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Description: In This Issue: Investing in Natural Defenses, Compliance & Contract Manufacturing, Contract Manufacturing, and Antioxidants

SU S BO PPL EE OT YS US H IDE AT Q W A VRM Media Publication Q1 ES 13 T September 2016 Go to sabinsa for info about this advertiser Go to nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 21 NO. 7 SEPTEMBER2016 F E A T U R E S 41 Without a Trace Not if the natural products industry has anything to say. Manufacturers and experts silence the critics by taking ownership of all facets of compliance and traceability. 50 Under Contract When considering new products or relaunches contract manufacturers help guide brand marketers to success. 54 A L S O I N S I D E 54 Investing in Natural Defenses With immune response in a constant state of adaption consumers interest in long-term natural approaches to health holds open the door for growth in this strong category. C O L U M N S 4 First Word 6 Legalities 60 Marketing Innovation 62 Functional Foods 12 20 22 36 38 40 64 65 69 71 71 72 62 Industry News Special Report Ingredient News AHPA Update Association News Science Update Conventions & Meetings SupplySide West Booth Preview Equipment & Packaging Advertiser Index Industry Events Supplier of the Month FREE Subscription (Print Digital or BOTH) & E-newsletter Available Copyright 2016. Nutrition Industry Executive (ISSN 2331-2602) Volume 21 Number 7 September 2016. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 4329288. 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 September 2016 Go to plt for info about this advertiser FirstWord Getting Social hen CRN informed me recently that they had attended this year s BlogHer conference (see news item on page 18) I admit my first thought was Why Show organizers say BlogHer is the largest annual celebration of women online content creators social media influencers and brand executives. The conference series started in 2005 as a community-building and education platform for the up-and-coming female blogger community and has since grown to host 3 000-plus attendees. This year the conference took place in Los Angeles CA on August 4-6 2016--the keynote speaker was Kim Kardashian West--who better I have heard about the conference and am definitely intrigued and after giving it some thought I realized CRN s interest in the event makes perfect sense. According to Statista there are more than 2.3 billion social media users all over the world who are active on networks such as Facebook Instagram Pinterest Twitter We Heart It and many more. Facebook is No. 1 with more than 1 590 million active users. Social media opinion leaders i.e. bloggers have credibility within the community of their specific field. A message from them in favor of a brand or ingredient if it s in their field of expertise can generate an intense interest within their followers who share their interest centers and trust the opinions of these influencers. According to marketing software company Augere constructing an influence strategy means weaving together sustained relationships with influencers. It s nothing magical the company stated it s a project that requires consistency invested time dedication and evaluation. CRN Senior Vice President Communications Judy Blatman explained that the council recognized the impor- W tance of the natural product industry developing these relationships several years ago and recently decided to re-start an inititative. During the conference attendees also asked CRN why they were exhibiting Blatman admitted during a phone conversation with me. But as a leading trade association for our industry it is imperative that we stay current with communications trends and adapt best practices Blatman explained. She said CRN wants to become lifestyle bloggers go-to trusted source for all questions related to dietary supplements and natural health. At the event the council s entourage included wellness ambassadors Patricia Bannan RDN nutrition consultant and author (Eat Right When Time is Tight) Holly Lucille ND RN expert in integrative medicine and TV radio talk show host Elizabeth Shaw RDN healthy living blogger (Shaw s Simple Swaps) and freelance nutrition writer Vandana Sheth RDN nutrition specialist with expertise for vegetarians and people with food allergies and Marie Spano RD sports dietitian and certified strength and conditioning specialist. While there CRN hosted a luncheon which featured a special presentation on the role of vitamins and other dietary supplements in living healthier lives by the non-profit Vitamin Angels Founder and President Howard Schiffer. Panelists included Wendy Bazilian DrPH RD educator author (Eat Clean Stay Lean) and journalist and Felice Gersh MD OB GYN and integrative medicine specialist and international speaker on women s health issues. The panel was be moderated by CRN s Duffy MacKay ND senior vice president of scientific and regulatory affairs. So while promoting a specific brand or ingredient to a popular blogger is obviously an important goal so to is working to enhance overall trust and credibility of the natural products industry through all media channels. Publisher Daniel McSweeney Editorial Director DanM Associate Russ Fields Publisher RussF Advertising Gary Pfaff Sales Manager GaryP Editor-in-Chief Janet Poveromo JanetP Managing Editor Shari Barbanel ShariB Associate Editor Nicholas Saraceno NicoS Contributing Writers David Biderman James Gormley Ronald McIntire Todd Pauli Ronie Schmelz Lisa Schofield Amanda Villalobos Art Director Robert Certo Production Manager RobertC Production Assistant Bryan Zak Graphic Designer BryanZ Circulation Manager Rosie Brodsky Rosie A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info Website VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and Fitness Trainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues See the Table of Contents page for price and ordering information. Connect With Us vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive September 2016 Go to jiaherb for info about this advertiser Legalities By David Biderman and Ronald McIntire Perkins Coie LLP M anufacturers continue to face claims that their product labeling is misleading due to slack fill. Extensive federal regulations govern this area as do additional state regulations and these regulations are both enforced by attorneys general and utilized by class-action plaintiffs attorneys. In addition a broader alternative theory of recovery--that packaging misleads reasonable consumers --has been invoked to expand consumer class actions beyond traditional slack fill claims. A recent federal court of appeal case however has severely curtailed the reasonable consumer doctrine. tions and lawsuits. Federal Regulation Non-functional slack fill is primarily governed by federal regulation 21 CFR 100.100 which provides that a product is deemed misbranded if its packaging is so made formed or filled as to be misleading. A container that does not allow the consumer to fully view its contents may also be considered to be misleading if it contains nonfunctional slack fill. If slack fill exists for any of the following reasons however it is considered functional and thus not misleading 1. Protection of the package s contents 2. Requirements of the machines used for enclosing the contents in the packages 3. Unavoidable product settling 4. The need for the package to perform a specific function that is inherent to the nature of the food and clearly communicated to consumers 5. Food that is packaged in a reusable container that is part of the presentation of the food and has independent and significant value (such as a gift product) or 6. Inability to increase level of fill or reduce the size of the package (e.g. where a larger package is necessary to accommodate required labels) 21 CFR 100.100(a). Slack fill that does not meet one of the criteria is potentially actionable. California Regulations As an example of state regulations California has its own set of standards governing non-functional slack fill which are collectively known as the California Fair Packaging and Labeling Act (CFPLA). One section of the California Business and Professions Code governs slack fill in food products while the other governs slack fill in the packaging of all other products. The section governing food products contains exceptions that mirror those in the federal regulation outlined above with one exception the California regulation generally defines non-functional slack fill as empty space in a package that is filled to substantially less than its capacity. Cal. Bus. & Prof. Code 12606.2. The federal regulation does not quantify slack fill in any way making the federal regulation potentially broader in application (i.e. it could apply to any amount of slack fill). September 2016 Slack Fill Slack fill refers to the empty space in packages between the contents and the packaging itself like the space at the top of potato chip bags or pill bottles. There are two types of slack fill functional and non-functional. Functional slack fill as its name suggests serves a purpose often to protect the food or other material inside the package. Non-functional slack fill on the other hand may be deemed misleading and has been the basis for many recent state and federal regula6 Nutrition Industry Executive Go to dpl-us for info about this advertiser Legalities The California statute relating to products other than food begins by forbidding false bottoms sidewalls and lids in containers that exist wholly or partially ... to facilitate the perpetration of deception or fraud. Cal. Bus. & Prof. Code 12606(a). This section has provisions similar to the six exceptions in the federal regulation governing slack fill but also adds eight more. Several of these exceptions such as one governing computer software are irrelevant to this audience but several may be applicable to the supplement and health industries. In these exceptions non-functional slack fill is defined as empty space in a package that is filled to substantially less than its capacity for reasons other than 1. The presence of headspace in a container to facilitate the mixing adding shaking or dispensing of liquids or powders by the consumer 2. A product delivery or dosing device in the exterior packaging either visible to the consumer or accompanied by a clear depiction of the device 3. The exterior packaging of the product is routinely displayed using tester units so consumers can see the actual container or a depiction thereof prior to purchase Cal. Bus. & Prof. Code 12606(b)(9) (10) (12). Companies selling products in California must be aware of these additional restrictions placed on packaging of non-food products. It is important to note too that some of the California regulations were recently held to be expressly preempted by the Federal Meat Inspection Act and the Poultry Products Inspection Act in a case involving pre-cooked packaged meat. See Del Real LLC v. Harris 966 F. Supp. 2d 1047 (E.D. Cal. 2013). Courts have yet to rule on whether the CFPLA is preempted by federal laws involving other types of foods. Enforcement and Litigation Traditionally lawsuits regarding nonfunctional slack fill have been filed by state attorneys general and local district attorneys with assistance from county officials identifying alleged weights and measures violations in various products. As with other types of food litigation California is a hotbed of such slack fill litigation. Local district attorneys throughout California have been particularly aggressive in bringing suit against companies violating the state s slack fill regulations. According to one source 27 cases have been settled by district attorneys and the attorney general s office over the last six years alone. Laura Northrup Slack Fill The Grocery Shrink Ray s Sneakier Twin The Consumerist (Sept. 28 2015) available at https 2015 09 28 sl ack-fill-the-grocery-shrink-rays-sneakiertwin . In the last few years however lawsuits filed by government officials have been eclipsed by a wave of plaintiff-led class action lawsuits targeting nonfunctional slack fill. Consumer class action lawsuits have targeted nonfunctional slack fill in products such as canned tuna pepper tins protein powders rice cookies and chocolate. For example a recent class action complaint filed in the Northern District of California against Mondelez International Inc. attacks the amount of September 2016 Go to comar for info about this advertiser 8 Nutrition Industry Executive Go to gencor for info about this advertiser Legalities slack fill in Go Paks of Nabisco brand cookies. The complaint alleges that the packaging of the Go Paks leads the reasonable consumer to believe that he or she is purchasing a container full of the advertised cookies when in reality the containers are uniformly underfilled by 25 percent or more. Complaint at 2 Bush v. Mondelez Int l Inc. et al. Case No. 3 16-cv-02460-JCS (N.D. Cal. May 5 2016). The complaint alleges that the slack fill is nonfunctional and therefore misleading to consumers and alleges violations of California s Unfair Competition Law Consumer Legal Remedies Act and False Advertising Law as well as breach of implied warranty unjust enrichment negligent misrepresentation and fraud. Id. at 3. Other recent cases include one in the Central District of California alleging that a grocery store chain s tuna cans are under-filled and substantially underweight a large multidistrict litigation challenging alleged under-filling of pepper tins by 25 percent and an action in the Southern District of New York alleging that containers of drinking chocolate misleadingly contain 46 percent nonfunctional slack fill. Generally plaintiffs assert two theories in bringing these lawsuits One there is an excessive amount of nonfunctional slack fill in the product packaging thus violating the federal or state regulatory regime or two while there may not be so much nonfunctional slack fill that it violates state or federal regulations a product nonetheless fails to meet the expectations of a reasonable consumer of the product. See Michelle Gillette & Josh Foust Ninth Circuit Refuses to Cut Plaintiff Slack in Ebner v. Fresh Inc. Retailer & Consumer Products Law Observer (May 12 2016) available at 2016 05 ninthcircuit-refuses-to-cut-plaintiff-slack-inebner-v-fresh-inc . The latter theory is particularly problematic for producers since consumer expectations are vague and variable. Recently it seems the legal landscape surrounding the reasonable consumer test may be changing in favor of producers. In March 2016 the Ninth Circuit decided Ebner v. Fresh Inc. which relied on a new formulation of the reasonable consumer test. Ebner was a consumer class action lawsuit alleging that cosmetics manufacturer Fresh Inc. falsely advertised its popular 10 Nutrition Industry Executive Sugar lip balm line. The lawsuit alleged that up to 25 percent of the lip balm in Sugar s metal tubes was unreachable due to the construction of the containers and that the lip balm s packaging and weight misleadingly led consumer to believe they were getting more lip balm than they could actually access. See Ebner v. Fresh Inc. 818 F.3d 799 802 (9th Cir. 2016). Recently it seems the legal landscape surrounding the reasonable consumer test may be changing in favor of producers. The Central District of California dismissed the complaint for failure to state a claim. The Ninth Circuit affirmed relying in part on its interpretation of the reasonable consumer standard. The Court found that Ebner could not plausibly allege that the omission of supplemental disclosures about product weight rendered Sugar s label false or misleading to the reasonable consumer. Id. at 806. The reasonable consumer test requires a plaintiff to prove the probability that a significant portion of general or targeted consumers could be reasonably misled. Id. For the first time the court found that this test could rely on whether packaging of the type challenged was commonplace in the market. Id. Since lip balm containers shaped like tubes with a screw mechanism to make the product rise to the top of the tube are commonplace in the market a reasonable consumer would know when she purchased the product that not all of the product would be reachable or that she would have to go to extra effort to extract the last of the product. Id. With that in mind a reasonable consumer would not expect to be able to use all of the lip balm in Sugar s containers despite the packaging and thus the packaging was not misleading. Id. Though this is not technically a case involving slack fill commentators are already positing that this new formulation of the reasonable consumer test could likely affect consumer class actions attacking nonfunctional slack fill. See Rick L. Shackelford & Daniell K. Newman Why Food Companies May See More Slack-Fill Class Actions Law 360 (April 12 2016) available at articles 783074 whyfood-companies-may-see-more-slackfill-class-actions. Conclusion It is not hard to see how Ebner could change the landscape in the food and supplement space. If a certain type of food or supplement is uniformly packaged the same way across the industry such as tuna cans or protein powders a company could reasonably argue that dismissal of reasonable consumer claims is warranted since reasonable consumers would come to expect there to be a certain amount of slack fill in containers of that type. This would narrow the scope of claims against manufacturers and lead to more predictability in making packaging determinations and litigating class actions. NIE David Biderman heads Perkins Coie s Food Litigation Group which defends food manufacturers in class actions related to nutrition and labeling throughout the country and publishes a bi-weekly food litigation newsletter Food Litigation News. He is also a member of the firm s Class Action Defense practice. David was lead counsel in Turek v. General Mills a Judge Posner decision which was the first federal appellate decision to address the scope of the NLEA preemption provisions. Ronald McIntire is a partner at Perkins Coie in the Food Litigation Group and Los Angeles Office Managing Partner. He focuses his practice on product liability as well commercial and real estate litigation and environmental litigation. September 2016 Go to alkemistlabs for info about this advertiser IndustryNews NPA Requests Extension Period for Commenting on NDI Notifications Guidance T he Natural Products Association (NPA) submitted a formal request to the U.S. Food and Drug Administration (FDA) for an extension of the comment period by 30 days regarding the opportunity for stakeholder comment on the newly released guidance re-draft for New Dietary Ingredient Notifications. Having been last updated in 2011 these changes were a long time coming and given the importance of these issues to the industry we believe additional time is needed to allow for sufficient stakeholder response said NPA CEO Dr. Daniel Fabricant. We still have concerns in this redraft which we will address during the comment period and we found inconsistencies and errors in the guidance. NPA believes that no harm will result from FDA extending the comment period due to the interest significance and complexities generated by the topics included in this re-draft Fabricant added. NPA looks forward to working with its member companies to engage this important public notice and comment period to make changes in helping to bring novel innovative dietary ingredients to the market safely. For more information visit Arnica Bulletin Released by Botanical Adulterants Program he ABC-AHP-NCNPR Botanical Adulterants Program announces the publication of a new Botanical Adulterants Bulletin (BAB) on arnica (Arnica montana). Arnica extract is a popular ingredient in topical gels and ointments for the relief of bruises sprains and localized muscular pain and is also widely used in cosmetic preparations. According to data from the market research firm SPINS sales in all channels (excluding sales in Walmart Whole Foods club and dollar stores) of topical arnica products sold predominantly as homeopathic remedies exceeded 20 million in 2015. Research has shown that some of the raw botanical materials labeled as Arnica montana contain so-called false arnica (Heterotheca inuloides) also known as Mexican arnica or other yellow-flowering species from the family Asteraceae. The new Bulletin coauthored by Wendy Applequist PhD associate curator at the William L. T Brown Center at the Missouri Botanical Garden and Stefan Gafner PhD chief science officer of the American Botanical Council (ABC) provides information on the cultivation harvest and market importance of arnica. It also lists the known adulterants potential therapeutic and or safety issues with the adulterating species and analytical approaches to detect adulterants. Thirteen expert peer reviewers have provided input on the Arnica Bulletin. Arnica is a widely used ingredient in topical products in the United States and internationally including in the homeopathic medicine industry said Mark Blumenthal founder and executive director of ABC and director of the ABC-AHP-NCNPR Botanical Adulterants Program. Our research suggests that it is possible that a considerable amount of the arnica being used in some of these products may be adulterated with a totally different species. We hope that industry members will heed this Bulletin and double- and triple-check their incoming arnica raw materials to ensure that they are purchasing the authentic arnica plant. Gafner who is also technical director of the Botanical Adulterants Program explained The occurrence of arnica adulteration with Heterotheca inuloides has been known for over half a century and is readily detected by macroscopic microscopic chemical and or DNA analysis. Nevertheless reports as recent as 2012 show that arnica adulteration is still quite common in the marketplace. Some of this may be due to the use of the common name arnica for a number of different plant species particularly in Spanish-speaking communities. However the comparatively high price for the authentic arnica raw material has also provided an incentive for economically motivated adulteration. For more information visit http bap index.h tml ts 1472244225&signature d9ae5a 269290c16d26cfbbb8e4fbd61b. CRN Appreciates President Obama s Swift Signing of Federal GMO Labeling Bill I n response to President Obama s July 29 signing of S.764 the Biotech Labeling Solutions Act the Council for Responsible Nutrition (CRN) issued the following statement We extend thanks to President Obama for his signature of S.764. This law is a constructive and practical solution for consumers seeking to educate themselves about whether food products contain genetically engineered ingredients in order to make informed 12 Nutrition Industry Executive purchasing decisions. Further CRN acknowledges the bipartisan efforts of Representatives Mike Conaway (R-TX) Collin Peterson (D-MN) Mike Pompeo (R-KS) and G.K. Butterfield (D-NC) and Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI). Demonstrating strong leadership their resolution showed an impressive spirit of compromise by putting the needs of consumers first. Now that the implementation of the law is in the hands of the U.S. Department of Agriculture CRN is optimistic that rules will be promptly developed and issued so that our industry can provide feedback on the new regulations. Consumers will be well served by a single federal requirement to allow them more information about the foods they eat and serve their families. For more information please visit September 2016 AAK Acquires CalOils AK (Edison NJ) has acquired the leading West Coast-based vegetable oils company California Oils Corporation from Mitsubishi Corporation of Japan. California Oils Corporation also known as CalOils had last year revenues of approximately SEK 1 350 million and a volume of approximately 110 000 MT with 65 employees. A strong presence on the U.S. West Coast has been priority for AAK since several years. The West Coast encompasses 20 percent of the U.S. population and this expansion has been identified as an important component of AAK s long-term growth strategy. The acquisition of CalOils will transform AAK into a true national specialty and semi-specialty edible oils company improving our ability to serve existing customers on a national scale while at the same time creating new customer opportunities said Terrence W. Thomas president of AAK USA. CalOils has important market positions up and down the West Coast. This acquisition establishes AAK A as the leading supplier of specialty and semi-specialty oils to the bakery dairy and chocolate and confectionery industries in California and across the west coast of the U.S. and Canada. In the medium term it also supports our U.S. foodservice platform Oasis Foods to develop into a national supplier. CalOils facility which is AAK s fourth production site in the U.S. is based in Richmond CA. This acquisition is an integral part of our company program AAKtion said Arne Frank CEO AAK Group. Not only will it strengthen AAK s presence in a very important market we will also bring our customer co-development concept to a national level in the United States and Canada. The acquisition will serve as a platform for increased sales of specialty and semi-specialty products within Food Ingredients and Chocolate & Confectionery Fats. The acquisition price is subject to final calculation of normalized working capital and is expected to be less than 3 per- cent of AAK s turnover on a cash and debt-free basis. The acquisition cost is funded by existing credit facilities. The transaction is expected to be finalized between end of August to end of September 2016 and is expected to start contributing to AAK s operating profit from the third quarter 2017. For more information visit OmniActive Wins Big With ASSOCHAM mniActive Health Technologies (Morristown NJ) has been presented two prestigious ASSOCHAM (The Associated Chambers of Commerce & Industry of India) Nutraceutical and Herbal Excellence Awards-- Best Quality Management Company of the Year and Nutraceutical Export Company of the Year --on July 5 2016 (New Delhi India) during the National Symposium-cum-Awards ceremony on Nutraceuticals Herbals & Functional Foods ASSOCHAM is globally recognized as a facilitator of sharing strategies regulatory updates innovation and technological advancements within the nutraceuticals functional foods dietary supplements and health foods industry. To be recognized with not one but two top awards by ASSOCHAM is a tremendous honor said Sanjaya Mariwala managing director OmniActive Health Technologies. These awards further validate our efforts in leading our industry as a supplier of quality ingredients as we propel our vision forward--to improve lives by enhancing nutrition and wellness using science and innovation. For more information visit Ancon International and B&D Nutritional Ingredients Announce New Alliance ncon International (Irvine CA) and B&D Nutritional Ingredients (Vista CA) announced an agreement to market food-derived peptides in the U.S. during the recent 4th Annual International Conference on FoodDerived Peptides held in China. This agreement will bring to the U.S. market a series of food-derived oligopeptides which are an advantaged delivery concept for proteins and amino acids due to their ability to provide rapid and superior digestibility while providing nutritional value their excellent water solubility their stability in the presence of temperature and pH changes and their ability to reduce or eliminate allergens common in food proteins. Peptides are combinations of two or more amino acids via amide bond. Oligopeptides are peptides noted for their shorter chain length (two-six amino acids) that are favored for their favorable digestibility profile. The research supporting the value of peptides continues to grow and many U.S. researchers now understand the benefits that peptides can deliver to address various health concerns as a source of protein and in providing personal care O A benefits. The Chinese National Research Institute for Food and Fermentation Industries (CNRIFFI) supports research of peptides and will work closely with Ancon and B&D. The peptides will be produced in a brand-new facility in Guangdong Province called Sino NutriFood. This is the largest facility in the world producing peptides. B&D was a natural choice to bring our peptides to the U.S. market. They have developed markets for other ingredients prior to this venture and have the reputation and knowledge needed to duplicate what has been done in China and Japan said Chris Cai vice president and founder of Ancon. Working with Chris and Dachao Zhang and understanding the role and benefits of peptides make this one of the most exciting agreements we have ever entered into added Bill Van Dyke president of B&D. The opportunity to represent Ancon across the U.S. further aligns our priorities and commitment to bringing valued brands to market. For more information visit September 2016 Nutrition Industry Executive 13 IndustryNews NPA Seeks Vitamin Inclusion in WIC Program he Natural Products Association (NPA) recently submitted comments to the Institute of Medicine advocating for expanding access to vitamins for low-income mothers and children. NPA submitted its comments as part of a Congressionally mandated study that will examine the impact of expanding the supplemental nutrition program for women infants and children (WIC) to cover certain vitamin and mineral products. Programs like WIC are a critical benefit for millions of families and there s no reason why we shouldn t look for ways to expand the program because every child in our community and across the country deserves the same opportunity at a healthy and successful life regardless of income said Daniel Fabricant PhD executive director and CEO of NPA. NPA urges the Institute of Medicine to consider including multivitamin supplements under the WIC pro- T gram. The Journal of the American Medical Association recently released a study concluding that Americans in or near poverty are not improving their diets as quickly as more affluent Americans. The percentage of lower income Americans with poor diets declined from 68 percent in 2003 and 2004 to 61 percent in 2011 and 2012. For more affluent Americans the rate declined from 50 percent to 36 percent. NPA also requested that the period for evaluation of foods made eligible to WIC participants be made more frequent than once every 10 years. A decade is too long to evaluate research and bring about fundamental and needed changes in the WIC program offer newer and updated education and expand greater options to address serious deficiencies in the population said Fabricant. For more information visit BGG Announces New Name for Algae Subsidiary and Website Launch GG (Irvine CA) has announced a new name for its algae subsidiary along with a new comprehensive website. The subsidiary will be called Algae Health Sciences Inc. moving forward which will be shortened to AlgaeHealth in its logo and for trade relations. AlgaeHealth s marketing tagline will be Improving Health with Algae. The new website can be found at We found ourselves in a trademark dispute with another company with a different but similar name and chose to change our name rather than litigate said Joe Huff CEO of AlgaeHealth s North American operation. To be honest this worked out fine as we prefer the AlgaeHealth name. It reflects our company s mission very well To research produce and market efficacious ingredients with unsurpassed quality from algae to improve health. The new website has some excellent features related to AlgaeHealth s flagship product AstaZine Natural astaxanthin including A list of more than 500 abstracts on astaxanthin separated into health benefit categories An extensive medical research library on astaxanthin A list of more than 200 structure function claims for AstaZine that have been submitted to the U.S. Food and Drug Administration (FDA) without objection We have the world s first organically certified astaxanthin farm and the world s second largest production capacity for natural astaxanthin along with unsurpassed product quality and we want to have a state-of-the-art website to match added Huff. For more information visit or B Sabinsa Sami Labs Recognized for Export Excellence abinsa Corp s (East Windsor NJ) parent company Sami Labs (Bangalore India) was recognized with the Platinum Distinction Special Recognition Award by the Visvesvaraya Trade Promotion Centre (VTPC) Government of Karnataka Organization. This is the fourth year in a row the company has been recognized by VTPC for export achievements. The State Export Excellence Awards are presented annually to the top exporters from the state of Karnataka for their outstanding performance. VTPC established for promotion of trade from the State of Karnataka is supervised and regulated by an autonomous body constituted by the Government of Karnataka. Operational since 1965 under the aegis of Department of Industries & Commerce VTPC is named after the Chief Architect of modern Karnataka Bharat Ratna Late Sir M. Visvesvaraya was instrumental in the industrialization of the state. Karnataka today is one of the key and leading states in exports from India holding the number one position in software exports with an overwhelming 38 percent share of total exports and the number four position in export of commodities. Sri Siddaramaiah honorable chief minister for Karnataka presented the award S to Neeraja Shetty director and president of strategy and business development Sami Labs Ltd. Developing and exporting phyto extracts made from medicinal herbs to customers all over the world supported by solid research is the mission and passion of all of us at the company said Shetty. We appreciate this recognition of the success of our outstanding team. For more information visit Sri Siddaramaiah (c) Honorable Chief Minister for Karnataka presented the Platinum Distinction Special Recognition Award by the Visvesvaraya Trade Promotion Centre to Neeraja Shetty (r) Director and President of Strategy & Business Development Sami Labs Ltd. September 2016 14 Nutrition Industry Executive Go to natreon for info about this advertiser IndustryNews Lonza Acquires InterHealth Nutraceuticals onza (Basel Switzerland) has agreed to acquire California-based InterHealth Nutraceuticals Inc. a leader in research development manufacture and marketing of value-added nutritional ingredients for use in dietary supplements based in Benicia CA (USA). InterHealth is a portfolio company of Kainos Capital. With this acquisition Lonza is taking a further step along our strategic path as a high-value supplier to the healthcare continuum said Richard Ridinger Lonza s CEO. Lonza will leverage the successful product portfolio of InterHealth on a global level and in turn L will be able to benefit from InterHealth s proven management and branding capabilities to promote Lonza s existing product portfolio. We see significant positive synergies from this combination. InterHealth offers more than 15 branded ingredients including its cornerstone ingredient UC- II which is revolutionizing the joint-health segment and it complements Lonza s existing nutritional portfolio in the area of sports nutrition weight management immune health and pet health. The acquisition will also expand Lonza s offerings into new areas such as cognitive and diabet- ic health. Lonza will acquire InterHealth for a total transaction price of up to 300 million USD representing a multiple of approximately ten times InterHealth s EBITDA for the 12 months ended July 2016 split into an upfront payment and an earn-out payment. Closing is expected to take place in September 2016 following customary closing conditions. The transaction is expected to be immediately accretive to Lonza s earnings. For more information visit or Utah Attorney General Sean Reyes Visits Twinlab Manufacturing Facility winlab (American Fork UT) recently hosted Utah s Attorney General Sean Reyes in a tour of the company s state-of-the-art 178 000-square-foot laboratories and production facilities located at the base of the Wasatch Range. We re delighted that Attorney General Reyes could visit our research and production facilities where our daily mission is to help people feel better look better perform better and live more fulfilling lives through superior nutritional products said Naomi Whittel Twinlab CEO. We share the Attorney General s commitment to the highest standards of professionalism transparency and trust--rolling up your sleeves and hitting the target by doing it the right way. This is how Twinlab has created a legacy brand trusted by retailers consumers and partners in over 55 countries since our founding in 1968. At a time when fewer and fewer nutritional brands make their own products Twinlab remains the exception. Our meticulous supply chain produces hundreds of premium products used by millions of people every year worldwide said Whittel. We provide healthy answers for life for every age and every stage--from pre-natal to anti-aging--including medicinal tea vitamins minerals sup- T plements weight loss weight gain and sports family of brands and even a specialized line to support the nutritional needs of Bariatric surgery patients. Twinlab makes its own products in the USA and provides jobs for 152 employees in Utah with a total 235-employee headcount nationwide. Control over quality from start to finish is absolutely critical added Greg Grochoski chief science officer. We research formulate build test market and sell our products so we take great care at every stage of the supply chain. To that end Twinlab has adopted a simple yet demanding process to maintain the highest standards in the industry Clinical Research. Twinlab s team of in-house scientists and researchers rely on gold standard clinical research to identify and source the right ingredients and produce best products at affordable prices Formulation & Development. With the latest science in hand Twinlab s expert chemists select high quality ingredients designed to deliver optimal health solutions Sourcing. Twinlab s skilled sourcing team works with farmers and suppliers both locally and from around the world to secure ingredients that meet their high standards and GMP (good manufacturing practice) certifi- Reyes (c) tours Twinlab facility cation. They search the globe for the right ingredients that ensure worldclass purity and potency. And they re proud to make their products right here in the USA. Production. After their premium ingredients are approved they re precisely measured for blending. It s vital that the raw materials are completely and uniformly mixed to ensure each serving contains the nutrients listed on the label. That s why Twinlab is an NSF-certified GMP facility--which guarantees better manufacturing testing and quality control. Finished Goods Testing. By the time Twinlab products are ready to ship they ve been tested and analyzed up to 50 times using sophisticated analytical technology. For more information visit 16 Nutrition Industry Executive September 2016 Go to herbakraft for info about this advertiser IndustryNews CRN Attends BlogHer16 the Leading Conference for Female Bloggers he Council for Responsible Nutrition (CRN) served as an exhibiting sponsor at BlogHer16 Experts Among Us the largest conference worldwide that brings together women bloggers that took place August 4-6 in Los Angeles CA. In addition to exhibiting at the three-day event CRN hosted a special luncheon on August 5 entitled Get Healthy Get Wise which featured an interactive panel discussion on the do s the news and the clues when it comes to understanding the role of vitamins and other dietary supplements in living healthier lives. The luncheon event also featured a special presentation by the non-profit Vitamin Angels Founder and President Howard Schiffer. Panelists included Wendy Bazilian DrPH RD educator author (Eat Clean Stay Lean) and journalist and Felice Gersh MD OB GYN and integrative medicine specialist and international speaker on women s health issues. The panel was be moderated by CRN s Duffy MacKay ND senior vice president of scientific and regulatory affairs. CRN also brought in a rotating line-up of reputable health care practitioners who served as wellness ambassadors at the association s exhibit booth available to offer suggestions and answer questions about improving nutrition filling nutrient gaps and T the role of vitamins and other dietary supplements in healthy living. In addition to Drs. Bazilian Gersh and MacKay the wellness ambassadors included Patricia Bannan RDN nutrition consultant and author CRN s Dr. Duffy MacKay speaking at BlogHer 16 (Eat Right When Time is Tight) Holly Lucille ND alongside Dr. Felice Gersh (L) and Dr. Wendy Bazilian RN expert in integrative platform for the up-and-coming female blogmedicine and TV radio talk show host ger community and has since grown to host Elizabeth Shaw RDN healthy living blogger (Shaw s Simple Swaps) and freelance nutrition 3 000-plus attendees. BlogHer Experts Among Us is produced by SheKnowsMedia writer Vandana Sheth RDN nutrition specialist with expertise for vegetarians and peo- a leading women s media company reaching 79 million women each month. ple with food allergies and Marie Spano As the leading trade association for our RD sports dietitian and certified strength industry it is imperative that we stay current and conditioning specialist. with communications trends and adapt best We know that blogging is all about the practices added Blatman. The BlogHer personal said Judy Blatman senior vice conference has a stellar reputation and the president communications CRN. It s a way community is made up of the savviest online of talking to one person who then talks to communicators. It was the ideal opportunity 10 people who then talk to 30 people. We for us as we seek to increase awareness of already are seen as a go-to source for tradithe benefits of dietary supplements and gentional media and so another one of our erate new relationships within the blogging goals it to be a go-to source for the industry to this community the blogging community. landscape. For more information visit The BlogHer conference series started in 2005 as a community-building and education MORRE-TEC Industries Inc. (Union NJ) has announced the appointment of Gary Romans as the company s vice president extracts and cosmetic ingredients business. In his new position Romans will be reporting to William Ludlum who was recently promoted to COO and assumed responsibility for all operational sales and marketing functions of the company. B&D Nutritional Ingredients (Vista CA) recently announced Chelsea Drinco as the company s new Southern California regional sales manager. Before joining B&D Drinco worked as an account manager at Ingredient Identity and as a business development assistant at Fresh Healthy Vending. BGG (Irvine CA) recently added two sales managers to cover the Eastern United States territory. Janelle Campana will be handling the Northeast territory. Campana comes to BGG after working in several positions in sales and marketing with increasing 18 Nutrition Industry Executive You reHired responsibility over the last decade with a decade of experience in the pharmaBASF and DSM. Angel Mendoza will be ceutical industry in varied sales posihandling the Southeast territory headtions. ing as far west as Texas. Mendoza forAAK (Edison NJ ) announced the merly served in various positions in addition of Jim Rethore to its AAK USA related industries including six years as leadership team. Jim Rethore joins AAK president and CEO of Farmacapsulas as vice president of operations. In his and COO of CapsCanada and 18 years new position Rethore will have responin steadily increasing positions with sibility for leading operations across Capsugel. AAK USA. The company also Biozyme USA (Malibu CA) welcomed Dr. James S. Jones named Bret Wyant as the new to its staff. Jones will lead its director of sales for the United AAK USA innovation team as States market working to provice president. Jones will have mote the brand and manufacresponsibility for leading all turing site as the premier supcustomer innovation activities plier of systemic enzymes into across AAK USA and Canada. the digestive health marketHORN (La Mirada CA) Christine place. announced the hiring of Minor HP Ingredients (Bradenton Christine Minor as senior FL) has announced that the company s account manager to serve HORN strong growth has necessitated the FoodTech s Southern California cusappointment of a regional manager tomers. Minor joins HORN with 26 and Sara Vissers was named to this years of expertise in food beverage newly created position. Vissers has had and nutritional ingredient sales. September 2016 Go to savesta for info about this advertiser SpecialReport FTC Distinguishes Between Natural and All Natural By Ronie Schmelz and Amanda Villalobos Tucker Ellis LLP n April the Federal Trade Commission (FTC) proposed settlements with four companies that market products containing artificial ingredients as all natural or 100 percent natural. In announcing the settlements FTC Bureau of Consumer Protection Director Jessica Rich said that at least according to the FTC [a]ll natural or 100 percent natural means just that--no artificial ingredients or chemicals. On July 13 after the period for public comment on the proposed settlements ended the FTC announced it approved the settlements and entered four final orders against companies doing business as ShiKai Natural Hair and Skin Care Rocky Mountain Sunscreen EDEN Bodyworks and Beyond Coastal. Among other things the final orders require the companies to have competent and reliable evidence to support any all natural or 100 percent natural claims. They also bar the companies from making unsubstantiated or misleading claims about the extent to which their products contain natural or synthetic ingredients and the environmental or health benefits of their products. In announcing final approval of the settlements the FTC released responses to comments it had received during the public comment period. One such comment sought to equate use of the term natural with all natural and impliedly expand the scope of the settlements to prohibit the use of the term natural when products contain any amount of synthetic ingredients. The FTC however rejected the notion that the term natural means the same thing as all natural stating in one response In your comment you state that products should not be represented as natural if they contain any amount of synthetic ingredients and that the term must be reserved only for companies that provide complete transparency and proof of the natural chemical makeup of their products. Thus your comment arguably implies that the consent agreement should prohibit the claim natural unless the product is all natural (i.e. contains I no synthetic ingredients). The record does not support revising the order in this way. We do not have evidence that consumers necessarily interpret natural to mean all natural or no synthetic ingredients. Absent such evidence we do not feel it would be appropriate in this case for us to presume that consumers have that understanding of the term natural. (Emphasis added.) The FTC continued that the final orders protect consumers by prohibiting the companies from using the term natural unless it is true and not misleading. For example if an advertisement states that a product is natural and if reasonable consumers would interpret the advertisement as a whole to imply that the product is all natural this claim would violate the order unless it is true and not misleading. While it is heartening to have the FTC concede that natural is not the same as all natural its foray into the debate over proper use of the terms does little to clear the muddy waters created by the U.S. Food and Drug Administration s (FDA) failure to define these terms. In 2014 the FDA invited public comment on how the term natural should be defined and used on food products. By the time the public comment period ended in May 2016 the FDA had received more than 7 500 comments. It will take months if not a year or more for the FDA to review all of the comments and issue a guidance addressing the issue. Whether the FDA ultimately defines the term natural on foods and the extent to which a definition would apply to cosmetics and other consumer goods remains to be seen. Unfortunately until the FDA enters the debate companies continue to be exposed to often-frivolous lawsuits claiming that the use of the term natural to describe their products is misleading. These lawsuits will turn on what reasonable consumers understand the term to mean when used to describe a particular product or brand. Plaintiffs in the scores of pending class actions will have to commission consumer surveys in the hope they will reveal that consumers do equate the term natural with all natural or containing no synthetic ingredients. Companies defending these suits will want to conduct their own surveys to show that reasonable consumers understand that even natural products contain some synthetic ingredients. Food cosmetics and other companies would do well to try to persuade the FDA to act hastily and finally issue a natural guidance. NIE Ronie M. Schmelz and Amanda Villalobos are counsel with Tucker Ellis LLP in Los Angeles CA. Schmelz represents clients in broad-based commercial litigation. She regularly counsels clients on litigation-avoidance strategies and ensurRonie M. Schmelz ing compliance with regulations enforced by the FDA FTC and other regulatory agencies California Proposition 65 and advertising labeling and claim substantiation. Schmelz has deep industry knowledge of and particular expertise in representing domestic and international cosmetic personal care and nutritional supplement companies in formulating best practices for preand post-market activities. She can be reached at ronie.schmelz Villalobos focuses her practice on litigation defense and product liability. Her work has been concentrated in the area of civil litigation defending high Amanda Villalobos profile corporate clients in general liability matters including pharmaceutical and medical device matters consumer class actions and cases involving personal injury and wrongful death. She formerly practiced in the area of intellectual property where her practice focused on patent litigation. She can be reached at amanda.villalobos September 2016 20 Nutrition Industry Executive Go to globalhealthlabs for info about this advertiser IngredientNews XYIENCE Protein Bars the First to Feature Sustamine L-Alanyl-L-Glutamine YIENCE headquartered in Texas has released XYIENCE Protein Bars the first such products to contain Sustamine L-Alanyl-LGlutamine. The non-GMO (genetically modified organism) gluten-free XYIENCE Protein Bars are designed to fuel the X body with the cleanest ingredients to provide sustained energy during workouts. They contain 20 g of protein and 1g of sugar sweetened with stevia and are soy free containing 15-17g fiber-- the bars are also made with quinoa and amaranth along with sustamine a dipeptide of two amino acids that help the body with hydration and sustaining physical performance. Sustamine L-Alanyl-L-Glutamine a dipeptide of glutamine provides several substantial benefits such as enhanced recovery immune system support and performance. On top of these benefits research suggests that sustamine is absorbed more than 200 percent better than standard L-glutamine. For more information visit FutureCeuticals elevATP Shown to Increase Strength Power and Performance llinois-based FutureCeuticals recently announced the publication of a new study supporting the functional efficacy of their Sports Nutrition and Healthy Energy ingredient elevATP. A proprietary combination of ancient peat and a proprietary apple extract elevATP had been shown in prior clinical studies to acutely stimulate the production and release of adenosine triphosphate (ATP) at the mitochondrial level. This new functional study demonstrates that supplementation with low-dose elevATP during a structured resistance training program can significantly increase human strength power and performance. elevATP is featured in many current pre-workout products. We needed to take the next step and provide evidence in a functional environment that elevATP supplementation really makes a difference in a variety of sports nutrition-related parameters said Andrew Wheeler director of marketing for FutureCeuticals. Endogenous ATP production and the associated healthy energy story are great marketing vehicles but a valid functional outcome is always the gold standard. We can now provide that critical support to our partners. Fully soluble elevATP is Non-GMO Project Verified vegan GRAS (generally recognized as safe) and suits a wide variety of delivery formats including beverages gels gummies capsules ready-to-mix beverages and functional foods. elevATP is also approved as a Natural Health Product by Health Canada. For more information visit I Study On Lutemax 2020Supporting Vision Featured in Research Journal he unique findings of a study on macular carotenoids from Lutemax 2020 conducted by the University of Georgia are the subject of a new paper Serum and Retinal Response to Three Different Doses of Macular Carotenoids Over 12 Weeks of Supplementation published in the July issue of Experimental Eye Research the official journal of the International Society of Eye Research. The macular carotenoids--lutein RR- and RS (meso)-zeaxanthin--have been shown to have neuroprotective and visual performance benefits once deposited in retinal tissue. The concentration of the three macular carotenoids in the macula is usually measured and expressed in terms of macular pigment ocular density (MPOD). Improvements in MPOD serum have been linked with potential improvements in visual function. LAMA--an acronym for lutein vision and mental acuity--is a group of studies showing the benefits of all three macular carotenoids from Lutemax 2020. This study--LAMA I--was a randomized double-blind placebo-controlled study in young healthy subjects supplementing with three different doses T of macular carotenoids specifically lutein and zeaxanthin isomers (RR- and RS(meso)-zeaxanthin) from Lutemax 2020 at 6 and 1.2 mg 10 and 2 mg and 20 and 4 mg respectively. Within two weeks there was a statistically significant increase in serum lutein and zeaxanthin concentrations at all three doses. More importantly in eight weeks the 10 and 20 mg doses resulted in a statistically significant increase over placebo in MPOD. Furthermore all three doses showed a sustained and significant increase over placebo in MPOD within 12 weeks. Even at the lowest dose supplementation resulted in a significant increase over placebo in MPOD much sooner than what has been predicted by previous findings from other studies. Additionally there was an improvement in the spatial profile of macular pigment where the greatest gains in optical density were shown in the very center of the macula where the highest risk of photooxidative damage exists. For more information call (866) LUTEMAX (588-3629). 22 Nutrition Industry Executive September 2016 Go to albion for info about this advertiser IngredientNews New Bionov Product Websites n an ongoing effort to boost its digital strategy and to strengthen the information on its range of active ingredients Bionov located in France and the world s largest producer of natural and bioactive SuperOxide Dismutase (SOD) has launched two new websites on its solutions SOD B EXTRAMEL and SOD B DIMPLESS. These user-friendly websites in modern design offer a faster and easier access to critical information on both solutions including clinical benefits scientific publications and way of actions. The launch of these product websites is part of the Bionov s strategy to enhance the quality and availability of information on its solutions to customers distributors and final consumers. As part of its objective to provide critical information on its active SOD B solutions and boost its digital strategy Bionov has launched two new websites on its solutions SOD B EXTRAMEL and SOD B DIMPLESS. These websites contain extensive product information on both solutions including specifications quality engagement clinical studies and way of actions. For more information visit and I Licorice Root Extract for Combating Cardiovascular Oxidation alifornia-based Allied BioNutrition Corporation a formulator and supplier of dietary nutraceutical supplements discovered a new breakthrough for combatting cardiovascular oxidation. The ingredient is licorice root in the form of a unique extract that comes from this natural ingredient. Recently the results from a double-blind placebo-controlled study were published in the scientific journal Food and Nutrition Research. The study examined the effect of a unique licorice-root extract on the thickness of the artery wall (carotid intima-media thickness or CIMT) in individuals with increased oxidation in the arteries. CIMT is considered a strong biomarker of overall cardiovascular and arterial health. People with increased oxidation total cholesterol greater then 240 mg do were randomly allocated to two groups as follows an experimental group that received 200 mg of the licorice root extract and a placebo group. One hundred ten participants were initially allocated to the two groups. After some withdrawals 94 subjects ultimately completed the trial. Following one year of licorice root extract consumption mean CIMT total cholesterol LDL levels and blood pressure decreased. This suggests that this ingredient may attenuate the development of oxidation and of related cerebral vascular issues. For more information call (888) 711-6668 or email info C Go to mackflavor for info about this advertiser 24 Nutrition Industry Executive September 2016 Steviva Ingredients Adds Ultra-Fine Mesh Powdered Erythritol Stevia Blend ith Oregon-based Steviva Ingredients new Erysweet Ultra blend clean-label sugar-free chocolate can be achieved. Erysweet Ultra is a super-fine mesh powder consisting of SteviaSweet 95-60 with Erysweet non-GMO (genetically modified organism) erythritol a polyol that provides natural low-calorie sweetening and bulk. This proprietary blend of highly purified steviol glycosides delivers an exceptionally clean flavor that is free from bitter notes and aftertaste commonly found in other stevia products. Non-browning Erysweet Ultra has excellent heat tolerance past 250 F and folds into any hot or cold process. Designed to be a replacement for super-fine powdered sugar Erysweet Ultra is ideal for tempering applications for chocolate coatings fillings frostings glazes fondants and icings. This is a game-changer for confectioners and baking manufacturers trying to achieve clean-label sugar reduction said Thom King president and CEO of Steviva Ingredients. Never before has there been an all-natural non-sugar solution that can not only withstand the tempering process of chocolate but also produce the same light mouth feel and brilliant flavor profile as confectioners sugar. Twice as sweet as sugar with just 0.2 calories per gram Erysweet Ultra is available in 20 kg poly-lined boxes. For more information visit Natreon s PrimaVie Collagen Gene Expression Study Published ew Jersey-based Natreon s PrimaVie a high-quality purified and standardized extract of Shilajit significantly up-regulated the genes responsible for collagen synthesis according to a human clinical study just published in the Journal of Medicinal Food. PrimaVie a GRAS (generally recognized as safe) affirmed and patented ingredient is comprised of mainly fulvic acids and DBPs (dibenzo-alpha-pyrones). Fulvic acid independently stimulates mitochondrial energy metabolism protects mitochondrial membranes from oxidative damage and helps channel electron-rich DBPs into the mitochondria to support the electron transfer chain. Several clinical studies have shown that PrimaVie can boost mitochondrial energy improve exercise performance and increase testosterone levels. It was shown to increase ATP synthesis and protect coenzyme Q10 from degradation by oxidative free radicals in the mitochondria. This most recent collagen expression study suggests PrimaVie s role in healthy aging. For more information call (732) 296-1080 or visit W N Go to get for info about this advertiser September 2016 Nutrition Industry Executive 25 IngredientNews ADM s Vitamin E Provides Natural-sourced Solution for Customers N ovatol Natural-Source Vitamin E provides a smart plant-based alternative for customers looking to comply with the U.S. Food and Drug Administration s (FDA) new labeling regulations recently went into effect. Alpha-tocopherol which the FDA s new rule regarding nutrition facts defines as vitamin E is an essential nutrient that is vital to human health but cannot be produced by the body itself. It is under-consumed by 90 per- cent of Americans according to the National Health and Nutrition Examination Survey (NHANES) so it is a popular additive in many food products to add nutritional value. This new rule regarding nutrition facts labeling requires manufacturers using synthetically produced (all rac-) vitamin E to incorporate twice as much of the ingredient to meet the same amount of vitamin E compared to using naturalsource (RRR-) vitamin E. ADM s Novatol Vitamin E is sourced from vegetable oils making it an ideal solution for formulators looking to incorporate natural-sourced vitamin E into their latest food innovations and dietary supplements. For more information visit novatol. New Leaky Gut Trial Shows Benefits of EpiCor Fermentate ccording to a new study published in the Journal of Thermal Biology EpiCor fermentate manufactured by Embria Health Sciences in Iowa not only helped to significantly reduce the likelihood of damage to gut lining caused by heat stress but also showed gut health benefits without heat stress. In this study conducted by Auburn University rats were put into two equal groups EpiCor fed and control. On the A last day of the trial half of each group were heat stressed at 45 C (113 F) for 25 minutes. The results of the study indicate that EpiCor may maintain gut health by helping to reduce the likelihood of intestinal barrier damage associated with leaky gut as well as the biochemical changes resulting from that damage. Additional biochemical observations in rats fed with EpiCor included a reduction of serum LPS endotoxins reduced eryptosis and a decrease in white blood cell count as compared to the control rats. These beneficial findings and the positive results from two other published in vitro studies on EpiCor s effects on the gut help to reconfirm EpiCor s beneficial impact on the digestive system and the growing link between immune and gut health. For more information visit or Go to ehp for info about this advertiser 26 Nutrition Industry Executive September 2016 Go to onceagain for info about this advertiser IngredientNews Clinical Study Shows Ester-C Stays in the Body Longer Than Other Vitamin C new clinical study conducted by NBTY based in New York demonstrated that Ester-C a patented form of Vitamin C stays in immune cells longer than regular Vitamin C (ascorbic acid) currently on the market. The study published in SpringerPlus reports that Ester-C significantly increases vitamin C concentrations in white blood cells (leukocytes cell of the immune system) up to 24 hours following a single oral administration of 1 000 mg vitamin C. This is the first clinical trial comparing vitamin C retention in leukocytes between Ester-C and ascorbic acid in both male and female nonsmokers. Dr. Susan Hazels Mitmesser author of the study and senior director of Nutrition & Scientific Affairs at NBTY said This study is a great example of the commitment NBTY has to scientific diligence around our product innovations. As new ingredients and areas of research emerge our scientific leadership will continue to be a priority and a differentiator in the scientific community and the supplement market with NBTY products leading the way. For more information visit Lactium Enhances Sleep Without Sedative Effects new study published in Behavioural Brain Research has shown that a patented hydrolysate of milk protein (Lactium) is capable of facilitating and promoting sleep with no or minimal sedative properties. According to the study s authors despite the putative sleep-promoting properties of bovine alpha S1-casein tryptic hydrolysate (CH also known as Lactium) no study has directly assessed the sedative and sleep-promoting effects of the ingredient. Thus in the present study the authors set out to evaluate these effects. The study found that Lactium induces sleep promotion as shown by an augmented pentobarbital-induced sleep in mice and an increased slow (delta) EEG wave in rats. This sleep-promoting effect they note is probably mediated through the GABAergic neurotransmitter system. Lactium can be used in a variety of food and supplement forms. Pharmachem in conjunction with confectioner Hillside Candies (Hillside NJ) recently developed Lactium honey drops which delivers 150 mg Lactium through a hard candy. For more information call (800) 526-0609 or visit A A Go to algatech for info about this advertiser 28 Nutrition Industry Executive September 2016 Go to euromed for info about this advertiser IngredientNews HP Ingredients Receives Health Canada NPN License for BERGAMONTE BPF he Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada concluded that HP Ingredients application for its proprietary bergamot ingredient known as BERGAMONTE BPF is in compliance pursuant to section 7 of the Natural Health Products Regulations (NHPR) and has thus issued product license NPN 80068556 for BERGAMONTE BPF capsules. Further the following claims are now allowed to be made for Canadian Bergamonte products (500 mg) helps maintain support healthy (total LDL HDL- ) cholesterol levels helps maintain support cardiovascular health pro- T vides antioxidants. BERGAMONTE BPF contains bioactive compounds of extract of the juice and albedo of citrus bergamia risso standardized to 30 percent polyphenolic flavonoids consisting of Naringin Neohesperidin Neoeriocitrin 1 percent Melitidine and 2 percent Brutelidine. These flavonoids are clinically proven to help maintain healthy cholesterol levels healthy blood glucose level and increase HDL-cholesterol. Bergamonte is produced using patented extraction technology. For more information call (877) 437-2234 or visit Soluble Dietary Fiber in Sunfiber Found to Improve Metabolic Health esearchers have long been fascinated with the beneficial relationship between soluble fiber and reduced risk of diabetes and metabolic syndrome. Now there s additional evidence that partially hydrolyzed guar gum (PHGG)--the soluble fiber available as Sunfiber--may help manage glucose levels after meals. This same human clinical study just published in the Journal of Functional Foods found that PHGG also called guar fiber improves cholesterol levels positively influences inflammatory markers and may lower body weight specifically abdominal fat. Many studies have shown that meals higher in dietary fiber result in smaller postprandial (post-meal) rises in blood glucose levels in people who are non- R diabetic pre-diabetic and diabetic. Fiber also is associated with lower risk factors for chronic conditions including glucose intolerance increased blood insulin and high cholesterol. Sunfiber is a soluble transparent and tasteless dietary fiber. It is low in viscosity improves stability of beverages at various pH levels and is resistant to heat acid and digestive enzymes. It can easily be added to a wide variety of foods beverages and supplements without impacting the flavor color texture or aroma. It is certified kosher gluten free vegetarian and non-GMO (genetically modified organism). For more information call (952) 697-5221 or visit Demand Surges for HyperPure Technology Based on Trust srael-based Frutarom Health BU reported a surge in demand for its EFLA HyperPure Line in the U.S. market since the beginning of 2016. The growth can be considered a result of diminishing consumer trust in supplements and the call for short ingredient lists. We ve received increased attention from U.S. supplement manufacturers concerned about possible contamination and thus are seeking botanical I Go to ayushherbs 30 Nutrition Industry Executive extracts with safety assurances--as with the EFLA HyperPure seal explained Holger Riemensperger general manager for Frutarom s Health BU. Our HyperPure technology has become an industry standard for safety and purity. Customers want to know more about this patented process they understand it helps create a competitive advantage for their herbal supplements. For more information visit September 2016 Go to lycored for info about this advertiser IngredientNews GanedenBC30 Enhances Protein Utilization and Vitamin Mineral Absorption hio-based Ganeden announced of its 24th peer-reviewed and published study along with new findings. The studies show that Ganeden s patented and science-backed probiotic strain GanedenBC30 (Bacillus coagulans GBI-30 6086) supports the body s utilization of protein and also enhances vitamin and mineral absorption. These findings confirm GanedenBC30 s benefits in a variety of functional food and beverage categories including sports nutri- O tion and meal replacements. As previously publicized in a study conducted by the University of Tampa and Increnovo LLC it was found that GanedenBC30 supports protein utilization as measured by a reduction of muscle soreness and increased perceived recovery. GanedenBC30 with just 20 g of protein was able to protect the muscle from damage as shown by perceptual measures and blood work resulting in improvement in five protein utilization end points decreased recovery time decreased soreness reduced swelling increased power and decreased blood kinase. The study which was run by the facilities of Dr. Jacob Wilson and managed by Dr. Ralf J ger is the first study of a probiotic showing ergogenic effects in athletes with results benefiting the sports nutrition and protein functional food and beverage categories. The study has been peer-reviewed and published in the PeerJ journal. For more information visit Study Explains L-Threonates Role in Brain Magnesium Introduces New Vitamin D3 alifornia-based AIDP announced that a peer-reviewed research paper recently published in the medical journal Neuropharmacology explains the mechanism through which threonates work and how they increase the amount C of magnesium in the brain when subjects were administered magnesium L-threonate the ingredient marketed into the dietary supplement market under the trade name Magtein. It also shows that threonate is the only ligand to efficiently Go to hsus for info about this advertiser 32 Nutrition Industry Executive transport magnesium to neuron cells in the brain. Until now while prior clinical research has substantiated this process this recent body of work further explores the intricate process through which Magtein is transmitted through the brain crossing the blood brain barrier. The paper is titled Regulation of structural and functional synapse density by L-threonate through modulation of intraneuronal magnesium concentration. It identified the molecular mechanism of action for Magtein further confirming the results of previous human clinical studies. The current study provides a scientific explanation for how Magtein works. The study concludes that intraneuronal magnesium is a critical regulator of synaptic density and plasticity critical factors that determine cognitive ability. Other magnesium salts lacking L-threonate failed to have the same results. AIDP also introduced a high purity vitamin D3 40 million IU g. Food-grade vitamin D3 has been available at a premium cost for some time yet generally testing consistently at a lower percentage and at a lower quality. AIDP plans to change this by offering a high purity material tested and verified by two independent laboratories that have both confirmed the exceptional quality of this form of vitamin D3. The vitamin D3 40 million IU offered by AIDP is considered a desirable premium ingredient priced competitively. It has also been tested to be low in heavy metals certified kosher halal and free of genetically modified organisms (GMOs). For more information visit September 2016 Go to herballyyours for info about this advertiser IngredientNews New Studies Published on Sabinsa s LactoSpore ew Jersey-based Sabinsa s shelfstable LactoSpore probiotic has been extensively researched in the 20 years since it was introduced and recently several new studies including clinical studies have been published. Areas researched include safety and tolerability shelf life stability genetic and phenotypic stability and anti-diarrheal activity all with positive and significant results. LactoSpore has recently obtained the approval as Natural Health Product (NHP) that allows formulators and marketing companies to market LactoSpore N in Canada as NHP. This approval renders Canadian market readily accessible by U.S. and Canadian marketing companies. Pre-approved NHP ingredients can reduce the review period of Product license application in Canada where a pre-market approval system precedes actual marketing. LactoSpore s approval in natural health products in Canada is also supported by Sabinsa s Utah facility a registered foreign site for manufacturing the NHP for the Canadian market. For more information visit Horphag Research Announces Education Campaign on Robuvit orphag Research New Jerseybased global supplier of the ingredient Pycnogenol announced that its patented standardized French oak wood extract Robuvit is now available to additional U.S. customers as a result of the completion of a dedicated production line in France. Interest in Robuvit has increased around the world as a number of recent peer-reviewed and published studies have illustrated the extract s support for vitality renewed energy and detoxification. The company is launching an education campaign to accompany the U.S. arrival of Robuvit so that consumers H manufacturers and wellness professionals can learn more about this new extract and the growing body of research exploring its efficacy. The research around Robuvit casts this French oak extract as a credible natural caffeine alternative for consumers who are seeking to overcome general fatigue and increase everyday energy said health and nutrition expert and best-selling author Dr. Fred Pescatore. It s also an emerging option as a natural energy booster for sports and athletic performance. For more information call (312) 981-8540 or visit Glanbia Nutritionals Launches New Whey Protein Flavor Technology alfornia-based Glanbia Nutritionals announced the launch of a new flavor technology EasyFla Whey designed to optimize flavor delivery and improve nutrition in whey protein systems. The flavor technology neutralizes the offnotes typically found in protein to provide a clean consistent flavor while enhancing the nutritional profile. Known for its flavor neutralizing capabilities in vegetable proteins EasyFlav flavor technology has now been specifically developed for whey protein systems for use in health and wellness and sports nutrition applications. By replac- C ing the traditional carbohydrate core with added protein and a stable flavor EasyFlav Whey delivers a protein-filled product with a clean label which delivers maximum nutrition. As well as increased protein content it allows for up to 30 percent reduction of carbohydrates for a pure nutritious product. This enables formulators to achieve higher protein levels with an appealing taste--previously challenging due to the bitter cardboard notes a high protein content would typically generate. For more information visit September 2016 34 Nutrition Industry Executive Go to welchs for info about this advertiser AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Experts Analyze Potential Impact of Brexit on Dietary Supplement Companies I t is likely too early for dietary supplement companies to enact changes in reaction to the United Kingdom s (U.K s) exit (or Brexit) from the European Union (E.U.) but the industry should be paying close attention to how Brexit is enacted to avoid potential pitfalls and capitalize on possible opportunities according to a panel of international supplement experts who spoke at a webinar presented in August by the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). The webinar featured insights from Simon Pettman the executive director of the International Alliance of Dietary Supplement Associations (IADSA) Brian Kelly Esq. associate in the London Life Sciences group at Covington & Burling LLP and Gert Krabichler PhD global head regulatory policy and intelligence at Merck Selbstmedikation Merck Consumer Health. The three discussed implications of Brexit for the marketing of food supplements in the U.K. and E.U. operates under roughly 130 separately negotiated bilateral treaties with the E.U. The U.K. could also adopt a free trade approach with no preferential access to the E.U. market. The implications of these options could be far-reaching and are more difficult to predict. current E.U. policy for botanicals varies widely. Each E.U. member has discretion to handle botanicals as it chooses according to Krabichler. Reaching a consensus among E.U. countries on how to treat botanicals could be a significant challenge even without having to negotiate with the U.K. Pettman noted. Similarly the U.K. and most other E.U. countries have different opinions about vitamins and minerals and Brexit could provide an opportunity for the U.K. to set more liberal policies and the E.U. to set more restrictive policies. According to Pettman the E.U. has been unable agree on maximum levels of vitamins and minerals. The U.K. has traditionally pushed for higher maximum levels so losing this member may enable E.U. countries pushing for lower levels to generate sufficient consensus to set lower maximum levels according to Krabichler. Uncharted Territory Reduced U.K. Influence in E.U. Policy No matter how Brexit is enacted it is unlikely that U.K. will continue to have the same level of influence in E.U. policies. Similarly the U.K. will likely have more discretion to set its own policies if it doesn t have to negotiate with other E.U. countries. This could be significant for both the U.K. and E.U. policies as the U.K. has been a prominent country that has generally supported more businessfriendly policies. Regarding food supplement policies the U.K. hasn t always seen eye to eye with the E.U. and Brexit could allow the U.K. and E.U. to adopt different policies moving forward. According to Pettman the U.K. has historically pushed for a more restrictive pharmaceutical approach to botanicals treating them as traditional herbal medicine. In contrast many E.U. countries support allowing botanicals to be more widely used in food supplements. While no one can predict what will happen Brexit provides an opportunity for the U.K. to enact more restrictive policies for herbs and botanicals and the E.U. to enact more liberal policies. It is important to remember that the Webinar presenters noted that the Brexit process is uncharted territory. They stressed that there are many options that negotiators could consider with each option potentially creating significant political and economic risks and opportunities for companies doing business in the U.K. and E.U. Webinar attendees were advised to be patient and not rush to act. Instead companies should stay engaged and informed to lessen the surprise of any significant changes created by the U.K. exiting the E.U. A recording of this webinar is available online here http ahpa. org news latestnews tabid 96 artmid 1179 articleid 686 default. aspx. NIE More Options Than Answers Due to the significant uncertainty about how Brexit will be enacted the presenters suggested companies take a watch and wait approach at this time. The U.K. has several options to execute its exit from the E.U. which creates much uncertainty for companies that market food supplements in the U.K. and E.U. One of the U.K. s least disruptive options would be to follow in the footsteps of countries like Norway and Iceland which joined the European Economic Area (EEA) which enables them to participate in the E.U. internal market and have relatively free movement of goods services and persons. Under this option it s very unlikely that there d be any material change to the legal position said Kelly Implementation of E.U. existing food law would remain valid and the U.K. However the U.K. would likely lose influence on E.U. policy under this option. The U.K. s exit from E.U. could be much more disruptive if it chooses a different option. Webinar presenters noted that U.K. could copy Switzerland which 36 Nutrition Industry Executive Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) September 2016 Go to rousselot for info about this advertiser AssociationNews NPA Launches Warning Letter Database for Member Companies he Natural Products Association (NPA) has announced the launch of its anticipated warning letter database. This database will be a free online tool for NPA members to view violations against the dietary supplement good manufacturing practices (GMPs) which are deemed as technical adulterations by the FDA (U.S. Food and Drug Administration) dietary supplement labeling regulation and making unauthorized health claims on products labels and in labeling. Regulatory compliance and QA QC personnel of dietary supplement manufacturing facilities own label distributors companies and retailers can use this information to monitor and track the top GMP violations by year and see how those trends are changing. The database will also allow end users to create their own reports. According to NPA CEO and Executive Director Dr. Daniel Fabricant NPA is proud to announce a database for the industry that is more than just warning letters. It differentiates itself by capturing enforcement actions from various agencies. While it is searchable in many different ways you would think a warning letter database would be it is also being designed to search disease claims claim categories and allow for customized reports by member end T users. The database is also beneficial for those responsible for labeling compliance to avoid the introduction of misbranded products into interstate commerce and those marketing with claims. The database also tracks enforcement actions taken by various agencies against companies. NPA wants their members to be able to view the entire scope of federal actions against the industry beyond a warning letter including seizures injunctions forfeitures and criminal actions. The database contains more than 440 warning letters that have been publicly released by the FDA in addition to the enforcement actions taken by the DOJ (Department of Justice) FDA and FTC (Federal Trade Commission) since 2008. It is searchable by company name product name issue date regulation disease claims claim category and FDA action taken. The comprehensive database is also a valuable tool not only for dietary supplement manufacturers but retailers or consumers who want to see if FDA has found any issues with a company s GMPs before purchasing their products. NPA will update the database weekly as new warning letters and enforcement actions are added through various public and federal agency media outlets. The comprehensive database is a valuable tool not only for dietary supplement manufacturers but also retailers or consumers who want to see if FDA has found any issues with a company s GMPs before purchasing their products. NPA will update the database weekly as new warning letters and enforcement actions are added through various public and federal agency media outlets. Tracking trends is always valuable for our members. That is something important for regulatory officers to know. It also begins to tells a story we could not tell previously without this data--are the violations changing as a result of a second deeper layer cut FDA maybe taking or are FDA s priorities changing One trend to note is that the top 10 list of GMP charges cited by FDA is changing. said Fabricant. This is one of several online tools we are offering members over the course of the next 12 months. For more information visit CRN Conference Breakfast With... Session to Feature Doris Kearns Goodwin he Council for Responsible Nutrition (CRN) has announced that presidential historian public speaker and Pulitzer Prize-winning author Doris Kearns Goodwin PhD will headline the popular Breakfast With... session at The Conference CRN s Annual Symposium for the Dietary Supplement Industry. This event takes place October 26 29 in tandem with The Workshop CRN s Day of Science at the RitzCarlton Laguna Niguel in Dana Point CA. During the Breakfast with... session to be held Saturday morning October 29 the final day of The Conference Goodwin a globally recognized scholar of the U.S. Executive branch will share insights on the current political land- T scape interpreting its unique and unprecedented character in the context of history. This breakfast address promises to offer an elegant alternative to the election year chatter Steve Mister president and CEO CRN explained. No matter where they rest on the political spectrum attendees will find themselves captivated by Ms. Goodwin as she decodes the events of the past year with authoritative grace. With a career spanning over 40 years Goodwin has become well-known for her frequent appearances and commentary on NBC MSNBC CBS ABC FOX CNN Meet the Press The Charlie Rose Show as well as for her award-winning and best-selling books The Bully Pulpit Theodore Roosevelt William Howard Taft and the Golden Age of Journalism Team of Rivals The Political Genius of Abraham Lincoln No Ordinary Time Franklin and Eleanor Roosevelt The Home Front in World War II Wait Till Next Year A Memoir Lyndon Johnson and the American Dream and The Fitzgeralds and the Kennedys An American Saga. Goodwin s address will be followed by one additional closing session to be announced soon. For more information and to register visit 2016events. September 2016 38 Nutrition Industry Executive Go to certifiednutraceuticals for info about this advertiser ScienceUpdate PUFAs Associated With Differential Risks for Type 2 Diabetes ifferent types of circulating polyunsaturated fatty acids (PUFAs) are associated with differing future risk of type 2 diabetes according to a large European study authored by Nita Forouhi of the MRC Epidemiology Unit at the University of Cambridge United Kingdom and colleagues and published as part of the PLOS Medicine Special Issue on Diabetes Prevention. Most dietary guidelines recommend the consumption of polyunsaturated fatty acids for cardiovascular health but it is unclear whether or how the individual types of omega-3 and omega-6 polyunsaturated fatty acids are related to type 2 diabetes. In particular there is ongoing controversy on the health effects of linoleic acid the most abundant omega-6 fatty acid. The researchers measured circulating PUFAs in the blood samples of individuals from eight countries in Europe who were part of EPICInteract the world s largest study of new-onset type 2 diabetes. They compared baseline levels of 11 different PUFAs (four long-chain omega-3 PUFAs and seven omega-6 PUFAs) between 12 132 individuals who sub- D sequently developed type 2 diabetes over a follow-up period of approximately 10 years (n 12 132) and 15 919 individuals in a sub-cohort representative of the whole EPIC study population. After adjusting for a number of factors that might influence risk of type 2 diabetes (e.g. age sex body mass index physical activity socioeconomic status smoking alcohol diet and preexisting health conditions) they found that higher levels of omega-6 linoleic acid which originates from diverse food sources including vegetable oils were associated with a lower risk of future type 2 diabetes. In contrast higher levels of four other minor individual omega-6 fatty acids were associated with higher type 2 diabetes risk while omega-3 fatty acids typically derived from fish or seafood sources were not associated with future diabetes and alpha linolenic acid a plant-origin omega-3 fatty acid was associated with a lower diabetes risk. The authors acknowledge limitations of their research including their inability to distinguish between dietary and metabolic influences on circulating blood PUFAs the possible residual role of other factors that they accounted for in the analyses and the observational nature of their research but their use of blood biomarker fatty acids helps to reduce issues of measurement error that arise from using dietary self-report that relies on questionnaires. This research does not support any adverse association of the major omega-6 PUFA on the development of type 2 diabetes. By combining large-scale population data with advanced laboratory analysis their research highlights a case to look more closely at the contribution of individual types of circulating polyunsaturated fatty acids rather than placing emphasis on the entire class of polyunsaturated fatty acids. For more information visit Vitamin D Levels Predict Risk of Brain Decline in Chinese Elderly esearch conducted by Duke-NUS Medical School and Duke University has associated low vitamin D levels with increased subsequent risk of cognitive decline and impairment in the Chinese elderly. Produced primarily in the skin upon exposure to sunlight vitamin D is necessary for maintaining healthy bones and muscles. It is now believed to also play a significant role in maintaining healthy brain function. An increased risk of cardiovascular and neurodegenerative diseases has been observed in those with low vitamin D levels and studies from Europe and North America have linked low vitamin D levels with future cognitive decline. This study asks similar questions of vitamin D levels and cognition in the Chinese elderly. It is the first largescale prospective study in Asia to study the association between vitamin D status and risk of cognitive decline and impairment in the Chinese elderly. One R thousand two hundred and two study subjects greater than or equal to 60 years of age from the Chinese Longitudinal Health Longevity Survey took part in this study. Their baseline vitamin D levels were measured at the start of the study and their cognitive abilities were assessed over two years. Regardless of gender and extent of advanced age individuals with lower vitamin D levels at the start of the study were approximately twice as likely to exhibit significant cognitive decline over time. In addition low vitamin D levels at baseline also increased the risk of future cognitive impairment by two to three times. Although this study was conducted on subjects from China the results are applicable to regions in Asia where a large proportion of the elderly are ethnically Chinese like Singapore said Professor David Matchar first author of the study and director of the Health Services and Systems Research Program at Duke-NUS Medical School. These findings reinforce the notion that vitamin D protects against neuron damage and loss and call for more intensive investigations into the effects of vitamin D supplements on cognitive decline. Better understanding of the mechanism by which vitamin D protects neurons may help identify effective interventions to stem the rapidly increasing prevalence of cognitive decline observed in aging populations. For more information visit September 2016 40 Nutrition Industry Executive Not if the natural products industry has anything to say. Manufacturers and experts silence the critics by taking ownership of all facets of compliance and traceability. By James J. Gormley The Participants Are Tony Blanch Director of Quality and Corporate Services Nutraceutix Redmond WA John B. Atwater PhD RAC CQA Senior Director USP Verification Programs United States Pharmacopia (USP) Rockville MD Christen Davis Senior Quality Assurance Manager Capsugel Greenwood SC C ompliance and quality are essential to maintaining consumer trust in the natural products arena. NIE discusses with industry experts the current status and where improvements can be made. NIE What are the biggest challenges to compliance and transparency for finished product manufacturers and suppliers claims GMP (good manufacturing practice) standards sourcing or something else and why Pontiakos Compliance and transparency start at the source and continue throughout the whole supply chain. Since adulteration and contamination can occur at any point in the supply chain every point is linked and presents a challenge. Sourcing is the most complex function of our industry not only because the raw materials and ingredients are geographically dispersed but because of differing currency language local regulations quality seasonality weather and much more. Once sourced George Pontiakos President and CEO BI Nutraceuticals Rancho Dominguez CA September 2016 manufacturing processes can influence compliance and transparency. Cross contamination with other products environmental contamination mix-ups and mislabeling could lead to poor quality material. These can be avoided by implementing good manufacturing practices. Blanch Evolving customer perceptions of quality and compliance are a significant challenge. Vocal consumer groups can drive product managers to ask for layers of raw material and product compliance that may be poorly defined may compromise supply chains or product stability or legal liability. Recent examples include GMOs (genetically modified organism) glutenfree claims total and added sugars free of or Made in USA claims. The GMPs have been in place for several years and dietary supplement contract manufacturers should be fully compliant. Dietary ingredient suppliers should be well along the path to FSMA (Food Nutrition Industry Executive 41 Safety Modernization Act) compliance with some tweaks to their current traceability and security programs. Davis Based on individual customer feedback as well as a recent Capsugel survey of 90 manufacturers and devel- opers the top concern among product manufacturers and suppliers is understanding the regulations for claims. An example is clean label claims a sensitive subject for many consumers. Despite the wide recognition of the term clean label there s no clear definition. Clean-label consumers however expect these ingredients to be limited more natural less processed made with familiar ingredients and clearly labeled. But without specific guidelines product manufactures and developers resort to free from proxy wording-- free from preservatives allergens gluten additives pesticides artificial sweeteners artificial colors artificial flavors and genetic modification to name a few. They also look to certifications to communicate quality to this consumer segment particularly vegetarian vegan non-GMO kosher halal and organic. Atwater One of the biggest challenges to compliance and transparency involves GMP standards and sourcing as it relates to the quality of dietary ingredients and dietary supplements. The current GMP requirements provide limited assurance that the dietary ingredients and dietary supplements are of adequate and consistent quality across different manufacturers who establish their own private quality standards. Stronger adoption of USP s sciencebased public quality standards by the industry or in the regulations would provide a solution to this issue. Public health is best served when public standards for quality are required as a minimum as is the case with drugs in the USA. Universal adoption of the USP-NF science-based public standards would serve regulators (e.g. FDA) manufacturers and consumers by improving the consistency and quality of dietary ingredients and dietary supplements marketed in the USA. NIE Concerns are sometimes raised about vendors and raw materials from the Asia Pacific region. What efforts and initiatives do you feel will improve the confidence of manufacturers retailers and consumers in the quality and purity of these ingredients and suppliers Pontiakos BI s concerns are never geographic focused they are supplier grower focused. There are professionally managed quality suppliers in every region worldwide. BI s Identilok Program ensures suppliers are compliant irrespective of location. To improve the confidence of manufacturers retailers and consumers in raw materials sourced globally suppliers need to have a stringent vendor qualification program. Quality and purity should start before the raw materials even enter a supplier s facility. A good vendor qualification program provides clear guidelines on specifications test methods and product quality to vendors regular audits of the manufacturing and lab facilities to assure compliance with September 2016 Go to nutraceutix for info about this advertiser 42 Nutrition Industry Executive Go to biova for info about this advertiser GMP and GLP (good laboratory practices) random audits of traceability to assure usage of correct raw materials random sampling and testing to ensure compliance with specifications and oversight of the vendor s entire QA QC (quality assurance quality control) program. Once raw materials enter the supplier s facility the product should be tested before during and after production. At the same time manufacturers also need to make efforts and initiatives to improve the confidence of retailers and consumers by choosing the quality supplier. If a supplier does not allow you to audit their facility a manufacturer should question that. If a supplier has a price point well below the market price a manufacturer should question that. Quality requires capital investment. Atwater The Food Safety Modernization Act (FSMA)--which was signed into law in 2011 and the corresponding regulations that the FDA (U.S. Food and Drug Administration) will begin implementing in September 2016--are expected to have a major impact in helping ensure the quality and purity of ingredients in the supply chain both in the Asian-Pacific region and elsewhere in the world. The intent of FSMA is to proactively prevent contamination and adulteration rather than reacting to it. Two major changes that FSMA is implementing are the new food GMPs in 21 CFR Part 117 and the foreign supplier verification program for importers of foods. These two activities will be centered on hazard analysis and critical control point (HACCP) risk assessments rather than end-product testing which for some manufacturers will represent a paradigm shift. Blanch Contract manufacturers that are GMP compliant should already have raw material qualification programs in place that evaluate and approve vendors and manufacturing sources of ingredients and should be monitoring those ingredients through testing for identity purity strength and known possible economic adulterations. Advertising copy that educates about 44 Nutrition Industry Executive these programs would go a long way to inform the consumer that we are doing everything possible to protect them in the sourcing of materials. A campaign like this should include language that there are economic tradeoffs driving the sourcing of materials from other regions of the world and these costs would naturally be passed on to the consumer. Contract manufacturers that are GMP compliant should already have raw material qualification programs in place that evaluate and approve vendors and manufacturing sources of ingredients and should be monitoring those ingredients through testing for identity purity strength and known possible economic adulterations. -- Tony Blanch Nutraceutix Davis Capsugel has a supplier certification program that includes several key steps in the verification of a supplier from any region of the globe to assure it meets our stringent cGMP screening that the material supplied is safe pure and effective. It includes Creating a purchasing specification based on a validated method and assuring the supplier can meet it. Thorough review of all documentation and descriptions of manufacturing processes. Obtaining certifications from third parties like NSF cGMP ISO 9001-2008 etc. Obtaining three consecutive lots of materials to test against the purchasing specification. Performing onsite audits. All our vendors must go through the same level of scrutiny and meet the same standards as part of the FDA guidelines. NIE Analytical labs play an important role in testing for heavy metals toxins and other contaminants. Discuss why this is so important. Davis Analytical laboratories are important because they secure the safety and security of the global supply chain. They ensure that regulatory specifics are met regardless of where raw materials and ingredients are sourced. By verifying results analytical laboratories provide confidence to manufacturers the overall market and ultimately the end-user consumer. Capsugel considers such analysis so critical that we have conducted our own testing of our capsules both ingredients and final product for our customers. As an industry leader we have deployed state-of-the-art technologies to monitor elemental impurities technologies that are now showing up in regulatory and compendia guidelines around the world. Atwater Analytical labs perform testing for chemical and microbiological contaminants that help manufacturers determine whether or not they have the appropriate in-process manufacturing controls to reduce or eliminate known or suspected contaminants to acceptable levels. In order to obtain accurate and reproducible test results the lab should use validated test methods that have been shown to be suitable for use for the product being tested. USP General Chapter 1225 Validation of Compendial Procedures and 1226 Verification of Compendial Procedures provides guidance to help laboratories ensure that their test procedures can produce accurate and reproducible test results. USP also provides test procedures and acceptance limits for several types of contaminants in dietary supplements including the following for heavy metals and microbiological contaminants USP General Chapter 233 Elemental Impurities--Procedures 2232 Elemental Contaminants in Dietary Supplements 2021 Microbial Enumeration Tests--Nutritional and Dietary Supplements 2022 Microbiological Procedures for Absence of Specified Microorganisms 2023 Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements. Blanch Many times the contract manufacturer does not want to make the large investment in resources to perform these tests themselves or their clients prefer to receive reporting from an independent source. Also having an approved backup lab can help when the company lab is over capacity or with new or novel testing method development. Pontiakos It is far more important to September 2016 Go to msc for info about this advertiser have a supplier that has the analytics in-house relying on outside lab services is a poor path to ensuring a quality product. Defending your marquee is a function of the professionalism of your supplier not on an outside lab result. NIE What are clean-label supplements and what are some of the best examples of this trend today Atwater Clean-label supplements can have a different meaning for each of us but generally a clean-label supplement means a product that has undergone minimal processing and does not contain artificial ingredients genetically engineered ingredients and synthetic ingredients with chemical sounding names. The best examples of clean-label supplements are supplements made in large part with nutrients derived from whole foods. Davis In order for a supplement to be considered clean label the entire dosage form needs to meet their claim requirements including the capsule when the product is encapsulated. Global consumers look for this too preferring vegetarian capsules now desired by 38 percent of supplement users according to SORD studies. But not all vegetarian capsules are alike. Capsugel s portfolio of vegetarian capsules meets the clean-label expectations. Encapsulated products can be free of binders fillers and undesirable excipients. Our capsules are free of gluten allergens artificial colorants starch and preservatives as well as vegan-approved non-GMO and certified by the Vegetarian Society. The selections include the low-moisture Vcaps and Vcaps Plus (HPMC) capsules for moisture-sensitive fills and dry herbal products the acid-resistant DRcaps capsules that are an ideal solution for probiotics and enzymes and the pullulan Plantcaps capsules that provide a more natural way to mask pungent odors like garlic and protect oxygen-sensitive ingredients. Pontiakos Clean label is an ambiguous term there is no formal definition. However most consider clean label as few free-from and minimally processed ingredients as well as natural 46 Nutrition Industry Executive alternatives to artificial colors flavors and preservatives. In the dietary supplement market clean label is usually associated with whole food powders that inherently contain the desired functionality and or nutrient like acerola powder with naturally occurring vitamin C instead of straight ascorbic acid. In order for a supplement to be considered clean label the entire dosage form needs to meet their claim requirements including the capsule when the product is encapsulated. -- Christen Davis Capsugel NIE What about ready-to-use premixes and semi-finished product for custom manufacturing Are there special quality or transparency challenges inherent in product formulations such as these Pontiakos There are definitely special quality and transparency challenges when it comes to ready-to-use premixes and semi-finished products. The closer a product is to a single-component whole form the easier it is to identify it and detect adulteration and contamination. Natural ingredients are already complex products to begin with and multicomponent blends make it more complicated. To address these challenges manufacturers should partner with a supplier who is well-versed in ready-touse premixes and semi-finished products and provide them with as much detail as possible from the very beginning like the botanical species of each ingredient proportions and allowable excipients. Blanch In premixes and blends of multi component dietary ingredients (think enzymes or herbal botanicals probiotic blends etc.) assaying for strength can be challenging but we find assay for identity is most vexing. Under GMP rules identity must be confirmed on each receipt of a dietary ingredient. Complex multi-component blends may interfere with identity testing or small percentage components may simply be impossible to retrieve from the blend matrix. This can be especially difficult when the blend is proprietary in nature and the manufacturer is resistant to disclose formulation. In some cases it is possible to work with the supplier to provide acceptable traceability reporting for identity testing of premixes and then confirm identity based on the reporting from the manufacturer and testing against a custom standard for the blend. In many cases it is easier to buy the individual components test them and build the blend yourself. Atwater In general ready-to-use premixes and semi-finished products for custom manufacturing have the same quality and transparency issues that concern ingredient suppliers and finished product manufacturers. Ready-to-use premixes and semi-finished products are just in-process manufacturing materials. However there are only a few public quality standards for such materials (e.g. Lutein Preparation USP). One should ensure that the ingredients used in the preparation of premixes and semi-finished products comply with appropriate quality standards e.g. USP-NF and FCC standards. NIE What are the steps that raw material suppliers and manufacturers should follow from soil to shelf to ensure quality and traceability Davis Capsugel insists on security of capsule raw materials. Our Supplier Selection and Qualification Program guarantees that our hard capsules meet the highest standards for quality traceability and integrity. This core fivephase program requires critical key raw materials suppliers to undergo an intensive yearlong selection and qualification process to make sure they meet the most stringent regulatory and industry standards that exist anywhere in the world. Here are the five components 1. Preliminary Investigation Reviews the supplier s quality system state of manufacturing technology and scope of products and services offered and determines the supplier s performance September 2016 metrics in details. 2. Manufacturing Suitability Evaluation Assess the crucial issue of whether the supplier s raw materials is compatible with Capsugel s manufacturing processes and protocols 3. Production Trial Use of supplier s raw material in large-scale high-volume production trials at various Capsugel sites to confirm both finished capsule quality and manufacturing efficiency performance levels. 4. Onsite Audit Full traceability exercise and quality system check to ensure compliance with applicable and Capsugel standards 5. Acceptance Contract Formalizes the technical and commercial requirements and expectations including both initial scale-up support and ongoing quality Once suppliers are selected and qualified we consistently monitor them to ensure ongoing quality. The evaluation process assures supply chain traceability and finished capsules that comply with the highest standards. The management involves constant testing and regular in-depth onsite audits. Blanch Know your suppliers--where are they getting materials from are the supplies stable or are they sourcing from whoever is providing this month s low bid Educate your suppliers about the changes coming under FSMA and help them to understand that compliance is not optional and in fact will eventually be demanded by more than their dietary supplement manufacturing clients it will come from their food clients as well. NIE Discuss food and ingredient authenticity. What needs to be done to make sure that economic adulteration and other issues are addressed and overcome as an industry Pontiakos First we not only need to acknowledge economic adulteration and other issues exist but also their prevalence. An issue that is not acknowledged to its full extent is an issue that will not be addressed and overcome. Ever since the actions of the New York attorney general last February lively discussions regarding economic adulteration and how to improve our industry have been more commonplace in client meetings industry conferences and the media. Second we need to improve our standards as a whole from the vendor who provides September 2016 the ingredient to the manufacturer who chooses which ingredient to purchase to the industry association who provides training to the FDA who upholds the standards. We as an industry understand that providing safe product is both an individual and team effort--each organization must do its own part to build a quality supply chain. One bad link disrupts the whole chain. Atwater The presence of products spiked with synthetic drugs marketed as dietary supplements demands the use of innovative tools to protect public health. USP has responded to the challenge by developing General Chapter 2251 Adulteration of Dietary Supplements with Drugs and Drug Analogs. Also the USP food ingredients intentional adulterants expert panel recently created the Food Fraud Mitigation Guidance (FFMG) that provides manufacturers and retailers with Go to kml for info about this advertiser Nutrition Industry Executive 47 a comprehensive practical four-step approach to help perform a vulnerability assessment and develop a customized food fraud mitigation plan. FFMG can help suppliers address some of the requirements of FSMA. Blanch Where there are test procedures available raw material testing as part of new qualification and periodic monitoring should help root out the bad players. Specialized contract labs almost always have a better understanding of current issues in adulteration and how to overcome it through testing. The industry needs to implement a zero-tolerance stance to economically adulterated materials even when the manufacturer doesn t know where it entered their supply chain. Davis Part of Capsugel s Supplier Selection and Certification Program is to make sure we are receiving what we ordered as it should be with any supplement manufacturer. One way to ensure this is to outline contractually enforceable purchase specification standards based on worldwide regulations and guidelines. Some of the key standards are Strict purity criteria Impurity limits to include contaminants elements and solvents Viral safety guarantees for animalderived ingredients (in our case bovine for capsules) Biological safeguards as it relates to GMO Controlled use or absence of allergens NIE Auditing testing of food ingredients supplements and training of production QA QC personnel. What do we need to focus on in these areas big picture and some best-case examples Blanch Choosing a supplier or manufacturer with audited certification or registration of GMP processing is a good first step especially if you understand the certifying body s requirements for compliance. Do they follow up on corrective actions what is the frequency of audits Is it a dietary supplement or food sanitation assessment Is the program rigorous enough to allow you to forgo auditing yourself Adequate training is always a challenge for production facilities and should be part of their GMP program. There should be basic sanitation PPE and safety training before starting work followed by intensified or specialized training on the job. A high employee turnover rate may be an indicator of dissatisfaction or may be related to growth and transfer opportunities in either case retraining new staff members can put a burden on managers and potentially compromise product quality. Davis Following a Quality by Design model Capsugel partners with its manufacturing customers to establish processes that will help them to become more self-sufficient and successful. As part of this model our Quality Engineering Services (QES) can collaborate with them through the entire manufacturing process--from receiving raw materials to supplement applications and production to improving capsule filling productivity for improved profits. For example we can conduct an audit of a manufacturer to assist them in setting up a regulatory foundation for their operation. Another example is assistance in capsule-filling operations either at original setup or to troubleshoot a problem. Matching a capsule-filling machine and capsule for the specific formula has proved to increase filling speed and yield while reducing downtime. In 2014 a survey of 41 Capsugel customers showed a combined aggregate savings of 10 million through improvements in productivity through this model--or 251 000 average per company. With an average capsule spend of 162 000 this represents a 155 percent recovery of the cost of the capsules simply by implementing improvements based on the model. Pontiakos For auditing the focus should be on GMP standards. Vendor s SOP (standard operating procedure) programs testing capabilities laboratory equipment sanitation program process control pest control program are some of the areas that should be evaluated. It is necessary to assess whether or not the vendor follows some form of GMP and GLP in terms of product and document traceability. September 2016 48 Nutrition Industry Executive For testing the focus should be on test method. It is very important for manufacturers to keep in mind that there are several different types of identification methods each with their own advantages and limitations. Since every natural product is different each requires specific test methods to optimally identify the species and plant part. Due to this manufacturers and suppliers need to collaborate with one another to determine the correct test methods to be utilized for each ingredient. As to training of production QA QC personnel when it comes to quality this contributing factor is often not top of mind for most people but it is actually the most important. The facility is only as good as the auditor that visits it. The testing equipment is only as good as the technician that handles it. Knowledgeable employees at every point of the organization is necessary-- from the buyer who is capable of mentoring vendors to the quality department that consists of botanists chemists and microbiologists to the sales representative who can automatically distinguish if their client s specifications are feasible. Not only do employees need to be knowledgeable in their trade but they also need to understand and live by the quality policy of the company. Atwater There is no shortage of auditing services available to manufacturers of food dietary ingredients finished products. USP recently launched a Quality Systems GMP Audited Certification Program for dietary ingredient and supplement manufacturers. USP s GMP facility audit program provides assurance that manufacturers not only meet FDA cGMPs they exceed them. That s because USP s GMP audit program is the only program that requires manufacturers to comply with both FDA and USP GMPs. USP s GMP audit program complements USP s product-focused verification program and can serve as a stepping-stone for manufacturers toward achieving USP s acclaimed dietary supplement USP Verified Seal. With regard to testing USP standards should be used more widely by the industry. Numerous FDA-conducted GMP inspections found that private specification set by manufacturers are often insufficient to ensure adequate quality of dietary ingredients and supplements. USP is recognized for the sciSeptember 2016 As to training of production QA QC personnel when it comes to quality this contributing factor is often not top of mind for most people but it is actually the most important. The facility is only as good as the auditor that visits it. The testing equipment is only as good as the technician that handles it. -- George Pontiakos BI Nutraceuticals ence-based quality standards it establishes for medicines and foods. USP quality standards include specifications for ingredients and finished products that list the tests and test procedures that need to be performed and acceptance criteria for the results of the tests. Tests are performed for an article s identification for purity or content for levels of potential impurities or contaminants and for performance (e.g. finished product disintegration or dissolution). Wider use of USP standards in conjunction with GMP compliance can help ensure quality and consistency of dietary supplements as they do for medicines. USP also provides training opportunities for QA QC personnel through its Pharmacopeial Education (PE) program offerings. USP PE training programs are focused on quality control operations in a GMP setting and cover topics such as setting specifications for ingredients and finished products test method validation and verification and laboratory controls and auditing. NIE Full disclosure and transparency have become more important in the weight-loss sports-nutrition area. What needs to be done to improve things Davis The weight loss sports nutrition market is rapidly expanding beyond the niche elite athletes to active nutrition consumers--you know weekend warriors fitness enthusiasts and general aging population looking to live longer better and wiser. These users just like other supplement users--are seeking clean label products and are consequently scrutinizing the products offered in this category more than ever. Pontiakos The weight loss sportnutrition area can improve things in both the back end and front end. In the front end manufacturers need to make sure their claims are accurate and true not exaggerated. In the back end weight loss sports-nutrition companies should be extra rigorous when screening weight loss sports-nutrition ingredients since they are more at risk for adulteration compared to most other areas. Remember a manufacturer should question if a supplier has a price point well below the market price. For those in the sports nutrition segment you can go even further and get your product NSF Sport Certified. NSF International created this certification program to minimize the risk that a dietary supplement or sports nutrition product contains banned substances. Atwater Stronger adoption of USP s science-based public quality standards by the industry or in the regulations would provide a solution to this issue. However for many weight-loss sportnutrition products new public quality standards need to be developed. USP can develop the necessary sciencebased quality standards for weightloss sports-nutrition supplements and does so following an open and transparent public consultation process whereby input from manufacturers regulators suppliers and any other interested party is considered and evaluated by volunteer experts organized in expert committees. USP is beginning to develop quality standards for sportsnutrition supplements and welcomes input from all interested parties. NIE Extra Extra Visit to read about the effects automation has on compliance and traceability. Nutrition Industry Executive 49 When considering new products or relaunches contract manufacturers help guide brand marketers to success. By Lisa Schofield C ontract manufacturers really do know it all--well at least when it comes to the dietary supplement industry they are on the frontlines of the regulatory environment trends and technology. There have been interesting areas of growth as several have witnessed. According to Chris Martin vice president of operations for Georgia-based Deerland Enzymes consumer buying patterns are frequently affected by both condition and age and the company he said continues to see its customers seek more robust conditionspecific product formulations. Brand marketers are increasingly looking to include enzymes and complementary ingredients that will work together to support a specific health condition. Digestive health is a good example one robust formula to support digestion can include enzymes probiotics prebiotics and even botanicals vitamins and minerals. These types of product formulations are ideal freeing the consumer from having to take several different single-ingredient supplements as part of their daily regimen. Further Martin sees the digestive 50 Nutrition Industry Executive segment of our market is growing at a higher rate than the supplement industry as a whole because research into the gut microbiomeand how it affects overall health is accelerating. Many researchers believe that supporting digestive health and restoring the integrity of the gut barrier will be one of the most important goals of health professionals in the 21st century he added. Emek Blair PhD chief scientist for Valimenta Labs of Colorado observed that increased absorption and bioavailability segment is outpacing the industry at large dramatically. Products such as liposomes and other high bioavailability delivery systems provide market differentiation through increased performance. He added that significant science supporting these products allow for fact-based marketing to connect with consumers. Brand marketers seeking to add new products or renovate existing lines have numerous exciting opportunities available to them. There are also several considerations to keep in mind. John Altenberg vice president of sales for California-based Vit-Best Nutrition advised to have a clearly defined consumer position. When choosing a contract manufacturer he said priority factors should include demonstrated and consistent quality processes and outcome a culture that seeks and provides solutions direct industry experience and management that conveys trust. Consumers expect consistent taste and appearance in their favored products as well as a continual stream of diversity according to Jan Thoele executive vice president of SternMaid America Illinois. If a product fails to meet consumer standards or satisfy expectations they will quickly find an alternative. For manufacturers this means focusing on quality reproducibility and operational flexibility he said. This requires state-of-the-art equipment complete control over the production process and formulas contamination prevention and full documentation of every batch that leaves the plant. According to Martin a prime objective should be achieving efficacious synergy with complementary ingredients. It takes extensive knowledge and September 2016 experience working with enzymes and or probiotics when formulating for supplements. Further when formulating a multi-component supplement blend challenges may be arise in fitting effective doses of all the ingredients into a predefined amount of space (capsule). Also ease of swallowing is a key concern among consumers and we address this issue by formulating with very concentrated enzymes and or probiotics which reduces the size of the capsule or tablet he said. Although FDA (U.S. Food and Drug Administration) compliance cGMP (current good manufacturing practice) certifications and high quality purity are a given noted Blair it is always helpful to have a common thread throughout the product line such as made in an allergen-free facility or made in a gluten-free facility as those are areas of increasing consumer demand. Raw materials he added are important details to be aware of. What type of ingredients are being sourced by the manufacturer For instance when using magnesium citrate is it magnesium citrate fortified with magnesium oxide or is 100 percent reacted mag- nesium citrate This impacts quality and efficacy. Changing Regulatory Environment There are several significant upcoming regulations and issues that will likely impact production. According to Thoele this September the majority of food producers and manufacturers needed to have a food safety plan in place that has been prepared by a preventive controls qualified individual (PCQI). The PCQI he explained is a qualified individual who has successfully completed a training program in the development and application of risk-based preventive controls which is in line with FDA s Food Safety Modernization Act (FSMA). The PCQI ensures that both customer and regulatory expectations are met during the manufacturing process. The simple steps of requiring preventive controls and at the same time food manufacturers to have a PCQI facilitates supplier control for our customers Thoele said. By 2017 pointed out Martin dietary supplement manufacturers must be compliant with the FSMA. For companies like ours who have made investments to achieve and sustain GMP compliance quality really shouldn t be impacted all that much he assured. On the other hand for those companies who have not been strictly adhering to GMP guidelines (and unfortunately there are still some out there) clearly the quality of their products will be impacted. For that reason I believe that ultimately these new regulations will change the way many companies do business and in turn improve the overall quality of the end products for the consumer. Martin reported that are two main additions that Deerland Enzymes will make in order to comply with FSMA. Food defense training is a food safety and defense plan that will be required for all employees its goal is to empower employees to help guard against any type of adulteration whether intentional or in process. Another significant addition will be video cameras and monitors installed in all production areas Deerland Enzymes has already begun the evaluation to plan for installation ahead of Go to vit-best for info about this advertiser September 2016 Nutrition Industry Executive 51 the federally mandated deadline he related. In Blair s view One of the most significant regulations that has started taking effect is the new RDA (recommended daily allowance) and facts panel that will be required by 2018 2019. Every brand owner needs to create a plan to transition to the new regulations by their deadlines. Without being active you could find your products out of compliance overnight he warned. What s New Blair reported that Valimenta Labs recently published the first peerreviewed clinical trial showing that its liposomal technology using liposomal vitamin C increases absorption of vitamin C and prevents oxidative damage during ischemia reperfusion injury (the type of injury that is experienced during cardiac events). This article appeared in the Journal of Nutrition and Metabolic Insight and a summary is on the company website. In tandem he added Valimenta Labs launched its liposomal vitamin C in 30-packet boxes. More clinical studies will be coming out on our liposomal glutathione in regards to mercury and heavy metal detoxification along with data on liposomal curcumin and other ingredients he revealed. And we are the only liposomal manufacturer that is cGMP certified specifically for liposome manufacturing. Recently SternMaid America sfood safety management system has been certified according to FSSC 22000 noted Thoele. On a product-by-product basis we can also offer non-GMO (genetically modified organism) gluten-free vegan kosher and halal certified foods. And furthermore we will soon receive a certificate for the manufacture of organic products. We re also in the process of obtaining current good manufacturing practice certification. Additionally Sternmaid America invested in another blending machine for pilot trials and for the production of batch sample quantities (25-200 kg). The facility will start production by the end of 2016. An extension of its copackaging capabilities is also planned. To accommodate the growing demand for high quality probiotic supplements Deerland Enzymes is expanding its manufacturing capabilities by opening a new state-of-the-art facility dedicated to probiotic supplement manufacturing. The new facility will be focused solely on producing probiotics in their ideal environment. According to Martin the state-ofthe-art facility will feature strict environmental control of temperature and humidity enhanced by sophisticated thermal and airtight building materials. Production suites are constructed of a cleanroom system in which the walls themselves have antibacterial properties. The warehouse includes a walk-in freezer for storage of finished goods and refrigerated storage of raw materials. The linear flow floor plan design of the facility eliminates over-handling and waste from raw material receipt to Go to generexlabs for info about this advertiser 52 Nutrition Industry Executive September 2016 What s Trending C The industry continues to innovate finished goods storage. because that s what consumers are Deerland Enzymes is continuing to demanding. Whether it s a completely invest in clinical studies and develop ontract manufacturers often see new product or line or a renovation of science-backed formulations. At press trends develop and can predict to such contract manufacturers are more time Martin reported the company an extent what may have staying able now than ever to ensure your completed double-blind placebo-conpower which can certainly validate brand brand s success of safe and efficacious trolled randomized clinical studies for marketers investments in production. products. NIE DE111 Glutalytic and ProHydrolase Jan Thoele executive vice president and others are currently underway. SternMaid America Illinois is seeing The entire supplement industry is personalized nutrition as gaining in appeal FORMOREINFORMATION and therefore there are some strong oppor- going through a time which could be Deerland Enzymes (800) 697-8179 tunities in this space. And he believes that it characterized as a clinical revolution in which the demand for clinical valida SternMaid America (630) 270-1100 is simply a matter of evolution Today tion for dietary supplement products Valimenta Labs (970) 825-5173 everything is personalized--the internet Vit-Best Nutrition (714) 832-9700 has never been higher he observed. advertising etc. so why not nutrition Why take a multivitamin product for example when your doctor or nutritionist has discovered that you only have a vitamin A and E deficiency for example he commented. Personalized nutrition he added offers manufacturers the chance to develop an ongoing relationship with consumers. This benefits both suppliers who can build a loyal customer base and consumers who obtain what they deem is a valuable personalized service. More and more people are putting a much stronger focus on what they eat. What with clean label organic and vegan growth consumers are increasingly aware of what constitutes a healthy diet he observed. Chris Martin vice president of operations for Deerland Enzymes of Georgia is seeing three product categories in increasing demand--gummies gluten-free supplements and protein supplements. He reported that an increasing number of the company s customers are interested in using flavored gummies as a delivery system. Consumers are more likely to stick with taking their supplements when they look forward to enjoying them in the form of a gummy. Its probiotic DE111 strain of Bacillus subtilis remains viable under a wide temperature range and processing conditions because of its spore-forming ability making it a good choice for products like gummies. Many of our customers have begun to focus on developing products for those with gluten sensitivity many of whom experience symptoms that manifest in multiple ways. Deerland Enzymes Glutalytic swiftly breaks down gluten proteins and it targets both the internal and external peptide bonds of gluten Martin said. Protein supplements continue to grow in popularity he continued. While whey has been a mainstay the demand for plantbased proteins such as soy rice hemp and pea is on the rise. ProHydrolase has been shown in two clinical studies to break down protein into smaller peptides in order for it to be used by the body for muscle recovery as intended and also reduce potential for digestive discomfort. Go to adh for info about this advertiser Nutrition Industry Executive 53 September 2016 With immune response in a constant state of adaption consumers interest in long-term natural approaches to health holds open the door for growth in this strong category. By Janet Poveromo T hough the function of our immune system may change throughout each of our life stages one of the biggest things we can do to help us be well and stay well is to have the proper nutrition to ensure our immune system is ready when we need it the most. Wisconsin-based Kerry s Donald Cox PhD research and development director-- Wellmune noted that looking at three distinct life stages--childhood active adulthood and aging--general immune health concerns can include 1. Childhood Children s immune systems are still developing so colds and other health issues can become more abundant because their bodies have yet to recognize and immediately attack many of the viruses that can impact their health. 2. Active Adults By the time we enter the adult stage of life our immune systems have matured and have learned to fight off most major pathogens whether through natural 54 Nutrition Industry Executive exposure or vaccination. If we lead healthy lifestyles and have decent genetics our immune systems should be in a relatively strong responsive state. But a major health issue adults face is the suppression of the immune system due to physical and physiological stress levels. Stress may prematurely age the immune system and can enhance the risk of illness such as upper respiratory tract infection symptoms as well as age-related diseases. 3. Aging As people age the body produces fewer immune cells the communication between cells breaks down and responses to health challenges diminishes. For seniors and aging populations the slow decline of immune function can significantly impact overall health and vitality yet the desire for an active lifestyle remains the same. To combat this older adults are aware of the importance of their immune health and its implications on the development of major health issues both short and long-term. Seniors need clinically proven support to help aid healthy aging by helping improve the overall effectiveness of key immune functions. Susan J. Hewlings PhD RD chief science officer IgY Nutrition in Oklahoma also pointed out that defining what can cause problems with immune health is a difficult thing to quantify because potentially all health problems are connected to the immune system. Immunity is not static but in a constant state of adaptation in response to environment lifestyle and the bacterial balance of the gut microbiome she said. It appears that dysbiosis is at the core of the majority of health related issues including diabetes metabolic syndrome arthritis irritable bowel syndrome colitis and more. And although consumers seem to show more interest in supporting their immune health during the winter months said Elodie Ruffin probiotics marketing manager with Lesaffre Human Care it is worth noting that they are increasingly aware of the need to September 2016 maintain a powerful immune system at all times in order to stay healthy year-round. Modern Society Immune Health Issues Megan DeStefano probiotics global marketing leader with DuPont Nutrition & Health in Wisconsin pointed out that chronic inflammatory diseases account for much of the health care burden of Western societies and the U.S. is no exception. In the United States we spend more on health care yet we have poorer health outcomes with greater prevalence of chronic diseases and shorter life expectancy than other Western societies such as the U.K. Among the list of most prevalent inflammation-related diseases in the U.S. are allergies and asthma and inflammatory diseases of the bowel such as Crohn s disease and colitis. The underlying causes of the most prevalent diseases are related to our modern society and all the technological advances it provides. The alteration of our natural microbiome is recognized as one of the contributing factors to this current state. Pinning down exactly who are affected by poor immune systems prove difficult. Tim Hammond vice president sales and marketing with Bergstrom Nutrition in Washington agreed that the number of Americans who have some slight immunological issues is relatively high though no concrete numbers exist for concerns that are difficult to diagnose and rarely reported. The primary causes stem from chronic inflammation and stress-related factors. Chronic inflammation can arise from environmental factors like toxins or lack of physical activity and from dietary factors like high levels of sugar or toxins. Stress itself whether physical or psychological has an immunosuppressing effect and is ubiquitous in the fast-paced American culture. On a positive note according to Cox consumers are taking a long-term approach to their health moving from reactive short-term fixes to a more pro-active preventative approach. He pointed to a Natural Marketing Institute report (2015) which stated 76 percent of U.S. consumers said that consuming healthy nutritious foods is important in how they achieve a healthy lifestyle. We believe this is leading to an increased understanding that immune health is the foundation to overall wellness is leading to a growth in consumer demand for functional products across multiple market segments. Because of this consumers are paying more attention to the nutritional value of the ingredients in their foods and are looking for safe natural and effective products that help benefit their overall health and wellness he said. Consumers such as children and families athletes and active adults and aging consumers are looking to boost their immune health through nutrition and functional prodSeptember 2016 ucts in ways that are more convenient and natural. Today s increasingly health-focused consumers are going back to the basics when it comes to what they eat according to Nielsen s Global Health and Wellness report and the overall survey results confirm the trend by revealing that the most important health attributes influencing purchase decisions are fresh natural and minimally processed. More and more people are indeed turning to products containing natural ingredients not only for themselves but even more so for their offspring said Ruffin. Indeed every parent wants what s best for their kids and natural ingredients are perceived to be healthier and safer than standard products although a formal definition of the term natural has yet to be issued by the FDA (U.S. Food and Drug Administration). According to Euromonitor International the American dietary supplements market targeting immune health has been consistently growing for several years ( 9.5 percent CAGR between 2010 and 2015) and is estimated to be more than 1.5 billion dollars. In addition Euromonitor estimates global sales of healthy food and beverage products are to reach 1 trillion by 2017. Gilbia Portela marketing manager NutraQ AS in Norway made note of the Euromonitor stats and also pointed out that U.S. consumers of dietary supplements are generally concerned about immune health. In the U.S. immune health consistently appears in the top five health concerns of supplement users according to the Council for Responsible Nutrition Consumer Survey on Dietary Supplements [2013 2014] she said. This is increasing to the demand for immune health ingredients for functional foods according to Mike Bush president of Ohio-based Ganeden executive board president of the International Probiotics Association. The market for immune health ingredients continues to grow especially in foods and beverages he said. Overall health including immune health is becoming a large focus for consumers. A recent consumer survey shows that consumers want ingredients that support immune health in a variety of categories. For example out of the respondents who did not typically purchase snacks healthy consumers would be 34 percent more likely to purchase a snack product if it had immune benefits. Peter Agostino vice president product development with Florida-based Viva 5 Corporation agreed and added that Immune Health Ingredient Go-tos H ilde Raa scientific manager with NutraQ AS said nutritional factors such as vitamins C D and selenium have been used as immune health ingredients for many years. They are essential for the normal function of the immune system and many people do not get enough of those through their normal diets. Vitamin C has a strong reducing potential and its key role is to maintain the redox balance in cells and tissues she said. Vitamin C is involved in numerous metabolic processes in the body but is also involved in immunological functions within both the innate and the acquired parts of the immune system. Immune cells use vitamin C as an intracellular radical quencher. During infections when reactive oxygen species (ROS) accumulate within the immune cells the consumption of vitamin C increases. This results in a decline in the concentration of vitamin C and need for additional supply. A number of studies in humans and other species underline the functional significance of vitamin C in infection resistance [Hemil 1999] and it has even been suggested to work in synergy with yeast beta-glucan in stimulation of immune system [Vetvicka 2014]. In addition Beyond its classical role on bone metabolism vitamin D has now been widely accepted as an important factor for proper function of the immune system. Vitamin D plays important roles in signalling during both the adaptive and innate immune response to viral and bacterial infection and epidemiological observations have revealed that there is a link between vitamin D deficiency and susceptibility to upper respiratory tract infection (URTI) [Ginde 2009]. Selenium is an essential micronutrient. It is present in soil and enters the food chain through incorporation into plant proteins. The selenium level in Scandinavian soil is low thus plants and grains produced here contain less selenium than those grown elsewhere and people living here risk getting too little selenium though their diet. Selenium is incorporated into proteins to make selenoproteins a class of enzymes which is important for many biochemical processes in the body including regulation of immune responses. Selenoproteins are necessary for proper function of both the innate and the acquired parts of the immune system. In immune cells selenoproteins perform antioxidant functions carry out protein folding and promote certain cell signalling events during activation [Huang 2012]. Nutrition Industry Executive 55 probiotics are the next wave of immune supplements. It is now well established that 70 percent of the human immune system is tied to the gut. As our gut flora is tied to our body s immunity supplementing with probiotics helps bolster immune defense. Highly researched probiotic strains are becoming more popular in the category. Probi probiotics for example have more than 50 clinical studies attesting to their quality safety and efficacy. Trends and News Suppliers have named a number of trends they are seeing in the immune health category such as a segmentation of the offering. We are seeing more and more products targeting a specific portion of the population seniors children athletes travelers Ruffin observed. Our immune health is constantly challenged through our daily lives and we are seeing the launch of products adapted to each of these occasions which could deplete our natural defenses. Innovative formats are also gaining grounds such as gummies and a wide variety of functional foods and drinks offering fun and creative alternatives to pills and powders. The market has moved beyond straightforward vitamins and minerals associated with the immune system and into new products with benefits beyond addressing deficiencies added Hammond. Consumers are looking for broader solutions to a complicated issue. At DuPont DeStefano offered more trend insight. We have seen the immune health category evolve from a reactive-only approach-- I have a cold and need something to help me with my symptoms --to also include a proactive approach to managing immune health-- help me stay healthy so I don t catch a cold. She noted while consumers are spending more time proactively managing their health they are also expanding the ways in which they think about health and wellness. Consumers consider food and nutrition just one piece of the puzzle for maintaining immune health they are also starting to consider stress management sleep quality and other softer pieces of wellness when consid- ering their health management. To be successful it will be important for food beverage and supplement manufacturers to understand how their products fit within consumers everevolving definition of health and wellness. There are clearly strong trends in favor of natural immune health and rising sales in this category. However there is still a gap between interest in functional foods and beverages and actual purchasing behavior. In a 2013 U.S. consumer study 88 percent of consumers were interested in purchasing functional foods and beverages to improve immune system but only 40 percent were actively purchasing in this area (Datamonitor Health & Wellness Trends in Food & Drink April 2013). We believe this is why we have seen strong growth in immune health over the last few years and that there is still room for continued strong growth in this category DeStefano continued. Ganeden has also seen a new focus on digestive health in connection with immune health said Bush. Seventy percent of the body s immune cells are located in the digestive system--which means digestive health has an impact on immune health. The immune cells in your digestive tract share the space with over 400 species of naturally occurring bacteria--both helpful and harmful. Go to aic for info about this advertiser 56 Nutrition Industry Executive September 2016 Go to bergstrom for info about this advertiser the immune system etc. cytokines and HSCRP. Dysbiosis According to Hewlings the connection between dysbiosis and immunity and the role that pro and prebiotics can play in correcting dysbiosis and thereby improving immune function. In addition the research indicating Keeping a healthy level of the good bacteria that 70-80 percent of the immune system originates in the GI (gastrointestinal) tract has or probiotics is key to maintaining both changed the way we look at health. digestive and immune health. Thanks to our I think this scientific awareness has lead patented and science-backed strain to the recognition that many of the lifestyle GanedenBC30 consumers can now get their diseases are connected to obesity and dysdaily dose of probiotics through everyday biosis and its effect on immunity and the foods and beverages (even outside of the associated inflammation Hewlings said. refrigerated dairy category) without taking a Which in turn is connected to the concept pill. that an unhealthy diet harms your short and Ruffin too said Lesaffre is witnessing the rising popularity of functional foods and bever- long term health beyond just being overweight. The discovery of the role that the GI ages among consumers who are looking to tract plays in lifestyle disease immunity consume products offering a specific health inflammation cognitive function diabetes benefit in order to achieve wellness through diet. Indeed functional foods commonly refer and so much more has advanced health and medicine and helped to change the way we to foods which may have a positive effect on look at disease. We no longer look at dishealth extending beyond basic nutrition. eases as disconnected separate conditions Nowadays strolling through the aisles of your instead there is awareness in the medical favorite grocery store it is not uncommon to community and now the mainstream that see cereal bars and chocolate enriched in prothese diseases are connected and need to be biotics or specialty coffee designed to support addressed as such. Addressing GI tract health and any potential dysbiosis is the place to start in improving overall health that therefore automatically addresses the underlying cause of so many conditions. In addition to a healthy diet pro and prebiotics help to correct dysbiosis. IgY Nutrition s IgY Ma works along with probiotics in that it helps to change the composition and activity of the microbiome according to Hewlings. IgY antibodies contained in IgY Max help the body eliminate only the harmful bacteria and leave the good microbes intact. IgY antibodies are antibodies from chicken eggs. They work by significantly reducing harmful bacterial adhesion and growth in the GI tract helping to minimize inflammaGo to somalabs tion by decreasing 58 Nutrition Industry Executive Ingredient and Product Offerings As Cox mentioned consumers are looking for more convenient and natural products that are clinically proven to keep them healthy daily. In the children s category gummies and ready-to-drink (RTD) beverages are big he said. For example Wellmune was recently incorporated in to two new dairy based products and a children s gummy Olly Kids Mighty Immunity released by Olly at Target stores. In the sports nutrition market we ve typically seen products that focus on building muscle or fueling endurance Cox added. But clinical studies demonstrating the impact of high-intensity exercise on the immune system has athletes coaches and nutritionists focusing on ways to help athletes stay well so training days and performance goals are not missed. We see an opportunity and trend for product manufactures to create innovative stand-alone or dual benefit products focused on immune health for athletes. These products can also have crossover appeal to recreational athletes eager to emulate the elite athletes they admire. Two new products with Wellmune highlight the demand for immune support for athletes including BodyShield Immunity Plus by Healthspan Elite a leading U.K. sports supplement company and Gold Standard BCAA Train Recover by Optimum Nutrition Inc. a leading sports nutrition manufacturer based in the U.S. While Wellmune is a natural yeast beta 1 3 1 6 glucan probiotics are also leading the charge in the category. Hewlings said There are the familiar ingredients such as vitamin C and zinc and echinacea but vitamin D and elderberry have risen to the forefront. However the top ingredient in the immune market is probiotics. Probiotic foods were a nearly 7 billion industry in 2013 according to NBJ and is projected to jump 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. DuPont s ingredient offerings include HOWARU Protect Adult (Bl-04 Bifidobacterium lactis) a clinically documented probiotic solution that helps active adults stay healthy. HOWARU Protect Sport (Bifidobacterium lactis Bi-07 and Lactobacillus acidophilus NCFM) is a documented probiotic solution to help physically active adults stay healthy for optimal sports performance. HOWARU Protect Kids (Bifidobacterium lactis Bi-07 and Lactobacillus acidophilus NCFM) is a blend of probiotics that helps promote optimal health in children and helps keep children healthy. HOWARU Protect EarlyLife (Lactobacillus rhamnosus HN001) supports immune health of expectant mothers and infants. A study on HOWARU Protect EarlyLife September 2016 showed the prevalence of eczema at two years of age was decreased by 49 percent in the group taking HN001 and persisted until six years of age when the presence was found to be 44 percent lower in this same group. At four years of age in the group supplemented with HN001 the relative risk of rhinoconjunctivitis (rhinitis and red eyes) was found to be 62 percent less At six years of age the group supplemented with the probiotic had decreased cumulative presence of positive skin-prick tests (indicating allergic sensitization) by 31 percent. At Lesaffre Human Care Ruffin said with its ability to increase human sIgA levels (our first line of body defenses) by creating a twofold protective effect the company s LifeinU Bacillus subtilis CU1 can help maintain a powerful immune system at all times helping consumers stay healthy and perform well every day. It can also provide long-term support to healthy people at risk of weakened immune defenses such as the elderly people suffering from chronic stress undergoing intense training etc. she said. Being highly stable LifeinU BSCU1 can survive extreme conditions which allows it to deliver its health benefits through a diverse range of dietary supplements as well as food and beverage applications. Offering immune support without side effects or habituation LifeinU Bacillus subtilis CU1 is a safe and effective prevention strategy perfect to empower consumers immune response. It is important to keep in mind that not all probiotics will have the same action and efficacy as the effects are strain-dependent Ruffin said. As live microorganism they can also be affected by their environmental conditions and it is important to make sure that the strains chosen are capable of surviving manufacturing processes and exposure to the gastrointestinal tract. Therefore there is a need for scientific evidence of the beneficial effect of each strain before it can enter the market as a health-promoting ingredient. Categories such as probiotics and immunobiotics are gaining traction for immune health Agostino confirmed. The most promising types of products shown to counteract upper respiratory tract infections (URTIs) as well as other infections at different locations of the body are probiotics and immunobiotics. As for probiotics well-designed clinical trials have demonstrated that specific probiotic strains can be used as preventive and therapeutic agents in upper respiratory tract infections with good results both in adults and in children. In a recently published Cochrane review it was stated that probiotics were found to be better than placebo in reducing the number of participants experiencing episodes of September 2016 acute URTI by about 47 percent and the duration of an episode of acute URTI by about 1.89 days. Probiotics may slightly reduce antibiotic use and cold--related school absence. Side effects of probiotics were minor and gastrointestinal symptoms were the most common. Immunobiotics such as Immuno-LP20 are a recent advancement in probiotic research. They are microbes that promote immune system health by stimulating various mechanisms of gut immunity Agostino said. Immunobiotics share traits with probiotics but work more directly to influence the 70 percent of our immune cells located in the digestive system promoting immune function Agostino said. The GanedenBC30 probiotic is used in more than 500 food and beverage products internationally many of which promote immune health benefits Bush said. Our studies show that when consumed daily GanedenBC30 supports the immune system and helps the body make the right choices to defend itself. Because of Ganeden s peerreviewed and published research the claim can be made on product packaging that GanedenBC30 supports immune health. Another ingredient option is Bergstrom Nutrition s OptiMSM which benefits the immune system by addressing chronic inflammation through reducing levels of inflammatory cytokines within the body and maintaining a proper inflammatory response. MSM also supports glutathione an internal antioxidant that is fundamental for healthy immune function and prevents immunosuppression caused by strenuous activity. tions What peer-reviewed research supports the health benefit of the specific functional ingredients under consideration What benefit claims does the research support Are the claims compelling enough to help increase market share Will the claims and supporting research withstand scrutiny from regulators and consumer interest groups NIE Extra Extra Visit to see a video on how yeast beta-glucan supports immune health. FORMOREINFORMATION Bergstrom Nutrition (360) 693-1883 (888) 733-5676 ((888) SEEK-MSM) DuPont Nutrition & Health (800) 255-6837 Ganeden (440) 229-5200 IgY Nutrition (405) 242-5380 Kerry (608) 363-1200 Lesaffre Human Care 33 3 20 66 68 34 Nutra Q AS 47 21 95 12 00 Viva 5 Corporation (727) 871-8124 The Focus for Formulators At Kerry Cox concluded that It is our belief that efficacy is key and stressed that successful functional food beverage and supplement products start with safe efficacious ingredients supported by numerous peer-reviewed clinical studies. When evaluating the efficacy of an ingredient formulators should ask four ques- Go to americanlaboratories Nutrition Industry Executive 59 MarketingInnovations By Todd Pauli The Shelton Group he most rewarding aspect of moving to the agency side of our industry a few years back has to be the many conversations with clients. Sure wearing a t-shirt to work whenever I feel like is great too but it doesn t beat discussing the launch of a new brand with a founder creating opportunities for a passionate industry member to provide education promoting best practices or helping an industry veteran figure out the best way to move a brand forward. Seeing the industry grow from this vantage point helping figure out the details and constructing and executing marketing plans that help companies flourish provides a perspective on what works and what doesn t in our industry. With the October SupplySide show being the place where 2017 ad con- T tracts are first discussed important meetings with industry editors occur and companies reveal impressive new trade show booths Suzanne Shelton and I thought this was the perfect time to share a few things we ve learned over the years. So here it is a few tricks of the marketing trade we hope you find helpful this fall forms of advertising that have emerged in recent years. Advertising Many times large brands advertise because it s been part of their marketing mix for so long but they often feel it s difficult to really know if the spend is working. For newer companies advertising can seem like a large expense among all of the other startup costs. The key to smart advertising no matter what stage you re in is to plan and track results while taking advantage of more content-driven Tracking Results Keeping track of ad placements and the audiences they reach is important to determine the success of your current campaign but it s equally important to help you figure out what to buy next year as ad contracts come up for renewal. For print ads keeping track of your placements and the total audience reached helps you understand the effectiveness of your ad buy. These numbers are useful as you negotiate placements. Break down your total spend with each media outlet to determine your cost-per-thousand or how much money it takes to reach a thousand people given the outlet s audience numbers. If you re paying September 2016 60 Nutrition Industry Executive higher rates with one particular media outlet make sure there is a good reason such as a more tightly targeted readership or higher inquiries from that audience. If not it s time to renegotiate or rethink your placements. Digital ads make measuring much easier as you ll have access to concrete numbers regarding views and clicks on your ads. These stats compared to the relative amount you are spending to get them will help determine where to put more digital ad dollars next year and where to pull back. Digital ad performance with a particular media outlet can also help determine if you re reaching the right audience using their print opportunities as well. While many reps will tell you the audience between their print and online readership varies we haven t found that to be the case generally speaking. It s safe to say if your digital ads aren t performing you re likely not hitting a better audience in print with the same media outlet. Look at Content Opportunities Over the last two years we have seen paid content marketing emerge in full force across our industry. We re seeing web seminars eBooks reports infographics and videos emerge as significant information sources from several trade publishers and they all need sponsors and content. Paid content marketing refers to the content programs industry media outlets are offering as opposed to the blog posts or other inbound marketing programs you have set up internally. I have been impressed by the design and depth of these programs and they have performed well for our clients. Paid content programs pull together educational content meant to benefit an audience while simultaneously promoting your brand. As a brand owner you are paying for access to the media outlet s audience which is likely larger than the audience you could pull from publishing the content internally. Good content programs work because they seek to engage potential customers with information they are interested in consuming. They operate on the basis of integrating into a potential buyer s search for useful information versus on the basis of trying to interrupt a buyer s search for information by prompting them to notice an ad. September 2016 Plan Your Audience s Experience If your digital advertising programs are working you ll see a significant influx of traffic to your site and how you choose to engage this audience can make a huge difference in whether or not you grow sales as a result. While the vast majority of links from both banner ads and content programs lead back to the sponsoring company s homepage there is no rule that says they have to. If a user clicks through to your site the more relevant the content the more likely they are to spend more time and get to know your capabilities. For instance if a banner ad touts the effectiveness of your curcumin is there any reason to dump the users who click the ad onto the homepage of your site hoping they search and find your curcumin product Instead try linking to a landing page containing a two-minute video of your chief scientist explaining the benefits of your curcumin along with prominent links to your curcumin product page and a contact form to request more information. With all of these advertising tricks of the trade it helps to think in terms of campaigns. Advertising a different product on each website where you purchase ads will make it hard to track results and plan for maximum engagement once a user clicks through. If you run a campaign across media outlets in an organized way you ll only have to plan once and you ll have an easier time comparing results across the board. motional in tone. Authenticity in content makes you a valuable resource and reinforces your leadership role. While some people think of PR as just sending out news releases that s far too simplistic a view. While they certainly have their role when you have real news to convey becoming a useful and reliable source for writers and editors is far more effective and increases your opportunity for visibility exponentially. For one of our clients that means every time product testing is written about their input is requested. Last year that totaled 90 separate editorial placements which must be a world record (that half killed us all to set). For another it means not only when specific herbs are covered but also the many conditions their products address. Doing this effectively means you give the writer substantial answers to their interview question (and always try to do this in writing rather than on the phone) on deadline. Advertising and PR should go hand in hand. While the ad sales department and editorial departments are separate keep in mind that the reason they are able to publish the articles to which you contribute is because they are supported by advertising dollars. Think of it more as mutually beneficial rather than pay for play a subtle but distinctive difference. As you head into the busy fall season we hope a few of these tricks of the marketing trade will help set your brand up to be successful for the rest of the year and well into 2017. NIE Weaving PR Into the Marketing Mix While PR and other forms of marketing have distinct differences in what they are and how you should approach them working together they make the sum greater than its parts. With content marketing the lines between advertising and PR can blur so it s important to keep their roles separate in your mind when they are being produced. Sponsoring a web seminar puts your brand name on it and gives you access to the leads it generates. It also says to the attendees that you are a leader on a topic they are interested in. When you have the opportunity to also provide content which happens sometimes but not always it s essential that content be strictly educational rather than pro- The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Todd Pauli works with clients to develop comprehensive marketing strategies that integrate social media advertising and content marketing. Prior to joining The Shelton Group Pauli led marketing communications efforts for several well-known businesses including NOW Foods one of the largest supplement manufacturers in the natural channel. Contact him at Todd Nutrition Industry Executive 61 FunctionalFoods Antioxidants have been around for years but new approaches for functional foods gain interest. By Nicholas Saraceno W hen one is out looking for nutrients the initial response may be to lean toward multiple ways of absorbing them such as by ingesting probiotics (in pill form) one s standard vitamins and taking supplements. Now the same statement can be made regarding antioxidants. Antioxidants which according to the National Center for Complementary and Integrative Health are man-made or natural substances that may prevent or delay some types of cell damage can also be consumed via functional foods. It comes as no surprise that people are in full support of keeping their trillion-plus cells in good standing. After all one only has limited chances at eating and living a healthy lifestyle. Antioxidant Benefits Antioxidants come in the form of many different vitamins and minerals with the most common ones including vitamin A (the body converts it from beta carotene) vitamin C vitamin E selenium 62 Nutrition Industry Executive and manganese. They could be consumed in a variety of forms whether it be liquid (via teas or red wine for instance) or traditional solids. Originally these were solely ingredients that were found in fruits and vegetables such as blueberries apples eggplant and spinach but their impact has expanded into other everyday foods cereal sports bars and beyond. Other ingredients are even beginning to emerge as more popular than the originals including turmeric. Soluble solutions are also emerging from the pack by yielding positive results with studies to prove it. Natreon s standardized aqueous extracts Capros (amla) for cardiovascular health AyuFlex (Terminalia chebula) for joint health Ayuric (Terminalia bellerica) for hyperuricemia are emerging antioxidants with multiple efficacy and safety studies to substantiate their health claims said Dr. Aparna Kalidindi technical sales and marketing manager with Natreon Inc. in New Jersey. For example Capros has shown to improve endothelial function increases nitric oxide levels by 50 percent increases HDL by 20 percent and decreases LDL by 25 percent. AyuFlex improves joint health by decreasing mWOMAC scores by 36 percent compared to placebo. Ayuric decreases uric acid levels by 28 percent compared to placebo and was 60 percent as effective as the prescription medication febuxostat. Another antioxidant ingredient that has flown under the radar as of late is glutathione which according to John Deaton vice president of science and technology at Georgia-based Deerland Enzymes is essential to the body. You might call it nature s strongest antioxidant --all living organisms have it and it serves as a recycling pathway noted Deaton. It contributes directly to the destruction of reactive oxygen compounds and maintains recycles vitamins C and E which also exert an antioxidant effect. It s a small peptide making it more accessible and easily absorbed. There are several foods and ingredients September 2016 that stimulate the production of glutathione in the body such as milk thistle. Nonetheless regardless of how beneficial antioxidants have showed to be their success truly relies on consumers decision to support and approve of them in the marketplace. Status As Steve Siegel vice president of New Jersey-based Ecuadorian Rainforest LLC noted the state of the market for antioxidants is stable and poised for growth due to the fact that consumers are becoming more aware of their various health benefits. This statement only proves to be truer when functional foods are part of the equation. When added to functional foods antioxidants may do even better due to the added benefits from other nutraceutical ingredients added Siegel. Consumers want to get their nutrients as easily as possible and functional foods help them achieve that goal so when antioxidants are added into functional foods it can only help the category grow. In essence just as an individual might start to reach for allergy medication when springtime approaches shoppers will tend to lean toward products that promote heart health and general immunity. Even more so this is the case for a portion of the older generation. According to Sloan Trends Healthy Agers is an identifiable 57 million person-strong Boomer sub-segment who are ready to make changes to their diets and lifestyles in the interest of remaining healthy and active said Deaton. It is predicted that this group will reach 33 percent of the adult population by 2020. Top health concerns among this target are weight heart health joint digestive health and energy levels. From companies perspective they are also benefitting from consumers desires for these products. Consumers are continuously in search of new products and they usually look to food first for enhanced nutrition and benefits added Deaton. As functional ingredients antioxidants are very appealing to food companies that are seeking to expand product lines and excite consumers. reducing ability of plasma (FRAC). However as Kalidindi mentioned the usefulness of ORAC has been questioned due to the fact that it is an in vitro test and does not measure bioavailability in vivo stability and retention of antioxidants by tissues. The ORAC score of a food or compound does not always predict the degree to which a compound is beneficial in the body. Nevertheless she added that ORAC could be utilized to identify foods that have shown to have in vivo health benefits. When added to functional foods antioxidants may do even better due to the added benefits from other nutraceutical ingredients. Consumers want to get their nutrients as easily as possible and functional foods help them achieve that goal so when antioxidants are added into functional foods it can only help the category grow. -- Steve Siegel Ecuadorian Rainforest Antioxidants protect the body from what are known as free radicals which form when an oxygen molecule splits into single atoms with unpaired electrons. As a result these electrons begin to search the body for a match damaging cells in the process according to This imbalance is known as oxidative stress. Deaton elaborated on this concept stating There are four different types of free radicals and until recently research has mainly focused on the hydroxyl variety. In fact the ORAC value has been a widely recognized indicator of antioxidant potency for many years. The ORAC method essentially uses a specific antioxidant component of vitamin E as the standard for comparison. The drawback in using this method exclusively is that this component of vitamin E is only one type of antioxidant. It s important to know that just because an ingredient doesn t correlate with the properties of vitamin E it doesn t mean it s low in antioxidant potency. Many researchers are finding that it makes more sense to combine the ORAC with other assays to get a more complete understanding. On the other hand he said there is no evidence that ORAC values have any biological significance following consumption of any food. Researchers today are focusing more on how to make antioxidant products that are more bio-accessible. Similarly FRAP is a measurement of antioxidant power that uses blood plasma. This test is also somewhat limiting as other tissues can be tested. Tests such as ORAC and FRAP are still relevant but only tell part of the story. There are now much more comprehensive testing methods available to determine the actual antioxidant potency of an ingredient. Both ORAC and FRAP have been used in antioxidant studies for years but scientists are beginning to look to other means for conducting their tests. Such uncertainty poses the question of scientific steps to take toward the future. Looking Ahead The future of antioxidants appears to be stable especially as the implementation of antioxidants to foods has been a positive one with more health-conscious consumers. Accurately informing the customer is the No. 1 priority--in order to do so Siegel suggested that manufacturers consider putting easy-to-understand antioxidant benefits along with the proper ORAC value on the front of their products. This could become a supplement to one s standard nutrition facts label or the newly signed federal GMO (genetically modified organism) labeling bill (S.764) which requires food with GMOs to disclose these ingredients. It can be done with a symbol regular label that could include a phone number to contact or quick response (QR) code that could be scanned. Research in functional foods with antioxidants should focus on two categories the ORAC value of the functional food and how the functional food directly impacts consumer health Siegel said. Both of these can lead to a more knowledgeable consumer brand recognition and brand loyalty. NIE Evolving Research Although additional processes exist antioxidants are typically measured via two main methods oxygen radical absorbance capacity (ORAC) and ferric September 2016 FORMOREINFORMATION Deerland Enzymes Inc. (770) 919-8907 Ecuadorian Rainforest LLC (973) 759-2002 Natreon Inc. (732) 296-1080 Nutrition Industry Executive 63 Conventions&Meetings Marketing Expert Explores Consumer Behavior at The Conference CRN-International Scientific Symposium T he Council for Responsible Nutrition (CRN) announced that John Gerzema best-selling author and social trends data analyst will present at The Conference CRN s Annual Symposium for the Dietary Supplement Industry taking place in tandem with The Workshop CRN s Day of Science October 26 29 at the Ritz-Carlton Laguna Niguel in Dana Point CA. In Gerzema s Thursday morning session Consumer Trends How Technology and Consumerism are Reshaping the Shopping Experience he will identify prevailing social changes among consumers and propose ways in which companies can tailor their business models to adapt to new trends and demands. For more information visit T he Council for Responsible Nutrition-International (CRN-I) the international arm of the U.S.-based Council for Responsible Nutrition (CRN) announced its seventh annual scientific symposium Optimal Nutrition and the Ever-Changing Dietary Landscape will be held December 2 at Le Meridien Hotel Hamburg Germany just prior to the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) meeting. Subjects to be covered include healthy aging and optimum health bringing the big data component into the wellness discussion social and economic considerations of the overfed and undernourished population the role of food supplements in the dietary landscape and more. Registration is complimentary to all Codex official country delegations and available for a small fee for industry executives. For more information visit Dietary Supplement cGMP Training Courses H eld September 20-21 and October 3-4 8 a.m.-5 p.m. at both Expo East Baltimore Convention Center in Baltimore and SupplySide West Mandalay Bay in Las Vegas NV the National Products Association s GMP (good manufacturing practice) training courses cover some of the more complex issues and provides tips for compliance. These courses are relevant and valuable for anyone whose job requires an understanding of the FDA (U.S. Food and Drug Administration) labeling and GMP rules for dietary supplements including senior management and regulatory affairs QA QC production and laboratory personnel. The schedule is as follows Consultation September 22 Las Vegas NV Dietary Supplement cGMP Training October 3-4 8 a.m.-5 p.m. Qualifying Your Dietary Supplement Claims October 5 9-11 30 a.m. Advanced Dietary Supplement Labeling Course October 5 1-3 30 p.m. Dietary Supplement Labeling Consultation October 5. For more information visit Baltimore MD Dietary Supplement cGMP Training September 20-21 8 a.m.-5 p.m. Supporting your Structure Function Claims September 22 9-11 30 a.m. Advanced Dietary Supplement Labeling Course September 22 1-3 30 p.m. Dietary Supplement Labeling THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE JOIN VRM MEDIA S FAMILY OF PUBLICATIONS NIE s Upcoming Issue Highlights Nov. Dec. 10 25 16 ad closing Washington and the Natural Industry Supply Innovation 2017 Media Planner Available Soon Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP 64 Nutrition Industry Executive September 2016 SupplySideWestBoothPreview October 4-8 2016 Mandalay Bay Expo Hall Las Vegas NV The following companies advertising in this issue have submitted information describing their plans for SupplySide West--product launches show specials and special services are all included below. Booth numbers are provided with each listing to encourage in-person meetings to learn more. Albion Minerals--Booth BB153 Balchem is a supplier of Albion Minerals (Clearfield UT) highly effective nutritional mineral forms that can be easily absorbed by the human body. These special organic molecules are known as mineral amino acid chelates they are used in nutraceutical supplements and food fortification to provide complete organic mineral nutrition giving consumers the greatest chance to absorb minerals for their best biological advantage. For more information call (800) 453-2406 or visit Ayush Herbs Inc.--Booth EE165 Ayush Extracts (Redmond WA) provides the world s finest India-sourced organic certified herbs and standardized extracts. Established in 1990 Ayush marries ancient ayurvedic principles with the latest scientific technology to provide the highest quality standardized herbal extracts and raw materials. Ayush was founded by ayurvedic and naturopathic physicians who believe in the healthy balance of body mind and spirit while maintaining the highest quality-control standards in the raw materials industry. Visit booth EE165 for special pricing. For more information call (425) 637-1400 or visit Algatechnologies Ltd.--Booth NN172 Algatechnologies (Kibbutz Ketura DN Hevel Eilot Israel) is a leading manufacturer of natural astaxanthin derived from microalgae in a sustainable closed cultivation system that utilizes the natural sunlight. Algatechnologies fully controls astaxanthin production and is able to track every batch throughout the supply chain. All AstaPure products are manufactured using supercritical CO2 technology obtaining astaxanthin in an oleoresin form with no solvent used our AstaPure product line is available from beadlets form powders emulsion to oleoresin. For more information visit American Laboratories Inc.--Booth R111 American Laboratories Inc. (Omaha NE) was founded 50 years ago based on the company s knowledge of providing enzymes proteins and flavors to various industries. Today American Laboratories is proud to offer an extensive listing of more than 300 products to the food processing pharmaceutical veterinary health nutritional and diagnostic industries in the United States and more than 50 countries worldwide. Through its high quality products and customer service American Laboratories has become an industry-recognized supplier for the products we manufacture. For more information call (402) 339-2494 or visit Alkemist Labs--Booth Q120 Industry leader Alkemist Labs (Costa Mesa CA) is an ISO 17025 flexible scope accredited contract-testing laboratory specializing in plant authentication botanical ingredient identification and quantitative analytical services to the food and beverage nutraceutical and cosmeceutical industries. Alkemist Labs offers a wide range of specialty research services to evaluate the identity purity and quality of botanical raw materials dietary ingredients and finished products and an array of critical tools for botanical identity verification. For more information call (714) 754-4372 or visit Avanti Polar Lipids Inc.--Booth P126 Avanti Polar Lipids (Alabaster AL) Analytical Services Division provides extensive laboratory testing using modern analytical techniques to the research food nutraceutical and pharmaceutical communities for their lipid related projects. Testing under cGLP and cGMP is available with appropriate notification and preparation. Visit Avanti s new website for more information. For more information call (800) 227-0651 or visit Bergstrom Nutrition OptiMSM--Booth P141 Bergstrom Nutrition (Vancouver WA) is the world s leading manufacturer of methylsulfonylmethane (MSM). For more than 25 years the company has set the standard for MSM in dietary supplements skin care sports nutrition and more. U.S.-made OptiMSM is the premium branded form of MSM that is GRAS--designated and supported by safety data and published clinical research. Trusted by manufacturers and consumers alike OptiMSM has earned the reputation as the purest safest most consistent quality MSM in the world. For more information call (360) 693-1883 or visit September 2016 Nutrition Industry Executive 65 SupplySideWestBoothPreview October 4-8 2016 Mandalay Bay Expo Hall Las Vegas NV Biova LLC--Booth QQ115 Biova (Olathe KS) will present its water-soluble egg membrane (WSEM) ingredients which offer formulators multiple delivery systems for expanded product lines greater market potential. Learn more about BiovaDerm for human skin care--reduces the appearance of fine lines and wrinkles BiovaPlex for animal health--promotes activity healthier skin and coat BiovaFlex for joint health--research proven fast five-day and range of motion (ROM) results plus offers the only 88 percent protein standard. For more information call (877) 682-2673 or visit ExcelVite Inc.--Booth Q126 ExcelVite Inc. (Edison NJ) showcases its natural beta-carotene derived from palm fruits. Unlike the conventional beta-carotene (synthetic- fermentative- and algae-betacarotene) EVTene is naturally extracted from palm fruits with similar carotene composition as found in carrot--33 percent alpha-carotene 65 percent beta-carotene and 2 percent of other carotenes (gamma-carotene lycopene). It is the only true natural mixed carotene complex in the market. ExcelVite will also showcase its flagship product--EVNol SupraBio-- patented full spectrum palm tocotrienol complex. EVTene and EVNol SupraBio are vegetarian kosher halal and non-GMO. For more information call (732) 906-1901 or visit Comar LLC--Booth F171 Defined by Comar s (Buena NJ) devotion to quality service and creativity the company is a leading manufacturer of plastic dosing and dispensing products bottles containers and closures. Comar provides its global customer base with a broad array of proprietary products custom molding printing and complex assembly capabilities. The company s expertise with all the major rigid plastic processing platforms including injection molding extrusion blow molding injection blow molding and injection stretch blow molding is available. For more information call (800) 962-6627 or visit Gencor--Booth L149 Make the most out of your attendance and visit the Gencor (Irvine CA) booth to learn more about the company s newer products such as Aquacelle technology which increases bioavailability of lipophilic ingredients. Gencor will have a 10-minute Q&A about ActivAMP with Jeff Hilton (Brandhive) on Thursday at 2 30 p.m. at the Central Stage. Gencor s VendorBrief A Discussion on Menopause will also be on Thursday from 3-3 50 p.m. featuring speakers Amanda Rao and Dr. Paul Clayton. For more information call (949) 502-5760 or visit DPL-US--Booth II181 DPL-US (Islandia NY) a division of Dr. Paul Lohmann is the premier supplier of high value mineral salts for the nutritional supplement market. DPL celebrating 130 years of operation produces all our products at one of the company s two GMP and ISO certified manufacturing sites in Germany. DPL-US offers customers the widest variety of minerals--more than 300 grades available non-GMO certifiable minerals fully reacted amino acid chelated minerals value added encapsulated micronized and direct compressible grades and minerals low in heavy metals. For more information call (631) 851-8810 or visit Global Health Laboratories--Booth Q127 Global Health Labs (GHL Amityville NY) is a highly qualified full-service manufacturing partner for clients seeking turnkey solutions. GHL specializes in customized nutritional formulations that meet and exceed every standard and expectation. GHL provides clients and their customers with exceptional finished products that deliver on quality value and results. The company s extensive resources along with highly experienced industry professionals and a long history and expertise in production all combine to bring you the best in cuttingedge nutritional formulations delivered on time as promised and fully documented. For more information call (631) 777-2134 or visit Euromed USA--Booth O124 Euromed USA (Presto PA) is featuring its proprietary PhytoProof process--the ultimate in quality control. Euromed s botanical extracts are manufactured according to the highest standards in the industry using good agricultural practices optimal extraction technology and performing 20 laboratory tests for identity purity and potency. This process represented by the PhytoProof seal is proof positive of the company s ability to consistently deliver a proven effective product. Everyone can Be Sure with Euromed PhytoProof. For more information call (412) 279-8808 or visit 66 Nutrition Industry Executive Hsu s Ginseng Enterprises Inc.--Booth 1669 Hsu s Ginseng Enterprises (Wausau WI) is one of the world s leader in the growing processing and production of American ginseng products powders and extracts. Visit Hsu s Ginseng Enterprises at booth 1669 to see the new products for 2017. Some of the great products include ginseng granolas a new line of flavored ginseng candies and our ginseng ingredients. Also get a glimpse into the 2017 International Ginseng festival to be held September 15-17 2017. For more information call (800) 388-3818 or visit September 2016 Jiaherb Inc.--Booth JJ151 Jiaherb (Pine Brook NJ & Anaheim CA) is the largest NSF-GMP certified natural ingredient manufacturer from China offering more than 600 ingredients. The company s commitment to its customers is to provide reliable high-quality ingredients supported by Jiaherb s superior customer service and competitive pricing. The company knows that the ingredients you choose to put into your products are a reflection upon your standards of quality and excellence. Jiaherb guarantees its customers consistent efficacy and efficiency through fast delivery large inventory of products complete regulatory documentation and uncompromised service and support. For more information call (973) 439-6869 or visit Lycored --Booth Y153 Lycored (Orange NJ) has developed a striking new lycopene seal that reinforces and strengthens its commitment to excellence as a creator and supplier of nutrition solutions backed by extensive and ongoing clinical research. The new mark also speaks to Lycored s dedication to vertical integration and complete oversight of the production process. Vertical integration means Lycored s partners can always depend on the quality of its lycopene and nutrient blends made with lycopene. Lycored grows its own tomatoes in farms across the world and and after harvest microencapsulates their lycopene to ensure optimal bioavailability. Natural lycopene such as Lycored s is the only source of lycopene with a clinical backing. For more information call (862) 221-1111 or visit MACK Flavor Ingredients Inc.--Booth H162 Visit MACK Flavor Ingredients Inc. (Riverside CA) at booth H162 at SupplySide West. The company is now offering all-natural non-GMO flavors and Bitterness Blocker. Stop by and inquire how Mack Flavor Ingredients can benefit you in all your flavor creation needs. Let the company apply its expertise to provide your company with top quality powdered flavors. For more information call (951) 683-6245 or visit Go to apl for info about this advertiser September 2016 Nutrition Industry Executive 67 SupplySideWestBoothPreview October 4-8 2016 Mandalay Bay Expo Hall Las Vegas NV Natreon Inc.--Booth TT135 Join Natreon Inc. (New Brunswick NJ) as the company sponsors a Breakfast Brief entitled AyuFlex Next Generation Vegetarian Choice for Joint Support on Friday from 9-10 a.m. registration is required. The joint health category s breakthrough ingredient is here. A new gold standard clinical study showed Natreon s AyuFlex (Terminalia chebula) dramatically improves joint mobility comfort and functional capacity. Get the insights about the science from the researchers and how this remarkable ingredient can support joint health formulations. For more information call (732) 296-1080 or visit Once Again Nut Butter--Booth 917 Visit Once Again Nut Butter (Nunda NY) at booth 917 at SupplySide West. The company will be introducing 12-oz. jar sizes of its almond and cashew butters. For more information call (585) 468-2535 or visit PLT Health Solutions--Booth MM143 PLT Health Solutions (Morristown NJ) is a discoverer developer and marketer of high-quality scientifically supported ingredient solutions for the natural products food and beverage and cosmeceuticals markets. The company s goal is to bring innovative and impactful solutions that help its consumer products customers develop new concepts new products and grow successful brands. Come visit PLT at Booth MM143 and check out the company s growing sports nutrition ingredient portfolio. This portfolio is characterized by one-of-a-kind and best-in-class ingredients that can help sports nutrition companies differentiate their brands and add value to their formulations in a wide variety of ways. For more information call (973) 907-0311 or visit Nutraceutix--Booth GG121 Visit the Nutraceutix (Redmond WA) booth to learn more about the company s latest exciting probiotic strain clinical research and its patented BIO-tract and Viablend delivery system advancements including the new patent-pending BIO-tract II delivery system. Also join Nutraceutix as the company sponsors the popular post-conference Probiotics Workshop. For more information call (425) 883-9518 or visit NutraGenesis Icon Group--Booth K162 NutraGenesis Icon Group (Brattleboro VT) are leading providers of proprietary branded nutraceuticals for dietary supplements and self-affirmed GRAS functional ingredients for foods and beverages. NutraGenesis Icon Group s clinically tested patented ingredients feature substantiated structure function claims in highly marketable wellness areas Stress Healthy Weight Management Energy Cognition Metabolic Cardiovascular Health Anti-Aging Antioxidant and Respiratory Immune Support. Visit the NutraGenesis Icon Group booth to learn about their new cardio-support Bergamot extract WellBody Fusion mushrooms grown on specialty grains and botanicals MycoFusion superfoods and Sports Nutrition applications. For more information call (802) 257-5345 or visit or Rousselot Inc.--Booth O121 Rousselot (Mukwonago WI) will be conducting a lunch brief at SupplySide West based on collagen peptides entitled Bioactive Protein-- What s their next role in healthy aging and mobility This brief will cover the latest global market trends around collagen showcase product innovations and formulations and reveal new scientific data from the University of Rochester (USA) demonstrating the efficacy and mechanism of Peptan collagen peptides for joint health. Join Rousselot to learn why the Peptan brand has gained global recognition as the leading all in one collagen peptides solution. For more information call (888) 455-3556 or visit Sabinsa Corporation--Booth Y135 Come see Sabinsa s (East Windsor NJ) latest award-winning science on Curcumin C3 Complex the official curcumin sponsor of the SupplySide West 2016 which is patented and the most clinically studied curcumin brand on the market today. New evidence and health claims in Sabinsa s shelf-stable spore-forming encapsulated probiotic LactoSpore will bring true benefit to marketing companies pitching a probiotic to their customers. For sport and performance visit the booth discuss with a new study on the horizon for the company s Sabeet brand. For more information call (732) 777-1111 or visit (Continued on page 70) 68 Nutrition Industry Executive September 2016 Equipment&Packaging Gargoyle Storage and Distribution Earns SQF Level 2 Certification Oregon-based Gargoyle Storage and Distribution Inc. (GSD) has earned its SQF Level 2 Certification for both the bottling of food-grade oils and storage of food products. SQF certification was the logical next step for our organization said Mark Nyman president and owner. We have been serving the industrial and food service markets as an oil supplier for almost a decade. Two years ago we decided to bring it in-house to ensure the high quality and consistency of our products. Now SQF Level 2 Certification allows us to expand our services as a co-packer that is capable of supporting the retail markets going forward. In conjunction with the SQF certification GSD is adding a second bottling line that will double production capacity and support a range of retail sized packaging options. For more information call (503) 404-0164. Launches Free Tools for New Nutrition Fact Requirements Florida-based is updating and adding new tools and content for their users in response to the U.S. Food and Drug Administration (FDA) announcing new format changes to nutrition facts found on food labels. The label retailer recently re-launched their free nutrition label generator to include the new required format in order to ease the burden on food manufacturers. This allows them to more easily create nutrition labels that comply with the FDA s new requirements. The free tool lets users download PDF and JPG versions of their generated label. Users will also be able to create their labels in three different layouts the traditional vertical the vertical with extra nutrient information and the horizontal tabbed layout. More features will be added in the near future as well. This includes the new dual column layout and new units of measurement as the FDA releases more information. Users will be able to purchase blank labels to print their nutrition facts in a variety of sizes. They will also be given the option to customize their product labels further and order them custom printed by For more information call (407) 936-3900 or visit AIMPLAS to Package its Products in Biodegradable Bags and Bottles AIMPLAS out of Spain has completed the research to develop new biopolymers from which it will be able to manufacture new biodegradable bottles bags and caps resistant to sterilization and pasteurization. Therefore they can contain dairy products such as fresh milk shakes and yogurts with probiotics. The project BIOBOTTLE developed within the European Union s Seventh Framework Program has been coordinated by AIMPLAS and has a budget of 1 million euros. ( 1.1 million). Seven companies and technology centers from five different countries have taken part VLB (Germany) OWS (Belgium) CNR (Italy) VIZELPAS and ESPA OPLAS (Portugal) and finally ALMUPLAS and ALJUAN (Spain). The packages for this kind of product are currently manufactured from polyethylene which although it is easily recyclable still ends its shelf life mostly in landfills due to the odor problems that this product s wastes cause. The aim of the project was having the new biodegradable packages manufactured with the biopolymers developed within the project complied with the mechanical and thermal aspects required for these applications as well as having them pass the microbiological tests without affecting the product s organoleptic properties. This results in monolayer bottles and caps and multilayer bags that are able to resist temperatures up to 95 C (203 F). For more information visit New Nutrition Facts Labels Incorporated Into Formulation & Labeling Software Oregon-based ESHA Research a provider of nutrition analysis and compliant food labeling solutions announced a software update for the Genesis R&D Product Development and Labeling Software. In response to the FDA s regulatory changes for nutrition facts panels Genesis R&D Version 11.1 now includes the new label formats and revised Daily Values. Genesis R&D Version 11.1 includes new formatting for standard tabular linear child pregnant and lactating dual column aggregate simplified and supplement facts labels. In addition many database foods have been populated with added sugar values and daily values have been adjusted to reflect the new rules. For more information visit September 2016 Nutrition Industry Executive 69 Equipment&Packaging Deitz Unveils Automated Neck Bander Packaging machinery manufacturer Deitz Co. (Wall NJ) has unveiled the Pharmafill NB-1 Series II neck bander. Automatically applying tamper-evident plastic shrink bands and or sleeve labels on bottles vials jars tins cans and other round and tapered containers the Pharmafill NB-1 Series II neck bander features a versatile design with a wide lay-flat range that accommodates banding materials from 25 mm-123 mm in width and up to 10 inches in length and caps from 14 mm-76 mm in diameter. Ideal for packaging supplements nutraceuticals pharmaceuticals cosmetics foods beverages and other liquid and dry products that require tamper-evident protection the new neck banding machinery features a compact design inviting full unencumbered access to the interior for easy material loading visual monitoring and fast changeovers. Designed and manufactured in the company s Wall New Jersey headquarters the Pharmafill NB-1 Series II neck bander is FDA- and GMP-compliant and comes with both a PLC-controlled interface for intuitively easy operation and a built-in bottle spacing wheel for on-the-fly operation that seals up to 100 bottles per minute. The automated shrink band machine integrates stainless steel in bottle contact areas with anodized aluminum for structural strength and reliable low-maintenance performance over the long term. For more information call (732) 681-0200 or visit ProcessPro Announces Microsoft Cloud Solution Minnesota-based ProcessPro a mid-market ERP software solution company announced its participation in the Microsoft Cloud Solution Provider (CSP) program in conjunction with its parent company Open Systems Inc. a recognized Microsoft Cloud Solution Provider. ProcessPro s cloud offering represents the next steps in its 30-year history of providing an industry specific ERP solution that tackles mission-critical business functions while integrating real-time data and business analytics reporting for process manufacturers. This advancement allows ProcessPro to provide customers stable and secure Microsoft Cloud (Azure) hosting manage backup services and monthly application and server updates. ProcessPro cloud-based ERP system provides a streamlined implementation approach and the flexibility to accommodate future growth and requirements. For more information visit SupplySideWestBoothPreview October 4-8 2016 Mandalay Bay Expo Hall Las Vegas NV (Continued from page 68) Savesta LifeScience Inc.--Booth RR111 Savesta LifeScience Inc. (Chatsworth CA) a global supplier of the highest quality ayurvedic ingredients pure as nature intended provides solutions to the Nutraceutical Cosmeceutical Food Beverage and Pet Industries. Savesta will be featuring the following at SupplySide West Amla 45% Tannins Gymnema 25% & 75% Boswellia acids 65% Ashwagandha 2.5% 5% & 7% Withanolides Shatavari 40% Tribulus 60% Boswellia acids 85% & 5% Natural AKBA Triphala 50% Curcumin 95% Turmeric 95% Garcinia 50% & 60% XanoMax Mangosteen 10% 20% 30% & 40% as well as Organic Amla Garcinia Moringa and Turmeric. For more information call (818) 709-2411 or visit Vit-Best Nutrition--Booth T115 Vit-Best Nutrition (Tustin CA) leverages 60 years experience in contract manufacturing of nutritional products for the global marketplace. Vice President John Altenberg will discuss the smart partner relationship that encompassing formulation procurement quality control compliance manufacturing and packaging at a Vendor Brief Presentation on Friday from 12 30-12 50 p.m. at booth UU111. For more information call (714) 832-9700 or visit Welch Foods Inc.--Booth R169 Welch s Global Ingredients Group (Concord MA) was formed to bring the goodness of the Concord and Niagara grape grown by the family farmers who own Welch s to new occasions and places around the world. Welch s products include grape concentrates and purees its FruitWorx line as well as a new line of powders that allow the company s grapes to get out of the bottle and into applications where they ve never gone before while delivering great taste and loads of health-benefiting polyphenols. For more information call (978) 371-3692 or visit 70 Nutrition Industry Executive September 2016 Advertiser Index ADH Health Products Inc. AIC Inc. Albion Laboratories Inc. Algatechnologies LTD Alkemist Labs American Laboratories Inc. Avanti Polar Lipids Ayush Herbs Bergstrom Nutrition Biova LLC Certified Nutraceuticals Comar LLC DPL-US EHP Products Inc. ExcelVite Inc. Euromed USA Inc. Generex Labs GE Nutrients Inc. Global Electronic Technology Inc. Global Health Laboratories HerbaKraft Inc. Herbally Yours HSU s Ginseng Enterprises Inc. Jiaherb Inc. KML Laboratories Inc. LycoRed Corp. Mack Flavor Ingredients Inc. Marine Stewardship Council Natreon Inc. Now Foods PL Nutraceutix Nutragenesis Icon Group Once Again Nut Butter PLT Health Solutions Rousselot Inc. Sabinsa Corporation Savesta LifeSciences Inc. Soma Labs Inc. United States Pharmaceopea Vit-Best Nutrition Inc. Welch s Foods Inc. 53 56 23 28 11 59 67 30 57 43 39 8 7 26 13 insert 29 52 9 25 21 17 33 32 5 47 31 24 45 15 1 42 C3 27 3 37 C2 19 58 C4 51 35 (845) 268-0027 (800) 238-0001 (801) 773-4631 972 (8) 635-6425 (714) 754-4372 (402) 339-2494 (800) 227-0651 (800) 925-1371 (360) 693-1883 (877) 682-2673 (951) 600-3899 (856) 507-5402 (631) 851-8810 (888) EHP-0100 (732) 906-1901 (877) 696-3960 (239) 592-7255 (949) 502-5760 (888) 775-1500 (631) 293-0030 (732) 463-1000 (480) 892-8220 (800) 388-3818 (888) 542-4372 (208) 267-0818 (877) 592-6733 (951) 683-6245 (206) 631-2498 (732) 296-1080 (800) 999-8069 (425) 883-9518 (802) 257-5345 (888) 800-8075 (973) 984-0900 (888) 455-3556 (732) 7 7 7 - 1 1 1 1 (800) 994-2987 (732) 271-3444 (301) 230-6361 (714) 832-9700 (978) 371-3692 adh aic albion algatech alkemistlabs americanlaboratories apl ayush bergstrom biova certifiednutraceuticals comar lohmann ehp excelvite euromed generexlabs gencor get globalhealthlabs herbakraft herballyyours hsus jiaherb kml lycored mackflavor msc natreon nowpl nutraceutix nutragenesis onceagain plt rousselot sabinsa savesta somalabs usp vit-best welchs Industry Events September 21-24 Expo East Baltimore Convention Center Baltimore MD (866) 458-4935 September 21-22 MinnPack Minneapolis Convention Center Minneapolis MN September 30 5th International Workshop Botanicals Nutrients & Food Supplement Claims Europe Brussels Belgium October 4-8 SupplySide West Mandalay Bay Expo Hall Las Vegas NV (866) 230-2311 October 20-23 The National Association for Holistic Aromatherapy (NAHA) Salt Lake City UT November 15-17 Advanced Manufacturing Expo & Conference Centro Banamex Mexico City Mexico September 2016 Nutrition Industry Executive 71 SupplieroftheMonth AIDP Inc. Edward Lee PhD President & Founder of AIDP Inc. 19535 E. Walnut Dr. S. City of Industry CA 91748 Phone (626) 964 6910 AIDP is a leader in functional ingredients with a focus on extensively researched products that meet consumer demand for wellness and healthy aging. The company s commitment is to source high-quality ingredients and provide proprietary solutions that address formulation challenges. AIDP s success is grounded in its depth of experience and commitment to strong science for functional food and beverage product development. Edward Lee PhD is president and founder of AIDP Inc. Founded in 1996 AIDP has grown to one of the largest ingredient suppliers to the dietary supplement industry. Lee sources only the finest ingredients at competitive prices. His resources in the industry and knowledge of current health trends have enabled AIDP to provide the most up-todate products. In recent years AIDP has invested in the development of several proprietary products in the joint and bone health industry and the cognitive space as well. Lee received his PhD in applied mathematics from the University of Florida. NIE AIDP recently introduced a High Purity Vitamin D3 40 Million IU g that is food grade and has been tested by two independent laboratories. What was the company s motivation behind making the product available Lee There are two reasons. We identified an opportunity as we noticed that the vitamin D3 coming from China was not as pure as it should be and was being priced inconsistently with large swings. We developed with our partners a low cost vitamin D3 that is as good as the best available on the market with long term price stability for our contracted customers. taken Magtein for three months. Approximately 70 percent of subjects saw improvement in memory attention and problem solving. This is the first study to show such drastic results. Another paper published in May of this year provides an explanation for why the threonic acid salt is an essential component of Magtein and supports the use of Magtein to promote cognitive abilities in humans. The study showed that out of the magnesium salts compared only Magtein brings magnesium to neuron cells effectively. a distributor agreement with Cypress Systems Inc. What does this mean for the company Lee In addition to our technologies AIDP looks to take advantage of our extensive market presence to distribute research based ingredients to customers. We only partner with manufacturers and suppliers who met those standards and where we can build a win-win relationship. Cypress Systems offers the selenium yeast with the most research and positive clinical studies. In particular the studies completed in partnership with the American Cancer Association are very encouraging. We want our customers to see the benefit of selenium yeast over Lselenomethionine. It has a much better sensory and taste profile and the research makes it the selenium source of choice for both supplement and food applications. NIE Research seems to be very important to the company. Please discuss recent studies on AIDP ingredients. Lee Two papers on Magtein were published during the past year. More will be published in the future. We have invested heavily on Magtein research. A human clinical study on Magtein for reversing cognitive decline was published last November. In this paper it showed that the brain age of the participants was reversed by nine years compared to the biological age after having 72 Nutrition Industry Executive NIE In May AIDP s range of XOS (xylooligosaccharide) prebiotics preticx secured a certified organic verification. How important was this for the company to receive that verification Why Lee AIDP has seen the growing consumer demand for ingredients that are organically grown as such we have been offering a range of organic products such as plant proteins vegetable and fruit concentrates. PreticX had to be certified organic to meet the needs of our customers to offer it to organic supplement users. NIE Where do you see AIDP headed in the future Lee AIDP will continue to search and help bring to market research based ingredients with technology partners. Our vision is to find and promote safe products where the consumer can see and or feel the benefits. September 2016 NIE Earlier this year AIDP signed Go to nutragenesis for info about this advertiser Go to usp for info about this advertiser