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Description: In This Issue: Industry Forecast, Heart Health, Digestive Health, and Tailoring Taste & Nutrition

Don t miss a single issue of NIE in 2017...go online to renew your free subscription today NIEmagazine.com JanFeb17 VI S BO EXP IT OT O W US H E AT 1 ST A VRM Media Publication 40 4 www.niemagazine.com January February 2017 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 22 NO. 1 JANUARY FEBRUARY2017 F E A T U R E S 34 Digestion s Beneficial Boost With digestive health products in high demand manufacturers are responding to the challenge as they develop products with influential ingredients that meet customer needs. 42 Keeping Rhythm As natural ingredients that address heart health continue to evolve and grow suppliers are working on broadening awareness. 48 A L S O I N S I D E 48 Industry Forecast With sweeping changes in the U.S. political landscape ushered in by the 2016 elections the natural products industry must navigate uncertain seas as it looks forward to 2017. C O L U M N S 16 24 30 31 32 33 56 58 59 59 Industry News Ingredient News AHPA Update Association News Science Update Conventions & Meetings Engredea Booth Preview Equipment & Packaging Advertiser Index Industry Events Supplier of the Month 4 First Word 6 Condition Specific 12 Legalities 52 Marketing Innovation 54 Functional Foods 12 60 FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.niemagazine.com Copyright 2017. Nutrition Industry Executive (ISSN 2331-2602) Volume 22 Number 1 January February 2017. 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 magserv.com www.niemagazine.com. Back Issues & Single Copies For order information contact (732) 432-9600 or info niemagazine.com. March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com plt for info about this advertiser FirstWord Watching Regulations eading over James Gormley s Industry Forecast article (see page 48) was a pleasure-- there were so many interesting responses to questions that are at the heart of the current state of affairs in the natural products industry. Not surprisingly there were contradictory opinions particularly regarding the role of the Federal Trade Commission (FTC). While one participant thinks FTC actions regarding the industry have been a good thing another would like to see the agency done away with. Another area of opposing views is the prospect of a Trump administration s favoring of deregulation. Concerning the latter many in business are eagerly anticipating what s to come. And why not Over-zealous and nonsensical regulations can put the kibosh on business advancement and competition. While looser regulatory stances can allow for more innovation from small niche players and allow the free market to set prices. Often prices drop as a result. However it is also fair to say that a federal government that views regulations with disdain can expose people to fraud and excessive risk-taking by companies that will do anything to gain higher profit. Also social concerns are lost. This reminds me of Florida last year when Govenor Rick Scott declared a state of emergency in counties on the state s Atlantic coast over expansive algae blooms in the St. Lucie River. The disaster earned the names green slime and Playa Guacamole. Not the superfood kind of algae--those thick toxic blooms ruin the river s ecology devastate waterrelated businesses and potentially R cause health problems for those in contact with the water. Pollutants from sewage fertilizer and manure that big business has been allowed to pump into Florida waterways--with little state government oversight--caused the outbreaks. The federal government refused Scott s request for aid and decided to let the state clean up its own self-inflicted mess. While some may disagree with this assessment the bottom line is pictureperfect blue waterways that make Florida a tourism mecca have come up green and choked with nasty toxic algae. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Gary Pfaff Sales Manager GaryP VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com Managing Editor Shari Barbanel ShariB VRMmedia.com Associate Editor Nicholas Saraceno NicoS VRMmedia.com Coming Together There are legitimate arguments to be made for both sides of regulatory theory and I believe the industry would be wise to work together and consider them equally. After all the goals are to provide safe efficacious products and run successful lucrative businesses. Also please note in the article Steve Mister s comment If there is a vacuum in the enforcement of federal regulation of dietary supplements state legislatures and state AGs will be eager to fill that void with their own requirements. I would add that consumer demands might also help fill that void. So while deregulation has appeal and benefits business integrity must remain intact lest the natural product industry gets slimed. P.S. New for 2017 www.niemagazine.com will feature a blog by Yadim Medore the founder and CEO of Pure Branding a brand development research and marketing agency for leading dietary supplement functional food and personal care companies. Contributing Writers James Gormley Satya Jonnalagadda Todd Pauli Ronie Schmelz Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Rosie Brodsky Rosie StarkServices.com 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 VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and Fitness Trainer 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 magserv.com www.niemagazine.com Back Issues See the Table of Contents page for price and ordering information. Connect With Us www.twitter.com www.facebook.com www.linkedin.com www.instagram.com www.pinterest.com vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com jiaherb for info about this advertiser ConditionSpecific Addressing Prostate Health Men of a certain age are looking for scientifically sound affordable alternative solutions for prostate health. B Y S HARI B ARBANEL s we age health concerns often become greater. While both genders may face issues with their hearts hearing and vision as they get older the health of the prostate may become a major area of concern for some men. According to the U.S. Census Bureau by the year 2030 20 percent (more than 20 million people) of the population will be over 65 years of age. With the aging population prostate health is of great concern for men today said Virginie Codran health product manager for New Jersey-based Frutarom Health adding that an enlarged prostate can cause several problems such as benign prostatic hyperplasia (BPH) or even prostate cancer but especially daily life altering problems such as urine leakage. Forty to 50 percent in men aged 51 to 60 to over 80 percent in men older than age 80 suffer A from BPH according to Baltimore Longitudinal Study of Aging. Prevention is key to reduce the risk of enlarged prostate and prostate cancer. Golan Raz vice president of health and nutrition at Lycored in New Jersey added Prostate health has major impact on one s quality of life. It is influenced by several key cellular processes that contribute enormously to the end-point symptoms men experience (e.g. urinary tract symptoms). Oxidative stress and inflammatory processes play a key role in prostate pathologies. Moreover imbalanced and elevated androgen signaling is a major risk factor he explained. In fact the most common clinical marker for evaluation of prostate condition is the level of PSA which is directly influenced by androgen signaling. Lastly prostate pathologies often stem from increased cell proliferation therefore supplements that support normal cell growth and by that prostate volume are desired. Dr. John Minatelli senior vice president of business development US Nutraceuticals LLC d b a Valensa International in Florida explained that as men age their rate of urine flow slowly decreases as the size of their prostate gland grows and eventually begins to restrict urination and complete bladder emptying which becomes a serious quality of life issue. A 2010 study in Lancet revealed that approximately 210 million men worldwide suffer from some form of BHP (6 percent of the overall population) and that a 46-year-old man has a 45 percent risk of developing BHP within the next 30 years he said. While prostate issues can cause many problems for men of a certain 6 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com nutrasolutionsusa for info about this advertiser ConditionSpecific age Codran said that these types of health issues often come with embarrassment so consumers often look for a solution on their own and this increasingly goes through natural remedies. Minatelli agreed adding that the average consumer wants scientifically sound low-cost alternatives to pharmaceutical or surgical intervention because of the many side effects and post-surgical risks associated with drugs or available corrective surgical procedures. Urologists are often very quick to employ expensive drugs or risky surgical procedures to resolve common decreased urinary flow. These risks include erectile dysfunction ejaculatory issues incontinence loss of libido and even special complications associated with drug therapy that can affect later cataract surgery. embrace natural solutions. For men there are a number of ingredients that support prostate health including saw palmetto berries lycopene and flax among others. In fact Guy Woodman Pennsylvania-based Euromed USA s general manager noted that the demand for saw palmetto berry oil extracts Pygeum africanum bark extract and nettle root extract has steadily grown due to the popularity of this category and the expanding body of scientific studies supporting efficacy. tion that has withstood the test of time Minatelli explained. It is often fortified with additional ingredients including beta-sitosterol African pygeum stinging nettle or pumpkin seed oil. Natural products such as saw palmetto have been shown to be safe and effective 5alpha reductase inhibitors that do not exhibit the serious side effects associated with pharmaceutical 5alpha reductase inhibitors like finasteride. According to Minatelli Valensa s facility was designed constructed and commissioned in 2002 specifically for the supercritical CO2 extraction of saw palmetto berries and has been supplying the industry with its unique Deep Extract USPlus branded CO2 extracted saw palmetto extract since that time. Valensa s mission is to provide the highest quality saw palmetto extract on the market. In fact we have confirmed that our product is indeed a 5-alpha reductase inhibitor through in-vitro enzymatic assay techniques he said. Ingredients As consumers are beginning to shy away from prescription products that may have an array of negative side effects many are also starting to Saw Palmetto Saw palmetto berries are beneficial for prostate health because they contain natural compounds called plant sterols including beta-sitosterol campesterol and stigmasterol. According to Memorial SloanKettering Cancer Center these compounds have anti-inflammatory effects and may also block 5-alpha reductase activity. Saw palmetto is the only clinically proven dietary supplement interven- Go to www.niemagazine.com apl for info about this advertiser 8 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com olcott for info about this advertiser ConditionSpecific Lycopene According to Lycored s Raz like saw palmetto lycopene has scientific background when it comes to prostate health. Lycopene the red pigment of tomato is a strong inducer of the antioxidant defense system he said. Interestingly other tomato phytonutrients work synergistically with lycopene to enhance the protective effect via this mechanism as well as others. In fact healthy diverse nutrition rich in phytonutrients that can work together in different mechanisms is a great strategy to optimize prostate health as well as achieving overall wellness. Lycored offers Lyc-O-Mato an ingredient that has been known to support healthy prostate for almost 20 years. Recently the company launched Lycored Nutrient Complex for Me (LNC for Men) a new proprietary technology for prostate health. According to Raz the new technology is a result of extensive pre-clinical research held by the department of clinical bio-chemistry in the BGU University in Israel. Both the legendary Lyc-O-Mato and the new LNC for Men are design to support men s health with specific focus on prostate health and healthy urine function he explained. The success of these technologies was and is demonstrated not just via scientific validation but also through success stories of healthy men from around the globe. Flax Flax is not only rich in fiber and omega-3s but also protects against inflammation and is beneficial for prostate health. Frutarom Health offers LinumLife one of the world s first flaxseed ingredients with a high level of lignans. According to Codran LinumLife supports men s health by balancing hormonal levels and is effective addressing the cause and symptoms of benign prostatic hyperplasia (BPH). We have had great success with our flaxseed extract LinumLife and we have worked on maintaining the scientific credibility Codran said. Consumers actively seek all-natural safe ingredients backed by research. Codren. Numbers don t lie so if the results are good there should be no problem convincing people to take the product. Setbacks & Trends When a certain ingredient is touted for a specific health benefit it is often thrown into the spotlight but sometimes nature does not accommodate consumer demand. For example Euromed USA s Woodman noted that there have been three consecutive low harvest volumes of saw palmetto berry in Florida. This has caused high demand for available fruit and higher extract pricing as it is a 10 1 concentration he explained. Higher saw palmetto extract prices and resulting finished products may dampen 2017 consumer sales. Category setbacks aside Frutarom s Codran said a category trend she is spotting is all-in-one formulations that include ingredients that target different aspects of men s health as well as provide consumer convenience. Raz agreed adding There is a growing understanding that not any antioxidant can support prostate health and the industry is looking for those sophisticated ingredients formulations with proven mechanism of action he said. Multifunctional formulations that address all these mechanisms of action are at the forefront of the prostate category. This multi-directional approach can be achieved by targeted combinations that synergistically act on all those mechanisms to allow a holistic effect that will really make a difference on quality of life. Science & Support Today s consumers are savvy and want to ensure that they are getting what they paid for. This is why having scientific evidence to back up ingredient product claims is essential. We make sure we have proprietary science that is published and available to manufacturers. We are always open to support in providing a clear message to their consumers noted Woodman pointed out that in 2016 Euromed published new research in Research and Reports in Urology noting the efficacy of its saw palmetto oil supercritical extract Prosterol. To allow its customers to communicate the quality of the saw palmetto oil extract in their product to consumers we developed the Prosterol tradename he said. In addition consumers can find products containing Euromed s extracts by looking for the PhytoProof logo on product labels. PhytoProof means that the ingredient was produced at a facility with seven industrial certifications applying a minimum of 20 laboratory tests from starting herb to finished extract. Woodman added that in order to set a solid standard in the industry it needs to provide a level of quality that will provide satisfactory results to consumers so their initial product trial is not disappointing. At the end of the day the consumer wants two main things--safety and efficacy. If a manufacturer (or a brand) can guarantee both safety and efficacy they are 80 percent there Lycored s Raz added. The other 20 percent is education. Prostate health is a serious concern of many people. For them to take the right decision about their health they need quality objective and reliable information. As of now the need for prostate support isn t going anywhere. The prostate health category is a steady category. Unfortunately the U.S. is ranked very high in the global list when it comes to the prevalence of prostatic health issues concluded Raz. Therefore there is constant need for quality proven natural health solutions. NIE FORMOREINFORMATION Euromed USA (412) 279-8808 Frutarom Health www.frutarom.com Lycored (877) LYCORED US Nutraceuticals LLC d b a Valensa International (877) USNUTRA 10 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com omniactive for info about this advertiser Legalities Did 2016 Come to a Natural Conclusion By Ronie Schmelz A s 2016 came to a close food nutritional supplement and cosmetic companies that sell natural products remained targets of and vulnerable to regulatory enforcement actions and consumer class actions. While 2016 saw some regulatory activity surrounding the terms natural all natural and 100 percent natural the year ended without the issuance of regulations or guidance on how these terms should be defined. As the new administration assumes office bringing with it an uncertain regulatory environment it remains to be seen what action if any the U.S. Food and Drug Administration (FDA) will take in this area among others. This uncertainty demands that companies be ever more vigilant in monitoring not only regulatory activity but the scores of pending lawsuits and judicial decisions they will spawn which in the absence of regulatory action will inform the debate over the reasonable consumer s expectations when purchasing a natural or 12 Nutrition Industry Executive all natural product. In the absence of regulatory activity companies may also want to consider pursuing certification from the myriad of private organizations that certify natural products. If marketed properly selling products with these seals of approval could provide some cover and defense to consumer class actions. Here I recap the actions taken in 2016 by the FDA and Federal Trade Commission (FTC) in this natural area and highlight several third-party certification programs that offer certification of natural products. FDA--To Define or Not Define As of December 2016 the FDA has considered use of the term natural only in the food context. Although the agency has yet to define the term it has adopted the following longstanding policy concerning use of the term in human food labeling natural means that nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to a food that would not normally be expected to be in that food. In 2016 as the number of natural food offerings has grown and in direct response to requests from consumers and courts the FDA asked for information and public comment on the following questions Whether it is appropriate to define the term natural If so how should the agency define natural and How should the agency determine appropriate uses of the term on food labels At the close of the public comment period the FDA had received a total of 7 690 responses. There is no indication how long it will take the agency to consider these comments or when we can expect the agency to announce whether it has decided to define the term natural and if so how. Even if a definition is forthcoming it will likely be limited to the labeling of food thereby leaving nutritional supplement and cosmetic www.niemagazine.com January February 2017 Go to www.niemagazine.com xsto for info about this advertiser Legalities companies to extrapolate how the definition might apply to their products. sition of their products 2) stating a product is all natural or 100 percent natural when it contains any natural or synthetic ingredient or component and 3) the environmental or health benefits of a product. The companies must also have competent and reliable evidence to support any of the claims they make about their products. Companies marketing products as all natural or 100 percent natural are well advised to review their product claims and make sure product dossiers contain similar evidence to substantiate their claims. food nutritional supplement and cosmetic companies await a regulatory definition of natural some have sought to fill a void by pursuing natural certifications by third parties. While passing certification and placing a seal on a product is not an absolute defense to a consumer challenge if marketed properly it could help defeat false advertising and misrepresentation claims. Listed below are three organizations with certification programs and brief descriptions of the criteria they impose. 1. Natural Products Association (NPA) NPA the nation s largest and oldest nonprofit dedicated to the natural products industry has developed a Natural Standard and Certification for Personal Care Products (the Standard ) which sets forth detailed requirements for obtaining an NPA Natural Certified seal. Among other criteria to obtain the seal natural products must Be made with at least 95 percent natural ingredients--excluding water Contain only synthetic ingredients specifically allowed by NPA and be environmentally friendly products that are nurturing to people and as harmless as possible to the earth Contain ingredients generally recognized as safe (GRAS) and come or be made from a renewable resource found in nature (Flora Fauna Mineral) no petroleum compounds allowed Contain synthetic non-natural ingredients only when there is no readily available natural alternative ingredient and only when there are no suspected human health risks as indicated by peer-reviewed thirdparty scientific literature and Not include certain prohibited ingredients including those that incorporate synthetic silicone or petroleum compounds. NPA developed an Illustrative List as a reference document that lists ingredients that meet the NPA definition of natural or are permitted synthetics. To obtain an NPA natural certification companies must also use a majority of recyclable and postconsumer recycled content in their packaging and at least 60 percent of their product line must qualify for NPA certification before the organization will certify any products. FTC-- All Natural means no synthetic ingredients but Natural is not the same as All Natural While the FDA has taken baby steps to address the debate over natural the FTC has taken more significant strides by pursuing actions against companies that market all natural and 100 percent natural products. Last summer the FTC announced it had approved settlements with four companies that market products as all natural or 100 percent natural when they contain artificial ingredients. Upon announcing the settlements FTC Bureau of Consumer Protection Director Jessica Rich stated that [a]ll natural or 100 percent natural means just that--no artificial ingredients or chemicals. Subsequently in response to a public comment the FTC rejected the notion that the term natural means the same thing as all natural stating it did not have evidence that consumers necessarily interpret natural to mean all natural or having no synthetic ingredients. In December 2016 the FTC issued an order against California Naturel Inc. finding that the company s marketing of its Sunscreen SPF 30 product as all natural was false and misleading since it contained dimethicone a synthetic ingredient. In reaching its findings the FTC relied on claims made on the company s website including a description of the sunscreen as a soft luxurious and non-oily all-natural sunscreen which uses only the purest most luxurious and effective ingredients found in nature. According to the FTC these claims together with the product packaging plainly conveyed to reasonable consumers that every ingredient in the product is natural. The FTC rejected the company s claim that a disclaimer added to the bottom of its webpage which was not visible without scrolling down sufficed to change the net impression conveyed to consumers. The settlements and the commission s order in California Naturel prohibits the companies from misrepresenting 1) the ingredients or compo14 Nutrition Industry Executive In response to a public comment the FTC rejected the notion that the term natural means the same thing as all natural stating it did not have evidence that consumers necessarily interpret natural to mean all natural or having no synthetic ingredients. Non-governmental Options Private Natural Certifications There are literally hundreds of green symbols on the market certifying everything from bubble bath furniture and household appliances to surfboard wax and cleaning goods. Some are issued by organizations with missions to protect the earth preserve the environment and conserve energy while others focus on safeguarding the health safety and well being of humans and animals. As www.niemagazine.com January February 2017 2. EcoCert Greenlife SAS This international organization was the first to develop standards for natural and organic cosmetics. Its standard for certifying natural cosmetics includes these mandates A minimum of 50 percent of all plant-based ingredients in the formula and a minimum of 4 percent of all ingredients by weight must come from organic farming Ingredients must be derived from renewable resources manufactured by environmentally friendly processes--products cannot contain GMO (genetically modified organism) parabens phenoxyehtanol nanoparticles silicon PEG synthetic perfumes and dyes or animal-derived ingredients (unless naturally produced by them e.g. milk honey etc.) and Biodegradable or recyclable packaging must be used. 3. Whole Foods Premium Body Care Seal Whole Foods Market perhaps the most influential national retailer of natural products has its own standards that companies must meet before the company will sell their products. For example Whole Foods has identified more than 75 ingredients common in conventional body care products that it does not allow in any of the products sold in its markets. It also developed its own Premium Body Care standards that impose strict criteria for ingredients which must come as close to nature and be as minimally processed as possible and have little environmental impact during manufacturing and when released into the environment. To date the company has identified more than 400 ingredients it deems unacceptable for the Premium Body Care seal including parabens polypropylene and polyethylene glycols sodium lauryl and laurel sulfates. It allows only natural essential oils or components of natural essential oils for use as fragrances and sells only sunscreens that create a physical barrier on the skin (zinc oxide and titanium dioxide) as opposed to chemical sunscreens (such as oxybenzone and octyl methoxycinnamate). There are more than 2 500 products bearing the Premium Body Care seal. Looking Ahead As we welcome 2017 the prospect of a regulatory resolution to the natural problem seems distant. The time may have come for us to work together and with third parties to try and stymie the onslaught of legal action that our natural industries face. Here s to a naturally prosperous and safe 2017. NIE Ronie Schmelz is an attorney with Tucker Ellis LLP in Los Angeles CA. She counsels clients on litigation-avoidance strategies and ensuring compliance with regulations enforced by the U.S. Food and Drug Administration (FDA) Federal Trade Commission (FTC) and other regulatory agencies. She can be reached at ronie.schmelz tuckerellis.com. Go to www.niemagazine.com generexlabs for info about this advertiser January February 2017 www.niemagazine.com Nutrition Industry Executive 15 IndustryNews Associations Submit Comments on the Revised NDI Draft Guidance S ome of the industries leading associations including the American Herbal Products Association (AHPA) Council for Responsible Nutrition (CRN) American Botanical Council (ABC) and the Natural Products Association (NPA) recently submitted comments to U.S. Food and Drug Administration (FDA) in response to the agency s revised New Dietary Ingredient (NDI) Draft Guidance released last year. FDA issued on August 12 2016 a revised draft guidance for industry titled Dietary Supplements New Dietary Ingredient Notifications and Related Issues. This revised draft guidance replaced draft guidance of the same name initially issued by FDA in July 2011. In the 2016 revised draft guidance FDA identifies two goals improving the rate of compliance with the NDI notification requirement and improving the quality of notifications. In its comments AHPA recognizes some improvements in the revised draft guidance compared to the 2011 draft guidance said AHPA President Michael McGuffin. However AHPA continues to have some of the same concerns about the content of the 2016 revised draft guidance and has additional concerns related to revisions in the 2016 revised draft guidance. AHPA noted in its comments that the 2016 draft NDI guidance would unnecessarily burden the dietary supplement industry and dietary supplement consumers and is wholly inconsistent with the economic and small business analyses prepared in connection with the NDI notification regulations in 21 CFR 190.6. According to Duffy MacKay ND senior vice president scientific and regulatory affairs CRN We have been waiting more than five years for this document and after close review consider it a step in the right direction. We re appreciative that the revised draft guidance appropriately addresses several issues raised by industry in response to the 2011 draft guidance and provided a better explanation of the agency s thinking but there are still items we take issue with. CRN takes issue with the agency s approach to evaluating evidence of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) marketing in order to create that authoritative list as well as its interpretation of other exceptions to NDI notification requirements. CRN remains concerned that a narrow interpretation of these exclusions will result in unnecessary NDI notifications for products with a long history of safe use. Also at issue is FDA s interpretation of sections of the Federal Food Drug and Cosmetic Act (FDCA) and DSHEA relating to the definition of dietary ingredient. Said MacKay In particular the agency s interpretation on this does not honor the spirit of DSHEA. One of ABC s several primary concerns with the 2016 draft guidance is FDA s focus on--and request for significant information on--the dietary supplement product itself. ABC set forth that the language in the NDI provision in DSHEA speaks to the dietary ingredient versus the finished dietary supplement product. ABC also references historic FDA actions that support the position that a NDI notification concerns the ingredient. ABC also expressed its concerns that FDA s language in the 2016 draft guidance suggests that almost any change in the manufacturing process or solvent used to make an extract might require an NDI notification due to possible chemical alteration of the ingredient. ABC provided examples where such chemical alteration may justifiably warrant a NDI notification and where it can be relatively insignificant and should not require a notification. ABC wishes to see rational regulations and guidance from the gov- ernment that protects consumers from inauthentic and or unsafe products and also allows members of industry to be able to produce supplements that meet or exceed required federal regulations for quality and safety said ABC Founder and Executive Director Mark Blumenthal. However some provisions proposed by FDA go well beyond what Congress intended when it conceived of NDIs and what the law actually requires and ABC is concerned that FDA s proposed guidance will not result in any meaningful consumer benefit. NPA expressed concerns the guidance could lead to unintended consequences and undermine the FDA s ability to promote public health. The way it stands now the guidance could actually result in more bad actors skirting the law entirely which is the opposite of what a sensible regulatory regime should be said Dan Fabricant PhD CEO and executive director of NPA. This economic burden to industry in following the food additive-level toxicology tests proposed in this draft guidance could harm small businesses and create a chilling effect on innovation and lead to fewer submissions from legitimate firms while encouraging fly-by-night companies to operate through NDI piggybacking until they are caught. It becomes FDA whack-a-mole all over again. NPA s 98-page comment brief underscores the need for significant changes to the current guidance in the best interest of public health. For more information visit www.crnusa.org www.ahpa.org http abc.herbalgram.org or www.npainfo.org. 16 Nutrition Industry Executive www.niemagazine.com January February 2017 IndustryNews FTC Issues Enforcement Policy Statement on Marketing Claims For Homeopathic Drugs he Federal Trade Commission (FTC) has announced a new Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs. An FTC workshop held last year to examine how such drugs are marketed to consumers informed the policy statement. The FTC also released its staff report on the workshop which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC. The policy statement explains that the FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is companies must have competent and reliable scientific evidence for health-related claims including claims that a product can treat specific conditions. The statement describes the type of scientific evidence that the Commission requires of companies making such claims for their products. For the vast majority of OTC homeopathic drugs the policy statement T notes the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product s efficacy. As such the marketing claims for these products are likely misleading in violation of the FTC Act. However the policy statement also notes the FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. Accordingly it recognizes that an OTC homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that 1) there is no scientific evidence that the product works and 2) the product s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. The policy statement notes that any such disclosures should stand out and be in close proximity to the product s efficacy message and might need to be incorporated into that message. It also warns marketers not to undercut a disclosure with additional positive statements or consumer endorsements reinforcing a product s efficacy. The statement warns that the FTC will carefully scrutinize the net impression of OTC homeopathic marketing claims and that if an ad conveys more substantiation than a marketer has it will violate the FTC Act. The Commission vote approving the enforcement policy statement and issuance of the staff report on the Homeopathic Medicine & Advertising Workshop was 3-0. For more information visit www.ftc.gov. Kemin and OmniActive Cancel Litigation Form Trade Organization n December 5 2016 OmniActive Health Technologies Ltd. (Morristown NJ) and Kemin Industries Inc. (Des Moines IA) resolved their legal differences placing the importance of human health above litigation according to the companies. Both parties will withdraw all legal complaints cross license each other s use patents and begin to form a Lutein and Zeaxanthin Trade Organization. On October 6 2016 Kemin filed a complaint with the International Trade Commission (ITC) requesting an investigation under Section 337 of the Tariff Act of 1930 with respect to the unlawful and unauthorized importation of infringing products by OminiActive. OmniActive then filed two inter partes review petitions on November 21 with the United States Patent and Trademark Office challenging the patentability of two patents of Kemin U.S. Patent Nos. 8 815 955 and 9 226 940. With this agreement Kemin and OmniActive agree to cross license our O current and future use patents on lutein zeaxanthin and their isomers worldwide and royalty free said Sanjaya Mariwala managing director and CEO of OmniActive Health Technologies. This agreement removes patent road blocks unleashes Kemin s and OmniActive s innovation for our customers worldwide and helps elevate the global usage of carotenoids. Litigation brought us together to find common ground. We see great value in eliminating lutein and zeaxanthin deficiencies in the human popula- tion to optimize human health through nutritional guidance. To do this Kemin and OmniActive jointly commit to advancing the science supporting the human health benefits of carotenoids added Dr. Chris Nelson president and CEO of Kemin Industries Inc. The first step to ensuring global alignment is to create a Lutein and Zeaxanthin Trade Organization to further lutein and zeaxanthin research and education for all population groups across the world. The organization will be open to all industry members said Mariwala. The details outlining the organization will be mapped out in the near future. The world is evolving the importance of supplementation is growing and Kemin and OmniActive are both committed to helping improve the health of our families through combined innovation and discovery said Nelson. For more information visit www.kemin.com or www.omniactives.com. 18 Nutrition Industry Executive www.niemagazine.com January February 2017 Lonza to Acquire Capsugel onza Group AG (Basel Switzerland) KKR and Capsugel S.A. (Morristown NJ) have entered into a definitive agreement under which Lonza will acquire Capsugel from KKR for 5.5 billion (U.S.) in cash including refinancing of existing Capsugel debt of approximately 2 billion (U.S.) through a transaction that has been approved by the Boards of Directors of both Lonza and Capsugel. This acquisition is fully in line with Lonza s stated strategy to accelerate growth and deliver value along the health care continuum by complementing its existing offerings and by opening up new market opportunities in the pharma and consumer health care and nutrition industries. With the acquisition of Capsugel Lonza will add a trusted brand with a large breadth of technologies and will expand the market reach of its contract development and manufacturing organization (CDMO) and products businesses. It will also support Lonza s strategic ambition of getting closer to the patient and end consumer. L The acquisition is designed to create a leading integrated value-added solutions provider in drug development formulation delivery technologies and manufacturing for the global pharma and consumer health care industries. The combined business will be well positioned to benefit from the dynamics in these industries and to anticipate and address technology trends in order to support the evolving needs of its customers. It will provide additional value by offering an integrated portfolio of industry-leading technologies from active pharmaceutical ingredients (APIs) through excipients to dosage forms and delivery technologies. With the addition of Capsugel s world-leading advanced oral dosage delivery technologies including its leading position in hard capsule technologies Lonza will become the partner of choice for its pharma customers along the entire value chain. The combined technologies and offerings will provide customers innovative solu- tions in both large and small molecules and solidify Lonza s position as the partner best able to support the pharma industry by bringing new differentiated medicines to market rapidly and efficiently. In addition the acquisition is expected to strengthen Lonza s position in consumer health care and nutrition as Lonza becomes a fully integrated and innovative service provider of active ingredients oral dosage forms development services and delivery technologies. As a result Lonza will be well positioned to meet the increasing need for optimized consumer health and nutrition through a wide offering of next-generation dosage forms. The combined business will also be able to leverage its bioavailability technology to create a new dietary ingredient-ready offering as well as capitalize on its formulation expertise to develop new ingredients and to market new combination products. With approximately 3 600 employees and 13 facilities on three continents Capsugel has a customer-centric entrepreneurial and collaborative culture that closely aligns with Lonza s corporate culture. Both companies focus on quality operational excellence and delivering on promises. This transaction brings together two leading companies that share a common vision--to deliver real value to customers by accelerating their ability to develop and commercialize innovative pharmaceutical and health care products said Guido Driesen president and CEO of Capsugel. The combination of our complementary technology platforms will put us in a strong position to benefit from evolving trends in the pharma and consumer health care markets. This new integrated approach will benefit our customers who will gain from the simplicity and efficiency of working with one company that can provide world-leading support from APIs to excipients and dosage forms added Richard Ridinger CEO of Lonza. The combined business will allow us to partner with our customers to help them bring highly differentiated products to market more quickly and efficiently. For more information visit www.lonza.com or www.capsugel.com. Go to www.niemagazine.com ayushherbs Nutrition Industry Executive 19 January February 2017 www.niemagazine.com IndustryNews Industry Associations Comment on Vinpocetine Ban he Natural Products Association (NPA) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency s recent actions to ban vinpocetine. FDA is collecting public comments following a Federal Register notice that would effectively ban vinpocetine a widely used product found in safe and legal dietary supplements. The FDA s decision could have major implications for new dietary ingredient (NDI) notifications and have an adverse impact on consumers and manufacturers of dietary supplements. Dan Fabricant PhD executive director and CEO of NPA said. We think our comments lay out a framework whereby vinpocetine fits as a dietary ingredient under the Federal Food Drug and Cosmetic Act. If this notice goes into effect it will distort the market and confuse manufacturers selling safe and legal products and do nothing to protect consumers he added. Because of the far-reaching implications this rule could have and the dangerous precedent it would set if allowed to move forward the FDA should conduct a full economic impact analysis and extend the comment period by a year or withdraw it effective immediately. The proposal has also received back- T lash from senior lawmakers including Senator Orrin Hatch (R-UT) who recently circulated a letter to the FDA asking the agency to review the impact this proposed rule could have on consumers and manufacturers of dietary supplements. The American Herbal Products Association (AHPA) also recommended the secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be a lawful dietary ingredient in comments submitted to the FDA. AHPA strongly encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future the ingredient would therefore qualify as a dietary ingredient. The Council of Responsible Nutrition (CRN) commented that the FDA s tentative decision to reverse its longstanding position that vinpocetine is a legal dietary ingredient is inappropriate when as here there are no safety concerns. Further it is an unprecedented move by FDA that threatens to undermine the dietary supplement industry s confidence in the NDI notification process. CRN added that FDA s unprecedented step comes at an inopportune time for the industry. CRN has been working with FDA in good faith on the policies and interpretations the agency announced in the original NDI draft guidance and its recent revision CRN stated. Threatening products that have been on the market for nearly 20 years after five NDI notifications the agency s notice on vinpocetine is not in the same spirit of cooperation. It also undermines the agency s goals. For example in the revised NDI draft guidance the agency encourages companies to submit NDI notifications even when the statute does not require them to do so. Companies now may be less inclined to participate voluntarily in the NDI notification process if the agency may simply reverse an acknowledgement at any time--for example when it receives pressure from a member of Congress. Such action by FDA also creates unpredictability in the marketplace thereby discouraging innovation and new product development. For more information visit www.npainfo.org www.ahpa.org or www.crnusa.org. Pharmachem Moves to Measure All Viable Cells in Probiotics vs. CFUs harmachem Laboratories Inc. (Kearny NJ) recently announced that it is now using flow cytometry to more accurately and quickly measure the viable cells in probiotic formulas as opposed to the traditional plating method which measures only colony forming units (CFUs). According to Alexis Collins director of scientific affairs for Pharmachem at least one-third of the company s probiotics customers now request flow cytometry for unique formulations. We offer many formulations using probiotics and plating is just too variable to accurately measure probiotics post-formulation she said. With flow cytometry probiotic cells are tagged with fluorescent markers which allow each cell to be counted by a laser as they pass through a tiny tube. The technology provides a method for counting live injured and dead cells in a P formula. You will often see higher numbers of viable cells versus CFUs because flow cytometry measures all viable cells explained Collins. At times a probiotic ingredient can contain up to 50 percent viable but non-culturable cells (VBNCs). The total count of viable probiotic cells equals CFUs plus VBNCs. Counting CFUs has been the standard measurement--but it does not count all efficacious cells Collins added. VBNCs are not measured via plating only cells that are happy enough can form colonies in that specific media environment. Pharmachem provides probiotics customers with total viable cell counts in active fluorescent units (AFUs) along with CFU counts. Another attractive benefit to flow cytometry is the speed-toresults said Collins. Plating typically takes days while flow cytometry gives you results in triplicate in under an hour. Flow cytometry has been used as a validated cell counting technique for decades but was first adapted for probiotic counting by Pharmachem s partner Probiotical (Novara Italy). It is the enumeration method they recommend all customers use. Flow cytometry method is universal and independent of the species analyzed so it is equally valid for L. acidophilus and B. breve for example explained Probiotical s Dr. Marco Pane. Traditional plating relies on methods that differ between species genus and even suppliers and laboratories. Since December 2015 the application of Flow cytometry for lactic acid bacteria enumeration has been published as an official International Standard (ISO) method (ISO 19344 2015 - IDF 232 2015). For more information visit www.pharmachemlabs.com. 20 Nutrition Industry Executive www.niemagazine.com January February 2017 Lonza to Divest Peptides Business and Operations in Braine-l Alleud Belgium to PolyPeptide L onza (Switzerland) and the PolyPeptide Group (Belgium) jointly announced that PolyPeptide Laboratories Holding (PPL) AB has entered into a definitive agreement with Lonza Sales AG and Lonza AG (both 100 percent affiliates of Lonza Group AG) to acquire the peptides business and operations of Lonza in Braine-l Alleud Belgium. Lonza s Braine facility with approximately 280 employees is the center for peptide chemical development and manufacturing within Lonza. The agreement is expected to close in the next weeks subject to customary closing conditions. The acquisition will enhance PolyPeptide s manufacturing capacity and capabilities and will enable seamless support for its broad portfolio as many products progress toward regulatory approval and commercial supply. Lonza Braine will provide immediate access to additional large-scale capacity in synthesis purification and isolation of peptides while PolyPeptide s existing complementary portfolio of late-stage products offers opportunities for synergies and continued growth for the company. The addition of Lonza s Braine facility to PolyPeptide is a great fit and will offer customers an even more comprehensive range of services for every stage of development said Jane Salik CEO of the PolyPeptide Group. With this acquisition we will be expanding our capacity to meet the needs of customers who demand the highest quality products with the most robust scalable and cost-efficient peptide manufacturing processes at every scale. This agreement is the result of our strategy of continuously reviewing our business portfolio and streamlining and optimizing our site and production platforms said Marc Funk chief operating officer of Lonza s Pharma&Biotech segment. The peptides chemical business is a niche business for Lonza with only limited synergies with other small molecule technologies. PolyPeptide is focused and dedicated to the production operations and sales of peptides so we believe that we have found the optimal partner for the business to give new perspectives to the Braine site and its employees. This move will also allow us to fully focus on our many other technologies which we will continue to develop further. Both PolyPeptide and Lonza have long and distinguished histories in peptide manufacturing. Lonza acquired the Braine peptide business in 2006 from UCB while PolyPeptide s corporate roots in peptide therapeutics date back to the 1950s. Both companies became successful in peptide manufacturing by building excellent reputations for quality service and GMP (good manufacturing practice) support. The acquisition announced will not affect ongoing activities at the Belgian facility before or after close and the integration process is expected to be seamless to customers. PolyPeptide Group announced that the harmonization of procedures to ensure consistency continuity and quality within its expanded Group will be implemented in the coming months. With this acquisition the PolyPeptide Group will employ close to 800 people worldwide with GMP facilities in the United States (Torrance and San Diego CA) France (Strasbourg) India (Ambernath) Belgium (Braine-l Alleud) and Sweden (Malmo). For more information visit www.lonza.com or www.polypeptide.com. QLaboratories Expands Microbial Identification Capabilities Q Laboratories Inc. (Cincinnati OH) has added another tool to its microbial identification capabilities by acquiring the Bruker MALDI Biotyper. This technology allows for rapid cost-effective accurate identification of thousands of microorganisms (including yeasts and filamentous fungi) using state-of-the-art technology. It can be used for environmental product and or research and development applications. Classification and identification are based on proteomic fingerprinting using high throughput mass-spectrometry. Turnaround time can be as little as one day. Currently celebrating 50 years in business Q Laboratories Inc. has recently opened a new dedicated microbial identification laboratory as part of our ongoing facility expansion. This space will house the Bruker MALDI Biotyper as well as traditional biochemical identification technology and will allow for additional microbial identification capability in the future. For more information visit www.qlaboratories.com. Go to www.niemagazine.com morretec Nutrition Industry Executive 21 January February 2017 www.niemagazine.com IndustryNews Fruit d Or Unveils New Partnership with Taiyo During Cranberry Harvest Symposium embers of the trade media industry stakeholders and customers converged on the Quebec headquarters of ingredient supplier Fruit d Or in October to literally get their feet wet during this year s cranberry harvest. This year s participants in the Fruit d Or Cranberry Harvest Symposium got the full farm-tofactory experience. The symposium included workshops designed to showcase the opportunities of marketing cranberry beyond urinary tract infections. M Also during the symposium Fruit d Or formally unveiled its new relationship with Japan-based Taiyo. A new branded ingredient SunCran combines Fruit d Or s Organic Cranberry Juice Powder with Taiyo s Sunfiber soluble guar fiber. It is available as both organic and conventional formulations. Taiyo Vice President Scott Smith stated We selected Fruit d Or as an ingredient partner not just for their leadership in delivering premium quality cranberry ingredients but also because their core values parallel ours in that we Nutrition Industry Executive s Editor-in-Chief Janet Poveromo visits Fruit dOrs cranberry bog during the symposium. are in business to produce and supply science-based quality ingredients with the highest concern for consumer health and safety. For more information visit www.fruit-dornutraceuticals.ca. Don t miss a single issue of NIE in 2017... go online to renew your free subscription today NIEmagazine.com JanFeb17 Ganeden Experts Take Unique Approach to Bust Common Probiotic Myths hile probiotics continue as a top trend misconceptions and confusion around the category and the benefits of these beneficial bugs linger. With new information being released daily on the topic it s difficult to sort out the facts from the hyperbole. That s why experts from the probiotic ingredient supplier Ganeden (Mayfield Heights OH) decided to provide education and awareness on the topic through a unique approach--a myth-buster series called Probiotics Beyond the Hype. Started last year Ganeden s myth-buster series dives into some of the most common probiotic myths to clear up misconceptions on each--in short and easy-to-read segments. To date the series has provided answers to a variety of probiotic questions including Does the Live & Active Cultures seal mean yogurt is probiotic Do fermented foods have probiotic benefits Can you add probiotics to skincare ingredients How many CFUs of probiotics do you need in a product Are all probiotic strains the same Is formulating with probiotics difficult Can probiotics be added to shelf-stable beverages According to the company the myth buster series has resonated with readers in both the business and consumer spaces--whether their interest is in formulating with probiotics writing about them or simply consuming them. We ve seen confusion relating to probiotics across all audiences from manufacturers to media to consumers themselves and we felt it was important to shed some light on the facts said Michael Bush president of Ganeden. The myth-buster series is designed to provide consumer- and media-friendly insights on a variety of topics to help set the record straight on common probiotic misconceptions. Regardless of their background all readers can benefit from it. Ganeden will continue to release myth busters on common probiotic topics throughout 2017. For more information visit www.ganedenprobiotics.com. W 22 Nutrition Industry Executive www.niemagazine.com January February 2017 Welch s and Blue Marble Biomaterials Announce Collaboration elch Foods Inc. (Concord MA) a global food and beverage manufacturer and biochemical manufacturer Blue Marble Biomaterials (Missoula MT) have announced their intention to collaborate to bring naturally derived biochemicals to the public. The collaboration would enable Blue Marble to expand its manufacturing capacity for natural ingredients (biochemicals) for use in food fragrance and lifestyle products such as cosmetics from low-value side streams generated during Welch s production of grape and apple juice. We have been working with Welch s for the past year to identify the numerous final products that we can manufacture from its side streams that normally are sent to compost or animal feed suppliers said Colby Underwood co-CEO of Blue Marble. Our natural chemicals offer manufacturers and W consumers a better choice and we are eager to explore commercial scenarios with Welch s to determine the most advantageous path forward. Blue Marble produces drop-in replacement biochemicals that are derived from organic materials--such as spent coffee and tea wood chips and the pulp and skin of fruits and vegetables--to replace chemicals derived from crude oil. We are excited to collaborate with Blue Marble and to do our part to create a more sustainable world said Bradley Irwin Welch s CEO. Welch s is owned by family farmers who have been growing fruit for generations. This partnership is an expression of their dedication to sharing what s good. For more information visit www.bluemarblebio.com or www.welchs.com. You reHired sions to develop and market products that Steven Tave has been named permanent meet consumer demands in an environment director of the U.S. Food and Drug of vague or non-existent regulatory guidance Administration s (FDA) Office of Dietary and regulation. Supplement Programs (ODSP). Tave Kemin Food Technologies (Des a lawyer has been temporarily leadMoines IA) has introduced three ing the ODSP since the Spring of new members in the fats and oils 2016. group. Jody Jenkin has joined the Euromed (Presto PA) has promoted team as product manager Chandra long-time U.S. Sales Manager Guy Jody Jenkin Ankolekar PhD is technical service Woodman as it general manager manager and Tony (GM). He had worked alongBombard is technical sales side the former GM who just manager. stepped down Joe Veilleux As product manager for many years and is Jenkin will provide direcprimed to take full responsition vision and optimizability for oversight of the Chandra Guy Woodman tion for the product lines firm s U.S. operations. Ankolekar and will drive achievement EuroPharma Inc. (Green of business targets for products sold Bay WI) maker of the Terry Naturally by the fats and oils business for the and EuroMedica lines of dietary supAmericas region. Ankolekar will proplements and natural products vide technical support to the fats announced that Alexander George and oils sales team as technical servPanossian PhD Dr. Sci. has joined Tony Bombard ices manager. As technical sales their company as a consultant and manager Bombard will focus on research and science director for growing the Kemin fat and oil business product development as an expert in herbal around their customer base. products. Nutrition 21 LLC (Purchase NY) has EAS Consulting Group LLC (Aleandria VA) announced that Salma Fathalla has joined the added Steve Armstrong JD to its cadre of independent advisors serving as an expert in company as the new director of quality assurfood law and regulations. Armstrong will play ance. Fathalla will be responsible for quality control and quality assurance of both the an integral role in EAS new Product Nutrition 21 and JDS Therapeutic product Development and Labeling Service a service lines. designed to help food firms faced with deciJanuary February 2017 www.niemagazine.com Nutrition Industry Executive 23 IngredientNews Probiotic Combination Reduces Post-Workout AlgaeHealth s Muscle Recovery Time Introduces New More AstaZine Makes Effective Probiotic Analytic Method NDI News Gains the performance (21 days) of a musclenew study published in the journal Nutrients has revealed that specific damaging exercise of the elbow flexors. European Approval probiotic supplementation reduced the amount of performance degradation and inflammation following a bout of muscle-damaging exercise. Probiotics have been purported to reduce inflammation but little was known about the potential effects on inflammation and performance in athletes after strenuous exercise said Dr. Ralf J ger of Increnovo LLC lead researcher. J ger in conjunction with researchers at Texas Christian University (Fort Worth TX) and Biolab Researh S.r.l. (Novara Italy) conducted a double-blind randomized placebo-controlled crossover study involving 16 healthy resistance-trained men. Each participant ingested a daily encapsulated probiotic containing five billion live cells of B. breve BR03 and S thermophilus FP4 each or placebo prior to A Performance of the elbow flexors and a marker of inflammation (interleukin-6) were measured prior to and following damaging exercise. Ingestion of the anti-inflammatory probiotics attenuated performance and range-of-motion decrements following muscle damaging exercise said J ger. The probiotics also reduced baseline inflammation and improved the inflammatory response to exercise. These data suggest that the specific probiotics may assist in recovery following exercise. Alexis Collins director of scientific affairs Pharmachem Laboratories distributor of the strains said the study is a boon for the new generation of sports nutrition supplements. For more information visit www.pharmachemlabs.com. Bergstrom Nutrition Announces Newly Approved Canadian Health Claims For OptiMSM ashington-based Bergstrom Nutrition announced that its product OptiMSM has received several new health claims from Health Canada s Natural and Non-prescription Health Products Directorate. OptiMSM is a branded form of methylsulfonylmethane (MSM) the only MSM manufactured in North America and the only GRAS (generally recognized as safe)designated MSM in existence. Health Canada is the federal department responsible for helping Canadians maintain and improve their health. The Canadian health claims for OptiMSM are Helps to reduce joint stiffness associated with osteoarthritis. Helps to temporarily improve joint function in osteoarthritis. Helps to maintain skin health. Helps to reduce fine lines and wrinkles. Helps to temporarily reduce mus- W cle pain and discomfort immediately after exercise. Supports antioxidant capacity after exercise. Reduces cell membrane damage after exercise. Reduces exerciseinduced oxidative stress. We would especially like to thank AIC our Canadian distribution partner for their support and help throughout this process with Health Canada said Eric Brown sales director Bergstrom Nutrition. World-renowned for joint health our research has been leading us toward additional OptiMSM benefits. AIC understands that Canadian companies will now be able to help even more people with other areas of health because of these new claims. For more information visit www.optimsm.com. alifornia-based Algae Health Sciences Inc. (AlgaeHealth) a subsidiary of Beijing Gingko Group (BGG) announced that it has submitted a new NDI (new dietary ingredient) to the U.S. Food and Drug Administration (FDA) for its flagship product AstaZine Natural Astaxanthin. This new NDI builds on a previous NDI in late 2015 for the use of AstaZine as a bulk dietary ingredient at a dose that does not exceed 12 mg of astaxanthin per day the new NDI has been filed at a dose that does not exceed 24 mg of astaxanthin per day for a period of 30 days. The new 24 mg per day dosage is the first in the astaxanthin industry over 12 mg per day. Based on published studies we generally recommend a dosage of 4 mg--12 mg per day over longer periods however we are aware that a growing number of people are voluntarily dosing at well over the 12 mg upper dosage range said Lixin Ding PhD chief operating officer of AlgaeHealth. In particular many athletes report that they get better results in the 24 mg per day dosage range. Published clinical research on natural astaxanthin has seen a wide range of dosages. For example research on immune health shows excellent results at 2 mg per day while there have been studies done at levels above 12 mg showing benefits in a few different areas. In particular the human studies on astaxanthin s benefits for cardiovascular health have shown positive results above 12 mg per day. In other news the company and BGG also announced that AstaZine Natural Astaxanthin has won Novel Food approval from the Food Safety Authority of Ireland. The new approval will allow BGG to market its AstaZine line throughout Europe. For more information visit www.algaehealthsciences.com. C 24 Nutrition Industry Executive www.niemagazine.com January February 2017 Digestive Health Ingredient Pylopass Launches Under the Life Extension Brand ylopass a nutritional ingredient will now be entering the U.S. market. Maypro Industries (Purchase NY) the sole U.S. distributor of this ingredient and Organobalance (Berlin) the German biotechnology company that manufactures Pylopass announced that Life Extension recently launched Gastro-Ease a dietary supplement containing Pylopass. Organobalance developed this patented bioactive against the stomach bacterium Helicobacter pylori a gramnegative spiral shaped bacteria that colonizes in the stomach using a natural lactic acid bacterium from its microorganisms strain collection made from spray-dried inactivated cells of P Lactobacillus reuteri. H. pylori can cause digestive issues. The bacteria secretes enzymes that neutralize stomach acid creating a fit environment for it to survive and burrow through the stomach lining. According to the Centers for Disease Control and Prevention (CDC) it is estimated that two thirds of the world s population is infected with H. pylori. Pylopass has a unique effect against this carcinogenic stomach bacterium said Dr. Christine Lang microbiologist and Organobalance s managing director. Unlike conventional therapies involving antibiotics which can harm the human microbiome consumers who are taking Pylopass can lower their Helicobacter pylori load without losing their natural bacterial balance in their gut. Many customers worldwide already use this ingredient in dietary supplements but Life Extension is the first company to launch this self-affirmed GRAS (generally recognized as safe) non-GMO (gentically modified organism) and shelf stable ingredient in the U.S. market. For more information visit www.organobalance.de en www.lifeextension.com and www.maypro.com. 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. Animal Study Shows Neumentix Enhances New Nerve Cell Growth indings from a recent study show Kemin s (Des Moines IA) proprietary spearmint-based cognitive performance ingredient Neumentix Phenolic Complex K110-42 enhances rates of neurogenesis at physiologically relevant concentrations in rat primary hippocampal cells. The study The effects of a proprietary spearmint extract on neurogenesis in rat hippocampal neurons was conducted at QPS in Grambach Austria. Key findings on the novel mechanism of action were presented at the Society for Neuroscience annual meeting Neuroscience 2016 in San Diego CA. This study was designed to test our hypothesis that neurogenesis is a mechanism of action for the clinically observed working memory improvements associated with Neumentix supplementation said Laura Wonderling PhD research and development director for the Human Nutrition and Health division of Kemin. For more information visit www.kemin.com. First Time Report on K2-7 to Lessen Severity of Peripheral Neuropathy Pain n a published study in The Indian Practitioner India s premier medical journal vitamin K2-7 was reported for the first time to alleviate intensity of symptoms of clinically confirmed peripheral neuropathy characterized by the colloquial pins and needles throbbing pain and weakness and numbness in extremities. This open-labeled clinical study registered with Clinical Trial Registry of India (CTRI) was conducted with 30 men and women 18 to 60 years old with peripheral neuropathy divided into a moderate pain group with a VAS score of 6 to 8 and a severe pain group with a VAS score of 8-9. (VAS is the Visual Analog Scale which assesses intensity of symptoms). Each participant of the study took 100 mcg vitamin K2-7 twice a day for nine weeks. The vitamin used was in form of 100 mcg gelatin capsules of vitamin K2-7 (brand MenaquinGold) provided by Synergia Life Sciences Pvt. Ltd. (A Viridis Group of Companies) Mumbai India. The VAS score in both groups reduced significantly at the study s conclusion from the baseline score of up to 9 to 1 to 2 score after nine weeks of vitamin K2-7. Study participants reported reduction in tingling numbness weakness fatigue and intensity of muscle cramps. For more information visit www.synergiasciences.com. F I Milk Specialties Global Expands Organic Dairy Protein Offerings ilk Specialties Global (Minnesota) a human and animal nutrition company in the health and wellness industry has announced the availability of a new instant organic whey protein using sunflower lecithin. Milk Specialties added the new organic offering to its product portfolio in response to increased demand from its M customers for organic dairy proteins. Milk Specialties new instant organic whey protein joins its existing organic offerings now providing customers with additional choices to better serve their products in numerous applications from nutritional powders and bars to ice cream and ready-to-drink protein shakes. We re excited about the availability of our organic whey and milk proteins in a greater variety of options to better support our customers needs in the growing organic space said Dustin Cosgrove senior director of business development at Milk Specialties Global. For more information visit www.milkspecialties.com. Nutrition Industry Executive 25 January February 2017 www.niemagazine.com IngredientNews Ingredient Business is Gelling at Vermont Soap ost people that love Vermont Soap (Middlebury VT) don t realize that the brand also makes products for many other companies as well as supplying manufacturers with bulk liquid and gel soap bases. In fact in most years more than 70 percent of Vermont Soap business is in private label finished goods as well as B2B bulk ingredients. Vermont Soap s eco-friendly solar and hydro-powered factory employs 25 people and has carved out a niche in the natural personal care products industry. Vermont Soap continues to M expand their organic ingredients business with Gelling with VS. Established brands and startups can now add bath and shower gels with USDA organic certification to their lines. As part of the Gelling with VS program Vermont Soap provides a full range of business services including organic product certification compliance labeling formula test runs packaging assistance graphic design and custom blending. Vermont Soap has rebounded from a devastating fire in 2014 by building a plant at a new larger facility down the street from its original location. The company used the rebuild as a chance to streamline upgrade and expand production processes. Vermont Soap specializes in organic personal care cleaning and pet products and is a USDA (U.S. Department of Agriculture) Organic Processor Handler. We are like an organic soap Sherpa and can carry your natural product through the organic certification process for you said Larry Plesent Vermont Soap CEO. Vermont Soap s products are so natural they are certified to USDA organic food standards. For more information visit www.vermontsoap.com. Valensa Launches Chia Seed Oil in EU after Novel Foods Approval alensa International (Florida) recently announced that it has begun offering its Chia Gold Stabilized Chia Seed Oil in Europe. The company gained Novel Food approval for the ingredient via a substantial equivalence opinion in September. The ingredient which was launched by Valensa in the United States in 2012 is one of the top-selling chia-based omega-3 ingredients in the U.S. market known for its exceptional shelf stability pleasant taste and overall quality based on Valensa s proprietary processing technologies. Chia Gold contains 550 mg of ALA omega-3 per gram of oil. It is a part of Valensa s portfolio of chia-based ingredients developed with the company s solvent-free supercritical CO2 extraction technology and proprietary O2B peroxidation blocker stabilization technology. Chia Gold is available for use in the same food categories and at the same use levels as Europe s existing chia oils which includes its use in fats and oils ( 10 percent) and in food supplements ( 2 g day). According to Sylvia de Jong vice president of sales and marketing at Valensa Novel Food approval for Chia Gold will allow European consumer products companies to enhance the omega-3 nutritional profile of their products in applications where taste and product stability are primary concerns. Omega-3s are among the most desirable nutritional ingredients in Europe and chia is emerging with consumers as a popular source because it is plant-based and sustainable. It has the potential to become a differentiator in a broad range of consumer products she said. With Chia Gold consumer product developers can use the best-tasting most shelf-stable chia oil product on the market unleashing their creativity in formulation while assuring the highest quality for their customers and building their brands she added. For more information visit www.valensa.com. V Comparison of Five Curcumin Brands Identifies Sabinsa s Curcumin C3 Complex as the Most Active Form ot all curcuminoid products on the market are the same according to independent academic researchers at the University of Louisville in Kentucky. Their study Strong Anti-Inflammatory Effects of Curcumin was published in the Journal of Nutrition and Health Sciences (JNutrHealthSci16-205 Vetvicka V University of Louisville Department of Pathology Louisville KY). In a detailed study that involved both in-vitro and in-vivo models the researchers compared both anti-inflammatory and antioxidant activity the two premier activities for which curcuminoids are noted among five brands on the market. They concluded that Sabinsa s C3 Complex was consistently the most active sample. The anti-inflammatory comparison involved the study of depression in the expression of the proinflammatory cytokines such as TNF- IL-6 IL-10 etc with C3 Complex out in the front. Also C3 Complex led in reducing acuteinflammation in a xylene-induced acute inflammation of the mouse ear model. Curcumin is more than just one of Sabinsa s ingredients it holds a special place in our hearts and minds because it can significantly enhance human health said Shaheen Majeed marketing director Sabinsa. Many people here have worked extremely hard to produce the best form of curcumin to deliver health benefits and are gratified to have their efforts confirmed by independent research. This is more evidence that the specific form of curcumin chosen for a formula is an important decision. For more information visit www.sabinsa.com. N 26 Nutrition Industry Executive www.niemagazine.com January February 2017 Lutemax 2020 Shows Improved Disability Glare Performance and Photo Stress Recovery OmniLean Obtains Self-Affirmed GRAS Notification mniActive s (New Jersey) Lutemax 2020 showed increases in macular pigment density (MPOD)--the thickness of the macular pigment which is made up of lutein and zeaxanthin isomers which lead to significant improvements in photo-stress recovery and disability glare in a recent study conducted at the University of Georgia entitled LAMA II-an acronym for Lutein Vision and Mental Acuity II. These findings of LAMA II were the subject of a paper Macular carotenoid supplementation improves disability glare performance and dynamics of photostress recovery which was published in the journal Eye and Vision 2016 (Stringham et al.). Photo-stress recovery is the amount of time the macula requires to return to its normal functioning level after expo- O sure to a bright light source. Disability glare is a degradation of contrast which has been caused by a reduction in visual performance. LAMA II demonstrated that MPOD visual performance in glare and photo-stress recovery significantly improved over placebo at both doses after six months of supplementation with additional improvements found at 12 months. The findings also suggest that lutein and zeaxanthin isomers from Lutemax 2020 is due in part to this formula that contains all three macular carotenoids-lutein RR-zeaxanthin and RS (meso)-zeaxanthin. Also OmniActive s OmniLean Salacia Extract has received self-affirmed GRAS (generally recognized as safe) notification by an expert panel who evaluated the ingredient in accordance with strin- gent U.S. Food and Drug Administration (FDA) safety criteria. OmniLean helps support metabolic health and was recently shown to reduce post prandial blood glucose and insulin in a human clinical trial in healthy individuals. Capsimax Capsicum Extract also received the notification. For more information visit www.omniactives.com. Natreon Files Lawsuit Against Ixoreal Shri Kartikeya Pharma ew Jersey-based Natreon Inc. supplier of ayurvedic ingredients including Sensoril ashwagandha filed a lawsuit against Ixoreal Biomed Inc. (California) and its parent company Shri Kartikeya Pharma Ltd. (India) in September. Natreon s allegations include unfair competition trade libel defamation and interference with economic relations among others. An initial filing stated that Ixoreal Biomed s KSM-66 contained hazardous Withaferin A levels but was ultimately modified. The recent allegations state that the defendant is making false representations about KSM specifically that it is a plant extract not derived from root powder pointing to various statements on IxoReal s website such as describing KSM as the highest-concentration extract on the world market and an ashwagandha extract. Natreon noted that plant extracts are known to have higher solubility in water than plant powders. Independent testing showed that that Sensoril has an aqueous solubility of over 90 percent as opposed to KSM which measured at about 35 percent indicating that the product N contains more root powder. The lawsuit also cites that ashwagandha extract costs almost five times more to produce compared to ashwagandha root powder. Natreon said it considers price cutting and falsely touting KSM-66 as a superior product unfair competition. The trade libel and defamation allegations originated from Ixoreal s accusations that Natreon s use of ashwagandha leaves created an adulterated product. According to the plaintiff Sensoril s process of using both ashwagandha roots and leaves is protected by U.S. Patents 7 318 938 and 6 713 092. Kartikeya Baldwa Ixoreal s director told Nutrition Industry Executive that on November 7 they filed a lawsuit and cross-complaint against Natreon and NutraGenesis (Vermont) which details their practices such as commanding a high margin of price over the cost basis severely distorting patent claims approaching Ixoreal in 2013 to join forces in an implicit col- lusion and presenting false identities to get access to its research and marketing material. This cross-complaint also states that Natreon and NutraGenesis make unsupported claims concerning Sensoril s health benefits such as suppressing food cravings speeding workout recovery time increasing metabolism and others. In addition Natreon s lawsuit alleges that Ixoreal KSM products contain undeclared milk allergens. Jeff Lind vice president of sales and marketing with Natreon stated that initially through independent labs five products showed the presence of dairy allergens. Since then 11 products have been added--Natreon has notified the FDA (U.S. Food and Drug Administration) of all 16 products testing positive for dairy allergens according to Lind. Declaring it a public health risk Natreon recommended that the defendants issue a voluntary recall of these products and urged that products containing KSM66 be tested immediately. We at Natreon stand by everything that s alleged against IxoReal Lind said. January February 2017 www.niemagazine.com Nutrition Industry Executive 27 IngredientNews Clinical Study Shows Natreon s Sensoril Can Significantly Improve Joint Health illions of Americans identify themselves as vegetarians or say they follow a largely vegetarian diet. Yet the most common natural approach to managing joint discomfort is a combination of animal-derived glucosamine and chondroitin. Now results of a human clinical trial published in the Journal of Ayurveda and Integrative Medicine provides strong evidence that Natreon s Sensoril a multi-patented standardized aqueous botanical extract of ashwagandha (Withaniasomnifera) roots and leaves provides an effective vegetarian alternative for promoting joint health. Sometimes called Indian ginseng because of its rejuvenating properties ashwagangha has been used for thou- M sands of years in ayurvedic medicine. It is known to possess a multitude of health benefits including helping to enhance joint and cardiovascular health anti-stress cognitive function and energy. This 12-week randomized doubleblind placebo-controlled study evaluated two different dosages of Natreon s Sensoril on 60 participants with knee joint discomfort. The subjects were randomized into three groups who received either 125 mg Sensoril 250 mg Sensoril or a placebo twice daily. The study subjects were evaluated using a Modified WOMAC Index Knee Swelling Index (KSI) and Visual Analog Scale (VAS) at baseline and after weeks eight and 12. At the end of 12 weeks consumption of both the 125 mg and 250 mg twice daily dosages of Sensoril produced significant reductions in all three parameters compared to placebo in a dose-dependent manner. Those in the 250 mg group also experienced significant improvements at the end of weeks four and eight which is a faster response time than has usually been observed in previous joint health studies evaluating glucosamine and chondroitin. Sensoril was also well tolerated in the current study with no reports of significant GI (gastrointestinal) issues while the use of rescue medication was lower in the Sensoril groups compared to the placebo group. For more information visit www.natreoninc.com. Ingredion and SweeGen Announce Distribution Agreement for Stevia Sweeteners ngredion Incorporated (Illinois) a global provider of ingredient solutions to diversified industries has entered into an agreement with SweeGen Inc. a California-based manufacturer of stevia-based sweeteners to be its exclusive global distributor of the company s novel nature-based stevia sweeteners in all markets except China. Ingredion will be a non-exclusive distributor in China. SweeGen s zero-calorie sweeteners are made using pure stevia leaf extract and a novel proprietary process. Ingredion will distribute these sweeteners initially in the United States and subsequently in other countries as additional regulatory approvals are granted. We are excited about the prospects of our promising and expansive partnership with Ingredion. Their strong go-to-market expertise and customer base complement our demand-driven R&D and manufacturing capabilities said Steven Chen CEO of SweeGen. For more information visit www.ingredion.com or www.sweegen.com. FMC Health and Nutrition Launches Aquateric N100 Enteric Coating MC Corporation s Health and Nutrition business has launched its Aquateric N100 enteric coating solution a new alginate-based product that simplifies processing for manufacturers and brand owners and improves the sensory experience for consumers. Aquateric N100 enteric coating is the newest addition to our nutraceutical portfolio said Ravi Annavarapu global product platform director FMC Health and Nutrition. It is a non-GMO (genetically modified organism) enteric coating solution and the first ever clean label option in the marketplace. This innovative solution not only simplifies the enteric coating manufacturing process but it also improves efficacy and flexibility in applications ranging from omega-3 to dietary supplements and botanicals. Aquateric N100 enteric coating works by protecting the capsule while in the acidic environment of the stomach keeping it intact until further along in the digestive process where it releases the active ingredient at low acidic conditions. FMC in partnership with customers has been successfully beta testing Aquateric N100 enteric coating for the past year. For more information visit www.fmc.com. I F New Research Shows BiovaDerm Reduces the Appearance of Wrinkles opical use of BiovaDerm a watersoluble egg membrane ingredient was shown to reduce the appearance of wrinkles after just eight weeks according to recently published peerreviewed research. Iowa-based Biova LLC is the manufacturer of BiovaDerm. The open-label study published in Clinical Cosmetic and Investigational Dermatology (DovePress 14 October 2016 Volume 2016 9 Pages 357-66) T showed daily topical use of BiovaDerm on facial skin significantly reduced the appearance of wrinkles after eight weeks as measured across three parameters roughness contour and depth. This study corroborates results seen in Biova s prior trial research studies. Further the researchers point to WSEM s association with additional mechanisms of cellular activity whereby BiovaDerm might offer natural skin health support and restoration especially under conditions of oxidative stress thus contributing to prophylactic anti-aging effects among other applications. For more information visit www.biova.com. 28 Nutrition Industry Executive www.niemagazine.com January February 2017 BLIS K12 Found to Provide Protection Against Non-streptococcal Infections in Children lis Technologies (Otago New Zealand) and Stratum Nutrition (St. Charles MO) announced the results of a new clinical study in children reporting the beneficial effects of the probiotic BLIS K12 (Streptococcus salivarius K12) on reducing the occurrences of streptococcal pharyngitis along with other non-streptococcal infections. This study was recently published in Drug Healthcare and Patient Safety and supports an already extensive body of clinical research showing B BLIS K12 s clinical benefits for reducing streptococcal pharyngitis and acute otitis media in children as well as streptococcal pharyngitis in adults. The findings reported in this new study suggest that the use of BLIS K12 might be helpful in protecting against nonstreptococcal infections such as tracheitis viral pharyngitis rhinitis acute respiratory infection (flu) laryngitis and enteritis. Di Pierro et al (Milan Italy) conducted the pilot clinical trial on 124 male and female children between the ages of 3 and 10 years. Children who exhibited recurrent streptococcal pharyngitis during the previous year were given BLIS K12 probiotic (n 48) while the children who did not experience recurrent streptococcal pharyngitis during the previous year served as the untreated control group (n 76). The BLIS K12 probiotic was administered for 90 days with an additional nine-month follow-up. For more information visit www.stratumnutrition.com. Research Highlights Efficacy of Oral Enzyme Combination Over NSAID in Treatment of Osteoarthritis new peer-reviewed study in the Journal of Pain Research indicates that Wobenzym an oral enzyme combination (OEC) containing proteolytic enzymes and bioflavonoid showed comparable efficacy and a superior tolerability and safety profile associated with a significantly lower risk of treatment-emergent adverse events compared to nonselective nonsteroidal anti-inflammatory drug (NSAID) Diclofenac in the treatment of osteoarthritis of the A knee. Osteoarthritis of the knee affects on average 25 percent of the general population in the Western world and is the most prevalent cause of pain and locomotor disability worldwide. Researchers at the Institute of Neurological Sciences Nuremberg Interdisciplinary Center for Pain and Palliative Care Medicine G ppingen Interdisciplinary Center for Rheumatology and Immunology Frankfurt and O. Meany Consultancy Hamburg Germany conducted this meta-analysis of six different doubleblind comparator-controlled intervention studies of Wobenzym versus NSAIDs in osteoarthritis. The original studies were sponsored by Mucos Pharma GmbH & Co. KG Germany a subsidiary of Atrium Innovations Inc. and all work was conducted independently without influence from the sponsor. For more information visit www.atrium-innovations.com. Applied Food Sciences Launches Two Organic Ingredients exas-based Applied Food Sciences Inc. (AFS) has taken the next step in their organic offerings as they introduced two new organic ingredients PurGinger organic ginger extract and Pur-C organic vitamin C extract at the BevNET Live conference held in December. Flavor is still the number one driver for all food purchases and the natural beverage industry has been without two of its key flavors the company stated. Up until now commercial availability of organic vitamin C has been all but nonexistent and organic ginger while available is a challenge to work with due to its lack of solubility. According to Innova Market Insights ginger is the No. 1 herb spice in supplements (25 percent) and functional food and beverages (21 percent [Innova 2016]). For AFS this is a huge opportunity and their two newest ingredients are game changers in the natural beverage industry according to the company. For more information visit www.appliedfoods.com. T January February 2017 www.niemagazine.com Nutrition Industry Executive 29 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Preparing for FSMA Community accepted methodological validation of DNA NGS is likely several years away. T he U.S. Food and Drug Administration (FDA) has begun implementing the Food Safety Modernization Act (FSMA) and most businesses in the dietary supplement industry will be impacted as the law is fully implemented in the coming years. FSMA seeks to ensure that the U.S. food and dietary ingredient supply is safe from contamination by taking a preventive rather than reactive approach. FSMA implements a selfenforcement review system of products facilities personnel and equipment along the supply chain that provides ingredients used in manufacturing dietary supplements. The American Herbal Products Association (AHPA) is working to help those in the industry understand their obligations and provide a roadmap to compliance. AHPA presented a webinar in December that featured David Doty international procurement manager at Mountain Rose Herbs Tony Young AHPA general counsel and partner at Kleinfeld Kaplan and Becker LLP and Rebecca Buckner associate director of FSMA Operations at CFSAN FDA. Doty stressed that the first step to complying with FSMA is determining what parts of the regulation apply to your organization (or parts of your organization). You need to determine what you are and what you are not he said. To determine which regulations apply he recommended companies define their 1. Business (farm food processing facility very small business dietary supplement manufacturer dietary supplement or food importer retailer etc.) 2. Product (dietary ingredient dietary supplement food food that requires further processing fresh produce etc.) 3. Supplier (farm foreign supplier very small foreign supplier packing facility food processing facility etc.) 4. Raw Material (dietary ingredient or supplement food contact packag30 Nutrition Industry Executive ing material animal food etc.) Doty noted that these are not comprehensive lists and companies may fall in to more than one category. In these cases a company may need to meet FSMA requirements for dietary ingredient operations and dietary supplement current good manufacturing practice (cGMP) requirements for supplement operations. AHPA has asked staff at FDA s Office of Dietary Supplement for more clarity and transparency regarding the application of certain subparts of 21 CFR 117 (FSMA s current good manufacturing practice [cGMP] hazard analysis and risk-based preventive controls for human food) to dietary supplement manufacturers that are regulated under 21 CFR 111 (cGMP in manufacturing packaging labeling or holding operations for dietary supplements). AHPA s goal is to ensure no surprises during inspections uniformity in application of the law and the safety of dietary supplements. Providing a legal perspective Young reminded webinar attendees that FSMA s cGMP hazard analysis and risk-based preventive controls for human food (21 CFR Part 117) in all its detail applies to dietary ingredient manufacturers and suppliers. Young reported that there are now FSMA-like FDA inspections of dietary supplement manufacturers being conducted and FDA inspectors take swabs in in drains ceilings and equipment to determine if pathogens are present. There is also more focus on testing of process water and whether laboratory analytical procedures are being followed he said. Dietary supplement manufacturers need to assure that their sanitation procedures are robust and likely to discover problems before they become big problems Young said. Young stressed that FDA has been concerned about microbial contamination of dietary ingredients and controlling microbial contamination is currently the number one issue facing ingredient suppliers because of the nature of the ingredients. This can be an additional challenge for natural products because steam sterilization appears to be the only viable kill step consistent with the law and the natural ethic. He encouraged companies to bring their processes and practices up to speed because customers will demand it. Buckner provided an update from FDA reporting that the agency is working to develop and implement inspection and enforcement strategies that facilitate consistent decision making by regulators. She also said that FDA plans to rank violations according to public health outcome recognizing that not all observations present equal relative risk and potential for public health impact. FDA is working to create a regulatory strategy that is dynamic according to Buckner. The agency will continue to facilitate stakeholder conversations for rule creation and solicit feedback on guidance documents. These regulations are a significant change for the regulated industry but FSMA was supported by the largest food associations. Using FSMA as an opportunity to examine supply chains and manufacturing facilities to ensure safety and quality could save the company money in the long run. A recording of the webinar is available at http ahpa.org news latestnews tabId 96 artmid 1179 articleid 743 webinarfsma-directimpacts-tomost-ahpamembers. aspx NIE Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) www.niemagazine.com January February 2017 AssociationNews CRN Applauds FDA s Transparency he Council for Responsible Nutrition (CRN) embraces FDA s (U.S. Food and Drug Administration) decision to make public data from FDA s Center for Food Safety and Applied Nutrition s (CFSAN) Adverse Event Reporting System (CAERS) calling it a demonstration of the agency s commitment to transparency. CRN noted however that publishing these reports online increases the potential for public misinterpretation of adverse event reports and stresses the importance of FDA providing context for its data. We re encouraged by FDA s move to make this information public as consumers expect and deserve transparency said Duffy MacKay ND senior vice president scientific and regulatory affairs CRN. When the Dietary Supplement and Nonprescription Drug Consumer Act was introduced our T industry was a strong proponent of its passing and emphasized the benefits it would provide consumers. Since the law s passage in 2006 the industry s track record demonstrates a strong safety profile for our industry both in comparison to other FDA-regulated industries and considering that more than 170 million Americans take dietary supplements each year. This law gave the FDA a valuable tool to identify potential safety concerns through patterns and signals. It s essential to understand however that an AER does not demonstrate a causal relationship. In its announcement FDA noted that adverse events about a particular product and the total number of adverse event reports for a product in the CAERS database only reflect the information reported and do not represent any conclusion by FDA about whether the product actually caused the adverse event(s). We advise the public to be cautious when reviewing these reports and to consider the fuller picture MacKay continued. If consumers are looking to make decisions about safe or unsafe products they would do best to pay attention to FDA s consumer advisories rather than looking at individual adverse event reports which at the end of the day may not be related to the supplement product. CRN reminds the dietary supplement industry that under the law supplement companies are required to report serious adverse events to FDA no later than 15 business days after the company receives the report. CRN urges the industry to follow the law. For more information visit www.crnusa.org. NPA Adds 18 Members Representing a Diverse Range of Natural Products he Natural Products Association (NPA) welcomes 18 new members to the organization. The 18 new members represent diverse areas of the natural products industry including supplements personal care products pet products food herbal products organic bedding and industry services. We are pleased to announce that NPA remains stronger than ever as we close out the year with the addition of 18 new members said Dr. Daniel Fabricant CEO and executive director of NPA. Our members see the results of the work that NPA has produced and see a vast return on investment from their membership. We look forward to working alongside these companies as we continue to be the leading voice for the natural products industry and the millions of American consumers that use our products every day to support their health and well-being. New NPA members include American Biosciences Inc. Annmarie Skin Care BioTectics LLC Botaneco Inc. Euphoric Birth & Herbals LLC Floridian Skins Inc. Harris Beach PLLC International Vitamin Corporation Jaabco Corporation Jetton Biochemistry Co. Ltd. Life Extension Foundation Michael Schaeffer LLC Naturepedic Organic Mattresses & Bedding Natureplex Solara Laboratories Strauss Naturals Thorne Research Turn Left Nutrition LLC Vitalize LLC For more information visit www.npainfo.org. T Go to www.niemagazine.com somalabs Nutrition Industry Executive 31 January February 2017 www.niemagazine.com ScienceUpdate Reducing Salt Intake May Help Protect Kidney Patients Heart and Kidney Health ew research indicates that reducing sodium intake may provide kidney and heart benefits for patients with chronic kidney disease (CKD). The findings appear in the Journal of the American Society of Nephrology (JASN). Urinary excretion of proteins including albumin is a hallmark of CKD. Therapies that reduce such albuminuria can slow kidney function decline and also have beneficial effects on the heart and blood vessels. Unfortunately currently available therapies do not eliminate albuminuria in many patients leaving these individuals with what is known as residual albuminuria. A team led by Martin de Borst MD PhD (University Medical Center Groningen in the Netherlands) studied two interventions that have demonstrated potential for reducing residual albuminuria dietary sodium restriction and a drug (paricalcitol) that activates the vitamin D receptor. In a random- N ized trial that included 45 patients with CKD each intervention was added to an optimized conventional treatment regimen during four eightweek periods. The investigators found that dietary sodium restriction led to a significant reduction of residual albuminuria and blood pressure whereas paricalcitol had no significant effect on these measures. The combination of paricalcitol and a low sodium diet however resulted in the lowest albuminuria levels. What we found was that sodium restriction provided a relatively large beneficial effect whereas the effect of paricalcitol was small. Thus the impact of the combined intervention was largely due to the protective effect of sodium restriction said de Borst. Most people consume twice as much sodium as the 2 grams daily recommended by the World Health Association. In our study patients consumed on average 4 grams of sodium per day which is well in line with global trends in sodium consumption among CKD patients said de Borst. Interestingly following our intervention aimed at reduced sodium intake patients consumed 2.5 grams per day which is still above the recommended level. This moderate restriction resulted in a strong reduction in albuminuria and blood pressure indicating that even a moderate reduction in sodium intake may provide serious health benefits. For more information visit www.asn-online.org. Daily Reminders to Increase Calcium Intake is Effective niversity of British Columbia (UBC) researchers have demonstrated that simple cost-effective email messages can help improve the health habits of Canadians. Mary Jung an assistant professor of health and exercise sciences at UBC s Okanagan campus recently completed a nationwide study with more than 730 Canadians who were not meeting Canada s recommended dietary intake for calcium. Participants received an email--with evidence-based daily tips and strategies on how to increase calcium intake--four days in a row. Jung a Michael Smith Foundation for Health Research Scholar professor wanted to determine if targeted messaging--making particular outcomes relevant to the population of interest-- could be a feasible public health strategy for improving calcium intake. Just four targeted messages made a remarkable difference in the consumption of calcium-rich foods said Jung. The majority of our participants increased their calcium intake by one U serving of dairy a day--pretty good results. Rather than tailoring messages to each individual which can be costly and intrusive the messages in this study highlighted outcomes Jung had found relevant to her targeted audience. Specifically she used evidencebased information including the suggestion of being a positive role model for one s children understanding the health benefits of consuming enough calcium as we age and strategies to keep up the required daily consumption. Despite the known health benefits of getting enough calcium such as bone health less than 40 percent of Canadians between the ages of 30 and 50 consume the right amount. Jung noted that this age group tends to encourage their children to drink milk but forgets the importance of ensuring they get enough calcium. Other than dairy products calcium can be found in green leafy vegetables like kale and broccoli as well as in almonds and canned fish with bones. Jung said her four emails arriving in email boxes early each morning resulted in an increase of more than 200 milligrams of calcium each day in participants--which was maintained four weeks after the emails were sent out. This study demonstrates that providing salient information along with relevant how-to strategies is an effective way to promote calcium intake in Canadian adults said Jung. These findings hold promise for future public health campaigns on a shoestring budget. By making messages meaningful to the targeted audience cost-efficient messages can change health behaviors. For more information visit www.ubc.ca. 32 Nutrition Industry Executive www.niemagazine.com January February 2017 Conventions&Meetings Third Annual PACK EXPO East P MMI the Association for Packaging and Processing Technologies brings the only processing and packaging events to the East Coast at PACK EXPO East (Philadelphia PA). The two-day trade show will focus on serialization packaging machinery automation packaging challenges and strategies for success and materials testing and government regulatory updates PMMI announced. Track and trace unique device identifiers supply chain security and temperature management serialization pilot tests and CMO s role and life sciences processing will also be covered. Attendees will be able to see innovation in action by watching machinery run at full scale build relationships by engaging with suppliers at exhibitor booths and gain a competitive edge through learning about the latest and trending issues. The expo will be held February 27 to March 1 at the Pennsylvania Convention Center. For more information visit www.packexpoeast.com. The Mexican Healthy Products Summit T he Sheraton Buganvilias Resort and Convention Center in Puerto Vallarta Mexico will be home to the Mexican Healthy Products Summit which will be held January 27-29. This is an invitation-only business-to-business trade show and conference linking healthy products suppliers with key retail buyers and distributors. There will be a variety of networking opportunities including a welcome reception evening cocktail gatherings meals (breakfast lunch and dinner) and entertainment. Expert speaker sessions will be in the morning with topics ranging from the Latest Healthy Lifestyle Trends in Mexico--Natural Marketing Institute (NMI) to How to do Business in Mexico--U.S. Commercial Service Office. For more information visit www.healthyproductssummit.com. The Changing Paradigm in Halal Certification T he 19th International Halal Food Conference April 1719 will focus on the future direction of halal certification and the formation of accreditation bodies to audit the halal certification bodies. At the Hyatt Regency O Hare in Rosemont IL join the conversation that will develop a robust halal certification and compliance system and prepare yourself for the future of the halal economy. For more information visit www.ifanca.org. Go to www.niemagazine.com mackflavor for info about this advertiser January February 2017 www.niemagazine.com Nutrition Industry Executive 33 DIGESTION S BENEFICIAL BOOST With digestive health products in high demand manufacturers are responding to the challenge as they develop products with influential ingredients that meet customer needs. By Nicholas Saraceno I f one comes to think of it digestive health is a major player in living everyday life. One cannot survive without food (and water of course) and once it is consumed the body begins the breakdown process. Unfortunately all does not always go according to plan once food is ingested. According to the American Nutrition Association 70 million people suffer from some form of digestive issue such as acid reflux irritable bowel syndrome (IBS) among others. People turn to items including pre and probiotics along with digestive enzymes to aid these problems which has helped contribute to the billion-dollar digestive health market that exists today (SPINS 2016). Although digestive health and item design may both present concerns manufacturers role in formulating products provides a positive outlook on not only the current market but on developments that could impact the future. 34 Nutrition Industry Executive Impactful Ingredients As referred to earlier with solutions to digestive issues diseases in high demand manufacturers find themselves relying on well-established ingredients within the industry to establish a successful formula. This includes digestive enzymes and herbs that have gained popularity in traditional medicine. The mainstay ingredients in digestive health supplements are probably digestive enzymes said Nena Dockery technical services manager with Stratum Nutrition (Missouri) which offers ACTAZIN a concentrated kiwi ingredient derived from New Zealand green kiwifruit. These have been around a long time and are used to support general digestion and to address deficiencies such as lactase supplementation to supply the critical enzyme for digesting lactose (milk sugar). Certain herbal ingredients have also been used particularly in traditional medicine to address digestive complaints. Ingredients such as ginger marshmallow and aloe are still popular in general digestive formulas. In the last decade or so probiotic supplementation has increased dramatically and is used to address multiple digestive issues as well as to support gut immune health. As Dockery stated ginger has been instrumental in this department not just for decades. In fact according to Lynda M. Doyle MS Human Nutrition and senior vice president at OmniActive Health Technologies in New Jersey it dates back as far as 4 000 years. Besides ginger s long history as a digestive aid it is widely viewed as a safe and well-researched option. Picking a safe and effective ingredient from a reliable responsible supplier of quality ingredients is the key to success when formulating a digestive health product Doyle noted. Gingever was developed with an emphasis on purity potency www.niemagazine.com January February 2017 and batch-to-batch consistency. Our supercritical CO2 extraction process produces a ginger extract with little damage or denaturing and without the use of harsh extraction solvents. Moreover just 60 mg of Gingever is equivalent to approximately 1 000 mg of ginger root powder allowing for lower doses. Dysbiosis a microbial imbalance that can target several parts of the body including the digestive tract (doctorshealthpress.com) can also be treated by prebiotics and probiotics. Susan Hewlings PhD RD and chief science officer of Oklahoma-based IgY Nutrition broke down pre and probiotics specific functions. In addition to a healthy diet she said pro- and prebiotics help to correct dysbiosis. While probiotics provide beneficial flora prebiotics may offer an alternative or symbiotic benefit to probiotics as they have been used to stimulate beneficial bacteria to help to restore balance. In contrast to the probiotic action which provides living microorganisms prebiotics stimulate the activity of healthful bacteria. centrated on using vegetarian capsules with specialized delivery features to prevent early activation before and after ingestion and to provide for targeted release into the intestines. An issue often faced by formulators comes down to the basics--there is sometimes confusion as to what a product s function truly is. While probiotics provide beneficial flora prebiotics may offer an alternative or symbiotic benefit to probiotics as they have been used to stimulate beneficial bacteria to help to restore balance. In contrast to the probiotic action which provides living microorganisms prebiotics stimulate the activity of healthful bacteria. -- Susan Hewlings PhD RD & Chief Science Officer IgY Nutrition A common challenge for manufacturers and formulators is a general lack of understanding how enzymes differ from other supplements said Mike Smith vice president Specialty Enzymes & Biotechnologies (California). For example vitamins and minerals have a daily value based on their weight. Vitamin C for example has a daily value of 60 mg. With enzymes it is their activity rather than weight that is important. For example protease can have an activity of 1000 HUT g and it can have up to 800 000 HUT g. That means the 800 000 HUT g protease will break down 800 times more protein than the 1000 at the same weight. For assistance it is always best to contact the technical support division of the enzyme company you work with. Without understanding the differences between products this could present a challenge when it comes to meeting the needs of consumers. Among consumers a common issue Concerns Still a cause for concern is how supplements and ingredients will survive transportation and storage conditions. This is especially important since some products may lose their benefit if not treated with proper care. Manufacturers need to be mindful of how to maintain the stability of probiotics and target delivery in the intestines where they work best said Missy Lowery MS senior manager of marketing at Capsugel Americas (South Carolina). The pressure and heat from the tableting process is harsh and can compromise the stability of probiotics. Transportation and storage issues-- such as length of time temperature fluctuation and exposure to moisture-- can put probiotics in yogurt products and other packaging like sticks and sachets at risk for early activation. Probiotics can also be acid-sensitive so as they transition through the stomach moisture and acid can cause early activation and degradation. Like probiotics enzymes can be acid-sensitive and might be prone to damage in the digestive process before they reach the small intestine. Encapsulation of these supplements is a step forward in offering more protection from moisture and delayed release. Capsugel in particular has taken several steps extra and con- includes the inability to digest of various products such as gluten among other food sensitivities. As Scott Ravech CEO of Deerland Ezymes in Georgia noted it is crucial that enzymes be created to work around these daily problems and help solve them. Consumers are increasingly recognizing that they might have difficulty with normal digestion of some wheat and dairy foods he said. 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 Enzymes latest products Glutalytic and Dairylytic have been designed to optimize digestion of gluten and dairy proteins. In turn providing safety and ease of use to the consumer is not only important to digestive products but also formulations on a broad-spectrum scale. State of the Market Being that digestion is an everyday process buyers are in constant need for products that can help solve digestive issues. In fact when it comes to new product development there is a strong focus on dietary fiber prebiotic and probiotic content claims according to Bill Driessen director technical sales (Central U.S. & Latin America) Taiyo International Inc. in Minnesota. Aside from new products the current market is driven by one s access to information. Via television radio social media and other platforms people are now becoming much more informed about ways to take better care of their bodies. Data from NBJ (Nutrition Business Journal) puts the estimated growth rate at just over 12 percent per annum for the digestive health market as it relates to dietary supplements said Mark Thurston president of ingredient supplier AIDP in California. There is much information in the news these days about digestive health and its importance in overall human health. Since launching a range of clinically proven prebiotics promoting Bifidobacterium growth AIDP has seen growth rates well in excess of the overall market as Nutrition Industry Executive 35 January February 2017 www.niemagazine.com DIGESTION S BENEFICIAL BOOST consumers begin to understand the benefits of feeding their own colonies of beneficial flora by using prebiotics. The temperature acid stability of prebiotics also makes it ideal for formulation in different types of foods beverages and supplements. As a result of this exposure to information there is an added pressure for manufacturers when it comes to the quality of ingredients that they need to produce. Consumers are expecting ingredients to deliver functionality and benefits that address health related issues but want to know they are safe noted Christopher Penet vice president BIOCAT Microbials (Minnesota). The regulations for new ingredients are under review and while the consumer-driven needs are emerging the time to market safety testing and adherence to science based results (clinical trials) takes time and effort. The shoppers who expect more from the ingredients that they purchase are not all limited to one particular age group as one might expect. Rather the demographic for digestive health products is arguably broader than it has ever been before. The demographic has broadened to range from young people that may live on tacos and ramen noodles to the elderly whose digestive function has slowed and everyone in between as understanding of the benefits various supplements can impart in good digestive health said Shaheen Majeed marketing director with Sabinsa Corp. in New Jersey. Besides having more access to information the wider range in consumers could also be attributed to having certain items target a specific audience. Mike Bush president of Ganeden (Ohio) and executive board president of the International Probiotics Association noted that this is quite popular in the case of probiotics. The demographic has expanded to include all age ranges and backgrounds though sometimes for differing reasons. While all consumers have an interest in probiotics for digestive health certain claims tied to a probiotic strain may be more important to certain audiences he said. For example our survey showed that parents have a strong interest in GanedenBC30 s immune health benefits in children s products and athletes and exercise enthusiasts are most concerned with its effect on protein utilization in sports nutrition products. As more targeted and specialized products become available there s becoming a probiotic solution for every lifestyle and preference. Scientific Research When it comes to improving ingredient advancements in digestive health the importance of research cannot be overstated. While suppliers may focus on a particular ingredient ultimately the goal is to help others. For instance Fruit d Or Nutraceuticals (Quebec Canada) is precisely interested in research regarding cranberry seed and probiotics for digestive and gut health according to Stephen Lukawski director of business development and global sales. Our research shows that cranberry www.niemagazine.com January February 2017 Go to www.niemagazine.com nutraceutix for info about this advertiser 36 Nutrition Industry Executive Go to www.niemagazine.com americanlaboratories for info about this advertiser DIGESTION S BENEFICIAL BOOST can provide greater benefits than UTI (urinary tract infection) he noted. High levels of soluble and insoluble PACs in cranberry can improve the microflora environment for gut health. Cranberry can act as a prebiotic pro- vide protein for immune support and improve the micro flora environment for gut health. It is highly recommended that companies test ingredients during various stages in order to ensure that customers are utilizing a product that is providing them with the full effect whether this product be a pre probiotic or a digestive enzyme. Our company and other manufacturers are also interested in testing for survivability said Bush. Many probiotic strains are very fragile due to the nature of the organism and most cannot survive in foods and beverages outside of the dairy category due to manufacturing processes. It is crucial to test any probiotic product to confirm efficacious doses at the time of consumption (not simply at time of manufacture) to ensure the end-user is receiving the expected probiotic benefits. One scientific advancement involves the effectiveness of probiotic strains even with cells that are no longer active. Nutrition companies are looking for strains with strong stability data said Dan Lifton president Maypro Industries (New York). Many manufacturers are still focused on how many billion CFUs of active bacteria they can offer in their probiotic products however more cutting-edge research points to the viability of heat-killed or inactivated probiotic strains that could also offer powerful effects on health without the worry of keeping cells alive. To stay ahead of the trend Maypro offers two of such wellresearched proprietary branded ingredients for digestion including Pylopass which is composed of spray-dried inactivated cells of Lactobacillus reuteri and L-92 which is made up of patented sterilized lactic acid bacteria. Microbiota As a result of these new ideas that may have been unheard of years ago the outcome is positive--there is now a clearer understanding of the relationship between cause effect and the factors that affect digestive issues and illnesses. It [research] has evolved from the focus on treatment and on identification of a single cause for gastrointestinal complaints to the awareness of the www.niemagazine.com January February 2017 Go to www.niemagazine.com igy for info about this advertiser 38 Nutrition Industry Executive Go to www.niemagazine.com deerland for info about this advertiser DIGESTION S BENEFICIAL BOOST complex connection between diet environment lifestyle and the microbiota said Hewlings. Identification of the microbiota and the idea that may play a role in digestive health is not new however there has been a resurgence of interest in the human microbiota and its role in health over the last two decades. This interest has been largely fueled by advances in DNA sequencing technology which have provided information about both individual human-associated organ-isms (genome sequencing) and microbial communities (metagenome sequencing). Efforts to characterize the human microbiota have increased our understanding of the types of organisms present in these communities and linked community composition to vari- ous host phenotypes including numerous diseases. In addition it has raised awareness that an imbalance in the microbiota can lead to symptoms ranging from sub-clinical gastrointestinal issues such as gas and bloating to irritable bowel syndrome and even conditions not typically identified as gastrointestinal such as metabolic syndrome and diabetes and immune system health. This opens the door for synergistic ingredients rather than single ingredient products ... as a result consumer consciousness of the critical link between the gut and the immune system is becoming more accepted and understood. A Look Ahead How exactly does the future of digestive health and its ingredient advancements pan out While there is no complete certainty as to what lies ahead there is plenty of potential. The future of digestive enzyme supplementation is certainly bright as research is now focusing on additional enzyme benefits like celiac disease management said Majeed. Furthermore in the near future we might look forward to condition-targeted supplements containing a tailormade combination of digestive enzymes probiotics and or botanicals to hit the shelves. For this to happen the industry needs to substantiate the safety and efficacy of such products with battery of clinical studies. NIE Extra Extra For information on microbiota and probiotics from the American Gastroenterological Association (via ScienceDaily) visit www.niemagazine.com. FORMOREINFORMATION Go to www.niemagazine.com biocat for info about this advertiser 40 Nutrition Industry Executive AIDP (626) 964-6910 BIO-CAT Microbials (877) 912-4622 Capsugel Americas (864) 942-3063 Deerland Enzymes (800) 697-8179 Fruit d Or Nutraceuticals (888) 472-2275 Ganeden (440) 229-5200 IgY Nutrition (405) 242-5382 Maypro Industries (914) 251-0701 OmniActive Health Technologies (866) 588-3629 Sabinsa Corp. (801) 465-8400 Specialty Enzymes & Biotechnologies (909) 613-1660 Stratum Nutrition (888) 403-5039 Taiyo International Inc. (763) 398-3003 www.niemagazine.com January February 2017 THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights March April May June 2 3 17 ad closing 2017 NIE Supplier Sourcebook Memory & Cognition Ingredient Marketplace Show Issue Science of Ingredients Pet Health 3 17 17 ad closing 4 11 17 ad closing 5 16 17 ad closing GMO Update Weight Management Our 2017 Media Planner Is Available At NIEmagazine.com 2017-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF VRMmedia.com Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP VRMmedia.com Keeping Rhythm As natural ingredients that address heart health continue to evolve and grow suppliers are working on broadening awareness. By Janet Poveromo A ccording to the Heart Foundation when it comes to heart disease statistics are still grim Heart disease (including stroke and other cardiovascular diseases) is the No. 1 cause of death in the United States killing nearly 787 000 people alone in 2011. Heart disease is also the leading cause of death for people of most racial ethnic groups in the U.S. including African Americans Hispanics and Caucasians. For Asian Americans or Pacific Islanders and American Indians or Alaska Natives heart disease is second only to cancer. Cardiovascular diseases claim more lives than all forms of cancer combined. Heart disease is clearly a public health concern especially for the aging population. However for children and young adults obesity and added sugars are proving to pose risks for future heart disease. According to Annie Eng CEO of Florida-based HP Ingredients the state of the market for natural ingredients that address heart health continues to grow 42 Nutrition Industry Executive rapidly. Many young adults today grew up with very poor diets setting the stage for high numbers-- cholesterol blood pressure blood glucose and many are overweight. In short from today s young adults through older middle-age many American consumers are dealing with metabolic syndrome and its companion condition non-alcoholic fatty liver disease (NAFLD). To a significant degree future heart problems such as CVD (cardiovascular disease) can be largely prevented barring the existence of genetic predispositions or congenital conditions the earlier an individual adopts a healthy lifestyle Eng added. Millennials are definitely getting the message and this generation appears to be much more health-conscious and willing to be preventative than any other previous generations. This bodes very well for the market. Aparna Kalidindi PharmD BCPS technical sales and marketing manager with Natreon Inc. in New Jersey pointed out that the heart health supplement category came in at 2.4 billion in 2015. Total supplement sales have been steadily increasing since 2004 she said. With pharmaceutical agents like statins under fire consumers are looking for new heart health supplements. Several supplement companies have launched new heart health supplement lines as fish oil sales decline due to several studies questioning their efficacy. And according to Golan Raz vice president of health and nutrition at New Jersey-based Lycored the market for heart health maintains its normal BPM with minor yet solid year over year growth. We see a growing interest in new technologies (compositions) that are designed to support multiple cardiac needs and risk factors he said and at the same time a decline in the demand for marker s specific ingredients like cholesterol management agents. Furthermore he said we see a deeper interest from leading brands as well as consumers in fully validated products that can provide solid scientific support to the efficacy of the finished product and not just to a single ingredient. www.niemagazine.com January February 2017 Array of Ingredients A large assortment of natural ingredients that support heart health exists. The most successful ingredients in the marketplace are clinically tested in one or more human clinical trials said Bruce Abedon PhD vice president of scientific affairs with NutraGenesis Icon Group in Vermont. Despite recent questions regarding efficacy Hugh Welsh president of DSM North America in Georgia maintains that the most important ingredients in the heart health category are EPA and DHA omega-3 fatty acids. CoQ10 and fibers are also products that consumers purchase he noted. EPA and DHA supplements are typically labeled as fish oil and more needs to be done by the industry to educate consumers to look for the EPA and DHA content in the fish oil they choose. The largest part of the category volume is driven by men 50 plus but many women also consume these products. Becky Wright marketing and communications director--Superba with Aker BioMarine Antarctic US in New Jersey agreed that for omega-3s in a nutshell research shows that omega-3s maintain blood pressure and cholesterol levels (within a normal range) help promote a regular heart rhythm and support normal blood clotting processes all helping to keep both the heart and its arteries healthy. Taking that a step further EPA and DHA omega-3s help reduce risk of cardiac death maintain healthy blood pressure levels and keep triglycerides within normal range. In fact EPA DHA are among the most researched nutrients in the world. Also supported by science and wellknown heart health ingredients are phytosterols and tocotrienols said Bryan See regional product manager with New Jersey-based ExcelVite. Natreon s Capros a super antioxidant is said to support healthy blood flow and healthy cholesterol levels. In addition more younger athletes and weekend warriors are also taking these supplements for better performance (improved endothelial function nitric oxide boosting) Kalidindi said. Lycored Nutrient Complex for Heart (Cardiomato) won an award for [finished] product of the year and that achievement is a wonderful recognition of the industry for Lycored s ongoing commitment to research and development Raz noted. Another good product he added is FruitFlow by DSM. This is an interesting technology that focuses on the improvement of platelets aggregation and blood flow. We also see the more traditional ingredients like CoQ10 preforming in a solid way. Missouri-based DuPont Nutrition & Health markets SUPRO brand isolated soy proteins which have been shown in clinical research to have a positive effect on elevated cholesterol levels said Jean Heggie strategic marketing lead. In fact that research formed the basis of soy protein and heart health claims that are now in place in 11 countries around the globe. Soy protein is the only protein source approved for such a claim. In the U.S. manufacturers who include 6.25 grams of soy protein per serving in their product and meet other nutritional criteria on fat saturated fat and cholesterol can include a claim on their labels linking soy protein to reduced cardiovascular disease risk. Ingredient Evolution Alongside launches suppliers have noted the evolution of key heart ingredients. Some include Bergavit 40 sold by NutraGenesis is derived from the fabled heart-healthy Bergamot citrus fruit (Citrus bergamia). It has been evaluated in human clinical trial testing and possesses flavonoid bioactives that help support healthy blood lipid levels as well as the quality of blood lipid types and that also help improve carotid intimamedia thickness. This ingredient is a more concentrated form of a previously sold ingredient so requires a lower clinically efficacious once daily dose. WellTrim iG a clinically tested African Mango extract and Synetrim CQ are marketed by Icon Group. These are weight management nutraceuticals that also provide significant metabolic wellness benefits in the area of cardiovascular health. Each has been evaluated in multiple human clinical trials using either once daily or twice daily dosing which has resulted in significant support of healthy blood lipid levels in addition to improvements in weight. Both ingredients help support cardiovascular health through antioxidant properties and other mechanisms. DSM s Meg-3 just launched a new technology called 3C which stands for concentrated customized and consistent. It allows supplement companies to innovate with high concentration EPA and DHA products--up to 85 percent--with economics that make standard fish oil a thing of the past. It also allows customization of the ratio of EPA to DHA so that a brand could innovate for example with an EPA only supplement for heart health. This technology also reduces dependency on the omega-3 content of the fish allowing for diversification of the fish oil supply chain to provide a sustainable operation without interruption risk because of weather patterns disruption some regional fisheries. Another bergamot ingredient HP Ingredient s Bergamonte contains bioactive compounds of extract of the juice and albedo of Citrus bergamia Risso standardized to 38 percent polyphenolic flavonoids consisting of naringin neohesperidin neoeriocitrin 1 percent melitidin and 2 percent brutieridin. It is produced using patented extraction technology through collaborative works of various universities and research institutions in Italy. Bergamonte has been found to help balance many of the risk factors of metabolic syndrome and attendant NASH (nonalco- Vitamin K Update N attoPharma USA (New Jersey) is making strides in the heart health market with its MenaQ7 product. Since it was first introduced novel technologies have been pioneered to expand the product portfolio said Eric Anderson senior vice president global sales and marketing. The MenaQ7 product range caters to a growing global demand of highpurity stable and well-researched vitamin K2 as MK-7 and is offered as a naturally fermented ingredient (MenaQ7 Crystals) or a nature-identical synthetic ingredient (MenaQ7PURE) in multiple dilutions and solubilities according to Anderson. NattoPharma s MenaQ7 Crystals represents a significant development of the vitamin K2 product line offering documented health benefits. The most substantial technological development in the new generation of MenaQ7 products is a proprietary multi-step process of purification condensation and crystallization of naturally derived vitamin K2. This innovative process leads to an end product that is more than 96 percent pure natural menaquinone-7 (MK-7). Further as it is manufactured using Bacillus licheniformis in a non-soy based medium MenaQ7 Crystals is free of soy products and all known allergens. Consumers vary widely Anderson added from kids who should be consuming K2 to young adults who want to maintain healthy cardiovascular function to those in middle-age and elderly active individuals who are very concerned about not having heart issues. Nutrition Industry Executive 43 January February 2017 www.niemagazine.com Keeping Rhythm holic steatohepatitis) NASH has been identified as the hepatic manifestation of metabolic syndrome. Recent evidence shows that Bergamonte when consumed by individuals with metabolic syndrome and NASH induces a significant reduction of fasting plasma glucose serum LDL cholesterol and triglycerides alongside with an increase of HDL cholesterol. In addition a significant reduction of both ultrasonographic TC scans and metabolic biomarkers of NASH as well as a significant reduction of small dense LDL particles were found after Bergamonte treatment suggesting a beneficial effect of bergamot-extract in individuals with metabolic syndrome and NASH. This suggests a potential preventive role of bergamot derivatives in reducing cardiometabolic risk. ExcelVite s EVNol SupraBio is a natural full-spectrum tocotrienol complex with patented self-emulsifying delivery system specifically developed to provide consistent and enhanced oral absorption of each individual tocotrienol isoforms. The SupraBio system is formulated with a proprietary blend of oil and food emulsifiers at an optimum ratio and homogenization process that will self-emulsify in the gastrointestinal tract that facilitates absorption. Further physiological processes generate conditions essential for optimal absorption of each isoform of tocotrienols into the plasma. This novel delivery system results in a rapid and consistent absorption of tocotrienols independent of dietary fat or food intake. Pharmacokinetic study with healthy human volunteers confirmed the efficacy of the SupraBio system which increases the rate and absorption of each individual tocotrienols by up to 300 percent (average 250 percent) (Ho D et al. 2003) compared to a conventional nonbioenhanced tocotrienol oil extract. Natreon s Capros is a super antioxidant (ORACFN of 47 000 moles TE g) and an excellent cardiovascular product derived from the edible fruits of Phyllanthus emblica. It is an aqueous extract vegetarian organic non-GMO (genetically modified organism) kosher and halal with a no objection GRAS (generally recognized as safe) letter from the FDA (U.S. Food and Drug Administration). The efficacy of Capros is backed by multiple clinical studies many of which have been published in 44 Nutrition Industry Executive Tocotrienol is scarce in nature. While palm oil is the most abundant source for tocotrienols one has to consume 80 g of palm oil to attain the 30-50 mg tocotrienols recommended for general wellness including heart health hence it is not a practical way of consumption due to the high calorie intake from the oil. -- Bryan See Regional Product Manager ExcelVite peer reviewed journals. Capros is soluble and stable in solution making it ideal in ready to drink beverages. In addition Capros can be offered in a small dosage form thus increasing consumer compliance unlike fish oil products which are large and often have an unpleasant aftertaste. Capros activates eNOS which results in increased production of nitric oxide and thereby improving endothelial function. Natreon s Crominex 3 is a trivalent chromium supplement that offers cardiovascular and blood glucose support. It is prepared by complexing chromium chloride with two natural products Phyllanthus emblica (Natreon s Capros) and Shilajit (Natreon s PrimaVie) in order to minimize conversion conversion of chromium III to chromium VI and to increase bioavailability. This complex produces significant synergistic activity. Crominex3 is water soluble manufactured by a completely aqueous extraction process in the US and kosher halal certified. Lycored Nutrient Complex for Heart (Cardiomato) was proven to support healthier post-meal fats and sugars management. Demonstrated in well-controlled clinical trials with over 150 healthy subjects one soft gel a day of Lycored Nutrient Complex for Heart (Cardiomato) reduced post prandial Ox-LDL levels and supported improved blood sugar levels triglycerides and insulin resistance all within the normal range. Lycored research teams demonstrated in both pre-clinical and clinical trials that this innovative technology activates NRf2 as well as NFkB related process and by doing that reduces Ox LDL levels manages blood pressure in the normal range and supports health endothelial function. Aker BioMarine s flagship product Superba Krill is rich in phospholipid omega-3s EPA and DHA important nutrients for a healthy heart. Scientists have proposed several different mechanisms by which phospholipid omega-3s promote cardiovascular health and since phospholipids assist in the more efficient cellular uptake of omega-3s they deliver EPA and DHA to the places your body needs them the most plus they are more readily absorbed by the body. Superba2 the next generation of Superba Krill Oil featuring a new and improved formulation with enhanced encapsulation properties such as improved smell taste and visual appearance. Superba Boost Aker s newest product is a krill oil concentrate which contains a significantly higher concentration of key actives including phospholipids omega-3s EPA DHA and choline. Effective Delivery Delivery of course depends very much on the nature of the ingredients. Take phytosterol as example said See. The recommended delivery system is through food such as bread spreads. For other oil soluble ingredients such as CoQ10 omega-3s and tocotrienols the preferred delivery system is generally through soft- or liquid-capsule dosage forms. Although consumer can obtain these ingredients naturally through food (like fish for omega 3) one must consume a large quantity of that food to obtain sufficient amount of ingredient that has been shown to bring about benefits See added. Tocotrienol is scarce in nature. While palm oil is the most abundant source for tocotrienols one has to consume 80 g of palm oil to attain the 30-50 mg tocotrienols recommended for general wellness including heart health hence it is not a practical way of consumption due to the high calorie intake from the oil. As a result the cost effective and healthy way to consume tocotrienols is through soft gel dosage www.niemagazine.com January February 2017 Go to www.niemagazine.com natreon for info about this advertiser Keeping Rhythm form. In addition traditionally EPA and DHA omega-3 have been delivered in the supplement industry in the form of soft gels to allow for a relatively high dose that meets the recommended level by world organizations for healthy consumers said Welsh. The market has experienced growth in the last few years with gummies which typically deliver about a third of the dose of a soft gel for that ingredient he said. The industry should consider opportunities to deliver new forms to delight the consumer an example could be a deliciously creamy smoothie like formula in which the amount of EPA and DHA per dose could be triple that of a soft gel. If the ingredient is water soluble other novel delivery forms are available such as stick packs dissolvable strips or liquid products such as shots or beverages. NutraGenesis Icon Group s Bergavit 40 WellTrim iG and Synetrim CQ work well with these traditional and non-traditional delivery vehicles since they are all watersoluble. As for MenaQ7 yogurt is a very effective delivery system as shown in studies said Anderson. A 2015 study that was published in The Journal of Nutritional Science adds to the growing body of evidence that vitamin K2 is a safe and effective supplement. A yogurt drink fortified with menaquinone-7 improves vitamin K status in healthy populations. facturers and consumers according to See. Also Eng noted that research into the link between NAFLD and metabolic syndrome and what ingredients can effectively provide protection against these conditions will be of significant importance to the cardiovascular support category. Soy Research on Cholesterol More human clinical studies have been conducted to assess the hypocholesterolemic effects of soy protein than any other cholesterol-lowering food ingredient said Michelle Braun PhD research scientist with DuPont Nutrition & Health. Multiple meta-analyses have been conducted confirming the cholesterol lowering efficacy of soy protein. There is interest in directly measuring not only risk factors for disease but the occurrence of the disease or its progression. Braun pointed to a large prospective population study The Shanghai Women s Health Study which showed that women in the highest tertile for soy protein consumption had a 75 percent lower risk for coronary heart disease and an 86 percent lower risk for non-fatal myocardial infarction compared to the lowest tertile over a three-year follow-up period (p 0.003 for the trend). Whether this reduction in cardiovascular events was due to soy protein s cholesterol-lowering effect or other properties remains to be determined. A controlled clinical study recently was able to investigate disease progression. Hodis et al. quantified the progression of intima-media thickness (a measure of atherosclerosis) in the carotid artery of postmenopausal women over a 2.7-year period. Although there was a non-significant (P 0.36) 16 percent decrease in the progression of intima-media thickness in the women who consumed 25 g day soy protein a subset of the women who were within five years of menopause onset showed a 68 percent lower carotid intimamedia thickness (insert p value) progression rate compared to women consuming an equivalent dose of milk protein. consume tocotrienol after a meal consists of oily food. Under this situation although the amount of tocotrienol being absorbed is increased the level absorbed is inconsistent and varies according to the amount and type of fats that has been consumed. The formulation challenge with tocotrienol lies in the need to ensure consistent and high absorption so that consumers really receive the optimal level of tocotrienols that show benefits in research. Hence the trend in the industry is moving towards bioavailability ie. absorption into the blood plasma. It doesn t just end at or with absorption bioavailability according to See. The next big trend in the industry is bioefficiency --the accumulation or deposition of an active phytonutrient into various vital human organs. To spread the word and help educate medical professionals on the high cardiovascular risk that the U.S. population is developing with its unhealthy lifestyle and diet choices DSM developed a campaign called Know Your O (www.knowyouro.com). This campaign aims at developing the awareness of HCP s on the U.S. population omega-3 status deficiency how much omega-3 to recommend to a patient what type of fish they should eat and how to select a good omega-3 supplement for those who do not or cannot consume enough omega-3 from diet alone. DSM is looking for consumer brands interested in joining this effort among doctors said Welsh. There is a tremendous opportunity to make the U.S. consumer healthier through this initiative drive category growth and gain a disproportionate share for the marketers willing to place their brands in the center of this initiative and in the doctor s office. NIE For a list of references visit www.niemagazine.com. Research of Interest Human clinical trials are the most reliable measure of a cardio health product s efficacy and safety profile. The best products use ingredients that have been evaluated using a Gold Standard protocol that includes randomization double-blinding and comparison to a placebo. Raz added that trials should be wellcontrolled performed in recognized medical centers and led by qualified specialists. Furthermore we see a great interest in the statistical power of the studies with a growing understanding among all parties involved (brands manufacturers) to the importance of the target population on which the study was performed. Scientific research conducted in humans with positive outcomes in cholesterol management usually interests suppliers manu46 Nutrition Industry Executive Extra Extra Visit www.niemagazine.com to read the details of studies on HP Ingredients Bergamonte. Working Ahead Oil or fat-soluble ingredients and certain botanical extracts that are insoluble at all pose the most challenges in processing and formulating according to See. 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. The oral bioavailability of tocotrienol is low and erratic by nature he added. To improve absorption a person will need to FORMOREINFORMATION Aker BioMarine (732) 860-0137 DSM www.dsm.com Dupont www.dupont.com ExcelVite Inc. (732) 906-1901 HP Ingredients (877) 437-2234 Lycored (973) 672-2160 Natreon (732) 296-1080 NattoPharma (609) 454-2992 Nutragenesis Icon Group (802) 257-5345 www.niemagazine.com January February 2017 Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS NIEmagazine.com VitaminRetailer.com FitnessTrainerMag.com NaturalPractitionerMag.com Our 2017 Media Planner Is Available At NIEmagazine.com 2017-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF VRMmedia.com Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP VRMmedia.com The participants are Darrin Duber-Smith Senior Lecturer Department of Marketing College of Business Metropolitan State University of Denver CO Jonathan Emord Esq. President Emord & Associates Washington DC Daniel Fabricant PhD Executive Director and CEO Natural Products Association (NPA) Washington DC Michael McGuffin President American Herbal Products Association (AHPA) Silver Spring MD Steve Mister Esq. President and CEO Council for Responsible Nutrition (CRN) Washington DC Joseph Weiss President Nutrition 21 Purchase NY With sweeping changes in the U.S. political landscape ushered in by the 2016 elections the natural products industry must navigate uncertain seas as it looks forward to 2017. By James J. Gormley W ith a backdrop of sweeping changes in the U.S. political landscape ushered in by the 2016 elections--from state legislatures to Congress to the presidency--the natural products industry has to navigate an uncertain sea marked by a new commissioner of the U.S. Food and Drug Administration (FDA) a new acting director of the FDA s Office of Dietary Supplement Programs continued questions regarding the term natural on food products renewed efforts to limit use of dietary supplements for military members a newly re-issued new dietary ingredient (NDI) guidance threats to continued sale of vinpocetine given FDA s recent posture regarding its identity and regulatory status passage of the federal GMO (genetically modified organism) labeling bill various state and territorial challenges to dietary supplements (such as Puerto Rico s draconian Administrative Order 346 which was shelved for now and more. Nutrition Industry Executive (NIE) asked a panel of experts to weigh in on what we might expect as an industry in the year ahead. NIE What were the biggest industry sur48 Nutrition Industry Executive prises of 2016 and why McGuffin The presidential election came as a surprise to many in the industry. The impact of the incoming Trump administration on the industry remains to be seen but Trump s anti-regulatory stance will likely provide new opportunities and challenges to the industry. It will be important for the industry to stay actively engaged with the incoming administration to identify and take advantage of the opportunities and address emerging challenges. The Drug Enforcement Agency (DEA) s proposal to essentially ban kratom also came as a surprise but the well-organized response by kratom supporters that resulted in the DEA delaying the ban to do a more thorough review of the plant was even more surprising. AHPA has expressed concern about the DEA using its scheduling authority to essentially ban a plant that is currently in the market because naturally occurring constituents of the plant are scheduled under the Controlled Substances Act. Emord Perhaps some were surprised by the FDA s NDI guidance or its actions against select ingredients. All of that appeared to me to be part of a logical www.niemagazine.com January February 2017 and misguided expansion of an unaccountable regulatory state. FDA has long been largely impervious to the actions of the courts and Congress and the will of the American people. The biggest industry surprises are likely to come in 2017 when the Trump administration implements a deregulatory agenda that may have spillover effects for FDA. Now that would be a change from the political agenda of the agency over the last eight years. Fabricant FDA s administrative proceeding on vinpocetine to ban it as a dietary ingredient. Why Because it was acknowledged by FDA without comment five times. There are no safety issues identified in the almost 20 years it has been lawfully marketed. These are also some very important arguments against FDA s position. It does fit under 201(ff)(1) of the Act as a dietary ingredient. Duber-Smith To this 25-year industry observer the biggest surprise each year continues to be the sustained growth of the supplement sector despite the myriad issues the industry continues to face. When is the last time you saw a positive report about supplements in the mainstream media for example Why does this industry seem to be immune to the effects of bad publicity The answer almost certainly lies in deeply held consumer attitudes toward managing their own health care. This phenomenon continues to fascinate me. NIE What trends segments and kinds of products are going to take off in 2017 and what has set the stage for this Fabricant Probiotics. I think FDA s recent attempts to regulate probiotics and their specific mentioning in the NDI guidance to notify all strains to the agency is a foreshadowing of what we will see on probiotics. Everyone seems to be doing colon health studies to substantiate their claims and that is a good sign of a responsible industry. I think the sky is the limit on probiotics. Mister CRN s 2016 Consumer Survey on Dietary Supplements revealed some interesting findings about our current consumer. For instance supplement usage among U.S. adults is increasing with 71 percent of Americans taking dietary supplements--that s more than 170 million Americans. Also energy has become the No. 2 reason why dietary supplement users are taking dietary supplements following the No. 1 reason which is for overall health and wellness benefits. It s too early to deem these shifts as trends but they are definitely shifts the industry should keep an eye on. Industry should also be aware that the Millennials are becoming avid users of many supplements and this segment is worth some attention as they are the future of the industry. Emord Targeted nutrition continues to be a fascination within the scientific community and among dietary supplement companies. The somewhat elusive goal of identifying the right peculiar mix of nutrients to complement individual body types appears closer to realization now than in years past although I suspect there is a bit of a way to go before the one-size-fits-all supplementation approach gives way to targeted recipes. Weiss With all the mergers and acquisitions in the sports nutrition space we will see more aggressive growth in the fitness and senior sub-markets of sports nutrition. Specifically there are great opportunities for manufacturers and marketers to support new line extensions and new product launches targeting weekend warriors and soccer moms as well as active Baby Boomers. In 2017 we will also see continued growth with brands that primarily serve the bodybuilding market. Attention to ingredients that support mental agility will also gain momentum in 2017. McGuffin Consumer interest in highquality sustainably produced products from socially responsible companies continues to grow. It isn t a new trend but companies that effectively demonstrate these qualities to customers will likely continue to thrive. Younger generations are also increasingly interested in maintaining health and well-being using supplements. The industry can expect continued growth as these younger generations mature and the benefits and safety of dietary supplements are increasingly documented. Duber-Smith I don t think that a large fairly mature industry usually does much to foster innovation. The supplement category continues to be driven by need-based health categories such as anti-aging fitness and self-care health maintenance. This really hasn t changed much in the 25 years that I have been observing the sector. After all consumers tend to buy benefits not features. Tell them that something meets a need and they are fairly likely to buy it regardless of what the particular supplement is. Indeed new botanicals and specialty supplements that address a variety of important health-related issues will emerge but who knows which of these will become the next hot nutraceutical Most of these newbies will enjoy short bursts of popularity and then fade into relative obscurity when the next big thing that addresses the need comes along. True innovation in this sector is rare. NIE Product registries are gaining traction both self-regulatory ones and the regulatory groundwork for them via NDI master filings of Christmas future. Is this good Are we moving too far down a pre-market approval and Health Canadaesque path Duber-Smith The industry has not done a very good job at self-regulation. This is a difficult fact for industry members to accept but this has been the case since DSHEA (the Dietary Supplement Health and Education Act of 1994) was enacted. Bad actors continue to dominate the landscape media attention is almost always negative and the spattering of industry groups appear to be primarily interested in making their varied cases for why a particular study is bogus or why the media is wrong rather than admitting it may have a problem. The industry should work with the FDA to welcome more regulation but on its own terms. If they do not do this the kind of regulation they get in the future might not be very palatable. The FDA and other agencies have very limited resources and so it does not really want to regulate the industry. It has better things to do and would much rather that we set our own guidelines and self-regulate. This is the way the agency approaches most industries. But in light of our track record I believe that increased regulation is imminent and the industry needs to do much more through its trade groups to demonstrate that it is serious about product integrity. Mister The Supplement OWL (online wellness library) is an industry-sponsored product registry that will allow for selfregulation in lieu of having mandates from the FDA. By being a voluntary registry it demonstrates both the accountability and transparency of the industry as a counter balance to governmentimposed regulation. Industry stakeholders--regulators retailers and consumers--want a better understanding of the size and breadth of the marketplace and the industry-run registry is a great way to answer those questions. Fabricant NPA has held a product regNutrition Industry Executive 49 January February 2017 www.niemagazine.com istry for the industry since the 1990s in TruLabel. It is a registration database as well as a testing post-market surveillance program. Self-regulatory programs are the sign of a mature industry and that is healthy for the future regarding NDIs and NDI master files. That is the statistic to file. You don t have to file in all cases and that is where our industry needs databases like NPA s soon-to-be-released Safe Harbor database of pre-DSHEA ingredients. They need to know what is old and what is a new dietary ingredient. This is also not to say NPA was silent on the NDI guidance. You will find that NPA has clearly been the leading critic of the NDI revised draft guidance. We responded with an unprecedented 98 pages of comments in our brief essentially asking them to rewrite it. McGuffin AHPA was the first trade association to encourage the industry to register products with the National Institutes of Health Office of Dietary Supplements Label Database. The success of and newly developing label registration programs will ultimately depend on the benefits outweighing the costs. Consumers and the industry will continue to support this system if it doesn t limit consumer choice by placing an unnecessary burden on the industry and if it provides additional accurate and useful information to consumers. Emord FDA s move to deem any change in manufacturing technology or delivery system for a supplement and synthetic forms of new dietary ingredients are acts beyond the limits of the agency s statutory authority and bode ill for innovation that can enhance effectiveness reduce risks and improve the quality of life. Once again FDA is on the wrong side of progress. fix them. Unfortunately the industry has been unable to adequately address important issues such as adulteration truth in labeling and the overbearing influence that the relatively small sports nutrition segment has had on its reputation--so it needs a regulatory assist in this regard. Checks and balances at this stage of the game would probably be a good thing. FDA s move to deem any change in manufacturing technology or delivery system for a supplement and synthetic forms new dietary ingredients are acts beyond the limits of the agency s statutory authority and bode ill for innovation that can enhance effectiveness reduce risks and improve the quality of life. -- Jonathan Emord Esq. President Emord & Associates Fabricant The way it stands now the [NDI] guidance could actually result in more bad actors skirting the law entirely which is the opposite of what a sensible regulatory regime should be. This economic burden to industry could harm small businesses and create a chilling effect on innovation and lead to fewer submissions from legitimate firms while encouraging fly-by-night companies to operate through NDI piggybacking until they are caught. It becomes FDA whack-a-mole all over again. NPA submitted a 98-page comment brief recently which underscores the need for significant changes to the current guidance in the best interest of public health. McGuffin AHPA has communicated to FDA that the latest version of this guidance is unlikely to achieve the agency s stated goals of improving the rate of compliance with the NDI notification requirement and the quality of notifications. AHPA has also expressed concern that the 2016 revision of draft guidance is contrary to the intent of the law in numerous areas and would unnecessarily burden the industry. Despite the fact that FDA s guidance needs improvement responsible compa- nies can still navigate NDI requirements successfully--as several AHPA members have done--in order to continue to meet consumer demand for innovative products. Mister There are some potential problems with the NDI draft guidance and significant issues of dispute that have not gone away but there are some parts where it is clear that the FDA has listened to the comments it received after it issued its first draft of the guidance five years ago. No the industry did not get everything it wanted but it did see positive changes in the latest draft of the guidance that show FDA s willingness to collaborate with the industry. Emord The guidance is a perfect example of over-regulation supplanting private choice with regulatory fiat in areas largely void of any quantifiable public health risk. Treating dietary supplements like food additives reduces their availability generally in place of case-by-case adjudication against those that truly pose risk decreases product availability and increases consumer cost. With any luck the new FDA commissioner will withdraw the guidance. NIE That being said the NDI Draft Guidance Part Deux has been released. Scuttlebutt suggests some wins regrandfathered lists etc. but does it point to an unwieldy pre-approval-laden leviathan that will stifle innovation and cripple companies or not so much Duber-Smith Not so much. The industry has been given much rope and it s about time that it recognizes its shortcomings and takes affirmative action to 50 Nutrition Industry Executive NIE What specific steps should the industry take in 2017 to join forces for transparency and ingredient quality Duber-Smith This is the most difficult question faced by contemporary industry leaders. Clearly the various trade associations must unite to become more integrated and more effective as a unified voice. A good self-regulatory move would be for the largest group the NPA as an example to truly push its natural certification system and to develop a similar system for nutritional supplements. Pre-market certification random testing and other industry concessions would be funded by the supply chain itself a group of well-meaning folks who have made quite a bit of money trying to do the right thing rather than taxpayers. I remember industry legend Loren Isralesen in an Expo West speech about 10 years ago on DSHEA [he made] a Wizard of Oz reference where he said that We aren t bad people we have just been very bad wizards. This is just as true today. Emord By and large the trend in the industry has been in that direction. Ironically one of the greatest impediments to more improvement is FDA censorship of health information. If a supplement company cannot compete with others based on a description of how ingredient kind and quality brings about www.niemagazine.com January February 2017 more reliable or achievable health benefits in reducing or preventing disease consumers remain in the dark and are disabled in their ability to discern why one product is superior to another. Only in a wide open and robust commercial marketplace in which the FDA comes to be restrained by the First Amendment will consumer interest in safety and efficacy of all products (foods and supplements) be maximized. Censorship always dumbs down transparency depends on a competitive market in ideas and information along with product offerings. lead FDA [to not] proceed with any ban on vinpocetine. FDA could still choose to require other manufacturers who have not submitted NDIs on vinpocetine to submit as per their statutory burden. NIE What do we expect from the FDA on vinpocetine in 2017 Mister FDA s tentative conclusion for vinpocetine is unsettling and disrupts the certainty and predictability of the marketplace. We along with the other trade associations are urging FDA to reevaluate its decision and have asked our friends in Congress to express their concerns with the agency. We re not saying FDA can never change its mind if the science has evolved or new safety concerns emerge but that s not the case here. The review of vinpocetine appears to be politically motivated. McGuffin AHPA has recommended the secretary of health and human services (HHS) consider initiating a rule declaring vinpocetine to be a lawful dietary ingredient. In addition AHPA encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future the ingredient would therefore qualify as a dietary ingredient. Fabricant As NPA noted in its recent comments filed with the FDA under a provision in the Code of Federal Regulations and promulgated and reinforced in FDA s draft NDI guidance it would appear vinpocetine s active moiety is identified to the active moiety of a botanical constituent in four plants. Therefore it fits as a dietary ingredient under the statute. Essentially NPA developed the pathway to market for vinpocetine which is a synthetic ingredient for the entire industry. However the active moiety of vinpocetine shares the same exact structure as the active moiety of a constituent compound of a botanical. While others are relying on the secretary of HHS to save vinpocetine from being banned through FDA s administrative proceedings NPA believes this argument provides a clear pathway to market in the dietary supplement space and will NIE As to the FTC a number of industry groups have pointed to the commission s overreach and bad decisions this past year regarding supplements. Any efforts to get this agency back on an even keel Emord Over the last eight years commissioners who harbor a strong bias against free market activity have dominated FTC. Under their view there has not as yet arisen a set of words that cannot be construed to be deceptive advertising even in the absence of empirical proof. Perhaps the new administration will put at the helm individuals who will change the agency paradigm to compel proof of actual deception not for a minority of individuals but for a majority of them and will otherwise rely on reasonable claim qualification to disabuse the public of provably misleading connotations. Only in instances of deception that result in provable injury (economic or physical) should FTC act. In a truly just world we would do away with FTC and leave enforcement against criminal fraud to the Justice Department. Duber-Smith The FTC has been rather kind to the industry over the years in my opinion and so if the agency is concerned about something (especially with its limited resources) there is probably a problem. The agency exists primarily to protect consumers from false and misleading advertising. This is a good thing. A larger threat looms however and that is the proliferation of non-profit watchdogs that have done what the FTC has been largely unwilling to do. There have been hundreds of private lawsuits against marketers using the word natural to position their products and just about every one of them has resulted in a settlement on the part of the marketer. This has applied more to foods and personal care products than it has to supplements but the idea is the same. If enough NGOs decide to go after supplement companies as they have natural then look out What is to prevent this from happening Again it s time to work with regulators and see them more as supervisors rather than external threats to business. NIE With a new presidential administration a Republican-controlled House and more state legislatures in Republican control what are your predictions as to what the impact might be on the natural products industry in 2017 and for the next several years McGuffin President-elect Trump s campaign rhetoric strongly suggests his preference for small federal government which could mean less pressure on business and industry as a whole. The Republican-controlled Congress could reinforce this impulse. The Republicancontrolled House and Senate may also create a favorable climate for fending off anti-supplement policy efforts by the industry s few congressional detractors. The Trump administration and Republican Congress aversion to federal regulatory intervention may also present opportunities to enact improvements to the existing dietary supplement regulatory framework in 2017. The dietary supplement industry s selfregulatory initiatives may take on even greater importance if president-elect Trump and Republicans weaken federal regulations. All of this indicates the need for continued engagement by the industry to identify emerging threats and opportunities. Mister CRN is excited about the prospect of a Republican House and Senate for moving forward our legislative agenda which will focus on including multivitamins in the Supplemental Nutrition Assistance Program (SNAP) and the Women Infants and Children (WIC) nutrition program and allowing consumers to purchase supplements with their health care savings accounts and flexible spending accounts. However if there is a vacuum in the enforcement of federal regulation of dietary supplements state legislatures and state AGs will be eager to fill that void with their own requirements. So CRN will be working to assure adequate funding and enforcement of DSHEA by FDA as well as close monitoring of the states for mischief. Duber-Smith This is also a huge wild card in 2017. Trump is not a traditional Republican and indeed DSHEA was a bipartisan act. But the industry has already lost its Democrat champion in Harkin and the primary Republican advocate for supplements is nearing retirement. When Mr. Hatch retires will the repeal modification of DSHEA be back on the table A review of the research that has been done on the industry will reveal that it needs more regulation. How government will go about this imminent oversight is up for (Continued on page 57) Nutrition Industry Executive 51 January February 2017 www.niemagazine.com MarketingInnovation By Todd Pauli The Shelton Group was standing in a strip mall parking lot staring into the open trunk of a company-issued Chevy Impala. Plastic milk crates crowded the space each filled with piles of company brochures product catalogs and flyers. You guys send me all of this [stuff] but this is the one piece that works. When can you get me a new one of these asked the veteran sales rep holding up a thick product catalog from several years back. Its pages were worn and sku numbers and prices were crossed out and updated. The cover showed a product line and marketing campaign that were long forgotten. I wondered why in the world we hadn t found room in the budget to update the printed product catalog clearly well past its prime. The divide between our sales and marketing teams shocked me. While we had been focused on I creating digital assets like a new website and interactive PDFs there was a portion of the sales team still working from old marketing collateral stored in the trunks of their cars. It was years ago and the industry was not nutrition but this moment has stayed with me as a vivid example of a common disconnect. Developing marketing materials in step with the sales team is crucial which we did. But instead of taking the time to learn how the whole team sold our products we chose to listen only to the few more progressive sales reps. Just like all aspects of marketing the tools we provide our sales colleagues to help communicate the brand are rapidly changing but there s still an important role to be played by the more traditional marketing collateral pieces. Our enthusiasm for developing new cutting edge tools caused us to forget there is still a crucial place for tried-and-true printed marketing collateral. Keeping it Together As we work with clients of all sizes we find that any effective mix of sales and marketing tools includes both digital and print collateral pieces that reach customers no matter where or how they encounter the brand. The key is to unify all your sales tools around a common set of brand objectives and messaging that clearly communicates those objectives. Of course this sounds like common sense and it is. But as marketing teams become immersed in the day-to-day of creating sell sheets web content and tradeshow materials it s easy to stray from the original brand message in subtle ways. A slightly different voice in the copy a different font 52 Nutrition Industry Executive www.niemagazine.com January February 2017 or a badly chosen stock photo and pretty soon the brand collateral looks like it represents several different companies. Keeping a consistent voice across all your marketing collateral starts with a solid plan. One way to ensure consistency is to create brand messaging and style guide documents which guide the creation of all new marketing pieces. Once they re created in PDF form they should be widely disseminated to your internal staff and any outside partners who create materials on behalf of your brand from your web designer to your marketing agency. It s the responsibility of the marketing team to learn how their organization s sales team operates and produce pieces that add real value to the selling process. that. Stepping through this process with clients we ve often begun with the direction to make sell sheets more technical then sometimes learn we need to go in the opposite direction. Every situation is different and taking time to learn from the sales team and use their input to inform your final design will produce the most usable materials in the end. And it certainly doesn t hurt the sales team s morale to know they have been heard and their knowledge respected so everyone benefits. expanded to the point that every organization has the ability to customize its sales collateral to include specific points and assets with the needs of a particular customer in mind. These same customized materials can also be used as downloadable lead generation pieces that complement your website content strategy and digital advertising activity. With the added freedom to create digital marketing collateral that speaks more specifically to future clients there also comes the responsibility of organizing the new material. Through many discussions with sales reps over the years we ve concluded that the familiar network folder strategy isn t the best. You probably know this one save everything in a sales team accessible folder called Marketing Materials and trust that a) people log in once in a while to grab new materials and b) no one decides to move rename or delete any of the subfolders you ve carefully curated. Sure it s a step toward organizing but fraught with limitations and vulnerabilities. There are numerous ways to step up your efforts to get the right materials in the right sales rep s hands. Many customer relationship management systems (CRMs) offer the ability to integrate marketing materials and several software products allow you to organize materials in the cloud. These options are great if you already run a CRM system or want to get more organized but don t need large amounts of customization. For brands seeking to customize their selling process and control the materials the sales team uses on a daily basis Partners in Design We ve all heard the term design by committee and know the negative connotations it carries. When it comes to the graphic design and layout sticking to a clear vision and following it through produces the best results but there are other steps before the graphic design phase that benefit from close collaboration. Your marketing collateral be it new company brochure or product sell sheet should encompass both the marketing objectives of the brand and the functionality the sales team needs to engage potential customers. What s the result of not bringing in the sales team early in the process More often than not the result is complete silence. Most reps I know are too busy (or polite) to track down the marketing folks and let them know they ve missed the mark. Instead they file your latest piece in their company car trunk and forget about it forever. More importantly they form the opinion that marketing doesn t understand their needs and so begins that sales marketing rift we so often hear about within organizations especially large ones. It s the responsibility of the marketing team to learn how their organization s sales team operates and produce pieces that add real value to the selling process. Gaining input from the sales team early on is crucial to the acceptance and use of any marketing materials you produce. A quick conference call with a well-rounded sample of the sales team will help you understand what works and what doesn t when they are faceto-face with a prospective customer. We have found there really isn t a better resource for knowing the customer and fine-tuning the materials you use to try and engage them than the people who spend their days doing just Digital Means Customization While we ve spent a little time discussing the enduring importance of printed materials we all know the value of digital. In fact we ve seen amazing strides in the way marketing and sales teams can deliver and access marketing collateral that is more customized to meet the needs of individual prospects. Digital sales collateral expands the quality of information you are able to deliver to your customers. The obvious benefit of digital or print on demand collateral is the ability to update it as needed. We ve all run into boxes of outdated sales brochures somewhere in an office closet. But the real benefit comes from the ability to add dimension to your marketing collateral. A printed diagram showing the steps you take to assure the quality of your products can easily evolve to an interactive infographic in digital format. Imagine touching different areas of the Q&A diagram so customers can experience an interview with the chief scientist or easily see sample test results run for products being considered. The range of possibilities even using PDFs has (Continued on page 57) Nutrition Industry Executive 53 January February 2017 www.niemagazine.com FunctionalFoods Taste & Nutrition By Satya Jonnalagadda PhD MBA RD A Functional Approach to W hen it comes to functional food and beverage product development relies on market trends taste and nutrition but also many technical aspects such as ingredient capability processing and shelf-life considerations. All of these aspects are essential to successfully taking a product from an initial idea to a consumer preferred food or beverage. So the question becomes How do you translate market demand and consumer expectations into a product that meets nutritional goals while satisfying taste expectations Companies and manufacturers need to approach product development with an understanding of market and consumer insights and the science and technology of taste and nutrition as it relates to health and wellness across all life stages and need states. Success will depend on understanding where the consumer is in their wellness journey to execute a successful and innovative product with functional benefits. But with tight resources it can be difficult 54 Nutrition Industry Executive to translate insights into products. Consumer Insights are Key If we look at today s consumer it is no longer a trend but a reality that people are becoming more proactive and informed about the role of nutrition and the impact it has on their overall health and wellness. Many studies have shown consumers are turning to food and beverages to provide them with functional benefits that meet their wellness goals. According to a Canadean Global Survey (2015) 79 percent of consumers prefer to consume healthenhancing ingredients through foods or beverages. Canadean also reported that 60 percent of consumers say they actively use foods and beverages to improve their health (Canadean Global Survey 2014). While the demand is clear food and beverage manufacturers are feeling greater pressure to align their product offerings with changing consumer interests and values. In the functional food and beverage space leveraging consumer insights to shape product solu- tions is the first step in creating a marketable product. Qualitative and quantitative insights are essential to understanding preferences and considerations needed to create products geared towards segments of health conscious consumers. Overall staying tuned into changing consumer preferences gives companies a strategic lead on creating products with value. A major roadblock for many companies can be the amount of time and resources needed to help them strategically identify understand and apply these insights in today s evolving functional food and beverage segments. Product innovation comes with its fair share of risk and failure but with the right consumer and market insights companies can increase the probability of success. And by doing so early in product development companies can avoid fads and trends that don t drive consumer value. Simply put leveraging consumer data can help manufacturers make smarter choices about product development and can lead to innovation. www.niemagazine.com January February 2017 Nutrition Expectations for the New Consumer As mentioned understanding nutrition as it relates to consumer demands across specific life stages and need states is a key factor in functional food and beverage product development. At Kerry we classify consumer nutrition demands into four key pillars that each require different nutritional considerations 1. The Free From pillar focuses on clean label intolerances and allergies e.g. gluten- or lactose free and is growing at double-digit rate currently 2. The Better for You pillar looks at reducing negative ingredients such as salt sugar or fat 3. The Good for You pillar adds ingredients to improve the nutritional quality of foods (currently the addition of protein fiber or healthy fats are popular) and 4. The Tailored for You pillar focuses on consumer-specific nutritional needs from infant and toddler nutrition to performance nutrition to healthy aging. These key consumer groups are driving demand for nutritious products and are leading the development of new products with functional benefits. For example one major market trend we are seeing is the rise in demand for plant proteins in the nutritional beverage market. Plant proteins are seen as a more healthy dietary option for consumer groups such as the Good for You and Tailored for You groups where consumers are particularly conscious of their food choices. The challenge here as with many functional ingredients is that while consumers are demanding plant proteins the science and technology of combining different proteins to achieve the optimal nutrient profile taste and texture can be difficult. Selecting the right combination of proteins that provides balanced nutrition involves expert knowledge of the nutritional attributes of each plant protein. There are also challenges with the taste profile of plant proteins which require expert knowledge to make them more palatable. Challenges such as these call for creating leading-edge solutions that require expertise in both processing and flavor-masking techniques to address the taste and texture challenges. It also requires the nutrition team s scientific knowledge that can help combine the right synergistic proteins to optimize amino acid profiles. This means the ability to tap specific technological and scientific expertise to deliver exactly what s in demand while allowing for the ability to manage resources efficiently. Overall as consumer s health concerns and attitudes toward proactive wellness continue to drive product development without the right partners in food science and nutrition it can be a challenge to formulate scientifically supported nutritious products that also taste great. Nutrition Demands Meet Taste Challenges While consumers are demanding products that offer health benefits to meet their specific needs we know the primary factor that drives consumer choice is taste. Because taste goes beyond flavor having a fundamental understanding of science around taste is key. Taste is a multi-sensorial experience--a layered effect of appearance sound touch taste mouthfeel or texture and aroma. To deliver on taste and nutrition companies need to look at this total consumer experience. Let s briefly examine the taste challenges that are associated with reducing sugar in a product. While consumers are calling for products with less sugar they still want great tasting products. For formulators this can pose immense challenges for example sugar reduction can have an impact on the overall texture of the final product. While no single sweetener or alternative can completely imitate the taste and functional properties of sugar there is a range of technologies formulators can use. Technical solutions focused on taste as an experience can be tapped to meet both taste and nutrition expectations and offer companies solutions when it comes to formulating functional food and beverages. One of the technologies we ve created at Kerry is TasteSense. This is a flavor modulator that allows up to 30 percent sugar reduction. It masks the negative tastes you might get when you reduce sugar levels and accentuates the perceived sweetness delivered by the remaining sugar in the food or beverage. We can achieve this by leveraging our scientific understanding of the inherent natural flavors in foods and beverages and how they interact with the taste receptors in the mouth. A cross-functional team including our nutritionists sensory scientists flavor chemists culinary experts regulatory and application teams created this product to provide a flavor modulation that offers a customized solution for each unique application challenge. So again the benefit to combining science and applications expertise enables formulators to bring innovations to the market. Taking a holistic style to building great taste by identifying both the scientific and consumer drivers that make up taste profiles product manufacturers can tackle taste challenges such as sugar reduction or other functional ingredient inclusions. But the need remains for collaborative partnerships rooted in taste and nutrition expertise across all areas of product development. Creating Healthy Formulations That Satisfy As the functional food and beverage market changes companies need to innovate to deliver healthful products that meet the needs of a growing number of consumers who opt for a complete approach to eating. But product manufacturers cannot approach these challenges alone. Whether it is formulating with functional ingredients or reducing ingredients such as sugar companies can improve their competitiveness through collaboration by leveraging expertise that looks at consumer demand combined with science and technology to drive the development of products that deliver on both taste and nutrition. NIE Satya Jonnalagadda PhD MBA RD is currently the director of Global Nutrition at Kerry. She is responsible for leading Kerry s nutrition function strategic nutrition research internal and external nutrition positioning and scientific communications while staying up-to-date of proposed food regulations and identifying new nutrition opportunities. Satya leads the Kerry Health and Nutrition Institute (www.kerryhealthandnutritioninstitute.com) a leading resource for health nutrition and general wellness science and policies in food and beverage product development. Nutrition Industry Executive 55 January February 2017 www.niemagazine.com EngredeaBoothPreview March 8-12 2017 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 with each listing to encourage in-person meetings to learn more. American Laboratories Inc.--Booth 580 American Laboratories Inc. (Omaha NE) was founded 50 years ago based on the company s knowledge of providing enzymes proteins and flavors to various industries. Today American Laboratories is proud to offer an extensive listing of more than 300 products to the food processing pharmaceutical veterinary health nutritional and diagnostic industries in the United States and more than 50 countries around the world. Through the company s highquality products and customer service American Laboratories has become an industry-recognized supplier for the products it manufactures. For more information call (402) 339-2494 or visit www.americanlaboratories.com. IgY Nutrition--Booth 475 IgY Nutrition (Oklahoma City OK) is the foremost authority on the development and production of specifically immunized egg supplements. Their ingredient IgY Max captures the capabilities of IgY immunoglobulins delivering targeted immune support to the digestive system for improved gastrointestinal and immune function. IgY Max supports the body s natural detoxification process to reduce bacterial competition in the gut and promote the growth of pre-existing probiotics. IgY Nutrition s mission is to deliver distinctive scientifically backed supplements to continuously improve core health and daily well-being of the global community. For more information call (405) 242-5383 or visit www.igynutrition.com. Natreon Inc.--Booth 779 With global headquarters located in New Jersey and a state-of-the-art R&D facility in Kolkata India Natreon Inc. serves a wide array of customer needs. Since the company s origins it has been focused on researching developing and marketing ayurveda-based active ingredients backed by extensive clinical and pre-clinical research safety studies a high degree of purity robust standardization and developing intellectual property for the benefit of Natreon and its customers. For more information call (732) 296-1080 or visit www.natreoninc.com. NutraGenesis Icon Group--Booth 440 NutraGenesis Icon Group (Brattleboro VT) are leading providers of proprietary branded nutraceuticals for dietary supplements and self-affirmed GRAS functional ingredients for foods and beverages. The companies clinically tested patented ingredients feature substantiated structure function claims in highly marketable wellness areas stress healthy weight management energy cognition metabolic cardiovascular health anti-aging antioxidant and respiratory immune support. Visit the NutraGenesis Icon Group booth to learn more about their new cardio-support bergamot extract and sports nutrition applications for many of its other ingredients. For more information call (802) 257-5345 or visit www.nutragenesis.com or http icongroupllc.com. www.niemagazine.com January February 2017 Ayush Herbs Inc.--Booth 576 Ayush Extracts (Redmond WA) provides the world s finest Indiasourced organic certified herbs and standardized extracts. Established in 1990 Ayush Extracts marries ancient ayurvedic principles with the latest scientific technology to provide the highest quality standardized herbal extracts and raw materials. Ayush Extracts was founded by ayurvedic and naturopathic physicians who believe in the healthy balance of body mind and spirit while maintaining the highest quality-control standards in the raw materials industry. For more information call (425) 637-1371 or visit www.ayushextracts.com. Deerland Enzymes - Deerland Probiotics--Booth 432 Come check out Deerland s (Kennesaw GA) exciting advances in probiotic manufacturing with a look at the company s new stateof-the-art facility. Learn more about adding the benefits of probiotics to your food products and enjoy samples of delicious chocolates fortified with the DE111 probiotic Deerland s strain of Bacillus subtilis. And just for fun stay a few minutes at the booth for your own Deerland Doodle a drawing of yourself designed by a caricature artist that you can take with you For more information call (800) 697-8179 or visit http deerlandenzymes.com. 56 Nutrition Industry Executive EngredeaBoothPreview March 8-12 2017 Anaheim Convention Center Anaheim CA Sabinsa Corporation--Booth 505 New clinicals focused on sports-related areas such as endurance covered by Sabeet and delayed onset muscle soreness (DOMS) by DigeZyme will take center stage at Sabinsa Corporation s (East Windsor NJ) booth. Discover the science and benefits these ingredients will have on your next supplement. Sabinsa a flagship Curcumin C3 Complex will showcase new clinicals and get caught up on Sabinsa s shelf-stable probiotic LactoSpore. Talk to the team about formulating and custom contract manufacturing your needs at the company s Utah USA facility. For more information call (732) 777-1111 or visit www.sabinsa.com. Xsto Solutions--Booth 453 Xsto Solutions (Morristown NJ) was established in 2004 to partner with ingredient manufacturers to drive sales of novel nutritional ingredients for the North American nutrition market. Xsto personnel have successfully and profitably launched new products driving sales by acting as a U.S.-based sales and marketing partner. Xsto handles a limited number of ingredients to focus on detailed scientific presentations. At Engredea 2017 Xsto will focus on Cuvitus a whole fruit extract sourced from cucumber for muscle and joint health. For more information call (973) 975-4224 or visit www.xstosolutions.com. (Continued from page 51) debate but I think that more regulation is on the horizon--maybe a lot more. I think that this is a good possibility and one for which supplement makers should prepare but industry can help mitigate the effects of this by adopting a much more concerted and objectives-driven effort at industry self-regulation. We must become better wizards. Fabricant The incoming administration presents significant opportunities for the industry especially if we step up politically utilize our grassroots capabilities and increase our fundraising. We are confident that we can form a productive and strong relationship to ensure the FDA enforces the rules it already has on the books while ensuring that consumers have confidence in the products they take each and every day. The natural products industry is important not only to the health of millions of Americans but also to the health of the United States economy and we look forward to working with President-elect Trump s administration on both of these fronts. Emord I suspect that the Trump administration will usher in a new era of deregulation that will constrain regulatory advance and reverse agency regulations that have over the past eight years been proven to retard economic growth in America. I believe we are on the verge of an unparalleled free-market renaissance where consumer choice economic opportunity and prosperity are just around the corner. NIE Extra Extra Visit www.niemagazine.com to read a continuation of this article with participants responses to questions on cannabis and kratom. MarketingInnovation (Continued from page 53) we recommend a web-based sales portal. Typically set up on a Wordpress platform brand sales portals provide a highly customizable easy-to-update library of materials easily accessible to anyone the brand adds as a user. This set-up allows brand marketers to provide full access to materials for internal sales team members but also allows outside partners like brokers or supply chain partners to have limited access to certain groups of information like logos or co-marketing campaigns. Once the sales portal is housing your digital marketing collateral the sales team can easily access the materials without the fear of removing or altering individual pieces. Some clients have also become more proactive by publishing internal newsletters to their sales teams to promote new materials with easy links for downloading. We have also worked with clients to distribute iPads to the sales team allowing reps to have instant access to customer incentive programs sell sheets demo videos and more. This method represents the leading edge of marketing collateral with reps having the latest sales and marketing messaging pushed to them automatically. They also have the ability to share the materials instantly with customers during sales calls which every sale rep we talk to says customers much prefer to hard copies. Whether it s tried-and-true sales brochures or the latest customized digital assets the key to great marketing collateral is that it has to help engage potential customers. Car trunk not required. NIE The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Todd Pauli works with clients to develop comprehensive marketing strategies that integrate social media advertising and content marketing. Prior to joining The Shelton Group Pauli led marketing communications efforts for several wellknown businesses including NOW Foods one of the largest supplement manufacturers in the natural channel. Contact him at Todd sheltongrouppr.com. Nutrition Industry Executive 57 January February 2017 www.niemagazine.com Equipment&Packaging NJM Packaging Introduces New Options for AUTOCOLT IV Labeler NJM Packaging (Lebanon NH) introduced new options for its AUTOCOLT IV pressure sensitive labeler. These options can be included on new labelers and most can be retrofitted on installed labelers in the field to expand production capabilities. AUTOCOLT IV is a high-speed servo-driven in-line labeler that competes in the market with complex rotary labelers in speed and versatility to offer much faster and easier changeovers with fewer change parts reduced maintenance a smaller footprint and a lower capital cost. Depending on the modules and options selected AUTOCOLT IV can accurately label square rectangular and round bottles from 1 to 14 inches (25 to 355 mm) in height and from 1 to 5 inches (25 to 127 mm) in diameter. It can apply a variety of label configurations including wraparound multi-panel front-and-back and outserts at speeds of up to 300 cpm. It can be changed over to handle a new container size and new label size in less than 20 minutes with no tools required. It can be equipped for e-pedigree serialization RFID tagging and other track and trace initiatives making it ideal for pharmaceuticals nutraceuticals biotech and veterinary products as well as foods beverages cosmetics personal care products and household chemicals. The new options include an oscillating pressure station for multi-panel labeling a vacuum-free loop for continuous printing of variable data a soft reject system for vials color coded change parts and a linear feeder for outsert magazines. For more information call (603) 448-0300 or visit www.njmpackaging.com. CEM Launches New Technology for Rapid Fat Oil Analysis CEM Corporation a supplier of process control solutions based in North Carolina introduced the allnew ORACLE Fat Analyzer based on a recent breakthrough in NMR technology. ORACLE is the first ever-rapid fat analyzer that requires no method development and can analyze fat in any unknown food sample with reference chemistry accuracy and exceptional repeatability according to the company. ORACLE is unique in that it completely eliminates method development and the need for reference chemistry. This is based on a newly developed NMR technique that isolates the fat response signal in any sample type or matrix. The instrument comes in two configurations rapid and high-throughput. The rapid system is paired with the newly released SMART 6 Moisture Solids Analyzer allowing for moisture and fat analysis in less than five minutes. The high-throughput option incorporates a robotic system allowing for the unattended processing of up to 100 samples. For more information call (704) 821-7015 or visit www.cem.com. Primera Introduces LX2000 Color Label Printer Primera Technology Inc. (Plymouth MN) a manufacturer of specialty printers announced its LX2000 Color Label Printer. LX2000 is Primera s fastest desktop color printer. It produces labels at speeds of up to 6 per second--about 25 percent faster than Primera s LX900 Color Label Printer (for comparable print quality). Large separate ink cartridges for cyan magenta yellow and black keep the cost per label low. Other features include pigment-based ink for stronger resistance to UV light chemicals and water built in pizza-wheel cutter viewing window to see label stock levels and wired Ethernet or USB 2.0 and wireless connection options. Typical applications include product labels for hundreds of specialty foods. LX2000 is also ideal for private labeling test marketing pre-press proofing and retail labeling. For more information visit www.primeralabel.com. Heat Shrink Tunnel Secures Tamper-Evident Neck Bands and Sleeve Labels The new Pharmafill HT6B Heat Tunnel from New Jersey-based packaging machinery manufacturer Deitz Co. automatically shrinks tamper-evident plastic neck bands and or sleeve labels on bottles cans jars vials tins and other plastic metal and glass containers. Designed for use with PET-G PLA PVC and other tamper-evident banding materials the company s latest heat tunnel features proprietary technology that uses forced air with a combination of convection and radiant heat to deliver uniform heat distribution throughout the entire length of the tunnel. The HT6B Heat Tunnel initially directs heated ambient air at the bottom of the neck band then gradually directs the air to the top of the neck band to promote consistent shrinking with a tight secure seal at speeds of 100 bottles per minute or faster. The affordable energy-saving heat shrink tunnel includes sturdy double-wall stainless-steel construction that creates an extra barrier between the heating elements and the plant environment along with a heat-resistant curtain at the tunnel entry to help maintain the high temperature inside the heat tunnel without leaking heat into the facility. Designed for easy integration in any packaging line the HT6B Heat Tunnel accommodates containers from 1 to 10 inches high and mounts onto nearly any plastic conveyor. An adjustable-height lift stand that raises and lowers the tunnel height and companion neck banders and conveyors are available as options. For more information call (732) 681-0200 or visit www.deitzco.com. 58 Nutrition Industry Executive www.niemagazine.com January February 2017 Advertiser Index American Laboratories Inc. Avanti Polar Lipids Ayush Herbs BIO-CAT Deerland Enzymes Generex Labs IgY Nutrition LLC Jiaherb Inc. Mack Flavor Ingredients Inc. MORRE-Tec Industries Inc. Natreon Inc. Now Foods PL Nutragenesis Icon Group Nutra Solutions USA Olcott Plastics OmniActive Health Technologies PLT Health Solutions Probi USA Inc. d b a Nutraceutix Sabinsa Corporation Soma Labs Inc. United States Pharmacopeia Xsto Solutions LLC 37 8 19 40 39 15 38 5 33 21 45 1 C3 7 9 11 3 36 C2 31 C4 13 (402) 339-2494 (800) 227-0651 (800) 925-1371 (877) 912-4622 (770) 919-8907 (239) 592-7255 (888) 998-3763 (888) 542-4372 (951) 683-6245 (908) 688-9009 (732) 296-1080 (800) 999-8069 (802) 257-5345 (631) 392-1900 (630) 584-0555 (866) 588-3629 (973) 984-0900 (425) 883-9518 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (301) 230-6361 (973) 975-4224 www.niemagazine.com americanlaboratories www.niemagazine.com apl www.niemagazine.com ayush www.niemagazine.com biocat www.niemagazine.com deerland www.niemagazine.com generexlabs www.niemagazine.com igy www.niemagazine.com jiaherb www.niemagazine.com mackflavor www.niemagazine.com morretec www.niemagazine.com natreon www.niemagazine.com nowpl www.niemagazine.com nutragenesis www.niemagazine.com nutrasolutionsusa www.niemagazine.com olcott www.niemagazine.com omniactive www.niemagazine.com plt www.niemagazine.com nutraceutix www.niemagazine.com sabinsa www.niemagazine.com somalabs www.niemagazine.com usp www.niemagazine.com xsto Industry Events February 7-9 2017 West Pack Anaheim Convention Center Anaheim CA (310) 445-4200 www.westpack.packagingdigest.com March 8-12 2017 Engredea at Natural Products Expo West Anaheim Hilton & Marriott Anaheim Convention Center Anaheim CA (866) 458-4935 www.engredea.com or www.expowest.com April 18-20 2017 Ingredient Marketplace Orlando World Center Marriott Orlando FL www.marketplace.supplysideshow.com May 9-11 2017 VitaFoods 2017 Geneva Palexpo Geneva Switzerland www.vitafoods.eu.com January February 2017 www.niemagazine.com Nutrition Industry Executive 59 SupplieroftheMonth Waitaki Biosciences Based in Christchurch New Zealand Waitaki Biosciences is a developer and manufacturer of science-based natural nutritional ingredients. Actively selling into global markets for nearly 30 years Waitaki s portfolio of unique ingredients have a focus on human bone and joint health anti-inflammation gut health and anti-aging products with cross over into animal nutritional applications and personal care. Craig McIntosh joined Waitaki Biosciences in March 2005. He has more than 25 years experience in international sales and marketing working with a wide range of products across a spectrum of industries from branded consumer products through to technical products for the industrial market. Craig McIntosh CEO 3 Desi Pl. Hillsborough 8022 Christchurch New Zealand Phone 64 3 337 6096 NIE Waitaki BioSciences launched ActiPhen CassiPure and PernaTec Oil earlier this year at VitaFoods. How do these products complement the company s portfolio of branded ingredients McIntosh Waitaki s product range has traditionally been in the area of bone and joint health and antiinflammation for use mainly in tablet and hard capsule formulations. Our new ingredients widen the net where our products have application providing our customers with a more complete range of health and wellbeing solutions. New ingredients like ActiPhen kiwifruit concentrate powder add strong functionality in gut health while a product such as CassiPure with high levels of anthocyanins can be used in formulations targeting eye health for example. While formulators may target these ingredients individually as a supplier we can now group our ingredient offerings into broad categories such as anti-aging digestive health and immune support bone and joint health anti-inflammation and animal nutrition offering a range of possible solutions in each of these areas. The new products also lend themselves to a wider range of delivery options such as soft gel capsules for example in the case of PernaTec oil or in functional drink applications like smoothies in the case of ActiPhen. environmentally sustainable growing practices are important to the company. How does Waitaki BioSciences utilize the above to set itself apart from competitors McIntosh There has been an increased focus in recent times on clean ingredients that are responsibly produced and that are very transparent in terms of where they come from. Selectively sourcing the raw materials we use in our manufacturing from local New Zealand producers means we have always been in that space and we certainly want to make sure that we remain known internationally for that. However it is also important to note that we don t overly rely on that as a point of difference and we don t expect that those factors will ensure we are a supplier of choice to our customer base. We must ensure we remain innovative and offer quality products backed up by sound science and high levels of service-- without these key elements the other messages lose impact. NIE The company recently completed an expansion project that increased capacity and developed new extraction technologies. Talk about the expansion and how it affects Waitaki BioSciences going forward. McIntosh The expansion project which is the first stage of a significant multi-stage development has been an ambitious one but necessary to increase capacity and to ensure we are able to meet a growing demand for new and innovative products. The first stage has involved the successful installation and commissioning of a new one-tonne freeze dryer adding an additional 200 MT of freeze-dried material to our annual production volumes. Simultaneously we have been building a custom-designed solvent extraction facility which has created an entirely new business for the company by adding high-value marine and botanical extracts to our product portfolio. This project also opens the door to future product developments that make the most of the wide range of currently under-utilized fruit and vegetable by-product streams available to us here in New Zealand. On top of that we are well down the track toward completion of a new GMP (good manufacturing practice) milling and packing facility which will enable us to meet the expectations of our Asian and European customer base in particular for GMP compliant ingredients. Plans are now underway to commence stage two of our expansion which will involve significantly more freeze drying capacity as well as new extraction technologies that will deliver very high yielding botanical extracts. Extra Extra Visit www.niemagazine.com to read the rest of the interview. NIE Non-GMO (genetically modified organism) ingredients sustainably sourced raw materials and 60 Nutrition Industry Executive www.niemagazine.com January February 2017 Go to www.niemagazine.com nutragenesis for info about this advertiser Go to www.niemagazine.com usp for info about this advertiser