgia. Our diets are filled with convenience foods that often contain preservatives artificial sweeteners and sugars that negatively affect the microbiome (bacterial population) of the gut by encouraging the growth of candida and undesirable strains of bacteria. It is important to take extra steps to maintain a healthy balance of bacteria in the gut and the right digestive health supplement can help create just that. Susan J. Hewlings PhD RD and chief science officer with Oklahoma-based IgY Nutrition added that research suggests that a disruption in the microflora of the GI (gastrointestinal) tract called dysbiosis creates an undesirable immune response and related chronic inflammatory conditions. It has been linked to many other conditions such as gastrointestinal malaise obesity diabetes arthritis etc. Dysbiosis is defined as a shift in the microbiota composition resulting in a decrease in the number of beneficial microbes accompanied by an increase of harmful microbes in the intestinal tract. There is a connection between dysbiosis and immunity. Research indicates that 70 to 80 percent of the immune system originates in the GI tract. Addressing GI tract health and any potential dysbiosis is the place to start in improving overall health that therefore automatically addresses the underlying cause of so many conditions. Enzymes The best ingredients for healthy digestion are enzymes already found and being produced in the human body January February 2018 said Brown. For example amylase is an enzyme present in the saliva of humans and some other mammals where the digestion process begins. By supplementing additional amylase in a diet it helps start the break down of starch. There is not one set group of consumers for digestive products because all people consume food and can use help digesting the individual components. Enzymes can help with the symptoms of poor digestion like bloating and gas to improve the way you feel. American Laboratories Pancreatin is a digestive enzyme secreted by the hog pancreas that the company isolates in its manufacturing process. Pancreatin contains protease amylase and lipase for the breakdown of proteins starches and fats respectively Brown explained. This all-encompassing product makes for a great overall digestive health product due to the three enzymes found within the product that each target a different component to break down. Pancreatin s enzyme components are a naturally occurring within the human body so by supplementing your diet with a digestive aid containing Pancreatin it helps boost your natural digestion process. Deaton noted that most consumers who incorporate enzymes into their supplement plan are well educated (they invest a lot of time researching the products that are best for them) brand loyal and typically lead healthier and more active lifestyles. Because our bodies natural ability to produce digestive enzymes declines as we age enzyme supplements are also a popular choice to aid in digestion for increasingly popular healthy aging market he said. Enzyme supplements continue to gain recognition among consumers for their role in digestive health and bioavailability of nutrients from foods. The ability to break down food into its basic and useful components is of critical concern for consumers interested in functional nutrition for growth development and supporting healthy aging. Marc Jensen technical marketing manager with Virginia-based BIO-CAT Microbials noted that along with essential vitamins and minerals the company believes that digestive enzymes and probiotic supplements are necessary since modern food production and processing may be eliminating these from the supply chain. Our aging population may be increasingly deficient in natural digestive enzymes. There is a growing list of health conditions where enzymes deficiencies have been identified and many of our most shelf-stable foods have been processed with pressure and heat to eliminate natural enzymes and beneficial microorganisms. BIO-CAT offers a curated portfolio of natural non-GE (genetically engineered) digestive enzymes in custom formulations blending to manufacturers specifications for optimal performance at physiological pH and temperature. Hydrolytic enzymes and beneficial living organisms that enhance metabolism by lowering the amount of energy required for digestion while reducing gas production and reducing the duration of bloating. Pro- and Prebiotics Regarding probiotics and prebiotics Deaton added We ve all witnessed the tremendous increase in awareness of the benefits probiotics can offer for digestive health by helping maintain a healthy balance in the intestinal microbiota. In fact accelerated product innovation and clinical research on the benefits of probiotics have created the momentum for an expected 6.5 percent CAGR (compound annual grown rate) in the probiotics market over the next five years. Probiotics such as Lactobacillus and Bifidobacteria have been well studied and the science is supportive of the benefits of these non-spore probiotic strains. Since different strains offer specific benefits our customers are increasingly seeking a multi-strain formulation of both non-spore and spore forming probiotics Deaton said. Based on this demand more science is emerging to support the benefits of spore forming probiotic strains such as Bacillus subtilis. Deaton explained that Deerland has genome sequenced for safety and clinically tested for efficacy DE111 a highly effective strain of Bacillus subtilis a very stable probiotic spore that supports digestive health and works as a complement to many of the non-spore strains that are also available. The genome sequencing confirmed the strain contained no plasmids antibiotic resistant or deleterious genes. Three separate human clinical studies have been performed on the strain which showed the strain s ability to control microbial populations aid in digestion maintain general health and support regularity he said. In addition research has shown that there are certain prebiotics that can increase the benefits of probiotics however these fiber-based prebiotics often come along with several drawbacks he said. In response to this growing trend Deerland s research and development team introduced a unique prebiotic that is not fiber or starch based is highly effective in small doses (15 mg) and does not exhibit any of the drawbacks of more commonly used prebiotics. This novel prebiotic called PreforPro is backed by both in-vitro and human clinical studies that demonstrate its superiority to the typical fiber-based prebiotics that have been used to date. Dr. Larry Robinson vice president of scientific affairs with Embria Health Sciences in Iowa noted that maintaining a healthy gut is not a one-size-fitsall proposition. That s why we believe that supporting your existing microbiome is the best way to start he said. Probiotics are a good way to introduce certain bacteria into the body but may not support the great diversity of beneficial bacteria present in the gut. Published human clinical studies have shown that the company s EpiCor fermentate a natural fermentation ingredient helps to beneficially shift the composition of the gut microbiome while reducing bloating and feelings of fullness. Prebiotic fibers on the other hand may increase bloating and feeling of fullness. Robinson added that combining probiotics and EpiCor could be a synergistic formula for consumers wanting an advanced solution. People who are looking to support their gastrointestinal health usually have moderate digestive problems Robinson said. He pointed to a study the company conducted in February 2017 of 1 052 people--18.82 percent of those surveyed take digestive supplements to support their overall health and wellness (20.3 percent) digestive discomfort (15.6 percent) and bowel function (15.23 percent). Further 69.10 percent of people surveyed are interested in digestive supplements but aren t taking one because they are confused about all the choices (21.94 percent) or don t suffer enough from digestive issues to buy a supplement (16.53 percent). There is still a lot of education needed to help consumers understand what digestive health options are available Robinson said. That s why in addition to providing published research to the Nutrition Industry Executive 45 January February 2018 Digestion Developments market Embria is continually contributing to awareness by creating educational content through video blog social media and website platforms. Probiotics in Breast Milk Among probiotics strategies the use of probiotics naturally found in breast milk is particularly interesting said Beatriz Botija R denas health care product manager at Biosearch Life in Madrid Spain (Stauber is the exclusive U.S. distributor for Biosearch Hereditum probiotics). Some of these microorganisms which contribute to initiating correct colonization in the infant intestine have been isolated and characterized showing a high probiotic potential R denas said. This is the case in Lactobacillus fermemtum CECT5716 LC40 a strain originally isolated from breast milk with high antibacterial and immunomodulatory potential. The beneficial effect of this strain has been demonstrated in several clinical tests among hundreds of children. Continuing with the strategy of using strains from breast milk origin Lactobacillus gasseri CECT5714 a strain isolated from breast milk in combination with a strain from goat milk Lactobacillus coryniformis CEC5711 induced changes in the water content of the feces stool volume and frequency of bowel movement evidencing the capability of this probiotic combination to improve intestinal function. This effect may be related to an increase in the production of short chain fatty acids (SCFA) R denas explained. These metabolites produced by microbiota activity are the main energy source for colonocytes and contribute to several gut functions including carbohydrate and lipid metabolism control of the colonic pH maintenance of the integrity of the colonic mucus intestinal mobility or absorption. Interestingly it has also been observed that an increase in the fecal bulk dilutes carcinogens mutagens and tumor promoters and results in a lower risk of colon cancer while a faster transit can reduce exposure of the gut mucus to potential cancer-inducing agents that may be found among the intestinal content. In addi46 Nutrition Industry Executive tion the presence of butyrate is usually linked to anti-neoplastic activities such as increased apoptosis lower proliferation rate or down regulation of angiogenesis. Therefore the maintenance of butyrate concentrations in the colon may be considered as a potential health-promoting factor because of its potential role in the prevention of colon cancer. The modulation of intestinal microbiota by probiotics is an efficient strategy to prevent diseases and alterations in the gastrointestinal tract R denas added. Probiotics originally isolated from breast milk are an excellent alternative for taking advantage of the strains naturally transferred from mothers to influence infant colonization she said. Ingredient Actions Embria s EpiCor ingredient is clinically shown to strengthen the immune system and support GI health Robinson pointed out. The latest human clinical trial shows that EpiCor significantly improves overall digestive comfort including less bloating and feelings of fullness while supporting stool consistency in those with mild constipation. EpiCor may also help increase the frequency of stools. All this is accomplished with a low 500 mg dose compared to multiple grams needed for prebiotic fibers. These improvements in digestive health may be linked to EpiCor s ability to help beneficially shift the microbio- me Robinson said. A higher ratio of firmicutes to bacteroidetes has been shown in subjects with constipationassociated digestive problems. EpiCor has been show to decrease this ratio through relative decreases of unfavorable bacteria within the Firmicutes phylum and a relative increase in the Bacteriodetes phylum. In particularly EpiCor helps boost beneficial bacteria by significantly increasing bacteroides and prevotella in the Bacteroidetes phylum which are known to help reduce gastrointestinal transit times. EpiCor was also shown to increase anaerostipes a beneficial genus in the Firmicutes phylum recognized for its health enhancing effects and contains acetate- and lactate-consuming bacteria and butyrate-producing bacteria. Butyrate is known to support immune health and this increase in anaerostipes may link EpiCor s ability to modulate the microbiome with its immune health benefits. EpiCor also helps increase Akkermansia muciniphila a genus important for proper gut function and is inversely correlated with metabolic disorders. Samantha Ford business development manager with AIDP Inc. in California said the company has several natural ingredients in the digestive health space that are scientifically proven through human clinical studies and consumer feedback to support digestive health. For example AIDP s PreticX XOS (xylooligosaccharide) prebiotic has been shown in human clinical studies to selectively boost healthy bifidobacteria while reducing unhealthy bacteria in the gut. A major advantage of PreticX is its clinical effectiveness at low dosages compared to other ingredients in this space thereby greatly reducing undesirable side effects Ford said. Another example is AIDP s Livaux prebiotic which is a whole kiwifruit ingredient shown to increase healthy Faecalibacterium prausnitzii (F. prau). F. prau is the most abundant bacteria species in the gut accounting for approximately 8 percent of the total colonic microbiota and is extremely important for production of short chain fatty acids in the gut maintaining gut barrier function and reducing oxidative stress. Despite its importance F. prau is sensitive to oxygen and cannot be obtained through supplemented probiotics lending to the uniqueness of Livaux and its ability to naturally support healthy F. prau levels. January February 2018 Supporting prebiotics Hewlings noted that IgY Max is a polyvalent antigen specific IgY product from specifically immunized eggs that target 26 of the most common human-relevant pathogens. It supports the role of prebiotics by aiding in immune system function and by decreasing bad bacteria while leaving the good intact. The ingredient promotes GI health by increasing gut wall integrity improving bowel function and reducing non-beneficial bacteria adherence. In addition to favorably altering the composition of the microbiome IgY Max supports the digestive tract lining promotes proper microbial adhesion supports immune system health supports the body s natural defenses and promotes proper cytokine balance. Moreover IgY Max is able to exert its activity within the entire length of the GI tract. Due to its mechanism of action IgY Max is an effective tool to address issues caused by dysbiosis. Ingredient Evolution BIO-CAT acknowledges a multitude of factors that aided the evolution. As the dominant supplier of digestive enzymes into the current supplement market Jensen said BIO-CAT continues to validate the premium quality of these enzymes supporting improved transparency within the Food Safety Modernization Act (FSMA) Farm to Fork and other initiatives. As a fully integrated manufacturer and supplier of shelf-stable probiotic strains BIO-CAT Microbials is identifying new probiotic delivery options for its customers to deliver living beneficial probiotics even at the end of shelf-life. Ford added that the knowledge on prebiotics has grown exponentially over the last five years which has led to new prebiotics such as XOS entering the market. She pointed out that AIDP s PreticX XOS received its U.S. Food and Drug Administration (FDA) generally recognized as safe (GRAS) notice in 2014 making it suitable for food and beverage applications in addition to dietary supplements. This is important as consumers are increasingly interested in alternative delivery formats--such as gummies stick packs ready to drink beverages and even functional snacks and bars as opposed to traditional capsules and tablets. Overall Consumers are drawn to natural ingredients that are not synthetically produced Brown said. She pointed out that Pancreatin an enzyme that has been on the market for more than 75 years has stood the test of time. Research and Trends Consumers are increasingly recognizing that they might have difficulty with normal digestion of some wheat and dairy foods said Deaton. Eighteen million Americans believe they have difficulty digesting gluten while a whopping 50 million report discomfort due to ingestion of dairy products (Center for Celiac Research and Treatment American Gastroenterological Association). Maximizing digestion of proteins helps to support overall health and wellness and enzyme-based solutions can help. To address the growing demand for products that address food sensitivities Deerland s products Glutalytic and Dairylytic have been designed to optimize digestion of gluten and dairy proteins. Robinson added People are hearing and learning more about the microbiome and we believe that it will be the Go to americanlaboratories for info about this advertiser January February 2018 Nutrition Industry Executive 47 Digestion Developments continuing trend in the digestive health area over the coming years. In fact according to our February 2017 survey more than half (55.71 percent) are aware of their gut microbiome. We expect this number to continue to increase. And consumers expectation for efficacy is high. We are encouraged by the increasing demand from our customers to develop more complex products that have scientific validation and human clinical support where appropriate said Deaton. Many of our customers continue to challenge us on a daily basis to ensure that our products are first and foremost safe and that they re efficacious. Brand marketers are rightfully so expecting clinical substantiation for their products. Conscientious brand marketers are supporting their efficacy claims with data grounded in good fundamental science. Oftentimes marketers are somewhat limited regulatorily in what they can claim in terms of efficacy. The FDA allows structure-function claims only which don t always resonate with consumers. Brand marketers rely on published human clinical studies that can really explain the effect of the product in depth. Formulating products with branded ingredients is especially beneficial in this regard since those ingredients are well studied and publicized--information that is easily accessible by the consumer. Also to consider said Jensen The natural food sector continues to expand through entrepreneurship and start-ups while major food companies are increasingly interested in competing by extending traditional and established product lines. Upstream processing using natural enzymes and the addition of digestive enzymes and probiotics into nondairy non-refrigerated shelfstable products will continue. Hewlings agreed noting that there are new products emerging all of the time too many to list but with varying mechanisms of action. I expect to see continued development in methodology and in defining what is a healthy microbiome. In addition I expect to see continued research on the connection between the microbiome and its human host at the genetic and molecular level and how nutrigenomics and other aspects of host environment impact this. This will lead to improved development of products to support the development of a healthy microbiome which will in turn positively affect health and potentially longevity. NIE Extra Extra Visit to read about certain fibers effect on appetite GI wellness and decreasing inflammation of chronic disease. FORMOREINFORMATION Go to adh for info about this advertiser 48 Nutrition Industry Executive AIDP American Laboratories BIO-CAT Biosearch Life Deerland Enzymes Embria IgY Nutrition January February 2018 THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights March April May June July August 2 2 18 ad closing Longevity & Aging Supplyside East Show Issue Bone Muscle & Joint Health Cognitive Health Science of Ingredients Vision Health 2018 NIE Supplier Sourcebook Company Profiles Compliance and Improving Quality 3 19 18 ad closing 4 11 18 ad closing 5 16 18 ad closing 6 28 18 ad closing Our 2018 Media Planner Is Available At 2018-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF Gary Pfaff at (732) 432-9600 ext. 103 or e-Mail GaryP From renewing its focus on science to experiencing an Amazonian market entry to re-thinking natural--the natural products industry forges ahead. By James J. Gormley The Participants Are Jonathan Emord JD Emord & Associates Clifton VA Arundhati Kasbekar Senior Manager Regulatory Affairs Freyr Solutions Princeton NJ Randy Kreienbrink Director of Marketing BI Nutraceuticals Rancho Dominguez CA Mark A. LeDoux Chairman and CEO Natural Alternatives International Carlsbad CA http Chair Board of Directors Natural Products Association (NPA) Washington D.C. 50 Nutrition Industry Executive Dan Lifton President Maypro s Proprietary Branded Ingredients Group Purchase NY T Michael McGuffin President American Herbal Products Association (AHPA) Silver Spring MD Steve Mister JD President and CEO Council for Responsible Nutrition (CRN) Washington D.C. Brian Zapp Director of Marketing Applied Food Sciences (AFS) Austin TX ransparency in the natural products industry is becoming much more than a business ethic--especially in light of a rise in cases of intentional adulteration of supplements-- what some might call a moral imperative. With the natural industry faced with dramatic price spikes from some foreign suppliers natural companies may well wonder what the future holds regarding internet commerce versus brick-and-mortar (can anyone say Amazon and Whole Foods ). Uncertainty also exists among regulatory prognosticators as to whether the anti-over-regulatory winds in Washington will blow elsewhere especially in states such as New York and California which have what many might call a hyper-regulatory or nanny-state posture in regards to dietary supplements. Concerns about this however are tempered by a general upswing in consumer interest in supplementation along with a growing industry focus on science and innovation. Innovation guru John Costa recently wrote that it s possible that innovation is less the elemental magic of creativity and more a function of timing and stimuli carefully injected into a linear process. He said January February 2018 that we shouldn t wait for those eureka moments but instead move the process along with well-placed nudges. Here s to more nudges and more science in 2018. NIE What do you feel were the biggest industry issues of 2017 and why LeDoux There were several major issues involving the industry in 2017. The FDA (U.S. Food and Drug Administration) appeared to take a more aggressive role along with the Federal Trade Commission (FTC) in dealing with products they deemed to be adulterated or misbranded. Seizures and fines were levied against several companies and individuals evidencing a renewed interest in achieving compliance with federal laws. There has also been a proliferation of all things CBD (cannabidiol) but my prediction is that the federal government in actions soon to be forthcoming from the Department of Justice will begin to reign in what many perceive as some rogue-state activities. Clearly there is room for federal oversight and regulation here given the obvious concerns over interstate commerce banking regulations and other statutes on the books already. The election of a new president in late 2016 and the resultant executive orders issued requesting reductions in regulations has been significant in our space as well. The delay in implementation of what many perceive as unnecessary changes to label presentations of nutritional facts in foods and supplements is also demonstrative of this bias. Foreign suppliers raised prices of raw materials in some cases by over 100 percent. Presumably this was caused by concerns over environmental pollution needing to be controlled in foreign markets such as China but this was also caused by problems in other production facilities in Germany which suffered from facility interruptions. These price increases are now negatively impacting many suppliers and retailers who have endured price increases without the capacity to pass these along to their customers. The internet commerce of dietary supplements and natural products is now becoming a game-changer when evaluating business models involving heavy capital expenditures and lease costs for brick and mortar businesses versus virtual companies with reduced distribution costs such as Amazon. The fact that Whole Foods Markets was acquired by Amazon also demonstrates the blurring of commercial lines of contact points with the retail customer. Mister Well I may be a little biased but I think the launch of the Supplement OWL the new dietary supplement registry was one of the most significant events for the industry. It has been well-received in the first few months by product marketers and retailers alike. The Supplement OWL has the potential to be a game-changer by showing our regulators and retailers a new level of transparency about our products and their supply chains. Beyond the Supplement OWL the Amarin complaint before the U.S. International Trade Commission (ITC) was a disturbing development this year. Its effort to gain a monopoly on esterified EPA fish oil by declaring it to be a drug was a broadside attack on accessibility of omega-3 products for consumers. As the year closed the ITC rejected the complaint but an appeal is in the works. CRN will continue to fight to keep these products widely available as dietary supplements. And lastly the direction of the new Trump Administration has recognized that burdensome regulation doesn t enhance public health but just creates unnecessary costs for compliance. The delay in the label change regulation the willingness of FDA to engage with industry on new dietary ingredient (NDI) master files and the realignment of expertise within the agency all illustrate a new--and welcome--approach by FDA. Emord A gift to Monsanto congres- sional passage of legislation to preempt state GMO (genetically modified organism) labeling laws was a great disservice to American consumers and the First Amendment. The Amazon Whole Foods union invites a potential for a vast expansion in the market reach of select industry products. Zapp An ingredient supplier has an interesting perspective when it comes to studying the changes within the industry. In 2017 we found a lot of companies coming to AFS with their challenges in achieving a clean label. While we all know that clean label generally refers to more natural and recognizable ingredients rather than chemical sounding synthetic ingredients. What most people don t realize is that using natural ingredients can be very difficult to formulate with and are not so simple to substitute in current formulations. Therefore to obtain the same flavors and functionalities as synthetic ingredients manufacturers need to find the right ingredient options for their products. The biggest hurdle is in solubility and flavor. But with the right extracts this can be achieved. It is really making clean label products particle. Another industry issue we are seeing emerge and become more important to manufacturers is sustainability. It is difficult to ignore the planet. Consumers are becoming more aware that in many cases where raw materials are sourced global living conditions are poor and the earth is easily taken advantage of. For companies like AFS we recognize this problem and have taken serious steps by creating our own responsible sourcing initiative that includes sustainable growing socially responsible sourcing and full traceability. Consumers feel it is their right to know where and how their ingredients are sourced. McGuffin There continues to be growing interest by larger companies to expand into the natural health product markets by purchasing brands that have built a reputation for quality and ethical business practices. This is in line with the broader trend of natural health products being adopted by mainstream America. Some examples of this in 2017 include the purchase of AHPA members Tazo and Pukka Herbs by Unilever and Nestle s purchase of Atrium which owned several brands including Garden of Life and Pure Encapsulations. The Trump Administration has provided an opportunity for the industry to request changes to regulations that Nutrition Industry Executive 51 January February 2018 impact them to reduce burdens on industry while continuing to maintain protection for consumers. Kreienbrink The biggest issues in 2017 will remain as challenges for the coming year. These include transparency quality and the existence of meaningful factual scientific efficacy studies. of concept and evidence of benefit conducted in a vigorous scientific method protocol are essential for having a shot at commercial success. Emord Contrary to media perception of the dietary supplement industry it has always been a dynamic everimproving industry providing overall better quality and service year after year. That is due to competition far more than to FDA prior restraints the latter create anti-competitive barriers to entry and often punish those innocent of causing any actual harm to consumers those whose only offense is a technical violation of regulation. NIE Companies are drilling down into better processing better bioavailability better delivery essentially better mousetraps. Is this good and if so why Are there no new mousetraps any more Lifton While on the one hand everything in nature or naturals already exists in some basic form it is also true that A we only have identified a small percentage of what exists and is potentially active and B we only understand a small fraction of what we have found actually does and C we are finding better and better ways to improve on what we are able to both harvest from nature and harness using science. And so as for better mousetraps a vast majority of the most exciting things in natural products research and development today are happening with proprietary branded ingredients natural ingredients extracted processed mixed composed or delivered in special more effective ways. LeDoux This is a very interesting development but points out the value of transparency in sourcing supply chain processing and finished product development and production. Companies that are willing to invest on the front end of the supply chain and further invest in the science of substantiating the finished product in populations of intended use are assuming leadership roles in the industry. No longer do celebrity endorsements carry the day with the marketing messaging. The FTC has also weighed in here on multiple occasions and in various selling channels such as multi-level marketing with the erection of some additional commercial guard rails. The real issue here is that just claiming a better mousetrap is not going to get a hall-pass from the regulators or the attorneys general any more. Proof 52 Nutrition Industry Executive can help consumers understand the strength of scientific evidence behind those claims. Moreover when a visual aid is included consumers perceive the scientific levels more clearly and have greater confidence in their meanings. Although these surveys suggest that consumers react differently to different advertisement claim levels it is not yet clear whether consumers understand the variations in the degree of scientific support. Understanding consumer responses to advertisement and mouse trap claims is critical when designing regulations. [The] government s goal is to permit the use of a larger number of better easily understood and up-todate scientific information on advertising messages to communicate how food choice can affect the health of consumers. Policymakers should therefore try to enact regulations that will ensure that the exact meanings of claims are presented to consumers. Qualitative studies such as focus group interviews may be helpful in identifying more specific disclaimers and effective ways of delivering health messages for food or food components. Zapp When it comes to working with botanical ingredients improvements are necessary to meet the demand for the natural and organic market. One great example is in answering the questions how do we improve absorption both in finished products and in the body This process starts by improved research and understanding of how specific compounds within botanical ingredients impact the human body. This leads to improving extraction methods to isolate targeted active compounds this leads to the need for improved identity testing and verification processes to ensure those actives are really present in the finished product. Trying to improve in all of these areas ultimately leads to new discovery of botanical ingredients that can do more. Kasbekar Most of global surveys provide compelling evidence that better mouse traps providing advertisement claims with qualifying language and differentiating levels of scientific evidence NIE While USDA (U.S. Department of Agriculture) Organic and GMO (genetically modified organism)-free have arguably become much more pervasive and a bit more cost-effective in foods and supplements there has been a big (perhaps) bigger push for local especially in the produce aisle. True If so is this good or bad Is local the new organic McGuffin AHPA has observed a growing trend of consumers willing to pay a premium for products made from U.S. domestic and locally produced ingredients. AHPA supports organizations helping farms meet this growing demand and featured two of these groups at the AHPA Botanical Congress. The recent efforts of the Appalachian Beginning Forest Farmer Coalition (ABFFC) and Vermont Herb Growers Cooperative (VHGC) is a testament to the growing demand for locally produced medicinal herbs. Zapp Consumer s drive to shop local hits on two core values trust and responsibility. To help align with these values local really translates to a desire for products to be more accessible transparent and trustworthy. But this idea of shopping local is really misleading as a majority of consumer packaged goods contain ingredients that are sourced from all over the world. January February 2018 Therefore the real challenge is to bring the values behind shopping local to the consumer no matter where the ingredients are sourced for the products they purchase. Manufacturers should ask themselves what would it take for our supply chain to be so transparent that consumers can feel that same trust and idea of responsibility no matter where their ingredients come from Sure any respectable supplier should have a FSVP (food safety verification program) in place which will provide some of that ground work. However consumers are really saying Show me don t tell me Show me who is growing these ingredients as if they were my local farmer. Show me how both the environment and the local people are being cared for so that future generations can benefit from the same ingredients I am benefiting from today. That is true transparency. That is the true value of local. Lifton Organic and natural have become very big and very important for the industry and for consumers. Local as in locally sourced ingredients and produce has become a buzzword that is true. And when local means supporting farmers growers and communities as in sustainable then I think there is real muscle behind the mantra. That s one of the reasons we ve become involved in the Organic & Natural Health Association because we re committed to the real power and promise of naturals not just the words. LeDoux With the Millennial market calling for non-GMO and organic products it is clear that the demand exists for these products. The challenge is in achieving and maintaining certification of these claims. Consequently there is now an undeniable trend for local source production of foods and this speaks to the tribalization of our culture which has been a mega-trend in consumer behavior for the last 10 years. Kreienbrink This is true. Local is certainly a positive but can be very confusing to the consumer. What is local If you live in Chicago and you re eating fresh vegetables from California in the middle of January is this considered local Marketers are stretching the limits and meaning of the term local. Kasbekar Is local the new trend like new organic Yes it is but let s bear in mind that this is not totally new. During the pre-globalization era our way of living was primarily local produce and local consumption. With globalization and efficient supply-chain infrastructure we now have access to a variety of global products in a competitive market with better prices. While it is certainly a great advantage we also have to face challenges such as longer shelf life requirements unwanted preservatives and ingredients that need to be regulated and monitored closely to avoid health risks and frauds. I believe in increasing awareness of organic operations that demonstrate protecting natural resources conserving biodiversity and using only approved substances. At the end of the day the responsibility lies with consumers to make the right choices based on scientific evidence their personal beliefs [about] ecological issues price points food and health needs. NIE While calcium may be an old standby magnesium has been attracting a great deal of interest over the last several years but is the industry doing Go to generexlabs for info about this advertiser January February 2018 Nutrition Industry Executive 53 a great job in making a case to consumers as to why we need to supplement with this heart-healthy mineral If this is a problem what would the lesson be LeDoux Amazingly the consumer knowledge of the role of magnesium is limited even though the established and ample body of science concerning bone mineralization shows convincing evidence that calcium is best metabolized in the presence of magnesium vitamin D and other micro-minerals such as boron. The economic question here is how does a company achieve a satisfactory return on investment of marketing messaging for what essentially is a commodity business Lifton There s a lot we can do to overcome the commoditization of magnesium and its bad rep. Magnesium is just one of many examples where both absorption and tolerability can be a challenge too. Sucrosomial Magnesium which we offer is a highly bioavailable complex of magnesium hydroxide providing elemental magnesium derived from the crystal-clear waters of the North Sea and which is encased in a liposomal-like structure helping consumers to avoid the diarrhea and nausea that are sometimes experienced with conventional magnesium ingredients. Emord The greatest impediment to dissemination of truthful information concerning the health benefits of magnesium (as well as all other vitamins and minerals) remains the FDA. The FDA s evidence based system of review for health claims manipulatively truncates the universe of reviewable scientific evidence to such an extent that credible science-backed claims continue to be suppressed long after the U.S. Court of Appeals in Pearson v. Shalala ordered otherwise. Rather than favor disclosure over suppression FDA continues to favor suppression over disclosure. as sildenafil. What are we doing right What do we need to do better Mister Companies across the industry are embracing what some have said for years you can t test quality into a product at the end quality is the result of attention paid throughout the supply chain. The adoption of good agricultural practices and cultivation practices and the increased focus on identity and purity throughout processing and manufacturing are evidence of that recognition. Quality issues that used to result from inadvertent errors or carelessness should be greatly reduced with this new paradigm. However kratom adulteration with sildenafil and the introduction of selective androgenic receptor modulators (SARMs) all illustrate another reality that some companies will intentionally ignore the law and put their consumers at risk. The greatest impediment to dissemination of truthful information concerning the health benefits of magnesium (as well as all other vitamins and minerals) remains the FDA. -- Jonathan Emord Emord & Associates As 2018 rises all responsible companies should recommit to drive these outliers from the industry by refusing to deal with companies who market these products. ABC s new program urging firms to destroy illegal ingredients when they receive them is one good way to start. LeDoux The recent proclamation from the FDA commissioner on this matter involving kratom is welcome. The presence of adulterants or APIs (active pharmaceutical ingredients) which are undisclosed in botanical blends is essentially criminal behavior and needs to be prosecuted to the fullest extent of the law. This means the FDA and ICE Homeland Security need to tighten the border entry points increase random raw material testing seize offending products and fine exporters and importers once evidence of criminal intent to create adulterated products has been established. This is a case begging for more enforcement versus more regulation. Kasbekar While there have been a number of FDA-enforcement actions in 2017 leading to recalls the number of hospitalizations due to food-based illness has not reduced. The records indicate that every year 130 000 people in the U.S. are hospitalized with a foodborne illness and out of them 3 000 people die. A new report from the Department of Health and Human Services Office of the Inspector General raises some red flags about the FDA inspections program. Overall the report concludes that the FDA consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations. And in 17 percent of the cases the FDA did not conduct a follow-up inspection at all. Also in some instances where inspectors found significant violations the FDA took no enforcement action. The creation of [an] oversight group within the FDA called SCORE which stands for strategic coordinated oversight of recall execution has played a critical role in thousands of product recalls that FDA oversees each year. FDA should continue to adopt creative ways of expanding public notification of recalls that may affect the most vulnerable consumers including the very young and elderly. NIE Industry organizations have endorsed GMPs (good manufacturing practices) for botanicals which is good but this year has also been a banner year for kratom sales and adulteration with undeclared drug ingredients such 54 Nutrition Industry Executive NIE Hemp madness is alive and well in this case CBD oil. The FDA does not seem to be a fan of CBD as an ingredient in supplements salves balms and other non-medical delivery forms correct With a murky landscape of IND filings and some companies throwing in the towel others are digging in their heels. Where do you think we will or should net out on CBD LeDoux My opinion is that CBD oils have remarkable benefits but they need to be produced under strict GMP guidelines and federal oversight of the FDA. This wild-west state s rights approach is leading to a myriad of problems which can significantly and negatively affect users given the real potential of variability in finished products in terms of purity and potencies. There are multiple reasons that the federal government needs to oversee this in terms of production licensure distri- January February 2018 bution and regulation and that is what I believe is going to happen in the not too distant future. Emord As with all ingestible products the standard needs to be the Paracelsian Principle of Harm. If CBD at the dose recommended produces adverse physiological effects it is properly forbidden by the FDCA (Federal Food Drug and Cosmetic Act) but only at that dose level and above. NIE Way back when mom and pop retailers were very worried about Whole Foods and Wild Oats stores opening up near them but in many cases net general interest in natural went up and mom and pop sales stayed steady or even grew as a result. Now Whole Foods is again on the radar in this case with Amazon. Now Kroger s sales are surging--is this a halo effect again or something else What does the whole Amazon Whole Foods thing mean for the industry short term and long term Kasbekar Amazon s acquisition of Whole Foods is not merely an expansion into the grocery business. I believe it is going to fundamentally change the way consumers buy and receive food. Amazon is following a market opportunity for [a] value vacancy that can be exploited through a digitally enabled business model. While groceries are not new to Amazon this acquisition is the company s first significant investment in the industry. Despite Amazon Fresh the grocery sector is one of the last large retail sectors where Amazon does not have a significant share. At the same time the food-delivery market represents a significant revenue opportunity. Amazon has made its fortune by selling products at prices most competitors can t match while driving revenue through membership programs and other services. In the short term Amazon doesn t have to operate at a profit as other grocery retailers do. In the long term if Amazon operates the fresh groceries business at a very low margin while driving profitability through its Prime membership and cash from other areas many grocery chains won t be able to compete. LeDoux A rising tide lifts all boats. The challenges here are remaining relevant to your consumer base. If you are running a small store or small chain what makes you locally essential for your community Is it education Is it carrying locally produced products Is it providing a value proposition that is larger than just having fair pricing Amazon s purchase of Whole Foods is really an endorsement of brick and mortar for local communities in terms of a centralized shopping experience. At the end of the day the consumer wants to buy their natural products where they buy their canned goods paper goods and household cleaners because it is all about convenience. There is a reason that Walmart is the largest grocer in America today. McGuffin It is likely too soon to assess the full impact of this acquisition but it is part of an increasing trend of large companies buying ethically focused brands that have built a reputation of providing high quality products that promote consumer health and wellbeing. These acquisitions also provide an opportunity to enhance both brands by combining their strengths. It can be a tenuous balance but other companies have walked this line successfully in the past. NIE Where did we as an industry wind up with the whole ODI (old dietary ingredients) list process Mister I think it s too soon to assess how FDA s efforts to create an ODI list will net out. If the FDA process only gives safe harbor to those ingredients already widely recognized as old will it be worth the trouble What we are seeing is a new openness at the agency to try and resolve the outstanding issues around NDI (new dietary ingredient) notifications. The industry needs to reach resolution on these issues because achieving a predictable and certain process for bringing new ingredients to market is desperately needed. The climate of uncertainty around NDIs will stymy innovations. Hopefully 2018 will provide strong progress in this regard. LeDoux I think the ODI list process was part theater and partly an exercise in regulatory discretion. The likelihood of a list being adopted by the FDA of pre-1994 DSHEA (Dietary Supplement Health and Education Act of 1994) usage for dietary ingredients is remote at best but the NPA just published for purchase a fairly seminal and exhaustive compilation that should withstand regulatory scrutiny should a dietary ingredient found there be challenged for suitability by regulators. Kasbekar We at Freyr as a regulatory consulting company have begun [advising] our customers about creating a riskbased analysis that entails compiling a Nutrition Industry Executive 55 January February 2018 list of every dietary ingredient in their products and then evaluating these ingredients. A detailed assessment based on the following questions is presented to the client for this purpose Does this ingredient meet the definition of dietary ingredient Is there adequate documentation for this ingredient s ODI status Has the product undergone a manufacturing change Does some food supply exemption apply and if so has the ingredient been chemically altered Has my supplier submitted an NDI notification or is there a GRAS (generally recognized as safe) affirmation No matter which way the list is analyzed the objective is to have a picture of the company s current exposure and an understanding of steps to take to minimize potential risks. This will help locate ingredients that may require an NDI notification so that a company can be fully prepared to submit a notification if it is determined to be ultimately necessary for regulatory compliance. While the past year has not provided greater insight into the long-term effects of the 2016 NDI Draft Guidance it has been helpful to have the time to digest the revisions and strategize future compliance. While there is no sign as to when the FDA will finalize the NDI Draft Guidance the industry [...] has started to determine how it will comply when the decision rolls out. It is expected that there will not be any major changes in the final guidance so the best step is to begin planning now to minimize potential pitfalls. NIE What are your big predictions for 2018 in terms of category growth specific supplements and ingredients challenges and opportunities at wholesale and retail Mister 2018 promises increased growth and acceptance of dietary supplements for promoting better health. The industry will make a strong case for allowing recipients of SNAP (Supplemental Nutrition Assistance Program) benefits to purchase a multivitamin with those benefits. This platform 56 Nutrition Industry Executive will allow us to raise awareness of the realities of nutrient insufficiencies particularly among low income Americans and the role supplements can play in alleviating them. Developing research on nutrigenomics and individualized medicine will help us better understand unique nutrient requirements and lead us toward more individualized supplement regimens. Probiotics will continue their growth along with overlooked nutrients like choline iodine and magnesium. And lastly even as the scrutiny from states attorneys general may be waning private class action litigation directed at the industry will continue. Fortunately several influential courts have signaled that they will require evidence of real harm to allow these cases to move forward. Zapp Complex flavors [are] on the rise--in foods and beverages we have had noticed a number of manufacturers requesting more complex flavors like turmeric. Generally the ayurvedic tastes of India tend to be on everyone s radar and ingredients like ginger and turmeric are heavily sought after right now in new product development and R&D. As food changes and adopts more of a clean-label footprint the landscape of supplements is slowly evolving to follow suit. Many large sports nutrition and supplement companies are now requesting organic ingredients to green-up their labels. Especially in sports nutrition labels used to be dominated by hard to pronounce branded ingredients the more the better. Today we are seeing products being developed in this space with fewer but more specific ingredients. Organic tends to be a big emphasis and we can expect that to continue in 2018. Kasbekar The industry is constantly trying to introduce a variety of products catering to different customer segments. For example there is an increasing demand for the vegan variants of nutraceuticals targeting the global vegetarian population. Omega-3s traditionally extracted from fish have been developed with vegan variants obtained from algae and flaxseed oil. There are also surveys that emphasize the increasing demand for vegan-based protein supplements. I believe some of the niche segments such as anti-aging energy boosting skin care digestive care may continue to grow in 2018. There are predictions for high growth in categories such as fortified water fortified noodles sports and energy drinks etc. LeDoux I think 2018 will see the advent of CBD regulations at a federal level. I think that Congress will be more receptive to the role of supplements in disease prevention or management and the value of having supplements and healthy foods as a component of the WIC (Women Infants and Children) and SNAP programs for people in need. Furthermore I think more and more large companies of all sorts will be making investments in this space and increasing consolidation because the consumer demand is real and growing. Challenges that remain will be spotty enforcement of economically adulterated goods or supplements with undisclosed APIs that are illegal per se and the industry needs to hold the regulatory agencies accountable for enforcement. I also think there will be some changes involving anti-doping of athletes enhancement of concussion prevention protocols in contact sports such as football and more work done on providing supplements to the fastest growing segment of the population namely the aging Baby Boomers who remain influential and affluent as they head for their sunset years. Lifton In terms of challenges intentional adulteration of dietary supplement formulas and ingredient mixes has become a big problem where we need much more enforcement in 2018 not more regulation. Plus we need a better argument to counter the anti-supplement narrative than Drugs are much more dangerous than supplements. As we double-down on self-regulatory initiatives and support agency efforts to make the marketplace completely inhospitable and even hostile to the bad actors operating on the periphery of the industry we must do a better job--and here s the opportunity--of spreading new science-backed messaging to get the word out on the ability of dietary supplements and functional products to improve health and make life better for so many people. NIE Extra Extra Visit to read about Michael McGuffin s thoughts about the major events of 2017 and what we need to keep in mind as an industry in 2018. January February 2018 MarketingInnovation ne of the most effective PR and marketing assets a company can have is visible industry leadership. It highlights your industry commitment creates opportunities to network with the people you do business with or would like to and provides access to industry intelligence sooner and often in more depth than other people get. It also provides platforms to demonstrate your expertise making your name more recognizable. All of this supports growing your business. So what makes a leader and how do you get to be one The short answer to become a leader is Examine your company and make sure you are following best practices Join and become involved in the industry s trade association Be transparent and authentic Tell your story through all available marketing avenues Do this consistently over time. We work with a lot of industry leaders and one thing they have in com- O mon is that they champion best practices. Another is that they are viewed as authentic in their commitment to the industry s future. They know who they are are clear on their mission and values and stay the course. And they are very successful at selling their products or services. Companies that sustain success and continue to grow are as a rule widely viewed as industry leaders. For those who are new to our industry or younger members intent on being the next generation of industry leaders let s take an industry-specific look at what that means. Who are the industry s leaders Likely some specific heads of trade associations come to mind first. Now think about a segment of the industry such as ingredient suppliers testing labs and brands--which companies come to mind first in those segments of the industry Which people at those companies specifically Why do you have the impression of them as leaders Does that enhance their credibility in your eyes I ve observed that visible leadership does enhance credibility whether you see these people speaking at industry events or frequently quoted in the industry s trade magazines as experts. Given that companies that emerge as leaders also tend to be successful in sales as well what s the connection What do those companies and the people within them viewed as leaders have in common And how is visible leadership established There are some qualities leaders share that are universal and can include Communicative Motivating Positive Trustworthy Demonstrate integrity Creative Lead by example Authentic Take responsibility Forward thinking Listens is responsive Practice transparency Nutrition Industry Executive 57 January February 2018 MarketingInnovation Today that last one transparency is linked to leadership in the eyes of consumers more strongly than ever before. There has been a lot of talk about transparency in the industry for several years emphasizing how important that is to long-term success of a company and the industry. Let s look at a few companies that do that well (some examples are clients which I ll identify as such and some are not but have impressed me all the same). Gaia Herbs Meet Your Herbs program is one of the industry s best examples of transparency fueling success. Consumers can go to and enter the product code from their purchase to see where the ingredients came from. They can also examine the Certificates of Authenticity (C of A) for every component. That s been a very successful program for the company as we ve all observed and has been a catalyst for some of their competitors to reveal more about where their ingredients come from. When a consumer has access to specific information about the origin of the herbs in the bottle they just bought it s a direct line to trust and loyalty. Gaia has inspired other companies to follow its transparency example but its leadership is indisputable. Another interesting example of leadership is Sabinsa s expansion of the company s contract farming program initially developed to ensure raw material supply in times of high demand but which has evolved into a fair trade type of program as well. This sets a far better example than approaching herb sourcing with a short-term view which in times of high demand or low harvest can result in buying god knows what raw material from god knows where a practice which has given the global supply chain more than one black eye. Sabinsa a long-time client of ours has demonstrated leadership in other areas for decades from investing in research before it was necessary to having branded ingredient credibility to developing proprietary ingredients patenting them across the globe and vigorously defending their intellectual property. This contract-farming program is Sabinsa s most recent example of best practices leadership. Sometimes to emerge as an industry leader just means using marketing and PR to highlight what you re doing already. There are a number of companies that have followed best practices 58 Nutrition Industry Executive for many years but didn t really talk about it until they realized competitors were taking bows for things they had always done quietly without kudos. Again I ll use clients as examples because we know them so well. In 2018 NOW celebrates its 50th year with its leadership indisputable and it s all based upon the founding mission and values that have guided the company for five decades. A noteworthy part of NOW s story is that the company is family-owned and management takes its guidance from the long-term vision of the owners on the board of directors rather than the more shortterm need to report strong quarterly earnings to outside investors. Once There has been a lot of talk about transparency in the industry for several years emphasizing how important that is to long-term success of a company and the industry. viewed primarily as a value brand today NOW is known as the standard bearer for quality. This was achieved by telling the company s story describing how it ensure quality and why using a variety of tactics--from trade magazine editorial and videos to manufacturing facility tours--while at the same time continually overachieving as the industry s quality bar was raised. Another example of leadership is when companies are vocal about weak points advocating for change and proposing a solid solution. In recent years there have been several companies speaking out about new methods of adulteration they have uncovered where once that would have stayed a dirty little secret the industry would just as soon remain unexamined. They have also found and recommended testing methods to detect and guard against that adulteration. Examples are Synutra Ingredients educating the industry about the best test methods to ensure chondroitin purity and more recently Sabinsa denouncing synthetic curcumin masquerading as natural and recommending a solution--radiocarbon testing. Alkemist Labs is an example of leadership in questioning long held nontransparent practices in the third party testing lab world such as keeping the identity of testing labs secret and not including what specific test methods were used to confirm identity on the certificate of analysis. The company was also among the first testing experts to immediately explain in detail why DNA testing was not fit for purpose when New York Attorney General Eric Schneiderman and the New York Times alleged that herbs sold by major chains were not what they claimed to be. Using expertise to both defend the industry and to push it forward toward continued improvement is a fantastic example of leadership. Some other important ways companies in the industry demonstrate leadership is involvement in trade associations often at the board level. The trade associations are at the forefront of such areas as education lobbying regulatory agency involvement and media relations on behalf of the broader industry or the segment upon which they specialize. One of the main things trade associations are is a platform for collaboration between companies to address industry s needs and challenges. Some estimates have less than 20 percent of the businesses in our industry holding memberships in even one trade association which is astonishing in light of the important role they play in protecting all of our ability to be a business. It s unlikely that a company would be considered a leader without trade association membership at the very least because that demonstrates a commitment to the industry outside of self-interest alone. Beyond that involvement in trade associations facilitates interacting with colleagues a significant aid in potential business deals. Many of the industry leaders have board-level involvement in a trade association sometimes more than one. A trade association board position requires a time commitment but it also gives you a seat at the table where industry policies and practices are dis- January February 2018 cussed. These are usually the bestinformed people in the industry and therefore excellent resources--it s useful (and often fun) to hang out with these people. Trade associations also have committees that you can and should be involved in. Some of them require a lot of time and work but also provide significant contributions to the industry. Some of the American Herbal Products Association (AHPA) committees are probably the hardest working groups in the industry but produce crucial tools such as the Botanical Safety Handbook used by experts from pharmacists and doctors to regulatory agencies and manufacturers. Other trade association committees are primarily informational but oh how valuable that information can be The Council for Responsible Nutrition (CRN) does this very well. They all allow for future industry leaders to network get involved and position themselves for future leadership. Several colleagues have commented that the pool of future dietary supplement industry leaders needs to be expanded and we must start fostering young industry members. Hopefully some of these ideas will help do just that. NIE The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Suzanne Shelton has provided public relations services to both international and domestic dietary supplement and natural products manufacturers suppliers and associations. (Continued from page 43) validated) and safety (absence of toxicity & GRAS) Bioavailability Stability Regulatory compliance federal and local regulations Compatibility in finished product Convenient delivery system Consumers are also looking at ingredients backed by research. DygloFit a product developed by Vermont-based Icon Group LLC an affiliate company of NutraGenesis LLC is backed by clinical trials. The most important research that can be performed on any heart health ingredient are human clinical trials said Bruce Abedon PhD vice president of scientific and regulatory affairs NutraGenesis LLC. DygloFit an advanced self-affirmed GRAS (generally recognized as safe) standardized extract of Dichrostachys glomerata fruit has had two randomized double-blind placebocontrolled human clinical trials performed which have shown that it is efficacious at helping to support healthy levels of important blood lipids that are associated with cardiovascular function. These trials have also shown that it is well tolerated. In fact DygloFit helps support cholesterol levels that are already in the normal range through its significant effect on LDL HDL and triglyceride levels at both once daily and twice daily dosage protocols. An area of study OmniActive Health Technologies is interested in is nitric oxide which has been shown to help with blood flow. New research that OmniActive has been focused on is in the field of nitric oxide enhancement and we re seeing growing interest among companies to tell that story Appell observed. Nitric oxide plays such an important part in heart health. The endothelium is the innermost layer of blood vessels and forms an interface between the blood and the vessel wall. It plays a critical role in the proper functioning of the blood vessels and the entire cardiovascular system including anticoagulation vasodilation and reducing smooth muscle proliferation (which plays a role in atherosclerosis). We believe this is a key area of focus and there s growing interest among companies to tell that story. These studies have continuously involved which opens up the door for new solutions in the health and wellness space. Over the years poor diet and lack of exercise have made the consumers more prone to cardiovascular issues said Chaudhari. As cardiovascular disease continues to be one of the leading cause of death around the world advancement of technology easy access of information shifting consumer trends and hectic lifestyle have motivated the scientists to persistently invent healthier solutions for heart health and wellness. Furthermore down the road changes in consumer preferences will help propel condition-specific products (such as those for heart health) forward. Back in the day most of the consumers used to buy supplements containing a broad spectrum of vitamins and minerals i.e. multivitamins he noted. Now the consumer preferences have changed to optimize the health by making up with only the deficient nutrients. So the demand for personalized nutrition will continue to drive condition-specific supplements containing vitamin D E Co-Q10 omega-3 and so on. NIE This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat cure or prevent any disease. References 1 Geleijnse JM et al. Dietary intake of menaquinone is associated with a reduced risk of coronary heart disease the Rotterdam Study. J Nutr. 2004 134 3100-5. 2 Beulens JW et al. High dietary menaquinone intake is associated with reduced coronary calcification. Atherosclerosis. 2009 203 489-93. 3 Gast GC et al. A high menaquinone intake reduces the incidence of coronary heart disease. Nutr Metab Cardiovasc Dis. 2009 19 504-10. Extra Extra Visit to read about a study explaining the biological reasons why women have a heart health advantage over men. FORMOREINFORMATION Aker BioMarine Balchem Albion Minerals DSM ExcelVite Sdn. Bhd. Lycored NattoPharma USA Inc. NutraGenesis LLC OmniActive Health Technologies Prinova Solutions Wacker Chemie AG Nutrition Industry Executive 59 January February 2018 FunctionalFoods The Changing Generations of Nutritional By Orlaigh Mathews RNutr and Jenna Mills MS RD Demand Beverage T he nutritional beverage space was once defined by three distinct groups hardcore sports nutrition consumers elderly consumers and consumers looking to lose weight. To these targeted consumer groups nutrition was typically the top priority with taste as an afterthought. However with increased consumer commitment to health and wellness and the blurring of lines across beverage categories nutritional beverages are expanding far beyond its historical niche territory. As consumers lead increasingly active busy lifestyles they seek out more convenient and portable means of nutrition. Contemporary beverages that deliver on both nutrition and taste via clean label formulations are resonating with consumers across life stages and need states. Introducing Gen Z Generation Z comprised of kids ages 3-17 are the youngest and perhaps most unpredictable consumer group when it comes to understanding food 60 Nutrition Industry Executive and beverage attitudes. They are considered digital natives having never existed at a time without smartphones social media and Google. Additionally they have grown up in a culture that has simultaneously celebrated food beverage and waged war against obesity and processed foods (Mintel 2016). Therefore Gen Z is considered both natural born foodies and nutrition savvy consumers and are an exciting target for nutritional beverage manufacturers. Unlike kids of the past Gen Z is gravitating toward healthier options and are moving away from the big food brands that dominated kid-oriented products of the past (Datassential). The clean label movement resonates with Generation Z as they were brought up in foodie households with millennial parents who are food label savvy skeptical of industry and shop at farmers markets. In fact consumer research shows that about two-thirds of Gen Z consumers prefer foods and beverages that only contain recognizable ingredients (Nation s Restaurant News). Additionally according to a study by BMC and Fluent most older Gen Z students are avoiding artificial ingredients in their beverages and their number one beverage purchase is bottled water (Food Business News 2016). About half of Gen Z students also reported that their main motivation for trying a new beverage is that it is healthy better for you (Food Business News 2016). Despite Gen Z s upbringing in a food-centric information-rich environment there appears to be some confusion regarding nutrition. According to the BMC and Fluent study 55 percent of students report that the healthiest sweetener is cane sugar (Food Business News 2016) which demonstrates the misperception of clean label as nutritious. This confusion is also illustrated by the plant protein beverage trend. According to the Dietitians of Canada many parents are viewing plant protein as a more natural and thus a more nutritious alternative to dairy and soy- January February 2018 based beverages. However unknown to many parents is that some plant proteins are in fact inferior sources as they are often low in fat calories and fail to provide all of the essential amino acids required for proper growth and development. Therefore while clean label is a key consideration for consumers it is also important for manufacturers to balance sound nutrition when formulating beverages especially those marketed to children. High-quality protein and sugar reduction are key considerations for nutritional beverages that support healthy growth and development in children. ality but also clean label products with 88 percent reporting that they would pay more for clean label products (Kerry Primary 2017). As mentioned above the Millennial consumer leads an active lifestyle balancing work social life exercise and now many are starting families. As their lives become increasingly busy millennial consumers will continue to seek out convenient beverages that offer functional and clean ingredients to help support vitality. Older Adults Although the industry tends to focus in on the younger generations it would be foolish to ignore the potential in the healthy aging population. Boomers like Millennials are focused on health albeit from a slightly different angle. While the Millennial consumer tends to be more proactive about health and wellness their Boomer parents tend to be more reactive. In other words Boomers who did not grow up in an era in which nutrition was mainstream are now taking agency of their health in response to current ailments. Unlike the generation beneath them Boomers are less likely to listen to their social network when it comes to health as they tend to trust health care professionals for that information. Therefore they may not be as willing as the Millennials to try something trendy but rather something proven and safe. They are currently managing ailments such as osteoarthritis high cholesterol and high blood pressure and are likely to purchase products that might help mitigate these conditions (Nielsen Spectra). When asked about influential health benefits for food and beverage purchases the Boomer groups unsurprisingly reported weight loss heart health cholesterol management and bone health (Kerry Primary 2016). In light of these influences Boomers might gravitate toward products with healthy fats that tout heart health benefits or high quality protein products that support muscle health. While Boomers are not typically associated with the clean label movement consumer research shows that this group is still thinking about clean label although in a different way than their younger peers. While Millennials tend to associate clean label with certifications such as organic and non- Millennial Parents Driving Trends While Gen Z s influence over the beverage market is growing most of the trends are still largely driven by their millennial parents a consumer group known to be passionate about health and wellness. This consumer group is becoming more aware of nutrition taking agency of their wellness and choosing products that support their busy active lifestyles like nutritional beverages. Millennials have taken a more holistic and proactive approach to wellness trading in restrictive fad diets for whole foods with functional health properties like immunity and digestive health. They are more likely to listen to health advice from their friends and their social network and therefore tend to jump on trends for the sake of achieving optimal health (Nielsen Spectra). For instance 79 percent of consumers prefer to consume healthenhancing ingredients through foods or beverages (GlobalDataGlobal Survey 2015 Q2). More specifically immunity is the second most desired health benefit from food and beverage products closely followed by digestive health illustrating the fact that consumers are proactively trying to prevent illness (GlobalDataGlobal Survey 2015 Q2). Proactive health consumers are seeking out positive nutrition in products that contain fermented ingredients with live and active cultures prebiotic fiber and immune ingredients such as yeast beta glucan. When asked about influential health benefits for food and beverage purchases the millennial groups reported weight loss heart health and immunity (Kerry Primary 2016). Like the generation below them Millennials not only seek out function- GMO (genetically modified organism) Project verified Boomers define clean label as foods free from certain ingredients like additives hormones and antibiotics. Additionally 78 percent of Boomers look for added sugar on a label more than the general population (Kerry Primary 2017). Nutritional beverages are ideal for a Boomer seeking out products to support healthy aging especially those that offer functional ingredients to help with age-related ailments without the added sugar preservatives and other artificial ingredients. It is clear that the nutritional beverage market is growing rapidly and moving beyond the traditional consumer. Beverage manufacturers have evolved to help support the general wellness needs of the modern consumer including clean label functional benefits and reduced sugar. However it is important to understand the consumer across various life stages before developing new products. Leveraging nutrition science food science sensory and marketing expertise and technological development is always market-led and nutritionally sound. NIE Orlaigh Mathews RNutr graduated with a BSc in human nutrition and dietetics from Dublin Institute of Technology and Trinity College Dublin. After working as a clinical dietitian specializing in maternal nutrition senior nutrition and critical care in a Dublin teaching hospital for several years Mathews joined Kerry s nutrition marketing team as a market analyst and has a particular focus on infant nutrition and health care nutrition. Jenna Mills MS RD is a registered dietitian and received her master s degree in nutrition and exercise physiology from Teacher s College of Columbia University. She has experience in food industry marketing corporate wellness and nutrition education and is currently a marketing communications and customer engagement specialist for Kerry s beverage systems team. Nutrition Industry Executive 61 January February 2018 EngredeaBoothPreview March 7-11 2018 Anaheim Convention Center Anaheim CA The following companies advertising in this issue have submitted information describing their plans for Engredea--product launches show specials and special services are all included below. Booth numbers are provided to encourage in-person meetings to learn more. Kyowa Hakko USA Inc.--Booth 3435 Kyowa Hakko USA Inc. (New York NY) is the North American sales office for Kyowa Hakko Bio Co. Ltd a world leader in the research and manufacturing of high-quality ingredients for use in dietary supplements functional foods and beverages. Key products include Setria Glutathione for immune health and detoxification Setria Performance Blend for nitric oxide support Cognizin Citicoline for brain health Sustamine L-Alanyl-L-Glutamine for hydration sports performance and Pantesin Pantethine for heart health. For more information call (800) 596-9252 or visit Sabinsa Corporation--Booth 3505 As Sabinsa celebrates 30 years the company is re-affirming its commitment to its customers by showcasing Sabinsa s legacy ingredients such as Curcumin C3 Complex BioPerine LactoSpore ForsLean and introducing new patented ones Black Cumin and Livinol. New application areas will be explored with Sabinsa s multi-enzyme complex DigeZyme clinically proven for delayed onset muscle soreness and the company will discuss its entrance into the protein marketplace with Promond Sabinsa s waterextracted water-soluble almond protein ingredient. Sabinsa s innovation is your answer. For more information call (732) 777-1111 or visit Conventions&Meetings Supplement Labeling Compliance Review to be Held in March M uch like food labels dietary supplement labels have come under increased FDA (U.S. Food and Drug Administration) scrutiny. How well do you know the current labeling regulations including how the new Nutrition Facts Panel requirements will affect dietary supplements Are your labels in compliance with requirements How can you keep on top of the latest labeling issues From March 5-6 2018 at Utah State University s Western Dairy Center (Logan UT) get an in-depth look at dietary supplement labeling from a former FDA labeling official who helped shape current labeling regulations as well as an internationally recognized labeling expert at EAS Consulting Group s two-day Dietary Supplement Labeling Compliance Review Seminar. You ll learn the basics of how dietary supplements need to be labeled to comply with the complex set of labeling rules and the latest issues that have gotten FDA s attention. Gain answers to your most challenging questions and learn to design FDA-compliant labels in this interactive learning environment. For more information visit seminars dietary-supplement-labelingcompliance-seminar . Annual PACK EXPO East Meets Again in Philadelphia P MMI the Association for Packaging and Processing Technologies will once again bring back the East Coast s processing and packaging event known as PACK EXPO East (Philadelphia PA). Attendees will be able to watch machinery run at full scale discuss specific suppliers with suppliers at exhibitor 62 Nutrition Industry Executive booths and gain a competitive edge through staying on top of emerging technologies industry trends and best practices across packaged goods industries. The expo will be held April 16-18 2018 at the Pennsylvania Convention Center. For more information visit January February 2018 Equipment&Packaging Pharmafill Line Now Features Casters as Standard Packaging machines in the Pharmafill line from New Jersey-based machinery manufacturer Deitz Co. now feature durable casters as standard at no extra charge. Introduced as an added convenience for food pharmaceutical nutraceutical and other manufacturers the non-marking casters allow the machines to be rolled safely and easily by one person for smooth installation quick setup and ergonomic access to the machine interiors for cleaning and inspection. Ideal for contract packagers the casters allow individual machines to be rolled from one filling and or packaging line to another for fast changeovers without requiring investment in multiple machines. Installed during machinery manufacture at the company s Wall NJ headquarters the rugged casters are included with new Pharmafill tamper-evident neck banders heat tunnels tablet-capsule counters desiccant inserters cotton inserters conveyors and rotary turntables. Companion leveling pads that minimize vibration and help secure the machinery in position are also included. For more information visit Revolutionary Supplement Formulation Software Now Includes Contaminant Tracking & Reporting ESHA Research (Oregon) a provider of food and supplement formulation and labeling compliance software solutions announced an update to their revolutionary supplement formulation software Genesis R&D Supplements. Genesis R&D Supplements is the industry s only program tailored specifically to the needs of supplement and nutraceutical manufacturers. We monitor the trends of the supplement-manufacturing industry and really listen to what they have to say so we can provide a software that responds to their unique needs said Craig Bennett CEO of ESHA Research. This update reflects our continued commitment to that principle. Genesis R&D Supplements version 1.3 integrates many user-requested enhancements including chemical impurities tracking. Many manufacturers use the California Prop 65 guidelines on contaminants. When a formula exceeds the Prop 65 threshold for a contaminant the program will alert the user. My development team really knocked this update out of the park said Josh Luth product manager at ESHA. I think our users will be impressed with what we have accomplished here. In addition to the major feature additions the program now includes a new U.S. Food and Drug Administration compliant two-column Supplement Facts label template and even more options for tailoring the Supplement Facts label. For more information visit Advertiser Index ADH Health Products Inc. American Laboratories Inc. Ayush Herbs FCC Products Inc. FutureCeuticals GCI Nutrients Generex Labs Jiaherb Inc. Kyowa Hakko USA Mack Flavor Ingredients Inc. Now Foods PL Olcott Plastics PLT Health Solutions Sabinsa Corporation Soma Labs Inc. 48 47 32 3 13 9 53 5 11 17 1 C4 C3 C2 12 (845) 268-0027 (402) 339-2494 (800) 9 2 5 - 1 3 7 1 (973) 535-3300 (888) 452-6853 (650) 697-4700 (239) 592-7255 (888) 542-4372 (212) 319-5353 (951) 683-6245 (800) 999-8069 (630) 584-0555 (973) 984-0900 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 adh americanlaboratories ayushherbs fccproducts futureceuticals gcinutrients generexlabs jiaherb kyowa mackflavor nowpl olcott plt sabinsa somalabs Industry Events February 6-8 2018 West Pack Anaheim Convention Center Anaheim CA March 7-11 2018 Natural Products Expo West Anaheim Hilton & Marriott Anaheim Convention Center Anaheim CA April 10-11 2018 SupplySide East Meadowlands Exposition Center Secaucus NJ May 15-17 2018 Vitafoods Europe 2018 Palexpo Geneva Switzlerland January February 2018 Nutrition Industry Executive 63 SupplieroftheMonth American River Nutrition Inc. 333 Venture Way Hadley MA 01035 Phone (413) 253-3449 Website American River Nutrition founded in 1998 is the producer of DeltaGold tocotrienols a beneficial form of vitamin E for cardiovascular health as well as other health benefits. The company is led by Barrie Tan PhD a pioneering scientist and researcher credited with identifying the primary sources of plant-based tocotrienols including rice palm and the virtually 100 percent tocotrienol-producing annatto plant. American River products are produced in Hadley MA using a proprietary process leading to the purest form of natural tocotrienols available according to the company. Dr. Barrie Tan earned his doctorate in chemistry in 1979 at the University of Otago in New Zealand and became a professor of chemistry and food science nutrition at the University of Massachusetts Amherst (1982 to 1992). His research expertise includes lipid-soluble nutrients (carotenoids E vitamers CoQ10 and omega-3s). He was the first to introduce tocotrienol s benefits to the nutrition industry and developed the first-ever tocopherol-free tocotrienol product derived from annatto. Today his research focuses on lipid-soluble nutrients that impact chronic conditions. Tan is the senior editor of Tocotrienols Vitamin E Beyond Tocopherols (2013) and continues to collaborate with numerous universities worldwide to further tocotrienol research. Barrie Tan PhD NIE Throughout 2017 you delivered presentations to industry members and health care providers on vitamin E and tocotrienol research. What do you want them to take away from your presentations Tan Our presentations aim to convey the full story of tocotrienols and tocopherols so that health professionals and consumers can make the most educated decision when choosing their vitamin E supplements. While general knowledge about vitamin E is widespread there are many misconceptions both among health professionals and the general public. This is due to sometimes erroneous or incomplete media coverage of vitamin E as a single entity vitamin (alpha-tocopherol) whereas it actually is a family of eight separate but related molecules. Alpha-tocopherol is known as a universal antioxidant and it still carries that designation to this day which gives a misleading indication of its value. Tocotrienols however are much more than simple antioxidants. Research has shown them to be potent modulators of lipid levels and inflammation and important contributors to overall cell health. These benefits are not shared by the better-known alpha-tocopherol. 64 Nutrition Industry Executive NIE DeltaGold is the only tocotrienol produced in the U.S. Please explain the significance of American River Nutrition s facility in Massachusetts. Tan For a number of reasons consumers feel more comfortable with ingredients made in the USA so that advantage is clear. Not only is our Western Massachusetts Pioneer Valley beautiful we are also fortunate to be surrounded by a plethora of exceptional educational institutions with which we have developed valuable relationships to further tocotrienol research. We are very proud to contribute to Massachusetts s economic development a state which has always been central in advancing health care and technology innovation. with Eastman Kodak we dedicated many years focusing on the science of annatto-derived tocotrienols. With an exciting new clinical study on DeltaGold that adds significantly to the existing body of science publishing shortly we felt it was time for American River Nutrition to move to the next level in marketing our DeltaGold. With our new look and website in place and more clinical studies in the works we are enthusiastic about future growth. NIE Is there anything else you would like to add Tan There are more molecules in the world than can be counted. Among them tocopherol has been known for almost a century and has had its heyday. Tocotrienol has only been known for half that time and it is just now being noticed. Why Because half of all tocotrienol research was published only in the last 10 to 15 years. We intend to be the standard bearers of this timehonored molecule that dials back the ravages of chronic conditions. NIE Earlier this year the company launched a new brand identity and website. What was the motivation behind the new branding Tan With our collective expertise no one has spent as much time working on tocotrienols as we have. Being the first to bring tocotrienols to the market after commercializing a process of extraction from palm oil in the early 90s and a short stint in the development of rice tocotrienols Extra Extra Visit to read the rest of the interview. January February 2018 Go to plt for info about this advertiser Go to olcott for info about this advertiser