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Description: In This Issue: The Lifelong Journey of Natural Heart Health, Digestive Health, Industry Forecast, and Sustainable Ingredients

A VRM Media Publication January February 2019 Don t miss a single issue of NIE in 2019 go online to renew your free subscription today JanFeb19 Go to sabinsa for info about this advertiser Go to certifiednutraceuticals for info about this advertiser Proud Supporter of TableofContents VOLUME 24 NO. 1 JANUARY FEBRUARY2019 F E A T U R E S 30 The Quest for Optimal Gut Health Driven by consumer demand the landscape for digestive health ingredients is being transformed. 37 The Lifelong Journey of Natural Heart Health Ingredient suppliers address consumers who over time will embrace many natural products and ingredients in the pursuit of cardio-metabolic wellness. A 43 2019 Industry Forecast NIE s panel of industry leaders and experts provide their thoughts on hemp FDA guidance mass-media confusion about recent studies and more. C O L U M N S 4 First Word 48 Functional Foods 6 Condition Specific 51 The Pitch 9 Legalities 6 30 L S O I N S I D E 12 Industry News 16 Ingredient News 21 Association News 24 CRN Update 25 SupplySide West Wrap Up 28 Science Update 53 Equipment & Packaging 54 Conventions & Meetings 55 Advertiser Index 55 Industry Events 56 Supplier of the Month FREE Subscription (Print Digital or BOTH) & E-newsletter Available Copyright 2019. Nutrition Industry Executive (ISSN 2331-2602) Volume 24 Number 1 January February 2019. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and September October) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 432-9288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Periodicals Postage Paid at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues & Single Copies For order information contact (732) 432-9600 or info March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive January February 2019 Go to bergstrom for info about this advertiser FirstWord New Year s Hemp Resolutions ll bet most of Nutrition Industry Executive s (NIE) readers know or know of Terry Lemerond natural product industry legend and founder of EuroPharma. I read his e-newsletter Terry Talks Nutrition for two reasons 1) because he is a contributor to Vitamin Retailer magazine of which I am the editor-in-chief and 2) because I am a fan of his work. In a recent newsletter post Lemerond offered New Year s advice I found to be a very beneficial reminder Take time to think about and set goals write them down and spend 15 minutes a day thinking about them and strategizing on achieving them. Say powerful and uplifting words (plant good seeds ) every day he added. He explained The mind is like a garden. Your thoughts are like seeds and they produce the fruits of whatever is planted. I appreciate his affirmation of taking control (even subconsciously) to make good things happen. I Cash Crop Speaking of planting seeds I m sure you heard that the president signed into law the 2018 Farm Bill at the end of last year which included the legalization of growing hemp (see the news story on page 12). After a long battle almost a century of hemp prohibition has been lifted. This means life for sellers of CBD just got a lot easier or has it According to Steve Mister from the Council for Responsible Nutrition (CRN) in NIE s new column CRN Update the FDA [U.S. Food and Drug Administration] has not given CBD the green light for inclusion of CBD in food and dietary supplements and that hurdle may be just as formidable. FDA s issues with CBD are unrelated to the ingredient s connections to marijuana and are multifaceted. Roadblocks still exist for lawful marketing of CBD as either a food or a dietary supplement. You can Publisher Daniel McSweeney Editorial Director DanM read the rest of the article on page 24. Associate Russ Fields James Gormley also reported on the Publisher RussF topic in this month s 2019 Industry Update Advertising Barry Young feature (see page 43). In the article the Sales Manager Barry American Herbal Product Association s (AHPA) Mike McGuffin said We underEditor-in-Chief Janet Poveromo stand their [FDA s] rationale and we can disJanetP pute some of the details they ve used to reach this conclusion but there is also a Managing Editor Shari Barbanel ShariB clause in the law that allows the Secretary of Health and Human Services to simply Associate Editor Nicholas Saraceno declare an exemption to allow these prodNicoS ucts to be sold. AHPA has adopted a position to advocate FDA to encourage the Contributing Writers Ryan Evans HHS secretary to provide this exemption. Ryan George This would allow the industry to discuss James Gormley issues with regulators like possible label Matthew Kaplan warnings dosage possible NDI (new Amy Summers dietary ingredient) status. Art Director Robert Certo It is in the interest of consumers FDA Production Manager RobertC and the industry to have these products regulated and it makes sense to regulate Production Assistant Bryan Zak them as dietary supplements which are Graphic Designer BryanZ defined in the law to include herbs and other botanicals. It ought to fit neatly into Circulation Manager Rosie Brodsky this class of goods McGuffin said. Rosie This is where the industry can make good use of Lemerond s New Year s A PUBLICATION OF advice by defining its goals on CBD supVRM MEDIA plementation and taking the reins to make those good things happen. President Updates Daniel McSweeney In 2019 you may notice a few changes to the magazine As noted CRN will be supplying CRN Update articles. And I am happy to welcome contributors Amy Summers who will be writing The Pitch articles on public relations (see her first entry on page 51) and Yadim Medore who will cover Marketing Innovations. Also members of Lonza s staff will be offering their expertise to the Ingredient Technology columns. I am excited to learn more from these respected natural product industry experts and I am sure NIE s readers are too. VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info Website VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and Fitness Trainer magazines. VRM Media is a proud member of Connect With Us Proud Supporter of Vitamin Angels vitaminretailer vitaminretailermagazine 4 Nutrition Industry Executive company vrm-media vitaminretailermagazine vrm_media youtube January February 2019 Go to balchem for info about this advertiser ConditionSpecific Addressing Pain & Inflammation B Y S HARI B ARBANEL t some point everyone deals with pain and inflammation in fact they occur to protect the body. Pain is the brain s message to the body while inflammation is the body s attempt to protect itself. Acute pain and inflammation is short lived ending when the body heals itself while chronic pain and inflammation remains in an active lingering state which can be incredibly harmful to the body. If left unattended chronic pain can not only interfere with a person s daily life but also take a toll on mental health while chronic inflammation can play a role in a number of health issues including rheumatoid arthritis cancer heart disease diabetes asthma and Alzheimer s disease according to Harvard Health. A A Growing Market While mainstream over-the-counter (OTC) and prescription products are what many consumers have been using for some time when dealing with pain and inflammation there has been an 6 Nutrition Industry Executive increase in the popularity of natural ingredients and remedies to help ease the issue. The reason the natural alternatives usually don t come with negative side effects. One of the main reasons that customers are looking to supplements for issues related to pain and inflammation is because of their concerns related to the safe use of OTC and prescription analgesics and anti-inflammatories explained Nena Dockery technical services manager for Missouri-based Stratum Nutrition. Consumers use analgesics and anti-inflammatories (NSAIDS) for everything from the painful twinges that result from a sudden awkward movement to the muscle and joint pain and swelling that results from playing sports too hard or doing that occasional strenuous job around the house. These routine aches and pains occur on an almost daily basis and many consumers simply don t want to or can t (because of the side effects) take NSAIDS or analgesics that often. Supplements provide an important niche in this area by providing products that can work alongside the body s own immune system anti-inflammatory processes to help quell the discomfort and swelling resulting from daily activities and exercise. In the past many may have come to the conclusion that pain was an issue that mostly older people dealt with. But people of all ages can be affected and a younger group is looking at prevention. According to S bastien Bornet vice president of global sales and marketing at Horphag Research in New Jersey more consumers entering the category want their joints to keep up with them later in life so they are taking proactive measures now. Fitness enthusiasts want to build their joints to keep up their muscle and endurance-building. And more consumers who are tired of covering up joint pain with pain relievers are exploring supplements to solve the problem and make their joints stronger and more flexible. While the 50-plus market remains a January February 2019 Go to gcinutrients for info about this advertiser ConditionSpecific core demographic for joint pain and inflammation supplements the market is evolving to include younger more active consumers who are interested in being proactive about their joint health he said. It s about more than just alleviating pain and now is aimed toward strengthening joints as part of their fitness routines. Recent reports show continued growth in the joint health supplement market with an anticipated growth increase to more than 14 billion by 2024. Bornet added that technology may also account for the pain and inflammation younger people suffer. we ve seen awareness about the younger generation sitting for long periods of time and recent reports show more young individuals developing neck pain from hunching over computers and phones also known as text neck he said. Individuals with an active lifestyle are also taking action early to preserve their mobility for their later years. Manufacturers should focus on younger consumers to educate them on the benefits of specific ingredients and research that they can apply to their own health concerns. Ingredients for Pain & Inflammation While there are a number of long-standing ingredients that have been used a number of new to the category ingredients are beginning to shine. Different ingredients are recognized based upon different aspects of their analgesic and anti-inflammatory qualities said Dockery. Some such as turmeric ginger or white willow bark that contain the active component salicin (the basis for aspirin) have been around for a very long time. However numerous other ingredients have arisen in the past few years to address different types of pain and inflammation. Changes in state laws governing the sale of CBD (cannabidiol) have brought this ingredient to the forefront of new products on the market. Helen Fitton PhD chief scientist for Australia-based Marinova added that long-standing ingredients used in pain and inflammation applications include chondroitin sulfate glucosamine omega-3s and collagen peptides. Seaweeds have also been well-known and utilized for their anti-inflammatory and pain-relieving effects for hundreds of years Fitton said. And more recently since technology has allowed 8 Nutrition Industry Executive the successful extraction and isolation of fucoidan compounds from seaweed there has been a rapid rise in the popularity of this ingredient. Marinova offers a range of high-purity Maritech fucoidan ingredients extracted from Fucus vesiculosus and Undaria pinnatifida seaweed species have demonstrated potent anti-inflammatory effects. They are highly sought after in nutraceuticals and dietary supplements for inflammatory mediating applications. Maritech fucoidans are extracted from wild seaweeds sourced from the remote and pristine waters of Tasmania Nova Scotia Patagonia and Brittany using best practice environmental standards noted Fitton. Once harvested all seaweeds are immediately sun dried to retain the natural bioactivity of the fucoidan compounds. Horphag Research s flagship ingredient Pycnogenol French maritime pine bark extract naturally inhibits the proinflammatory master switch NF-kB by more than 15 percent. According to the company it is backed by more than 40 years of research and one of its primary mechanisms of action is its anti-inflammatory effects. Most pain and inflammation ingredients only work by supporting cartilage health in joints to alleviate discomfort. In contrast Pycnogenol turns to the root of the problem inhibiting the production of the pro-inflammatory enzymes 5-LOX and COX-2 Bornet explained. Recent research shows that that the polyphenols found in Pycnogenol are absorbed directly into the joints supporting this antioxidant s ability to alleviate inflammation in individuals with arthritis. Dockery noted that CBD is new and different and continues to grow in the marketplace. However it still has a steep regulatory hill to climb before many manufacturers will feel comfortable marketing it. Most recently the market has been flooded with CBD products that purport to be able to control pain and inflammation she explained. Though there is some evidence that this is true the regulatory climate for CBD within the supplement market is very tenuous and companies will need to keep a close eye on FDA (U.S. Food and Drug Administration) actions. In addition Stratum Nutrition offers NEM brand eggshell membrane that has been extensively studied for its impact on pain and inflammation. The company can also create proprietary formulations that employ the use of other ingredients with anti-inflammatory and analgesic benefits (either ones that Stratum offers or those of the customer s choosing). For example Stratum also sells a vegetarian omega fatty acid ingredient derived from Ahiflower (Buglossoides arvensis) Dockery said. This ingredient is rich in omega-3 fatty acids which are well recognized for their anti-inflammatory and antioxidant benefits. Another possibility would be a combination with curcumin. Curcumin exhibits significant antiinflammatory characteristics. Stratum offers Curcumin 95 as well as an (Continued on page 11) January February 2019 Legalities By Matthew I. Kaplan and Ryan J. Evans of Tucker Ellis LLP hile the term data privacy may evoke memories of the Cambridge Analytica scandal a new California law will affect industries far outside of Silicon Valley. Our industry is no exception. The health wellness and supplement market is highly fragmented. Small and large-scale vendors compete for greater market share in an industry where the top five branded dietary supplement manufacturers together hold less than a quarter of overall market share. The bulk of supplement sales occur online. According to a recent article in the Wall Street Journal the global conversion rate for online shopping is only 2.86 percent. To succeed in such a highly competitive environment many players seek more data about W prospective and actual customers as they pursue increased online conversion and consumer loyalty. But more information also means more risk. In a matter of only a few days last June California legislators drafted a rushed data privacy framework behind closed doors called the California Consumer Privacy Act (CCPA). When the news broke many hoped it would mirror the terms of the European Union s General Data Protection Regulation (GDPR) governing use and collection of E.U. citizens personal information making global data privacy compliance requirements uniform. While the California law shares common concepts with the GDPR it imposes different requirements. As businesses just begin to recover from their estimated 8 bil- January February 2019 lion efforts to comply with the GDPR they must now determine what impact the CCPA will have on their operations and plan for additional expenditures in this burgeoning global patchwork of somewhat amorphous privacy laws. Although the CCPA does not become operative until January 1 2020 the time to start planning for it is now. What is the CCPA The CCPA is a law designed to protect consumers personal information. It imposes a general duty on businesses to implement and maintain reasonable security procedures and practices appropriate to the nature of the information collected to protect against unauthorized disclosure. For purposes of the Act consumers Nutrition Industry Executive 9 Legalities means all California residents including every individual domiciled in California who is outside the state for a temporary or transitory purpose. The CCPA stands out for its protection of personal information which is broadly defined to include any information that relates to [or that could] reasonably be linked with a particular consumer or household. Thus much of the data relied on by behavioral scientists and marketing professionals household consumption data IP addresses purchase histories geolocation data consumer profiles based on inferences etc. fall within the definition of personal information. Notably personal information need not be connected with one particular person s name to fall within the personal information definition of data protected by the CCPA. information. Thus for example it appears that a retailer who offers to pay the cost of a joint promotional mailer in exchange for sharing a mailing list would be violating the law. Yet the rush to pass something quickly created a loophole that seems to undermine the entire purpose of the law since this opt-out right extends only to the sale of a consumer s personal information not the free sharing of the information by a business. California consumers will also have the right to obtain from the business a disclosure of the types of information a business collects and or sells the uses to which the business puts that information and the right to be forgotten. That is consumers have Who must comply with the CCPA The overwhelming majority of businesses will be impacted by nature of conducting even transitory business in California which is the fifth largest economy in the world. The CCPA applies to any entity falling into one of the three following categories (1) any business with annual gross revenues exceeding 25 million (2) any business that annually buys receives sells or shares alone or in combination the personal information of 50 000 or more consumers households or devices a term so broadly defined as to apply to businesses that simply collect IP addresses or (3) any business deriving 50 percent or more of its annual revenue from selling consumers personal information. What rights do California consumers have under the law So long as a business has an authorized reason for keeping a consumer s personal information the CCPA places few limits on its use. But under the law consumers can exercise an opt-out right that prohibits the business from selling the consumer s personal information. This prohibition applies not only to the monetary sale of information but also the receipt by the business of any valuable consideration in exchange for the personal 10 Nutrition Industry Executive the right to request access to the specific pieces of personal information a business has collected and the right to demand that a business delete any personal information about them. And to further protect consumers businesses are prohibited from discriminating in terms of price quality service etc. against a consumer that exercises his or her rights under the law. A business must respond to a consumer s requests about his or her protected information within 45 days. To protect businesses the CCPA insures that they only have to honor consumer requests to opt-out be forgotten or disclose how they collect and use personal information when they receive a verifiable request from the consumer. What constitutes a verifiable request A request that is made in accordance with yet-to-be written regulations of the California Attorney General. The Attorney General is required to draft regulations by the operative date of the act (January 1 2020) and the regulations must address rules and procedures for facilitating and responding to consumer requests under the law. The right to be forgotten is both the most dramatic new provision and the one that has drawn the most attention of privacy advocates and concerns from businesses. In an effort to strike a balance between privacy rights and legitimate customer service and other business needs the legislature included nine exceptions to the right to be forgotten. These exceptions allow a business to keep personal information notwithstanding receipt of a consumer s request to be forgotten. The exceptions generally relate to whether a business has an ongoing business relationship with the consumer and if it is required by other law to maintain the records protect the integrity of computer systems prevent against fraud or other misconduct enable solely internal uses that are reasonably aligned with the expectations of the consumer based on the consumer s relationship with the business or otherwise use the consumer s personal information internally in a lawful manner that is compatible with the context in which the consumer provided information. The exceptions appear imprecise and they are. Businesses should carefully evaluate what type of approach they want to take with data storage in general. While superficially it may seem like a good idea to retain data since computer systems are inexpensive and there may someday be a profitable use discovered for the data a business may find that the long-term costs are much greater in the event of a breach of regulatory requirements or other legal action. In other instances however developing and maintaining large and robust data sets about consumers may be of such importance that a business will want to structure its customer relationship so that one of the exceptions January February 2019 to deletion applies. For example a subscription-based business model or automatic renewal program would allow a business to retain consumer information even in the face of a consumer request to be forgotten and the business could use the customer information to design and implement new products services or business strategies. The CCPA imposes several notable obligations on businesses to facilitate the ability of consumers to exercise their rights. For instance businesses will be required to establish a tollfree telephone number for consumers to submit requests for information about a business s data collection program and to exercise their rights under the statute. And if the business operates on the internet they must include a web page to enable these requests to be made online. Many online businesses do not provide a channel for telephone communication preferring instead to drive consumers toward email communications. But these businesses will be required to establish toll-free phone services along with the other implementation costs. How will the CCPA be enforced and what are the penalties for violating it The CCPA has two enforcement mechanisms. First the California Attorney General may enforce all provisions of the law and pursue civil penalties up to 2 500 per violation should a business fail to cure a violation within 30 days (or 7 500 per intentional violation). Alternatively consumers who are impacted by unauthorized disclosure that has not been cured within 30 days can bring a private right of action to recover actual or statutory damages of between 100 and 750. The law does not define what it means to cure a breach of the obligations under the CCPA and class action lawsuits are allowed. Although the law is not operative until Jan. 1 2020 businesses should immediately begin to manage cov- ered consumer data since consumers are entitled to obtain data about themselves reaching back 12 months before the date of their requests. Thus consumer information on a business s computer system as of Jan. 1 2019 must be kept in such a manner that a business can provide that information to a consumer who requests it on Jan. 1 2020. NIE Matthew Kaplan is a partner and co-chair of the Food Cosmetics & Dietary Supplements Group in the Los Angeles CA office of Tucker Ellis LLP. He can be reached at matthew.kaplan Ryan Evans is an associate in the Business Litigation Group in the Los Angeles office of Tucker Ellis LLP. He can be reached at ryan.evans tuckerellis.c om. ConditionSpecific (Continued from page 8) enhanced absorption curcumin ingredient BioCurc. Addressing Concerns Today s consumers expect ingredients and products that are effective well researched and sustainable and they are able to find this information in the palm of their hands. Consumers are doing more research than ever on products and ingredients before purchasing and they re interested in natural ingredients backed by science to improve their health concerns Bornet said. Manufacturers should be taking into consideration the reputation and scientific research behind the ingredients they are including in their products. This includes certifications like GRAS (generally recognized as safe) and GMP (good manufacturing practice). Bornet noted that Horphag Research has always made research an integral part of its ingredient marketing. The company utilizes a multi- faceted approach that not only educates manufacturers on its science but also consumers by means of comarketing programs. According to Paul Garrott Marinova managing director Marinova addresses consumer concerns through significant investment in R&D. In fact 25 percent of total company revenue is reinvested back into independent scientific studies including human clinical trials to uphold the company s commitment to providing credible ingredients with demonstrated efficacy he explained. Marinova has a strong ethos in clearly communicating the safety and efficacy of its range of Maritech fucoidan ingredients. Stratum Nutrition is committed to the market of high-quality wellresearched ingredients with demonstrated benefits in the human body. Dockery noted that the company believes that research into an ingredient s function is never complete as there is always more to learn. Stratum strives to support our customer s success in every way possible January February 2019 whether it be through assistance with marketing or technical support through formulation assistance and providing answers to the difficult questions surrounding an ingredient s functioning she said. The pain and inflammation category is only growing stronger and larger as people young and old are recognizing the benefits of a proactive approach. With more and more consumers seeking quality nutritional products there is increasing demand for dietary supplements containing effective niche nutritional ingredients like fucoidan concluded Garrott. The pain and inflammation category shows no indication of slowing down given the combination of consumers who live less active lifestyles aging populations and increased uptake of nutritional and dietary supplements. NIE FORMOREINFORMATION Horphag Research Marinova Pty Ltd. Stratum Nutrition Nutrition Industry Executive 11 IndustryNews New Farm Bill Ends Era of Hemp Prohibition but Supplements Get Dropped From SNAP Program n Dec. 20 President Trump signed the 2018 Farm Bill including the provisions that legalize the domestic cultivation production and commercial development of hemp and hemp products at the federal level. This action comes after the Senate passed the legislation on Dec. 11 and the House of Representatives a day later. The National Sustainable Agriculture Coalition (NSAC) a coalition of more than 120 farm and food-focused organizations working together to advance sustainable agriculture through federal policy and grassroots advocacy applauded the bill s passage. America s family farmers rural communities and food insecure families have waited long enough for a new farm bill said Juli Obudzinski NSAC interim policy director. We are grateful that the president did not impose any further delays on this already prolonged process and thank him for moving swiftly to sign the 2018 Farm Bill into law. Through the new bill growing hemp became legal for the first time in nearly a century. Hemp is defined in the new law as the plant Cannabis sativa L. and any part of that plant including the seeds thereof and all derivatives extracts cannabinoids isomers acids salts and salts of isomers whether growing or not with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis. Provisions of the bill also amend the definition of marihuana in Schedule I of the Controlled Substances Act thereby completely removing hemp and all parts of the plant and all derivatives from that definition. This effectively removes all U.S. Drug Enforcement Administration (DEA) authority regarding hemp cultivation production or commercial activity for products that contain hemp or constituents of hemp. The 2018 Farm Bill amends the Agricultural Marketing Act of 1946 with permanent amendments that categorize hemp as an agricultural commodity under the regulatory purview of the U.S. Department of Agriculture (USDA). By recognizing hemp as an agricultural commodity this crop will now be eligible for federal programs such as crop insurance agricultural research grants and certification of organic production practices under the National Organic Program. Classification as an agricultural commodity also benefits hemp industry access to the financial services needed to O 12 Nutrition Industry Executive support agricultural production of hemp and hemp products. Other hemp provisions in the 2018 Farm Bill create requirements for hemp plans administered by individual States or Tribal governments such that hemp production is under individual State (or Tribal) controls. Over a one-year transition period hemp plans (consisting of a system for tracking properties where hemp is grown and various controls to verify the crop is hemp) will be submitted to the USDA. Companies such as Calfornia-based Dr. Bronner s have supported efforts by Vote Hemp a grassroots organization dedicated to the legalization of hemp farming in the U.S. and other advocates in the hemp movement such as the Hemp Industries Association to engage State and Federal legislators on the legalization of hemp farming. The company said it applauds the work of all of the tireless activists whose leadership and dedication has been fundamental in achieving this historic victory. This monumental progress toward returning hemp to American farmlands is in large part the result of Vote Hemp s dedication and tenacious strategic advocacy over the last 19 years said David Bronner cosmic engagement officer (CEO) of Dr. Bronner s which is a brand of natural soaps in North America that uses hemp seed oil in its products. Dr. Bronner s has advocated for the legalization of hemp farming since we added hemp seed oil to our products in 1999 and fought and beat the DEA [U.S. Drug Enforcement Administration] during the Hemp Food Rules Challenge from 2001 to 2004. As a maker of hemp products we are eager to source the 20 tons of hemp seed oil we use annually from American farmers. The Council for Responsible Nutrition (CRN) had a mixed reaction to the bill s passage. As noted by Steve Mister the associa- tion s president and CEO the final version of the farm bill does not include a provision that would allow SNAP (Supplemental Nutrition Assistance Program) benefits to be used to purchase certain multivitamin-mineral dietary supplements. CRN applauds the inclusion of the Hemp Farming Act in the Farm Bill that removes hemp from the definition of marijuana in Schedule I of the Controlled Substances Act and provides a framework for the lawful cultivation and marketing of hemp and its constituents including cannabidiol (CBD) Mister said in a Dec. 13 statement. This provision removes one of the barriers to the lawful marketing of CBD in a range of dietary supplement food and personal care products and will allow for greater research and understanding of this substance as a legitimate agricultural commodity. The dietary supplement and functional food industry is now able to work with FDA to address the legal concerns it has raised with respect to CBD as a legitimate ingredient in food and dietary supplements. However in anticipation of increased market interest in CBD CRN reminds industry that the Farm Bill has no effect on FDA s position that CBD is excluded from use in food and dietary supplements citing a definitional matter that prohibits ingredients from being marketed in food or supplements if they were previously studied in clinical trials for pharmaceutical purposes. CRN looks forward to engaging with FDA to address those concerns. CRN is also disappointed that the SNAP Vitamin and Mineral Improvement Act was dropped from the conference version of the Farm Bill. An important step toward improving the nutrition status of low-income Americans this provision would have allowed Supplemental Nutrition Assistance Program (SNAP) recipients to purchase a multivitamin-mineral dietary supplement with their program benefits. CRN is encouraged by the strong support this effort received within Congress and among industry stakeholders despite ultimately being derailed by political concerns. We are saddened that low-income Americans will not be given access to this option to help improve nutrient gaps in their diet. CRN remains committed to expanding consumer access to multivitamins and will continue to support policies that ensure all Americans regardless of socioeconomic status have equal opportunity for good nutrition. January February 2019 Establishing the National Bioengineered Food Disclosure Standard n Dec. 21 U.S. Secretary of Agriculture Sonny Perdue announced the National Bioengineered Food Disclosure Standard. The National Bioengineered Food Disclosure Law (NBFDS) passed by Congress in July of 2016 directed USDA (U.S. Department of Agriculture) to establish this national mandatory standard for disclosing foods that are or may be bioengineered. The Standard requires food manufacturers importers and certain retailers to ensure bioengineered foods are appropriately disclosed. The National Bioengineered Food Disclosure Standard increases the transparency of our nation s food system establishing guidelines for regulated entities on when and how to disclose bioengineered ingredients. This ensures clear information and labeling consistency for consumers about the ingredients in their food said Secretary Perdue. The Standard also avoids a patchwork stateby-state system that could be confusing to consumers. The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through lab techniques and cannot be created through conventional breeding or found in nature. The implementation date of the Standard is Jan. 1 2020 except for small food manufacturers whose implementation date is Jan. 1 2021. The mandatory compliance date is Jan. 1 2022. Regulated entities may voluntarily comply with the Standard until Dec. 31 2021. USDA s Agricultural Marketing Service (AMS) developed the List of Bioengineered Foods to identify the crops or foods that are available in a bioengineered form throughout the world and for which regulated entities must maintain records. The records will inform regulated entities on whether the food must have a bioengineered disclosure to be communicated to consumers. Regulated entities have several disclosure options text symbol electronic or digital link and or text message. Additional options such as a phone number or web address are available to small food manufacturers or for small and very small packages. The implementation of the Standard concludes a rulemaking process that began in July 2016. AMS gathered information needed to develop the National Bioengineered Food Disclosure Standard O and program in part through a public comment period. More than 14 000 comments were received and taken into consideration during the rulemaking process. Prior to this AMS received more than 112 000 comments in response to 30 questions provided on the AMS website regarding establishment of the Standard. In response Steve Mister president & CEO of the Council for Responsible Nutrition (CRN) released the following statement CRN welcomes the release of USDA s Final Rule implementing the National Bioengineered Food Disclosure Standard (NBFDS). The Final Rule advances transparency for consumers about the presence of bioengineered (BE) material in both food and dietary supplement products. It requires food manufacturers importers and other entities that label food for retail sale to disclose information about BE food and BE food ingredients. The BE disclosure issue is complex and USDA has struck a careful balance between empowering consumers to make informed decisions about the food and dietary supplement products they purchase while not creating unnecessary regulatory burdens or misleading warnings about these products. CRN submitted comments to the Agricultural Marketing Service regarding the NBFDS in July. CRN encouraged the AMS to develop a uniform standard and national system for BE disclosure to allow food manufacturers to provide consistent information regarding BE foods and we offered recommendations on several specific items unique to dietary supplements and functional food. The final Standard closely aligns with CRN s comments and incorporates many of those suggestions. CRN is also pleased that the timing of this Final Rule allows companies to implement these requirements at the same time they are finalizing FDA s mandated changes to the Supplement Facts and Nutrition Facts labeling. The implementation date of January 2020 will allow companies to make all these changes at once thus reducing compliance costs of two separate mandates. CRN is optimistic that this ruling will create a better and more transparent system for consumers. For more information visit documents 2018 12 21 2018-27283 nationalbioengineered-food-disclosure-standard. Lesaffre Completes Full Acquisition of Gnosis L Lesaffre Human Care in 2007. Its mission has been to develop and supply ingredients issued from yeast and bacteria fermentation to the global human care industries. From nutritional and fortified yeasts to yeast fractions probiotic yeasts and bacteria or pure molecules Lesaffre Human Care targets a wide range of applications digestive health immunity enhancement joints and liver health woman s health vegetarian support overall wellbeing and personal care. By completing the full acquisition of Gnosis Lesaffre said it is combining Gnosis and Lesaffre Human Care teams into a single unit to propose a unified range of products and services to its nutritional ingredients and human health customers and partners and to continue its growth. For more information visit or January February 2019 Nutrition Industry Executive 13 esaffre (France) has announced the full acquisition of Gnosis an Italian biotechnology company specializing in the development manufacturing and sale of fermentation-derived ingredients and natural finished products for use in the pharmaceutical nutraceutical veterinary and cosmetic industries three years after acquiring a majority shareholding of this company. Founded in 1989 Gnosis has experienced strong growth since its inception. It now possesses skills and expertise in microbial fermentation and in the recovery and purification of molecules derived from yeasts and bacteria. Gnosis owns two GMP (good manufacturing practice) manufacturing sites (Sant Antonino in Switzerland and Pisticci in Italy) and two commercial offices (USA and China). The company s offices and R&D facility are based at Desio near Milan. Lesaffre created the business unit IndustryNews Biovation Labs Expands Supplement Manufacturing Capabilities iovation Labs (Salt Lake City UT) has announced it is expanding its capabilities to better serve its clients with the installation of an Aquarius G-J high-speed rotary tablet press from Kikusui. As a contract manufacturer flexibility and versatility are core to our offerings said Justin Bath president of Biovation Labs. By investing in the best and most versatile press on the market we can serve our clients better with the capability to produce almost any size and shape of tablet that is available on the market. As a full-service contract manufacturer this enables us to bring even more value to the market. The high-speed single-side rotary press can be tooled for each batch to exacting specifications allowing Biovation Labs to produce several mil- B lion tablets each day. It can produce not only regular tablets but also tablet-intablet products on the same machine. Plus the imprinting capabilities mean each tablet can be branded with names logos images embossing raised letters and so on. This latest addition to Biovation Labs encapsulation and tablet manufacturing equipment extends its production capacity and strengthens the company s ability to support client needs. Quality is of the utmost importance and while our clients serve the nutraceutical and supplement space this tablet press is designed to meet the exacting needs of pharmaceutical production said Scott Jenkins COO of Biovation Labs Furthermore with this equipment we can handle practically any batch size and with a simple module change or quick turret removal we can change capabilities on the fly. Biovation Labs is adding new coating pans and equipment which will allows for various colors flavor enhancers and so on. The company is also adding new personnel to operate the equipment. For more information visit Sabinsa Signs Memorandum of Understanding with Japan External Trade Organization Opens Toronto Office abinsa Japan Corporation a division of the Sami-Sabinsa Group (East Windsor NJ) has signed a Memorandum of Understanding (MOU) with the Japan External Trade Organization (JETRO) to support Sabinsa s expansion in Japan. The MOU was signed during the 13th India-Japan Annual Summit held between the Honorable Prime Minister of India Narendra Modi and the Honorable Prime Minister of Japan Shinzo Abe on Oct. 29 in Tokyo. As we continue our global expansion we deeply appreciate the support of the Government of India and the trade development programs of the countries in which we do business such as JETRO said Sabinsa Founder Dr. Muhammed Majeed. Although we have had an office in Japan for some time the support of the Government of Japan as we continue our investment in that country will allow us to more quickly make our products to enhance human health available on a wider scale to the people of Japan. In other news Sabinsa has opened an office in the greater Toronto area expanding the company s already significant presence in the Canadian dietary supplements market. Sabinsa currently has 30 Natural S 14 Nutrition Industry Executive Product Numbers (NPN) approved by Health Canada. Curcumin C3 Complex Curcumin C3 Reduct LactoSpore BioPerine and ForsLean are among Sabinsa s research-backed branded ingredients available for Letter of Access requests. Sreelal Mooliyil Mowanchery Director Sabinsa Japan This new office Corporation and Tomohiro Takashima Director General and any cusInvest Japan Department. tomers in Canada can also coordigrowth by facilitating access to our nate contract manufacturing services ingredients by Canadian companies and from Sabinsa s Utah Contract its end consumers said Shaheen Manufacturing facility which has a regis- Majeed president worldwide Sabinsa. tered Foreign Site Reference Number The office will help serve our Canadian (FSRN) a service offered by Health customers with information on health Canada to permit Canadian importers claims approved by the Canadian to more efficiently demonstrate compliHealth Directorate (NHPD). ance with various regulations for Nida Saleem sales and marketing Canada. executive is managing Sabinsa Canada The Canadian supplement industry operations. has been growing at a robust pace For more information visit Sabinsa wanted to contribute to this January February 2019 BI Achieves ISO IEC 17025 2017 Laboratory Accreditation I (Rancho Dominguez CA) has announced successful completion of its ISO IEC 17025 2017 certification. After evaluation of the company s quality management system and testing procedures American Association for Laboratory Accreditation (A2LA) recognized BI for demonstrating technical competence in the field of Biological Testing. ISO 17025 is one of the highest standards that a testing laboratory can achieve. Internationally recognized the certification indicates tech- B nical proficiency and the ability of a laboratory to generate accurate and consistent data. The ISO 17025 embodies BI s commitment to quality within our manufacturing operations said Rupa Das BI s vice president of global quality and compliance. The certification will provide further assurance to our customers related to accuracy of testing and reporting as well as product safety. Due to the level of recognition for ISO IEC 17025 the certification will also help facilitate acceptance of test reports between laboratories improving operations overall. ISO 17025 includes two main sections management requirements which relates primarily to operation of a laboratory s quality management system and technical requirements which determine the reliability of the laboratory s testing. A laboratory must have a thorough and documented quality management system to be considered for accreditation. For more information visit Ingredion Invests 140 Million to Accelerate Growth in Plant-based Proteins ngredion (Westchester IL) has announced several steps to accelerate production of plant-based proteins globally. The combined 140 million of strategic investments will further position the company with an expanded broad range of plant-based protein solutions to support increased global demand. As a result two North American manufacturing facilities will produce pea-protein isolates and a range of pulse-based flours and concentrates in 2019. In February 2018 the company purchased a soy processing facility in South Sioux City NE and is making significant capital investments to transform the site to produce protein isolates from peas with expansion plans to include production of isolates from other pulses as well. Once the investments are completed this facility will produce ingredients that enhance the company s current VITESSENCE Pulse protein isolate line to include higher protein isolates primarily for the nutrition health and wellness categories. I The company has also entered into a joint venture agreement with Verdient Foods Inc. a Canadian company based in Vanscoy Saskatchewan jointly owned and operated by Oscar-winning film director James Cameron and Suzy Amis Cameron and a local Saskatchewan family office PIC Investment Group. Investments are being made within the existing facility to make pulse-based protein concentrates and flours from peas lentils and fava beans for human food applications. We ve identified plant-based proteins as a high-growth high-value market opportunity that is on-trend with consumers desire to find sustainable and good tasting alternatives to animalbased proteins said Jim Zallie Ingredion s president and CEO. We re excited by what these investments represent for Ingredion. Being a sustainable and trusted source of plant-based proteins provides us with another major ingredient platform to complement our offerings in clean label wholesome texture and nutritional ingredient solutions. According to the company an increased number of consumers are switching to plant-based diets for many reasons including protecting animals preserving the environment general health concerns or changing taste preferences. As more consumers seek these alternatives the market for plant-based proteins is rapidly growing and extending beyond North America and to sources beyond soy and wheat protein. The global market for non-soy glutenfree plant-based proteins is projected to be 1.5 billion by 2022. For more information visit You reHired New Jersey-based Vitaquest International LLC has appointed Patrick Brueggman as the new president and CEO of the company. Prior to joining Vitaquest International LLC Brueggman had more than 25 years of experience in the specialty chemical ingredient industry. Valensa International has announced that Sendhil Pani former president of Rabo Bayir Inc. will lead the Orlando FL-based nutraceutical manufacturer s expansion into the micoalgae markets featuring Parry Organic Spirulina and Parry Organic Chlorella. With more than a decade experience in business development Pani will serve as director of sales for Valensa s flagship Patrick Brueggman Microalgae division. January February 2019 Nutrition Industry Executive 15 IngredientNews DuPont Nutrition & Health Helps to Reduce Health Risks for Overweight Consumers uPont Nutrition & Health (Delaware) has released new findings from a clinical study of a synbiotic dietary supplement that gives hope to overweight consumers at risk of health complications. Combining the benefits of a proven probiotic with a prebiotic fiber HOWARU Shape has proven potential to improve metabolic health while supporting weight loss. D In a previously published clinical study a trial group that received HOWARU Shape had 4.5 percent less total body fat and 6.7 percent less trunk fat than those who received a placebo supplement. The improvement in lean body mass was still evident one month after the end of the trial. New findings from this study published in Beneficial Microbes found a beneficial impact on the gut microbiota in individuals who consumed HOWARU Shape daily over six months. Modifications to the gut microbiota that resulted from probiotic consumption included a greater abundance of the bacterial species Akkermansia muciniphila which is associated with improved metabolic health. For more information visit Lonza Brings Portfolio of Clean Label Capsules to Hi Europe Granted U.S. Patent for L-Carnitine in Animal Nutrition onza (Switzerland) highlighted its next-generation clean label dosage form capabilities at Hi Europe held in November 2018 in Frankfurt Germany. The Consumer Health & Nutrition team showcased the latest colors to be added to its range of food-colored capsules. The innovation sees coloring foods used to create vibrant shades of Capsugel Vcaps Plus vegetarian capsules with the high-performance shell made from plant-based hypromellose and water only. As the new capsules add color to the finished product without an E-number labeling requirement they appeal to consumers looking for a clear transparent and L clean label. The latest product in the line the Vcaps Plus Purple Carrot capsule will enable food supplement manufacturers to create attractive and distinctive brand identities. In other news Lonza has been granted U.S. Patent 10 016 382 for LCarnitine use in pet food for its beneficial impact on performance and recovery in active dogs. Proven to help maintain lean muscle mass by reducing muscle degradation and oxidative stress resulting from intense physical exercise the patent confirms evidence that small daily doses of Lonza s Carniking L-Carnitine may positively enhance quality of life and function for active dogs and working ani- Biova Receives E.U. Novel Foods Approval he European Food Safety Authority (EFSA) has recently approved Biova s egg membrane ingredient as a Novel Food. Under E.U. (European Union) regulations any food that was not consumed significantly prior to May 1997 is considered a novel food according to EFSA. Biova s eggshell membrane is the first of its kind to receive E.U. Novel Foods approval according to the company. The E.U. market is very important and therefore Biova pursued Novel Food status for their patented watersoluble eggshell membrane ingredients. As the first to be approved Biova will have exclusivity in the E.U. for a term T 16 Nutrition Industry Executive of five years. Novel Foods approval means that companies can import Biova s ingredients into E.U. member countries without concern of being stopped at the borders. Amanda Orloske Biova s senior director of marketing & international sales noted that U.S. customers will also have a wider range of global expansion opportunities with our ingredients now. For more information visit mals such as service dogs and tracking dogs. Other applications are pending in Brazil Canada Europe and Japan. For more information visit innoVactiv and Nippon Flour Mills Obtain First NPN for Myoceram nnoVactiv (Canada) and Nippon Flour Mills a Japanese ingredients and food manufacturer announced that their nutraceutical ingredient Myoceram has been granted two health claims by the Natural and Non-Prescription Health Product Directorate of Health Canada. The following approved claims confirm the safety and efficacy of Myoceram for use in beauty- from-within dietary supplements helps support healthy skin barrier function helps lessen the loss of water through the skin. Natural Product Number (NPN) 80089056 has been obtained following a strict safety efficacy and quality evaluation of the technical dossier of Myoceram. These claims are associated with a daily intake of 30 mg of ricederived Myoceram (Myoceram-RPS) which offers a superior alternative to other commercially available vegetable ceramides in terms of daily dosage and allergen-free labeling. For more information visit and http . i January February 2019 Salt of the Earth Expands Global Availability srael-based Salt of the Earth Ltd. announced new exclusive distribution agreements for Australia Poland South Africa and Thailand of its clean-label Mediterranean Umami savory flavor enhancement and sodium reduction ingredient. The company is expanding offerings of the plant-based ingredient by partnering with leading food ingredient distributors around the world. These global deals have served to underline the broad functionality of this ingredient and have elicited the company to identify several key factors for marketing Mediterranean Umami in four new countries In Thailand Wang Chemicals Co. Ltd. will market Mediterranean I Umami as a natural alternative to MSG as well as for salt-reduction. Natural products and clean-label ingredients are on-trend in Thailand. Ingredientbox Pty. Australia is focusing on the savory flavor enhancement properties of Mediterranean Umami for a number of food products. Bajar Poland cites a growing demand for premium products using only natural ingredients. In addition many Polish food manufacturers specialize in private label manufacturing for export to Western Europe and so are required to adhere to WHO (World Health Organization) and EFSA (European Food Safety Authority) sodium recommendations. WCA Life Science (Pty) Ltd. will provide the natural salt-reduction solution to manufacturers meeting compliance with South Africa s mandatory salt reduction policy. The growing acceptance of Mediterranean Umami in the market is supported by the increased consumer demand for healthy and clean label foods. For more information visit Fibersol Offers Solutions for More Fiber Less Sugar Expands Health & Wellness Offerings With Onavita Algal DHA Powders DM Matsutani LLC (Illinois) showcased Fibersol the line of soluble prebiotic dietary fiber ingredients. The Fibersol line of ingredients is included in the FDA (U.S. Food and Drug Adminstration) s list of dietary fibers and can fulfill consumer desires for tasty fiber-full products that are well tolerated and have demonstrated satiety benefits. Consumers are interested in lowcalorie reduced-sugar and nosugar-added foods and beverages with clean and simple labels. They are in tune with their personal health and wellness and are seeking healthier foods that still taste great. According to a 2017 report by The Hartman Group 63 percent of respondents say they are trying to add fiber to their diets. Fibersol s functional benefits can help product developers create new and improved food beverage and supplement products that taste great and enable a variety of label claims including sugar and calorie reduction digestive health or weight management that consumers are seeking. These products demonstrate how A Fibersol can help developers meet consumer demand for better nutrition. When used in foods and beverages Fibersol requires minimal formulation and process adjustments is tasteless and odorless and adds minimal viscosity. In addition it can mask off and bitter notes improve mouthfeel and offer excellent binding properties. For vitamins and supplements it is a lower-calorie carrier and is also available in tableting form. ADM also announced the addition of Onavita algal DHA powder to its line of omega-3 product solutions. The new omega-3 powder is part of ADM s expanding portfolio of health and wellness ingredients such as probiotics vitamins botanical extracts nutritional oils and more all designed to give developers the January February 2019 ingredients they need to get to market faster with products consumers are seeking. Omega-3s are vital for proper cell function and credited with powerful benefits for the brain and body including cognitive development and heart and eye health in every stage of life for humans. ALA is the essential omega-3 which must be obtained through diet since it is not produced by the body. DHA is derived from ALA in the body but scientific experts believe dietary consumption of DHA is also important. Today s health-conscious consumer is driving demand for functional products that support their personal health and wellness goals. That s why we re excited to expand our product line of high-quality sustainably sourced omega-3 ingredients to include yet another option for product developers who are seeking ingredients that help support cognitive heart and eye health said Jen Hogan business manager nutritional oils. For more information visit and onavita. Nutrition Industry Executive 17 IngredientNews OmniActive s CurcuWIN and Lutemax 2020 are USP Verified ew Jersey-based OmniActive Health Technologies CurcuWIN Curcumin with Enhanced Absorption and Lutemax 2020 Lutein and Zeaxanthin Isomers are now both US Pharmacopeia (USP) Verified. USP is a global scientific organization that sets quality standards for medicines food ingredients and dietary supplements that are used in more than 140 countries. USP Dietary Ingredient Verification Services include GMP (good manufacturing practice) facility auditing ingredient N quality control manufacturing documentation review and ingredient testing. Produced using OmniActive s proprietary UltraSOL Delivery System CurcuWIN is recognized for its high bioavailability with demonstrated relative absorption of total curcuminoids 46-times over standard curcumin as well as clinically demonstrated sports and heart health benefits according to the company. CurcuWIN is also patented for improving muscle performance endurance capacity and resistance to fatigue during exercise. Proprietary Lutemax 2020 is a naturally derived marigold extract providing all three macular carotenoids lutein and zeaxanthin isomers (RR-and RS [meso]-zeaxanthin) at the same 5 1 ratio as found in the diet. Multiple clinical studies have demonstrated Lutemax 2020 s health benefits including eye brain and skin health as well as supporting a modern digital lifestyle. For more information visit Fucoidan Extracts Reduce Gut Inflammation n the latest advance in gut health scientists have uncovered new evidence supporting the effects of a natural seaweed extract in reducing gut inflammation. New research has found that Maritech fucoidan a bioactive compound extracted from seaweed significantly inhibited the production of key pro-inflammatory biomarkers that are clinically relevant in acute and chronic gut conditions. When tested in ex-vivo human blood and compared to controls results showed that fucoidan inhibited the release of three inflammatory I mediators TNF- IL-1 and IL-6. TNF- and IL-1 are drivers of major inflammatory processes. Prolonged and raised levels are linked to inflammatory bowel disease (IBD) which affects 10 million people worldwide and includes Crohn s disease and ulcerative colitis. Blocking these chemical messengers can result in a rapid and sustained reduction in disease severity. Maritech fucoidan was found to reduce TNF- levels by more than 70 percent and IL-1 by more than 54 percent. The pro-inflammatory cytokine IL- 6 also plays a central role in uncontrolled intestinal inflammation. It can alter the balance between proinflammatory and immunosuppressive immune cells and has been associated with IBD and colon cancer. In the study Maritech fucoidan inhibited the production of IL-6 by more than 43 percent. Maritech fucoidan ingredients are extracted from wild Undaria pinnatifida and Fucus vesiculosus macroalgae by Australian biotechnology company Marinova. For more information visit Probiotic Strain DE111 Found to Reduce Pro-inflammatory Compound in Athletes new study has found that athletes who consumed a probiotic daily may benefit by boosting immunity and recovery following strenuous training or play by reducing levels of tumor necrosis factor-alpha (TNF- ) a proinflammatory compound. The study called Effects of Probiotic (Bacillus subtilis DE111) Supplementation on Immune Function Hormonal Status and Physical Performance in Division I Baseball Players was recently published in the journal Sports. The study sought to determine effects of probiotic (Bacillus subtilis DE111 in a dose of 1 billion CFU) in college-aged male athletes after 12 weeks. The double-blind placebo-controlled randomized study gave a group of division 1 male baseball athletes either the A 18 Nutrition Industry Executive probiotic or placebo and looked at their markers of immune and hormonal status via blood and salivary samples pre- and post-training. Specifically biochemicals investigated were circulating concentrations of testosterone cortisol TNF- interleukin-10 (another pro-inflammatory compound) and zonulin (a protein associated with intestinal permeability) as well as immunoglobulin A (SIgA) and immunoglobulin M (SIgM) in the saliva which shows mucosal immunity. After the three months of intense training in both groups TNF- concentrations were significantly lower in DE111 group compared to placebo. These findings indicate that DE111 supplementation may reduce systemic lowgrade inflammation in trained athletes. In an earlier study on female collegiate athletes supplementing with B. subtilis DE111 for 10 weeks along with post-workout nutrition improved their body composition and certain athletic performance indices. For more information visit January February 2019 New Delivery Form of Ashwaghanda Ensures Purity and Potency rjuna Natural Ltd. (India) has developed new technology that ensures the safe delivery of its proprietary Shoden ashwanghanda extract at a new level of purity and bioactivity. Innova Market Insights data has reported a 48 percent increase in the number of food and beverage launches in 2018 globally compared to 2015 with the U.S. taking the lead. This spike may have been spurred by growing consumer demand for this acclaimed adaptogenic herb to help overcome the stresses of modern life. Ashwangandha growth is especially strong in the sports industry. According to Innova data one A in three product launches of the ingredient have been under the nutritional sports category globally between 2015 and 2018. A further two in five launches featured an energy or alertness claim. The Shoden product is now bioactivity protected and contains ashwagandha extract standardized with 35 percent withanolide glycosides which is the most active component of ashwagandha. Shoden is manufactured from carefully selected ashwagandha roots and leaves. New Concept Offers Indulgent High-protein Biscuits Without the Downsides new concept from Arla Foods Ingredients (New Jersey) will help biscuit manufacturers tap into the high-protein and healthy indulgence trends while overcoming technical challenges. According to Mintel one in four consumers now look for cookies or biscuits that are high in protein. The number of sweet and savory biscuit launches in North America and Europe featuring protein claims has more than doubled in the last five years. However producing indulgent high-protein biscuits can come with processing and sensory challenges. Arla Foods Ingredients new Whey-Pro Biscuit concept features Nutrilac the company s whey protein ingredient in an indulgent biscuit recipe with a premium look taste and feel. The concept was designed to create biscuits with the right structure and appearance after baking as well as low water activity for long-lasting crispness and low risk of microbiological spoilage. It helps overcome issues such as unpleasant aftertaste and unattractive appearance and qualifies for a high-protein claim in the E.U. A E.U. Regulation (EC) No 1924 2006 A claim that a food is high in protein and any claim likely to have the same meaning for the consumer may only be made where at least 20 percent of the energy value of the food is provided by protein. Arjuna developed its Bioactive Ingredient Protection System (BIPS) proprietary safety technology to ensure optimal delivery of the bioactive components of ashwagandha. BIPS is a patented procedure in which all the active molecules are encapsulated in a shield to deliver them safely and at the desired potency. This process makes Shoden active even at a low dosage. For more information visit Deinove Will Market a 2nd Proprietary Carotenoid-based Cosmetic Active Ingredient rance-based DEINOVE a biotech company that discovers develops and produces high value-added compounds based on rare bacteria notably from the Deinococcus genus confirmed that it is developing a new carotenoid for cosmetic applications. It is an innovative carotenoid produced with an exclusive bacterial fermentation process. It has been developed as an active substance for dermocosmetic use in an indication that is on the rise and which remains confidential at this stage. R&D teams have developed and optimized a proprietary strain for the optimal production of this new carotenoid and developed fermentation and extraction processes allowing high levels of production with a view to industrialization. Once validated at the pilot stage these processes will be scaled-up. Furthermore the active properties have been tested in vitro with promising efficacy data. When the final formulation is validated the product will undergo clinical testing. Deinove is targeting this active ingredient for marketing in 2019. For more information visit F BioCell Technology Announces NOW s Launch of BioCell Collagen Dietary Supplement alifornia-based BioCell Technology LLC announced that its flagship clinically tested healthy aging ingredient BioCell Collagen has launched as a standalone ingredient featured in a new dietary supplement from the esteemed finished product manufacturer NOW (Illinois). NOW s BioCell Collagen delivers C 1 000 mg in two capsules providing 570 mg of type II collagen peptides 95 mg of hyaluronic acid and 190 mg of chondroitin sulfate. This science- January February 2019 based ingredient supports joint skin and connective tissue health. For more information visit and and 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. Nutrition Industry Executive 19 IngredientNews New Data Find Adonat-SAMe Helpful for Depressive Symptoms new clinical study shows the effects of a S-Adenosyl methionine-based dietary supplement (SAMe 200 mg die - Adonat SAMe ingredient manufactured by the Italian biotech company Gnosis SpA - plus vitamin B-complex) in improving mild and moderate depressive symptoms. The nutraceutical product tested is commercialized by Abela Pharm (Belgrade Serbia) under the brand name of Tensilen. The study included 60 patients randomly allocated into two groups. The study group was treated with SAMevitamin B complex while the control A group was administered a placebo once a day for three months. To assess the efficacy in relieving depression symptoms well-established research ratings were evaluated such as the Hamilton Depression rating scale (HAMD17) and the Clinical Global Impression-Severity scale (CGI-S) for the measurement of symptoms severity as well as the Clinical Global Impression-Improvement scale (CGI-I) scores for the assessment of improvement or worsening after treatment relative to the baseline state. The results of the study are very positive for all the different kinds of tests with statistically significant differences between the study group and the control group. For more information visit Sensoril Improves Strength Training Adaptations and Recovery in Published Clinical Trial n a recent trial Sensoril a patented ashwagandha extract by New Jersey-based Natreon showed significant improvement in both upper and lower-body strength in recreationally active men over a 12-week resistance training and supplementation period. This U.S.-based study conducted at The Center for Applied Health Sciences (Ohio) was a 12-week randomized parallel-group placebo-controlled clinical trial to examine the impact of Sensoril on strength training adaptations. Subjects were all healthy males between the ages of 18 45 I years who were recreationally active training no more than two to three days week. Subjects were randomized to either receive Sensoril 500 mg day or a placebo. Subjects in the Sensoril group significantly improved their squat strength by 90 percent an increase in leg strength of more than 9 kg compared to the placebo. There was also a 60 percent improvement in upper body strength (as assessed by the bench press) by more than 4 kg. Sensoril was also found to significantly improve perceived recovery by 14 percent compared to the baseline while the placebo group showed a significant increase in muscle soreness by more than 40 percent. For more information visit Sabinsa s Nigellin Black Cumin Seed Extract Identified as a Favorable Immunomodulation in Asthma Inflammation ecent research published in Frontiers of Pharmacology identified Nigellin BCS - Amber New Jersey-based Sabinsa s Black Cumin (Nigella sativa) seed extract as being the most effective of the 10 Nigella sativa (NS) extracts used in an in-vitro study which suppressed the release of the most active cytokines and identified a prostanoid with inflammatory properties which may possess a favorable effect in the context of asthmatic conditions. Researchers evaluated 10 different NS extracts and top ranked the extract provided by Sabinsa s parent R 20 Nutrition Industry Executive company and manufacturing arm Sami Labs (India). It surpassed the second ranking extract in terms of the active constituent thymoquinone (TQ) by more than 300 percent. Anti-inflammatory and immunomodulating properties are among the most valued in anti-asthma herbal products. Sabinsa s Nigellin had the highest effects in suppressing the release of cytokines IL-2 IL-6 and PGE2 in T-lymphocytes and also in monocytes hindering the expression on IL-2 and PGE2. These are among the most active cytokines involved in asthmatic conditions. The investigators noted a positive relationship between the TQ level in the preparations and its inhibitory potency on IL-6 and PGE2. However PGE2 does exhibit beneficial bronchodilatory effects in human lung epithelial cells and Sabinsa s extract showed an enhanced PGE2 expression in A549 human epithelial cells lines demonstrating an interesting activity behavior of the maximumTQ containing Sabinsa s extract. The results presented in this paper formed the biochemical basis of a subsequently conducted clinical trial. For more information visit January February 2019 AssociationNews Trade Associations Warn Consumers of Dangerous Substance Illegally Marketed as a Dietary Supplement he dietary supplement industry has sounded the alarm about the dangers of phenibut a substance being illegally marketed in products fraudulently labeled as dietary supplements. Developed and used as a drug in the former Soviet Union for its supposed brain-enhancing properties phenibut is not approved as a drug in the United States nor does it meet the regulatory requirements to be sold in or as a dietary supplement. The ingredient should be considered dangerous and has been associated with potentially serious side effects and great risk for addiction. The responsible dietary supplement industry learned that phenibut has been found in adulterated products fraudulently labeled as dietary supplements and is warning consumers to avoid purchasing any products with this ingredient. The leading trade associations of T the dietary supplement industry stand together in opposition to this illegal and unapproved substance and have taken action to keep tainted products falsely claiming to be dietary supplements out of consumers hands. The industry has notified the U.S. Food and Drug Administration (FDA) and fully supports the agency s legal authority to immediately remove these dangerous products from the market. In addition the trade associations have contacted several online retailers selling tainted products containing phenibut urging them to remove these items from their digital shelves at once. The American Herbal Products Association (AHPA) Consumer Healthcare Products Association (CHPA) Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) unequivocally warn manufacturers marketers and retailers and consumers to immediately halt the production sale promotion or consumption of this unapproved illegal and dangerous substance. Retailers of dietary supplements including online retail portals should refuse to stock or sell any product containing phenibut. Manufacturers marketers and retailers should refrain from promoting any product containing phenibut. Consumers should avoid any product containing phenibut. For more information visit or UNPA and TraceGains Partner to Promote Supply-chain Quality he United Natural Products Alliance (UNPA) and TraceGains a leading provider of supplier compliance and quality management software for the food beverage and supplement industries has announced a strategic partnership designed to increase quality management and transparency in the global supplement supply chain. TraceGains is an advanced network platform that allows companies to automate and streamline their processes through instant information sharing and collaboration throughout the supply chain. In addition to facilitating compliance documentation companies using TraceGains can access a directory of suppliers and ingredients that currently includes more than 5 900 suppliers in 90-plus countries more than 100 000 ingredients and a library of 550 000-plus discoverable documents. We have an increasingly complex supply chain and regulatory landscape said Loren Israelsen UNPA president. Both domestic and foreign suppliers are often not T equipped to meet the new Food Safety Modernization Act (FSMA) recordkeeping requirements and the industry as a whole is suffering from certifier audit fatigue. UNPA chose to partner with TraceGains because the supply chain transparency its software provides is in alignment with UNPA s long-standing mission to help industry provide end-use consumers with natural health products of superior quality benefit reliability and sustainability. Supplement companies are struggling to stay on top of the growing mountain of regulatory January February 2019 documentation required to ensure product safety TraceGains CEO Gary Nowacki added. It s also time-consuming and difficult for manufacturers to find compliant suppliers and key ingredients. We recognized these challenges and built an advanced network platform that s revolutionizing information exchange between buyers and sellers. We re pleased to partner with UNPA to ensure more businesses can join us in transforming the supply chain. TraceGains which recently purchased the assets of Oregon-based Healthnotes and UNPA will jointly conduct educational programs to help address industry pain points such as FSMA new product development and audit readiness. Additionally the UNPA-TraceGains alliance will work collaboratively to develop and promote industry best practices around raw ingredient sourcing to boost supply chain trust and transparency. For more information visit or Nutrition Industry Executive 21 AssociationNews ABC Partners With Sustainable Herbs Program to Promote Business Consumer Awareness he American Botanical Council (ABC) has partnered with the Sustainable Herbs Program (SHP) as part of ABC s ongoing commitment to medicinal plant conservation and sustainability education. The SHP website is being developed as a new educational resource for the international herb and medicinal plant communities. SHP was founded in 2015 as the Sustainable Herbs Project by Ann Armbrecht PhD an anthropologist and author who became interested in herbal healing after conducting research in Nepal for her doctorate. Armbrecht and ABC are sharing the responsibilities of developing new educational content and maintaining the program s website. ABC also has taken on responsibilities related to development fundraising and marketing. SHP s website is a valuable resource for consumers herbalists manufacturers and others in the herbal healing community. The many videos are particularly compelling. Ranging from one to 15 T minutes in length these short videos offer an in-depth look at the multifaceted issues that face the herb industry and touch on quality and sustainability raw material processing quality control and testing and the wild-harvest of medicinal plants. In addition to focusing on supply chain sustainability SHP will also provide herb businesses access to resources to become more sustainable in their warehousing processing and administrative operations said ABC Founder and Executive Director Mark Blumenthal. This is part of our education and inspiration goal. We want to inspire and stimulate more awareness of sustainable activities in the herb industry at all levels of operation. At a time of increasing herbal supplement sales discerning consumers demand more from their products including social empowerment efforts organic and sustainable harvesting regenerative farming practices and supply chain transparency. Younger genera- tions of consumers in particular are responding positively to companies they perceive as responsible trustworthy and environmentally conscious. Companies are taking notice of this trend and engaging in marketing strategies that emphasize their commitment to better business practices for the people and the planet. Blumenthal added We re inviting people from all over the herb community to collaborate with us. SHP is designed to invite and promote responsible information on herb sustainability from many sectors of the herb and medicinal plant communities in all parts of the globe. At present there are 17 Inaugural Underwriters that represent leading stakeholders in the herbal supplement industry. These underwriters include botanical ingredient suppliers and branded product manufacturers including a leading dietary supplement trade association. For more information visit Botanical Adulterants Prevention Program Publishes Cranberry Guidance Document he ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announced the publication of a new Laboratory Guidance Document (LGD) on cranberry (Vaccinium macrocarpon). Cranberry-derived dietary supplements and beverages are widely used for the prevention and adjuvant treatment of recurrent urinary tract infections. In the United States cranberry was the third top-selling botanical dietary supplement ingredient in U.S. mainstream retail outlets (drug stores grocery stores etc.) in 2017 with sales of 68.12 million. There are important differences in the composition of the various cranberry supplements on the market. This is particularly true with regard to the content of proanthocyanidins (PACs) which are considered the main cranberry compounds responsible for preventing bacterial adhesion in the urinary tract. PAC concentrations vary from 0.8 to 24 percent in commercial cranberry extracts with the majority of products containing between 0.8 and 1.5 percent PACs. T 22 Nutrition Industry Executive Depending on the PAC concentration bulk cranberry products were sold for 50 to 600 per kg in 2017. The availability of lower-cost PACs from other plant sources such as peanut (Arachis hypogaea) skin or grape (Vitis vinifera) seed has led some unscrupulous suppliers to dilute or replace cranberry PACs without labeling such dilution or replacement for financial gain. Other known adulterants of cranberry include anthocyanin-rich extracts from other lower-cost materials. Anthocyanins range in color from red to blue and anthocyanin-rich extracts are used to mimic the red color found in authentic cranberry extracts. A summary of these methods of cranberry adulteration was published in BAPP s Cranberry Botanical Adulterants Prevention Bulletin in December 2017. The new LGD was written by John H. Cardellina II PhD a noted expert in natural products chemistry and analysis and American Botanical Council (ABC) Chief Science Officer and BAPP Technical Director Stefan Gafner PhD. The LGD evaluates the usefulness of published analytical methods to detect cranberry fruit product adulteration and summarizes the main advantages and disadvantages of each method regarding its suitability for use in a quality control laboratory. The document also details the chemical composition of cranberry fruit potential confounding species and known adulterants. The LGD was peer reviewed by 20 international experts from academia the government third-party contract analytical laboratories and the herbal industry. The variability in manufacturing processes and accordingly the composition of commercial cranberry ingredients makes it challenging to find an analytical method that is able to detect all the different types of adulteration Gafner explained. Depending on the product specifications a suite of test methods may be needed for unambiguous identification of a cranberry fruit extract. For more information visit http BAP ml ts 1543860226&signature 506d395 fe155b268484e83579a9e9216. January February 2019 Gottlieb Announces New Dietary Supplement Working Group n Dec. 13 Scott Gottlieb MD commissioner of the U.S. Food and Drug Administration (FDA) announced a new Dietary Supplement Working Group during his speech at the Food and Drug Law Institute (FDLI). I ve formed a Dietary Supplement Working Group within FDA to take a hard look at what more the FDA can be doing within our existing authorities including reexamining our own internal operating structure and procedures and what new authorities might make sense he said. We have some specific new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements. In response to the announcement the Council of Responsible Nutrition (CRN) released the following statement CRN welcomes the announcement from FDA Commissioner Scott Gottlieb MD on the agency s efforts to re-examine its policies and approaches for dietary supplements stated Steve Mister CRN president & CEO. He s correct that the dietary supplement industry has grown tremendously since the enactment of the Dietary Supplement Health & Education Act (DSHEA) in 1994 due to the emerging science that further sup- O ports the health benefits of these products and the continued growth in consumers interest to take more active roles in their health and wellness. We look forward to learning more about the recommendations of FDA s Dietary Supplement Working Group and to working with the agency in evaluating these approaches. Since Dr. Gottlieb s arrival at FDA we have seen increased enforcement against bad actors that mismarket drug ingredients as dietary supplements the implementation of the Program Alignment initiative to make FDA inspectors stronger experts in the product facilities they inspect and a willingness to work with the industry on Supplement Facts label changes. We applaud these efforts. The Natural Products Association (NPA) asked to join the new Dietary Supplement Working Group. While we share the commissioner s concerns and hope FDA gets serious about bad actors who illegally sell drugs under a dietary supplement label or make false claims we disagree with his suggestion that more or different rules are needed or that the industry s outstanding safety record has changed said Daniel Fabricant PhD president and CEO of NPA. We ve urged FDA to get tougher on bad actors and we hope they do that but in the meantime they should also lead the discussion on new areas like cannabidiol (CBD) and other promising natural products not playing catch-up. NPA does disagree with the commissioner s characterization that the supplement industry is riskier. Dietary supplements remain the only food commodity for which there is a mandatory reporting requirement for serious adverse events (SAERs) said Fabricant. The latest SAERs for supplements are still very low consistent with prior years and still pale in comparison to prescription drugs. NPA is pleased FDA appears poised to act on our repeated calls for stronger enforcement and is eager to participate in the new working group to make sure Americans have continued access to safe natural and affordable supplements and natural products. For more information visit ABC s Gayle Engels to Receive Inaugural Award for Excellence in Herbal Education he American Botanical Council s (ABC s) Special Projects Director Gayle Engels will receive The Herb Society of America s (HSA) inaugural Madalene Hill Award for Excellence in Herbal Education at the HSA s Educational Conference and Annual Meeting of Members in Madison WI in June 2019. According to the HSA the Hill Award honors those who have a passion for promoting the knowledge use and delight of herbs through educational activities and show a great zeal for sharing their passion for herbs with the public. The award is named in honor of the Grand Dame of Herbs Madalene Hill who died in 2009 at T the age of 95. Engels who has worked at ABC for 23 years helps manage the nonprofit s educational efforts garden development and other projects. Her work with the HerbDay Coalition and active membership with the HSA allow Engels to share her love of botanicals and their beneficial qualities with students herbalists and the general public. Her deep knowledge of herbs and medicinal and aromatic plants has expanded with her duties as the project manager for ABC s HerbMedPro database. She also has co-authored more than 30 herb profiles for ABC s quarterly journal HerbalGram. Through these efforts January February 2019 Engels has immersed herself in scientific and clinical research traditional uses sustainability issues and distribution of hundreds of plants. For more information visit http press 20 18 EngelsReceivesHSAAward.html. Nutrition Industry Executive 23 CRNUpdate Will CBD Become a Shakespearean Tragedy By Steve Mister president & CEO CRN To CBD or not to CBD that is the question hakespeare posed plenty of contemplative questions but for today s dietary supplement marketers retailers and consumers perhaps nothing is more pressing than nor as confusing as the decision whether to jump into the cannabidiol (CBD) market or not. No ingredient in recent memory has attracted the level of buzz that CBD has. By some estimates the over-thecounter market for hemp-derived food supplement and personal care products containing CBD exceeded 190 million last year and is projected to surpass 650 million in five years. It has been added to everything from pills and powders to gummies from snacks and teas to toothpaste and lotions. All this while the ingredient was arguably still illegal under both the Controlled Substances Act and the Food Drug & Cosmetic Act. So the passage of the 2018 Farm Bill is welcome news to would-be marketers looking for some clarity as to the legal status of CBD. The inclusion of the Hemp Farm Act in the final legislation removed hemp from the definition of marijuana which is a Schedule 1 controlled substance provided the plant contains not more than .3 percent THC (the pyscho-active substance that gives marijuana its high ). By effectively taking hemp and products derived from the plant off the federal controlled substances list the Farm Bill allows for legal cultivation harvest transport marketing and research of hemp and its constituent CBD and it eliminated a significant legal barrier to lawful marketing of CBD-containing products. S CBD Restraints But not so fast. While the DEA (Drug Enforcement Administration) issues have been addressed FDA (U.S. Food and Drug Administration) has not given CBD the green light for inclusion of CBD in food and dietary supplements and that hurdle may be just as formidable. FDA s issues with CBD are unrelated to the ingredient s connections to marijuana and are multifaceted. Roadblocks still exist for lawful marketing of CBD as either a food or a dietary supplement. First and foremost FDA has repeatedly opined that it believes CBD does 24 Nutrition Industry Executive not meet the definition of either a dietary supplement or a food because of an exclusion buried in the definitions of both terms in the federal Food Drug & Cosmetic Act. That law excludes from those definitions any article that was previously studied as a drug in a substantial clinical investigation prior to it being marketed in one of those categories. No ingredient in recent memory has attracted the level of buzz that CBD has. This provision first appeared in DSHEA (Dietary Supplement Health and Education Act of 1994) and was later replicated for food to provide pharmaceutical companies with exclusive use of compounds for which they had invested research before they were marketed as supplements or food. In other words the law provides that if researchers get interested in a compound for potential drug purposes after it is already marketed as a food or supplement the drug and the supplement must coexist in the marketplace together (think omega-3s or niacin) but if the drug research comes first then the pharmaceutical gets the monopoly and the article doesn t qualify as a food or supplement. This provision is the crux of the litigation from the 1990s involving red yeast rice and why today supplement manufacturers are prohibited from standardizing the levels of lovastatin in those products. FDA has invoked this obscure provision (found in 21 USC 321(ff)(3)(b) if you want to go look for yourself) in a series of warning letters over the past year with the perspective that CBD was first studied for its eventual use in the drug Epidiolex before it was lawfully sold in a food or supplement. At CRN s conference in October FDA s Director of Dietary Supplement Programs (ODSP) Steven Tave stated emphatically from the podium that FDA believes the clinical investigation clause precludes lawful marketing of CBD in either supplements or food. Fortunately an escape hatch exists. The statute also permits FDA to exempt a particular article from the exclusion on marketing as a food or supplement if FDA in its discretion issues a regulation after notice and comment finding that the article would be lawful ... And there are some compelling public health reasons why FDA could be motivated to use this provision to make an exception for CBD. As I mentioned earlier the proverbial horse is already out of the barn when it comes to CBD. The market for CBD products legal or not is exploding. Despite warning letters and podium policy consumers are demanding access to CBD and marketers are already responding with 190 million of products. So FDA faces a choice continue to rail at the wind without the enforcement resources to put the horse back into the barn or devise another way to regulate CBD. Allowing the sale of food and supplements containing CBD would permit FDA to impose GMPs mandatory adverse event reporting notification of claims access to safety data and other regulatory requirements onto the sector. FDA could determine that in the interest of public safety an exception to the clinical investigation clause is both expedient and justified for CBD. Claims and Safety Concerns FDA has also expressed concerns about CBD products that claim to prevent treat cure and mitigate diseases. Such claims are limited to drugs. CBD marketers should be especially cautious not to make drug-like claims for their products because doing so could turn even otherwise lawful CBD products into unapproved new drugs. But there s another reason to be conservative in marketing claims the publicly available research on the benefits of CBD reveals that the science behind (Continued on page 27) January February 2019 SupplySideWestWrapUp SupplySide West Holds its 22nd Year With Record Attendance that companies shouldn t miss the forest by looking at a tree. He advised that companies and marketers should look at a consumer s lifestyle not just at the product they are buying. Later that day the American Botanical Council celebrated its 30th anniversary with a reception at the Mandalay Convention Center. The American Herbal Products Association (AHPA) hosted tors formulators or producers who want to make clean label supplements said its member reception Educational Events Steve Peirce president of RIBUS. The while New Jersey-based Attendees were offered companies we have aligned with are the suppliers FCC Products ample education opportumost knowledgeable leaders in the Inc. celebrated its 40th nities at this year s event dietary supplement industry that can anniversary 1970s style. including a series of workprovide support and problem-solving The SupplySide shops focused on market solutions. Launchpad a feature of trends clinical research Peirce said the purpose of the Clean the SupplySide Central formulation considerations Label Alliance is to offer free counsel Stage showcased suppliregulatory changes and and technical support to dietary suppleers presenting information more. On Nov. 8 featured Michael Solomon on new ingredients cours- ment companies by providing top-ofspeaker Michael Solomon the-line resources and solutions to effies presented with NSF PhD author of Marketers Tear Down ciently produce clean label suppleInternational (Michigan) offered training These Walls Liberating the Postmodern ments. around key GMP (good Consumer shared insights into growing During the Keep It manufacturing practice) the bottom line through a deeper conClean event guests issues. The SupplySide nection with customers. The single enjoyed a full family-style West Exhibitor Presentation biggest challenge today is engaging breakfast with mocktails Theater featured sponyour customer because there are so and a clean comedy rousored presentations by many things competing for their attentine by Saturday Night industry professionals tion Solomon said. He added that the Live alumni LaKendra majority of purchase decisions are made addressing science trends Tookes. Guests were and market data. at the emotional level. greeted at the event by Missouri-based RIBUS In regard to the natural space RIBUS latest clean label Inc. hosted its annual Solomon said that the culture has shiftSteve Peirce excipient Nu-BIND which SupplySide West event on ed from a reactive health model to a was brought to life by real Nov. 9 unveiling its latest proactive wellness culture but noted Las Vegas supporting actors who excipient Nu-BIND and bonded with guests and escorted officially launched the them to their seats while providing the Clean Label Alliance excipient s list of attributes. Further along with companies RIBUS awarded New York-based Gemini BIOGRUND (Germany) Pharmaceuticals with an Early Adopter Bosch Packaging Award for producing more than a thouTechnology (Germany) sand SKUs using RIBUS clean label Lonza Inc. (Switzerland) excipients. Advanced Orthomolecular and Natoli Engineering Research (Canada) was also recognized Co. (Missouri). More than for becoming the latest member of the 100 people attended the RIBUS Certified Contract Manufacturer event. Program. We want Clean Label Also of note was AHPA s 7th Annual Alliance to be the go-to Botanical Congress an annual event turnkey solution for any NIE Associate Publisher Russ Fields (left) with FCC CEO Gerard Woods (center) and NIE Publisher Dan McSweeney. that convenes leading herbal industry challenges facing operaupplySide West the leading ingredients and supply-chain event for the health and nutrition industry gathered 1 300 exhibitors with more than 17 000 global professionals an 8 percent increase from 2017 and a record for the show. Now in its 22nd year the event returned to Mandalay Bay in Las Vegas NV from Nov. 6-10. SupplySide West showcased top ingredients and technologies that will fuel growth and drive trends in dietary supplements foods beverages and sports nutrition products. The four-day event featured a robust education program two-day tradeshow and impactful networking opportunities. S January February 2019 Nutrition Industry Executive 25 SupplySideWestWrapUp veterans to discuss issues impacting the herbal product and herbal supplement industries. The event featured a video presentation by U.S. Food and Drug Administration (FDA) director of the Office of Dietary Supplement Programs (ODSP) Steven Tave who highlighted recent collaborations between the responsible supplement industry and FDA toward the shared goal of a wellregulated dietary supplement market. One of the things I have really come to appreciate since I ve been in this job is the enormous amount of common ground between our goals at FDA and the goals of the responsible participants in the dietary supplement industry said Tave. Anyone who is paying attention can t help but see that responsible dietary supplement firms today are looking for ways not just to comply with the law s requirements but to set higher standards for themselves and to hold the entire industry to those standards. He outlined several areas where FDA and the supplement industry have recently cooperated to further ODSP s top three priorities 1. Safety Protecting consumers from harmful products 2. Product Integrity Ensuring product identity and quality 3. Informed Decision Making Enabling consumers and health care providers to be well informed about supplement products New in 2018 the Esca Bona at SupplySide West platform debuted as a way to bring more natural and organic food and beverage ingredient suppliers and buyers together with a focus on ingredients and finished products for the good food movement. 26 Nutrition Industry Executive Thoughts & Trends Aker BioMarine (Norway) showcased a new clinical study that investigates how phospholipid-rich krill oil can help benefit people with lupus and more. SupplySide West 2018 was a fantastic show for the team at Aker BioMarine said Andreas Berg Storsve PhD director of R&D. Our company is venturing into new territories like never before working hard to push the boundaries with science and innovation. We are continually working to spearhead new research and investigate product development opportunities to uncover krill s full potential. At the show in November we saw that some of the areas we are looking at for krill are becoming increasingly popular across the industry. Active lifestyles sports nutrition and lifelong wellness were common themes seen throughout the event seminars and educational content platforms Storsve said. Discussions around Millennials and younger generations of sports nutrition consumers were all the rage. We are also seeing that the sports nutrition is a growing market and is spanning well beyond traditional bodybuilders and athletes and to that end there are more and more possibilities for krill for within the active lifestyles space. Due to its inherent advantages krill oil has enormous potential for the sports nutrition active lifestyle sector and preliminary data shows that this area is the ideal place for krill products due to its health benefits for athletes. SSW is always an amazing platform to see new ideas and industry trends come to life. In addition transparency continues to be a high priority. SupplySide West truly does continue to be a hub for the latest news in ingredients and functional foods noted Cheryl Costanzo director of global communication at New Jersey-based Horphag Research (exclusive worldwide supplier of Pycnogenol and Robuvit). One of the main trends I saw during the show was a focus on transparency of ingredients and product labels. There s an emphasis on single ingredients with multifunctional benefits. More consumers are interested in naturally sourced functional ingredients like Pycnogenol or Robuvit and they know to look for these ingredients on product packages. Branded ingredients in particular are instrumental in this category as consumers seek out science-backed quality products that are supported by global marketing and brand awareness education campaigns. One could say that participating in product transparency and clean labels are part of corporate social responsibility OmniActive Health Technologies (New Jersey) has helped contribute to the cause via its Improving Lives Foundation. One of the trends that we saw at the show (if you can call it a trend) was a more active interest in sustainability and corporate social responsibility specifically as it relates to more tangible real results of these efforts explained Brian Appell the company s marketing manager. Moving forward I think it ll not only be about the effort but the results real numbers or the real impact on people and their communities. With our Improving Lives Foundation we ve tried to capture that as well as the more human stories of the real impact our program has made. We also saw a greater need for ingredient versatility for functional foods and beverages and the need for more efficacious doses in these delivery systems. As the functional food category evolves I think we ll see a shift to using more efficacious January February 2019 amounts of ingredients to support health benefits and make more substantiated claims that consumers are looking for in some of these ingredients (curcumin being a good example). For New Jersey-based Natreon among its various efforts the company was able to continue spreading the word on Sensoril Ashwagandha derived from the leaves and roots of the Withania somnifera plant. Overall it was an excellent show for us due to being able to showcase our ingredients in the increasingly popular categories as in adaptogens said Bruce Brown MPH MA the company s president. We had a great presence at our booth and around the show with new material focusing on our flagship ingredient Sensoril Ashwagandha. We were able to continue to drive the science behind Sensoril with a new sports performance study new whitepaper and an educational video focused on consumer understandings. Now consumers are shifting to more of a holistic perspective when it comes to their daily regimen. Specifically some of the key observations or trends from the show were that brand marketers are really focused on natural botanicals and the science to support the position of their retail products Brown added. We are also starting to see personalized nutrition begin to really come to the forefront. Whether it s through engagement with an app or a novel delivery form to adapt to the ever-changing demands of people s lifestyles consumers are seeking to find brands that can adapt to their evolving lifestyle needs. They are not just looking for a single health benefit product anymore they are looking for a true holistic approach to reduce stress improve sleep and to improve overall quality of life. Awareness is growing regarding the fact that natural adaptogens can really help deliver on those consumer needs. Looking Ahead Beginning in 2019 SupplySide West will be co-located with Food ingredients North America (FiNA) bringing this global event to the United States for the first time. The combined event will serve large food and beverage brands as well as the fast growing natural organic and functional food & beverage companies that are driving significant growth in the market. The next SupplySide show will be Supplyside East which will return to the Meadowlands Exposition Center in Secaucus NJ April 9-10 2019. SupplySide West 2019 will be held at Mandalay Bay Oct. 15-19. For more information visit CRNUpdate (Continued from page 24) this compound is still in its infancy. Without sound clinical research supporting the promoted health benefits marketers are vulnerable to investigations of their claims and whether they meet the competent and reliable scientific evidence standard the long-established threshold for advertising claims at the Federal Trade Commission. In fact a review of recent FDA warning letters espousing objections to CBD on definitional grounds suggests that drug-like claims for the products may have triggered the closer scrutiny by FDA in the first place. Lastly and perhaps most critical are the potential safety concerns for CBD. A review of the extensive precautions and warnings in the drug labeling of Epidiolex indicates that at higher dosages safety issues may exist. Would-be CBD marketers should remember that FDA s position that CBD was not marketed as a supplement prior to the clinical trials of CBD as a drug inherently reveal FDA s view that CBD was not on the market prior to 1994 and thus it qualifies as a new dietary ingredient. That triggers an obligation to submit a New Dietary Ingredient (NDI) notification to the agency complete with evidence why the marketer believes it is reasonably expected to be safe. So firms should already be developing their safety dossiers on their method of manufacturing CBD and preparing these submissions for when the other issues have been resolved. Alternatively companies could decide to assemble their own panel of experts and develop a self-affirmed GRAS (generally recognized as safe) certification as one prominent marketer has already done but that takes time and planning too. Either avenue underscores the need to demonstrate that each unique CBD offering is safe for consumers. So the journey toward getting lawful CBD products to the supplement and January February 2019 food marketplace has begun but additional obstacles still lie ahead. Passage of the Farm Bill was a critical first step but it doesn t address these other issues. Industry will need to work collectively through the trade associations to address FDA s concerns. If we do the market for CBD could bloom like Juliet s rose to smell as sweet and flourish to its full potential. Otherwise this could become the winter of our discontent. And CBD by any other name will still be a missed opportunity. Steve Mister is the president & CEO of the Council for Responsible Nutrition (CRN) the leading trade association for the dietary supplement and functional food industry. Nutrition Industry Executive 27 ScienceUpdate Scoliosis Linked to Essential Mineral start manganese supplements because we already know that too much manganese can be harmful. About 3 million new cases of scoliosis are diagnosed every year. Most are mild and require only that doctors keep a watchful eye on the condition. Children who develop a moderate bend to their spine may need to wear a back brace until they finish growing. In rare cases the curvature is so pronounced that it requires surgery to correct. Cases of scoliosis tend to cluster in families but not in a simple way which suggests that many different genes each play a small role in increasing the risk of the disease. To identify such genes Gurnett and a research team including Matthew Dobbs MD the Dr. Asa C and Dorothy W. Jones professor of orthopaedic surgery and postdoctoral researcher and first author Gabriel Haller PhD scanned all the genes in 457 children with severe scoliosis and 987 children without scoliosis. They found a variant in the gene SLC39A8 in only 6 percent of the healthy children but 12 percent of the children with severe scoliosis. A second analysis in a separate group of 1 095 healthy children and 841 children with moderate to severe scoliosis also found that children with scoliosis were about twice as likely to carry the variant. When the researchers bred zebrafish with a disabled SLC39A8 gene the fish developed movement and skeletal abnormalities including curves in their spines. This gene hasn t been studied much but there are some reports that it helps cells take in minerals such as zinc iron and manganese. Haller and Gurnett found that human cells with the gene Go to somalabs for info about this advertiser variant successfully obody knows why some children s backs start to curve to one side just as they hit puberty. Most children diagnosed with scoliosis or curvature of the spine have no known risk factors. A new study published in Nature Communications suggests that the body s inability to fully utilize the essential dietary mineral manganese might be to blame for some cases of severe scoliosis. Researchers at Washington University School of Medicine in St. Louis have found that children with severe scoliosis are twice as likely as children without the disease to carry a gene variant that makes it hard for their cells to take in and use manganese. Manganese is required for growing bones and cartilage. Our study links a common disease scoliosis to something that s potentially modifiable in the diet said senior author Christina Gurnett MD PhD a professor of neurology of orthopedic surgery and of pediatrics. But we don t want people to go out right now and N 28 Nutrition Industry Executive took up zinc and iron but failed to take in manganese. They also discovered that children with the gene variant had significantly lower levels of manganese in their blood than those with the more common form although both groups were still within the normal range. Our goal in studying the genetics of this disorder was to see if there was anything we could learn that might change how we treat patients said Gurnett who is also director of the Division of Pediatric and Developmental Neurology and neurologist-in-chief at St. Louis Children s Hospital. And we came across this gene variant that affects the level of manganese in the body. That tells me maybe we should start thinking about studying nutritional treatments for some children at risk. Manganese is both an essential mineral and a toxin. High doses can cause manganism a permanent neurological condition characterized by tremors and difficulty walking as well as psychiatric symptoms such as aggression and hallucinations. The mineral also has been linked to Parkinson s disease schizophrenia and high blood pressure. Too little manganese on the other hand can cause manganese deficiency although this is rarely seen in people because the human body needs only trace amounts that are easily obtained from food. But animal studies show that lack of manganese can result in problems metabolizing fat and sugar impaired growth difficulty walking and curvature of the spine. The children with the genetic variant did not have manganese deficiency but they may be unable to use manganese as efficiently as others. The genetic variant does not stop the gene from working entirely it s just not working optimally Haller said. So maybe most people need a certain level of manganese in their blood but if you have a bad gene variant like this one you need more. Any manganese supplementation would have to be carefully measured to avoid raising the risk for other serious diseases the researchers cautioned. We ve started doing these studies in zebrafish by adding manganese to their water Gurnett said. But we still need to do human studies to figure out how much exactly is both safe and effective. For more information visit https January February 2019 THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights March 2 8 19 ad closing Weight Management SupplySide East Show Issue April 3 19 19 ad closing Compliance & Improving Quality Bone Muscle & Joint Health May 4 10 19 ad closing Science of Ingredients Vision Health June 5 16 19 ad closing 2019 NIE Supplier Sourcebook July August 6 27 19 ad closing Company Profiles Washington & the Natural Industry Our 2019 Media Planner Is Available At 2019-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF Barry Young at (732) 432-9600 ext. 103 or e-Mail Barry THE QUEST FOR OPTIMAL GUT HEALTH Driven by consumer demand the landscape for digestive health ingredients is being transformed. By Nicholas Saraceno T he digestive system holds the key to one s overall health and it ought to be treated as so. Digestive diseases affect approximately 60 to 70 million Americans annually according to the National Institute of Diabetes and Digestive and Kidney Diseases while 36.6 million people were told they had a gastrointestinal disease upon primary diagnosis in 2010. The urgency for products that support digestive health remains and ingredient suppliers and manufacturers are working on transforming the landscape of the category. Popular Ingredients Probiotics are a major player in the quest for optimal digestive health. Ohio-based Kerry Functional Ingredients & Actives offers GanedenBC30 a probiotic bacteria known as Bacillus coagulans GBI-30 6086 referred to as a sustainable naturally occurring non-GMO (genetically modified organism) ingredient on the company website. 30 Nutrition Industry Executive The big step forward in recent years has been the emergence of spore-forming probiotics like GanedenBC30 noted John Quilter vice president & general manager Ganeden and Kerry. Spore-forming probiotics are much more resistant to the extremes of pH heat cold and pressure than vegetative probiotic cells making them a better fit for the fortification of everyday foods and beverages. This has transformed the landscape for probiotics companies opening up multiple new channels beyond chilled dairy. IgY Nutrition LLC based in Oklahoma offers IgY Max an egg-based immunoglobulin which can be formulated as a standalone product or in combination with other ingredients via powder capsule or chewable. There is a recent focus on prebiotics probiotics and other ingredients like IgY Max (specifically immunized egg) on improving microbial balance in the GI (gastrointestinal) tract explained Susan J. Hewlings PhD RD the company s chief science officer. Besides a healthy diet pre- and probiotics help to address dysbiosis. While probiotics provide beneficial flora prebiotics may offer an alternative or symbiotic benefit to probiotics to stimulate beneficial bacteria. Probiotic foods were nearly a 7 billion industry in 2013 according to NBJ and are projected to increase to nearly 10 billion by 2018. The probiotics supplements market which brought in approximately 1.2 billion in 2013 is expected to almost double in size by 2018.1 The change in focus is driven by the research that suggests that digestive and overall health are driven by a balanced microbiome. Pre- and probiotic ingredients are preferred because they are effective safe and attainable via supplements and diet. In addition enzymes work in tandem to help with digestion. The basics are protease lipase and amylase said Mike Smith vice president of California-based Specialty Enzymes & Probiotics. Protease digests protein lipase digests fats and amylase digests starch. These three enzymes are an attempt to mimic the January February 2019 Go to biocat for info about this advertiser THE QUEST FOR OPTIMAL GUT HEALTH activities of your natural endogenous enzymes pepsin and pancreatin. However more sophisticated blends can increase the efficiency of digestion helping to digest legumes grains dairy and other foods. Waitaki Biosciences (New Zealand) offers its own kiwifruit powder concentrate an antioxidant grown in New Zealand kiwifruit offers various benefits not only helping with digestion of proteins but protection from the sun as well. Our ActiPhen freeze dried kiwifruit powder concentrate is a premium digestive health enhancer and anti-oxidant manufactured entirely from New Zealand grown GMO-free green kiwifruit (Actinidia deliciosa) said Sue Finderup sales manager. ActiPhen contains a naturally potent proteolytic enzyme actinidin which enhances protein digestion. In-vitro studies have shown that actinidin enhances the digestion of a number of different food proteins including soy red meat milk gluten and gliaden. Phytonutrients and fiber in kiwifruit are not just isolated in the flesh but are also present in high concentrations in the skin. Kiwifruit grown in New Zealand have built up high levels of sun protection in their skins due to the intense sunlight and low levels of pollution in this part of the world. ActiPhen is produced in our custom designed freeze drying equipment in a processing facility registered with the New Zealand Ministry for Primary Industries (MPI). Innovation Creativity can come in many forms many packaged foods are finding ways to incorporate gut health ingredients into their products. Generally we are seeing tremendous innovation in packaged convenience foods that contain ingredients specifically to promote digestive health said Sam Michini vice president of marketing & strategy with Deerland Probiotics and Enzymes in Georgia. As one example Kellogg s recently launched a digestive health cereal line Happy Inside featuring probiotics a prebiotic and fiber. There s also a new ice cream line containing probiotics. It s a great time to be involved in such imaginative product development The Clean Label movement which is powered by the idea of transparency has 32 Nutrition Industry Executive affected the way ingredients and finish products are produced. The increase in application of digestive aids into functional food applications is changing the market and interest of the consumer observed Mike Petteruti vice president Gnosis by Lesaffre (Pennsylvania). The dramatic reduction in food processing ingredients and excipients and fillers clean labeling has had a positive reception by consumers and data is suggesting this will have a positive impact on their gut literally. Petteruti added that the history of our company is in fermentation and microorganisms understanding how they can generate beneficial nutrients and how they can be beneficial to the human well being and gut. We have and continue to grow our line of strains understand[ing] how they individually and in combination with some of our unique nutritional compounds can benefit metabolic and microbiome needs in human care. Hewlings noted that the awareness of the importance of digestive health has not only contributed to market innovation but also helped create a category of functional foods and spoke on IgY Max s contribution to the gastrointestinal market. IgY Max is an innovative ingredient that utilizes passive immunity she said. IgY Max is from specifically immunized eggs that target 26 of the most common human-relevant pathogens. It supports the role of prebiotics by aiding in immune system function and by decreasing bad bacteria. IgY Max is a unique digestive and immune function ingredient that promotes GI health by increasing gut wall integrity improving bowel function and reducing non-beneficial bacteria adherence. It supports the digestive tract lining promotes proper microbial adhesion supports immune system health supports the body s natural defenses and promotes proper cytokine balance. IgY Max can exert its activity within the entire length of the GI tract. Due to its mechanism of action IgY Max is an effective tool to address issues caused by dysbiosis. It is technology that enables manufacturers to offer new ways of featuring probiotics in their products according to Kerry. In the U.S. Quilter explained probiotics were popularized by the dairy category with more than half of all yogurt sold being fortified with probiotics.2 But novel approaches in probiotic technology are allowing manufacturers to provide probiotic options that consumers want beyond traditional formats such as dietary supplements and yogurt. Spore-forming probiotics like GanedenBC30 are much more resistant to the extremes of pH heat cold and pressure than vegetative probiotic cells making them a better fit for the fortification of everyday foods and beverages. GanedenBC30 is highly stable and offers up to three years of shelf life. It has a natural protective shell that shields it from both stomach acids as well as food-processing conditions like heat shear HTST (high temperature short time) and HPP (highpressure processing) pasteurization. This increased stability opens up new avenues of innovation because it means it can be used not just in chilled dairy products but also in applications such as non-dairy beverages frozen foods cereals baked goods better-for-you snacks and even hot drinks. He referenced some examples of products that are formulated with GanedenBC30 such as Lola Bars A range of plant protein and probiotic snack bars Rob s Brands Vegan Rob s Probiotic Cauliflower Puffs Bigelow Herb Plus Probiotic hot beverage tea that supports healthy digestion FlapJacked Probiotic and protein shake with Greek yogurt Betty Lou s Probiotic bites (nutritional bars) that support digestive health Purely Elizabeth Probiotic granola Good Spread Probiotic unsweetened peanut butter Smith agreed that probiotics have seen growth this includes a demand for combination products such as enzyme-probiotic blends so much that the company changed its name to help promote that service. As a true enzyme and probiotics manufacturer Specialty Enzymes & Probiotics concentrates on providing quality enzymes and probiotics to the various marketing companies and contract manufacturers January February 2019 Go to deerland for info about this advertiser THE QUEST FOR OPTIMAL GUT HEALTH that produce finished products for consumers Smith said. Our trademark products offer a convenient solution for these companies providing advanced formulas that are already developed. However if a company would like a custom formula our technical support team is ready to help. To keep up with demand Specialty Enzymes & Probiotics also offers enzyme blends for those concerned with gluten sensitivity. The current trend for digestive enzymes is to create condition-specific products he explained. Most notably digestive enzyme blends for dairy intolerance gluten sensitivity and overall gastrointestinal health have become a significant part of the entire digestive supplement market. For example as a result of increasing public concern about gluten sensitivity we have introduced DPP-IV enzymes blends (dipeptidyl peptidase IV). This can help those individuals with sensitivity to gluten and also protect against hidden gluten in some processed foods. Specialty Enzymes & Probiotics SEBGluten Relief is a powerful enzyme blend that includes seven different proteases. (AGA) Institute defines good digestive health as a digestive system that has appropriate nutrient absorption intestinal motility immune function and a balanced microbiota. Hewlings noted that the market for digestive health can be made even more lucrative by stepping back and taking a look at the bigger picture. According to the Natural Marketing Institute s (NMI) Nielsen s recently published report Opportunities in Digestive Health this is a U.S. 65 billion market in the United States and 37 percent of consumers consider themselves to be managing some digestive health issues. I anticipate growth in the market for digestive health supplements. Awareness of the connection between gut health and overall health is increasing. Research continues to define what constitutes a healthy Market Status As mentioned products in the digestive health field are growing in popularity being that gastrointestinal issues impact consumers across the age spectrum the market presents plenty of promise. One of the most visible and active categories digestive support products are being sought by more and more adult consumers of all ages Michini said. Digestive wellness used to be considered an issue that was either embarrassing or only a problem for older people. This has changed dramatically. Consumers understand that there are links between stress poor diet and gastric upset and they want symptomatic relief as well as long-term support for healthy digestion. According to Mintel in 2018 total retail sales in the U.S. digestive health market were expected to reach nearly 5 billion. This market grew 11.7 percent between 2013 and 2018. Further 59 percent of adults use OTC (over-the-counter) digestive health products. It behooves manufacturers to keep in mind that the American Gastroenterological Association 34 Nutrition Industry Executive microbiome. Consumers are increasingly aware of the connection between probiotics and digestive health. The result is increased in demand global sales of probiotics foods and supplements are predicted to grow to 42 billion in 2016 up 48 percent from 2011. Globally the market is expected to grow 6.8 percent every year until 2018.3 Sales of pre and probiotics are up 18 percent in 2016 compared to 2015. Food insensitivities such as gluten-intolerance and celiac disease also drive consumer demand.4 Sales of food products for gluten sensitivity are estimated to reach 14.4 billion in 2016 according to NBJ. However when compared to other international markets some argue that the U.S. has room for improvement which can occur as long as education is in place. The market for digestive health ingredients in the U.S. we believe is in early stages when compared to markets like Asia where gut health has always been very central to overall wellbeing Finderup pointed out. Western markets and the U.S. in particular have only relatively recently started to understand this idea. Continued growth in this area will require a concerted effort on the part of marketers to educate consumers in an area that can be complex. Research Some studies on digestive health may prove difficult. There are not many wellcontrolled double-blind clinical studies on digestive enzymes Smith explained. Those studies that exist tend to be anecdotal. The reality is that it is difficult to demonstrate the effect of enzymes within the gastrointestinal system without significant invasive techniques. There is some very ingenious in-vitro research. TNO Nutrition & Food Research has some excellent work with their gastrointestinal model TIM-1 that can mimic digestion ( en). For its branded products Deerland Probiotics and Enzymes invests in in-vitro and human clinical studies. In tests with its probiotic PreforPro for instance the company found significant results. In response to the growing demand for prebiotics Michini said the scientists at Deerland developed PreforPro a unique prebiotic that is not fiber or starch based is highly effective in small doses (15 mg) and does not exhibit any of the drawbacks of more commonly used prebiotics. In-vitro lab testing has shown PreforPro promotes the growth of beneficial Lactobacillus Bifidobacterium and Bacillus subtilis strains when competing with E. coli bacteria. In a randomized double-blind placebo-based clinical study 36 participants consumed 15 mg of PreforPro daily for 30 days. The results showed that PreforPro affected the microbial population in the gut substantially enhancing the growth of the beneficial bacteria Bifidobacterium animalis Lactobacillus delbrueckii and Lactobacillus lactococcus. We also observed a decrease in LDL (low-density lipoprotein) cholesterol for the total study population and especially for those with excess lipids in the blood. In addition there was a decrease in IL-4 a cytokine that signals allergic reactions indicating a decrease in systemic inflammation. Biotechnology company Gnosis is interested in a plethora of topics such as Promotion of microbiome diversity Reducing digestive discomfort Fighting opportunistic gut bacteria flora balance Improving enhancing nutrient absorption January February 2019 Go to specialtyenzymes for info about this advertiser THE QUEST FOR OPTIMAL GUT HEALTH Curbing recreational eating weight reduction The company pointed out that directly evaluating individuals with tests that help determine genetic deficiencies has seen an increase in interest among consumers. The simple recruitment for healthy and challenged populations has become much easier. The consumer is more willing to participate in evaluations Petteruti explained. The use of SNP (single nucleotide polymorphisms) testing to detect deficiencies in genetic makeup has assisted in identifying candidates and how to more precisely help them. Waitaki Biosciences who has its eye on the relationship between gut health and chronic disease including neurodegenerative disorders such as Alzheimer s and Parkinson s (known as the gut-brain axis) has noticed that GI studies have evolved over the years. In fact unexpected factors are actually being considered as useful towards a healthy digestive system. Research into gut health has moved beyond bowel function and regularity to try and gain a more in depth understanding of how the gut microbiome is intricately linked with overall health and wellbeing expressed Finderup. Even aspects such as sleep quality are being investigated as a potential benefit of gut healthy ingredients. It is important to keep in mind that manufacturers are on an ongoing hunt for the most dependable ingredients what qualifies one as such would include ease of formulation along with clear evidence of safety efficacy and quality. With the multitude of probiotic strains available manufacturers are sorting through options to choose science-backed ingredients that are well positioned and can be efficiently formulated into better for you versions of everyday foods and beverages said Quilter. The ingredients that win out are well-studied branded probiotics that easily convey a benefit-driven story that consumers can understand and trust. A strong branded functional ingredient should be backed by documented safety efficacy and quality. NIE References 1 Runestad T. Probiotics are now kings of immune health. NBJ. 2015 Sept 21-24. 2 MarketsandMarkets Probiotic Market Sept. 2017 3 Deep Dive Digestive Health 2015 The Gut Ground Zero for Good Health Engredea Monograph 4 Ducatelle R A review on prebiotics and probiotics for the control of dysbiosis present status and future perspectives. Animal. 2015 9(1) 43 48. Extra Extra Visit to read how walnuts can help play a role in gut health and in reducing colorectal cancer. FORMOREINFORMATION Deerland Probiotics and Enzymes Gnosis by Lesaffre IgY Nutrition LLC Kerry Functional Ingredients & Actives Specialty Enzymes & Probiotics Waitaki Biosciences Go to americanlaboratories for info about this advertiser 36 Nutrition Industry Executive January February 2019 Ingredient suppliers address consumers who over time will embrace many natural products and ingredients in the pursuit of cardio-metabolic wellness. By Janet Poveromo T he increasing cases of mortality rate due to cardiovascular diseases is raising the global demand for heart health products. According to the World Health Organization (WHO) 17.9 million people died from cardiovascular disease (CVD) in 2016 which accounts for 31 percent of all deaths worldwide. This makes CVD the world s No. 1 killer. According to Market Research the global heart health products market is estimated to grow more than 6.5 percent during 2016-2022. The U.S. is one of the major markets holding a major share. Sanni Raju PhD CEO and chairman with New Jersey-based Natreon Inc. said natural ingredients continue to grow in popularity in a variety of markets including heart health. As cardiovascular disease is a major cause of mortality worldwide and prescrip- tion medications have side effects many customers are looking for dietary supplements that complement their prescription medicines diet and lifestyle. Natural ingredients are no longer a feature in heart health products but a requirement. Consumers choices continue to trend toward natural non-GMO [genetically modified organism] and vegan product options. As sourcing and regulatory requirements continue to be more restrictive premium quality non-GMO organic natural ingredients standardized to key bioactive are becoming more difficult to achieve. A second observation of the heart health market is the consumers expectation for clinically studied ingredients Raju noted. In order to be successful in the heart health market these clinical studies must show benefits across a variety of January February 2019 health conditions including healthy subjects those with type 2 diabetes or diagnosed with metabolic syndrome. When it comes to cardio-metabolic wellness added Karin Hermoni PhD and head of science and nutrition at New Jerseybased Lycored today s consumers are seeking natural solutions to help support their wellness over time. The heart and metabolic health indication is saturated with different natural solutions aiming to benefit different aspects of cardio-metabolic wellness. Nowadays she continued industry and consumers alike are more inclined to embrace the notion that supporting cardiometabolic wellness is a multi-factorial practice that requires a holistic approach. While designing such solutions we need to take into account the many risk factors that Nutrition Industry Executive 37 impact this process. There is no one magic risk factor that holds the key to cardio-metabolic health and it is a lifelong journey of embracing healthy choices and active lifestyle. Supplements are exactly as their name suggests supplementing (not replacing) a healthy lifestyle to help consumers meet their wellness goals. Mark Mueller founder and chief technology officer with Wisconsin-based Botanic Innovations agreed that driving the market for heart health are natural ingredients. But more interestingly natural oils have fastgrowing consumer regulatory and scientific interest. Omega-3s from fish and plant sources such as flax chia and berry seed oils have been recognized for heart health support for decades. And the FDA [Food and Drug Administration] announced in November that it would allow producers of edible oils that contain at least 70 percent oleic acid (like high oleic sunflower seed oil) to make qualified health claims that their products contain cardiovascular benefits. Botanic Innovations house brand Immuno-Viva promotes Core (a blend of organic black cumin and black raspberry seed oils). Core is clinically demonstrated to support heart health so we use it as a prototype to create blends featuring black cumin seed oil. Heart Health Ingredients Formulators and consumers have a significant range of ingredients for heart health at their discretion. Regarding natural oils Mueller stated that a diversity of mixed botanical oils with a diversity of nutrient profiles is best. Targeting fatty acid ratios omega 3-5-69 and optimizing diverse antioxidant benefits (carotenoids vitamin Es phenols) black cumin seed oil is optimal when blended with other oils such as cranberry raspberry flax and chia seed oil. We have a patent supporting synergistic antioxidant activity with black cumin seed oil when blended with other cold-pressed seed oils. This phenomena is real. And why use one ingredient when combining them gives better benefits Many of the Botanic Innovations fruit vegetable and seed oil portfolio are appropriate for inclusion in heart support formulas. We have human clinical data for organic black cumin seed oil blends so we start 38 Nutrition Industry Executive there Mueller said. We have made these ingredients for almost 20 years and since 2009 have pressed more than 175 000 pounds of organic black cumin seeds. Berry seed oils are excellent to feature in heart support blends with black cumin seed oil as would be tomato chia or other novel oils. Headquartered in France Naturex has developed a blood flow and cardiovascular platform based on the emerging superfruit aronia. Dan Souza vice president of sales and marketing said We ve recently completed a randomized double-blinded placebo controlled human clinical trial in which we demonstrate significant improvements in blood flow (endothelial function) after chronic consumption of our full spectrum aronia powder and significant improvement in blood flow after both acute and chronic consumption of Aronox our polyphenol-rich aronia extract. These data support our previously published studies on Aronox demonstrating improvement in blood pressure cholesterol and triglycerides. Also in our recent study strong correlations were shown between aronia consumption aronia polyphenol metabolites in plasma and improvement in endothelial function. Lycored s journey in supporting cardiovascular wellness began with the flagship proprietary tomato extract Lycomato which contains a synergistic blend of tomato phytonutrients that work together to provide cardiovascular benefits. Within the last few years Lycored has launched its second-generation solution which is a cardio-optimized and strictly standardized tomato Nutrient Complex called Cardiomato. Inspired by the vast benefits lycopene the red carotenoid giving tomato its bright color and the synergy with other tomato phytonutrients such as vitamin E which contributes the protection of cells from oxidative Cardiomato was formulated to foster improved cardio-metabolic wellness over time. This proprietary patented composition is standardized to preserve and enhance the natural efficacy of tomato nutrients utilizing the patented ratio with natural phytosterols that work together synergistically to deliver a wealth of benefits. Chris Speed Norway-based NattoPharma s (with a North American subsidiary in New Jersey) senior vice president of global sales and marketing noted that vitamin K2 as MK-7 is starting to earn recognition as an essential nutrient for cardiovascular health as it is the only known compound to impact hardening of the arteries (i.e. atherosclerosis) caused by plaque building up inside the arteries. Over time plaque (primarily made up of calcium) hardens and narrows the arteries. This limits the flow of oxygen-rich blood to your organs and other parts of the body such as the heart brain arms legs and kidneys Speed explained. As a result he noted different diseases may develop based on which arteries are affected Coronary heart disease (CHD) also called coronary artery disease occurs when plaque builds up in the coronary arteries Carotid artery disease occurs when plaque builds up in the arteries on each side of your neck (the carotid arteries) Peripheral artery disease (PAD) occurs if plaque builds up in the major arteries that supply blood to the arms legs and pelvis Chronic kidney disease (CKD) can occur if plaque builds up in the renal arteries This calcification was once thought to be an age-related condition that calcification simply builds up over time. A nutritional scientist and dietician Speed added that in fact NattoPharma contends that this condition is not simply age-related rather atherosclerosis is the product of a vitamin deficiency vitamin K2. Matrix Gla Protein (MGP) is the most potent known inhibitor of vascular calcifica- January February 2019 Go to kyowa for info about this advertiser tion to date he said. MGP is a K-dependent protein already present in the body but it needs adequate vitamin K2 in order to be activated to perform its function. It is also worth noting that K2 works synergistically with other nutrients that are already used in cardiovascular health products Vitamin D3. Both bone and cardiovascular health are dictated by how the body utilizes calcium. Ideally the body will bind calcium to the bone mineral matrix making stronger denser bones. But if left unattended calcium does not make it to our bones. Rather it will deposit in arteries blood vessels and soft tissues increasing risks for developing cardiovascular diseases. Vitamin D3 synthesizes the proteins that help the body utilize calcium (i.e. osteocalcin for bone MGP for heart) while vitamin K2 activates those proteins so they perform their respective functions. Omega-3 is widely recognized as a cardio-supportive nutrient earning a qualified health claim for the reduction in risk of CHD in the U.S. and 4 EFSA (European Food Safety Authority) claims for cardiovascular health. While omega-3 s mechanism of action is linked to supporting healthy inflammation triglycerides blood pressure and promotion of arterial health it is not recognized for impacting vascular calcification which is what makes vitamin K2 a perfect complement. Focusing on omega-3s Norway-based Aker BioMarine a biotech innovator and Antarctic krill-harvesting company has been producing ingredients for essential fatty acids (EFAs) for 12 years. Aker BioMarine s flagship product Superba Krill has come a long way over the past decade and has opened the doors to many new opportunities for the company and industry alike including Superba 2 and Superba Boost noted Katrin Berntsen director of communication with the company. In addition at Wacker Biosolutions Wacker Chemie AG Munich Germany Rachela Mohr manager of business development nutraceuticals said the company offers two different food supplement types which influence the heart health of customers the nature-identical hydroxytyrosol HTEssence and CAVAQ10 a CoQ10 gamma-cyclodextrin inclusion complex. Mohr explained that the nature-identical 40 Nutrition Industry Executive hydroxytyrosol HTEssence is able to significantly reduce LDL (low density lipoprotein) and in turn lower the risk of coronary heart disease. According to a study a significant LDL-cholesterol reduction was seen after intervention with the pure synthetic hydroxytyrosol in comparison to placebo (Siefer et al. 2018 Nutritional Medicine and Diet Care). Due to its diverse modes of action hydroxytyrosol is a popular ingredient in dietary supplements. Wacker s patented process makes it possible to synthesize a nature-identical substance of much greater purity free of unwanted by-products and with a defined amount of active ingredient. Available as an odorless water-soluble powder and liquid HTEssence is suitable for use in functional foods and dietary supplements such as tablets capsules energy bars and functional beverages. factor of 18 compared to a conventional CoQ10 product. Also addressing absorption of an ingredient OmniActive offers a unique curcumin to the marketplace. Because of curcumin s inherent bioavailability challenges the company developed its UltraSOL technology to increase its absorption said Brian Appell marketing manager with OmniActive Health Technologies in New Jersey. UltraSOL is a molecular dispersion process that converts lipophilic nutrients into water-dispersible ingredients to enhance bioavailability and retention greater than standard curcumin powder and other enhanced curcumin products. The results of a study the company conducted showed that CurcuWIN has 46 times higher relative absorption than standard curcumin (Jager R et al. 2014). CurcuWIN is a potential strategy for the early prevention of CVD and its associated costs. In a study using flow mediated dilation to assess endothelial function CurcuWIN can significantly increase FMD (flow mediated dilation) in healthy subjects that may potentially reduce CVD risk by as much as 50 percent. CurcuWIN s high bioavailability and long-lasting action play a vital role in its demonstrated benefits at a low dosage and provides greater formula flexibility and consumer compliance for those looking to formulate effective curcumin formulas (Oliver J et al. 2016). Evolution of Ingredients Studies also indicate a beneficial effect of CoQ10 on heart health through different mechanisms. It assists in maintaining the normal oxidative state of LDL cholesterol helps assure circulatory health and supports optimal functioning of the heart muscle. Research has shown that CoQ10 levels are lower in patients with heart failure. Moreover CoQ10 biosynthesis decreases with age and its deficit in tissues is associated with degenerative changes appearing in the course of aging. However many products on the market cannot ensure adequate bioavailability since CoQ10 is a fat-soluble substance which is poorly absorbed. This problem has been solved with CAVAQ10 CAVAMAX the natural cyclodextrins from Wacker which permits the molecular encapsulation of substances. With the help of gamma-cyclodextrin the bioavailability of CoQ10 can be increased significantly by a A study of a specific ingredient disputed a long-held assumption. Natreon noted that amla extract has been a very popular ayurvedic product for centuries and the belief was that it is very rich in vitamin C said Raju. He said that Natreon has shown that amla fruit has very little vitamin C but it has more powerful antioxidants. The company has done clinical studies in heart health and found that its patented Capros amla extract has excellent endothelial function and lipid profile enhancement properties along with platelet aggregation inhibition activity. It also reduced HbA1c by half a point in T2DM subjects. An ischemia-reperfusion injury animal study at University of Connecticut has shown that Capros significantly mitigated the heart muscle injury caused by ischemia reperfusion. That is how Capros evolved as a heart health product Raju said. Anne Trias product director with Massachusetts-based American River Nutrition a manufacturer of annatto-derived tocotrienols (patented and trademarked as DeltaGold) which are naturally tocopherolfree said the company s expertise in tocotrienols dates back to the 1990s. That s when Dr. Barrie Tan was the first to commercially extract the ingredient from palm oil January February 2019 Go to lycored for info about this advertiser through its extraction from rice bran oil and finally the discovery of annatto as a most unique source of 100 percent tocotrienols. In that sense DeltaGold annatto tocotrienol is the newest and most innovative vitamin E product currently on the market Trias said. As we work with our brand partners to introduce novel education avenues of vitamin E the old and the new consumers are beginning to take note of the superior benefits tocotrienols have to offer Trias explained. Alpha-tocopherol is no longer the universal and only vitamin E choice to consider. Vitamin E in the form of alphatocopherol may shore up to be an antioxidant and nothing more as one researcher and vitamin E expert of the Linus Pauling Institute at Oregon State University succinctly put it. Unquestionably vitamin E is the most prevalent and important antioxidant in the lipid cell membrane and is uniquely shaped to reside within the bilayer to protect its integrity. Of the vitamin E forms tocotrienol simply does a better job being 50-fold as potent as an antioxidant compared to tocopherol. More importantly tocotrienol provides benefits that are not shared by tocopherol such as its hypocholesterolemic and significant anti-inflammatory properties. A recent clinical study also highlighted tocotrienol s benefits in reducing cardiometabolic symptoms improving Fatty Liver Index and lowering triglycerides body weight and inflammatory markers. She added One critical element is to consistently recommend tocotrienol supplementation apart from alpha-tocopherol as combining the two was repeatedly shown to interfere with tocotrienol functions and benefits. Also addressing tocotrienol ExcelVite s science-based ingredient for heart health is the EVNol SupraBio. It is a patented and bio-enhanced natural full-spectrum palm tocotrienol complex that ensures an up to 300 percent increase in absorption for each tocotrienol isoform according to Bryan See business development manager with ExcelVite in Malaysia. It is the only tocotrienol complex in the market that is clinically proven and substantiated with both bioavailability (absorption into plasma) and bioefficiency (accumulation in vital human organs) studies. As such EVNol SupraBio is 42 Nutrition Industry Executive the second generation of tocotrienol formulation with for assured bioavailability and bioefficiency. EVNol SupraBio is in a liquid form which can be directly encapsulated into a soft gel or liquid capsule dosage form. EVNolMax on the other hand See added is an enhanced delivery tocotrienol complex in powder form for manufacturers who want to develop tablets or functional food or drinks to deliver heart health benefits to consumers through a more variety of formats. At Botanic Innovations Mueller noted that botanical oils are generally consistent with their component nutrients. They have always supported heart health and other wellness benefits but we are seeing an evo- lution with growing awareness and acceptance of the wonderful benefits of botanical oils. Key supplement formulators are maximizing heart and wellness benefits by developing high performance blends of botanical oils. One oil could do a good job supporting heart health but why wouldn t we blend the oils for optimal support Proven by Science As for the science of interest to formulators Mueller said Safety first. Formulators of dietary supplements only work with ingredients that are proven safe and proven unadulterated with key labs and appropriate protocols. The scientific want list is extensive and we re working hard to ensure that our partners get what they need. Botanic Innovations has multiple patents featuring black cumin blends and our partners use these as a springboard to develop safe and effective products. As we are experiencing an increase in consumer awareness and demand for trans- parency the industry is shaping to be more clinically responsible said Hermoni. Consumers are less interested to see animal studies. Although still not yet the standard we see more companies gravitating toward full scale well-designed double blind placebo controlled studies. We also see a lot of focus on bioavailability research. Consumers and industry alike want to make sure that what we put in the supplement is in-fact well-absorbed in the body. Ingredient suppliers also noted other areas of interest. Souza noted improvements in blood flow as demonstrated by our Aronia Full Spectrum and Aronox powders allow our customers to not only position Aronia in the nearly 3 billion U.S. dietary supplement market but also into applications where improved blood flow can have a positive impact such as the growing sports nutrition cognition and skin beauty from within market. Cost effectively delivering significant improvements in endothelial function is a foundational mechanism for cardiovascular health. Endothelial dysfunction may be considered relevant for classifying subjects in terms of CVD risk. In fact recent meta-analysis has shown that a 1 percent improvement in endothelial function correlates to a 8 to 12 percent reduction in risk of CVD. Speed noted that manufacturers are interested in research and trials that will make an impact down at the store level. Namely that there is research supporting an ingredient s safety and efficacy and that that research is the basis for approved structurefunction claims that can gain attention on the shelf. When it comes to Vitamin K2 MenaQ7 is the only K2 as MK-7 that can offer that sort of support. Raju noted the pragmatic aspects. The scientific research helpful to manufacturers focus on the chemistry of the ingredient is it soluble in water Does it contribute to color taste odor Is it in powder liquid semi-solid The information needed to help manufacturers work with an ingredient more efficiently is not necessarily the same scientific research suppliers and consumers require. The best research available on an ingredient will substantiate a scientifically proven attractive and marketable claim. To achieve such a claim a supplier must invest in randomized double-blind placebo-controlled trials showing positive outcomes that will then substantiate marketing claims. Appell added Since heart health is primarily a category built on prevention assessing the benefits of nutraceuticals will depend on indices correlated to healthy cardiovascular function. These may include measuring the impact on cholesterol and or (Continued on page 50) January February 2019 2019 INDUSTRY FORECAST By James J. Gormley The Participants Are Jonathan Emord Esq. President Emord & Associates Washington D.C. Randy Kreienbrink Vice President of Marketing BI Nutraceuticals Long Beach CA Daniel Fabricant PhD President and CEO Natural Products Association (NPA) Washington D.C. Dan Lifton President Proprietary Branded Ingredients Group Maypro Purchase NY Kurt Jetta PhD Executive Chairman and Founder TABS Analytics Shelton CT Michael McGuffin American Herbal Products Association (AHPA) Silver Spring MD Mark LeDoux Chair and CEO Natural Alternatives International (NAI) Carlsbad CA Steve Mister President and CEO Council for Responsible Nutrition (CRN) Washington D.C. The Hartman Group Bellevue WA Mintel Group Chicago IL January February 2019 W ith the CBD locomotive tearing down the tracks our panel of industry leaders and experts helps sort out everything from recent FDA guidance on probiotics to tariffs on Chinese goods to mass-media confusion about recent studies. And since 2018 saw the passing of Frank Murray panelists reflect on the importance of passing the health-freedom torch to a new generation of leaders. We appreciate market data provided by TABS Analytics The Hartman Group and the Mintel Group. NIE What do you feel were the biggest natural products industry issues of 2018 and why Fabricant The Grinch that caught people off guard and has the biggest financial impact to ruin Christmas and the New Year was the tariff issue. Here is why it was so big. First the industry expected an exclusion process for List 3 which encompasses many dietary ingredients used in dietary supplements but it never came. NPA did manage to influence exclusions for two ingredients that are predominantly sourced in China. Second some in the government never thought Trump Nutrition Industry Executive 43 2019 INDUSTRY FORECAST would stick to his guns to keep the tariffs in place. Trump did not fold to China. Third there are many companies who export supplements back to China as U.S. products are preferred over Chinese-manufactured products. This results in a double hit because of the Chinese tariffs on finished consumer goods. Fourth the tariffs increase from 10 to 25 percent very soon and that will cause pain in the industry. Regulatory reform took center stage in 2018. The Trump administration tasked industry to identify regulations for change in the current code of federal regulations. NPA participated in that process and we are not finished yet. There is much left to do in regulatory reform as federal agencies have only seemed to respond to the Trump regulatory reform agenda by dumping old proposed rules that have not been pulled from dusty FDA shelves for many years. The issue that had sizzle but went out with a fizzle is CBD. Everyone has been waiting to see what Congress would do on hemp in the Farm Bill. Unfortunately any changes on CBD in Farm Bill do not affect how FDA (U.S. Food and Drug Administration) views CBD as a dietary ingredient for use in dietary supplements. If you don t know how FDA views CBD in dietary supplement products just ask them. The final big issue of 2018 centers around advocacy. How many years has it been since Tom Harkin left the Senate He was never replaced on that side of the aisle. Now we have Senator Orrin Hatch leaving. The industry has benefited greatly from advocacy and the actions of those two members. If industry does not make advocacy and lobbying a priority in 2019 we may be in for a rude awakening over the next decade. Mister The biggest issue in 2018 was this exploding interest among consumers in CBD as a dietary ingredient. Every time we go to trade shows it is the one ingredient that has the most buzz around it. Of course the problem is that currently it s not a legal ingredient. Hopefully the Farm Bill has taken care of the DEA (Drug Enforcement 44 Nutrition Industry Executive Agency) problems it will remove hemp from the definition of marijuana in the Controlled Substances Act so that solves your problem in that hemp would no longer be a controlled substance. But you have all of these other issues regarding FDA that you have to deal with. The first of which is this problem that if it was not marketed as a food or a supplement prior to the [epilepsy drug] clinical trials being conducted the statute says it can t be a supplement and it can t be a food. So we ve got to address those kinds of definitional issues with FDA so that companies can really feel safe bringing it to market. 2018 will likely be remembered as the year Congress de-criminalized hemp and CBD. Michael McGuffin McGuffin 2018 will likely be remembered as the year Congress de-criminalized hemp and CBD. This was a monumental step forward but there is much work that needs to be done. Next the industry has to tackle FDA oversight. FDA has stated that CBD is not a dietary ingredient that can be sold in dietary supplements and foods. We understand their rationale and we can dispute some of the details they ve used to reach this conclusion but there is also a clause in the law that allows the Secretary of Health and Human Services to simply declare an exemption to allow these products to be sold. AHPA has adopted a position to advocate FDA to encourage the HHS secretary to provide this exemption. This would allow the industry to discuss issues with regulators like possible label warnings dosage possible NDI (new dietary ingredient) status. It is in the interest of consumers FDA and the industry to have these products regulated and it makes sense to regulate them as dietary supplements which are defined in the law to include herbs and other botanicals. It ought to fit neatly into this class of goods. If FDA regulated these products as dietary supplements then requirements like cGMP (current good manufacturing practice) serious adverse event reporting drug claim limits all apply to these goods. It is an excellent regulatory model to fit hemp and CBD products. The 2018 mid-term elections were another big story that will impact the industry. The supplement industry has been preparing for years for the retirement of our key Senatorial champions by building relationships with incoming lawmakers and educating them and their staff about supplements and how they are regulated. Emord The biggest issue was the widespread rise of CBD state laws protecting CBD and FDA and DEA angst over how to cope with the conflicting sovereigns and the rapid rise in distribution and use. The state-federal conflicts may be even more significant for defining federalism than those that arose in the 1980s and 1990s from the sagebrush rebellion as Western states and localities battled the feds over property rights and historic rights of way over federal lands. Lifton I also think one of the hottest set of issues this past year revolved around hemp and CBD. While the Farm Bill just passed and this should make CBD marketers and growers very pleased indeed the FDA has indicated that it is deferring to a patent and IND approvals that it has granted to a British pharmaceutical company for its epilepsy drug and needless to say it does not regard CBD products as dietary supplements. However in the midst of all of this a very ill-considered FDA guidance has been issued regarding probiotics and misinformation has been reported by media regarding omega-3 science. LeDoux I believe that clearly the most important issue that transpired was the imposition of tariffs on materials that come from China. Given that China has essentially dominated the supply chain space for many commodities for a variety of reasons the impact here is substantial to the P&L of American industry using these goods. While there has been some shared pain with the economics of the tariffs it is clear that the president and the USTR (U.S. Trade Representative) have every right to January February 2019 impose these given the history of cited abuses involving theft of intellectual property and a litany of other issues raised by the USTR that raise to the undeniable fact that one of our largest trading partners has played fast and loose with the cost architecture of their raw materials. Kreienbrink Adulteration was critical as both intentional and non-intentional adulteration is a top issue. This can only be addressed with validation and testing methods. Safety was also and is also a paramount issue. Suppliers must implement validated kill steps for microbes in raw ingredients. And while CBD is trending up in every industry right now the big question moving forward is how does CBD fit into the supplement category And what are the legal issues surrounding the use of CBD Also some suggest we are seeing a stagnation of sales in the industry especially for omega-3s but others disagree. We do know that some of the sectors such as omega-3s have experienced negative press recently. How will the negative press impact future growth And we have also seen continued consolidation of the industry. NIE The natural products industry lost a modern-day icon in 2018 Frank Murray. The author of More Than One Slingshot How the Health Food Industry is Changing America (1984) and well over 50 health books Murray fought for the passage of the HosmerProxmire Vitamin Bill along with attorney Milton Bass Clinton Ray Miller NNFA (Natural Nutrition Food Association) President Max Huberman and others. What health-freedom messages do we need to pass along today to the newest generation of natural products industry leaders Fabricant Frank Murray was a legend to the natural products industry. He wrote the history of the Natural Products Association when it was called the NNFA. He chronicled the many battles fought by NPA with federal agencies over the past six decades. When you read More Than One Slingshot and I urge everyone to go read it there is one takeaway message The health of this natural products industry is predicated on having strong advocacy and the ability to challenge agencies with sound arguments when they overstep. To the new generation of the industry who were not around in those landmark fights of the 1960s through the drafting of the Dietary Supplement Health and Education Act of 1994 the old guard set the bar and made the industry viable today. Will the Millennial generation of natural products leaders study history and reinvest in advocacy Time will tell. What folks can do in the interim is engage in the process now. They can go to advocacy pac for more information and to contribute that way. They can write their Congressperson. We have oven-hot ready-to-go letters on a number of issues on The advantage here is that the letters get past email filters to reach Congressional staff. Mister It was the Proxmire Amendment that led to the creation of CRN. So that issue in particular is very near and dear to us. It was at that moment that some of the members of industry decided that they couldn t just continue to say no to all regulation and that there had to be some kind of legal framework in order for the industry to flourish. It couldn t just continue as a Wild West. And it was those companies that started CRN. The last 45 years is history. And regarding history and as we look back at those people I think it s important to remember that we are the stewards of that message today and that there are all these new threats to consumer s ability to access these kinds of products. Sometimes these threats or challenges come in the form of state attorneys general. Or maybe the FDA or maybe the state legislatures. But there are threats and we ve got to January February 2019 always be diligent. And to continue that legacy of making sure consumers have access to these products to stay healthy. Yet this is not a health care system that necessarily rewards people for staying healthy in the first place. And so we need to be sure to protect that right for consumers who want to be actively involved in their own health care before they get sick. Emord Although the United States Court of Appeals for the D.C. Circuit held in the 1999 landmark case of Pearson v. Shalala that FDA censorship of nutrient-disease relationship claims is unconstitutional under the First Amendment the FDA remains in the business of prior restraint and censorship failing to implement the constitutional mandate of that case. Complacency in the face of FDA s effective licensing regime for nutrient-disease claims maintains a chronic state of suppression denying manufacturers and consumers alike the freedom to exchange vital health information needed for informed choice in the market. Present and future generations must maintain the legal and political fight against the censorship or in the face of complacency we are likely to see FDA become even more suppressive of nutrient-disease information. Lifton While we do need to remind today s and tomorrow s industry leaders about the health-freedom battles that have been fought we need to also make sure that we don t encourage an us versus them knee-jerk response to every question about science efficacy safety and quality that emerges. By leading with science leaders will always be in a strong position. LeDoux With a new administration focused on removing some of the regulatory burdens imposed by prior administrations we need to maintain a careful watch on actions taken by various agencies. Furthermore we need to stress that advocacy remains a vital component for the simple fact that Congress and the agencies have the authority to change our landscape very quickly and often in punitive ways. We also need to continue to invest in primary research and publication of findings that bolster our point of view. NIE 2018 witnessed a number of studies and reviews that were seized on by the mainstream media as Aha moments supposed proof that specific nutrients or foods may not be as great as Americans thought they were case in Nutrition Industry Executive 45 2019 INDUSTRY FORECAST point The Vitamin D and Omega-3 Trial (VITAL) initial results for which were recently published online in The New England Journal of Medicine. But the media coverage largely missed the fact that the findings showed a 30 percent reduction in heart attacks in the fish oil group and a 40 percent reduction in people who seldomly eat fish. Is there a message here for our industry and for companies that formulate and market omega-3s Mister The VITAL Trial really underscores some important points the importance for industry to monitor these studies as they come out and then engaging with them. So for example when you peel back the first layer of headlines around the VITAL Trial you do find significant reductions in heart attack. So the industry has to engage and be critical about how these studies get reported if what s really there is being glossed over. The second thing is for the industry to get more engaged in helping to design and conduct the research. All of this being said we need to be careful that we don t let any one study distract us from the whole body of research. For example the U.S. Preventative Services Task Force has looked at vitamin D and calcium and finds real benefits for older Americans in helping to prevent falls and fractures in the first place. Fabricant The message to consumers of omega-3s and the industry is to remember totality of the evidence. One study does not negate all other studies that came before it. It is one data point. The totality of the evidence is overwhelmingly in favor of omega-3 consumption. Who eats fish on a daily basis Omega-3s should be part of WIC (Women Infants and Children). There should also be HSA (health savings account) coverage for omega-3s as there should for other supplements. LeDoux The message here is that industry involved in various segments of primary research needs to get the word out through peer review published studies demonstrating the value propositions of the underlying premise of the 46 Nutrition Industry Executive research namely that it is difficult if not impossible to achieve appropriate levels of nutrient intake through the normal American diet. If that were not the case why would be seeing the extraordinary rise in type II diabetes and morbid obesity showing up at alarming levels in our society McGuffin We always have to remain vigilant of industry critics who will stretch the truth and ignore facts to misrepresent the dietary supplement industry in order to support their agenda. Media outlets often quote these critics without providing additional context. Fortunately most consumers trust their brand so these companies are in a good position to set the record straight. Emord The elephant in the dietary supplement tent has always been the pharmaceutical industry which pokes its head in whenever a supplement shows promise as a disease risk reduction agent (for example [drug makers ] NSAIDs successfully blocking glucosamine and chondroitin sulfate osteoarthritis risk reduction claims). FDA is the pharmaceutical industry s handmaiden. That industry has tremendous suasion over the agency the Congress and the media. The dietary supplement industry must call out the misleading reports and conflicts of interest held by expert observers in the pocket of drug companies who frequently skew scientific reporting to benefit those from whom they receive support. Lifton It is hard to imagine a category that has stronger science behind it than marine oils. Omega-3s are also an area that has experienced exponential advances in harvesting processing and extraction technologies especially in the category of krill oil. The American public is a lot more savvy than the naysayers believe as they don t automatically swallow these sour pills of unwarranted skepticism. NIE And regarding guidances the FDA also came out with a guidance on probiotics what it termed its Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials. However while quantitative (or volume-based measures) for nutrients they do not work for probiotics where colony forming unit (CFU) is the scientifically accepted unit of measure for probiotics. Labeling live microbial dietary ingredients in CFUs gives consumers information regarding the levels of viable microorganisms in the product throughout its shelf life. Agreed What should be the next steps for developers or marketers of probiotics Just wait and see Lifton The problem with the Draft Guidance for Industry Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials is the new recommendation that the label has to also list the quantitative amount by weight. While it applies to other supplements weight does not correlate with the number of viable microorganisms in a probiotic supplement. It isn t even possible to accurately or reliably list both weight and CFUs for these products. The FDA should consider removing this provision before its starts exercising any enforcement discretion regarding probiotics as this would unfortunately foist an impossible burden on manufacturers and confuse consumers more just as they were beginning to get used to comparing products partly based on CFU levels. Mister CRN has been pushing the FDA for some time to revise its requirements for how you label probiotics. Because what is important to consumers is how many of these organisms are alive at the point at which they are being used because they have to be alive to work. And so we petitioned the FDA to allow us to use colony forming units as the basis of measurement. But what we got was about half of the right answer. The FDA s response allows us to put CFU on the label but it does not excuse companies from also listing the weight of the ingredient which is completely irrelevant to the consumer. Unlike vitamins and minerals and many other nutrients where you re looking for a mg serving what consumers care about when it comes to probiotics is how many live organisms are in the bottle. So we have reached back to the agency with a second round of comments trying to clarify with them that CFU should be the sole unit of measure [for probiotics]. NIE In the meantime the FDA has tentatively concluded that vinpocetine is neither a true dietary ingredient nor a true dietary supplement claiming that it is synthetically produced. In 2016 the FDA opened a comment period soliciting responses to these conclusions. On November 7 2018 an FDA press officer wrote that The FDA has not reached a final position on vinpoce- January February 2019 tine s regulatory status and we are continuing to consider the more than 800 comments received on our Federal Register notice. Any speculation about this or the larger picture of the FDA going back and questioning the status of ingredients that have been on the market for 10 15 or 20 years McGuffin AHPA recommended the Secretary of Health and Human Services consider initiating rulemaking to declare vinpocetine to be a lawful dietary ingredient in comments submitted to the FDA. AHPA also 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. AHPA contends that vinpocetine s use as food was possibly overlooked or that it could come into use as a food in the future. AHPA also noted that Congress provided the Secretary of HHS with authority to create exceptions to normal exclusions from the definition of a dietary supplement. Although this authority has not been used in the 22 years since this statutory provision was established it should be assumed that the Congress foresaw that there might be circumstances in which it would be appropriate for the Secretary HHS to undertake the described regulatory steps to create such an exception. Fabricant We met with FDA over the summer and an FDA official stated that a final position on vinpocetine would move forward in the fall. Interestingly neither the vinpocetine administrative proceeding nor the NDI final guidance showed up on the OMB OIRA Fall 2018 Unified Agenda for rules and guidance. We need Congress to place pressure on FDA to withdraw the vinpocetine administrative proceeding. It is causing confusion in the marketplace and more importantly it sets a dangerous new precedence outside of Administrative Procedures Act to allow the Agency to re-review any New Dietary Ingredient. NPA will continue to deal with the vinpocetine issue in 2019. Hopefully regulatory reform will root it out of the federal register. Emord The DSHEA (Dietary Supplement Health and Education Act of 1994) specifically contemplates synthetic analogues as within the definition of dietary supplements. In this instance as in many others FDA endeavors to chip away at the plain and intended meaning of DSHEA so that it may avoid constraints that were meant to limit its power to constrain the availability of these products. NIE What calls-to-action or general market comments do you have What predictions do you have for the natural products industry for 2019 Emord The industry should embrace a more aggressive agenda against agency efforts to take away constitutional and statutory protections that enable supplement products to be marketed and claims to be made about them. Without constant vigilance in defense of those freedoms they may well be lost. Mister We think the Supplement OWL (Online Wellness Library) dietary supplement registry is a very important piece for industry to demonstrate that we can regulate ourselves. If we don t continue to build this and demonstrate a level of transparency around our products that the OWL provides we might very well find ourselves in a situation where regulators are calling for some sort of mandatory listing process at FDA. And I think we would all rather be able to do this on a voluntary basis rather than it coming from the FDA [as a mandate]. Second we are going to see changes in the Supplement Facts labels over the next year because there s a deadline of January 2020 for those changes. And it can t be overstated that CBD will be a very big part of the environment in 2019 and trying to knock down some of these regulatory obstacles for companies so that they can lawfully January February 2019 market CBD products as supplements is going to be a big part of the year as well. McGuffin 2019 presents good opportunities to build new relationships with incoming lawmakers and work to educate their staff about the benefits of herbal products and how they are regulated in the U.S. to ensure safety and quality. Bolstered by increasing consumer confidence in natural products like herbal supplements the industry continues to build on it s reputation of being responsible. This is having many beneficial effects on the industry including increased collaboration with FDA. At several events in 2018 FDA officials recognized that the majority of the dietary supplement industry are responsible firms that share the same goals as FDA. Responsible dietary supplement firms today are looking for ways not just to comply with the law s requirements but to set higher standards for themselves and to hold the entire industry to those standards. We expect this collaboration between FDA and the supplement industry to increase in 2019 and beyond. This will ultimately benefit consumers the industry and federal regulators. Kreienbrink We need an increase in self-policing by supplement manufacturers to continue to sift out the bad characters. The 2019 market will be flat with the exception of CBD and hemp-related products. Lifton Every day consumers are showing legislators the media and manufacturers that taking dietary supplements is important to them as a nutritional insurance policy and to tackle health issues linked to age sex or activity levels. Legislators need to remember that and agencies charged with implementing the will of the American people need to remember that and to also make sure that consumers have access to more information not less regarding products and ingredients they consume for health and wellness. NIE Extra Extra Visit to read a Q&A with Kurt Jetta PhD the executive chairman and founder of TABS and lead product developer for TABS Analytics about the TABS Analytics 11th Annual Vitamin Study findings. Nutrition Industry Executive 47 FunctionalFoods Sustainable Ingredients How CPG brands are reacting to increased consumer demand for ingredients with a story. By Ryan George F rom once only appealing to a niche environmentally conscious consumer sustainability has moved beyond being a trend to a point of differentiation and a clear unique selling point. We are on the cusp of reaching a tipping point where it is mainstreaming rapidly. It is no longer a nice to have for global brands and ingredient manufacturers. It has now put simply become a license to operate. Whether its concern regarding climate change global population growth and the impact this is likely to have on food security or responsible production of agricultural raw materials with the expectation that companies source responsibly and ethically while being mindful of the impacts on the earth s natural resources. These all feed into the increasing consumer demand for greater ingredient transparency so that they can make environmentally and ethically informed purchasing decisions. The failure of food businesses to engage with consumers on sustainability has the potential to pose a severe risk to business continuity. Over the last number 48 Nutrition Industry Executive of years many prominent consumer packaged goods (CPG) companies and brands have and continue to drastically diversify their portfolios in response to consumer sentiment regarding sustainability. Several recent deals in the U.S. highlight the mainstreaming of once niche categories. Coca-Cola acquiring Honest Tea in 2015 enabled them to bolster their portfolio by adding a socially responsible health-oriented brand that carried both an organic and fair trade label that resonated with consumers. More recently the backing of plant protein producer Beyond Meat and labgrown meat startup Memphis Meats by Tyson Foods demonstrates that Big Food is coming to accept that sustainability has and will continue to disrupt markets. Unless established CPG companies and brands continue to stay ahead of the curve they face the risk of being left behind. It is no longer acceptable to blatantly disregard the present threat to the earth s planetary boundaries. In other instances not only have companies reacted but many have been proactive and taken the baton to lead from the front. If we look to the U.S. government s decision to renege on the Paris Climate Accord in 2017 it was corporate America that responded with a resounding we re still in. Large corporations with significant purchasing power and supply chain influence such as Walmart are now leading from the front in demanding more from their suppliers greater transparency challenging environmental stewardship commitments and a firm commitment from their supply chain partners to operate in a socially responsible way. The reward for doing so is that consumers now more than ever want to buy from companies and brands that are environmentally responsible and strive for fair and equitable practice within the supply chain in which they operate. Many companies in recent years have responded by publicly embracing sustainability and holding themselves to account for the impacts of their operations on the environment and society. Failure to do so could potentially lead to a lack of consumer trust and a consequential decline in sales. January February 2019 Brands That Demonstrate a Commitment to Sustainability Outperform Those That Don t Within the U.S. consumer interest in sustainable products is on the rise. According to data from Nielsen 64 percent of U.S. households buy sustainable products which is an increase of 4 percent over last year. This supports the claim from Unilever earlier this year that for the fourth consecutive year its sustainable living brands have outperformed the remainder of its portfolio. In 2017 these brands with a strong sustainability backstory delivered 70 percent of its turnover growth and grew 46 percent faster than the rest of the business. Consumers now more than ever expect the private sector to assume responsibility for their impact on the environment and society. Showing leadership on sustainability is a business imperative. Companies that fail to respond could run the risk of being singled out by activists who wish to make an example of them and with the proliferation of social media this type of modern activism can be hugely detrimental to businesses within a very short space of time. Furthermore failing to acknowledge the growth of sustainable brands could render current household brands irrelevant as they get left behind by the emerging brands that are built around purpose and have positioned sustainability front and center. largely social media consumer trust in the eco-label alone within the U.S. is low. This can in some part be attributed to the lack of regulation to back up sustainability claims. Sustainability is a broad and complex topic and label claims such as natural and grass fed have largely been left to the subjectivity of the manufacturer with no universal definition having been endorsed. It is for this reason that in Nielsen s 2017 global sustainability survey only 15 percent of Americans trusted all natural claims. It is therefore vitally important that brands determine those labels that carry the most credence with the consumer. Consumers now more than ever expect the private sector to assume responsibility for their impact on the environment Communicating Brand Sustainability Certification and Onpack Labeling Brands are increasingly seeking to capitalize on their investment in sustainability. There are several tried and tested mechanisms however the most prominent is on-pack labelling. According to Euromonitor the total market for sustainable food and beverage products in the U.S. in 2017 that carried an ethical label on-pack relating to people environment and animal welfare was estimated to be worth approximately 262.5 billion (U.S.) in 2017 rising to 267.4 billion in 2018. Despite the apparent growth of brands carrying an eco-label in the U.S. there have been criticisms in recent years that the proliferation of eco-labels on supermarket shelves has served to do the opposite of what they were intended to do in educating the consumer but rather they are now causing consumer confusion. Granted there was a place in time when consumers required mobilization to act on sustainability however as the consumer is now more informed through alternate information channels including and society. Notwithstanding the consumer skepticism concerning on-pack ecolabels ingredient-driven interest in sustainability is growing rapidly. The 2017 Kerry proprietary research report Beyond the Label The Clean Food Revolution found that clean label is multi-dimensional for consumers and it is the combination of ingredients nutrition and sustainability that equates to trust in a product. Through further analysis of consumer responses Kerry derived that consumers are particularly interested in sustainability claims such as organic and non-GMO (genetically modified organism) as well as ingredients that are ethically produced and overall focus on environmental impact including reductions in waste and packaging. This focus toward ingredient-driven growth within the market is increasing however the emphasis on no-no lists and consumers seeking to determine what ingredients don t feature detracts from the clean label attributes or sustain- January February 2019 ability backstory that might be there on those that are present. Brand Philosophy Communicated Through Marketing Given the ambiguity and confusion concerning on-pack sustainability labeling many CPG companies are now channeling marketing efforts into integrated marketing campaigns to educate customers about the efforts they are making and what their sustainability claims actually mean. The backstory is becoming vitally important consumers no longer are motivated solely by price but more so want to know the backstory of the food they are purchasing. Manufacturers must determine the values they want their brand their brand to stand for and the stories that will resonate with their target consumer. Given the broad nature of sustainability there is no one size fits all approach. Consumers are motivated to varying degrees by certain sustainability messages and this is largely dependent on their own moral standing. However through research such as Kerry s Beyond the Label we can decipher what resonates at a given point in time and this goes some way in shaping both the sustainability focus and consumer proposition of food businesses. The resulting story can then be elevated using social media and other digital platforms to deliver a more tailored message direct to the consumer. What Defined a Sustainable Ingredient Both Kerry s Beyond the Label Clean Label research and Nielsen s Product Insider determined that consumers are interested primarily in traceability sustainable agriculture and social responsibility. Ingredients with a story are becoming increasingly important with the social and environmental impact of agriculture now under more scrutiny than ever. Take palm oil as an example a crop that is highly contentious if produced unsustainably and linked to mass deforestation and consistent campaigning by environmental NGOs (non-governmental organization). Yet when produced sustainably palm oil is one of the most versatile efficient and highest yielding oil crops available. Through the Roundtable on Sustainable Palm Oil (RSPO) the industry is seeking to unite voluntarily on addressing the negative social and environmental impacts of the palm oil sector. The agrifood industry is seeking to push the Nutrition Industry Executive 49 FunctionalFoods agenda of the RSPO further and Kerry for example collaborates with supply chain partners with a firm focus on the environmental impacts however the economic and social benefits for palm producing regions and families can often be overlooked. Kerry works toward solutions that can support sustainable production and prevent further deforestation. As part of these efforts the company is undertaking a smallholder program in collaboration with partners at each level of the palm oil supply chain. The goal of the program is to support smallholders with less than 50 hectares of land to improve their yields thereby increasing production without the need for additional land and helping to improve the livelihoods of farm families. Smallholder programs similar to this are being implemented across Kerry s raw material categories as they are valuable in that they allow the organization to go deeper into the supply chain understand the regional and local challenges and provide support to those who need it most. (Continued from page 42) blood sugar levels and other physiological functions like flow mediated dilation (FMD) what we focused on in our FloMeD study. I believe that direct measures like FMD will continue to become a prominent indicator for long-term heart health. News and Trends While some ingredients remain the same a new test and a delivery method are moving the category in new directions. It s important to point out that low omega-3 levels are associated with a multitude of health issues including heart disease Berntsen said. And while we understand that omega-3s are essential for our health we can t feel a low omega-3 level just as we can t feel a high cholesterol level or high blood sugar level or even high blood pressure. But like cholesterol and glucose omega-3 levels can be measured in a 50 Nutrition Industry Executive Sustainability is a Shared Responsibility private sector government and NGOs in addressing these issues. NIE It is ingredient sourcing impact projects such as these that resonate with brands and consumers. The corporate sustainability reporting template is well worn at this stage while the information is broadly welcomed by investors it is rarely targeted at the consumer. The challenge is that when a business communicates the positive progress they ve made there is often external attention diverted to the lesser efforts made on other aspects of their business or accusations of greenwashing can be heard. In this age of consumerism it is no longer sufficient to claim to be transparent food and beverage brands must communicate the demonstrable impact they are having within their supply chains. However it is no longer sufficient to place all the responsibility on the producer as without a consumer demand there would be no need. Consumers must also foot some of the responsibility for the challenges facing our planet and support the ongoing collaborative efforts of the blood test called the Omega-3 Index. The Omega-3 Index ranges from about 3 percent to 12 percent (or more) and those with higher levels are at a lower rate for heart disease. Some experts even consider the Omega-3 Index Test the new cholesterol test. Michelle Paule director of sales with Botanic Innovations also pointed out that leading encapsulating companies who have emerging capsule technologies are changing the landscape in this category. They create deliveries to promote products that consumers prefer like dual capsules to deliver oils and powders in one capsule or capsules that time release the contents for better bioavailability. Our botanicals haven t changed but creative delivery systems and manufacturers are upping the game and helping our ingredients better impact users. Natreon s Raju predicted that new products like urolithins will be the future heart health products. Any new natural anti-diabetic products would also add to the arsenal of heart health products he said. And according to Appell Look to see more of heart health evolving in the sports nutrition market. He explained More than any other system a properly functioning cardiovascular system is critical for perform- Ryan George Regional Sustainability Communications Manager (Kerry North America) completed his studies at Queens University Belfast Trinity College Dublin and the University College of Dublin Ireland. Most recently graduating in 2017 with a first-class honors master s degree in food business sustainability with a specific focus on the business case for sustainability within the agri-food sector. He is a member of Kerry s marketing team in North America and is responsible for managing internal and external engagement on Kerry s Towards 2020 sustainability strategy and supporting Kerry s internal and external sustainability communications. ance and recovery by supporting oxygen and nutrient availability and uptake into working muscle cells and efficient removal of metabolic waste produced during exercise (eg lactic acid). It is a big reason why we did our FloMeD study with CurcuWIN and we re happy to see it had such a big impact on vasodilation which is important during performance. NIE Extra Extra Visit to learn about Wacker Biosolutions recent clinical study on HTEssence. FORMOREINFORMATION Aker BioMarine American River Nutrition Botanic Innovations ExcelVite Lycored Natreon NattoPharma Naturex OmniActive Health Technologies Wacker Biosolutions January February 2019 ThePitch Before You Hire That Razzle Dazzle PR Firm (ask these questions) By Amy Summers President Pitch Publicity PitchAmy ne of my all-time favorite Broadway scenes is in the show Chicago when Roxie Hart s lawyer preps her for the witness stand to portray her as an innocent damsel who in reality murdered her lover. The lawyer Billy Flynn said Give em the old razzle dazzle referring to the media and jury. And razzle-dazzle them he does while making a lot of money doing it for many other not-soinnocent murderesses in the Cook County jail. This is a similar scenario that many companies describe to me as their experience with hiring public relations firms. I m the first to admit PR professionals have a terrible reputation. In fact a survey from 2015 carried out by research firm Reputation Leaders interviewed more than 2 000 adults and found that 69 percent of respondents did not trust public relations while only 12 percent said they did. What s more most PR firms charge like attorneys (by the hour) which can really rack up the expenses In response my entire business model for Pitch Publicity is designed to counter a bad experience from the way we charge for services to how we deliver. Regardless I still find myself doing a lot of apologizing on the behalf of the PR industry for taking advantage of companies who have been razzle-dazzled. All that said there are some really good PR practitioners out there and some very good PR firms but in order to find them you have to do your research ask some tough questions and avoid being swept into a razzledazzle sales pitch. O First Steps When you set out to hire a PR firm the first step you need to take is to sit down with your team and clearly think through your purpose for hiring a PR professional and objectives. What is it that you need them to do that you can t do as well internally What areas do you need the most help with What are your expectations of the PR agency What type of results are you looking for them to deliver within what timeline What is the budget you are willing to spend for public relations If you do not take time for this self-assessment you are doomed. It s like going shopping for a puppy without any clear idea of what kind of dog you want. It s almost guaranteed you are going to walk out with the first one that licks your face. Once you have a clear plan in hand spread a wide net and interview more than one PR firm. It s important for you to interview at least four to five firms so you can have a fair comparison. If the product or service you are promoting is national interview firms from all over the country. If your product is only available in one or two cities then keep your search radius for firms in those specific cities. Interview firms that are known within your industry and a few that are more general in scope. You can use an RFP (request for proposal) method but I highly recommend you actually talk to the person that runs the firm and the person who is going to be your dayto-day contact as RFPs don t always tell the whole story. If the firm is large enough to have a sales team you probably won t speak to the owner or account executive initially but if you are ready to take the next step with them insist on it because the salesperson is most likely making a commission off your contract and is not going to be answering to you once January February 2019 you become a client. Even if you speak to the owner or partner of the agency who also clearly has a stake in signing your company still insist on a meeting with the account executive who will be assigned to run your campaign. That s the person at the firm who will be able to tell you if your expectations for publicity are realistic as well as if your product or service is newsworthy. In speaking to this person you will be able to see their level of enthusiasm to represent whatever it is you are expecting them to promote. If they don t seem too excited or are aloof or confused by what you are saying consider it a red flag and that you will have an uphill battle with your campaign. Before hiring an agency be sure to ask these questions How many clients do you have What is your maximum client load Insider tip Remember it s not bad to hire a small firm because sometimes you will get more attention than at a larger agency. Just make sure their client load is manageable for the amount of people they employ to execute on the campaign. What percentage of the firm works on the public relations campaign How many people will be assigned to our campaign Insider tip At larger agencies it s typical to offer marketing advertising and public relations services. Usually in these situations the PR team is the smallest at the agency but ask to make sure. If publicity is primarily what you want it may be overkill to hire a large firm if you plan on only using one of their services. Equally important is to know exactly how Nutrition Industry Executive 51 ThePitch many people will be working on your campaign at once and what their roles will be for the duration of the campaign. If all the work is being assigned to one person it may be more economical for you to hire a freelance PR practitioner to do the work. Who will deliver the interviews for my publicity campaign Will you work with key opinion leaders or spokespersons Insider tip It is another red flag if there has been no discussion of who the spokesperson will be or who will actually be conducting the media interviews. Ideally this should be sorted out before you sign a contract so you do not waste two months of the campaign trying to find the right key opinion leaders to deliver the message you are trying to communicate to the public. Do you offer any personal guarantees on your service What s the average amount of exposure you typically secure each month for a company in our industry What happens if we get no media exposure during the campaign Insider tip When it comes to earned media no one can guarantee exposure especially specific exposure as PR practitioners are at the mercy of journalists to accept or reject a pitch. However if the agency is successful in gaining earned media exposure for their clients they should have a general idea of how much exposure to expect on a similar industry campaign and also have a plan in place to revamp the campaign if what they are pitching is not resulting in media exposure. Tell me about a publicity campaign you executed that did not gain very much media and how did you turn it around or make good on it for the client Insider tip Counter the PR big game talk by asking them to tell you about a campaign they struggled with and how they turned it around for the client. Very similar to a strength weakness standard interview question this will tell you how they overcome adversity in pitching. Every good PR practitioner has struggled with at least one campaign in his or her career. If they haven t it is also a red flag that they haven t been pitching for long. How do you charge What are the miscellaneous fees I can expect Are there any hidden charges that you can disclose Insider tip The three most popular ways PR agencies charge for services includes retainer pay-for-play and pre-packaged all-inclusive project fees. All methods have their advantages and disadvantages for both the client and the agency but understanding why the agency uses a certain form of billing will help you understand their business model and shed light on how day-to-day interaction will look like with the client. If the price seems too 52 Nutrition Industry Executive good to be true ask probing questions such as how much do they typically charge for miscellaneous fees each month and what are examples of those fees. Also ask for full disclosure on hidden charges or markups that can sometimes be padded in the expense of outside vendors contractors and spokespersons. Many times it s worth paying the upcharge so you don t have to handle these details but not knowing what those upcharges are upfront is dishonest and a foreshadowing of how they treat clients. There are many more questions that should be asked of a PR agency before you commit but these questions are great to start with and will let the agency know that you know enough about the service to not be razzledazzled with pie-in-the-sky promises or wining and dining. In the second half of Act II from Chicago there is a disheartening scene when Roxie Hart is alone in her jail cell crying out to her lawyer Mr. Flynn for help but he s already moved on to another more exciting client. Roxie s cellmate Velma Kelly turns to her and says How does it feel kid Pretty soon we couldn t find your name in the papers. Don t be like Roxie Hart and lose faith with publicity and public relations if you ve been razzle-dazzled. There are good PR firms out there but like any good relationship in your life it takes time to find the right person or team to match your goals and expectations. Most importantly when you find the right PR firm that is getting you results hold on to them and be wary of moving on to the latest razzle-dazzle firm that may only last for one act. NIE Amy Summers launched Pitch Publicity in 2003 in the face of a rapidly changing climate for communication and media relations. She has 20 years of experience working with major clients in the natural products industry to increase visibility and exposure to targeted audiences through national publicity exposure across all mass media outlets high-level fundraising campaigns and developing key strategic communication strategies. She serves on the board of directors of the University of Florida Alumni Association and the University of Florida College of Journalism and Communications Public Relations Advisory Council. Pitch Publicity is based in New York City. Receive free daily pitch tips from The Pitch with Amy Summers flash briefing on Amazon s Alexa Google Play iTunes and Podbean ThePitch. For more information visit January February 2019 Equipment&Packaging NJM Introduces Model 403 Final Touch Print & Apply Labeler Canada-based NJM a ProMach (Kentucky) product brand introduces the Model 403 Final Touch Print & Apply Labeler. The 403 features a modular design flexible PLC controls and a variety of optional label applicator tools to maximize production versatility and ease use when labeling cases and shrink-wrapped bundles. The Model 403 Final Touch Print & Apply Labeler is ideal for product manufacturers and contract packers handling foods beverages cosmetics personal care products household chemicals pharmaceuticals nutraceuticals and more. For more information visit or Double Production Speed With Automated Cotton Inserter Nutritional product manufacturer Lifeplus (Arkansas) has more than doubled the speed of its filling line and cut labor costs in half by replacing its cotton inserter with the automated Pharmafill CS10 cotton inserter from New Jersey-based Deitz Company. Increasing the line speed from 40 bottles per minute to 90 bottles per minute the new CS10 cottoner allows Lifeplus to capitalize on the high speed of its tablet counter filler and accommodate projected growth rates while eliminating the need for costly overtime and returning production to a single shift. With the CS10 we instantly cut our labor costs on the tablet line in half and more than doubled our speed with the same number of workers said David Burrus plant manager for Lifeplus. The Pharmafill CS10 automatically separates cotton from a continuous roll into individual pieces up to 9 in. long shapes them into an inverted U and inserts them into the center of solid dosage bottles with 100 percent accuracy. Featuring dual filling heads the cottoning machine inserts the cotton into two bottles at the same time for twice the speed of machines using a single filling head. For more information visit Flexible Screw Conveyor Quick-Ship Program Flexible screw conveyors in popular sizes are now available for shipment in two-to-five days as readyto-assemble packages with Pennsylvania-based Flexicon s Quick-Ship Program the company announced. Conveyor tubes and screws offered through the program are supplied in any length from 10 to 40 ft. (3 to 12 m) in diameters from 2.625 to 4.5 in. (67 to 115 mm) OD. Also included as standard are a stainless steel floor hopper 45 or 90 degree discharge adapter TEFC or wash-down duty motor and UL Listed NEMA 4 control panel. All product contact surfaces are of stainless steel with the exception of the polymer conveyor tube. Non-product contact surfaces are of carbon steel construction with durable industrial finish. The conveyors can transport a broad range of bulk materials from large pellets to sub-micron powders including friable products abrasives and materials prone to pack cake bind or smear with no separation of blends. For more information visit Witte Company Celebrates 80th Anniversary Richard Witte founder of The Witte Co. tests his pioneering vibrating process equipment. The fourth-generation familyowned company he founded in 1938 is celebrating its 80th anniversary. Process equipment manufacturer The Witte Co. (New Jersey) celebrated its 80th anniversary as a pioneer in the development of vibratory fluid bed dryers coolers classifiers screeners and other machinery. Founded by Richard Witte in New York in 1938 to meet demand for dependable material handling machinery the company developed proprietary vibration technology for conveying and screening quickly earning a reputation for skilled engineering and responsive customer service. Soon after under the direction of Eugene Witte the family-owned and operated company introduced the concept of vibratory fluid bed drying and cooling that continues to form the foundation of every vibrating fluidized bed dryer or cooler manufactured to this day. As the plastics industry grew in the 1960s Witte realized there was an immediate need for machinery to classify plastic pellets by size and shape. This prompted the launch of the Witte 200 Series. Today this Witte signature design has become the preeminent solution for drying and cooling fine powders that cannot be efficiently processed by conventional fluid bed systems. For more information visit January February 2019 Nutrition Industry Executive 53 Equipment&Packaging On-demand Color RFID Label Printer Primera Technology Inc. (Minnesota) s RX500 is the world s only full-color RFID (radio frequency identification) on-demand RFID label and tag printer according to the company. Labels are encoded verified and printed in a single pass. Finished labels are then cut with the internal guillotine-style cutter and dispensed one at a time. On-demand printing makes the printer ideal for applications such as visitor or trade show badges where just a single label at a time with unique information is required. Batches of many labels or tags at a time can also be encoded and printed. The built-in UHF RFID reader encoder module is supplied by New Jersey-based Honeywell. It is compliant with EPC Global Gen 2 Class 1 and ISO 18000 b and c specifications for the widest range of deployments in real-world applications. For more information visit Conventions&Meetings Industry-wide Dietary Supplements Regulatory Summit T he five major trade associations of the dietary supplement industry announced that registration is open for the Dietary Supplements Regulatory Summit (DSRS) taking place Tuesday May 14 2019 at the historic Mayflower Hotel in Washington D.C. The DSRS is a collaboration between the American Herbal Products Association (AHPA) the Consumer Healthcare Products Association (CHPA) the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA). The one-day regulatory summit will feature updates and insights from U.S. Food and Drug Administration (FDA) officials including Steven Tave director of the agency s Office of Dietary Supplement Programs and industry experts with a focus on compliance. A reception will follow the summit. As the dietary supplement industry marks the 25th anniversary of the Dietary Supplement Health and Education Act (DSHEA) in 2019 it has become a mainstream contributor to Americans health and wellness. More than 170 million Americans take dietary supplements every year now 75 percent of the adult population. FDA too has evolved striving to meet the challenges of a global supply chain and stay apace with scientific innovation. The summit now in its fourth year brings together FDA and industry to continue to build on this growth and provide a venue to share concerns collectively learn from one another and foster the consumer confidence-boosting synergy that thrives when responsible industry and regulators work together. The DSRS is an industry-wide event designed specifically for manufacturers marketers and regulators of dietary supplements in the regulatory and quality disciplines. Discounted registration is available to members of AHPA CHPA CRN NPA and UNPA but membership is not required to attend. For details and registration visit Don t miss a single issue of NIE in 2019 go online to renew your free subscription today JanFeb19 54 Nutrition Industry Executive January February 2019 Advertiser Index American Laboratories Inc. 36 (402) 339-2494 americanlaboratories Balchem 5 (845) 326-5600 balchem Bergstrom Nutrition 3 (360) 693-1883 bergstrom Bio-Cat 31 (877) 912-4622 biocat Certified Nutraceuticals 1 (951) 600-3899 certifiednutraceuticals Deerland Probiotics & Enzymes 33 (800) 697-8179 deerland GCI Nutrients 7 (650) 697-4700 gcinutrients Kyowa Hakko USA 39 (212) 319-5353 kyowa LycoRed Corp. 41 (877) 592-6733 lycored Olcott Plastics C4 (630) 584-0555 olcott PLT Health Solutions C3 (973) 984-0900 plt Sabinsa Corporation C2 (732) 777-1111 sabinsa Soma Labs Inc. 28 (732) 271-3444 somalabs Specialty Enzymes & Probiotics 35 (909) 613-1660 specialtyenzymes Industry Events February 5-7 West Pack Anaheim Convention Center Anaheim CA March 5-9 Natural Products Expo West Anaheim Hilton & Marriott Anaheim Convention Center Anaheim CA April 9-10 SupplySide East Meadowlands Exposition Center Secaucus NJ May 7-9 Vitafoods Europe 2019 Palexpo Geneva Switzerland October 15-19 SupplySide West Mandalay Bay Convention Center Las Vegas NV Join VRM Media s FAMILY OF PUBLICATIONS Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF Barry Young at (732) 432-9600 ext. 103 or e-Mail Barry January February 2019 Nutrition Industry Executive 55 SupplieroftheMonth Valensa International Umasudhan P. CEO President and 2751 Nutra Ln. Eustis FL 32726 Phone (877) 876-887 (352) 357-2004 Headquartered near Orlando FL Valensa International is a leading nutraceutical provider of science-based intellectual property-protected Valensa International ingredients proven to benefit human health and wellness. With more than 60 U.S. and international patents for formulations and manufacturing Valensa continues to innovate in four areas men s prostate health joint health immunity and healthy aging. Founded in 1999 Valensa International is a wholly owned subsidiary of EID Parry and produces the following flagship products marketed under the brands USPlus Saw Palmetto Extract Zanthin Natural Astaxanthin FlexPro MD Flex Pro ES Joint Health Formulation Eye Pro MD Immunum Parry Organic Spirulina Phycocyanin and Organic Chlorella. Umasudhan P. has dedicated himself to the world of nutraceuticals and functional foods for the past two decades. He is currently the CEO president and board member of Valensa International. Umasudhan has been part of the leadership team to keep Valensa on a fast growth trajectory as an indication-specific health solution company focused on three main strategic value pillars microalgae greens joint health and men s health. Before joining Valensa he was part of the management team at Parry Nutraceuticals building a global microalgae business through branded ingredients like Parry Organic Spirulina and also developed strategic alliances into new business categories like natural carotenoids. Umasudhan has a bachelor of engineering in agriculture master s in international business leadership program - Universitas 21 Harvard Manage Mentor certification executive MBA - University of Central Florida and Wharton Business School finance and accounting program certification. Board Member of NIE What is the Florida GEMS program How is it helping the saw palmetto supply chain Umasudhan Valensa International a global leader in saw palmetto harvest and extraction initiated its Florida GEMS program to ensure traceability sustainability purity and responsibility throughout the saw palmetto value chain. Strong published science shows that only a standardized saw palmetto extract at a dose of 320 mg effectively supports prostate health and normal urinary flow. However not all products or ingredients labeled saw palmetto are alike and forces including unlicensed berry poaching product adulteration untested extraction methods and the trade of unsubstantiated crushed (unripe) saw palmetto berry powder threatens sustainability. Our vision is to offer the highest quality and pure saw palmetto extract in the hands of the global consumer. NIE Valensa s saw palmetto extract has been recognized as Fresh From Florida by the Florida department of Agriculture and Consumer Services. What does this mean for the company and its customers Umasudhan The Fresh From Florida status is a mark of authenticity which recognizes that saw palmetto 56 Nutrition Industry Executive berries are a sustainable renewable crop harvested in Florida. Valensa employs licensed responsible harvesters of saw palmetto berries providing income and employment on farms and ranches in Florida during the critical summer months. Saw palmetto berries used in USPlus Saw Palmetto extracts are grown within 200 miles of Valensa s CO2 ultrahigh pressure extraction facility. Saw palmetto is not found in any other part of the world except the Southeast United States. The extracts sourced from other parts of the world are likely not truly saw palmetto but rather adulterated material as shown in different tests and published reports. The Fresh From Florida logo provides Valensa customers further confidence their saw palmetto is from the Florida geographic region. NIE In 2018 the company announced its expansion into the microalgae markets. What steps is the company taking Umasudhan Valensa and its sister company Parry Nutraceuticals recognizes the health benefits derived from sustainable vegan and bioactive microalgae for functional foods beverages and dietary supplements. Our commitment to quality and purity is second to none with certificates affirming Organic (USDA and E.U.) USP Verified Organic Spirulina non-GMO (genetically modi- fied organism) verified and tested for toxins heavy metals etc. Currently offering Zanthin Natural Astaxanthin for joint and eye health Parry Organic Spirulina Organic Chlorella Euglena for immune health (Immunum) and proprietary phycocyanin-based formulations Valensa believes that as the global population increases demand for sustainable healthy ingredients will likewise rise. As such microalgae will always be featured prominently in our product lines. NIE Research and development is obviously important to the company. Please discuss Valensa s commitment to R&D. Umasudhan Valensa continues to lead with science and research. We ve recently added a new chief science officer Margaret Dohnalek PhD who brings expertise from PepsiCo. We ve always provided science-backed focused research for the ingredients and blends we supply. This year alone we concluded several study areas including prostate and urinary health on its USPlus Saw Palmetto extract on Zanthin Natural Astaxanthin s strong antioxidant property which was published recently by Clemson University. Valensa is also publishing another human RCT done on its Flex Pro MD formulation to provide an effective alternative to glucosamine and chondroitin in the joint health space. January February 2019 Go to plt for info about this advertiser Go to olcott for info about this advertiser