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Description: In This Issue: The Path to Compliance, Weight Loss, Premixes, and Proteins
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NI Ne A VRM Media Publication V w isi W tO Em eb u ag si r az te in e. co m www.niemagazine.com June 2015 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com healthco for info about this advertiser TableofContents Proud Supporter of VOLUME 20 NO. 5 JUNE2015 F E A T U R E S 18 The Perks of Premixes Manufacturers looking to stay ahead of the game are finding the benefits of outsourcing especially because premixes are offering the latest for health and wellness concerns. 22 The Path to Compliance Compliance and transparency are the keys to rebuilding and maintaining consumer confidence and trust. 27 The Weight-loss Challange A L S O I N S I D E 6 11 12 15 16 17 43 43 43 44 Industry News Conventions & Meetings Ingredient News AHPA Update Association News Science Update Equipment & Packaging Advertiser Index Industry Events Supplier of the Month When offering natural ingredients suppliers are taking a multi-pronged approach to address the complexities of weight management. C O L U M N S 4 First Word 35 Marketing Innovation 37 Nutraceuticals 41 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 5 June 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 June 2015 Go to www.niemagazine.com plt for info about this advertiser FirstWord Grievances Voiced he Society of Professional Journalists (SPJ) one of the oldest organizations representing journalists offers people in media a code of ethics statement of abiding principles. In its preamble it states that members of the Society of Professional Journalists believe that public enlightenment is the forerunner of justice and the foundation of democracy. Ethical journalism strives to ensure the free exchange of information that is accurate fair and thorough. An ethical journalist acts with integrity. However SPJs Code of Ethics is voluntary and the SPJ does not have a mechanism for investigating complaints or enforcing discipline on SPJ members much less other journalists. The society s leadership has debated the question of enforcement off and on for decades. The majority has felt that establishing a quasi-judicial system such as those found in some other professions would inevitably lead to actions by governments courts or their proxies that would restrict the rights to free speech and free press guaranteed by the First Amendment to the U.S. Constitution. Limiting free speech rights in the pursuit of ethics is not something the SPJ wants to see. Objectivity in journalism is impossible--just the topic a journalist covers can be biased. And that is fine-- hopefully media consumers are aware and can form their own decisions based on that understanding. It is the accurate fair and especially thorough aspects that are important and often appear to be lacking T in mainstream news media coverage. So when HBO s Real Sports with Bryant Gumbel decided to cover the subject of supplement use in the military (read the news report on page 9) it is unfortunate to find yet another one-sided hack job that incorrectly portrays the supplement industry. It s especially frustrating to learn that when industry associations manufacturers retailers and distributors reached out to HBO repeatedly to offer their viewpoint no one at the cable network bothered to return their calls. On its website the SPJ states Our hope is that the public and other journalism professionals will have in our code the tools necessary to evaluate journalism behavior and hold journalists ethically accountable for their actions. Indeed the code specifically calls on journalists to clarify and explain news coverage and invite dialogue with the public over journalistic conduct to encourage the public to voice grievances against the news media and to expose unethical practices of journalists and the news media. Although the rebuttals by Senator Orrin Hatch Council for Responsible Nutrition United Natural Products Alliance etc. may not be quite as compelling as a highly polished HBO report they don t go unnoticed by the public and other news media. For example the Natural Products Association s Dr. Daniel Fabricant wrote an excellent op-ed piece on the HBO topic that was published in The Salt Lake Tribune and picked up by other news outlets. Again a strong defense is a necessity in these situations. Here s to a strong offense as well. 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 Managing Editor Shari Barbanel ShariB VRMmedia.com Assistant Editor Cristina Goodwin CristinaG VRMmedia.com Contributing Writers Suzanne Shelton 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. Connect With Us www.twitter.com vitaminretailer www.facebook.com www.linkedin.com www.instagram.com www.pinterest.com vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com June 2015 Go to www.niemagazine.com jiaherb for info about this advertiser IndustryNews VRM Media Announces Editorial Staff Promotions Janet Poveromo to take over professionals. Barbanel had RM Media (East Brunswick NJ) the editorial reigns at Vitamin most recently been the the healthy business media commanaging editor for NP pany has announced the promoRetailer said Daniel tion of two editorial staff members McSweeney VRM president. while also contributing to Janet Poveromo and Shari Barbanel. Since first joining the VR VR as well as NIE. Poveromo who serves as editor-in Shari is a very skilled staff nine years ago Janet chief (EIC) of VRM s Nutrition Industry business editor and I know has risen up the ranks from she will have a tremenassociate editor to managing Executive (NIE) has been named EIC of dously positive impact on editor and now to editor-inVitamin Retailer (VR) the leading B-to-B Shari Barbanel chief of Vitamin Retailer. I publication for retailers and other memNatural Practitioner bers of the dietary supplement industry. congratulate Janet on her McSweeney commented. Poveromo who has been with promotion and look forward Since 1994 VRM Media has been a VRM Media since 2006 was to seeing Janet put her own leading business media company most recently the managing personal stamp on VR s ediserving the informational needs of the editor for VR. She will continhealth and natural products industry. torial content. The company s stable of B-to-B publiBarbanel who first joined ue to serve as EIC of NIE cations also includes the recently VRM in January 2011 has magazine. acquired Fitness Trainer a digital been named the new EIC of Our company is very pleased to have someone magazine for personal trainers and fitNatural Practitioner (NP) with as much industry expeness instructors. the business magazine for rience business knowledge For more information visit alternative complementary Janet Poveromo and media expertise as www.niemagazine.com. and integrative health care V Industry Supports Those Affected by Nepal Disaster n April 25 a 7.8-magnitude earthquake hit Nepal which has reportedly killed more than 7 500 people and injured more than 14 500. Hundreds of thousands of others were left homeless when entire villages were flattened and hundreds more are still considered missing. In addition aftershocks and a continued risk of landslides may cause even more devastation. After seeing the devastation in Nepal the natural supplement industry has offered its support in a number of ways. Washington-based R U Ved Inc. is supporting relief efforts by matching funds up to 1 000 while ZYM (Chicago IL) is donated both proceeds and electrolyte drink tabs to the victims. The company donated 20 percent of purchases made through May 31 2015 on its website goZYM.com to the Nepal Relief Fund. Vitamin Angels (Santa Barbara CA) is responding to recent requests from partner NGOs in Nepal following the earthquake. Partners including Global Nutrition Empowerment and Project for a Village have expressed the need for additional micronutrient supplement grants to expand their O reach to affected communities. While not a disaster relief agency Vitamin Angels is responding to the emergency by expediting and increasing the number of vitamins being sent to the country. After the immediate crisis has been addressed Vitamin Angels will work to rebuild nutritional security in Nepal by partnering with local organizations focused on longterm strategies for fighting undernutrition. The importance of proper nutrition in the aftermath of disasters is vital to maintaining good health when those already at risk of undernutrition are faced with even greater challenges in obtaining food and clean water as well as increased exposure to illness said Howard Schiffer president and founder of Vitamin Angels. Schiffer founded Vitamin Angels in the wake of the 1994 Northridge earthquake in California. NOW Foods (Bloomingdale IL) is also joining in on the relief effort. According to NOW Board Member Sharon Wong the company just set up an employee match for Nepal via World Relief s partnering NGO Integral Alliance and local churches in the area. They are able to help with shelter food water medical attention and long term needs she said. We also have an employee match with Vitamin Angels to increase the amount of vitamins for the area to help support nutritional needs. Whatever our employees want to donate will come directly from their paychecks and NOW will match the amount that they donate. New York-based NBTY Inc. will be donating 500 000 worth of Nature s Bounty vitamins and supplements as well as nutrition bars from Balance Bar. The donation was made through the Feed The Children organization. NBTY has also made a monetary contribution to aid in the relief efforts. As a global leader in the wellness industry we at NBTY recognize our compelling corporate responsibility to do whatever we can to help alleviate some of the suffering being experienced by the people impacted by this horrific event said Andrea Staub vice president of communications and corporate social responsibility at NBTY. We wish the people of Nepal solace and strength as they begin the enormous task of rebuilding their lives and their country. 6 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com June 2015 China Passes Food Safety Law Implications for Supplements n April 24 China s National People s Congress passed the Food Safety Law which has implications across the entire food sector including dietary supplements. Since 2010 the U.S.--China Health Products Association has been encouraging the Chinese government to move their dietary supplement known as health food legislation towards a more open system based on notification. Over the last five years the association has summited numerous comments to China s FDA (Food and Drug Administration) as well as the National People s Congress Legislative Office. The association also cooperates with the U.S. International Trade Administration in Washington D.C. and the Foreign Commercial Service at the O U.S. Embassy in Beijing China to encourage productive dialogue. In conjunction with other organizations all this work is finally coming to fruition with the passing of the Food Safety Law. The new regulations will go into effect on October 1 2015. Although what has been released by the government in terms of the dietary supplement segment of the industry is not very detailed China s FDA and the National Health and Family Planning Commission (NHFPC) will be releasing implementation regulations leading up to October 1 which will hopefully clarify exactly how the new legislation functions. Since the beginning of 2014 China s FDA and Administration of Quality Supervision Inspection and Quarantine (AQSIQ) made importing supplements that were not registered with FDA as health food products impossible. Previously many foreign companies were importing supplements as food not health food. This practice persisted due to unclear regulations and loopholes which FDA is keen to rectify. As of October 1 2015 companies will be able to import supplements on a notification basis. However to qualify supplements can only contain ingredients that are on a list yet to be created approved by FDA and NHFPC. Previous draft regulations and USCHPA meetings with FDA have revealed that this list will be made up on vitamins and minerals. For more information visit www.uschinahpa.org. SunOpta Facility First to Receive Non-GMO GE USDA PVP Certification unOpta Inc. (Edina MN) has announced that its Hope MN facility is the first food manufacturing facility in the United States to receive U.S. Department of Agriculture (USDA) Process Verified Program (PVP) verification for non-genetically modified organisms (GMP) non-genetically engineered (GE) products. In compliance with the AMS Quality Assessment Division policies and procedures the USDA has granted approval for SunOpta s Hope facility to produce PVP verified non-GE GMO (genetically modified organism) food-grade soybeans and corn. SunOpta s soybeans and corn will be the first produced in the United States to have the full auditing and verification of the USDA. SunOpta s Hope facility processes non-GMO and organic soybeans and corn and the company has implemented the required quality management processes for food safety and transparency. SunOpta was granted approval for an initial six-month period at its Hope facility and will apply for a verification extension at the end of the period. SunOpta intends to expand the PVP standards at more facilities across its vertically integrated platform. Becoming the first PVP verified nonGMO food manufacturing facility in the United States is a great honor for SunOpta and consistent with our commitment to non-GMO and organic food products which are in high demand with today s consumers said Steve Bromley CEO of SunOpta. Having USDA verify that we are complying with our standards ensures that our customers can be S confident that they are getting the highbalance the needs of both industry and est quality non-GMO soybeans and consumer. corn. We look forward to implementing For more information call the USDA PVP program at other (952) 820-2518 or visit SunOpta facilities across our vertically www.sunopta.com. integrated platform. The USDA program verification makes it possible for SunOpta to label its foodgrade soybeans and corn as nonGMO GE. I applaud the work of both SunOpta and USDA for their innovative approach said United States Congressman Tim Walz who represents Minnesota s 1st District. The voluntary certification gives certainty to consumers and is flexible enough that it doesn t put undue burdens on companies that choose to use GMOs in their products. This is the perfect example of the private sector and the public sector workGo to www.niemagazine.com nutritional ing in tandem to Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 7 June 2015 www.niemagazine.com IndustryNews InterHealth Acquires Next Pharmaceuticals nterHealth Nutraceuticals Inc. (Benicia CA) has announced that it has acquired the assets of Next Pharmaceuticals a Salinas CA-based raw material dietary supplement supplier. Brands acquired from Next Pharmaceuticals include Relora Sytrinol Seditol and Nexrutine. Relora and Sytrinol are the leading brands from this acquisition. Relora is a leading natural dietary supplement ingredient that helps support healthy stress and weight levels. Sytrinol is a patented blend of flavones and tocotrienols for heart health. I The acquisition of the Next Pharmaceuticals brands and in particular the Relora and Sytrinol brands provides InterHealth with increased market share in the weightmanagement and cardiovascular categories. The product line represents InterHealth s introduction into the mood category. Next Pharmaceuticals has built best-in-class brands which fit nicely in the InterHealth brand portfolio commented Paul Dijkstra president and CEO of InterHealth. The transaction marks the third acquisition completed by InterHealth since its acquisition by Kainos Capital in November 2013. InterHealth acquired Chick Cart manufacturing facility March 2014 and the brand 7Keto from Humanetics August 2014. For more information call (800) 783-4636 or visit www.interhealthusa.com. SourceOne Partners With Gee Lawson ourceOne Global Partners (Chicago IL) has announced it has reached an exclusive distribution agreement with Gee Lawson (London England) for key European countries. According to Jesse Lopez CEO and founder of SourceOne the partnership S will help to meet the growing consumer demand for enhanced bioavailability absorption and efficacy of unique science-based ingredients and proprietary formulas through the use of innovative delivery system technologies such as VESIsorb. The patented VESIsorb delivery system is an innovative Swiss technology that features a naturally self-assembling colloidal droplet system. It has been clinically tested and shown to increase the bioavailability of science-based nutritional supplements functional food and beverages and cosmetic ingredients. SourceOne has recently added several new patented ingredients like Cholesstrinol HPe GymnePURE and LeptiPURE to its constantly growing IP portfolio of natural product solutions. I ve known Jonathan Shorts managing director of Gee Lawson for many years and I have the utmost Go to www.niemagazine.com somalabs Celebrating 20 Years of Excellence 1995-2015 respect and appreciation for him and his team Lopez said. Their expertise representing branded ingredient suppliers is peerless and their reputation for having an uncompromising commitment to science innovation quality and integrity is why we chose them. We ve watched SourceOne s innovation and technology platform grow and evolve with the needs of the marketplace said Shorts. Our commitment to delivering the best natural sciencebased ingredients and delivery system technologies to our customers makes representing SourceOne strategically important to our long-term success meeting customer needs for differentiated products. Shorts added that securing the VESIsorb technology will allow key brands to develop their sales through working with the Source One Gee Lawson partnership as well as developing products and being able to purchase finished dosage forms. By having the VESIsorb technology Gee Lawson has made a solid first step in continuing our growing value-added propositions said Shorts. For more information visit www.source-1-global.com or www.geelawson.com. www.niemagazine.com June 2015 8 Nutrition Industry Executive Industry Responds to HBO Real Sports Segment O n May 19 HBO s Real Sports with Bryant Gumbel aired a segment titled In Harm s Way. In the segment journalist Soledad O Brien reported on the deaths of several members of the U.S. military tied to dietary supplements sold at their bases--and also ties those deaths to Senator Orrin Hatch (RUT) and what she noted as his ongoing efforts to limit the supplement industry from being regulated. Few of these troops realize the potential risks (posed by supplements) but our research suggests they can be severe O Brien said. Using open records requests and reviewing military medical studies Real Sports found hundreds of serious military health problems associated with supplements ... health problems that in some cases could have jeopardized missions. In response to the Real Sports segment Sen. Hatch s office the American Herbal Products Association (AHPA) United Natural Products Alliance (UNPA) and the Council of Responsible Nutrition (CRN) released the following statements Our office sought to discuss with HBO s Real Sports the nature of the supplement industry and Sen. Hatch s extensive efforts over the course of many years to ensure its effective regulation. Unfortunately the producers were focused on exploiting a tragedy and telling a pre-crafted story even if mostly inaccurate said Sen. Hatch s office in a statement to The Salt Lake Tribune. Contrary to erroneous claims dietary supplements are in fact regulated and subject to enforcement. Despite our encouragement Real Sports failed to speak to any FDA (U.S. Food and Drug Administration) regulators refused to interview industry representatives who work on product safety and ignored studies by the Department of Defense that complicate HBO s pre-determined narrative. The Dietary Supplement Health Education Act (DSHEA) specifically acknowledges that improving the health of all United States citizens ranks at the top of the national priorities of the Federal Government and provides the Food and Drug Administration with ample authority to protect consumers-- including our military personnel--from any products for which there is a significant or unreasonable risk said AHPA President Michael McGuffin. To suggest otherwise represents a complete misunderstanding of this law. Also the Real Sports segment seems to imply that inappropriate industry influJune 2015 www.niemagazine.com ence was behind the adoption of this law which has provided informed access to a wide range of safe supplements for over 20 years McGuffin continued. In fact it was the nearly 50 percent of Americans who regularly consumed dietary supplements prior to the adoption of this law in 1994 who demanded the U.S. Congress protect their unencumbered health care choice to use these products. Millions of consumers use dietary supplements daily and do so safely and with great benefit added UNPA President Loren Israelsen. This is in large part due to the efforts of Sen. Hatch who has tirelessly worked to assure continued access to safe and beneficial products. Based on his record we are surprised and disappointed that HBO missed the mark so badly. Regrettably HBO has chosen to misinform its viewers on the regulation and safety record of supplements he continued. And while we agree that rogue players and products do exist this is not because of DSHEA or Sen. Hatch who has consistently worked to preserve the rights of consumers to access safe dietary supplements. More than two thirds of American adults--including those in the military-- take dietary supplements every year and the overwhelming majority do so safely stated Steve Mister president and CEO of CRN. We understand those in the military in particular need to be in the best physical shape possible to withstand the stress and rigor of defending our country and numerous dietary supplements can help maintain and improve good health. However we share the concerns raised by HBO s segment last night about stimulant ingredients like DMAA and CRN has expressed support for FDA s position that DMAA and similar ingredients are illegal because they lack adequate evidence of safety and present unreasonable health risks. On the other hand we are disappointed that HBO ignored our requests to provide perspective from the mainstream responsible dietary supplement industry as we would have confirmed our position that the products the segment focused on are being illegally marketed as dietary supplements in violation of the requirements for new ingredients he Celebrating 20 Years of Excellence 1995-2015 continued. Further we would have provided accurate information and a more balanced perspective of the numerous provisions in the law added with the passage of DSHEA and beyond that have given FDA more authority than it previously had to remove unsafe products from the market and ample tools to enforce the law. To that end we are concerned that FDA has not always acted as swiftly as appropriate to remove from the market these kinds of questionable products and we continue to urge for further resources financial and otherwise for FDA to more fully enforce the law. For more information visit https unpa.com www.ahpa.org or www.crnusa.org. Industry Veteran Nathan L. Skop Passes Away at 89 he Skop family has announced the passing of Nathan Nat L. Skop 89 on April 24. Skop led Solgar s production facility Oxford Laboratories for 30 years. Skop joined Solgar Vitamins in 1972 to initiate and lead its original in-house manufacturing facility Oxford Laboratories in Guttenberg NJ. Oxford produced virtually all of Solgar s product requirements from solid dosage forms to liquids and powders. Skop began his career in the pharmaceuticals industry and was the first to bring analytical standards and testing protocols to Solgar that far exceeded the industry norm and existing regulatory requirements. He was a pioneer in the effort to improve the quality of dietary supplements and became known as the man who enforces the tough standards at Solgar. So synonymous was he to the company s quality efforts that he was featured in its trade advertising campaign in the 1980s with the headline Mr. Skop is actually a very nice man. Just don t mess with his vitamins. Under Skop s leadership the small factory became well known for enormous output and top quality. He leaves a strong legacy to the industry and his family. His two sons Mitch and Bruce followed him in the industry. Mitch Skop is senior director new product development for Pharmachem Laboratories Inc. while Bruce Skop is senior vice president brand and business development for Windmill Vitamins. T Nutrition Industry Executive 9 IndustryNews Alkemist Labs Campaigns to Demystify Testing lkemist Labs (Costa Mesa CA) has launched a program to educate the industry on the ins and outs of successful product testing in light of increased emphasis from ingredient suppliers and manufacturers. Topics the company has addressed include criteria for choosing a testing lab why products fail tests and how to minimize confusion how phytochemical reference standards support GMP (good manufacturing practice) compliance and a number of other facets of testing designed to help companies be smarter consumers of testing services. We re seeing a lot of companies that have not had robust testing programs begin to raise the bar on quality by instituting more comprehensive testing in response to the changing landscape said Elan Sudberg CEO of Alkemist Labs. It s a very good thing to increase quality assurance but A we ve seen many companies that are at the beginning of the learning curve who could benefit from the education we are providing. Among Alkemist s educational offerings is the Sid Talks Testing column by Dr. Sidney Sudberg founder and CSO in the Alkemist monthly newsletter Lab Notes. Each month Sid offers clarification on a potentially confusing aspect of product testing. In April he explained that uncertainty of measurement in the testing world actually helps minimize uncertainty. In May he discussed how to handle a failed sample and how to navigate the learning curve involved. The company also released a series of short informative videos produced by The Shelton Group which describe how testing labs impact GMP compliance how to choose a testing lab and considerations when testing botanicals. Another aspect of testing many companies need help in understanding is the use of phytochemical reference standards and Alkemist is helping with that important component too. Phytochemical standards are pure substances existing in and mostly derived from plants for which chemical structure has been determined and for which purity has been accurately measured. In April Alkemist became the U.S. distributor for Extrasynthese of Lyon France a worldwide leader in phytochemical standards. Alkemist has a dedicated expert Petra Erlandson to guide customers through the process of incorporating these standards into their testing programs. Alkemist is developing language customers can use in their marketing materials to explain how the use of these standards helps guarantee product quality. For more information visit www.alkemist.com. Go to www.niemagazine.com jtnaturals for info about this advertiser 10 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com June 2015 You reHired Rudi De Man has been appointed vice NBTY Inc. (Ronkonkoma Stephanie Udell as the new president of sales and business develNY) has announced the director of marketing. As maropment of NattoPharma ASA (Oslo appointment of Matthew keting director Udell will overNorway) responsible for Europe and Roberts PhD to the newlysee the marketing of UP4 Asia. De Man will be responsible for created role of chief scientific Probiotics Multi-Flora driving sales in Europe and Asia while officer. In this role he will lead Probiotics Cardioviva Matthew growing awareness of MenaQ7. He the company s innovation Probiotics and UAS Labs busiRoberts will provide technical expertise to efforts by creating and executness-to-business private label regional partners and key ing product development and contact manufacturing. accounts identifying and strategies enhancing product Certified Laboratories (Plainview developing opportunities to offerings and driving product NY) has announced the addition of leverage existing proprietary advancements. Bob Colvin to its business developMenaQ7 Vitamin K2 science Patrick Inman has ment team. Colvin will assume and technology and directly joined Wixon (St. the role of vice president contributing to the company s Francis WI) as operaresponsible for generating global strategy and growth ini- Laura Schild tions demand planning new client business and tiatives. manager. Inman s responsibiliincreasing existing client revAmino GmbH (Frellstedt Germany) ties include oversight of comenue in the U.S. with a focus has named Laura Schild marketing and prehensive forecasting and in the Northeast region. Bob Colvin sales representative for North and scheduling activities associated Verdure Sciences South America. In her new role Schild with customer orders such as invento(Noblesville IN) has appointed Jim will be responsible for sales and strate- ry management master production Goad as its strategic marketing mangic customer support. planning real-time assessment of ager. Goad will advance business Orcas Naturals (Landing NJ) has ingredient and component availability development seek new markets and added a seasoned professional and optimized utilization of staff and set the strategic path for the company. Michael Casciano taking the key posiequipment resources. He will also inteErika Harvey has joined HORN tion as operations manager. The comgrate advanced planning software that Nutraceuticals (La Mirada CA) as pany also announced the promotion of seamlessly integrates with ERP (enteraccount manager. Harvey brings to Vijay Khadse as quality director taking prise resource planning). HORN 12 years of industry expertise to control of quality assurance and qualiUAS LifeSciences (Madison WI) has provide added sales support for HORN ty control. announced the appointment of Nutraceuticals California territories. Conventions&Meetings AHPA-AHP To Co-Host Workshop O n June 15-16 at Portland State University in Portland OR AHPA (American Herbal Products Association) will host the AHP (American Herbal Pharmacopoeia) workshop from 8 a.m. to 5 p.m. for a maximum of 30 attendees. The workshop will a cover a range of topics including botanical macroscopic and organoleptic identification methods quality assessment techniques and terminology and demonstrate how these techniques are used to evaluate crude plant parts in a scientifically valid manner. Presenters will include Roy Upton RH DipAyu herbalist and executive director for AHP Steven Yeager botanist QA QC manager and laboratory manager for Mountain Rose June 2015 www.niemagazine.com Herbs. In addition the monitor for the two-day event will be Maged Sharaf PhD chief science officer for AHPA. Areas that will be covered at the workshop include botanical identity current good manufacturing practice (cGMP) compliance requirements strengths and weaknesses of various analytical technologies (botanical morphological microscopic chemical DNA) botanical terminology and botanical identification of plant materials language of botanical pharmacognosy and organoleptics terminology and assessment techniques for roots leaves stems barks flowers fruits seeds developing and documenting macroscopic and organoleptic assessments in a scientifically valid Celebrating 20 Years of Excellence 1995-2015 manner common and uncommon botanical adulterants how to detect and how to avoid them and sourcing of botanical reference materials and developing internal standards. Additionally discussions will be followed by hands-on instruction on how to prepare botanical vouchers and in-house herbarium collection as well as examining various plant parts provided to them. For more information visit https gmod-connect.aptean.com f index.php. Nutrition Industry Executive 11 IngredientNews Study Confirms Presence of Probiotics in Breast Milk of Chinese Mothers A study has shown that bifidobacteria and lactobacilli are present in breast milk from Chinese mothers strengthening the case for adding clinically documented probiotics to infant formula in order to improve nutrition. In the last decade research has shown that breast milk from Western women contains bacteria such as bifidobacteria and lactobacilli. Bifidobacteria are known to play an important role in the development of a healthy microbiota in infants and children which is beneficial to the digestive and immune functions. A new study now confirms a presence of the same bacteria in breast milk from Chinese mothers. The study was initiated by Chr. Hansen and conducted in collaboration with Shanghai Institute of Pediatric Research. The main author Dr. Linxi Qian presented the results at the European Society for Pediatric Gastroenterology Hepatology and Nutrition 2015 in Amsterdam. Chr. Hansen has invested in clinical studies within the infant segment and previous studies have shown that the probiotic Bifidobacterium strain named BB-12 may be effective in preventing gastrointestinal and respiratory infections in infants and children. The product portfolio also includes Lactobacillus LGG which is the world s best docu- mented lactobacillus. Mikkel Jungersen scientific advisor Human Health & Nutrition with Chr. Hansen noted The confirmed presence of bifidobacteria and lactobacilli in Chinese breast milk is essential knowledge for all those who are active in the infant formula business in China. It makes sense for a mother who is feeding her baby with infant formula to prefer a product resembling real breast milk the most and this study shows that bifidobacteria and or lactobacilli are essential additives to nutritious infant formula. For more information visit www.chr-hansen.com. Bergstrom MSM Study Accepted for Publication or the first time a study reported that concentrations of MSM (methylsulfonylmethane) reliably increased in human serum levels when chronically treated with MSM. The randomized double-blind placebo-controlled study was titled Serum MSM Concentrations Following One Month of MSM Treatment in Healthy Men and published in Clinical Pharmacology & Biopharmaceutics. Richard J. Bloomer and Daniel A. Melcher both with the University of Memphis Department of Health and Sport Sciences and Rodney L. Benjamin director of research and development for Washington-based Bergstrom Nutrition conducted the study. While MSM has been known to have excellent bioavailability published data within the public domain regarding serum concentrations following chronic ingestion is minimal said Benjamin. The publication of this study may help other researchers by reporting values as measured by NMR and demonstrating how daily MSM supplementation impacts human serum concentrations over the course of a four week period. We found the increase of MSM in serum appeared to be somewhat time-dependent with the majority of subjects experiencing a continued rise from week two to week four said Bloomer. This provides a starting point for potential future studies related to dosage and timeranging. As the popularity of formulating with MSM continues to grow the information related to ideal dosing conditions is invaluable to manufacturers and researchers alike according to the company. OptiMSM has been included in products targeted for the following categories joint health exercise recovery nutricosmetic beauty-from-within and healthy aging. For more information call (360) 693-1883 or visit www.bergstromnutrition.com. Super CitriMax Certified by LabDoor aliforniabased InterHealth Nutraceuticals announced that Super CitriMax InterHealth s Garcinia cambogia weight-loss ingredient is now the only Garcinia cambogia certified by LabDoor. Having LabDoor independently test our Super CitriMax brand Garcinia cambogia further ensures our customers and consumers of the purity behind our leading weight-loss brand commented Paul Dijkstra president and CEO of InterHealth. We want manufacturers and consumers to know that there are varying qualities of Garcinia cambogia on the market he said. Several samples of Super CitriMax products were tested by LabDoor for hydroxycitric acid (HCA) content and heavy metals and met all quality metrics. In addition all chemical testing was performed at FDA (U.S. Food and Drug Administration)-registered analytical laboratories. Super CitriMax is GMP (good manufacturing practice)manufactured and three-tiered intensive quality tested. Super CitriMax goes through a program of intensive independent quality testing stateside and internationally before product is released to the market. Super CitriMax is a patented extract of Garcinia cambogia standardized to 60 percent HCA ionically bound to calcium and potassium for greater bioavailability and efficacy. It is supported by numerous published clinical research and safety studies and is self-affirmed GRAS (generally recognized as safe). For more information call (800) 783-4636 or visit www.interhealthusa.com. F C 12 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com June 2015 New MetabolAid Addresses Key Causes of Metabolic Syndrome fter four years in development Monteloeder located in Spain has launched MetabolAid a botanical ingredient that tackles metabolic syndrome. Water soluble the ingredient is suitable for use in dietary supplements beverages and some food products. It is a combination of two plants a hibiscus variety (Hibiscus sabdariffa) and lemon verbena (Aloysia triphylla). Together these well-known and safe herbal extracts provide a synergistic effect that addresses the key causes of metabolic syndrome. Pre-clinical tests involving mice fed on a high-fat diet have shown that the active compounds in MetabolAid influence key metabolic enzymes that regulate cholesterol levels glucose accumulation and lipolysis (fat breakdown). The studies showed an activation of PPARalpha a receptor that promotes the breakdown of fat and lowers cholesterol and AMPK an enzyme that promotes energy burn. Researchers also observed that in the mice an inhibition of FASN an enzyme that promotes the creation of fat. A pilot clinical study involving 50 overweight and moderately obese volunteers is currently underway at the University Miguel Hern ndez de Elche in Spain to demonstrate the benefits of MetabolAid in humans. The subjects were divided into two groups with one receiving a formula containing 500 mg of MetabolAid and the other a place- A bo. In total 17 participants completed the first month of analysis and the results show the following a greater reduction in blood pressure in the MetabolAid group than in the placebo group higher levels of HDL (good) cholesterol in the MetabolAid group compared with a small decrease in the placebo group a reduction in LDL (bad) cholesterol in the MetabolAid group compared with an increase in the placebo group a lower level of the transaminases (enzymes) associated with liver damage in the MetabolAid group than in the placebo group. Fernando Cartagena director of Monteloeder said the launch of MetabolAid means there is now a natural safe and proven ingredient with the potential to help alleviate the burden it places on health care systems and enable people everywhere to lead healthier and happier lives. For more information call 34 965 68 52 75 or visit www.monteloeder.com en. Natural Factors Adds Wellmune to Whole Earth & Sea New Product M innesota-based Biothera s Wellmune a clinically proven immune health booster is a key ingredient in the newly launched Whole Earth & Sea Pure Food Super Mushroom from Natural Factors. For consumers looking to promote their health and wellness this new product enhances key immune functions to help maintain healthy energy levels stay healthy during times of stress and improve overall physical health. According to Yolanda Fenton director of product development at Factors Group Just like a key in a lock the binding of the beta glucan contained in Wellmune to cellular receptors literally flips the switch in white blood June 2015 www.niemagazine.com cells putting them on alert and primed for action. Double blind placebo-controlled studies involving marathoners firefighters and other individuals with stressful lifestyles found that Wellmune reduces incidence of upper respiratory tract infection symptoms and improves a sense of overall health. One clinical trial found those taking Wellmune reported 22 percent higher scores in vigor a 48 percent reduction in fatigue a 38 percent reduction in tension and a 38 percent reduction in confusion compared to the placebo groups. For more information visit www.wellmune.com. Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 13 IngredientNews OraftiSynergy1 Improves Appetite Regulation In Obese Children new study conducted by the research team of Professor Raylene Reimer from Calgary University in Canada showed that the prebiotic chicory root fiber OraftiSynergy1 from Canada-based BENEO improves appetite regulation and decreases food intake in overweight and obese children helping those children to eat less naturally. For this study the team aimed to evaluate the potential of OraftiSynergy1 in 42 overweight and obese children aged 7 to 12 who were closely followed for 16 weeks. Results were presented at the American Society for Nutrition s Scientific Sessions at Experimental Biology 2015 in Boston MA which illustrated that children with 8 g daily of OraftiSynergy1 supplementation A had significantly higher ratings in their feeling of fullness and satisfaction and a lower prospective food consumption also satiety was significantly higher with the fiber supplementation. At an ad libitum breakfast buffet the children consumed about 100 calories less with OraftiSynergy1. At the end of the study the lower food intake showed a definite impact. BMI z-scores were significantly reduced in the prebiotic chicory fiber group but not in the control group. These results confirmed that in the children studied long-term intake of the prebiotic fiber OraftiSynergy1 can lead to reductions in energy intake with positive impact on body weight a reduction in body fat and fat mass index. OraftiSynergy1 supplementation also contributes to higher satiety and fullness. Earlier research in this series including several human intervention studies with the prebiotic chicory root fibers OraftiP95 and OraftiSynergy1 also provided positive evidence for the parameters relevant to assessing the potential of an ingredient to contribute to weight management including subjective appetite rating satiety regulation on hormonal basis energy intake on long-term covering potential compensation aspects body weight and body composition (fat mass in particular trunk fat). Reimer and her team concluded that prebiotic chicory root fiber is a potential tool for the prevention and treatment of pediatric obesity. For more information call 32 16 801 301 or visit www.beneo.com. Frutarom BU Health Debuts Incaberrix rutarom BU Health located in Switzerland launched a new super berry ingredient Incaberrix. The water-soluble extract rich in phytonutrients is prepared from the ancient Andean physalis fruit (Physalis peruviana) also known as Inca berry cape gooseberry or golden berry. According to Yannick Capelle product manager for Frutarom Health The concentrated nutrient value adds health benefits combined with fun and an exotic touch to a wide range of food applications. But the sweet and tart berry s primary category is beverages including soft drinks nutritional beverages and more. Incaberrix is particularly rich in B-complex vitamins protein and minerals such as iron zinc and phosphorus. It also is high in vitamin C and carotenoids. Recent tests in Frutarom Innovation Center show that clear Incaberrix is stable in beverage applications. For more information call 41 44 782 64 64 or visit www.frutaromhealth.com. Life Extension Offers Chol-Support With Pantesin Pantethine lorida-based Life Extension recently introduced a new cholesterol-management supplement called Chol-Support that utilizes Kyowa Hakko s (New York NY) Pantesin Pantethine and an artichoke extract. Chol-Support contains a 300 mg dose of Pantesin Pantethine--a branded form of a vitamin B5 derivative that has been shown to promote already healthy levels of LDL and non-HDL cholesterol levels while increasing valuable CoQ10 stores as published in a study published in Vascular Health and Risk Management. It s combined with 250 mg of Pycrinil artichoke extract from the plant s leaves. For more information visit www.kyowa-usa.com or www.pantesin.com. F F Applied Food Sciences PurCaf Obtains GRAS Compliance n independent third-party expert panel led by a team at Washington-based AIBMR Life Sciences has independently and collectively critically evaluated the safety of Texas-based Applied Food Sciences (AFS) PurCaf derived from unroasted raw green coffee beans and is standardized for its caffeine content. It concluded that the intended use is generally recognized as safe (GRAS). PurCaf is intended to function as a natural replacement for synthetic caffeine and for use as a caffeine delivery ingredient in conventional standard finished food and beverage A products that utilize and list caffeine as an ingredient. PurCaf is USDA (U.S. Department of Agriculture) Certified Organic but also available in a non-organic format and by obtaining GRAS compliance PurCaf hopes to make it easier for manufacturers to usher in the new wave of natural energy products. As the FDA (U.S. Food and Drug Administration) continues to focus its attention on manufacturing compliance for dietary supplements many companies are looking to reposition their liquid products as beverages. A fundamental aspect of beverages is that all Celebrating 20 Years of Excellence 1995-2015 ingredients must be approved food additives or GRAS says Justin Prochnow shareholder at Greenberg Traurig LLP located in England and part of AFS legal counsel. For more information call (800) 345-9666 or visit www.appliedfoods.com. www.niemagazine.com June 2015 14 Nutrition Industry Executive AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers USDA Verifies Non-GMO Claim Through Process Verified Program he U.S. Department of Agriculture (USDA) Process Verified Program (PVP) has verified SunOpta s Hope MN manufacturing facility for non-genetically modified organisms (GMO) non-genetically engineered (GE) products. This is the first time PVP has been used to verify a company s non-GMO claim according to reports of a letter from Agriculture Secretary Tom Vilsack to USDA staff. Reportedly USDA will announce the program soon and other companies are lining up to have their non-GMO claims verified by USDA through PVP. SunOpta has developed a black and green logo to brand its program according to Rob Litt the company s director of global communications. Litt noted that the company must also include the red white and blue USDA process verified shield and qualifying claim on all marketing materials. It is important to note that USDA has not set a non-GMO standard. Instead it has verified that one company s manufacturing facility has met its own standard when making a claim that its product is non-GMO. In other words USDA has certified that SunOpta s Hope manufacturing facility s process ensures that the corn and soy ingredients it uses are not genetically modified. USDA s PVP provides companies with the opportunity to assure customers of their ability to provide consistent quality products or services according to the PVP website. Companies with approved USDA PVPs are able to make claims associated with their process verified points. These include age source feeding practices or other raising and processing claims--and market themselves as USDA Process Verified with using the USDA Process Verified shield. Companies must pay to have their process verified by USDA through PVP. The PVP is administered by USDA s Agricultural Marketing Service (AMS) the same group that administers the organic certification program. However the two programs will remain separate according to a report by T Supermarket News that quotes Sam Jones-Ellard a spokesman with AMS. This means that even if a product has been certified organic and is therefore non-GMO its producer must go through a separate process to have its non-GMO claim verified by the USDA according to the Supermarket News article. There is some concern that this program doesn t seem to be coordinated with the National Organic Program (NOP). Products that meet the NOP standard should also have their non-GMO labels recognized as verified instead of having to pay an additional fee for a claim that has already been verified by AMS through NOP. USDA should be commended for their effort to meet consumer demand for information about non-GMO products but it seems unlikely that the PVP will provide the comprehensive solution needed to address this issue. Ultimately a more comprehensive solution is needed. AHPA continues to advocate for a federal standard companies can voluntarily use to label products that don t include GMOs as the most practical and immediately achievable method to inform consumers about GMO-free products. Resources www.sunopta.com www.ams.usda.gov AMSv1.0 processverified www.supermarketnews.com Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) Go to www.niemagazine.com herballyyours for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 15 June 2015 www.niemagazine.com AssociationNews ABC Welcomes 13 New Advisory Board Members he American Botanical Council (ABC) has welcomed 13 new expert members to its Advisory Board. The addition of these distinguished individuals six of whom are from outside the United States represents ABC s continued goal of expanding its international relationships and educational impact. They join 127 existing members including 32 international experts. The new members will bring their perspectives and experiences from numerous scientific fields related to the study of medicinal plants including ethnobotany pharmacognosy phytotherapy pharmacy organic and biochemistry natural products research and more. We are deeply grateful to these highly qualified new members of the ABC Advisory Board for their willingness to engage formally with ABC and help us promote our nonprofit educational mission said Mark Blumenthal founder and executive T director of ABC. These people constitute some of the leading experts in their respective fields and their active association with ABC will help ensure the high quality accurate and reliable educational information for which ABC is known. ABC Advisory Board members generously volunteer their time to peer review articles that appear in HerbalGram HerbalEGram HerbClips as well as various other peer-reviewed ABC publications. Additionally ABC management and HerbalGram editors seek feedback and advice from Advisory Board members on research questions article ideas ABC policies and book reviews among many other topics. One of the most exciting aspects of the work at ABC is to have this unique network of experts in the many aspects of botanical medicine available noted Stefan Gafner PhD ABC s chief science officer. The breadth of knowledge that the new members will bring to ABC is extraordinary and I am looking forward to a closer interaction with this talented group of individuals with expertise in traditional use clinical studies molecular biology formulation chemical analysis and regulatory aspects of medicinal plants. The newest ABC Advisory Board members are the following Valerie Assinewe PhD Alan Bensoussan PhD DipAc Chantal Bergeron PhD Nadja Cech PhD Zo Gardner Gabriel Giancaspro PhD Joerg Gruenwald PhD Pierre Selim Haddad PhD James Harnly PhD Michael Heinrich Dr. rer. nat. habil MA Dipl. Biol FLS Andrea Ottesen PhD Guido Pauli PhD FAPA Alain Touwaide PhD For more information visit www.herbalgram.org. AHPA Provides Expertise at World Tea Expo he American Herbal Products Association (AHPA) provided regulatory and technical expertise on safety and compliance issues to attendees of the World Tea Expo an annual tradeshow for the specialty tea industry held in Long Beach CA on May 6-8. AHPA also held an industry roundtable discussion during the tradeshow as a forum for companies to learn about current trends and concerns and to share insights and best practices. The meeting was well attended by a variety of companies of all sizes from ingredient suppliers and importers to finished product manufacturers and retailers. California s Proposition 65 and the proposed amendments to this state law was a hot topic at the roundtable. The specialty tea category has not been the subject of notice letters or litigation under California s Proposition 65 and we are working to preserve that track record said AHPA President Michael McGuffin. Informing members on potential T concerns for botanicals allows industry to remain proactive and employ appropriate testing protocols to ensure the finished product is high-quality and in compliance with Prop 65. AHPA continues to work with the enforcement agency for Prop 65 the Office of Environmental Health Hazard Assessment (OEHHA) and other interested parties to provide industry expertise and ensure botanicals are understood and considered during rulemaking processes. The Food Safety Modernization Act (FSMA) and potential implications for the specialty tea category were also addressed at the roundtable. Anticipated FSMA changes include additional steps in supplier verification and written documentation of verification programs. Knowing your suppliers and having ingredient specifications will be two essential steps in a successful supplier verification protocol stated Tami Wahl special regulatory counsel for AHPA. This may curCelebrating 20 Years of Excellence 1995-2015 rently be a commonplace practice however FSMA will require formal documentation of these measures. The specialty tea industry on the whole is eager to learn of current trends and concerns and most importantly open to strategies and best practices to stay in compliance and ultimately provide the highest quality end product possible stated Wahl. AHPA offers extensive guidance documents and training sessions to ensure members and others in the industry have current and accurate information on regulations and what is required to sell product in this category. AHPA also represents the needs of consumers and the industry when policymakers consider laws and regulations for specialty tea products. For more information visit www.ahpa.org. www.niemagazine.com June 2015 16 Nutrition Industry Executive ScienceUpdate Vitamin D Can Affect Pain Movement ccording to a University of Florida (UF) study higher levels of vitamin D may decrease pain and improve function in obese individuals with osteoarthritis. Findings published in The Clinical Journal of Pain indicate that obese individuals who suffer from osteoarthritis and have adequate vitamin D levels could walk balance and rise from sitting to standing better than obese participants with insufficient vitamin D levels. The findings suggest an association between obesity and vitamin D status for tasks such as standing from a seated position. Adequate vitamin D may be significant to improving osteoarthritis pain because it affects bone quality and protects cell function to help reduce inflammation. Vitamin D maintains calcium and phosphate concentration levels to keep bones strong said lead author Toni L. Glover an assistant professor in the UF College of Nursing A part of UF Health. Increased pain due to osteoarthritis could limit physical activity including outdoor activity which would lead to both decreased vitamin D levels and increased obesity. Osteoarthritis is the most common form of arthritis affecting millions of people worldwide. It occurs when the protective cartilage on the ends of bones wears down over time causing pain stiffness and loss of joint movement. The researchers analyzed blood samples for vitamin D levels from a racially diverse group of 256 middle-aged and older adults. Participants also provided a self-report of knee osteoarthritis pain and completed functional performance tasks such as balance walking and rising from sitting to standing. This study was part of a larger project that studies racial and ethnic differences in pain in individuals with osteoarthritis. Among the 126 obese participants 68 were vitamin D deficient while only 29 of the 130 non-obese participants were deficient suggesting obesity is significantly associated with clinically relevant vitamin D deficiency. Obesity is associated with vitamin D deficiency knee osteoarthritis pain and poor functional performance. Vitamin D is stored in the liver and human fat cells and previous research has shown that the larger fat amount in obese people can cause vitamin D to be stored instead of circulated in the body. For more information visit www.ufl.edu. Vitamin E Effective for Treatment of Non-alcoholic Steatohepatitis esults revealed at The International Liver Congress 2015 show that vitamin E (d-alpha-tocopherol) is an effective treatment for non-alcoholic steatohepatitis (NASH). NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels which can eventually cause cirrhosis. A pooled analysis of data from two randomized trials comparing vitamin E versus placebo and the placebo group from another trial comparing vitamin E use versus non-use demonstrates that the efficacy of vitamin E is comparable to other treatments for NASH including pioglitazone metformin and obeticholic acid. In addition treatment with vitamin E is associated with significant improvements in both NASH histology (45 percent vs. 22 percent in those not treated with vitamin E) and resolution of disease (38 percent vs. 20 percent in those not treated with vitamin E). There was no increase in cardiovascular events and no adverse lipid profiles were observed with vitamin E treatment. A total of 347 patients (155 treated with vitamin E 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH the PIVENS TONIC and FLINT trials. Histologic improvement was defined as 2 point improvement in NAS with no worsening of fibrosis and NASH resolution measured effectiveness. The study supports the use of vitamin E as a treatment for NASH. For more information visit www.easl.eu. R June 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 17 The Perks A ccording to Russ Hazen PhD premix innovations manager for New York-based Fortitech Premixes by DSM the outlook of the market for premixes and custom blends continues to be bright. While the food and beverage market has been flat in recent years the trend toward niche products targeting specific health conditions will continue to offer opportunities for the continued use of custom premix solutions in the functional foods arena he explained. In addition to consumers looking for products that offer health and wellness benefits they are focusing on quality. Consumers are becoming more conscious about nutrient contents and the quality of the products they consume added Jayesh Chaudhari MS certified nutrition specialist for Illinois-based Prinova Solutions. of Premixes ages premixed ingredient systems exist to allow manufacturers benefits and savings that require almost no effort to attain. Premixes also offer manufacturers greater product consistency and greatly reduce the chances of using incorrectly weighed materials during finished product manufacturing especially when considering that the levels of certain nutrients must be rendered in the microgram range. Manufacturers utilize premixes for multiple reasons but for most the biggest reasons have to do with the reduction in both purchasing and manufacturing complexity according to Alison Raban certified food scientist with New York-based BI Nutraceuticals. When a manufacturer purchases a blend versus multiple ingredients they are eliminating multiple invoices testing processing steps and more while reducing labor time. This leads to more efficiency and less waste resulting in both time and money savings. In addition to manufacturing and purchasing efficiencies premixes are extremely beneficial when working with Celebrating 20 Years of Excellence 1995-2015 Manufacturers looking to stay ahead of the game are finding the benefits of outsourcing especially because premixes are offering the latest for health and wellness concerns. By Cristina Goodwin high potency vitamins and minerals that have a low use level added Raban. Premixes ensure even distribution of the actives during manufacturing. Also premixes can be utilized depending on the batch specifications in some cases making it easier for production and protecting sensitive actives. Prinova Solutions according to Chaudhari with its Provia Functional Market Forms (encapsulated agglomerated spray dried and micronized) offers raw materials as a single homogenous matrix which provides the nutritional value it promises without altering the sensory qualities of the finished product. We ensure that every batch we produce meets the customer specifications and also provide every batch with full certificate of analysis he said. Ultimately we can deliver a total solution that arrives ready to be packed pressed or put into its final retail form. In developing and manufacturing a custom premix for an application there are a number of benefits when working with an ingredient supplier said Mike Petrushka general manager Prinova www.niemagazine.com June 2015 Manufacturing Benefits According to NutraSolutions.com With the wide variety of vitamins minerals botanicals and nutraceuticals that can be used to fortify foods and bever18 Nutrition Industry Executive Solutions. For example We simplify inventory management and reduce risk. We have economies of scale that do-ityourselfers may not be able to achieve since we are constantly pooling nutritional ingredients. This allows manufacturers the luxury of focusing on what they do really well ... so our customers can benefit from us as we have better control over inventory shorter turnaround time and provide homogeneous complete blends with competitive pricing he noted. Securing Supply Chain Prinova Solutions is finding cases where its integrated supply chain coupled with the flexibility in its manufacturing and packaging can drive down total system costs Petrushka added. Growing categories are looking for speed and responsiveness and they re looking to offload some of the risk inherent in custom blends and matrices. We are able to simplify inventory maintenance and the manufacturing process. We can reduce risk to customers because we re able to make and test the batch in-house to ensure that it meets customer specifications before it even leaves our lab. Reliability is intrinsically linked to everything we do from supply chain and regulatory support to troubleshooting and technical services. As a proactive player we have the ambition to determine--and meet--our customers requirements in advance Hazan added. We ve established tracking procedures that control and verify product characteristics at every stage of the manufacturing process--from the arrival of raw materials through to storage production warehousing distribution and sales. As for BI Nutraceuticals the company requires that all products be checked at every stage before during and after processing. In addition with its proprietary Protexx HP Green Steam sterilization method and Identilok genus and species verification system the company offers peace of mind needed when sourcing botanicals and functional ingredients from all the over the world. Another way to approve raw material is by evaluating at least three different lots of material from the supplier. Before approving the material we make sure that the three different lots of that material should match well in June 2015 www.niemagazine.com physical chemical and micro-biological characteristics Chaudhari explained. Non-GMO (genteically modified organism) and allergen gluten free are also the important criteria for selection of product Chaudhari noted adding that a premix scientist s role is to develop precise timely dry and liquid blend formulations that meet customer specifications. To satisfy customer demands we need to design a formulation which is not only compatible with their product but should also meet their regulatory criteria i.e. nonGMO status minimal contaminants and micro-organisms load allergen gluten free natural etc. Of course time and money savings are considerations but not at the expense of sacrificing technical expertise Hazan added. Throughout each development cycle Fortitech Premix experts work closely with a customer s R&D team to address the specific formulation issues that may arise throughout the product development cycle. Our scientists are experts in delivering multiple nutrients in a single premix while preserving three key elements of a successful end product taste stability and texture. Key to our strategy is developing formulations using functional ingredients that serve a dual purpose i.e. delivering a health benefit while also providing processing advantages such as better distribution for homogeneity. Clean Sophisticated Blends Consumer demand has driven the growth of healthier and more natural products with cleaner labels and while they still want to see the standard nutrients on their packaged food labels they also want antioxidants and other phytochemicals from all-natural plant sources incorporated into the products they buy. According Raban Although vitamin and mineral premixes still dominate sales BI Nutraceuticals saw a gain in botanical blends particularly fruit and vegetable blends. This can be attributed to the clean label trend currently dominating the dietary supplement and food and beverage industries she continued with minimal chemicals and contaminants. Big-Name Food Manufacturers Take On Clear Labeling A ccording to survey data published by market research firm Packaged Facts in the new report Nutritional Labeling and Clean Labels in the U.S. Future of Food Retailing 87 percent of Americans look at the Nutrition Facts panel on packaged foods and beverages with 56 percent looking to find nutritional information and guidelines on the label. These companies are acting proactively as they feel the winds of change--whether from potential government legislation nutritional recommendations or consumer demands-and are willing to overhaul their products and even their most iconic brands stated the report. Below are a few examples where companies are making nutritional changes shown on their labels Kraft Foods Group announced that it will be removing artificial colors and preservatives from its flagship Original Macaroni & Cheese Celebrating 20 Years of Excellence 1995-2015 boxed dinner mixes taking into effect in January 2016. The Hershey Co. announced that it will begin reformulating its products with simpler and easier-to-understand ingredients following a threeprong strategy simpler more natural ingredients transparency and ingredient information shared with consumers and sourcing responsible and sustainable ingredients. Hershey s and its competitor Nestl USA announced they would stop using artificial colors and flavors in all of their chocolate by the end of 2015. Tyson Foods promised that by September 2017 the company will no longer give its chickens antibiotics that are also used in human medicine. Tyson is a major chicken supplier to McDonald s which a month earlier announced that its 14 000 U.S. units will stop selling chicken raised with human antibiotics within the next two years. Nutrition Industry Executive 19 of Premixes Premix manufacturers can offer a broad range of nutrients and the best of these suppliers offer a deep understanding of final product manufacturing Hazan added. This expertise allows the custom premix to transform from just a simple blend of materials into a solution to some of the challenges manufacturers are facing. Working closely with your premix provider allows these companies to leverage the vast experience of the premix manufacturer to get the most out of the opportunity for using a premix in your facility. Hazan noted that the variety of ingredients being included in complex premixes also continues to expand and has gone from blends of basic vitamin and minerals to much more complicated blends involving macronutrients as well as colors and flavors. All premixes require micronutrients vitamins minerals trace elements--in small quantity for growth maintenance and activity however macronutrients protein carbohydrates fats--are sources of energy which benefit manufacturers that target the active consumers. Chaudhari said Prinova Solutions has also seen a large increase in inquiries The Perks for formulations for sports nutritional drinks targeted for sustained energy with high protein low carb and clean label concepts. We re seeing more customers asking for portion packaging (putting fully tested premixes into portion-sized packages). We re seeing more desire for complete formulations which we re fulfilling with drum to hopper formulations (active ingredients flavor sweetener color and food additives excipients) for powdered drinks and tablets chews he explained. Lately we have noticed a significant increase in demand for formulations for pre-workout and post-workout concepts containing BCAA s (branchedchain amino acids) other amino acids with protein and B vitamins for powdered drinks targeted. In addition because premixes are now available in powder form consumers are able to receive several servings of greens or fruits and vegetables in just one product they would otherwise not be receiving Raban said. Along with their nutritional appeal some of these blends may improve color or flavor as well. Condition-Specific Beyond basic nutritional needs health and wellness blends are gaining recognition. Requests for formulations to improve the overall nutrient profile of a product or a formulation that is condition-specific continue to be of interest The Role of the Premix Purchaser A 2008 document issued by Flour Fortification Initiative report recommends that purchasers of premixes should attempt to be very clear on what they want to order and should include the following the country in which the premix will be used the product that will be fortified the quantity of premix to be ordered where the premix is to be delivered when the premix is to be received or shipped the addition rate of the premix stated in grams of premix per metric ton of whatever units are used the fortification standards that the premix must achieve or the types and levels of micronutrients to be added at a specified addition rate but not both the exact composition of the premix (i.e. the percentage of each ingredient in the premix) unless specified by country regulations. In addition Flour Fortification 20 Nutrition Industry Executive Initiative advises that purchasers should always try to order the premix in a timely fashion to avoid hurried orders that require special production and delivery. They should also avoid ordering excessive amounts that will result in the product exceeding its expiration period tenders may specify package type container net weight and religious dietary status if samples are requested the manufacturer should provide production samples of the same premix if they have made it in the past. If they have not previously made this particular premix or have no samples of it manufacturers are required to provide a sample using all the same ingredients that they would use under actual production if the purchaser requires some form of preshipment inspection it is the responsibility of the purchaser to make arrangements for doing that. Celebrating 20 Years of Excellence 1995-2015 Raban explained. With Baby Boomers being a significant portion of the consumer demographic formulations that support a healthy aging platform are in demand. These are condition-specific and range from anti-aging to bone joint health to cardiovascular health just to name a few she said. Premix products are helping customers deliver high quality finished products that meet consumers expectations Hazan added. These finished goods represent an increasing array of forms targeting a variety of target markets. These may be a condition-specific bar application or a general immunitysupporting beverage he noted. Now that the condition-specific line has expanded to target different health concerns manufacturers are looking to the suppliers to create a custom blend for their product whether a food beverage such as an energy drink or supplement. According to Hazan many companies are evaluating the potential to streamline their businesses. As they do the ability to limit inventory decrease production complexity and consolidate a variety of operations through outsourcing some aspects of production will make the manufacturing of custom blends of materials increasingly popular. This will contribute to the increase in premix opportunities. Custom premixes are always improving to ensure the needs of the customer. As for formulation techniques the straight-forward answer is that as technology and ingredient options evolve our ability to develop and utilize innovative formulation techniques will evolve as well Hazan concluded. NIE Extra Extra Visit www.niemagazine.com to watch a video with premix supplier Watson Inc. s Vice President of Quality and Nutritional R&D Alice Wilkinson give an informative presentation for manufacturers on what to look for in a premix supplier. FORMOREINFORMATION Fortitech Premixes by DSM (518) 372-5155 Prinova Solutions (630) 868-0300 BI Nutraceuticals (631) 232-1105 www.niemagazine.com June 2015 Go to www.niemagazine.com pinnaclelabs for info about this advertiser INDUSTRY ROUNDTABLE he issue of compliance has affected many aspects of the natural products industry. Nutrition Industry Executive (NIE) asked natural product industry experts to discuss this topic and offer their thoughts on what the industry can do to ensure safe products that comply with government regulations and help T gain the confidence of consumers. NIE How important is attaining certifications to upholding the reputation of the industry Are attaining certifications a way to stand out in the market Potocnjak All certifications prepare us for meeting and exceeding industry standards and federal regulations. They The Participants Are Daniel Fabricant PhD Executive Director & CEO of the Natural Products Association (NPA) Washington DC www.npainfo.org Michael McGuffin President of the American Herbal Products Association (AHPA) Silver Spring MD www.ahpa.org Mimi Potocnjak President of Herbally Yours Inc. Gilbert AZ (480) 892-8220 Richard Soltero PhD President of InstantGMP Inc. Cary NC (919) 657-0714 Elan M. Sudberg CEO & Microscopist of Alkemist Labs Costa Mesa CA (714) 754-4372 Lisa Thomas General Manager of Dietary Supplement Programs NSF International Ann Arbor MI www.nsf.org Daniel Fabricant Michael McGuffin Rick Soltero Elan M. Sudberg Lisa Thomas serve as constant reminder and encourage third-party comments and ideas to help advance our own practices. Sudberg In the lab category being ISO 17025 accredited is the highest level of achievement. While it is recommended to have such accreditation it is not mandatory. Still it is an indication that important hoops have been jumped through and verified by an independent accredited body. It is important though to understand the scope of the accreditation. Many don t realize that most ISO 17025 accreditations are for a specific procedure or methodology and not the lab s quality as a whole. This is why even with such a high level of achievement an on-site internal audit must be performed. Soltero Certifications demonstrate to customers that the manufacturing organization takes quality seriously. Good certifying organizations like NSF and GMPCertification.org set high standards for facilities procedures and documentation that ensure the quality of the final products. The certifications are viewed by customers as a stamp of approval that helps them trust the www.niemagazine.com June 2015 22 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 products they buy. Customers typically are not aware of the FDA (U.S. Food and Drug Administration) regulations and look to the certifications as something that differentiates the products they consume. There is a clear trend in the dietary supplement industry to seek out certification. It is likely there will come a point in time when all customers will expect GMP (good manufacturing practice) certification for all their products. Thomas NSF International Dietary Supplement and NSF Certified for Sport certification has really emerged as the champion of self-regulation in the dietary supplement industry. There are a number of reasons for the wide adoption of these programs 1. NSF International Dietary Supplement and Certified for Sport programs are based on an accredited consensus-based standard that was developed with balanced input from regulatory industry and academic representatives (NSF ANSI 173). This group continually updates the standard to incorporate the latest science regulatory and consumer information pertaining to dietary supplement safety and quality. 2. NSF International is a truly independent organization and for more than 70 years our mission has been to protect and improve public health conducting more than 200 000 audits annually in food water health sciences and other industries. 3. This is why the NSF mark is widely recognized by consumers regulators and retailers as a mark of quality and safety. When a consumer sees the NSF mark on a dietary supplement it means that the product has been tested and certified to verify label contents and that the product contains no harmful levels of specific contaminants. The manufacturing facility is also audited twice annually to verify compliance with good manufacturing practices (GMPs) in accordance with the federal regulation for GMPs--the FDA s 21CFR111. When a consumer sees the NSF Certified for Sport mark on a dietary supplement it means that in addition to the testing and auditing described above the product has also been screened for nearly 300 athletic banned substances. This is why the NSF Certified for Sport program is used by the NFL MLB PGA LPGA the Canadian Centre for Ethics in Sports (CCES) and the New York City Police Department. June 2015 www.niemagazine.com Fabricant I think the way you stand out in the market is transparency. If the certification is done right and it s a transparent audit or inspection process you have the ability as a firm to pass that information on to your customer. Opening yourself up to added transparency is really where the marketing differential comes in. There is a clear trend in the dietary supplement industry to seek out certification. It is likely there will come a point in time when all customers will expect GMP (good manufacturing practice) certification for all their products. -- Richard Soltero PhD President of InstantGMP Inc. NIE What are some of the actions your company takes to ensure compliance Potocnjak Herbally Yours an innovative forward-thinking responsible contract manufacturer whose employees are trained in GMPs and federal guidances takes an extra step to educate our customers and walk with them though the process of creating new products or revising existing ones. Sudberg In order to provide high quality data which is what my clients seek we ensure that internal operations are in compliance with the appropriate guidelines and best practices. This means a robust internal QA (quality assurance) team equipment maintenance programs and regular internal and external audits to cGMP and or ISO 17025 standards. We do this internally so that we can provide high quality data to our clients ultimately for their compliance requirements. NIE How does your company aim to not only meet but also exceed industry standards Sudberg Unfortunately there is not much regulation of labs in the Natural Products Industry. There are best pracCelebrating 20 Years of Excellence 1995-2015 tices however nearly no mandatory oversight of the labs exists. This means that it s up to the members of the industry to regularly audit their thirdparty labs and do their own challenge testing of the labs (send a sample of known quality to several labs and compare results). An onsite physical audit by someone who knows what to look for is always the best way to check. Alkemist Labs exceeded industry standards by being first in the industry to offer only fully transparent HPTLC ID lab reports. We have always felt there is nothing proprietary about test methods and reveal them freely because it s science and is supposed to be representing the quality of our clients products. If the lab results and methodology is hidden then what does that say about the product We also were first on the scene with only botanical microscopy and HPTLC fit for purpose testing where we employ not the shiniest piece of equipment or methodology but rather techniques that have been time tested and globally approved and most importantly are fit for the job. We ve all see all too clearly recently how disastrous using testing methods that are not fit for purpose is. Lastly our company is small and still has a soul that its employees care about. For that reason there is a sense of pride in the work we do and our customer support is unparalleled. NIE How do associations and organizations assist companies in the industry in ensuring their compliance McGuffin AHPA helps members and others in the industry comply with federal and state laws and regulations by producing a host of resources from guidance documents and best practice policies to educational events that explain regulatory requirements and provide strategies to meet these requirements. AHPA also maintains working relationships with policymakers to ensure that consumer and industry interests are continually represented in emerging areas of concern and during the drafting of laws and regulations. Soltero InstantGMP develops electronic batch record software and SOPs that reinforce good manufacturing practices. The software manages workflows and quality checks that are necessary for manufacturing products that must comply with FDA regulations. Each of the software modules such as specifications inventory and batch records Nutrition Industry Executive 23 ensure that users are following GMPs. This makes manufacturing products that are in compliance with GMPs easy. Thomas Retailers and consumers want to know that they can trust the safety and quality of supplements. NSF International has analytical testing and technical auditing experts that help the industry fulfill this need by providing essential product testing and certification GMP auditing and registration and training programs for dietary supplements companies. NSF International also brought together experts from regulatory agencies industry and academia to develop the only consensus-based and accredited American National Standard for dietary supplements (NSF ANSI 173) which NSF has been testing and certifying products to for more than 12 years. The number of certified products has doubled just in the last year as consumers seek safer supplements and companies step up to meet this demand. We now have more than 750 products certified. Fabricant Information education and certification. People look to associations for rapid communication when there are any new rules or interpretations of rules that affect their business so I think that information is step one. Step two is the education. I think that this organization [NPA] educates both retail and supply members on the appropriate aspects of the laws and regulations that affect their business. And finally is certification. It s one thing to have the education and have the information--but having a certification program there is a huge value in that. We ve had or GMP certification for a long time and we ve had our natural certification in the marketplace making sure that the products that claim natural on the label certainly meet that. I think that there is a huge value in that in terms of assisting companies with assuring their compliance. NIE Are companies putting more emphasis on demonstrating the credibility of their ingredients and communicating this to the public How so 24 Nutrition Industry Executive McGuffin Verifying and demonstrating the quality of ingredients remains a top priority for herbal supplement companies especially with the inherent challenges of an expanding global supply chain. Many AHPA member companies that have spent years building a reputation for quality are benefiting from the recent scrutiny of the industry as consumers place more emphasis on highquality herbal supplement products. Potocnjak As contract manufacturer FDA registered and inspected NSF cGMP certified we understand that we are crucial part of the nutritional supplement supply chain therefor we operate under the quality system driven by transparency. Our efforts are emphasized on the quality of the ingredients we purchase and the testing to confirm the quality of those ingredients. It is our responsibility as contract manufacturing to help create products that enhance people s life and heighten the credibility of the entire industry. Verifying and demonstrating the quality of ingredients remains a top priority for herbal supplement companies especially with the inherent challenges of an expanding global supply chain. -- Michael McGuffin President of American Herbal Products Association (AHPA) Sudberg The only thing Alkemist Labs sells are lab services composite reference botanicals and most recently added phytochemical reference standards from France s Extrasynthese. The last two are to support other labs spanning from universities to the dietary supplement industry in their efforts to comply with cGMPs and other regulations. We sell no ingredients to the industry or consumers and are solely a testing lab. What we are putting emphasis on is transparency in testing. We believe that manufacturers owe it to their customers to tell them where how and why they test their products. The days of keeping your testing lab a secret need to end. Celebrating 20 Years of Excellence 1995-2015 We have also begun a campaign to demystify testing and are working to educate the industry through a series of videos articles and other content marketing vehicles that explain some of the really geeky aspects of what we do. We re passionate about testing and love to share that dedication. Soltero I see many companies put more emphasis on making the public aware of their product s quality and compliance. This effort preceded the recent attorney general s public display. It seemed more in response to a public that is becoming more informed and who actively seeks out information on the ingredients and benefits of the products they consume. The more the customers learn the more they ask and the more the companies publish information that satisfies the public s need to know. Thomas Absolutely. Evidence of this can be seen in the fact that the number of dietary supplements certified by NSF International has doubled just in the last year alone as consumers seek safer supplements and companies step up to meet this demand. Companies earn this certification because they see it as an investment in quality control risk management and--in the case of NSF Certified for Sport--the ability to sell to elite and professional athletes. Fabricant Whether they ve got a federal regulatory agency in their facility or a third party auditor they are constantly opening themselves up to strangers and that word of mouth travels. That s really the key thing Is the science behind it Is the manufacturing procedure behind it Those things can be communicated those things are measurable. There s a metrology so any time there is some sort of measurability people are going to put that out there--which isn t a bad thing. NIE What ways can the industry exhibit compliance and transparency to gain trust from consumers McGuffin The continued steady growth in herbal supplement sales indicates that most consumers trust these products and the industry. That said there are still prevalent misconceptions about the industry. Correcting these misconceptions and providing accurate information to consumers and lawmakers about the current comprehensive regulatory requirements that the industry must comply with would help bolster consumers confidence in this class of goods. www.niemagazine.com June 2015 Go to www.niemagazine.com alkemistlabs for info about this advertiser Potocnjak Media is always looking for sensational news and often our industry is portrayed in negative light often with outdated research disproven studies etc. We are still carrying the century-old burden of state fair snake-oil salesmen. But modern industry can regain that trust of the consumer by providing them evidence in the form of stability studies clinical studies research community outreach and communication. Industry associations like NPA or Vitamin Angels are just few examples of what an incredible job our industry can do when we join forces and unite. Sudberg It s time to take quality out of the closet and wear it on your sleeve. Consumers want to know that the products they are taking match what the label says. By employing a quality centric value proposition rather than just hot new ingredients or small study backed claims the consumers may begin to trust the industry again. I envision a day when you can go to the store grab a product off the shelf run its lot number using an app on your phone to bring up a detailed C of A for each and every ingredient. It doesn t matter if the user knows what a good chromatogram looks like or what a bad base line looks like. It s about accessibility of data and willingness to make it available that will earn the trust of the consumer back. The good news is that per cGMPs these tests should already be performed and data available. Now it s time to pay a web developer to make it accessible on your websites. It s not that difficult or expensive to have PDFs posted and accessible. This is something only the good guys will do sharing your quality is an underutilized competitive advantage. Soltero The best way to exhibit compliance and trust is to establish open communication. Be transparent about your process and quality controls. Make yourself available for customer questions and be honest with your answers. There are many FDA requirements that the industry takes for granted because they want to be in compliance and produce high quality products. Thomas Product certification and 26 Nutrition Industry Executive third-party GMP auditing and training are by far the best ways to demonstrate the safety and quality of dietary supplements to consumers. Fabricant The more firms are willing to pull back the curtain and let consumers see inside of the facility--that doesn t mean you have to give up trade secrets or anything but the more you can display the sorts of attributes and the more you can answer tough questions--front facing instead of waiting for things to be asked. Are you pushing that information out I think that s the difference with this marketplace right now because if you re not pushing information out someone else can control your stories. What information are you pushing out Is it transparent Is it the kind of information that informs consumers decisions I think those are really the key factors. tation is for since some labs don t and the accreditation may not be for something relevant to the testing you need. NIE What changes do you foresee with the Food Safety And Modernization Act (FSMA) McGuffin The Food Safety Modernization Act (FSMA) is the most comprehensive change to the Food Drug and Cosmetic Act (FDCA) since it was initially passed in 1938 and the rules implementing FSMA will be coming into effect in 2015 and 2016. The FDA will be more involved in all steps of a food product operation starting with the initial supplier of an ingredient both foreign and domestic to the finished product manufacturer. The rulemaking process has been an excellent opportunity for FDA to engage with industry to understand the complexity and nuances of a manufacturing operation. FSMA takes into account the uniqueness of smaller farming operations and farmers that service local farmers markets which operate significantly differently than large scale farms. AHPA will be working to educate the industry to ensure it understands the new FSMA requirements and is prepared to comply. AHPA is also working to ensure FSMA regulations are consistent with congressional intent maximize flexibility for compliance and minimize confusing language that could hamper compliance especially for small businesses. To date AHPA has submitted more than 400 pages of comments and recommended changes to the draft regulatory language issued by FDA to implement FSMA. Potocnjak One of the biggest changes to the industry will be introduction of new dietary ingredients (NDIs). We foresee that it can provide positive change if we learn and encourage better communication and sharing of data research and marketing between ingredient manufacturer us as contract manufacturer and final distributor which can only ensure that consumer is better informed and educated. On the opposite side our concern is that NDI application will be costly and lengthy process preventing creative start-up companies from succeeding. Sudberg The Food Safety Modernization Act (FSMA) is the newest and biggest change to the Food Drug and Cosmetic Act (FDCA) to date. It s It s time to take quality out of the closet and wear it on your sleeve. Consumers want to know that the products they are taking match what the label says. By employing a quality centric value proposition rather than just hot new ingredients or small study backed claims the consumers may begin to trust the industry again. -- Elan M. Sudberg CEO & Microscopist of Alkemist Labs NIE What are your company s goals going forward in regard to compliance Potocnjak As contract manufacturer we realize that our work with compliance is always evolving as regulation are changing and we welcome new challenges and new certifications. Our laboratory is growing in educated personnel new testing methods are being developed daily as new modern laboratory equipment is constantly added. We constantly challenge ourselves by adding new certifications which serve as test of our abilities and commitment to quality we provide. Sudberg Our immediate compliance goal is to achieve ISO accreditation from A2LA. Our application went in this recent March and we are excited for our next audit. We also intend to be sure and share what scope the accrediCelebrating 20 Years of Excellence 1995-2015 (Continued on page 40) www.niemagazine.com June 2015 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 By Janet Poveromo M ore than 35 percent of adults in the U.S. (estimated 78 million adults) are either overweight or obese according to the CDC (Centers for Disease Control and Prevention). Further being overweight or obese increases health risks for metabolic syndrome including heart diseases hypertension and type 2 diabetes. Annie Eng CEO of Florida-based HP Ingredients noted that according to Statisticbrain.com survey results released on January 26 2015 sourced by the University of Scranton and the Journal of Clinical Psychology reported that losing weight was the No. 1 resolution held by Americans. However a paltry 8 percent say they have been successful in achieving their New Year s resolution in the past. All this adds up to a juggernaut of a market The market for weight management supplements continues to grow said Bruce Abedon PhD director of scientific June 2015 www.niemagazine.com affairs with Vermont-based Icon Group LLC. As Americans become more overweight and obese they are increasingly looking for ways to augment healthy diet and lifestyle changes with dietary supplement products that utilize clinically tested nutraceuticals with demonstrated weightmanagement benefits. Supplements will always be an important part of the weight-management category because of their convenience agreed Mitch Skop senior director new product development with New Jerseybased Pharmachem Laboratories Inc. Our challenge as an industry is to put their use in perspective and not overpromise which leads to regulatory problems and negative publicity. And according to Vladimir Badmaev MD PhD and CEO of New York-based American Medical Holdings There are many promising nutritionals in the field of fighting overweight and obesity but they need to be systematically and consistentCelebrating 20 Years of Excellence 1995-2015 ly researched to arrive at a safe and effective weight management product. The reason why we are losing battle with obesity may be as simple as the lack of distinction between the cause of obesity and the risk factors that increase the likelihood of developing overweight or obese conditions he said. The caloriedense Western-type diet super-sizing meals overeating snacking and sedentary lifestyle qualify as the risk factors. However a common cause of obesity may ultimately be not in the calories carbs and fats but in the mechanism that directly and actively promotes obesity. Each of us has a natural protective metabolic mechanism against obesity which can be overwhelmed when the body is frequently barraged by food. When we arrive to that turn-around point the body can respond with misguided pathological mechanisms which in time become the cause of obesity and or type 2 diabetes mellitus. Nutrition Industry Executive 27 To sum up Badmaev added the current state of the market for weight-loss supplements is ready for a change of direction into seeking and addressing the cause of obesity and the related treatment rather than fight the risk factors with supplements that may be a BandAid fix. oped to be multifunctional incorporating a range of mechanisms to support a comprehensive weight management regimen including satiety appetite control thermogenesis by non-stimulant means support of healthy leptin and adiponectin function control of digestive enzymes that break down carbohydrates and lipids and enhancement of antioxidant activity. Thermogenesis Satiety and More Xiaoming Sandy Chien PhD vice president of Innovative Products with California-based HORN Nutraceuticals confirmed that thermogenics and satiety suppressants are both important for weight management. Thermogenesis can be stimulated by certain supplements to increase the energy expenditure and fat oxidation she said. Satiety suppressants are used to reduce hunger and decrease appetite or food intake. While thermogenesis controls the output satiety suppressants controls the input. So both thermogenesis and satiety control can work synergistically to help in weight loss. Anurag Pande PhD vice president of scientific affairs with New Jersey-based Sabinsa Corporation agreed that different factors work in unison and help support healthy weight loss. It is true that both thermogenesis and satiety play important roles. The presence of both factors actually synergizes the weight-loss effect. However since no two individuals are the same nor are their lifestyles it is worthwhile noting specific consumer interest can often focus on either a product that provides thermogenesis or satiety. Marketers in this area typically have focused in on one of them in more recent times lack of innovation has led to formulations involving both aspects but that may not be optimal for every consumer. There is also interest in products with a more personalized approach when it comes to these two factors. Abedon noted that while experts agree that both thermogenesis and satiety are mechanisms for losing weight these are not the only mechanisms available for promoting healthy weight management he added. The best ingredients encompass multiple mechanisms thermogenesis satiety as well as others. That is why Icon Group ingredients have been devel28 Nutrition Industry Executive To sum up the current state of the market for weightloss supplements is ready for a change of direction into seeking and addressing the cause of obesity and the related treatment rather than fight the risk factors with supplements that may be a Band-Aid fix. -- Vladimir Badmaev MD PhD Weight management via natural ingredients is a broad and promising--albeit sometimes confusing--category because of the variety of different mechanisms that are related to the energy management component of weight control added Dr. Barbara Davis vice president medical and scientific affairs with New Jersey-based PLT Health Solutions. A sensible long-lasting way to manage a healthy weight is to incorporate multiple modifications into a person s lifestyle Davis said. Of course these modifications involve healthier eating and physical activity. Supplements can also play a critical role--helping with hunger helping to improve satiety manage blood sugar and enhancing results. They can help people take charge of their lives and reinforce these modifications with progress. PLT Health Solutions participates in the weight management space with ingredients that operate in three approaches to weight control--appetite modification (satiety) control of fat reserves and the increase of thermogenesis. Whether as standalones or as ingredients in combination with other weight management approaches these are all safe effective science-supported ingredients that can be used to help companies in both the natural products and food and beverage markets develop effective products that consumer can trust Davis noted. said because each human organism is unique in how it responds to the two stimuli. We would certainly encourage consumers to take time to ponder and understand the most significant reason they are overweight--lack of exercise eating too much or the wrong types of foods. For that reason we d like to add another ingredient category carb blockers. Numerous studies have shown that carbohydrates are the culprit contributing to most weight gain Skop said adding that consequently the use of a carb blocker such as white kidney bean extract can be an important tool to help consumers bring their weight under control. In the largest human study conducted to date those subjects taking a proprietary extract of the white bean PhaseLite (Phase 2 Carb Controller) lost significantly more weight than those on placebo after 12 weeks. In addition 73.5 percent of the participants in the weight management phase successfully maintained their body weight after 24 weeks. In the doubleblind weight-loss phase 123 subjects were randomized to receive either the bean extract or placebo. All subjects adhered to a mildly hypocaloric diet. Body weight and other body composition parameters were measured at baseline and every four weeks thereafter. During the single arm open label weight management trial energy intake of the 49 subjects was not controlled. Efficacy parameters were measured at baseline weeks 12 and 24. According to lead researcher Dr. Barbara Grube the researchers also discovered other secondary efficacy parameters. For instance after 12 weeks the active group lost significantly more body fat mass and waist circumference compared to the placebo group. The researchers concluded that the reduction in body weight was due to the loss of fat mass instead of muscles. Improvement in body composition was also shown in the significant reduction in waist measurement in the active group compared to the placebo group. Weight-loss Advances In the past many weight management ingredients were stimulant-based to help increase metabolic rate as a mechanism to address weight issues noted Icon Group s Abedon. These days weightmanagement ingredients utilize a range of healthy mechanisms of action to help promote weight loss. For example Icon Group ingredients such as LeptiCore WellTrim iG Synetrim CQ and DygloFit www.niemagazine.com June 2015 Carbohydrates and Weight Loss The question of satiety or thermogenesis is difficult to answer definitively Skop Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com cheminutra for info about this advertiser explained. To gain lean body mass it is important to increase fat metabolism in the body Pande explained. It was observed that this fat metabolism could be enhanced by using the break-block-burn effect. This effect is found in the synergistic blend of LeanGard a blend of natural patented plant extracts of coleus address weight management by helping forskohlii (ForsLean) black pepper extract to increase satiety and appetite control (BioPerine) and garcinia extract promote thermogenesis by non-stimulant (GarCitrin). This combination helps in the means support healthy function of leptin and adiponectin control activity of diges- management of healthy weight by breaking the fat in fat cells with forskolin and tive enzymes that break down carbohydrates and lipids as well as utilize antioxi- burning the fat by the HCA in the GarCitrin. Fat formation was also inhibitdants to support superior health he ed by HCA s effect on citrate lyase and said. excess calories were reduced because of Earlier weight-loss products often garcinia s appetite suppressant effect. used to target quick weight reduction According to Chien another noteworbut a more recent concept that has thy advancement in weight-loss ingredicaught lot of interest is about increasing ents promotes healthy blood sugar manlean body mass added Pande. Lean agement such as in MealShape HORN s body mass is healthy mass and makes patented and scientifically proven ingrethe body more muscular. In weight-loss dient that can instantaneously reduce programs the emphasis should be on postprandial glycemia. Another advanceincreasing lean body mass while decreasment targets toxic visceral fat which an ing the overall weight this will ensure ingredient like ChalCurb has been clinithat the body doesn t lose vital compocally proven to reduce. There is a rightnents such as proteins from the body ful demand for science-based ingrediwhich form the muscular structure he ents such as MealShape and ChalCurb which we recognize is not fleeting trend Chien added. The idea of eatting 20 Years 1995 Celebra ing food to lose 2015 of Excellence weight is ironic said Skop. But there are some ingredients such as Phase 2 that can be incorporated into food and work www.GlutenFreeRetailer.com www.VitaminRetailer.com in-vivo within the food matrix to help www.NaturalPractitionerMag.com encourage satiety www.NIEmagazine.com thermogenesis and carbohydrate www.FitnessTrainerMag.com absorption inhibition. What s very new from our perspective is a culinary herb-infused Phase Contact One of Our 2 sprinkle powder Ad Specialists Today prototype we call Russ Fields at 732-432-9600 ext. 102 DietSpice he or e-Mail RussF VRMmedia.com added. Open the Roy Kieffer at 719-358-9838 pack of your taste or e-Mail RoyK VRMmedia.com buds desire (Asian Gary Pfaff at 732-432-9600 ext. 103 Italian Herb and or e-Mail GaryP VRMmedia.com Butter and Cinnamon) and sim- ply sprinkle it on or mix it into a carbohydrate-containing meal or serving. Consumers do not have to learn how to open a package and eat--and many want to spice up what s on their plates for a more enjoyable dining experience Skop noted. The fact that weight-conscious consumers can now obtain specific benefit through this food product is or should be a new hybrid category of active benefit-supplement and functional food. Missed Opportunity The concept of healthy aging a term that typically is applied to ameliorating conditions occurrences that are specific to an older demographic is also appropriate for weight loss according to Davis. It is probably accurate to say that weight management is the single most important and effective thing that people can do-- at any point in their lives--to age more healthfully. An unhealthy weight is the underlying or contributing cause to any number of chronic health conditions present in later years such as CVD (cardiovascular disease) and can exacerbate others like joint health. In fact more than one-third of older adults aged 65 and over was obese in 2007 2010. WHO EU (World Health Organization European Union) data reported that in all countries higher prevalence of overweight and obesity was demonstrated among older people (50 64 years) than in the younger age group (25 49 years). (Doak 2012 Obesity Rev). And yet there are relatively few weight-loss supplement products targeted to the senior demographic Davis noted. If you Google weight loss and seniors almost every product you can buy is for a dog This may be because of a concern about the impact of a weightloss program on muscle mass and bone mineral density. Most products for seniors focus on fixing existing issues providing supplemental nutrients and weight muscle gain. At the same time there is a great deal of solid science that shows that properly applied weight management has a number of extremely important benefits for seniors--both metabolic and functional. Davis noted that while most weightmanagement ingredients can be formulated as a supplement things like protein and fiber are more challenging to deliver this way. And seniors are often thought of as having a pill burden. So a weight-management product that featured these important constituents would www.niemagazine.com June 2015 Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS 1995 20 Y ars Celebratingellence e of Exc 2015 30 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com lonza for info about this advertiser Studying the ECS for Weight Loss A be best formulated as chews beverages or in functional foods. Utilizing Ingredients PLT Health Solutions markets three different ingredients in the weight management control space--Xanthigen Satiereal and Adipromin. Xanthigen supports healthy body weight through the synergistic effects of the natural compounds found in brown seaweed (Undaria pinnatifida) and pomegranate seed oil. Separately the bioactive compounds in these two ingredients target pathways involved in body weight regulation including adipocyte differentiation resting energy expenditure and lipid metabolism. Combined they support weight loss as demonstrated by clinical research. Satiereal derived from saffron induces a satiated feeling and encourages weight loss while eliminating frustration. This product has a unique mechanism that not only creates satiety but helps avoid snacking and compulsive eating behaviors which in turn may lead to reduction in weight and inches. Adipromin is a patent-pending clinically studied dietary ingredient composed of Moringa olifera Murraya koeingii and turmeric extracts that targets body composition by inhibiting adipose (fat) cell formation and enhancing the breakdown of fatty tissues. In a double-blind placebo-controlled human study Adipromin has been shown to promote weight loss reduce body mass index (BMI) and positively impact cholesterol triglycerides and serum adiponectin levels. HP Ingredients Eng said unique but powerful blends of raw materials make for compellingly effective weight-control ingredients (among other condition-specific applications). For example the company s CitruSlim is an innovative nutraceutical ingredient for healthy weight management. It is a proprietary blend of citrus flavanone-O-glycosides from bergamot and eurypeptides from Eurycoma longifolia that can promote an anabolic state reduce cortisol activate AMPK (AMP-activated protein kinase an enzyme) reduce triglycerides and help balance blood glucose levels. CitruSlim can promote healthy weight loss by 32 Nutrition Industry Executive ccording to Vladimir Badmaev MD PhD CEO American Medical Holdings in New York the emerging target mechanisms in dietary intervention against obesity is the endocannabinoid system (ECS) and its role of regulating metabolic functions satiety and energy homeostasis. Badmaev explained that the ECS which also regulates mood memory and pain sensation owes its name to Cannabis indicis since it mediates the psychoactive effects of cannabis. The ECS consists of circulating endocannabinoids derived from cell membrane n-6 fatty acids mainly arachidonic acid and the corresponding network of cannabinoid receptors 1 and 2 i.e. CB1 and CB2 scattered throughout the body especially in some of the oldest parts of the central nervous system (CNS) i.e. limbic system hypothalamus and medulla oblongata. Those brain structures command the most basic functions of the organism like motivation and drive compulsive behavior functions of the autonomic nervous system and endocrine system he said. The ECS is well recognized in the literature for its appetite-promoting or orexigenic effects utilized in cannabis medical applications in terminally ill and cachectic patients. The CB1 receptors are among the most important receptors in the central nervous system but are also found in metabolic organs such as the liver adipose tissue gut pancreas and skeletal muscle. The CB2 receptors are predominantly operating in the immune and haemopoietic systems but also present in the brain liver pancreas adipose tissue and cardiac muscle. A high-fat diet and obesity stimulate the ECS and up-regulate CB1 and B2 receptors by increasing synthesis of endocannabinoids activating CB1 and CB2 receptors. Arguably the stimulation of the endocannabinoid system starts with excess dietary fatty acids that gradually incapacitate hepatocytes (liver cells) and compromise one of the major functions of the liver oxidation and utilization of fat for energy Badmaev continued. A liver burdened with accumulated fat clinically is referred to as non-alcoholic fatty liver disease (NAFLD) and can be compared to a vacuum cleaner clogged with excess dirt. As a result of the clogged liver condition nutritional fat is deposited throughout the body leading to a characteristic central or abdominal obesity pattern. Typically people with NAFLD present several co-morbidities along with obesity e.g. adult-onset diabetes mellitus and metabolic syndrome. The increase in circulating endocannabinoids activation of CB1 and CB2 receptors and NAFLD positively and significantly correspond with increased body mass index waist circumference abdominal adiposity overweight and obesity pre-diabetes diabetes and metabolic syndrome. As the endocannabinoids are predominantly products derived from dietary fats the healthy diet consisting of eating whole unprocessed foods low in polyunsaturated n-6 and high in polyunsaturated n-3 fatty acids is--and should be considered to be--the first line of approach to down-regulate the overactive ECS and its metabolic consequences. Providing metabolic healthpromoting n-3 fatty acids and replacing n6 fatty acids also serves the purpose to gradually diminish synthesis and availability of endocannabinoids. The stress is on gradually diminish synthesis as opposed to the pharmacological approach of blocking of overactive ECS and CB receptors-- the latter mechanism being known to effectively reverse metabolic deterioration and obesity but also to negatively affect the mood (e.g. Rimonabant--the CB1 blocker by Sanofi-Aventis has been taken off the market due to mood side effects). The task of gradual nutritional intervention to normalize the ECS is accomplished by diminishing absorption of dietary fatty acids with the food supplement composition called FB3 Fusion Ingredient. This is a novel herbal composition of Coleus forskohlii Salacia reticulata and Sesamum indicum standardized for forskolin salacinol and sesamin respectively. The ingredient was shown in-vitro to inhibit pancreatic lipase with differing degrees and dynamics. The published study of the formula demonstrates that its botanicals synergistically prevent absorption of excess dietary fat (n-6 fatty acids are typically abundant in the Western diet). Hypothetically preventing absorption of excess dietary fat and n-6 fatty acids may gradually normalize the overactive endocannabinoid system thereby preventing obesity especially if this approach is combined with consuming an n-3 fatty acidsrich diet which competes with n-6 fatty acid absorption. Reference Badmaev et al Preclinical and clinical effects of Coleus forskohlii Salacia reticulata and Sesamum indicum modifying pancreatic lipase inhibition in vitro and reducing total body fat. Journal of Functional Foods May 2015 (44-51). www.niemagazine.com June 2015 Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com nutragenesis for info about this advertiser helping dieters maintain high energy levels during weight-loss programs prevent the body from storing fat and reduce appetite. Consumers vary in the types of delivery systems they prefer for weight-management products and so nutraceutical ingredients that can be utilized in multiple delivery systems have an advantage in today s market said Abedon. Icon Group ingredients may be used in dry applications such as capsules tablets and dry mix formulations. Because these ingredients are water-soluble they may also be incorporated into gummies and liquid supplements such as shots and RTD (ready-to-drink) beverages Abedon added. The majority of Icon ingredients are GRAS (generally recognized as safe)affirmed as well allowing them to be used in foods such as bars and also in beverages sporting a nutrition facts panel. The garcinia extract CitrinK sold by Sabinsa is another example which has caught lot of interest also with food formulators. CitrinK is included in several food products on the market such as in coffee tea and water. Since the taste profile is adequate for adding in such beverages without impacting taste CitrinK has become part of several liquid supplements and beverages. While interest in beverages continues the mainstay for this category continues to be capsules and tablets. Chien noted that liquids and beverages can still be a challenge for many marketers depending on the stability and solubility of each ingredient. HORN BlastMax is a new delivery form that stores active ingredients in a universal bottle cap. When in need you just place the HORN BlastMax cap on a water bottle blast the ingredients into the water with a push of a button and you will enjoy your drink instantly Chien explained. The HORN BlastMax technology can increase the shelf life of the actives. It can also reduce the use for fillers and excipients. Consumers are very concerned about the safety of weight-loss ingredients therefore suppliers are putting more effort in conducting safety as well as efficacy studies in establishing the science behind all the products. conducting safety as well as efficacy studies in establishing the science behind all the products. Both MealShape and CharCurb have double-blind placebocontrolled studies to back up the science said Pande and we are continuing to do more studies to support these innovative weight loss products. While providing healthy weight management benefits and also contributing to metabolic wellness in such areas as blood sugar balance cardiovascular health and healthy blood pressure Icon Group s Abedon noted that The industry s top finished goods marketers are looking for multifunctional ingredients to formulate with that provide benefits of this type which have been evaluated in human clinical trial research. Because of these requirements and also to substantiate structure function claims in the areas of weight management and metabolic wellness each Icon Group ingredient has been studied in one or more randomized double-blind placebo-controlled human clinical trials and have been shown to be significantly better than a placebo group for a large number of weight and metabolic-related health benefits. This type of research is considered the gold standard by the scientific community for demonstrating an ingredient s efficacy as well as safety. As ingredient suppliers Pande added we re constantly asked for clinicals using our branded ingredients tested for a variety of parameters. Interestingly the more reputable marketing companies are not just looking for significant weight loss they want to make sure the patients are healthy even after the clinical has ended. The double-blind placebo-controlled study is the gold standard of scientific work in the industry. Beyond this studies need to have enough subjects to be sufficiently powered said Davis. They need primary endpoints that are relevant. They shouldn t be designed around diseases and conducted with unhealthy subjects--because these results invite drugtype claims. The real answer is you re never done studying the ingredients you Celebrating 20 Years of Excellence 1995-2015 market. It s a form of support for your customers who are looking to build their own consumer brands and these brands need continued nurturing. We can always learn more about the impact of our ingredients in supporting good health. Things like mechanism of action dose response (can we do the same thing with less ) and corollary benefits are examples of why we might continue to study our ingredients once they have achieved the claim threshold. Ensuring efficacy and safety of these products requires human clinicals hands down said Skop. This info is frequently filtered to the retailers and their consumers and many consumers do not understand how to interpret the relevance of rat studies for their own benefit. While we industry-ites appreciate what animal studies can teach us if that s all there is consumers won t bite. Pande concluded that in terms of safety the age-old rule applies test test and test again. For efficacy clinicals are nice but ensure they are repeatable with scope to learn about possible side effects. NIE Extra Extra Visit www.niemagazine.com to read Dr. Badmaev s thoughts on vertical integration and sustainability for ingredient suppliers and supplement manufacturers as well as more information on weight-loss ingredients from Chemi Nutra. FORMOREINFORMATION Studies on Weight Consumers are very concerned about the safety of weight-loss ingredients therefore suppliers are putting more effort in 34 Nutrition Industry Executive American Medical Holdings www.adaptrin.com HORN Nutraceuticals (800) 442-4676 HP Ingredients (877) 437-2234 NutraGenesis TradeWorks Group Icon Group (802) 257-5345 Pharmachem Laboratories (800) 526-0609 PLT Health Solutions Inc. (973) 984-0900 Sabinsa (732) 777-1111 www.niemagazine.com June 2015 MarketingInnovations Successful products have science behind their marketing good marketers make sure to avoid common pitfalls. By Suzanne Shelton cience drives supplement sales. When the body of science confirming benefits reaches a certain point sales take off. Most recently curcumin has enjoyed overnight success. A decade ago it was omega-3s. Consumers want to know that there are established benefits to the products they spend money on and put in their bodies and that requires investing in science. Since this investment can be significant make sure that it s science you can actually use in your marketing. And in today s changing l.andscape your testing program falls under the umbrella of marketing your science. There s a conversation that takes place between industry consultants on a far too-regular basis usually at a trade show that goes like this I just met with a prospective client. Interesting products smart people--I liked them a lot and would love to work with them. Really Great Do they have science Um yeah but we can t use it. Oh too bad. I hate that. I know. Me too. They wasted a lot of money. So please save me from having this conversation at every trade show for the rest of my life and bring your science and marketing departments together before you fund any more studies. The goal is to develop a body of science that demonstrates safety and efficacy of your product within the regulatory limitations of our industry. Clinical studies can prove new concepts substantiate existing claims support regulatory compliance S and differentiate products. And it s imperative to do your own studies on your own products. Developing Science I ve enlisted a few of my smartest industry pals to help me give you some pointers. I asked my colleagues to weigh in on two questions 1) What is the one thing you most want companies to think about when marketing science 2) What is the most common mistake you see Our collective goal is to help companies develop science to market dietary supplements without making drug or disease claims. I d be happy to never again sit down with a company that proudly shows me their portfolio of studies on the cancer fighting properties of their material. I m so sorry to disappoint you but I won t get excited about something we can t use to help market your products. We encourage you to fund studies on your own products. There was for too long a tendency among some industry supply members to borrow science which is actually IP theft. Yes clinical studies are indeed intellectual property. It s an unethical and unsustainable practice. Marketing on someone else s science is misleading to consumers since rarely are branded ingredients in the dietary supplements industry identical and these days a consumer can track down any kind of information they want to right there in the store on their smartCelebrating 20 Years of Excellence 1995-2015 phones. IP theft discourages companies from investing in the studies if they view it as essentially financing competitor s marketing. Science begets innovation which helps drive industry growth. Undermining that process is shortsighted. Loren Israelsen president of the United Natural Products Alliance and one of the few people said to have been involved in writing DSHEA (Dietary Supplement Health and Education Act of 1994) who actually was has been cautioning against borrowing science for 20 years. When a company is sitting down to talk about marketing science the first thing Loren wants them to ask is Did we pay for this science Science is expensive and good research is very valuable he said. Using science on another product to support your own claims in not only improper it is not condoned by the FTC (Federal Trade Commission). The borrowing of research is a disservice to all concerned. The most common mistake Loren sees The same issue--using science unrelated to your specific product which includes citing such studies as the basis for substantiation when in fact it is not your research he said. Sabinsa Corporation may well be the poster child for having their science borrowed or as I like to call it stolen. Because they have so much intellectual property between their nearly 100 patents and a gazillion studies on their Nutrition Industry Executive 35 June 2015 www.niemagazine.com MarketingInnovations ingredients over the years it makes sense to hear from Shaheen Majeed Sabinsa s marketing director. Shaheen said the first thing he recommends companies think about when bringing science to their marketing is consistency. Too often I see companies that market their science in a sporadic form taking tidbits here and there some science that may not even be theirs he noted. The good companies know what bullet points to take away from their recent studies and which of those bullet points will drive consumer (or even B2B) awareness and understanding. Don t let it be lip service. Marketing science is an art. From advertisements to brochures and of course websites the science a company is marketing must be consistent and in line with what evidence can substantiate their product. The most common mistake Shaheen said he sees in marketing science is making unsubstantiated claims. We as consumers are going to believe what is written. If you caught our attention and then we search on the web and find out you ve misled or cannot support the claims you made well that just undermines all marketing he stressed. But this is a common mistake as is borrowing science for your marketing purposes. Companies like Sabinsa that fund clinicals get involved with universities host and promote education seminars around the world to disseminate information on their ingredients--to be then hacked by competitors copying the same marketing materials--is a real shame. Marketing science is an art. From advertisements to brochures and of course websites the science a company is marketing must be consistent and in line with what evidence can substantiate their product. -- Shaheen Majeed Marketing Director Sabinsa information in order to understand its complete meaning he said. In designing a study it is extremely important to ensure that an adequate protocol has been designed in terms of the methodology and adequacy of the number of subjects he added. When designing a study you should ensure that the results will be able to withstand scientific scrutiny. One potential issue in designing a study for use on a dietary supplement is that the subjects must generally be healthy and the study may not have disease endpoints. If a study on a food or dietary supplement is intended to demonstrate an intent to use the substance in the diagnosis cure mitigation treatment or prevention of disease then FDA (U.S. Food and Drug Administration) will require that an Investigational New Drug Application (NDI) be filed-- www.fda.gov downloads drugs guidancecomplianceregulatoryinformation gui dances ucm229175.pdf--and using such a study to support a structure function claim may cause FDA to take the position that the company actually intends to market the product for its drug benefits. This is also a potential concern for studies performed in countries where U.S. FDA NDI would not be an issue. Attorney View Steven Shapiro Esq. of noted industry regulatory attorneys Ullman Shapiro & Ullman has quite a few constructive points to make The science used to market a product must conform to the actual product being marketed he noted. For example a study with results on a 50 mg serving size may not support claims for a product that has 25 mg of the ingredient. If the study was based on three servings per day then the product should recommend three servings per day. Moreover any discussion of the science must not only be truthful it must also be non misleading and balanced. It is not enough just to provide the good results if there is anything negative or potentially confounding in the study that must be disclosed as well. Finally there must be enough information provided to ensure that a person reviewing the information will be able to comprehend the results. For example a chart taken from a study may be insufficient without adequate 36 Nutrition Industry Executive reporter Anahad O Connor the science of product testing is now front and center so it s important to be transparent about that science too. Smart marketers have already included information on their testing programs in their marketing. This helps protect against regulatory action class action lawsuits and reinforces customer trust. Elan Sudberg CEO of Alkemist Labs has come out very strongly in favor of taking quality out of the closet. It s always been important to clearly and simply inform a customer as to why they need your product. Now it s smart to reassure them through full transparency of the high level of quality behind the product. Today that is just as important as the science behind the product s benefits. Market them equally and I believe confidence will rise. The most common mistake made in product testing that Alkemist Labs sees will sound familiar employing the wrong test methods. It wasn t started by the NYAG but new on the scene is improperly utilized DNA barcoding and FTIR analysis. The first can t determine plant part quantity or quality and the second is a disservice unless utilized with a robust and verified library. There has long been the practice of companies saying they test their ingredients or finished products but they do not provide details. Given the volume of media coverage asserting that many dietary supplements are adulterated your marketing must encompass how you test who does it and why the chosen methods are the right ones. A handful of companies are now revealing test results on their products and I believe we will see more of that. The past few months have set the industry up for some profound changes and the smart companies are going to be proactive and get their science and marketing ducks in order. Be one of them. 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. www.niemagazine.com June 2015 Clear Vision Finally one must also be concerned with the FTC s review of dietary supplement advertising. Among other things FTC would be concerned if appropriate disclaimers were not used when necessary. If the company was involved in running or funding the study that must be clearly indicated as FTC views such information as material to consumers considering the results of the study. In the past when we ve talked about science in the context of dietary supplements it has referred to either safety data or health benefits. But thanks to the New York attorney general (NYAG) and his new best friend New York Times Celebrating 20 Years of Excellence 1995-2015 Nutraceuticals Curcumin Power As curcumin becomes more popular ingredient suppliers and manufacturers are making quality and research priorities. By Shari Barbanel chemical compound found in turmeric (Curcuma longa) curcumin has been utilized for thousands of years as a spice in food and is known as a principal healing agent in ayurveda. Further curcumin s powerful antioxidant factor and anti-inflammatory effects have made it a rising ingredient on the market. According to Pete Maletto president and senior scientist for New Jersey-based PTM Food Consulting a company that has formulated a number of products with curcumin the market for this active ingredient continues to grow as more scientific data continues to build about its benefits. Maletto noted that turmeric is so promising there have been more than 3 100 medical reports on animals and humans that show amazing promise in preventative medicine and has been found to have the following effects Antioxidant scavenges free radicals and inhibits lipid peroxide formation especially in the liver Antitumoral inhibits the formation of tumors including cancerous ones Antimicrobial inhibits the action of microorganisms such as bacteria Antihepatotoxic has a protective effect on the liver Antihyperlipidemic inhibits the excessive buildup of lipids in the blood Anti-inflammatory reduces inflammation Anti-amyloid destroys the deadly A brain plaque beta amyloid. Curcumin has been widely researched for its anti-inflammatory mechanisms. As we know inflammation is the underlying cause of many diseases and ailments added New Jersey-based DolCas Biotech s Lauren Goldberg-Samot RD. Curcumin s chemical properties allow it to impact the body in such a way that gets to the root cause of these issues. For example there is research that indicates curcumin not only affects neurotransmitters in the brain but can also disaggregate beta-amyloid plaques that cause cognitive issues. A Wide Range of Benefits Because of its anti-inflammatory properties curcumin is beneficial to a number of the body s systems. Curcumin now has a place in supplements for joint health inflammation sports nutrition liver support healthy cholesterol support general health and wellness and as an antioxidant explained Anurag Pande PhD vice president of scientific affairs for New Jersey-based Sabinsa Corporation. There have been some interesting recent developments showing positive effects beyond curcumin s joint health benefits such as on lipid levels in obese and metabolic syndrome subjects. According to Pande while the joint health supplement category was once limited to glucosamine and chondroitin supplements curcumin can Celebrating 20 Years of Excellence 1995-2015 help reduce inflammation in the joints helping to improve joint function and mobility and reduce stiffness. Additionally curcumin can be used in place of NSAID drugs because it is unlikely to cause side effects. Curcumin is an excellent free radical scavenger which helps in maintaining the redox balance in the body and reduces oxidative stress Pande said. While curcumin is well known for benefiting the joints research has shown that it is being utilized for healthy aging and cognition as well. And with approximately 10 000 Baby Boomers reaching retirement age each day the demand for ingredients and products that will help them age gracefully is in high demand. Healthy aging continues to be a focus for consumers with brain aging gaining in importance said Jennifer Atkinson marketing coordinator for Verdure Sciences in Indiana. We see a demand for consumers to find supplements with the same clinical dose of supporting studies in addition to the ability to want to learn more about ingredients and the differences among different curcumins. DolCas Biotech s Goldberg-Samot agreed that many curcumin supplements are being geared toward healthy aging and cognitive health. The brain controls so much of the body that providing this type of support can help improve over all well being she explained. We have conNutrition Industry Executive 37 June 2015 www.niemagazine.com Nutraceuticals centrated our research on common diagnosed diseases arthritis cancer and depression which can be brought on by stressful lifestyle habits and an aging population. Cardiovascular health is another promising area for curcumin. According to the University of Maryland Medical Center curcumin has been found to lower total cholesterol and LDL cholesterol levels and to prevent the blood from clotting. With increase in cardiovascular problems arising from dietary habits with high lipid levels and or obesity the use of the curcumin in management of healthy lipid levels has been of increasingly great interest Pande noted. Several mechanisms related to its lipid management activity have been cited such as stimulating biliary excretion of lipids down regulating the de novo lipid biosynthesis etc. Clinical studies on curcumin in obese subjects as well as subjects with metabolic syndrome have shown its potential in management of lipid levels. Issues and Concerns While curcumin does offer support to a number of the body s systems there can be issues such as quality bioavailability and delivery that ingredients suppliers and manufacturers face head-on. Consumers are concerned about a variety of issues concerning curcumin. They are concerned about pesticides where the turmeric is grown metal content additives and solvent use said Goldberg-Samot. They are also concerned about adulteration and use of synthetic compounds. DolCas Biotech s curcumin BCM95 is grown in India with minimal pesticide use and organic growing practices. BCM95 is 100 percent turmeric derived with no additives or fillers. Manufacturers receive our documentation and know that we use equipment such as ICP-MS to test for heavy metals Goldberg-Samot said. We only use class 3 solvents (the safest category) and use GC Headspace to test for residual solvents to ensure each batch is compliant with USP (U.S. Pharmacopeia) standard ensuring a safe product. Formulation difficulties are another concern. According to Sabinsa s Pande curcumin is not easy to formulate for a number of reasons one of which is the staining nature of the ingredient. Understanding the need of the market Sabinsa introduced various grades of Curcumin C3 Complex such as HBD (high bulk density) and DC (directly compressible) versions. The company also recently introduced the water-soluble version uC3 CLEAR which supplies more curcumin to the body than ever in water-soluble form and can be formulated into a liquid dietary supplement without any unsavory appearance. There has been a lot of demand from consumers for curcumin in beverage grade form however owing to its poor solubility and staining nature it has been quite a challenge to provide beveragegrade curcumin Pande explained. Using the GRAS (generally recognized as safe) ingredient Curcumin C3 Complex scientists at Sabinsa formulated a beverage grade form of curcuminoids under the brand name of uC3 CLEAR which can provide them for beverages with stable formulation and good taste without compromising the quantity or quality. Verdure s Longvida Optimized www.niemagazine.com June 2015 Go to www.niemagazine.com verdure for info about this advertiser 38 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 Go to www.niemagazine.com dolcas for info about this advertiser Nutraceuticals Curcumin was developed by neuroscientists approximately 10 years ago to answer the bioavailability issues associated with 95 percent curcumin to pass the blood-brain barrier and assist in healthy brain aging. According to Atkinson Longvida s SLCP (solid lipid curcumin particle) promotes absorption by lymphatic uptake of free curcumin on first pass metabolism which allows Longvida to be better absorbed maintain a higher half-life and is supported by several clinicals which ensures formulators of their choice. There is a lot of chatter about bioavailability but our foundation is based on bioavailability so there is not a need for us to develop a new curcumin product Atkinson said. claims that producers are making to ensure that the claims are backed by solid research (pre-clinical and clinical) said Atkinson. They need to ensure traceability of ingredients are equally important to the research and safety data. Sabinsa s Pande agreed noting that it is important for manufacturers to understand the needs of the market and provide products which are not only safe and efficacious but also affordable for common person. Sabinsa has been supporting clinical studies from independent researchers and universities by providing them quality ingredients and formulations on curcuminoids and thus enhancing the knowledge base of curcuminoids for whole dietary supplement industry. These efforts have resulted in the topnotch research on curcuminoids and results published in international journals bringing the benefits of curcumin to light. And while research is a vital part of gaining trust and educating the consumer it has to be authentic. Verdure s Atkinson said that the market is often tainted with companies trying to borrow science and technology from other companies which can confuse consumers. There are many more studies continuing which is great however many companies do not have the understanding or desire to truthfully compare the data on the scientific merit she explained. In addition many consumer media places continue to write about the health benefits of turmeric from a generic standpoint however with optimized curcumins available it is not apples to apples and we need to better educate. While the road may not be an easy one the future seems to be bright for curcumin. Today the curcumin market is tipping toward becoming the next omega-3 of the dietary supplement industry with loads of new evidence pointing toward health benefits of this versatile natural compound Pande concluded. NIE Research is Key These days research is incredibly important for both an ingredient and finished product to be successful. People want to know that the product they are purchasing is not only safe but does what it claims to. Manufacturers need to be sure to do their homework when it comes to FORMOREINFORMATION DolCas Biotech (973) 347-1958 PTM Food Consulting (888) 736-6339 Sabinsa Corporation (732) 777-1111 Verdue Sciences (317) 776-3600 (Continued from page 26) been around since 1938 however FSMA will change manufacturing requirements for ingredient suppliers and the like. Ultimately increased compliance to regulations is a good thing for the consumers but it also creates a level playing fields which is good for the long term sustainability of the industry. Soltero The FDA has a history of expanding the sphere of influence for GMPs. They started with GMPs pharmaceuticals 40 years ago then expanded to medical devices and then to dietary supplements. It is likely that they will find more areas where making 40 Nutrition Industry Executive products using GMPs will be useful for protecting public health. Thomas The FSMA makes significant amendments to the FDCA. It requires FDA to implement a sweeping array of new regulations and enforcement policies intended to better ensure the safety of food products marketed in the U.S. including dietary supplements. Dietary supplement companies must understand the key elements of FSMA that may impact their operations and in particular the requirements around imported dietary supplement ingredients and products. Foreign suppliers will be required to comply with U.S. regulations for dietary supplements and the responsibility will be on the importing company to verify and demonstrate this compliance. Because of our global reach NSF International has been very active in helping facilities outside the U.S. demonstrate compliance with U.S. GMPs for dietary supplements through Celebrating 20 Years of Excellence 1995-2015 the NSF International GMP Facility Registration program. More than 400 facilities have earned NSF International GMP Facility Registration and of those over 100 are outside the U.S. including facilities in Austria Belgium Bolivia Canada China Ecuador India Indonesia Japan Korea Malaysia Mexico Netherlands Norway Russia Spain Switzerland and Taiwan. Fabricant I think it just adds that ingredient suppliers will have to submit to those preventive control rules which I think many of them already do. But it is good for them to have a system they can point to and say Hey look this is how we do business. It gives you an even playing field to start from. I think that that s really the most encouraging thing. NIE Extra Extra Visit www.niemagazine.com to read the rest of the roundtable discussion. www.niemagazine.com June 2015 FunctionalFoods 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 Whether animal or plant consumers capsules protein is driving innovative formulations. appetite for to a By Cristina Goodwin minimum 2015 Market Update from Batory Nutra (Des Plaines IL) reported that in 2015 and beyond natural product formulators understand that a consumer s appetite for protein doesn t stop at the supplement store and two thirds of people say they aim to consume moderate or high amounts of protein according to Datamonitor. The Institute of Food s technologists found that in 2012 40 percent of the best-selling new better-for-you foods and beverages carried a high-protein claim. In addition according to the Wall Street Journal Nielsen research found that U.S. sales of packaged foods with protein-related claims on their labels rose to 7.5 billion in 2014 over 50 percent more compared to the same period four years earlier. According to Hartley Pond senior vice president of technical sales for Illinoisbased FutureCeuticals protein is the primary ingredient in functional foods today ... from meal replacements to green drink mixes from sports nutrition to weight loss formulations. Proteins have become the centerpiece for many formulations he said and consumers are making purchasing decisions based on the amount and the type of protein contained in a product. Gil Bakal managing director for New Jersey-based A&B Ingredients reported June 2015 www.niemagazine.com Protein Demand A that protein-based products reach three distinct market segments professional -- Marci van der Muelen National sports individuals active people conSales Manager Nordic Naturals cerned about their lifestyle and mass market health conscious. The professional sports people know very well their needs and how to match them with the right protein or even protein mix. They analyze in detail the amino acid profiles of different proteins and a trainer or even a doctor often advises them. The active lifestyle group knows the advantages of protein for their muscle health and or their protein diet but they are not as focused on the details. And finally the general consumer understands that proteins are good for their general health but don t consume them consciously although they do pay attention to product claims and are in favor of overall healthier products. Animal or Vegetable The first choice food manufacturers need to make is whether to use animal (e.g. whey protein and caseinate or other) or vegetable protein (e.g. rice oat soy and or pea protein) Bakal said. Make no mistake however protein devotees are not necessarily consuming more meat according to Batory Nutra. In fact Datamonitor found that 41 percent of people globally eat a low-meat diet while 13 percent eat meat-free. Further Mintel s research reveals that Celebrating 20 Years of Excellence 1995-2015 demand for high-protein products is also coming from consumers who are avoiding animal sources of protein for either health environmental or ethical reasons. Products launched in the U.S. with both a high protein and vegan claim have shown a steady increase since 2008 posting 54 percent growth in the past five years (to 2012). One does not need to eat animal products to get all the protein they need in their diet. Vegetarians are able to get enough essential amino acids by eating a variety of plant proteins. Therefore meat is no longer the be-all end-all. We believe the next protein trend will be focused on whole-food proteins from vegetables and legumes which are naturally rich in protein and deliver intact levels of micro and macronutrients Pond said. Brown rice hemp and pea proteins have become very popular in the last decade he continued. In addition protein-enhancements have led to even newer ingredients including pulses (not pea) chia hemp algal and insects. In fact for the Global Food Forums Inc. s first Protein Trends & Technologies R&D Survey protein-knowledgeable food technologists were asked Do you see the use of the following protein types (as a powdered ingredient within formulated products) as decreasing increasing or remaining the same in the U.S. in the Nutrition Industry Executive 41 FunctionalFoods next two years The 78 respondents were given a list of 17 ingredients to choose from. The results showed that pea protein was identified by 89 percent of participants to increase in the next two years. Pulses (not pea) chia hemp rice and algal proteins followed with 80 74 69 67 and 58 percent of respondents saying they would increase in use. However the survey also showed that 36 percent and 35 percent of the proteinknowledgeable food technologists predicted an increase in the use for proteins from soy that is most known and trending and insects which is said to be a highly sustainable source of protein. With these results and similar studies suppliers see a growing market and are jumping at the opportunity. Spotting the shift in the consumer mindset to whole foods FutureCeuticals responded by creating the company s Terasante line of organic whole food plant proteins. We standardize these blends guaranteed at a minimum 20 percent plant protein in the whole food matrix so obviously the intent is to not compete directly with mega-dose extracts Pond stated. For the high-dose extracts instead of trying to out run them FutureCeuticals introduced QuinoaTrim and AncienTrim to dramatically improve the flavor and texture of high-dose brown rice and pea protein formulas. For Batory Nutra finding the right protein source is just the start its proteins offer the market a world of flavor and application variety. We offer top-of-line protein sources like soy dairy and albumin as well as choices like fava bean pea wheat ancient grains and lentil. Hemp and rice will arrive later this year the company announced. In addition consider the vegan market once limited to soy soy and more soy. A&B Ingredients noted the health benefits its protein products provide to consumers. Proteins can be effective for people suffering from sarcopenia (loss of muscle mass and strength) or osteoporosis (loss of bone mass) ... Our Pisane pea protein contains three important amino acids for this specific target group Bakal said. Pisane is rich in leucine which is essential for bone health as well as lysine and arginine two amino acids important for muscle synthesis he continued. According to Loretta Martin associate director of research and development for Idaho-based Glanbia Nutritionals Ingredient Technologies another target group for plantbased proteins are those who suffer from food allergies. Consumers that need to avoid soy or dairy allergens seek vegetable sources such as pea or rice proteins she said. Beefing Up A benefit of animal-based proteins is that they are much more similar to human proteins. New York-based T. Colin Campbell Center for Nutrition Studies found that substrate amino acids derived from animal based proteins are more readily available for our own protein synthesizing reactions which allows Go to www.niemagazine.com futureceuticals 42 Nutrition Industry Executive Go to www.niemagazine.com americanlaboratories Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com June 2015 them to operate at full tilt. Plant proteins are somewhat compromised by their limitation of one or more amino acids. Amanda Brown sales representative for Nebraska-based American Laboratories Inc. said that beef protein is becoming more widely used because of the digestible protein content in the material as well as being a material with no associated allergens. Knowing a material does not have allergens associated with it allows it to be marketed to a larger group of people she explained. She said she sees the market for animalbased proteins coming back because of the high protein percentage in the material. Humans have been eating meat as a source of protein for thou- sands of years. This is still the main source of protein in an average diet she said. Beef protein is also soluble in water so it is great for protein shakes and bars Brown added. The flavor can be easily masked to cover the neutral beef taste. Beef protein is a great addition to these products due to its mild flavor profile its highly soluble protein content and because it is how people have been getting their protein for years. In conclusion Pond noted that consumers are focusing on both the protein content and the form of protein as primary criteria for determining to purchase one product over another. This is driving formulators to provide a wide range of options from the convenience of great tasting ready to drink beverages to elite sports nutrition products to the health food and organic market sector Pond added. The protein market is vast and evolving and consumer demand is driving innovative new formulations at a rapid pace. NIE FORMOREINFORMATION American Laboratories Inc. (402) 339-2494 A&B Ingredients (973) 227-1390 Batory Nutra (800) 451-9067 FutureCeuticals (815) 507-1400 Glanbia Nutritionals Ingredient Technologies (800) 735-8137 Equipment&Packaging FastPack Delaware based Bilcare Research Inc. has introduced FastPack a process for determining the optimum blister film barrier properties for the packaging of products and includes Bilcare Optima service. FastPack determines a product s susceptibility to environmental factors and helps packaging engineers and formulators overcome the time and resource crunch they face when attempting to achieve successful stability studies. The new delivery system was devised from sensitivity profiling conducted on hundreds of pharmaceutical formulations over the past 15 years. FastPack advantages include avoiding analytical and material cost of multiple packaging stability studies and reducing the machine s downtime due to improper settings among others. For more information call (302) 416-0974 or visit www.bilcaresolutions. Advertiser Index Alkemist Labs American Laboratories Inc. Chemi Nutra DolCas Biotech LLC FutureCeuticals Healthco Herbally Yours Jiaherb Inc. JT Naturals LLC Lonza Inc. Nutragenesis Nutritional Engineering Inc. Pinnacle Labs International Inc. PLT Health Solutions Inc. Sabinsa Corporation Soma Labs Inc. United States Pharmaceopea Verdure Sciences 25 42 29 39 42 1 15 5 10 31 33 7 21 3 C2 8 C4 38 (714) 754-4372 (402) 339-2494 (866) 907-0400 (973) 347-1958 (888) 452-6853 (800) 477-3949 (480) 892-8220 (888) 542-4372 (417) 553-0977 (800) 365-8324 (802) 257-5345 (760) 599-5200 (800) 600-4634 (973) 984-0900 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (301) 230-6361 (317) 776-3600 www.niemagazine.com alkemistlabs www.niemagazine.com americanlaboratories www.niemagazine.com cheminutra www.niemagazine.com dolcas www.niemagazine.com futureceuticals www.niemagazine.com healthco www.niemagazine.com herballyyours www.niemagazine.com jiaherb www.niemagazine.com jtnaturals www.niemagazine.com lonza www.niemagazine.com nutragenesis www.niemagazine.com nutritional www.niemagazine.com pinnaclelabs www.niemagazine.com plt www.niemagazine.com sabinsa www.niemagazine.com somalabs www.niemagazine.com usp www.niemagazine.com verdure Industry Events July 20-23 NBJ Summit St. Regis Resort Dana Point CA (866) 458-4935 www.nbjsummit.com 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 June 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 43 SupplieroftheMonth Horphag Research (USA) S bastien Bornet Vice President 5 Marine View Plaza Ste. 403 Hoboken NJ 07030 Phone (201) 459-0300 Horphag Research (USA) Inc. is the exclusive North American supplier of Global Sales and Pycnogenol (pic-noj-en-all) French marMarketing itime pine bark extract. Based in Hoboken NJ Horphag Research (USA) has the exclusive rights to market and sell Pycnogenol and works with hundreds of companies to help them develop innovative and effective Pycnogenol product formulas. The company mission remains deeply rooted in a commitment to scientific research surrounding high-quality nutritional ingredients and this is reflected in the quality of products offered to customers. Director of Product S bastien Bornet is the vice president of global sales and marketing at Horphag Research. He is in charge of providing support and Development expertise to customers worldwide and developing sales and marketing strategies and new business opportunities. Carolina Burki-Sozzi director of product development for Horphag Research has more than 20 years of experience in scientific research and the pharmaceuticals industry. In this role she leads the development of innovative products corporate patenting of new products and centralization of corporate clinical trials research for Horphag s flagship ingredient Pycnogenol. Her areas of expertise include the identification of new products management of scientific intelligence and monitoring of clinical trials. Carolina Burki-Sozzi ducting research on the various benefits of Pycnogenol. How important is research to the company Bornet Scientific research has been a priority for us for the last 40 years and has allowed us to truly define Pycnogenol s health benefits and how that translates to real world results for our customers . In our industry research is as important as marketing in protecting brands and gaining third-party recognition of product benefits. The science behind the product makes it more effective to illustrate the deliverables to consumers as they search through store shelves looking for products that are worthy of their investment and daily routine. This level of credibility is a key factor in why Horphag Research has attained a pioneer role in research and development on its trademarked extract Pycnogenol--a standardized natural extract from French maritime pine bark. Through decades of independent research--mostly peer-reviewed and published--Pycnogenol is one of the most well researched ingredients available on the market with over 130 clinical studies on the extract on 10 000 patients. Its reputation of being the gold standard ingredient in the industry is the result of years of dedication to research and ultimately consumers satisfaction. 44 Nutrition Industry Executive NIE Horphag is continuously con- NIE Pycnogenol supports many striction of arteries and blood clotting. aspects of health. What is it about Pycnogenol pine bark extract that makes it beneficial for a number of the body s systems Burki-Sozzi The quality of Pycnogenol is unique in itself--its composition is made constant due to the fact that the bark is not subject to seasonal variations unlike other plants which makes it an ideal botanical source. The Pycnogenol extraction process complies with the highest quality standards. The manufacturing plant is GMP (good manufacturing practice) compliant and the production process does not include any toxic solvent. Pycnogenol has a unique blend of active compounds that has four basic properties--it s a powerful antioxidant acts as a natural anti-inflammatory helps generate collagen and hyaluronic acid and aids in the production of endothelial nitric oxide which helps to improve blood flow. These components work synergistically and provide multiple health benefits which has been reflected in our research and clinical studies. In addition Pycnogenol helps to mop up aggressive radicals before they cause damage by oxidative stress. Its super-antioxidant capabilities help boosts the immune system and it strengthens blood vessel walls and capillaries. It also supports a better circulation by preventing stress-induced con- today and where do you see it headed in the future Bornet As the nutritional supplement industry expands it is imperative that manufacturers continue to invest in further research and development of products to ensure consumers can be confident in their wellness investment. This kind of research shows effectiveness real-life benefits and refutes studies that seek attention by pushing consumers away from the assets that can help contribute to their greater health and wellness. At Horphag Research such investment in research is why Pycnogenol is one of the most well-researched ingredients available on the market and one of the top branded ingredients being searched by consumers. While this is a reflection of our increased brand awareness we recognize there is tremendous opportunity and room for worldwide growth. Our job today is to continue to propel Pycnogenol forward to help people and support sales growth with our business partners while keeping the brand true to its roots. NIE Where is the Pycnogenol brand Extra Extra Visit www.niemagazine.com to read the rest of the interview. www.niemagazine.com June 2015 Celebrating 20 Years of Excellence 1995-2015 THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE 1995 20 Y ars Celebratingellence e of Exc 2015 NIE s Upcoming 2015 Issue Highlights July August September October Nov. 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