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Description: In This Issue: Government Plans to Regulate Non-GMO Labeling, Immune Health, Contract Manufacturing, and Certifications

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NI W Visi eb t O Em si u ag te r az in e.c om A VRM Media Publication www.niemagazine.com September 2015 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 20 NO. 7 SEPTEMBER2015 F E A T U R E S 25 Contract & Custom Manufacturing Update Contract and custom manufacturers work with formulators to create the latest and greatest products. 34 Proactive Immune Health Consumers are seeking targeted functional benefits in their immune health products. 38 Government Plans to Regulate Non-GMO Labeling A L S O I N S I D E A panel discussion on potential industry impact. 10 18 22 22 24 50 51 51 51 52 Industry News Ingredient News AHPA Update Association News Science Update Conventions & Meetings Equipment & Packaging Advertiser Index Industry Events Supplier of the Month C O L U M N S 4 First Word 6 Legalities 42 Production Line 46 Marketing Innovation 48 Functional Foods FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.NieMagazine.com Copyright 2015. Nutrition Industry Executive (ISSN 2331-2602) Volume 20 Number 7 September 2015. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by Vitamin Retailer Magazine Inc. 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 432-9288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Application to Mail at Periodicals Postage Prices is Pending at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com. Back Issues & Single Copies For order information contact (732) 432-9600 or info niemagazine.com. March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Go to www.niemagazine.com plt for info about this advertiser FirstWord Just Label It ecently GNT a global provider of food and beverage ingredients made exclusively from fruits vegetables and edible plants unveiled a study on global purchasing behavior. GNT found that consumers all around the world are paying closer attention to what they eat and how they choose their food products. This becomes apparent in the supermarket setting 64 percent of Americans take a critical look at the product before placing it in their shopping cart evaluating both the front and back of the package. For the study the market research institute TNS interviewed more than 5 000 consumers from 10 countries in Asia America and Europe on their shopping and eating habits. The study concluded that natural ingredients play a significant role in the way consumers purchase food and beverages. In order to make a substantiated purchasing decision however shoppers depend on easy to understand product information for 67 percent of all consumers worldwide clarity of ingredients and additives determine their choice of food and drinks. They look for short ingredient lists whose components they know and understand. In the U.S. 65 percent of the respondents look for recognizable clean label ingredients within the food product. R tant all around the globe. Many manufacturers already comply with consumers wishes for example by using color solutions exclusively made from fruit and vegetable sources and clearly indicating that on the label. This development will continue to gather momentum in the upcoming years said Dr. Hendrik Hoeck managing director of the GNT Group. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Roy Kieffer Sales Manager RoyK VRMmedia.com Advertising Gary Pfaff Sales Associate GaryP VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com Labeling GMOs Last year Evolution Salt Co. proudly put a label on its packages of Himalayan salt proclaiming they contained no genetically modified organisms (GMOs). That should come as no surprise considering that salt does not have genes. But the chief executive of the Texas-based company said advertising the absence of GMOs was good business. In this month s feature article panel discussion on genetically modified (GM) ingredient labeling written by Cara Waters (see page 38) Lisa Katic RD principal of K Consulting explained that the main factors driving companies to seek non-GM certification are predominantly due to negative public discussion surrounding GM ingredients. Consumers do not fully understand genetic engineering and how it is being used in agriculture she noted. They also don t have a solid understanding of how food is typically grown in the U.S. and what it takes to get foods from the farm to the market and ultimately the dinner table. As a result of these two voids consumers buy into a lot of the hype and misinformation being spread about GM foods and therefore are asking for non-GM ingredients based on little knowledge and incomplete information. Companies are caught in a dilemma as they know the technology is safe but want to provide their customers with options hence the decision to seek non-GM certifications for their products or ingredients. I wonder who does have complete information about GMOs But for the natural industry especially whether GM labeling is strictly a marketing strategy or a quest for true transparency investment in the label will probably prove lucrative. Managing Editor Shari Barbanel ShariB VRMmedia.com Assistant Editor Corinne Anderson CorinneA VRMmedia.com Contributing Writers Tony Andrew Jeanne Cullen Esq. Anne Lee Lisa Schofield Suzanne Shelton Cara Waters Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Rosie Brodsky Rosie StarkServices.com A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Gluten Free Retailer Natural Practitioner and FitnessTrainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com Back Issues See the Table of Contents page for price and order information. How Consumers Make a Purchase Decision When looking at a label consumers do not evaluate every component of a product individually but rather they use a method of elimination whereby they scan the label for certain ingredients that they personally avoid. If they discover them among the contents the product is put back onto the shelf. The study also found that the presence of a front of pack icon stating the product is colored with fruits and vegetables resulted in an increased willingness to pay more for that product. The study s results clearly show that natural ingredients are becoming more impor- Connect With Us www.twitter.com www.facebook.com www.linkedin.com www.instagram.com www.pinterest.com vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Go to www.niemagazine.com jiaherb for info about this advertiser Legalities Part 1 Overview Labeling Claims and Class Action Lawsuits By Jeanne Cullen Esq. M ore than ever before American consumers are growing interested in and paying more attention to their health fitness and nutrition. The 2014 Food & Health Survey Consumer Attitudes Toward Food Safety Nutrition & Health commissioned by the International Food Information Council Foundation found that 71 percent of consumers are evaluating their food choices from a healthfulness perspective up from 61 percent in 2012. The availability and demand for locally produced and organic sources is unprecedented in recent years. With a rising uptick in consumer demand for these sources the food and beverage industry has responded by providing more different and healthier product options for consumers to make individualized choices. Product manufacturers have also provided more information on both their product labels and websites to aid consumers with their choices. Along with the growing demand for and attention to product ingredients food and beverage manufacturers con6 Nutrition Industry Executive tinue to be under a growing attack from class actions and other lawsuits involving their product labels advertising campaigns and websites. In short plaintiffs argue that these products are not what they say they are do not contain what they say they contain and are not made in the way or manner in which they say they are made. While the defense continues to repel these claims supplement manufacturers are now finding themselves a new growing target by plaintiffs in many of the same attacks drawn from plaintiffs playbooks against food and beverage manufacturers. Who are the Attackers and Why There have been many contributing factors to the surge in purported class action lawsuits other litigation and investigations against the food and beverage industry over the past halfdecade. Increased attention to and changes in requirements concerning labeling have magnified scrutiny from the regulatory world in many ways. Fueled by the issuance of an open letCelebrating 20 Years of Excellence 1995-2015 ter to the food industry by the FDA (U.S. Food and Drug Administration) Commissioner in 2010 and subsequent warning letters focused on health and nutrient content claims the FDA declared its priority of highlighting the importance of scientific accuracy of food labeling. Subsequently in 2014 the FTC (Federal Trade Commission) which governs consumer product advertising publicly announced Operation Full Disclosure a concerted effort warning more than 60 advertisers covering a wide range of industries including food and consumer products of misleading product statements concerning labels and in digital media. Since then instances of FDA and FTC warning letters and lawsuits against food and beverage manufactures have accelerated. The focus on product labeling has also received great attention by state legislatures as well. Many states have proposed various bills regarding new labeling concerning certain product ingredients. Over the past several years www.niemagazine.com September 2015 Go to www.niemagazine.com olcott for info about this advertiser Legalities more than 70 bills have been introduced in more than 30 states requiring certain additional labeling of food products. It is therefore no surprise that there has recently been new proposed legislation nationally affecting supplements as well. This increased regulatory and government attention has not gone unnoticed by opportunistic plaintiff attorneys. With a historic shift away from litigation to arbitration given AT&T Mobility v. Concepcion which recognized contractual consumer class action waivers the change in law heightening pleadings standards in securities actions and the relative wind down of mass torts litigation involving asbestos and tobacco class action plaintiff attorneys were fast to recognize this new area ripe for litigation. Plaintiffs actions have been further fueled by social media campaigns involving popular food blogs and bestselling books attacking the food and beverage industry. Following the growing attention by social media with these claims comes the growing national media attention from news outlets as well. Adding to the flux in litigation risks a new source of private litigation outside of class actions blossomed given the 2014 U.S. Supreme Court decision in POM Wonderful LLC v. Coca-Cola Co. solidifying competitors filing claims under Section 43(a) of the Lanham Act involving false and misleading advertising. And to further up the risk ante there have been highly publicized prosecutions and convictions of corporate officers under the resurrected Park Doctrine over the past few years. Under the Park Doctrine a corporate official can be held liable and criminally prosecuted under the Federal Food Drug and Cosmetic Act (FDCA) without any proof that the executives had any specific knowledge or participation in the alleged offense. following. The focus on the type of claim being targeted by plaintiffs has varied but the recent trends for 2015 mostly fall into the following five broad categories in the order of popularity No. 1--claims involving statements using all natural or natural. Plaintiffs argue that such a label is deceiving fraudulent or otherwise misleading to consumers when the products allegedly contain GMOs (genetically modified organisms) food coloring additives artificial or synthetic ingredients or are otherwise processed. Other common allegations include statements involving alleged false statement of fact which can come in many different forms. For example these complaints contain allegations that the product contains less protein than represented or is labeled healthy when it fails to meet certain standards. Alleged omissions complaints including labels that fail to properly warn consumers or Proposition 65 cases are also a strong focus. Recently these complaints focus on the issue of whether the product contains allegedly unsafe levels of lead or harmful chemicals. Statements involving country of origin such as Made in the USA are an additional focus for plaintiff attorneys. Lastly allegations around alleged health misrepresentations involving sugar and fat sources remain popular as well ( evaporated cane juice contains no trans fats ). Another growing trend involves not only what is or is not contained within the product but how the product is packaged grown manufactured or priced. With some of these claims plaintiffs argue that consumers are misled because the packages contain nonfunctional slack-fill deceiving consumers into thinking they are purchasing more product than they really are. Products promoted and sold that they are farmed in an ecologically friendly and otherwise sustainable manner are also now under attack. Plaintiffs challenge production methods including handmade labels when manufacturers are using some form of automation or include a mechanized process. Further statements regarding pricing such as compare at or compare to have also been targeted in the last year. Since these types of claims are not product specific plaintiffs can transfer these themes challenging the supplement industry as well. Other targeted statements specific to supplements in the past year include supports heart health supports immunity and sciCelebrating 20 Years of Excellence 1995-2015 entifically proven. These lawsuits reach a broad range of consumer products and in 2015 alone examples of products scrutinized by plaintiffs include protein or snack bars supplements including Gingko biloba and St. John s wort energy and caffeine supplements instant noodles various beverages including liquor wine beer iced tea juices and energy drinks pretzel chips cacao powder coffee creamer pet food sauces mixes infant formulas and foods among others. In challenging these products plaintiffs causes of action include allegations that the product manufacturer retailer or advertiser s promotional statements or product labeling are false or misleading to the reasonable consumer and otherwise constitutes a deceptive or wrongful act in violation of the state s consumer protection statutes. Other causes of action include alleged breach of express and implied warranties intentional and negligent misrepresentation and unjust enrichment among others. Since class certification is critical for plaintiffs since it is not economical for the plaintiff to continue the lawsuit without a class much of the battle occurs and ends either with initial motions to dismiss or in the class certification phase. Given this process few if any cases have been fully litigated creating precedent or clarity on the substance of the issues. Why the Recent Focus on the Supplement Industry Similar to the food and beverage industry the supplement industry has recently been the target of regulators the government and plaintiff s attorneys. Following the trend by the FDA in issuing numerous citations to the supplement manufacturers for alleged violations of current good manufacturing practices (cGMPs) in 2015 alone the FDA issued more than 75 warning letters and public notifications to supplement manufacturers alone expressing a heightened interest against dietary supplements. Likewise attorneys general from across the country have filed numerous lawsuits in the last year against popular energy drink and vitamin supplement manufacturers calling out for the substantiation for their product claims and otherwise alleging that they engaged in deceptive advertising. On the heels of these suits the attorney general of New York issued a press release in February issuing cease and desist letters to four major retailers to stop selling certain dietary supplewww.niemagazine.com September 2015 What are They Attacking Increased and widespread governmental regulatory and public attention to product labeling and advertising has paved the way for fertile ground for consumer class actions and other litigation. Plaintiff attorneys continue to file actions nationally testing different jurisdictions with more favorable consumer protection statutes. In recent history the preferred states for these claims include California (by far the dominant leader) with Florida New York New Jersey Missouri and Illinois 8 Nutrition Industry Executive ments. The letter alleged that the retailers sold herbal supplements that could not be verified as containing the substance(s) listed on the label or that the supplements included certain ingredients that were not identified on the label. Since then numerous other attorneys general around the country sent a letter to Congress requesting that the legislative branch conduct an investigation into the herbal supplement industry and reevaluate the FDA regulatory authority over the supplements industry. (www.ag.ny.gov press-release agschneiderman-and-ag-zoeller-leadbipartisan-group-14-attorneys-generalcalling) As demonstrated through recent history with the food and beverage industry plaintiffs have filed dozens of class actions since April of this year accusing retailers of fraud through the sale of herbal supplements. But why do the plaintiff attorneys believe the supplement industry is an attractive target They argue that given the relatively minimal regulation of supplements this industry is fertile ground for scrutiny. However the FDA regulates both finished dietary supplement product and dietary ingredient labeling through regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the FTC further regulates dietary supplement advertising. Although dietary supplement manufacturers must register their facilities with the FDA they are not required to get FDA approval before producing or selling the supplements. Unlike drug products that must be proven safe and effective for their intended use before marketing under the DSHEA dietary supplement manufacturers do not need prior approval from the FDA before they are marketed. As further explained on the FDA website it is the manufacturer who is responsible for determining that its supplements are safe and its claims are not false and misleading. Given the lack of FDA guidance on interpreting certain statements made by supplement manufacturers similar to the all natural labeling plaintiffs are developing and testing their own interpretations. nificant increases in further litigation against it. It is clear that every statement made on a product on a company s website or other advertisements may be targeted and subject to both regulatory and litigation risk. However there are many actions the industry can learn from both the plaintiffs prior playbook and defense successes from the food and beverage industry. NIE Look for Legalities Labeling Claims and Class Action Lawsuits Part 2 Avoiding Lawsuits in the October Issue. Jeanne Cullen is a partner in the commercial litigation and product liability groups in the Chicago office of Perkins Coie LLP where her practice focuses on alleged false labeling litigation alleged breach of contract and other UCC issues and labeling and advertising counseling concerning retail and consumer products. She is also a member of the firm s retail & consumer products food & beverage and advertising marketing & promotions groups. What Does the Future Look Like Given a historic review of the actions by the regulatory government and plaintiff attorneys against the food and beverage industry a similar pattern is developing against the supplement industry supporting predictions of sigSeptember 2015 www.niemagazine.com Go to www.niemagazine.com fenchem for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 9 IndustryNews Organizations Join to Help Ensure Adequate Iodine Intake in Pregnant and Lactating Women ll pregnant and lactating women should supplement their diet with a daily multivitamin that contains 150 mcg of iodine according to a recent article published in Natural Medicine Journal authored by three scientists at the Council for Responsible Nutrition (CRN). This science-based recommendation is supported by the American Thyroid Association Endocrine Society and the American Academy of Pediatrics. According to the scientific paper s lead author Duffy MacKay ND senior vice president scientific and regulatory affairs CRN Scientific evidence supports iodine s role in healthy brain development in utero and during early childhood however many U.S. adult women of childbearing age may be iodine-deficient putting their unborn children at risk for irreversible brain damage and other neurological abnormalities. Data from the National Health and Nutrition Examination Survey (NHANES) suggests that iodine intake has decreased dramatically over the past several decades with the percentage of women of childbearing age with iodine deficiency rising from 4 A to 15 percent. Ensuring sufficient iodine intake in this population is an important public health goal in the U.S. This past January CRN released recommended guidelines for the dietary supplement industry urging manufacturers to include a daily serving of at least 150 mcg of iodine in all multivitamin mineral supplements intended for pregnant and lactating women in the U.S. Health care providers play a key role in helping prevent iodine deficiency in pregnant and lactating women. Said MacKay We urge clinicians to support public health efforts to ensure adequate iodine intake in pregnancy and lactation by urging that any prenatal dietary supplement product they recommend con- tains a daily serving of at least 150 mcg of iodine. The paper published in Natural Medicine Journal underscores that healthy growth and development of fetuses and breastfed infants are dependent on sufficient maternal intake of iodine. CRN member companies are expected to be in compliance with the CRN recommended guidelines for iodine quantity in multivitamin mineral supplements for pregnancy and lactation within 12 months of the Jan. 27 2015 release date. The iodine guidelines are just one of a suite of proactive science-based guidelines CRN developed as part of its self-regulatory initiatives. CRN also has recommended guidelines for labeling and formulation of melatonin-containing dietary supplements for sleep support caffeine-containing dietary supplements labeling of protein in dietary supplements and functional food and best practices for enzyme dietary supplement products and safety considerations for dosage recommendations and labeling. For more information visit www.crnusa.org. Natreon Receives Strategic Investment From DSM atreon Inc. (New Brunswick NJ) has received an equity investment from DSM Venturing B.V. the corporate venture capital arm of the global life sciences and materials sciences company Royal DSM (Heerlen The Netherlands). We are pleased to welcome DSM as a strategic investor as we expand Natreon s clinically proven high quali- N ty ayurvedic product lines said Natreon s CEO and chairman Dr. Sanni Raju. DSM is a global leader in the dietary supplement market and their expertise and domain knowledge will help accelerate our growth. Natreon s focus on rigorous science and clinically demonstrated natural herbal supplements separates them from their peers added Greg McParland senior investment manager of DSM Venturing. Their products are focused on highly relevant health and wellness categories that consumers are demanding. We are looking forward to supporting the Natreon team as they expand their business. For more information visit www.natreoninc.com or www.dsm.com. Deerland Enzymes Joins International Probiotics Association eerland Enzymes (Kennesaw GA) recently announced that the company has joined the International Probiotics Association (IPA) the global voice of the probiotics industry. As a new IPA member Deerland Enzymes strengthens a collaborative effort of members equally divided between industry and academia. Deerland Enzymes increased involvement in the probiotic market is a reflection of the company s continued D focus on developing science-backed supplement formulations for gut health. Enzyme-based supplements lend themselves primarily toward digestive health and as such probiotics have become an integral part of many of our formulations said Scott Ravech CEO of Deerland Enzymes. We are proud to become an industry member of IPA and look forward to the opportunity to participate in this unique forum for the exchange of research and the latest Celebrating 20 Years of Excellence 1995-2015 breakthroughs in probiotic technology and new product development. For more information call (800) 697-8179 or visit www.deerlandenzymes.com. www.niemagazine.com September 2015 10 Nutrition Industry Executive Go to www.niemagazine.com qualitas for info about this advertiser IndustryNews OmniActive s Fourth Facility Passes Rigorous FDA Audit mniActive Health Technologies (Morristown NJ) Supa India facility is the fourth to successfully complete the FDA (U.S. Food and Drug Administration) CFR110 cGMP (current good manufacturing practice) audit joining the company s facilities in Oros Pune and Talwar India. OmniActive consistently strives to meet the highest quality and regulatory controls by continuously optimizing our operations and facilities stated Chaitanya Desai the company s COO. Our efforts in meeting and exceeding O the world s strictest standards serve as the foundation of our achievements as recognized by the FDA. OmniActive ensures that all personnel are fully trained in several aspects of operational excellence and quality control standards and its facilities are certified cGMP and ISO9005 22000. In addi- tion as a responsible supplier OmniActive s ingredients are produced through effective efficient and sustainable operations. We take great pride in our efforts and being recognized for doing so under rigorous analysis by the U.S. FDA further solidifies our dedication to deliver the industry with premium innovative ingredients said Lynda Doyle OmniActive s vice president of global marketing. For more information visit www.omniactives.com. Sabinsa Facility Receives Foreign Site Registration Number From Canada abinsa Corporation (East Windsor NJ) has received a Foreign Site Registration Number for its Payson UT finished product-manufacturing facility from Health Canada s Natural and Non Prescription Health Product Directorate (NNHPD). This Sabinsa manufacturing plant was recently assessed by NHPD for Natural Health Product s GMP (good manufacturing practice) standards and quality system and was deemed as compliant for manufacturing health products. Foreign Site Reference Number 5000311 allows Sabinsa to manufacture natural health products for the Canadian market in the Utah facility. The Utah facility is also NSF certified. Sabinsa Corporation already had multiple Masterfiles and Natural Product Numbers (NPN) approved for use in Canada which allows several of its extracts in the form of finished products in the Canadian market. LactoSpore BioPerine Curcumin C3 Complex Curcumin C3 Reduct and ForsLean among Sabinsa s proprietary products are available for Letter of Access requests. The most recent NPN obtained by Sabinsa is for their room temperature stable probiotic LactoSpore MTCC 5856. Availability of the NPNs with Sabinsa s original sciencebacked ingredients and the Foreign Site license for our Utah facility will greatly benefit our customers by considerably reducing the time required for product launches in the Canadian market said Shaheen Majeed marketing director Sabinsa Corp. As a global company working with regulatory agencies in an array of countries has become customary for us but it is always rewarding to achieve another milestone like this one. For more information call (732) 777-1111 or visit www.sabinsa.com. Lycored Puts Cultivating Wellness at the Heart of New Brand Identity ycored (Orange NJ) has launched a new corporate brand identity that cements its commitment to wellbeing and enhances its image globally the company stated. The new strategic positioning is fronted by a contemporary logo that echoes Lycored s strength and heritage as a supplier of natural ingredients derived from the tomato. This is complemented by a slogan that captures the values at the heart of the new brand identity-- Cultivating Wellness. Our new slogan represents how we operate as a business but also describes how we are as people said Rony Patishi-Chillim president and CEO of Lycored. We want every team member to feel inspired by our work and our relationships. Lycored is a global entity but we have retained the mentality of a small business where teamwork and collaboration--both among ourselves and with our partners-- underscore our uniqueness and lead to personal wellness and business success. As part of Cultivating Wellness Lycored has revamped its logo so that it offers an at-a-glance snapshot of the qualities that make the company both a confident leader in its field and a trusted partner. It resembles the crosssection of a sliced tomato--mirroring the raw material used in Lycored s core offering of tomato ingredients which are extracted from tomatoes in California and Israel. The extracts are used as natural bio-actives in nutrition products and as natural colors and ingredients for taste and texture improvement in foods and beverages. This is Lycored s third logo since the company was founded 20 years ago. For more information visit www.lycored.com. S L 12 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Go to www.niemagazine.com indfrag for info about this advertiser IndustryNews Sensient Flavors on Track to Remove PHOs Before Compliance Date ensient Flavors LLC (Hoffman Estates IL) has made significant progress in its efforts to remove partially hydrogenated oils (PHOs) from its entire line of products according to the company. All products made at its Harbor Beach MI and Juneau WI manufacturing sites are now PHO-free. Sensient Flavors manufacturing sites at Indianapolis IN and Celaya Mexico will complete the conversion to PHO-free before the FDA s (U.S. Food and Drug Administration) target compliance date. When the transition is complete all products previously containing PHOs will instead contain a non-hydrogenated liquid vegetable oil with high oxidative stability. This announcement comes on the S heels of the FDA s June 16 2015 ban which gives manufacturers three years to either reformulate products with partially hydrogenated oils or petition the FDA for an exception. We started this process more than a year ago in anticipation of the FDA s ruling so that our customers can make the proper formula recipe and label modifications well in advance of the regulatory deadline said Jeremy Thompson general manager savory flavors at Sensient Flavors. Our customers can rest assured we are committed to providing quality ingredients that meet and even exceed regulatory standards. Though the process of hydrogenation transforms liquid oil into shortening thereby changing their functionality and improving their oxidative stability it also creates trans fat which has been shown to stimulate the production of low density lipoprotein (LDL) and decrease the amount of high density lipoprotein (HDL) in the bloodstream. Because high LDL and low HDL levels have been linked to heart disease and arteriosclerosis the FDA has taken steps to remove PHOs from the list of GRAS (generally regarded as safe) food ingredients. With many of our customers operating in the natural products market we at Sensient Flavors made it a priority to remove all PHOs from our product line ahead of the FDA s deadline added Thompson. We look forward to offering a completely PHO-free portfolio in the very near future. For more information visit www.sensientflavors.com. Prinova IN Ingredients Announce Exclusive Partnership P rinova (Carol Stream IL) has announced its partnership with IN Ingredients (Columbia TN). As of July Prinova is the exclusive North American distributor for all of IN s clinically proven trademarked ingredients including Cinnulin PF Oxyjun CellBerry Nelulean Testafuranol and many more. Leveraging Prinova s strong distribution presence as well as their work with nutritional blends and formula- tions they were a natural fit for IN Ingredients. We are extremely excited to distribute the proven and innovative ingredient line from IN said Brent Laffey commercial director of nutrition Prinova. We believe this addition will be a nice fit into our growing product development line and we look forward to formulating with IN s ingredients. I expect to see strong developments for both companies as we unite IN s innovation and Prinova s distribution and blending abilities. We are pleased to be in partnership with Prinova. They fit the precise need IN Ingredients has to further our overall business objective of becoming a leader in innovative ingredients added Gus Romero president of IN Ingredients. For more information visit www.prinovausa.com or http in-ingredients.com . Ecuadorian Rainforest to Unveil New White Paper and Ingredients Map cuadorian Rainforest (Belleville NJ) will be releasing a new white paper aimed to help buyers navigate through the purchasing process. The white paper 4 Steps to Selecting an Ingredient Supplier and accompanying Ingredients Map will debut at SupplySide West (SSW) in October. The company s new white paper brings to the forefront many of the steps prospective nutraceuticals purchasers must take in order to ensure they receive the ingredients they need. Those who read this new white paper will learn how choosing the right supplier quality control logistics and consistency all play vital roles in determining E who to choose as an ingredient supplier and how that will affect the success of the product according to the company. Included with 4 Steps to Selecting an Ingredient Supplier are six ingredient profiles. These profiles will highlight ingredients such as mango coconut water and chuchuhuasi among others showcasing not only these ingredients nutritional value but also the intriguing benefits each ingredient possesses. Also included with Ecuadorian Rainforest s new whitepaper is the company s new Ingredients Map. The Ingredients Map will take travelers on a nutraceutical journey scouring the world for natural ingredients in their Celebrating 20 Years of Excellence 1995-2015 indigenous habitats. The Ingredients Map lists the world s most popular ingredients by region and more. For more information visit www.intotherainforest.com. 14 Nutrition Industry Executive www.niemagazine.com September 2015 Kyowa Hakko Creates Global Brand Marketing Center K yowa Hakko Bio Co. Ltd. (New York NY) is taking a major step in strengthening its global marketing strategy in order to fully support its customers and leverage the clinical science and quality behind its branded ingredients the company stated. The company has established a Global Brand Marketing Center comprised of members from Kyowa s headquarters in Japan and regional offices in North America Europe and Asia Pacific. In addition to creating the Kyowa Quality logo Kyowa has built a portfo- lio of branded ingredients that reinforce the company s vision to contribute to the health beauty and well-being of diverse populations around the world. Each ingredient is backed by rigorous science. Branding their ingredients helps to distinguish Kyowa s products from competitors protects their science supporting these products reinforces the quality of the raw material and provides a consistent message to consumers. We understand the impor- tance of marketing locally but as our brands grow and develop we needed a more structured organization to ensure our branding activities were consistent globally said Karen E. Todd RD senior director of global brand marketing for Kyowa. Kyowa s key branded ingredients include Cognizin Citicoline Setria Glutathione Sustamine L-alanyl-L-glutamine and Pantesin Pantethine. For more information visit www.kyowa-usa.com. Consuming Adequate Choline is Critical During Pregnancy holine is an essential nutrient critical to overall health. It is especially important during pregnancy. Choline plays a vital role in development of the brain in the fetus and in infants. Insufficient choline in the fetal brain adversely affects the development of the hippocampus and cortex--areas of the brain that regulate higher thinking and memory including visual memory. These are the brain areas children use for mental math and adults employ to remember where to find their car in a parking lot. According to Steven Zeisel MD PhD Kenan distinguished professor in the Department of Nutrition and director of the Nutrition Research Institute at University of North Carolina a mother s choline consumption during pregnancy affects the child s IQ and memory tests. The mother s choline intake during pregnancy can be related to children s performance when they re school age Zeisel said. He noted that children born to women with lower intakes of choline during the first and second trimesters of pregnancy did not perform as well in intelligence and visual memory tests at seven years of age as did children born to women who had consumed higher levels of choline during pregnancy. In 1998 The Institutes of Medicine-- the public health arm of the National Academy of Sciences--documented the important role of choline in pregnancy and lactation. They set the adequate intake (AI) recommendations at 425 mg per day for women 450 mg per day for pregnant women and 550 mg per day for lactating women. In addition to its impact on the brain throughout life choline also acts like a folate in preventing neural tube defects (NTD) in fetal development. Neural tube birth defects C such as anencephaly or spina bifida occur early in pregnancy before many women realize they are pregnant. Currently more than 90 percent of the U.S. population does not meet the AI recommendation for choline. Because consumption of choline-rich foods like eggs and liver has decreased in recent years it is almost always necessary to supplement the diet with choline. Women should check their prenatal vitamins for choline not all multivitamins including prenatal vitamins contain choline. For more information visit www.thecholineinformationcouncil.com. Go to www.niemagazine.com herballyyours for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 15 September 2015 www.niemagazine.com IndustryNews You reHired The American Herbal Products BENEO has appointed Jon Peters Association (AHPA) has announced to the position of president of that Amber Bennett joined its staff BENEO Inc. Peters will lead the in a newly created position as company s business for the director of membership developAmericas Region (U.S. Canada ment. Bennett will be Mexico and South responsible for establishAmerica) from BENEO s ing and implementing U.S. headquarters in strategies that maintain New Jersey. and expand AHPA memLars Asferg has bership creating and joined Lallemand Inc. implementing member (Montreal Canada) and recruitment and retention will be heading its Biostrategies and coordinatIngredients Division. He ing sponsorship and will succeed Kevin Jon Peters advertising initiatives to Kraus next year when expand AHPA s size and influence Kraus moves to a new senior manand promote AHPA s participation agement position. in herbal industry activities. Missouri-based RIBUS Inc. has Missouri-based National Enzyme added two new managers to its Company (NEC) recently welcomed staff. As global marketing manager Naeem Shaikh PhD to its leaderLaurie Wittenbrink will manage all ship team as vice president of marketing efforts globally for the research and innovation. company. Lisa Harter will lead Florida-based HP Ingredients has RIBUS global dietary supplement announced that industry veteran group and manage its broker and Hame K. Persaud has been distributor network in 23 countries. appointed executive vice president. InstantGMP (Cary NC) has Over the past 25 years announced the addition Persaud has held senior of Angelo Nardone as management positions at chief technology officer. Aveda Corporation Nardone will be responGarden State sible for the next phase Nutritionals and Sabinsa of development of Corporation. InstantGMP s Dr. Frederick Khachik Manufacturing a renowned carotenoid Execution System scientist joined the which will include barHame K. Persaud Kemin (Des Moines IA) code functionality human nutrition and health diviworkflow overhauls mobile and sion. The driving force for Khachiks data design. reunion with Kemin is the compaColinKurtis Advertising (Rockford ny s focus on exploring the health IL) has announced the addition of benefits of dietary carotenoids in Valette Piper-Bledsoe. Bledsoe maintaining and promoting health. joins the team as account director Kemin and Khachik collaborated in and will be responsible for many of 1994 on the commercialization of the agency s key accounts. FloraGLO Lutein. Archer Daniels Midland Company California-based HORN has (ADM Chicago IL) has named announced that Jeff DaVanon has Kenneth Campbell president of the joined its sales roster as account company s WILD Flavors business. manager. Representing HORN The company also named Manda Nutraceuticals DaVanon will develTweten president of the company s ope the business unit s distribution Specialty Commodities business reach in Texas. (SCI). 16 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Industry Attorney Robert Ullman Passes ndustry attorney Robert (Bob) Ullman has died leaving a legacy of significant contributions to shaping the dietary supplements industry. Ullman and his wife Joan died together in an accident on August 15 2015 leaving behind their son Marc Ullman and daughter Gail Ullman Corbett according to a press release by The Shelton Group. Ullman who was born in Frankfurt Germany on December 26 1933 graduated from New York University B.S. magna cum laude in 1955. He was a member of The Law Review at New York University School of Law from which he graduated with honors in 1961. Upon graduation he joined the firm of Bass and Friend which evolved into Bass and Ullman in 1969. Thirty years later when Bass and Ullman dissolved Ullman formed Ullman Shapiro & Ullman LLP with his son Marc Ullman and colleague Steve Shapiro. A seasoned litigator with 45 years experience practicing law in the dietary supplements industry Ullman was awarded the President s Award from the National Nutritional Foods Association (now the Natural Products Association [NPA]) in recognition of his contributions in 2005. Bob Ullman was a true pioneer when it came to representing the industry said NPA Executive Director and CEO Dr. Daniel Fabricant. His and Milt Bass work on so many landmark cases as NPA s attorneys still reverberates through all I we do defending the industry on the regulatory judicial and legislative fronts. In addition to the wonderful work he did those who knew Bob knew him as dedicated husband father and friend. He will be sorely missed. Ullman was not only recognized for his day-to-day work in defense of industry interests but for his involvement in pivotal vitamin hearings before Congress and related lawsuits against the FDA (U.S. Food and Drug Administration) in the 1970s. These cases included the vitamins A and D case where the FDA attempted to categorize high dose vitamins as drugs as well as other precedent setting cases that have helped protect consumer access to dietary supplements. In the mid 1990s he handled the landmark FTC (Federal Trade Commission) case defending calcium s bone building properties on behalf of Metagenics. He was lead counsel in the Traco and Oakmont Black Currant oil cases which ended FDA s attempt to regulate dietary supplements as food additives and were cited by Senator Hatch as one of the justifications for his introduction of DSHEA. Ullman also tried U.S. Postal and FTC advertising cases involving dietary supplements and direct marketing. My father literally dedicated his life to defending this industry and inspired us all by the passion he brought to defending his clients and the industry said son and partner Marc Ullman. Contributions in honor of Bob and Joan Ullman can be made to the Alzheimer s Association at www.alz.org. Marc and Bob Ullman after Bob was honored with the NPA Presidents award in 2005 for his lifetime commitment to the industry. September 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 17 IngredientNews Lipogen Targets Stress Management With New PSPA Ingredient ith 25 years of specializing in natural phospholipid research development and production Israel-based Lipogen Ltd. has launched the next generation of PS brain ingredient Lipogen PSPA. Lipogen PSPA is a new patent-protected solution for stress management and brain health support. PSPA is a natural high quality blend of phosphatidylserine (PS) and phosphatidic acid (PA). Lipogen PSPA efficacy has been successfully tested in two clinical trials David Rutenberg CEO of Lipogen. The separate controlled trials showed improved stress response under psychological and socially W demanding conditions measured by lower levels of stress hormone (cortisol). According to an article published in Forbes magazine January 2015 workplace stress caused additional expenditure up to 190 billion of annual U.S. health care costs. According to Lipogen the biggest factor of this cost stems from modern stressful and demanding work. A randomized doubleblind placebo-controlled study of 75 healthy male volunteers published in July 2014 by Hellhammer et al. in the peer reviewed journal Lipids in Health and Disease examined the effects of six weeks of daily oral supplementation of PSPA 400 (PAS 400) a complex containing 400 mg PS and 400 mg PA. Results showed that supplementation was effective in stabilizing the endocrine response to a stress test (Trier Social Stress Test) in chronically stressed subjects and observed normalization of cortisol. Lipogen PSPA a new plant lecithinderived ingredient was designed to help reduce the response to the stressful modern lifestyle and improve cognitive performance on a daily basis Rutenberg said. Lipogen PSPA is available in both a liquid and powder formula and is non-GMO (genetically modified organism) and kosher verified. It has been proven safe and effective for daily use according to Lipogen. For more information call 972 (0)52 474-2965 or visit www.lipogenbio.com. Natreon Receives Patent For Sensoril Conjugates atreon Inc. located in New Jersey is focused on developing and marketing ayurvedic products backed by extensive research high degree of standardization multiple clinical studies safety stidoes and intellectual property. Recently the company received a new patent for isolation purification and synthesis of Indolealkylaminowithasteroid conjugates from Sensoril with potenetial benefits for Alzheimer s. Natreon s Sensoril (Withania somnifera) also know as ashwagandha in ayurvdea is an adaptogen used to promote health and longevity by augmenting the body s defense mechanisms against disease arresting the aging process revitalizing the body in debilitated conditions and creating a sense of wellbeing. Several earlier human clinical studies have shown the Sensoril is very effective in decreasing stress levels and improving cognition. This latest patent describes a group of indolealkylamino-withasteroid conjugates isolated from Withania somnifera and purified for possible treatment of dementia and dementia-related disorders such as Alzheimer s such as Aricept and Exelon are marginally effective at best and can have serious side effects. These indolealkylamino-withasteroid conjugates isolated from Withania somnifera may help fill this need. For more information visit www.natreoninc.com. Stratum Nutrition and BLIS Technologies Announce Approvals for BLIS K12 tratum Nutrition (St. Charles MO) and BLIS Technologies (Dunedin New Zealand) announced new claim approvals from Health Canada for the use of BLIS K12 probiotic in supplement products. Working in partnership Stratum and BLIS submitted a master file to the Natural and Non Prescription Health Products Directorate (NNHPD) within Health Canada for the probiotic ingredient BLIS K12. A subsequent Product License Application (PLA) referencing the master file recently gained Health Canada approval and was issued a natural product number (NPN). This approval allowed Canadian manufacturers and marketers to make substantial and specific label claims on their products which contain the BLIS K12 ingredient. Their strategy of focusing on getting through regulatory approvals is a means of opening up markets Barry Richardson CEO of BLIS Technologies said. As arduous as the process is each successful regulatory approval prepares the ground for the sales and marketing effort that follows. After reviewing the supporting science and safety publications Health Canada has approved products containing BLIS K12 to claim language such as the product promotes oral health [through the recolonisation of the oral cavity] that it is an oral probiotic for recolonization of the oral cavity after antibiotic treatment that following oral antimicrobial rinsing Streptococcus salivarius K12 supplementation helps reduce volatile sulfur compound levels (halitosis) and that it can help reduce the incidence of Streptococcal pharyngitis tonsillitis (sore throats caused by pathogenic variants belonging to the Streptococcus genus. Kevin J. Ruff PhD MBA CCRP director of scientific and regulatory affairs said Stratum was pleased to be able to use our regulatory expertise in Northern America to open up the Canadian market for BLOIS K12 and we expect the strong efficacy claims that were approved to really resonate with Canadian consumers. For more information visit www.stratumnutrition.com or www.blis.co.nz. N S 18 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Japan Bio Science Laboratory Awarded NSF Certification for Nattokinase J apan Bio Science Laboratory (JBSL Osaka Japan) founded in 1974 specializes in the development and manufacturing of functional health supplement and food ingredients. JBSL is the industry s leading manufacturer and supplier of nattokinase and was awarded the NSF Certification for NSK-SD. This certification provides addition validation for our NSK-SD ingredient and we will continue to rely on the science behind NSK-SD to provide differentiation in the marketplace Vincent Hackel president of JBSL-USA Inc. said. NSK-SD is the only nattokinase ingredient fermented from the original Bacillus subtilis natto strain. It has demonstrated the ability in numerous clinical studies to help dissolve excess fibrin reduce blood platelet aggregation decrease blood pressure and improve circulation. Earning NSF Certification of NSK-SD is a direct example of JBSL s dedication to providing our industry with the premium nattokinase backed by more than 35 studies Hackel said. Research has uncovered properties of NSK-SD that make it an attractive daily supplement to support healthy cardiovascular function. Specifically studies have shown NSK-SD to promote arterial health via thrombolytic activity reduce whole blood viscosity promote normal blood pressure and normal clotting inhibit platelet aggregation and increase healthy blood circulation. NSK-SD it the only nattokinase for example whose thrombolytic activity (dissolving greater than 20 000 fibrino- gen degradation units per gram) has been demonstrated in human studies Hackel said. Currently JBSL has two Japanese patents and three U.S. patents for its technology in producing NSK-SD. The registration by NSF International states JBSL is in compliance with current good manufacturing practices (GMPs) as set forth in NSF International Certification Guideline 229 Functional Foods. These GMPs are consistent with Food & Drug Administration (FDA) cGMP for food products (21 CFR 110.3). For more information visit www.jbsl-net.com. Daily Cognizin Citicoline Improves Attention in Adolescent Males esults of a double-blind placebo-controlled human clinical trial showed that nearly one month of oral supplementation with New Yorkbased Kyowa Hakko U.S.A. s Cognizin citicoline resulted in improved attention and motor function in healthy adolescent males. The study published in the August edition of the Journal of Attention Disorders followed 75 healthy male adolescents who received either a placebo 250 mg of Cognizin citicoline supplement or 500 mg of Cognizin citicoline supplement for 28 days. After the 28-day study period participants who received Cognizin citicoline R showed statistically significant increased motor speed improved attention and decreased impulsivity compared to the placebo group. The authors noted the results of this study support previous research that has demonstrated citicoline s positive impact on the brain s frontal lobe which is still maturing during adolescence. Further enhanced motor speed visual selective attention and reduced impulsivity could prove to be useful in an adolescent population experiencing neural development and increased risktaking behavior. We re pleased with the findings that indicate daily supplementation with Cognizin citicoline enhanced attentional processes in healthy adolescent males said lead researcher Deborah Yurgelun-Todd PhD University of Utah. This is the first study of its kind that has examined the effects of Cognizin citicoline in an adolescent population--natural supplementation is key especially during adolescence when the brain s frontal lobe is still in development. These statements have not been evaluated by the Food and Drug Administration and are not intended to cure or prevent disease. For more information visit www.cognizin.com. TSI Group Obtains GRAS Status for PEAK ATP T SI Group Ltd. based in Montana announced that its ingredient PEAK ATP (Adenosine 5 -Triphosphate Disodium or ATP) was granted selfaffirmed GRAS (generally recognized as safe) status for use in functional food bars and powders. The new accreditation compliments a comprehensive technical dossier that includes strong efficacy and safety date non-GMO (genetically modified organism) kosher and cGMP (current good manufacturing practice) manufacturing accreditations. September 2015 www.niemagazine.com A leading independent panel of experts reviewed the ingredient s comprehensive scientific evidence covering the oral use of PEAK ATP for application in nutritional bars and powders prior to issuing their favorable GRAS opinion. There is tremendous demand today for us to expand our ingredient reach into the food and functional foods markets Larry Kolb TSI USA Inc. president said. Having this GRAS affirmation allows us to take PEAK ATP s unique performance and health benefits into foods and that s an exciting development for PEAK ATP. According to the company PEAK ATP is patented and clinically proven to increase strength and power during times of intense exercise. It also improves blood flow lean body mass and reduces muscular fatigue. This ingredient is not listed on the World Anti-Doping Code 2013 prohibited list by the World Anti-Doping Agency (WADA) the company said. For more information visit www.peakatp.com. Nutrition Industry Executive 19 Celebrating 20 Years of Excellence 1995-2015 IngredientNews Unexpected Discovery of Biomarkers of Effective NAD Precursor C alifornia-based ChromaDex Scientific Advisory Board member Charles Brenner PhD presented data that revealed the discovery of an unexpected and sensitive biomarker of effectively increasing NAD metabolism with nicotinamide riboside (NR). A provisional patent on the discovery was filed. The University of Iowa discovery was confirmed in the first controlled clinical study on the use of ChromaDex s NIAGEN NR which was presented at the Fourth Federation of American Societies for Experimental Biology (FASEB) Science Research Conference on NAD Metabolism and Signaling held in Germany. Data presented indicated that single doses of NR can elevate NAD in the blood by as much as 2.7-fold. Moreover Samuel Trammell and Charles Brenner discovered from their first n 1 experiments that nicotinic acid adenine dinucleotide (NAAD) is an unanticipated and highly sensitive biomarker of increased NAD metabolism. The results showed NAAD increases from non-detectable levels prior to NR supplementation to levels that are clearly correlated with increasing levels of NAD with NR supplementation. The dramatic fold-change increases of NAAD validates NIAGEN as an effective agent at elevating blood cell NAD metabolism in healthy human beings. Nobel Laureate Dr. Roger Kornberg who chairs ChromaDex s Scientific Advisory Board commented Cellular NAD is a highly abundant metabolite and is under tight controls that limit its rise and fall. The high endogenous concentration of NAD and the mechanisms that buffer changes in NAD make it a challenging molecule to monitor for significant increases due to NR supplementation. Dr. Brenner s new finding revealing NAAD is an ideal biomarker for measuring the effectiveness of a NAD precursor NR is a game changer in understanding and studying NAD metabolism. ChromaDex s NIAGEN is the first and only commercially available form of NR and is supported by five patents issued and several pending with patent rights acquired from Dartmouth College Cornell University and Washington University the company said. For more information www.chromadex.com. Vitamin K2-MK7 Recognized by EFSA Actazin Verifed as Non-GMO ew Zealand-based Anagenix and Missouri-based Stratum Nutrition announced that Actazin a digestive health ingredient derived from green kiwifruit received certification from the Non-GMO Project as being Non-GMO Project Verified. Actazin is a whole-fruit powder derived from New Zealand green kiwifruit. It is a rich source of naturally occurring vitamins minerals polyphenolic compounds and fiber and has been shown in vitro to provide prebiotic activity making it a good companion to probiotics the company said. The non-GMO (genetically modified organism) status of Actazin increases its opportunities to be included in nonGMO supplements and functional foods. While New Zealand is GMO free by law we wanted to take a leadership role and ensure that our product aligned with consumer insights and global demand by having Actazin independently verified as a non-GMO product. After careful consideration of the organizations that are set up to perform this type of verification we chose the Non-GMO Project as we believe they have the most credibility Chris Johnson group managing director for Anagenix said. Ongoing support of research and development and gaining third-party certifications from organizations like the NonGMO Project underpin the Stratum promise of empowering product innovation. We are extremely pleased to work with companies like Anagenix that share our values and commitment to innovative safe and reliable ingredients like Actazin said Jeremy Moore president of Stratum Nutrition. The news of Actazin attaining non-GMO verification comes after Actazin s recent clinical trial published in the May 2015 issue of Nutrition Research which demonstrated significant digestive health benefits in a healthy cohort the company said. E uropean Food Safety Authority (EFSA) approved and recognized Indiana-based Vesta s natural vitamin K2-MK7 as Novel Food in E.U. and Norwaybased CLS Technology has been given the right to distribute it in Europe the companies said. As one of the founders of NattoPharma I introduced K2 in the market in 2009. The market for vitamin K2 is still a niche market because both the quality and price have not been good enough. After years of product development Vesta has been able to make what I would say is the best quality natural K2 at a competitive price Morten Sundstoe chairman of CLS Technology. The distribution agreement with CLS Technology and Vesta is exclusive. N We are very pleased to be Vesta s representative in Europe and we see great potential for our K2 products in Europe now that it is recognized as Novel Food Sundstoe said. Most people have never heard of vitamin K2 and it is rare in the Western diet. However the nutrient plays an essential role in health and may be the missing link between diet and several killer diseases the company said. For more information visit www.cls.technology. 20 Nutrition Industry Executive This product has not been evaluated by the FDA and is not intended to diagnose treat prevent or cure any disease. For more information visit www.stratumnutrition.com. www.niemagazine.com September 2015 Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com kyowa for info about this advertiser AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Defending the Current Proposition 65 Safe Harbor for Lead he American Herbal Products Association (AHPA) is working with several other trade groups with the California Chamber of Commerce (CalChamber) as the lead organization to oppose two challenges to the California Proposition 65 (Prop65) current maximum allowable daily level (MADL) safe harbor of 0.5 micrograms per day for lead exposures. The current safe harbor for lead was established by OEHHA in 1992 and any product sold in California that presents an exposure above that limit is required to provide a state-mandated warning that such product contains a chemical known to the state to cause birth defects and other reproductive harm. T The Challenges In January the Mateel Environmental Justice Foundation--a prominent Prop 65 plaintiff--sued the California Office of Environmental Health Hazard Assessment (OEHHA) alleging that the office did not follow the statutorily mandated evidence and standards required when it established this MADL. Mateel has requested the court to order OEHHA to vacate and rescind and not ... implement or enforce the 0.5 g day regulatory safe harbor level for lead under Proposition 65. There were some early favorable indications from the court hearing this case when the judge issued a tentative ruling in early June in support of OEHHA s motion for judgment and CalChamber s demurrer which would have had the effect of dismissing the case in its entirety with no leave to amend. Unfortunately the judge reversed these tentative decisions so the case will still be heard. Even as the Mateel lawsuit winds its way through the court the Center for Environmental Health (CEH) filed a petition in July demanding OEHHA repeal or amend the MADL for lead and issue a regulation clarifying that the MADL for lead is a single day exposure limit and that averaging exposures over time is not permitted. OEHHA responded on August 3 advising CEH that it will initiate rulemaking to revise the existing MADL for lead. OEHHA will hold a hearing on the petition on October 9 at 10 a.m. in Sacramento CA. Defending the Safe Harbor The CEH petition and Mateel lawsuit are now intertwined. CalChamber has advised a dual strategy to defend against the Mateel case and to actively engage with legal counsel and toxicologist experts to try to affect the outcome of the CEH petition. Hundreds of Prop 65 notices have been issued to companies that manufacture and sell consumer products including dietary supplements personal care food and more. If the Mateel lawsuit or the CEH petition are successful the lead MADL could be withdrawn or substantially amended. This could force companies to choose between withdrawing products from the California market or adding Prop 65 warnings to product labels. Ensuring consumers have access to safe products is a top priority for AHPA and its members but eliminating this safe harbor would provide no benefit to consumers. Instead it would force more businesses to provide warnings that are arguably inaccurate and overly alarming. AHPA has made financial contributions to CalChamber to support the organization s efforts to oppose these efforts by CEH and Mateel to upset the status quo. If your company would like to make a financial contribution to support industry s efforts in these matters please contact the association. For more information call (301) 588-1171. Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) AssociationNews AHPA Relocates NDI Database he American Herbal Products Association (AHPA) recently announced that it has moved the AHPA NDI Database to http ndi.ahpa.org. The AHPA NDI Database provides online access to more than 725 notifications submitted to the U.S. Food and Drug Administration (FDA) for new dietary ingredients (NDIs) that are used in dietary supplements and FDA s responses to these notifications. AHPA s NDI Database provides a valuable resource for any company looking to develop and market new dietary ingredients in dietary supplements. The database helps companies avoid common mistakes by highlighting issues that T cause FDA to object to a notification or determine the notification to be incomplete. Database users can also access notifications that were successfully filed without substantive comment by FDA. Subscribers can browse NDI notifications and search by the NDI s generic and brand name the Latin name (genus) of herbal NDIs report numbers assigned by FDA and or the name of the submitting firm their counsel or other consultCelebrating 20 Years of Excellence 1995-2015 ant. Currently the AHPA NDI database now has more than 725 notifications available for subscriber access. As the only up-to-date compilation of NDI notifications the AHPA NDI Database is a searchable platform that allows users to easily find all notifications that have been submitted for any specific ingredient or by any particular company. Non-AHPA members can subscribe for 495 per year and AHPA members are eligible for a member s only discount code to receive an exclusive 195 year rate. For more information visit http ndi.ahpa.org. www.niemagazine.com September 2015 22 Nutrition Industry Executive THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE 20 Y ars Celebratingellence e of Exc 1995 2015 NIE s Upcoming 2015 Issue Highlights Nov. Dec. 10 23 15 ad closing Supply Innovation 2016 Media Planner Coming Soon Contact Your Advertising Sales Specialist for More Details Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF VRMmedia.com Roy Kieffer at 719-358-9838 or e-Mail RoyK VRMmedia.com Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP VRMmedia.com ScienceUpdate Vitamin C Related to Reduced Risk of Cardiovascular Disease Early Death ew research from the University of Copenhagen (Denmark) and Herlev and Gentofte Hospital shows that high vitamin C concentrations in the blood from the intake of fruit and vegetables are associated with a reduced risk of cardiovascular disease and early death. The study which was published in the American Journal of Clinical Nutrition is based on the Copenhagen General Population Study. As part of the study the researchers had access to data approximately 100 000 Danes and their intake of fruit and vegetables as well as their DNA. We can see that those with the highest intake of fruit and vegetables have a 15 percent lower risk of developing cardiovascular disease and a 20 percent lower risk of early death compared with those who very rarely N eat fruit and vegetables. At the same time we can see that the reduced risk is related to high vitamin C concentrations in the blood from the fruit and vegetables said Camilla Kobylecki a medical doctor and PhD student at the Department of Clinical Biochemistry Herlev and Gentofte Hospital. Among other things vitamin C helps build connective tissue which supports and connects different types of tissues and organs in the body. Vitamin C is also a potent antioxidant which protects cells and biological molecules from the damage which causes many diseases including cardiovascular disease. The human body is not able to produce vitamin C which means that we must get the vitamin from our diet. We know that fruit and vegetables are healthy but now our research is pinpointing more pre- cisely why this is so. Eating a lot of fruit and vegetables is a natural way of increasing vitamin C blood levels which in the long term may contribute to reducing the risk of cardiovascular disease and early death. You can get vitamin C supplements but it is a good idea to get your vitamin C by eating a healthy diet which will at the same time help you to develop a healthier lifestyle in the long term for the general benefit of your health said Boerge Nordestgaard a clinical professor at the Faculty of Health and Medical Sciences University of Copenhagen and a consultant at Herlev and Gentofte Hospital. The researchers are now continuing their work to determine which other factors combined with vitamin C have an impact on cardiovascular disease and death. For more information visit http healthsciences.ku.dk. Using Garlic to Combat Antimicrobial Resistant UTIs arlic extract may be an effective weapon against multi-drug resistant strains of pathogenic bacteria associated with urinary tract infections (UTI) according to a recent study published in the Pertanika Journal of Tropical Agricultural Science. Conducted by researchers at the Birla Institute of Technology and Sciences in India the study found that even crude extracts of [garlic] showed good activity against multidrug resistant strains where antibiotic therapy had limited or no effect. This provides hope for developing alternative drugs which may be of help in fighting the menace of growing antibacterial resistance the team stated. A UTI is the second most common infectious disease encountered in community practice. Worldwide approximately 150 million people are diagnosed each year with a UTI at a total treatment cost in the billions of G dollars. Although UTI is usually treated with antibiotics emerging antimicrobial resistance compels us to look back into traditional medicines or herbal products which may provide appropriate acceptable alternative solutions the authors argued. Garlic (Allium sativum) has been traditionally used for the treatment of diseases since ancient times. A wide range of microorganisms--including bacteria fungi protozoa and viruses-- are known to be sensitive to garlic preparations. Allicin and other sulphur compounds are thought to be the major antimicrobial factors in garlic. In the study the team found that 56 percent of 166 bacteria strains isolated from the urine of people with UTI showed a high degree of resistance to antibiotics. However approximately 82 percent of the antibiotic resistant bacteria were susceptible to a crude aqueous extract of Allium sativum. According to the researchers ours is the first study to Celebrating 20 Years of Excellence 1995-2015 report the antibacterial activity of aqueous garlic extract against multidrug resistant bacterial isolates from infected urine samples leading to UTI. To conclude there is evidence that garlic has potential in the treatment of UTI and maybe other microbial infections the team said. However it is necessary to determine the bioavailability side effects and pharmacokinetic properties in more detail. For more information visit www.pertanika.upm.edu. 24 Nutrition Industry Executive www.niemagazine.com September 2015 Manufacturing One of the most challenging issues with combination products is being able to include therapeutic levels of key ingredients while keeping the daily serving of tablets or capsules to a minimum -- Marci van der Muelen National Sales Manager Nordic Naturals Contract & Custom Update Contract and custom manufacturers work with formulators to create the latest and greatest products. By Lisa Schofield he dietary supplement industry is the perfect example of true synergy. On one hand there are the creators the formulators the idea-drivers--and on the other is the expertise and capabilities of a number of contract and custom manufacturers. Together they forge the latest excitement for new September 2015 www.niemagazine.com T products that consumers can enjoy trying out. The industry encourages continued innovation because consumers demand it. Laurel-resting is frowned upon as the voluminous research demonstrating and validating health benefits continues to cascade motivating formulation renovations and fostering brand new creations. Scott Ravech CEO of Deerland Enzymes in Georgia which specializes in contract custom manufacturing of enzyme- and probiotic-based supplements related that brand marketers typically like to focus on their core competencies which in the case of many of our customers lies with Nutrition Industry Executive 25 Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com drvita for info about this advertiser Manufacturing Contract & Custom Update driving their consumer connection and marketing the features and benefits of their products. The intricacies complexity and cost associated with manufacturing can in many cases be a distraction away from what they do best. Deerland Enzymes he added provides value beyond expert blending encapsulation and bottling to include expertise in product formulation and regulatory support. The company begins its relationships at the concept phase of product development to ensure thorough understanding of the brand marketer of the benefits of the products and then the company customizes the solution. We call this no-cost service YourBlend he said. The landscape of contract and customized manufacturing has grown to see two types of fulfillment. Tee Noland CEO of Georgia-based Pharma Tech Industries explained that the larger ones are seeking strategic business partners to integrate with their supply chain organizations as well as to develop specialized technical solutions to streamline the process. We are seeing a significant increase in the number of new products we are developing with our customers many of them new to enzymes. We re fortunate that not only is our customer base expanding but the number of new products being launched also continues to increase. The landscape of contract and customized manufacturing has grown to see two types of fulfillment. Tee Noland CEO of Georgia-based Pharma Tech Industries explained that the larger ones are seeking strategic business partners to integrate with their supply chain organizations as well as to develop specialized technical solutions to streamline the process. Smaller brand marketers tend to want a CMO that can own the supply chain and as a result they stay out of much of the detail. Go to www.niemagazine.com jtnaturals for info about this advertiser 28 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Go to www.niemagazine.com pinnaclelabs for info about this advertiser Manufacturing Contract & Custom Update Both large and small brand marketers want to make their lives easier relative to supply chain management to allow them to focus on what they do best--marketing and selling their products to their customers he remarked. And all brand marketers are expecting more and more from their contract manufacturers. Beyond the expectation that the contract custom manufacturer adhere to cGMPs (current good manufacturing practices) the demand for a vari- Go to www.niemagazine.com nutraceutix for info about this advertiser 30 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 ety of certifications has risen as they convey quality to the consumer and in tandem a higher sense of trust. Quality and safety are so important because they are the foundation of trust that brands make to the consumer and the manufacturer makes to the brand owner said Noland. The requirements of quality safety and compliance he noted can and do add complexity to the manufacturing process from an equipment and data gathering perspective to ensure the quality is consistent in real time. Items like fill weight tolerances often come into play especially as you use more automation and higher speed equipment and must come up with a method to sample output for conformance. Another specialist is Nutritional Engineering Inc. in California which focuses on nutraceutical liquid products for which there is increasing demand from health-minded consumers who dislike tablets or capsules. And here said Cesar Castaneda safety director new requirements and certifications are helping the company s business grow by ensuring that all processes are performed correctly. Nutritional Engineering Inc. implemented new certifications internal audits and safety programs that help establish GMPs. Accidents can happen for any manufacturer he conceded which is why we perform ongoing hazard analysis and preventative practices to lower risks by certifications that provides our employees with the skills and knowledge needed to achieve our companies quality and safety goals. Overall our compliance with the increased requirements for quality and safety has set us apart from other companies in the same business. Reyna Montalvo Nutritional Engineering Inc. s quality assurance manager GMP coordinator added that the increasing requirements from FDA s (U.S. Food and Drug Administration s) new regulations include both raw materials and finished product testing which may sometime delay the manufacture date or shipping date. In addition its customers are requiring the company to www.niemagazine.com September 2015 have more documents and certifications such as gluten-free and nonGMO (genetically modified organism). As such she reported that we have now become gluten-free certified and are required to be audited yearly by a GFCO (Gluten-free Certification Organization) company. We are also cGMP certified by NSF which take our audits biannually. Since joining Deerland Enzymes in 2006 Ravech expressed that he has been pleased to see the importance its customers place on marketing science-supported products and compliance with FDA regulations. As an active member of the Enzyme Technical Association (ETA) and Council for Responsible Nutrition (CRN) Ravech has seen firsthand the industry s commitment to increase regulatory compliance efforts including more frequent on-site vendor facility audits more companies seek- FDA first introduced GMP regulations for dietary supplements in 2007 with the intent of industry-wide compliance by 2010. By now all companies should be GMP compliant. -- Scott Ravech CEO of Deerland Enzymes ing GMP certification and increased testing capabilities. FDA first introduced GMP regulations for dietary supplements in 2007 with the intent of industry-wide compliance by 2010 reminded Ravech. By now all companies should be GMP compliant he emphasized. As the marketplace demands more transparency we have seen a significant increase in requests from customers to perform their own audits of our facility. Deerland Enzymes often hosts audits conducted by its customers and encourages all of its customers to do so. The company grants full access Go to www.niemagazine.com nutritional September 2015 www.niemagazine.com Go to www.niemagazine.com uckele Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 31 Manufacturing Contract & Custom Update to the facility for a complete audit concealing only the identity of its other customers in order to ensure confidentiality. Innovations Continue Nutritional Engineering Inc. s latest technical innovation includes a new state-of-the-art high-speed filling line to support bottle sizes of 1- 2- 4and 6-oz. that can be made in plastic or glass reported Ginny Laoudis CEO and president of the company. There is an increasing need for bottles of this size for both new and current customers she observed. We are also able to pack in display cartons for retail businesses. The benefits in purchasing the new equipment In the 1990s herbs such as ginkgo kava and horny goat weed were the rage so these and other botanical supplements were being produced in higher numbers at contract custom manufacturing facilities. Now it s other ingredients but also other technologies. variety of dosage forms he added. At Deerland Enzymes one of the largest investments has been in stateof-the-art laboratory equipment to provide further insight into a raw material s identity purity or potency said Ravech. These include a microplate reader HPLC (high-performance liquid chromatography) and PCR (polymerase chain reaction) instruments. Further he announced that Deerland Enzymes recently began packing and shipping all of its customers bulk products with the advanced DehydroDryDrum (D3) System. This packaging system includes a laminate-lined drum with an improved lid style to provide a better seal. This system provides a superior vapor barrier for shipping bulk blends and capsules in comparison to standard fiber drums. As a further safety measure Deerland Enzymes utilizes inventory software that provides instant traceability of all products and raw materials. All raw materials that are received into inventory are bar-coded allowing each ingredient to be tracked at any time both during and after production of the finished good and after shipping. not only include being cost effective for our customers in launching new products as well as increasing their needs for future orders. Pharma Tech said Noland has placed significant emphasis on enhancing customer service through IT integration. For example the company is working to roll out electronic batch records with several key customers by the end of 2015. Pharma Tech also offers inventory replenishment from a forecasting and order management perspective which Noland said can save a lot of planning and coordination resources for its customers. We are also innovating quite a bit on the process side with some state of-the-art high-speed powder-filling equipment across a Go to www.niemagazine.com somalabs Celebrating 20 Years of Excellence 1995-2015 Market Trends In the 1990s herbs such as ginkgo kava and horny goat weed were the rage so these and other botanical supplements were being produced in higher numbers at contract custom www.niemagazine.com September 2015 32 Nutrition Industry Executive manufacturing facilities. Now it s other ingredients but also other technologies. For example Ravech noted that Deerland Enzymes customers are increasingly interested in delivery forms and packaging options that will increase stability or shelf life any technology that may work to limit the product s exposure to moisture heat or oxygen is of particular interest. Product-wise digestive support is growing at a higher rate than the supplement industry as a whole he observes. Products containing probiotics continue to gain popularity. Since different strains offer specific benefits he said that Deerland s customers are increasingly seeking a multi-strain formulation of both nonspore and spore forming probiotics. Based on this demand more science is emerging to support the benefits of spore-forming probiotic strains such as Bacillus subtilis. Deerland Enzymes has genome sequenced and clinically tested DE111 a highly effective strain of Bacillus subtilis a very stable probiotic spore that supports digestive health and works as a complement to many of the non-spore strains that are also available he explained. Pharma Tech Industries is seeing more requests for line extension opportunities into innovative dosage forms said Noland. Brand marketers see this as a low cost low risk way of extending their brand into a new package form that creates more differentiation to the consumer. Unitdose package formats in particular seem to be more highly demanded as consumers tend to want more portability and ease of use he reported. In liquid supplements Laoudis observed that Nutritional Engineering Inc. is seeing steady demand for targeted health conditions encompassing memory and cognitive support joint care support and anti-aging products. We have also started a brand new cosmetic product line and are in the process of developing pet products she revealed. The natural health product field has indeed flowed from human health needs to cosmetics that are not only cleaner but also provide nutraceutical values and of course companion animals (pets). This spread creates even more of a need for contract custom manufacturers to specialize and or keep abreast of providing solid effective and regulated services. Laoudis summarized Industries are always advancing forward and are in need of finding the right company to provide them the services that can take on any project from start to finish. NIE FORMOREINFORMATION Deerland Enzymes (800) 697-8179 Nutritional Engineering (760) 599-5200 Pharma Tech Industries (706) 246-3555 Go to www.niemagazine.com generexlabs for info about this advertiser September 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 33 Consumers are seeking targeted functional benefits in their immune health products. By Anne Lee C all it a gut reaction or call it a change in direction. As more people seek products that promote immune health the shelves of the wellness marketplace are getting stocked as much with enriched drinks and foods as with jars of supplements. Developers and manufacturers in the field of wellness health foods believe the state of the immune health market has been shifting gears dramatically. The market for functional beverages has exploded during the past decade noted Richard G. Mueller chief executive officer of Minnesota-based Biothera the Immune Health Company. According to a Euromonitor International study the global market for functional and fortified beverages has more than doubled in the past decade to 86 billion last year. Deanne Dolnick science director for TR Nutritionals in Georgia pointed to another Euromonitor study one indicating a decrease in the immune health supplement category by 29 percent from 2009 to 2014. For many years consumers were boosting their immunity by 34 Nutrition Industry Executive taking mega-doses of vitamins and other dietary supplements she said. The fact that consumers have moved away from boosting immune health through dietary supplements doesn t mean that the consumer no longer cares about boosting their immunity Dolnick said. The healthy organic food category has grown exponentially during the same time period that dietary supplement sales have fallen. Most people would find it almost impossible to get all their micronutrients solely through their diets Dolnick added. Vitamin supplements will always be necessary but should be used as an adjunct to a healthy diet. Pro-active Approach Mueller described consumers embrace of food beverage and supplements created to provide immune health benefits as a recent phenomenon. He explained that 20 years ago consumers were focused on the absence of nutritional negatives in beverages (low sodium refined sugar artificial sweeteners). They ve since come to accept the presCelebrating 20 Years of Excellence 1995-2015 ence of nutritional positives (calcium fiber) but now are seeking targeted functional benefits (immune health digestion). It is a shift driven by consumers taking a long-term approach to their health moving from reactive short-term fixes to a more pro-active preventative approach Mueller said. Dan Lifton president of Proprietary Branded Ingredients Group of Maypro Industries (New York) pointed to the most recent Consumer Survey on Dietary Supplements survey published in October 2014 by the Council for Responsible Nutrition (CRN). Twentyfive percent of consumers take immunehealth supplements with immune support consistently among the top five health concerns among consumers he said. Not only that--immune health supplement sales were predicted to reach nearly 2.5 billion in 2014. Sales of single vitamins are down but up are innovative whole-food-based vitamins Pete Maletto founder and CEO of PTM Food Consulting in New Jersey said. It s big businesses. People www.niemagazine.com September 2015 don t buy soy but they buy whey. Vegan protein exploded over past year. Perceptions of Immune Health Recognition of the importance of immune health is increasing. It has improved over past three or four years even doubled Maletto said. People see what they are ingesting as important to the immune system. I only see it growing from here. Like Maletto Dr. John Deaton vice president of technology at Georgiabased Deerland Enzymes said a properly functioning digestive system is the key to immune health and noted that more immune cells reside in the intestines than anywhere else in the human body. He described probiotics as beneficial bacteria playing a crucial role in the development and operation of the mucosal immune system in the digestive tract. Deaton explained In many cases immune dysfunction begins with a failure to communicate in the human gut. Considering 80 percent of the immune system is located in the digestive tract maintaining a healthy gut is becoming a major focal point in the pursuit to support overall health and immunity. When the digestive system is functioning properly it serves as a barrier to bacteria viruses and pathogens. Deaton added poor digestion leaves the body and the immune system with a lack of nutritional factors that support immune function and the function of the entire body. Consumers are educating themselves more and are looking for the actual research and information to support their lifestyle choices. Mueller noted that Biothera believes the next big driver of market growth will be immune health. As Michael Bush senior vice president for Ganeden Inc. in Ohio said It s an evolving marketplace with new and interesting immune support types. In the Marketplace Bush explained that Ganeden makes one primary ingredient Probiotic Ganaden BC30 which he described as a Probiotic starter culture kept in purified strains in a deep freeze. Ganeden markets BC30 in various forms and formats to manufacturers of more than 100 finished products including probiotic teas by Bigelow and Yogi a cereal by Post and a host of sparkling beverages and dairy products. In all cases the organism itself is exactly the same and genetically the same with lots of QC (quality control) he said. We produce it it s patented by us and we have about 115 patents. According to Bush Ganeden s clinical studies have been run by outside firms. Founded in 1997 Ganeden launched a line of supplements in approximately 60 000 stores in 2007 and sold that business when it shifted roles and became an ingredient supplier in 2011. Ganeden has a worldwide presence. In the last quarter we shipped to 16 different countries all around world Bush said. Maypro s AHCC (Active Hexose Correlated Compound) is the top-selling immune support ingredient in Japan. Lifton described AHCC as a cultured extract of mushroom mycelia that is rich in immune-supportive alpha glucans and its manufactured as a patented extended liquid culturing process that makes its active components different from other mushroom extract products. He added that one of the attributes of AHCC is superior absorption and strong clinical efficacy. AHCC is supported by more than 20 human clinical studies and is used in more than 1 000 clinics across the globe Lifton noted. Studies on the compound have been conducted at some of the finest research institutions in the world including highly regarded Ivy League universities. It is unique in that it modifies both the innate and adaptive immune response. Mueller said beverage food and supplement products utilize Biothera s Wellmune a natural immune health Categorizing Immune Health Immune health has always been one of the largest categories within the nutrition category and has recently passed heart health as the No. 1 condition-specific category according to Karen E. Todd a registered dietitian and senior director for global brand marketing with New Yorkbased Kyowa Hakko U.S.A. Inc. Our research has shown that over 70 percent of adults are making some effort to strengthen their immune system she said. Immune health is clearly a large category and the size and growth will only expand. The changes are in the ingredients and not in how people perceive immune health Todd continued. What have changed recently in the immune health category are all the new ingredients jumping into the category to gain consumer interest making it extremely difficult for a consumer to overlook the ones making the most noise and look to the ones with the best support she said. September 2015 www.niemagazine.com ingredient around the world. It is the active ingredient in the MRM Immune Sport a new beverage sachet supporting the special immune needs of hard-training athletes. Wellmune also is being used in Enfagrow & Enfakid toddler formula sold in Thailand and Mexico by Mead Johnson Nutrition in Emergen-C Immune dietary supplements and in FruitActiv Immuniboost bars from SunRype Products Ltd. based in British Columbia. Numerous published peer-reviewed clinical studies support the ingredient s ability to help safely and naturally support the immune system Mueller said. Studies involving marathon runners women aging populations and individuals under stress have demonstrated that Wellmune can enhance key immune functions improve overall physical health help consumers maintain healthy energy levels provide immune support as people age and keep people healthy during times of stress. Kyowa s major immune health ingredient is called Setria Glutathione and the brand name according to Todd came about by the root of the words set meaning balance and tria short for tripeptide a protein made up of a chain of three amino acids. Setria she explained is Kyowa s branded form of glutathione the body s master or most important antioxidant. Clinical studies show Setria increases blood glutathione levels and supports the immune system Todd said. Glutathione levels should be replenished every morning when levels are at their lowest and oxidative risk is high. She listed Setria s three important benefits providing antioxidant protection promoting detoxification and fortifying the immune system. Setria is a supplement intended for healthy aging and for the effective use of vitamins C and E. Vitamins Standard to the wellness market are vitamins. Since its inception in 2005 TR Nutritionals has supplied vitamins to the dietary supplement industry in the United States and throughout the world offering nine essential in its portfolio C biotin cyanocobalamin methylcobalamin K1 niacin pyridoxine riboflavin and thiamine and Pyridoxal-5-Phosphate (P5P). Dolnick explained that P5P is the metabolically active (co-enzyme) form of B6 (pyridoxine) and has recently been gaining attention. This form of B6 can set apart a Nutrition Industry Executive 35 Celebrating 20 Years of Excellence 1995-2015 multivitamin from the competition she said. P5P is required by various enzymes to carry out reactions in the body. It is vital for a healthy immune system formation of glucose and niacin red blood cell metabolism and synthesis of several neurotransmitters including serotonin and GABA. P5P is involved in more than 100 individual reactions and when taken in supplemental form is readily utilized by the body. TR is the No. 1 supplier of Pyridoxal-5Phosphate in the world purchasing its material from one of the most respected manufacturing facilities in China. The production process yields P5P that consistently meets purity levels of no less than 98.5 percent Dolnick added. In May Pennsylvania-based Genestra Brands introduced a new product Cor Defense a once-daily capsule free of dairy and gluten that contains European elderberry flower extract vitamins C and D and zinc combined with EpiCor a clinically tested dried fermentate of Saccharomyces cerevisiae (baker s yeast) manufactured by Iowa-based Embria Health Sciences. In a press release Genestra noted that a double-blind placebo-controlled crossover study by Jenson et al. found that within just two hours 500 mg of EpiCor supplementation enhanced activation of natural killer (NK) cells and significantly increased antioxidant protection. EpiCor s fast-acting antioxidant power is just one possible way in which it provides respiratory immune and healthy sinus support. doesn t require refrigeration. Deaton pointed to a randomized double-blind placebo controlled human clinical study that showed the ability of DE111 to support healthy gut microflora by controlling microbial populations. The same study also demonstrated the strain s ability to maintain healthy levels of cholesterol glucose and triglycerides. Consumers The consumer base for immune health products specifically and for supplements is varied. Lifton of Maypro noted that approximately 70 percent of women and 65 percent of men take supplements. He described those consumers as predominantly college educated and over the age of 35 who regularly read supplement labels and who have household incomes above 50 000. Consumers are looking beyond echinacea and are today much more sophisticated and practical in terms of immunehealth products they are purchasing at retail Lifton said. By sophisticated I mean that they are looking beyond traditional botanicals and vitamin and mineral supplement selections and increasingly-- from what we see at Maypro in terms of what ingredients are more and more popular--choosing products with effective proprietary ingredients that have a compelling story and are supported by published research. He added By practical I mean that they want more bang for their buck and seem to be increasingly buying products with key ingredients that offer multiple structure-function benefits in addition to immune health. Todd said that Kyowa s top consumers are interested in strengthening their immune system overall and take a proactive approach to their diet and nutrition versus waiting until it is too late. Typically such consumers have been in the habit of taking supplements or eating functional foods to support their immunity. Mueller reported that Biothera sees a high interest in immune health products among three main groups mothers and children athletes whose immune systems can be temporarily weakened by intense exercise and older adults taking a proactive approach to healthy aging. A Gallup study found that immunity is the most sought after health benefit by moms for their children Mueller said. Biothera research found that 77 percent of moms with young children would Probiotics Maletto called probiotics the first line of attack in the immune system noting the importance of good bacteria in your gut. Among Deerland s products is DE111 termed as a highly effective strain of Bacillus subtilis a probiotic spore that works as a complement to many of the non-spore strains on the market today by Deaton. DE111 has been fully genome-sequenced and uploaded to GenBank the National Institutes of Health genetic sequencing database. DE111 Deaton added supports digestive and general health by producing enzymes that aid in the digestion of dietary fats and complex carbohydrates into beneficial small chain fatty acids such as omega-3 and omega-6. Physiological testing and a human clinical study have been performed to demonstrate the strain s ability to control microbial populations in the gut and maintain general health Deaton said. Stability studies show that this spore-forming probiotic remains viable under a wide temperature range and Go to www.niemagazine.com americanlaboratories Celebrating 20 Years of Excellence 1995-2015 (Continued on page 50) www.niemagazine.com September 2015 36 Nutrition Industry Executive Go to www.niemagazine.com lonza for info about this advertiser Government Plans to Regulate GMO Labeling A panel discussion on potential industry impact. By Cara Waters D riven by consumer demands for transparency and concern about the safety of genetically modified organisms (GMOs) and genetically engineered (GE) foods--consumers suppliers manufacturers non-GMO certification organizations food industry groups and politicians--have been working to address the issue of ingredient disclosure on food labels. Natural product companies have been leading the way in giving consumers what they want in producing certifying and labeling non-GMO products. While others in the food industry continue to promote genetically engineered foods as safe saying there is no Introducing the panel David Carter CEO FoodChain ID Fairfield IA dcarter foodchainid.com Lisa Katic RD Principal of K Consulting Soy Connection Consultant Washington DC www.kconsultingonline.com www.soyconnection.com Steve Peirce President RIBUS Inc. St. Louis MO Steve ribus.com (314) 727-4287 ext. 105 Courtney Pineau Associate Director Non-GMO Project Bellingham WA www.nongmoproject.org George Pontiakos CEO President BI Nutraceuticals Long Beach CA (310) 669-2158 gpontiakos botanicals.com www.botanicals.com Mark Vieceli Senior Director of Sales Marketing and Business Development Capsugel Greenwood SC (864) 942-3851 mark.vieceli capsugel.com David Carter Lisa Katic Steve Peirce Courtney Pineau George Pontiakos Mark Vieceli material difference between GMO and non-GMO foods. The federal government has proposed legislation to address the GMO nonGMO labeling issue with the reintroduction of the Genetically Engineered Food Right-to-Know Act (H.R. 913) by Senator Barbara Boxer (D-CA) and Representative Peter DeFazio (D-OR) the Safe and Accurate Food Labeling Act of 2015 (H.R. 1599) by Mike Pompeo (R-KS) (which passed the House on July 23 2015 and is now under review by the Senate) and an announcement by the United States Secretary of Agriculture Tom Vilsack that the Agricultural Marketing Service was working on the development of a voluntary USDA (U.S. Department of Agriculture) Process Verified Program for companies wishing to receive verification for non-GMO nonGE products. If passed into law H.R. 1599 would make labeling of GMO and non-GMO products voluntary and override Vermont s Act 120 and other individual state efforts to require mandatory labeling of GMOs. This year 2015 could mark a turning point for how this labeling issue will be www.niemagazine.com September 2015 38 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 resolved. Legislation and proposed bills at both state and federal levels currently undergoing review could determine how GMOs GE foods non-GMO and natural products labeling will be regulated in the years ahead. How could these proposed government regulations impact the non-GMO and natural products industries Nutrition Industry Executive (NIE) magazine invited a panel of experts to weigh in. NIE What are the main factors driving companies to seek certification for nonGMO labeling of products Carter 1. Non-GMO Project Verified companies see an average sales increase of five percent in the first year of getting verified. 2. To stay current with consumer and retailer demands. 3. Third-party verification increases brand loyalty and consumer confidence. 4. Opens doors to global market with non-GMO policies. 5. Compliance with emerging industry retailer and government regulations. 6. Personal philosophies against GMOs. Katic The main factors driving companies to seek non-GM certification are predominantly due to negative public discussion surrounding GM ingredients. Consumers do not fully understand genetic engineering and how it is being used in agriculture. They also don t have a solid understanding of how food is typically grown in the U.S. and what it takes to get foods from the farm to the market and ultimately the dinner table. As a result of these two voids consumers buy into a lot of the hype and misinformation being spread about GM foods and therefore are asking for non-GM ingredients based on little knowledge and incomplete information. Companies are caught in a dilemma as they know the technology is safe but want to provide their customers with options hence the decision to seek non-GM certifications for their products or ingredients. Peirce Consumer demand. Period. As consumers have been taught to read and understand food labels (fat protein allergens salt sugar etc.) as well as learn more about GMO concerns they have expressed their interest in knowing about GMOs in their food as well and they want GMO food labeled. Pineau The main driver of companies seeking Non-GMO Project Verification is consumer demand. According to the 2015 LOHAS MamboTrack Research Survey a majority of shoppers (83 perSeptember 2015 www.niemagazine.com cent) indicated it is important that GMOs be labeled and more than half (57 percent) said that non-GMO was key to brand buying. Currently the Non-GMO Project provides the only label in the marketplace based on third-party verification to transparent consistent standards. It provides assurance for shoppers that a product has met rigorous best practices including ongoing testing and has passed third-party audits and inspections for GMO avoidance. As consumers have been taught to read and understand food labels (fat protein allergens salt sugar etc.) as well as learn more about GMO concerns they have expressed their interest in knowing about GMOs in their food as well and they want GMO food labeled. -- Steve Peirce President RIBUS Inc. According to SPINS data annual sales of Non-GMO Project Verified products are now more than 12 billion dollars. This number accounts for the sales of more than 30 000 products that are verified with 1 915 participating brands. The Project also works with more than 2 000 retailers through its supporting retailers program and education and outreach campaigns. Pontiakos It is customer driven. If there is demand then there is incentive to get certification. Otherwise it is just a waste of effort and money. As with any investment a company must do their research to weigh the costs and benefits of pursuing a certification. It is not a simple application process it requires capital knowledgeable personnel time and sometimes even modifications to existing procedures. This customer-driven model explains the many non-GMO certified ingredients products currently out in market actually have zero risk of being genetically modified. Vieceli Consumer interest in non-GMO certification has grown significantly in importance in supplement decisions over the last four years. Our research shows a consumer demand for more transparency in the source of ingredients used in supplements is at the top of the list of what consumers want most. Capsugel s market research has shown that consumers check certification on the labels of their products before they decide to buy food and supplements--vegetarian vegan gluten-free halal and kosher among others. However the interest in nonGMO verification is recent in comparison especially among new young Millennials (ages 15 to 35). According to the 2013 Natural Marketing Institute SORD (Supplement Over-the-Counter and Rx Database) Study which Capsugel helps to underwrite 42 percent of supplement users said they consider non-GMO compliance important in their purchase decision 54 percent among Millennials. This growth is tied to the top lifestyle values--including knowing the source of ingredients (71 percent of supplement users feel this is important) from natural sources (66 percent) and environmentally responsible brands (55 percent)--all of which reflect a consumer demand for more transparency in the source of ingredients used in supplements. NIE How is non-GMO certification of ingredients and products currently being done Carter The Non-GMO Project s (NGP) Product Verification Program (PVP) is a process based verification program. The core requirements are continual testing of high-GMO-risk inputs supply chain traceability obtaining inputs in accordance with uniform and meaningful specifications accurate and clear product labeling and maintaining operational consistency while addressing non-conformities in a prompt manner. FoodChain ID as a technical administrator of the PVP does a document review of input spec sheets process flow charts proofs of purchase product labels manufacturing SOPs storage and cleanout details etc. to ensure all documentation is strong and in compliance with the Non-GMO Project Standard. Also if deemed necessary we generate customized sampling and testing protocols for inputs which must be tested by an NGP approved ISO accredited lab and review the test results as well as conduct on-site inspections where the product(s) seeking verification are last handled in permeable form. This is done annually to maintain verified status. Katic The most prevalent method Nutrition Industry Executive 39 Celebrating 20 Years of Excellence 1995-2015 Government Plans to Regulate GMO and Non-GMO Labeling Practices being used to certify non-GM ingredients is to work with suppliers that can provide non-GM crops. This is often verified by creating separate supply chains that can handle these ingredients and document that they have been sourced from nonGM farms and protected from the farm to the factory. Peirce There are third-party certifications with a strong emphasis on consumer products. Many ingredients have documented their own non-GMO status and or have gone to third-party certifiers. Pineau The Non-GMO Project s Product Verification Program is a processbased and product-based program designed to assess compliance with the Non-GMO Project Standard. The three major aspects of our Standard are testing traceability and segregation. The verification process is handled by independent third-party technical administrators who determine if a product complies with our standard. The Non-GMO Project seal provides consumers assurance that a product has met rigorous best practices including ongoing testing and has passed thirdparty audits and inspections for GMO avoidance. Pontiakos Currently it is voluntary through industry organizations. As the non-GMO debate continues we are seeing more customers looking elsewhere for assurance. They are accepting wildcrafted or organic ingredients as a nonGMO guarantee. Wildcrafted ingredients are inherently non-GMO there is no incentive to gene splice a one-off ingredient only grown deep in the Andes. And organic ingredients cannot be genetically modified by requirement. Vieceli Capsugel has always stated that its products are non-GMO based on self-certifications. We base this on the industry-standard polymerase chain reaction (PCR) testing. PCR testing has been considered the most reliable and sensitive testing method to determine genetic DNA alteration. Third-party laboratories perform PCR testing for our products. Testing results meet European regulations. In fall 2013 however Capsugel became the first empty-capsule manufacturer to have products that are verified by the Non-GMO Project. Those capsules were two vegetarian capsules Vcaps Plus 40 Nutrition Industry Executive and Plantcaps. Since then two more capsules--Vcaps and Licaps Vcaps Plus-- have been verified by the Non-GMO Project bringing the total to four. While these capsules have been selfcertified non-GMO this verification from the third-party Non-GMO Project brings new value to customers. We believe our Non-GMO Project verification will help our customers expedite their process for applying for verification for their finished products. NIE What is your opinion as to how new government regulations may directly affect suppliers of non-GMO products and non-GMO certification services over the next three years Carter There will probably be little impact over the next three years as the current direction is toward voluntary labeling of products with GMOs versus non-GMO labeling. Of course the current legislation prohibits states from creating their own labeling regulations so current non-GMO certifications will continue to be required. Further as the current proposed legislation will also allow products with a natural label to contain GMOs if it is passed in that form then there may be increased demand for natural products to verify that they are nonGMO. Many consumers today may be assuming that natural products are nonGMO but the new legislation might increase awareness that this is not the case making the importance of thirdparty certifications grow. Katic I think government regulations can affect suppliers of non-GM products and non-GM certifiers a bit differently. In terms of the suppliers of non-GM the playing field will become more standardized and therefore level for all those involved. The reporting requirements will be more stringent and defined which might make it more costly and time-consuming for those wanting to provide nonGM ingredients. If new legislation is passed in Congress that seeks to define natural and imposes additional requirements on the use of non-GM on labels then the cost of doing business in this space will surely increase and become more layered with bureaucracy. For those providing verification seals and assurances for non-GM products new regulations may decrease or diminish their business. Many of these providers are able to exist now where there are voids in the regulatory space. If this space is further defined and actualized then it can greatly impede on the verifying companies or organizations ability to do their work. In other words Celebrating 20 Years of Excellence 1995-2015 they may be rendered obsolete. Peirce The Pompeo bill waters down the issues at hand. It allows GMO processing aids and enzymes to be used in foods labeled as non-GMO. It stops short of requiring GMO labeling and simply allows non-GMO labeling. This is an attempt to pass legislation and to close the subject. The FDA has already made its statement that GMOs pose no added food safety risk. However the consumer wants to know whether what they are eating is GMO or non-GMO. This is about the only area in foods that the consumer is being told they don t have the right to know. Why not If there s nothing to hide then they should label their items proudly. Pineau H.R. 1599 includes a mandate for the USDA (U.S. Department of Agriculture) to create its own non-GMO certification program. This program would operate to drastically lower standards than the Non-GMO Project. While it won t remove the Non-GMO Project Verified seal from the marketplace as written the bill would create a competing label that would confuse shoppers and undermine the tremendous progress the Non-GMO Project has made on setting a high standard for GMO avoidance. This is a serious concern for the Project a nonprofit that has been working since 2007 to successfully establish a consistent and rigorous standard for nonGMO claims. Pontiakos It ultimately depends on two factors the standards set forth by the government and if the supplier offers at-risk ingredients. Since the former currently does not exist I will speak on the latter. For suppliers with at-risk ingredients they would need to invest in nonGMO resources and verification processes if they have not done so already some may even have to completely adjust their supply chain as well as their operations and quality procedures to meet requirements. A majority of the current supplier base is not prepared to make the change and GMO labeling regulations will force manufacturers to narrow down their supplier base to those that have an understanding of nonGMOs heavy investments in testing and quality and a strict vendor qualification program. For suppliers with no at-risk ingredients only additional documentation should be required of them. Value can only be found in extensive nonGMO verification for ingredients with risk of genetic modification otherwise certification becomes just another irrelevant marketing tool to consumers just as the term natural did. www.niemagazine.com September 2015 NIE What are your thoughts as to if these government regulations programs meet consumer demands for transparency on labeling of GMO non-GMO or natural products in the marketplace Carter The current legislation in the federal government appears to be focused on creating a single federal standard for labeling rather than the potential for 50 different sets of regulations in 50 states. However it is also recommending a voluntary labeling scheme for products with genetically engineered ingredients which most likely will result in a minimum number of products carrying such a label. As the option for voluntary labeling has always existed and companies have not used it it seems unlikely that companies will exercise that option in the future. If that proves to be the case then the new legislation will not increase transparency as consumers will not be able to tell which products do or do not contains GMOs unless a product carries a third party seal such as the Non-GMO Project. With reference to natural products the current legislation also creates a legal definition of natural stating that such products may contain genetically engineered ingredients. It does not define other aspects of what natural might or might not legally mean. Since such products would not be required to disclose the use of GMOs this would not improve transparency but likely further confuse consumers. Third party verification seals such as Non-GMO Project Verified might remain the only way consumers are able to know which products other than organic but including natural have been verified as non-GMO. The new legislation is also calling for the USDA to develop a non-GMO labeling program. It is hard to predict how long such a program would take to develop and what it might look like. For example if such a program did not address the issues of GMO feed in animals and animal derivatives or did not address issues such as synthetic biology or genetically engineered enzymes bacteria and other processing aids then the public might still look for a verification seal that addresses these issues. On the other hand a comprehensive and rigorous USDA program would certainly have an impact on the overall landscape of non-GMO labeling and would signal the arrival of Non-GMO as an important and accepted category of consumer food choices. Katic Unfortunately new regulations or labels on GM foods will not do much to meet consumer interest in or demand for transparency. What consumers really September 2015 www.niemagazine.com want and or need is accurate information about food biotechnology and how it is being used to increase crop yields and improve certain traits in plants. A product label will not meet this need. On the other hand if the FDA is required to define the term natural and implement standards for non-GM labeling then consumers will see a more equitable use of these terms in the marketplace. Right now these terms are undefined and therefore often overused or misused on products. Consumers perceive a term to mean one thing and a company may be defining it very differently. This can be mitigated and standardization of these terms would be beneficial for both companies and consumers. Unfortunately new regulations or labels on GM foods will not do much to meet consumer interest in or demand for transparency. What consumers really want and or need is accurate information about food biotechnology and how it is being used to increase crop yields and improve certain traits in plants. A product label will not meet this need. -- Lisa Katic RD Principal of K Consulting Soy Connection Consultant Peirce Short of regulations that require GMO labeling regulators are not giving the consumers what they are asking for. There is overwhelming support nationwide for GMO labeling. Additionally steps are being taken to prevent States (Vermont) from doing what their citizens have voted for--require GMO labeling. What is the real opposition to required labeling at the national level Pineau The House s passage of H.R. 1599 is a blow to democracy. Nine out of ten Americans support GMO labeling and with this vote our elected officials in the House have failed to represent the will of the people. H.R. 1599 would prohibit any current or future state law requiring GMO labeling while at the same time dramatically undercutting federal state and local government over- sight and regulation of GMOs. By preempting all state and local oversight of GMOs the bill would negate more than 130 existing statutes regulations and ordinances in 43 states at the state and municipal level. Pontiakos We need a precise definition and concise directives before we can determine if they meet consumer demands. We the industry as a whole are at the receiving end of these demands and so we should be leading the efforts. We are the experts when it comes to GMO non-GMO and natural products a third-party body does not know the nature of our products and complexities of our supply chain as we do. As mentioned above non-GMO labeling is customer-driven and so it should be the supplier driving the cause. NIE Are there any other comments you would like to share on how government legislation regulating the use of GMO non-GMO and natural on labels may impact the natural products industry in the future Katic One last observation if the FDA is required to define the term natural in the proposed Safe and Accurate Food Labeling Act then the natural products industry will be greatly impacted as it could limit the use of this term on labels and in marketing. It would also level the playing field for all players in this space as the term will be better understood and not left open to individual interpretation a potential benefit for all. Peirce GMO is an emotional topic for all sides. The consumer would simply like to know if a product contains any GMO ingredients. I also do not believe that the government will attempt to define or regulate the word natural. Pineau The natural products industry continues to grow at an incredibly fast rate in large part due to shoppers looking for products that offer ingredient transparency. It is important for manufacturers retailers and consumers to let the government know that they want meaningful mandatory GMO labeling. Bills like H.R. 1599 that take away the FDA s ability to implement mandatory labeling and that create a weak labeling program undermine all of the powerful work the natural products industry has done to provide shoppers accurate information about the food they buy. NIE Extra Extra Visit www.niemagazine.com to read about Capsugel s NonGMO Project Verified products. Nutrition Industry Executive 41 Celebrating 20 Years of Excellence 1995-2015 ProductionLine Empower Your Brand with Certifications By Lisa Schofield merican consumers are swayed and influenced by seals of approval and quality. In fact for some the lack of any such thing will result in that product being put back on the shelf in favor of one that does. Simple. We like to feel secure and safe with what we use and consume. And the dietary supplement industry is no different nowadays. Certifications matter. Each instantly conveys to a consumer that the product is non-GMO (genetically modified organism) kosher vegan halal or gluten free. With millions of individuals requiring that what they put into their bodies is free of an allergen or conforms to religious dietary rules going through the process of certification to capture those specific interests will go a long way to long-term success of your supplement product. Dr. Cheryl Luther general manager of the NSF International s Dietary Supplement Program stated that retailers and consumers want to know that they can trust the safety and quality of supplements. Most dietary supplement brand marketers seek to produce safe quality products and are striving to restore and maintain brand integrity by demonstrat- A ing their commitment to producing safer products for their customers. Third-party certification showcases their commitment to this practice. Yet she warned NSF International s research has shown that some supplements in the market can contain harmful ingredients and contaminants including drugs and compounds that are not always listed on the label. A pattern of methamphetamine compounds such as DMAA DEPEA and DMBA are cropping up under the deceptive guise of botanical extracts. This gives consumers the false impression that the ingredient is derived from plants. NSF International s third-party dietary supplements certification program was created to test products to confirm what is on the label is in the product and the product doesn t contain harmful levels of contaminants. Luther reported that the number of products certified by NSF International doubled in 2014 and continues to increase as consumers seek safer supplements and companies step up to meet this demand. NSF International now has more than 750 ingredients and products certified. NSF also has successfully audited and registered more than 400 manuCelebrating 20 Years of Excellence 1995-2015 facturing facilities to the good manufacturing practices (GMPs) specified in 21 CFR Part 111. Another mounting concern among consumers nationwide is the presence of GMOs in produce and in food products made with natural ingredients including supplements. The need for non-GMO labeling is real as indicated by growing consumer demand and consumer advocacy groups said Kelly Mae Heroux of Iowa-based FoodChain ID. She added that research conducted by NMI and others show that interest in GMO labeling for food products is on the rise. NonGMO Project Verified went from a 5 billion to 12 billion industry in the last decade. Further kosher and halal certifications for dietary supplements assist millions of individuals with strict religious dietary concerns. Muhammad M. Chaudry PhD president and CEO of The Islamic Food and Nutrition Council of America (IFANCA) explained For consumers halal certification of finished products is a must to be able to select suitable products. For sellers including manufacturers marketers and foodservice providers halal certification is a gateway to the halal consumer. www.niemagazine.com September 2015 42 Nutrition Industry Executive For importing countries halal may be part of the import requirements for any product entering the country. With more than 1.6 billion Muslims many countries require halal certification for ingredients and finished products to be allowed into the country. He added that even with products that may seem unquestionably halal certification of such dramatically reduces the number of questions customer service representatives must field saving time and money. In order to produce halal-certified finished products manufacturers need halal certified ingredients. With the low cost of halal certification ingredient companies are seeking halal certification for their ingredients to be acceptable to brand marketers that seek to address this market. Rabbi Fogelman of OK Kosher Certification explained that kosher certification is a protocol of dietary laws that date to the time of Moses. Several million buy kosher for religious reasons and there are several million consumers of kosher for health reasons meaning if they are lactose intolerant they seek out the kosher parve symbol which means that there is no dairy in the product. The K enclosed by a circle symbol conveys that we as the certifying agency are testifying that the product from the source is made from the kosher protocol. Now people think that kosher means that a rabbi blesses the product--this is the farthest from the truth. According to Lowery within the natural products consumership vegetarians are central with vegans as a critical subset acting as the trendsetters. In the U.S. 38 percent of supplement users say that a vegetarian or non-animal source is important when choosing a supplement in 2013 up from 35 percent in 2011 and 26 percent in 2006 this market segment is among the most frequent users of supplements. (Natural Marketing Institute Supplements OTC Rx Database 2013 & 2011.) Although not stemming from thousands of years of religious protocol vegan certification provides assurance for the growing number of individuals who have made a dedicated choice to use only products that have no animal sources or testing. We believe that the vegan certification of our plant-based capsules would further help our supplement manufacturing customers enhance the attractiveness of their overall products to this evergrowing targeted market Lowery remarked. Our vegan-certified empty vegetarian can help our supplement manufacturing customers expedite their process of applying for vegan certification for their finished products. Expanding Vegan Certification Although not stemming from thousands of years of religious protocol vegan certification provides assurance for the growing number of individuals who have made a dedicated choice to use only products that have no animal sources or testing. When it comes to dietary supplements in capsules many ingredients are naturally vegan however choices had been extremely limited until recently. In 2013 New Jersey-based Capsugel announced that it had been awarded vegan certification for four plant-based capsules--Vcaps Vcaps Plus DRcaps and Plantcaps--which are free of additives preservatives allergens starch and gluten plus are non-GMO kosher and halal certified and approved by the Vegetarian Society. But we felt a vegan certification would further expand the appeal of our plant-based capsules into a very targeted niche in the booming lifestyle driven market explained Missy Lowery senior marketing manager Capsugel Americas. September 2015 www.niemagazine.com More Than Just a Symbol There are still many glass-half-empty people who believe that certification symbols are merely marketing tools with no true merit or significance. To achieve non-GMO certification FoodChain ID provides its Non-GMO Project Verification. According to Herous this process begins with evaluating products in order to verify or certify that they are compliant with the requirements outlined in the Non-GMO Project Standard. The Standard s core focus is on continual testing of high-GMO-risk inputs supply chain traceability obtaining inputs in accordance with uniform and meaningful specifications accurate and clear product labeling and maintaining operational consistency while addressing non-conformities in a prompt manner. Being Non-GMO Project Verified with FoodChain ID signifies that a product has been produced in accordance with the best practices for GMO avoidance she said. IFANCA provides full halal certification covering all consumables as well as personal care products and even vaccines and it signifies that a product or ingredient meets the halal criteria required by Islamic law. In July noteed Chaudhry IFANCA introduced a new Five Star Halal Identification System to provide additional transparency on meat and poultry products. The system identifies that the slaughter person is Muslim if the slaughter was performed using the traditional horizontal cut if the animal or bird was fed an all natural diet of plant origin if the slaughterhouse meets animal welfare guidelines and if stunning was used prior to or after slaughter. This is relevant for bovine-sourced capsules and other animal-based ingredients used in supplements. According to Luther NSF developed the only accredited American National Standard for Dietary Supplements (NSF ANSI Standard 173) more than 15 years ago. NSF offers a manufacturing facility GMP registration and two levels of product certification based on the requirements of this standard NSF Dietary Supplement Certification and NSF Certified for Sport. Manufacturing facilities can earn NSF s GMP registration if they are successfully audited twice a year to verify continued compliance with GMPs specified in 21 CFR Part 111. Any issues of non-compliance to the GMP requirements must be addressed with corrective actions before the manufacturing facility is approved as NSF GMP Registered. Facilities that achieve NSF GMP registration are listed on NSF s website so that they can be easily identified by those wishing to manufacturer a supplement in an NSF registered facility. The second level of product certification is the NSF Certified for Sport Certification program which builds on the first program by also screening the product (on a per lot basis) for more than 200 athletic banned substances. Exacting Assessments Achieving a certification for your product and or product line entails a complete dedication among the company culture. Each is time-consuming and rejections may occur at any point verifying that achieving such certification is indeed a Nutrition Industry Executive 43 Celebrating 20 Years of Excellence 1995-2015 ProductionLine worthwhile endeavor. When it comes to halal Choudhry asserted that the assessment is very thorough. The process begins with the completion of an application for halal certification. This is accompanied by a listing of all the products to be certified the manufacturing facilities involved the ingredients used in the products and all plant chemicals and lubricants used in the process. You will also need to submit replicas of the product labels that will be used. All this is reviewed by IFANCA s team of food scientists to ensure everything conforms to the halal requirements. If the review reveals any ingredients that do not conform the team develops alternatives for the manufacturer. This is followed by an inspection of the manufacturing facilities and review of the process flow HACCP procedures warehouses storage facilities packaging and any associated activities. During this review IFANCA reps meet with plant quality management to incorporate halal control points into the HACCP procedure as well as educate plant staff about their responsibilities in conforming to the established Halal requirements. Items to be conscious of and be vigilant about include the chance of crosscontamination with non-halal items particularly ingredients derived from animals and alcoholic beverages Choudhry explained. If a plant is not producing halal certified products 100 percent of the time procedures are implemented to ensure the halal integrity of the products is maintained from initial production to final shipping out of the facility. Rabbi Fogelman explained that to certify a dietary supplement as kosher is no different than any other product. For the supplement to be kosher he asserts it needs two factors it must contain kosher ingredients and it must be manufactured on kosher equipment which means that no non-kosher supplements can be made with the same equipment. If it is then the equipment must be thoroughly cleaned and purged from any residue of the nonkosher supplement it may have clinging to it. There are naturally kosher ingredients (such as produce-derived) ingredients that can never become kosher such as shark cartilage or ingredients that may or may not be kosher he explained. For example vegetable oil is kosher while oil from non-kosher animal fat is not. There are several steps to achieve and maintain product certification to the NSF Dietary Supplement program according to Luther. First the manufacturing facility must earn the NSF GMP registration that 44 Nutrition Industry Executive verifies compliance with GMPs as specified in 21 CFR Part 111 this requires ongoing monitoring via audits twice a year. Next the product must be tested and reviewed annually. This includes a toxicology and label claim review to verify product formulation and label claims and that what s on the label is in the bottle as well as contaminant testing to ensure there are no harmful levels of specific contaminants. This testing is required annually. If the product meets the auditing and testing requirements it is then authorized to show the NSF dietary supplement certification mark on the bottle. Further the product will be included in the listing of certified products on the NSF website. We evaluate supplier documentation on all inputs including main ingredients carriers processing aids flow agents substrates fermentation aids enzymes and others as well as require the biological sources of material in order to evaluate GMO-risk. Other required documents are detailed SOPs on handling shipping and storage clean-out segregation etc. The Standard requires we look in detail at the system products are manufactured in order to ensure said systems are designed to avoid GMOs. Ongoing Work In addition to a document review she noted ongoing testing is required for many products and ingredients a specialized sampling and testing protocol is developed for these and manufacturers work with a non-GMO-approved ISOaccredited lab for the tests. FoodChain ID evaluates the results against the Standard s requirements for action thresholds. To achieve its vegan certification Capsugel submitted a complete list of ingredients and included any processing aids used in manufacturing but not part of the final product according to Lowery. We confirmed with each vendor that no animal testing had been used and all non-GMO information was also confirmed. We further submitted information regarding our manufacturing process to ensure there is no cross-contamination of non-animal products with material of animal origin. She added that Vegan Action reviewed the products accepted the application and approved use of the trademark for 12 months in the United States and Canada. Capsugel is now listed on the Vegan Action website and it pays an annual licensing fee. Capsugel Lowery noted is responsible for notifying Vegan Action if the ingredients in any approved product should change. Supplements without any certifications may get bypassed for those competitive products that do. Certifications also quiet the naysayers who repeat the myth that supplements are not regulated by the FDA (U.S. Food and Drug Administration) by proving that certification is achievement of safety and quality. NIE To earn NSF Certified for Sport certification the product must first meet the requirements of the general Dietary Supplement Certification Program (the facility must by audited to ensure compliance with GMPs and the product must undergo toxicology and label claim review and contaminant testing). To earn NSF Certified for Sport certification the product must first meet the requirements of the general Dietary Supplement Certification Program (the facility must by audited to ensure compliance with GMPs and the product must undergo toxicology and label claim review and contaminant testing). Then on a per lot basis it also is screened for more than 200 athletic banned substances as determined by the U.S. and the World Anti-Doping Agencies MLB and NFL among others. Once the product achieves certification it is authorized to bear the NSF Certified for Sport mark in its label and added to NSF s list of Certified for Sport products. The NSF Certified for Sport Certification program is supported by the NFL NHL MLB PGA LPGA Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department Luther said. FoodChain ID s Heroux explained guides manufacturers in mapping out the supply chain of the products they wish to have verified via the procurement of supplier manufacturer documentation which identifies the inputs and processes involved in the product manufacturing. Celebrating 20 Years of Excellence 1995-2015 FORMOREINFORMATION Capsugel www.capsugel.com FoodChain ID Inc. (866) 440-3242 IFANCA (847) 993-0034 NSF (800) 673-6275 OK Kosher (718) 756-7500 www.niemagazine.com September 2015 MarketingInnovations By Suzanne Shelton 015 has been an extraordinarily challenging year for the dietary supplements industry between legal challenges scores of negative news reports and substantial questions about industry practices from members of the U.S. Congress--and the year isn t over. There are a lot of conversations taking place among members of the industry about what changes need to be made to address the concerns. What those changes will look like have yet to be determined but you can bet the farm that things are going to change and we ll go through a period of uncertainty when they do. Now more than ever to have a sustainable business in this industry you have to be involved and your marketing has to reflect that involvement. One of the advantages of being an industry veteran is having learned an essential component of marketing products in our business committed involvement. What we mean by the word involvement encompasses many of its synonyms immersion participation connection contribution engagement envelopment association and commitment. None of these happen overnight 2 but all of these aspects of industry involvement are components of successful marketing in our corner of the business world. Well-informed A long time ago when Bill Knudsen was still running the R.W. Knudsen Family company the company s extraordinary immersion in the industry at the time remains an example we still think about. Aside from trade association board participation and strong retailer support the management there knew everything that was happening in the industry and shared the information internally. The company distributed a regular internal update alerting their people to key personnel moves both at the retail level and with competitors potential legislative and regulatory activity rumors of acquisitions and investment trade association activities and anything that had the potential to impact the industry and their sales and marketing programs. At the time R.W. Knudsen was a significant player in the industry commanding the majority of the shelf space in the beverage section of every health food store. Celebrating 20 Years of Excellence 1995-2015 Sure the company s products were great but everything R.W. Knudsen did was informed by its immersion in the industry which had a huge impact on the company s success from product development to marketing programs to employee recruitment. It was no wonder Smucker s wanted to acquire the company. One of the best ways to stay well informed is through trade association membership and active involvement. Financial support of the people on the front lines of dealing with the media Congress and regulatory agencies even when it seems a loosing battle should be a priority for anyone whose livelihood is derived from our industry. The trade associations are also an excellent source of information that helps you be prepared for challenges and opportunities. Each trade association has a different focus and areas of strength so the type of information and guidance they provide will reflect those differences. We re members of CRN (Council of Responsible Nutrition) UNPA (United Natural Products Alliance) NPA (Natural Products Association) and AHPA www.niemagazine.com September 2015 46 Nutrition Industry Executive (American Herbal Products Association)--each of them is valuable to us for the success of our business and part of the reason we re always very well informed. CRN does an incredible job with media relations knowing in advance when a news outlet is working on a story about the industry reaching out to them to provide input letting members know what s coming and providing focused well-informed counterpoint to the headlines to use with concerned customers. AHPA concentrates on all things herbal particularly with technical aspects and regulatory issues. NPA has been especially effective with GMP (good manufacturing practice) compliance training since the year 2000 and is the only main association that includes retailers. UNPA offers members uniquely informative and insightful detail on events and concerns along with very focused training and networking. Another factor in being informed is networking knowing and talking to a lot of people in leadership positions. Trade association membership trade shows conferences and events and just staying in touch with people helps you know what s going on beyond what you read in the trade magazines. Those other synonyms for involvement--immersion participation connection contribution engagement envelopment association and commitment--are often intertwined and are certainly most effective when they are. Total engagement is probably the best marketing tool a company has. For new brands stepping into the industry every dollar spent needs to be scrutinized and industry involvement in the way of associations and active participation at conferences etc. is often tough on a tight budget. But it s one of the best ways to tap into a network of industry veterans who have built the industry from the ground up. The overwhelming majority of long time industry leaders started with just an idea and a mission to make people healthier. Forging genuine relationships with these folks will pay off in countless ways from networking learning the ways of succeeding in the industry long term and helping to keep the industry viable for the future. Get involved and use your membership actively. There is a huge difference between companies that trumpet their support of natural products retailers in marketing campaigns or to win back shelf space after an unsuccessful attempt at the mainstream and companies with a long September 2015 www.niemagazine.com track record of commitment to the health food channel. A great example is NOW Foods the reigning icon of the health food channel the company serves as an example of how all of these aspects of involvement contribute to long term sustainable success in the industry. NOW s ubiquitous shelf presence illustrates that walking your talk resonates with retailers and consumers. minimum in testing or you can have 128 employees performing 16 000 individual assays per month. You can host an occasional seminar to educate retailers or you can commit resources to a robust education program tailored to the needs to the people selling your products. Becoming and remaining an industry leader requires knowing the culture and respecting and supporting it in your business practices. NIE The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Suzanne Shelton has provided public relations services to both international and domestic dietary supplement and natural products manufacturers suppliers and associations. Active Participation A campaign or a sponsorship is good but what really matters long term is consistency. Actively participating doing things for the good of the industry and becoming involved for bigger reasons than short-term profit will eventually pay off among health conscious informed consumers who care about a brand s genuine commitment to its mission. Walking the walk is what consumers expect and it earns their loyalty. Marketing comes back to the show don t tell mantra of storytelling. A brand becomes a valued part of the industry and benefits from that position by demonstrating its involvement over time. This means a brand telling its story of industry involvement on a month-tomonth basis through the social posts it shares the blogs it writes about industry issues the videos it shoots portraying a real commitment to the values and product quality customers deserve. Dedication to the industry and dedication to the company mission should be complementary. If they are and the details are portrayed for customers to see at every step along the way the results will be far more fruitful than any ad that says we have the best product. You can either talk about support for trade associations or have a long history of actually doing so. You can do the bare Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 47 FunctionalFoods Focusing on Functional Ingredient Trends One of the most challenging issues with combination products is being able to include therapeutic levels of key ingredients while keeping the daily serving of tablets or capsules to a minimum -- Marci van der Muelen National Sales Manager Nordic Naturals Functional and super ingredient trends offer new product opportunities for food and beverage manufacturers. By Tony Andrew DuPont Global Product Line Leader for Specialty Soy Protein hen it comes to nutrition healthy diets and weight loss it s evident that consumers are looking for nutritious options and giving careful consideration to their diets. However a saturated marketplace is leaving consumers unsure. In fact 64 percent of Americans are confused over conflicting information they read or hear about health foods and 63 percent of Americans claim they do not know enough about how much of the health foods to consume for the desired health benefits. As healthrelated trends continue to evolve more consumers are taking an interest in finding identifying healthier food options. According to Mintel in 2014 nearly a quarter of U.S. consumers said they would like help in understanding healthier food options up from 17 percent in 2011. Among these misunderstandings is the difference between functional ingredients and super ingredients. While there is 48 Nutrition Industry Executive W a generally accepted definition for functional foods there is no sciencebased definition for super foods and neither term bears a regulatory definition to help guide consumer understanding and use. Food and beverage manufacturers continue to capitalize on the functional ingredient trend and product positioning based on science-based health benefits to further promote brand differentiation. Ingredients with Health Benefits Drive Product Differentiation Functional foods are a key trend in the food industry today. A functional food is known to have a positive health effect on consumers expanding beyond basic nutrition. A 2013 survey found that around one-third of consumers indicated using functional foods to replace some medicine in the context of their overall health approach. Convenience and functionality Celebrating 20 Years of Excellence 1995-2015 bring tremendous value to consumers today and several ingredients that offer these benefits continue to gain recognition. Currently at the forefront of this trend are fiber probiotics and protein. Consumers concerned with regularity add fiber to their diet to support digestive health. Probiotics while supporting digestive health also are known for supporting immune health. In fact recent study results suggest certain strains of probiotics help to maintain respiratory health and have a beneficial effect on respiratory illness episodes onset and duration in healthy adults. In the last few years protein has continued to gain momentum. The Food Technology 2012 report on functional food trends cited protein as a strong mega trend and we ve seen this trend continue in recent years. In fact the International Food Information Council Foundation s (IFIC) 2015 Food & Health Survey finds that 90 percent of consumers www.niemagazine.com September 2015 recognize it is important to get enough protein. Food manufacturers are addressing this trend by incorporating protein into products. One of the most appealing qualities contributing to protein s popularity is its ability to prolong satiety. Consumers are recognizing this benefit and taking a greater interest in their protein intake to assist with losing or maintaining weight as part of a calorie-restricted diet. This has created a growing demand for higher value protein among consumers focused on weight management. Consumers are also adding protein to their diet to meet the needs of an active lifestyle or because they are growing older and want to maintain muscle mass. Protein boasts an impressive r sum of nutritional and health-related benefits so it s no surprise that by 2018 protein ingredient manufacturers are forecasting the production of more than 5.5 million metric tons generating global sales of nearly 31 billion. According to IFIC s 2013 Functional Foods Consumer Survey 90 percent of consumers agree that certain foods have benefits beyond basic nutrition--the main idea behind a functional food. Soy protein delivers on that high value proposition. In fact the same report found that nearly half of Americans agree that soy is part of a healthful diet. It s a functional food source that can be used in a variety of applications and it s an economical source of protein which offers great nutritional benefits. Furthermore soy protein is a high quality protein that is comparable to high quality animal proteins such as eggs milk and beef. Soy protein is unique in that it is the only complete source of vegetable protein widely available. Isolated soy protein has the highest protein content of all soy foods and is used primarily as a source of high quality protein. There are health benefits to soy protein as well. Research finds that 25 grams of soy protein per day as part of diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease. Functional foods provide the added September 2015 www.niemagazine.com benefit of containing health-promoting properties for supporting certain aspects of health. Soy protein continues to play a role as a functional ingredient based on its unique health benefits for heart health and supporting muscle health. Consumer Demand Continues to Drive New Application Development The application in which ingredients are used also plays an integral role in food development and consumer demand. Convenient nutrition in the form of beverages and bars continues to be popular with consumers. Growth in functional beverages is outpacing carbonated beverages and other high-sugar empty calorie beverages. Consumers are looking to functional beverages to satisfy a variety of needs including providing nutrition in addition to refreshment acting as a quick meal snack-on-therun and providing hydration. Beverages are a versatile format for providing nutritional and functional benefits offering consumers a variety of textural and sensory experiences. However the health benefits are still important. Food and beverage marketers recognize the potential of the health conscious consumers but they may not yet have a strategy for capturing that full market. For example today many beverages are focused on the general health and wellness population that needs a supplement in a beverage format however DuPont Nutrition & Health s research indicates there is a group of busy active consumers that are interested in certain health benefits--such as blood sugar management heart health muscle health digestive or immune health. By targeting some of these areas of health interest beverage marketers could reach an even broader audience of consumers. protein in familiar foods they enjoy. As food manufacturers look to consumers to continue to direct them to what is important to them we don t see the trend of healthy ingredients disappearing anytime soon. Consumers are actively choosing foods that offer added nutritional and health benefits and give them an advantage whether it is improved satiety weight management or foods that help them beat their best performance. NIE References www.foodinsight.org Content 5519 Functional%20 Food%20Consumer%20Survey%20Media%20Webcast. pdf. Mintel Menu Insights Foodservice Webinars-- Addressing today s trending food concerns--US-- August 2014 with Sr. Analyst Paul Pendola. Hasler CM Brown AC. (2009) Position of the American Dietetic Association functional foods. JADA 109(4) 735-46. Functional Foods Key Trends & Developments in Ingredients. Published Feb 25 2015. http www.packagedfacts.com Functional-Foods-Key8540424 . West et al. Clinical Nutrition (2014) Probiotic supplementation for respiratory and gastrointestinal illness symptoms in healthy physically active individuals. www.foodinsight.org sites default files 2015%20F ood%20and%20Health%20Survey%20-%20FINAL.pdf (slide 50 53). Data Monitor London. www.datamonitor.com store Product opportunities_in _plant_based_proteins productid CM00234-033. http www.foodinsight.org Content 5519 Function al%20Food%20Consumer%20Survey%20Media%20W ebcast.pdf (slide 9). www.fda.gov Food GuidanceRegulation GuidanceD ocumentsRegulatoryInformation LabelingNutrition uc m064919.htm. What s Next in Future Trends In recent years we have seen expansion of soy into other exciting applications such as cereal snacks and baked goods providing the consumer with even more ways to find Tony Andrew is the Global Product Line Leader for the Specialty Isolated Soy Protein business within DuPont Nutrition & Health. He is responsible for developing and implementing global strategy and product development for isolated soy proteins for the nutrition and health & wellness industries. Andrew graduated from the University of Missouri with a degree in Economics. He also holds a master s degree in business administration from St. Louis University. Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 49 Lifton said that in addition to AHCC probiotics and polyphenols are attracting a good deal of interest. Research Interests Mueller of Biothera noted that successful functional products start with safe efficacious ingredients supported by numerous peer-reviewed clinical studies. Quality clinical research can earn credibility among consumers and support compelling marketing claims that can help better define the product withstand regulatory scrutiny and ultimately drive consumer value. Mueller also said that Biothera has conducted immune health research that shows consumers attribute a variety of positive benefits to a healthy immune system including wellness productivity energy mood mental clarity stress management athletic performance and quality of life. Dolnick of TR Nutritionals pointed to the need to follow a gold standard for research which she described as a double-blind placebo-controlled study with enough participants to achieve statistically significant results. Lipkin of Maypro weighed in on the importance of clinical research-- proprietary ingredients backed up by human clinical studies as is the case with AHCC for immune health. While research showing benefits to fruit flies and cultured cells may be intriguing ingredients supported by a portfolio of human clinical data ultimately spell efficacy and immune health products that work make manufacturers happy and consumer end-users coming (Continued from page 36) probably buy or definitely buy a food or beverage containing Wellmune. Prominent Ingredients for Immune Health In addition to probiotics the team at Genestra Brands listed the following ingredients as gaining prominence in the development of immune health products yeast beta-glucans mushroom extracts vitamin D magnesium and omega-3 fatty acids. Public relations account executive Gabriella Gasparich also noted that yearround immune health support is an increasing concern among their clients. Maletto made note of echinacosdes natural phenols which he described as a mainstay from the 70s. And he named goldenseal a big one especially because of the alkaloid it contains berberine. The raw herb doesn t do as much Maletto said. It needs to be concentrated extracted. I actually work on delivery systems using coding emulsification nano technology and the micronizing of ingredients. He also recommended citrus bergamot in the form of an essential oil for reducing cholesterol as well as turmeric in soft gel capsules for its anti-inflammatory properties. back for more. Todd of Kyowa also made note of the gold standard. At Kyowa we are providing the scientific support through our clinical studies but are taking it a step further and have data on the immune health category as a whole and tie it back to claims that can be made to support consumer s interest she noted. Maletto said that when a manufacturer client asks him to explore every single aspect of immunity on a product he is developing he would test for a footprint. He also makes use of existing clinical research such as that published in National Institutes of Health peerreviewed journals. Bush said Ganeden has 21 published clinical trials most looking at digestive function and some at protein utilization. Sports nutrition work he concluded is very interesting to us. There s a lot going on. NIE Extra Extra Visit www.niemagazine.com to read about CRN s survey findings on dietary supplement users and healthy lifestyle choices. FORMOREINFORMATION Deerland Enzymes (800) 697-8179 Ganeden Inc. (440) 229-5200 Genestra Brands (888) 737-6925 Kyowa Hakko USA Inc. (212) 319-5353 Maypro Industries (914) 251-0701 PTM Foods Consulting (888) 736-6339 TR Nutritionals (404) 935-5761 Conventions&Meetings 26th Annual AHG Symposium T he American Herbalists Guild (AHG) will present its 26th Annual Symposium New Horizons in Clinical Herbalism to be held October 15-19 2015 in Granby CO. Featuring keynote speaker Ethan Russo the 26th Annual Symposium hosts some of the world s leading herbal educators delivering cutting edge presentations on a wide range of topics in herbal medicine. The symposium will feature more than 40 lectures as well as pre- and post-symposium intensives with ses- sions ranging from beginner to advanced. Herbal practitioners medical professionals students and novices can interact with renowned botanists on plant walks join open discussion panels and meet with some of the leading companies in natural health at the vendor showcase. This year the symposium offers a special track of diverse classes addressing chronic disease and herbal therapies. Participants who attend four workshops in the chronic disease track as well the post-sympo- sium intensive will earn a certificate of completion in Chronic Disease and Herbal Therapies Training. The AHG continues to award continuing education credits for classes taken at each year s Annual Symposium. All classes are eligible for NCCAOM (National Certification Commission for Acupuncture and Oriental Medicine) PDAs (Professional Development Activities). For more information call (617) 520-4372 or email symposium americanherbalistsguild.com. 50 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com September 2015 Equipment&Packaging Chris Hillseth Debuts Changsung Servo Drive Soft Gel Encapsulation California-based Chris Hillseth Enterprises official U.S. distributor of Changsung soft gel equipment has announced that the new 880R machine will make its U.S. debut at Supply Side West 2015 in October. The servo-drive 880R machine is a jumbo encapsulation machine specifically created for mass production purposes. The servo drive replaces the need for a gearbox improving the precision of the machine exponentially according to the company. It also automatically programs the motors of the machine without operator assistance thereby eliminating human error and backlash. Additionally the machine requires minimal maintenance and can be set up within minutes. When compared to its competitor servo drive machines the Changsung model is less expensive easier to clean and includes options for customization including bigger die rolls. Unique features of the 880R machine include an automatic filling volume adjustment system (AFA) automatic gel net thickness control system (AGT) titanium plungers and a newly designed touch screen to control temperature speed and more. Alignment and injection timing of the die rolls is precisely measured by lasers and set up through the touch screen. The machine boasts advanced safety features and easy cleaning. For more information visit www.chrishillsethenterprises.com. Cruise Control and Counting Capabilities on VeriSym Optical Inspection Systems Washington-based Symetix expanded the value of its VeriSym optical inspection systems for solid dose pharmaceuticals and nutraceuticals with the introduction of two new features--cruise control and counting. Cruise Control precisely regulates VeriSym s throughput optimizing the inspection system to accurately remove defects and foreign soft gels and tablets. The Counting tool eliminates the need for a weigh scale by enabling VeriSym to fill bulk boxes containers to the desired count which reduces capital costs better utilizes floorspace and improves the accuracy of the count. These software-driven capabilities are available as an option on all new VeriSym systems including the compact VeriSym SE mid-size VeriSym SL and full-size VeriSym. The upgrade can be installed on any VeriSym in the field with the addition of Symetix s infeed shaker on select models. VeriSym verifies product color size and shape identifying and ejecting defects and foreign soft gels and tablets from the product stream to ensure product quality while reducing labor costs. Ideal for product manufacturers and co-packers operating continuously inline or in batch mode the compact VeriSym SE inspects up to 300 000 soft gels or tablets per hour and the full-size VeriSym inspects up to 1 000 000 doses per hour. For more information call (509) 394-3370. Advertiser Index American Laboratories Inc. Dr. Vita Fenchem Inc. Generex Labs Herbally Yours Indfrag Jiaherb Inc. JT Naturals LLC Kyowa Hakko USA Lonza Inc. Now Foods PL Nutraceutix Inc. Nutritional Engineering Inc. Olcott Plastics Pinnacle Labs International Inc. PLT Health Solutions Inc. Qualitas Health Inc. Sabinsa Corporation Soma Labs Inc. Uckele Health & Nutrition United States Pharmaceopea 36 26-27 9 33 15 13 5 28 21 37 1 30 31 7 29 3 11 C2 32 31 C4 (402) 339-2494 (888) 793-0351 (909) 597-8880 (239) 592-7255 (480) 892-8220 (904) 233-1173 (888) 542-4372 (417) 553-0977 (212) 319-5353 (800) 365-8324 (800) 999-8069 (425) 883-9518 (760) 599-5200 (630) 584-0555 (800) 600-4634 (973) 984-0900 (432) 242-4620 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (800) 248-0330 (301) 230-6361 www.niemagazine.com americanlaboratories www.niemagazine.com drvita www.niemagazine.com fenchem www.niemagazine.com generexlabs www.niemagazine.com herballyyours www.niemagazine.com indfrag www.niemagazine.com jiaherb www.niemagazine.com jtnaturals www.niemagazine.com kyowa www.niemagazine.com lonza www.niemagazine.com nowpl www.niemagazine.com nutraceutix www.niemagazine.com nutritional www.niemagazine.com olcott www.niemagazine.com pinnaclelabs www.niemagazine.com plt www.niemagazine.com qualitas www.niemagazine.com sabinsa www.niemagazine.com somalabs www.niemagazine.com uckele www.niemagazine.com usp Industry Events September 16-19 Expo East Baltimore Convention Center Baltimore MD (866) 458-4935 www.expoeast.com October 5-9 SupplySide West Mandalay Bay Expo Hall Las Vegas NV (866) 230-2311 www.marketplace.supplysideshow.com September 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 51 SupplieroftheMonth Lycored Ltd. Lycored USA 377 Crane St. Orange NJ 07050 Phone (844) 668-2483 Rony PatishiChillim CEO Lycored Headquarters POB 320 Hebron Rd. Industrial Zone Beer Sheva 84102 Israel Phone 972 0732327301 Email info lycored.com For 20 years Lycored has been committed to exploring the diverse wellness possibilities that result when you combine nature s most potent nutrients with cutting-edge science. The company believes that wellness is a right not a privilege for all people regardless of health concern age gender or location. Initial research around lycopene led to the study of other carotenoids and the development of a suite of products from natural ingredients for supplements to food premix and even carotenoidbased colorants. Lycored serves customers around the globe through its labs and production and research facilities in Israel the United Kingdom the United States Ukraine Switzerland and China. Before joining Lycored as CEO Rony Patishi-Chillim spent several years at Adama Agricultural Solutions Ltd. where she served as senior vice president of business development & global corporate communications. Prior to that she acted as senior vice president at the Investment Banking Group of Barclays Capital. She brings with her not only an understanding of corporate strategic review process but also an appreciation for the complexities involved with establishing a fully defined and distinct international brand. NIE Lycored is celebrating its 20th anniversary. What are the company s plans for the future RPC We ve been leaders in the nutritional space for the last two decades due to our commitment to nature science and wellbeing. We are pioneers. That startup spirit is alive in everything we do and will always be a large part of who we are and how we re different. Our ultimate goal is to position Lycored as a truly premium wellness brand. We ll do this by continuing to expand and strengthen our portfolio of natural ingredients which are the result of an exceptional collaboration between our scientific and operational teams. Additionally we want to further bolster our commercial and go-to market activities. Commercially we d like to reach both the dietary supplement and food industries. For us true wellness is the result of both spaces working in tandem. Together they allow us to promote a healthier more nutritionally comprehensive diet and ultimately facilitate and celebrate a lifestyle that is very much centered on wellbeing. These last two decades underscore a privilege and a duty we have to ourselves and to our communities. This milestone allows us to reaffirm our commitment to our people and our partnerships to stay true to our creative roots and to continue improving our sustainable business foundation to 52 Nutrition Industry Executive better serve us now and in the future. For me personally this event is a chance to consider how we want to promote and advance wellness in a genuine way and then act on those ideas and dreams. selves as a caring engaged company. It was important that our brand promise and tagline echo that sense of humanity. NIE Let s talk about the company s new brand identity. What is Cultivating Wellness all about RPC Our brand promise makes it clear that we always do our best however there s always room for hope and further discovery. This notion encapsulates everything we proudly stand for. It speaks to how we support overall wellness by looking at nature and human relationships for inspiration and guidance. It also speaks to our humility-- growth and exploration are incredibly important to us. There is no end to our work in a sense. The word cultivating alludes to our methodology. We are deeply committed to developing and growing the relationships we have with one another our customers our suppliers and our partners. We re also dedicated to focusing on what we do best and seeing just how far we can take those abilities and insights. The word wellness nods to the kind of products and solutions we deliver. The combination of personal health and partnership health has the power to make Lycored a stronger and more focused organization. At the end of the day we see ourCelebrating 20 Years of Excellence 1995-2015 NIE The company recently invested in a skincare clinical trial. Talk about the trial and what you hope to achieve. RPC Our most recent product developments are indication-specific compositions. We ve done this in an effort to better address the consumer trend towards personalized preventative care. Skin protection and health is something many consumers including ourselves are very concerned about and we wanted to tackle that head on. Based on our tomato technology we ve been able to develop a specific blend of nutrients that can help protect skin from the harmful effects of UVA and UVB light. We fully believe in the combined power of science technology and nature but not without testing research and clinical trials. We ve conducted a number of trials in Europe for this composition in an effort to prove its efficacy and better understand its potential. So far we are seeing very positive results and we are currently expanding this effort further over the next few months. Extra Extra Visit www.niemagazine.com to read the rest of the interview. www.niemagazine.com September 2015 FAMILY OF PUBLICATIONS www.GlutenFreeRetailer.com Branch Out and Join VRM Media s www.VitaminRetailer.com 1995 20 Y ars Celebratingellence e of Exc 2015 www.NaturalPractitionerMag.com www.NIEmagazine.com www.FitnessTrainerMag.com Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF VRMmedia.com Roy Kieffer at 719-358-9838 or e-Mail RoyK VRMmedia.com Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP VRMmedia.com Go to www.niemagazine.com usp for info about this advertiser