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Description: In This Issue: Sport Stars, Washington & The Natural Industry, Stress & Sleep, and Marine Ingredients

SO VIS UR IT O em CE UR ag B az OO ON ine K L .co T IN A VRM Media Publication m OD E so ur AY ce ww w. ni bo ok www.niemagazine.com October 2016 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 21 NO. 8 OCTOBER2016 F E A T U R E S 22 Taming the Beast The natural products industry has different views on how to tackle the FDA and the challenges that confront us in 2017. 28 Sport Stars Sports nutrition ingredients reflect athletes goals to build muscle reduce catabolism and enhance recovery. 22 A L S O I N S I D E 32 Creating the Perfect Chill Pill Americans are more stressed and sleep-deprived than ever here s how to help provide some relief. C O L U M N S 6 14 19 20 21 43 46 47 47 Industry News Ingredient News AHPA Update Association News Science Update Nutraceuticals Equipment & Packaging Advertiser Index Industry Events Supplier of the Month 4 First Word 36 Research & Development 38 Food Technology 40 Financial Concepts 36 48 FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.niemagazine.com Copyright 2016. Nutrition Industry Executive (ISSN 2331-2602) Volume 21 Number 8 October 2016. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 4329288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Periodicals Postage Paid at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com. Back Issues & Single Copies For order information contact (732) 432-9600 or info niemagazine.com. March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive www.niemagazine.com October 2016 Go to www.niemagazine.com plt for info about this advertiser FirstWord Valuing the Oceans ccording to a World Wildlife Fund report on ocean economy estimations of the financial worth of oceans is about 24 trillion. This high value of the ocean includes the direct outputs from the ocean like seafood its contribution as an essential shipping medium the worth of its vast coastline and also its capacity of absorbing nearly 30 percent of our total carbon emissions. This appraisal is only based on current value of marketable services and goods it does not consider the intangible worth of oceans such as biodiversity water filtration by wetlands and mangroves as well as climate regulation. For the natural industry the ocean is a vast and in many ways unexplored inventory of future possibilities in the area of nutraceutical cosmeceutical cosmetic and personal care to name just a few said Jim Titus CEO Newgen Biotech USA in Texas. He responded to questions I asked for this month s Nutraceuticals column on marine ingredients (see page 43). Though oceans provide a treasure trove of nutritional ingredient possibilities sustainability continues to be an issue and improvements are needed to allow the industry to move forward in a positive way said Becky Wright marketing and communications director--Superba with Washington-based Aker BioMarine Antarctic US. Wright noted the Sustainable Fisheries Partnership (SFP) recently released its annual sustainability overview of reduction fisheries (i.e. process fish krill further for meal or oil) and for the second year in a row Aker BioMarine s krill fishery was the only one to receive an A rating. SFP analyzed data from 20 stocks from 13 species and two main groups (fish and crustaceans) rated according to the sustainability assessment presented on FishSource (www.fishsource.com). The fisheries were A ranked into four sustainability categories A--very well-managed fisheries B1--reasonably well-managed fisheries B2--reasonably managed fisheries and C--poorly managed fisheries. Although Aker BioMarine received a very good rating improvements to the overall marine omega-3 segment are needed. David O Leary commercial manager of Marigot Ltd. the creators of Aquamin (derived from seaweed) in County Cork Ireland said sustainability is a key area for any company that is specializing in marine derived products. Food producers and end consumers need to have confidence about product origin and responsible sourcing renewability and accountable environmental practices. O Leary noted that Marigot Ltd. has undertaken extensive sustainability programs with external stakeholders to ensure that all of the steps from ocean floor to finished mineral ingredient are handled with a mindful approach to the environment. By working closely with experts in the field of marine geology and botanical experts we have been able to develop a strong program for harvesting our seaweed minerals. This is independently monitored to ensure that all components are clean safe and of the highest quality but also ensure that the plant in its early stages of life is allowed to continue growing without interruption or to the surrounding ecosystems. Only through open discussion and direct engagement with relevant experts in the field noted O Leary can it be possible to ensure that products of the highest quality with strong sustainability credentials are produced with the confidence of supporting traceability systems for both customers and consumers. This is support sorely needed. As for the ocean s fish Wright said the SFP s annual sustainability overview shows that less than 60 percent of the volume comes from reasonably well-managed fisheries. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Gary Pfaff Sales Manager GaryP VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com Managing Editor Shari Barbanel ShariB VRMmedia.com Associate Editor Nicholas Saraceno NicoS VRMmedia.com Contributing Writers Haley Chitty James Gormley Lisa Schofield Chuck Slotkin Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Rosie Brodsky Rosie StarkServices.com A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and Fitness Trainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com Back Issues See the Table of Contents page for price and ordering information. Connect With Us www.twitter.com www.facebook.com www.linkedin.com www.instagram.com www.pinterest.com vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive www.niemagazine.com October 2016 Go to www.niemagazine.com jiaherb for info about this advertiser IndustryNews NPA Keeps Pressure on Puerto Rico Over Arbitrary New Fees he Natural Products Association (NPA) recently urged the Congressional Task Force on Economic Growth in Puerto Rico to highlight the damaging effects of Administrative Order 346 which established barriers to retailers and distributors of natural products in Puerto Rico through new fees and unnecessary regulations making it difficult for products to reach consumers. The Task Force is scheduled to issue its report on Puerto Rico s economic status and recommendations by December 31 2016. NPA noted it was the only trade association in the industry that worked directly with Congress during the pas- T sage of PROMESA (Puerto Rico Oversight Management and Economic Stability Act) ensuring the industry would have an opportunity to voice its concerns about the order and its negative impact on consumers of dietary supplements and natural products. This is nothing more than a potentially illegal money grab by Puerto Rico that will be passed onto consumers in the form of a hidden tax said Daniel Fabricant PhD CEO and executive director of NPA. It was virtually imposed in the middle of the night and was not subject to public review comment or official rulemaking procedures. Not only is it significantly burdensome to businesses consumers and the dietary supplement industry at large it will not alleviate Puerto Rico s budgetary situation added Fabricant. We are hopeful the Task Force will take NPA s comments into consideration and help raise awareness of the damage this wrongheaded policy will have on Puerto Rico. For more information visit www.npainfo.org. FDA Considering Vinpocetine Ineligible as a Dietary Ingredient he U.S. Food and Drug Administration (FDA) recently released a Federal Register (FR) notice (Docket No FDA-2016-N2523) with major implications for acknowledged new dietary ingredient (NDI) notifications. FDA appears to be attempting to shift the burden of demonstrating reasonable expectation of safety for vinpocetine on the industry by stating that it can t qualify as a dietary ingredient. Vinpocetine has five acknowledgements from the FDA in their NDI Database. This means that vinpocetine has already undergone intense scrutiny five times over by the leading authority on food safety in the US. Each time FDA responded with a letter stating that they had no concerns over the ingredient or the data provided in their safety dossiers. From the FR notice FDA does not appear to have any clear safety signal based on SAERs or other means. However the agency is looking to remove the ingredient via a rendering that they have been silent on for approximately 20 years regarding the ingredient s status. This notice comes on the heels of the recently released redrafted NDI guidance. Additionally on October 6 2015 Senator Claire McCaskill (DMO) the ranking member of the US Senate Special Committee on Aging T called for the FDA to suspend sales of supplements containing vinpocetine pending an investigation. McCaskill sent letters to 10 retailers to ask them to voluntarily remove it from their shelves despite no rendering from the FDA that it was not a legitimate dietary ingredient. This is a form of double jeopardy said Dr. Daniel Fabricant Natural Products Association s (NPA) CEO and executive director. To go through the regulatory gate a second time is akin to finishing a round of golf and winning but then having to play a second round while someone charges at you while you hit each golf shot. This sets a very bad precedent and is no environment to conduct business in. The FR notice was also absent of any economic impact analysis. There is an economic impact here as firms have been lawfully marketing this ingredient since it was successfully notified in the 90s. Consistent with the statute is the agency planning to conduct an economic impact analysis The original economic impact analysis on 21 CFR 190.6 never presented a situation where a properly notified ingredient considered lawful for a period of time could be removed instantaneously approximately 20-years ex post facto said Fabricant. It would appear that removal of this ingredient would bear little incremental public health effect (per the notice) but a significant incremental cost associated with the change in regulatory status which is by law generally considered in such actions and how to provide more or other cost-effective alternatives or enforcement discretion. No discussion on enforcement discretion is present either. Why Is this what responsible industry can expect in the future with other new dietary ingredients NPA will be submitting comments and will release those when available. FDA will be accepting comments from the public until November 7 2016. In addition to engaging government on the matter NPA will be reviewing the FDA s publication reaching out to our members to assess its impact on the dietary supplement industry. For more information visit www.npainfo.org. 6 Nutrition Industry Executive www.niemagazine.com October 2016 Go to www.niemagazine.com gencor for info about this advertiser IndustryNews Britain s Informa to Boost U.S. Presence with Penton Deal ritish business information group Informa Plc (INF.L) said on September 15 it had agreed to buy U.S.-based information services company Penton for 1.56 billion to expand in the United States and grow its global exhibitions business. The transaction is set to be funded by a combination of new debt and equity including a fully underwritten rights issue to raise 949.2 million. Informa said it will buy Penton from private equity firms MidOcean Partners and Wasserstein & Co. which will receive 1.11 billion pounds in cash ( 1.47 billion) and 76 million pounds ( 100.9 million) in Informa equity. The deal will help Informa generate nearly half its annual pro-forma revenues from the United States and make its global exhibitions division one of the three largest in the country with more than 70 U.S. shows annually. We want to grow in exhibitions and trade shows business intelligence and information services. We see the natural next rotation step for growth as being the United States CEO Stephen Carter told Reuters. Penton owns brands in aviation agriculture natural food products infrastructure and technology media and telecommunications sectors Carter added. Informa which also publishes real-time news research market data B and academic books bought U.S. trade show operator Hanley Wood Exhibitions in 2014. Informa s global exhibitions business runs 170 trade and consumer events annually including the China Beauty Expo World of Concrete and Arab Health. The division accounted for about 22 percent of revenue in 2015. We see the deal as a major positive for Informa being earnings accretive and increasing its exposure to geographically and divisionally attractive areas Liberum analysts said. The deal expected to close in November would add to the company s earnings in the first full financial year since completion. Liberum expects the addition of Penton to add 7-8 percent to Informa s earnings in 2018. Informa s shares closed up 4.9 percent at 709.7 pence on the London Stock Exchange. Analysts also expect attention to switch to other potential events merger and acquisition targets including UBM Plc (UBM.L) and Tarsus Group Plc (TRS.L). For the private equity firms that owned Penton for a decade the sale represented a positive outcome six years after Penton had filed for bankruptcy. Wasserstein & Co. first invested in the company in 2005 when it bought Primedia a media company that later merged with Penton. It will generate 4.2 times its investment. MidOcean Partners which invested in 2007 will see a return of 3.5 times sources familiar with the matter said. Morgan Stanley Centerview Partners Rothschild and Barclays Bank PLC advised Informa. Milk Specialties Global Acquires Wisconsin Facility ilk Specialties Global (Eden Prairie MN) has announced that it has acquired the Saputo facility in Monroe WI. This acquisition will allow Milk Specialties to grow its whey protein ingredients through the company s advanced Ultrafiltration process while enhancing Milk Specialties commitment to its strategic supply partners. The Monroe facility is a whey processing plant located in a favorable location for cheese producers. This investment will support our ongoing commitment to our valued whey suppliers to provide a consistent market for whey protein stated Tom Benson senior vice president of strategic sourcing and risk management for Milk Specialties. Investing in an area that is soaked with a proud cheese making tradition will allow both our cheese makers and Milk Specialties to continue to grow. Currently Milk Specialties has nine certified manufacturing facilities spread across the Midwest and California. The Monroe facility and its 14 employees will join the industry-leading manufacturer as the 10th facility location further supporting the company s next level of growth. For more information call (952) 942-7310 or visit www.milkspecialties.com. M AIC and Sanat Products Limited Announce Partnership IC (Framingham MA) has announced its latest partnership with Sanat Products Limited a producer of plant extracts phytochemicals spirulina and food supplements. As an NACD & ISO registered sales and marketing company AIC said it is looking forward to expanding Sanat s presence in the North American market. Sanat Products Limited is an emerging pharmaceutical company headquartered in New Delhi India. Sanat has advanced manufacturing units clinically proven ingredients and R&D labs that are run by their team of scientists. In partnering with Sanat Products Limited we recognize them as a wellrespected and responsible manufacturer of natural ingredients which will A have excellent synergy with AIC s existing product portfolio said Mark Robertson executive vice president of marketing at AIC Inc. Sanat provides the quality and technical expertise our customers and the market demand. We foresee a collaborative partnership with AIC and will assist in managing and optimizing customer s requirements added Amit Sharma business head of Sanat. This partnership supports the idea of capitalizing rightly on Sanat s intellectual property assets and AIC s access to the market. This strategic partnership with AIC is a testimony of our commitment to provide innovative solutions to our customers at their doorstep. For more information visit www.sanat.co.in or www.aicma.com. October 2016 www.niemagazine.com Nutrition Industry Executive 8 Go to www.niemagazine.com savesta for info about this advertiser IndustryNews Industry Collaborates on Adulterated St. John s Wort Investigation Proposes Enhancements to Authentication idney Sudberg Alkemist Labs (Costa Mesa CA) founder and CSO and other notable industry experts co-authored a study that identified adulterated St. John s wort (SJW) products and recommended specific ways to improve testing of the popular herb. The study St. John s Wort versus Counterfeit St. John s Wort An HPTLC Study published in the Journal of AOAC International (Vol. 99 No. 5 2016) was a collaborative effort by D bora A. Frommenwiler and Eike Reich of CAMAG Maged H.M. Sharaf of American Herbal Products Association (AHPA) Anton Bzhelyansky of United States Pharmacopeial Convention (USP) Ben Lucas of Arizona Nutritional Supplements and Sidney Sudberg. The article can be found at www.ingentaconnect.com content aoac jaoac 2016 00000099 00000005 art00 010. The study which investigated SJW ingredients and products suspected to be adulterated based upon a simple preliminary test proposes enhanced authentication procedures along with a decision flowchart to systematically rule out SJW adulteration. One of the top-selling botanicals globally for many years the high value of SJW makes it a target for adulteration. From a total of 37 samples of SJW herb dry extracts and commercial products tested in this study S approximately 38 percent were proven inauthentic either due to admixture of synthetic dyes combined with an uncharacteristic flavonoid pattern (approximately 22 percent) or by exhibiting an uncharacteristic flavonoid pattern only (approximately 16 percent). None of the raw herb samples were adulterated with dyes the latter were only found in extracts and finished products. It s common knowledge that when an herbal product is a strong seller there will be unscrupulous vendors who try to find ways around established testing methods said Sudberg. Collaboration between industry experts to strengthen analytical methods is the best way to combat this practice and for people like us it s incredibly satisfying. I think this work is an excellent example illustrating the great potential of HPTLC unlocked by standardized methodology suitable equipment and validated methods provided by CAMAG when it comes to analysis of highly complex and naturally variable samples such as botanicals stated Frommenwiler. For more information visit www.alkemist.com. Sabinsa Defends Proprietary Distinctiveness in Boswellin is Recognized for Excellence in R&D abinsa Corporation successfully defended its proprietary rights on European Union Community trademark 000379743 for BOSWELLIN in international class 05. The legal action was jointly initiated by Sabinsa Corporation New Jersey and its trademark licensee Walmark a.s. Oldichovice Tinec. The companies sought a declaration of invalidity of contested trademark Boswellin registration number 270659 for goods and services in International Classes 5 29 31 42 and 44 owned by Orling s.r.o. st nad Orlic . In the decision the Sabinsa Walmark Application for a Declaration of Invalidity was successfully upheld by the President of the Industrial Property Office Mgr. Ing. Josef Kratochv l in Prague. The legal course extended over six years for us said Dr. Muhammed Majeed founder and owner of Sabinsa Corporation. The costs were also high. However we were steadfast in our commitment and efforts towards the legal process simply because we understand that our brands and associated products are the fruits of years of top quality research. We will not permit any unfair market practice that would undermine customer confidence vested in our brands. In other news Sabinsa s parent company Sami Labs Ltd. was recently honored with the DC Media Kerala MSME Excellence In Research and Development Award in conjunction with an event highlighting the growth of micro small and medium size businesses in the state of Kerala India. The Honorable Finance Minister of Kerala Sri T. M. Thomas Isaac presented the award to Sami and Sabinsa s founder Majeed on August 25 at Hycinth Trivandrum. It s an honor to have our dedicated research and development teams recognized for their achievements he said. For more information visit www.sabinsa.com. S Fuji Health Science Announces Name Change uji Health Science Inc. (Burlington NJ) has announced that as of September 1 2016 the name of the entity has become Fuji Chemical Industries USA Inc. to align fully in identity and mission with its parent company Fuji Chemical Industries Co. Ltd. a worldwide leader in pharmaceutical ingredients and biotechnology. As we celebrate our 70th anniversary of Fuji Chemical Industries Co. Ltd. this name change allows us to present ourselves in alignment with the global Fuji Chemical Industries Group a leader in pharmaceutical F ingredients and spray dry technology with an exceptional track record of innovation and superior quality. The name change also enables us to expand on our basic business to begin aggressively marketing contract manufacturing services in addition to excipients said Charles DePrince president of Fuji Health Science Inc. The company continues to operate customarily in its current structure. However the email addresses have changed to fujichemicalusa.com and its homepage has become www.fujichemicalusa.com to reflect and strengthen its corporate identity. 10 Nutrition Industry Executive www.niemagazine.com October 2016 Go to www.niemagazine.com albion for info about this advertiser IndustryNews Mazza Innovation Earns GMP Registration for Botanical Extraction Facility azza Innovation Ltd (Delta BC Canada) has announced that its Delta botanical extraction facility is now a good manufacturing practices (GMP) facility registered by NSF International. Mazza s facility produces high-quality clean-label botanical extracts for health nutrition beauty and personal care products using its awardwinning PhytoClean water-based extraction method. Mazza s process is a significant quality and earth-friendly advance beyond current industry solvent-based extraction technologies and the company has already achieved organic certification under the U.S. Canadian European and Japanese organic regimes. Earning GMP registration from NSF International verifies that Mazza s botanical extract production facility has the proper methods equipment facilities and controls in place for producing dietary supplement ingredients at a M consistently high level of quality. NSF s certification parameters were developed in accordance with the U.S. Food and Drug Administration s (FDA) 21 CFR part 111 regulations for the manufacturing packaging and distribution of dietary supplements. The entire Mazza team is exceptionally pleased to achieve NSF International GMP facility registration that is recognized by the U.S. FDA and throughout the global marketplace said Mazza Innovation president Benjamin Lightburn. We ve had an outstanding response from so many potential customers since we opened our new production facility earlier this year and GMP registration confirms to the marketplace that Mazza has the quality processes to match its exciting innovative technology. We view GMP registration as a significant company milestone. NSF International welcomes Mazza Innovation Ltd. as a GMP registered facility said Dr. Cheryl Luther general manager dietary supplement program NSF International. NSF International is the leader in dietary supplement GMP facility registrations and Mazza Innovation joins over 567 NSF GMPregistered facilities who have met the requirements of the most rigorous GMP program available. For more information visit www.mazzainnovation.com. You reHired Q Laboratories Inc. (Cincinnati OH) has announced a number of new appointments. Michael Baim PhD has been named analytical lab director where he will oversee the everyday operation of the chemistry and analytical research and development laboratories. Patrick Bird MS has been promoted to microbiology research and development laboratory supervisor. In his new role Bird will coordinate the various projects and functions of the microbiology R&D laboratory. Erin Crowley MA has been appointed chief scientific officer at Q Laboratories Inc. Crowley will be responsible for the acquisition and development of new technology for Q Laboratories as well as discovering new areas of business and determining the facility requirements of integrating new technologies. Lastly Daniel Barket has been named microbiology technology leader at Q Laboratories. He will be responsible for transitioning new microbiology technologies into Q Laboratories microbiology lab as well as investigating cost-efficient and work-flow expedient methodologies. www.niemagazine.com October 2016 Go to www.niemagazine.com herballyyours for info about this advertiser 12 Nutrition Industry Executive Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS NIEmagazine.com VitaminRetailer.com FitnessTrainerMag.com NaturalPractitionerMag.com NIE s Upcoming Issue Highlight Nov. Dec. 10 25 16 ad closing Washington and the Natural Industry Supply Innovation Our 2017 Media Planner Is Available At NIEmagazine.com 2017-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF VRMmedia.com Gary Pfaff at (732) 432-9600 ext. 103 or e-Mail GaryP VRMmedia.com IngredientNews Cranberry Institute to Standardize Cranberry Material Used for Health Studies anada-based Fruit d Or Nutraceuticals is supporting a recent Cranberry Institute Symposium Summary which closely mirrors the company s ongoing work to strengthen the three primary pillars it says are essential to the future growth and survival of the cranberry industry authenticity standardization and efficacy. To support research conducted and underwritten by the Cranberry Institute the organization developed its own whole cranberry powder from the fruit itself. Then working with Complete Phytochemical Solutions a third-party consulting and testing botanical ingredi- C Vitamin K2 Necessary for Supporting Bone & Cardiovascular Health pen Heart has published a new paper that explores better strategies for optimizing bone strength and reducing risk of fracture while at the same time decreasing risk of cardiovascular disease. The paper found that vitamin K2 is recognized along with calcium vitamin D and magnesium as essential in supporting strong bones and healthy arteries. In the paper Nutritional strategies for skeletal and cardiovascular health hard bones soft arteries rather than vice versa the authors cite a U.S. Surgeon General s Report that states that one in two Americans over age 50 is expected to have or to be at risk of developing osteoporosis which causes 8.9 million fractures annually with an estimated cumulative cost of incident fractures predicted at 474 billion over the next 20 years in the U.S. Further a Mayo Clinic study reported that compared to 30 years ago forearm fractures have risen more than 32 percent in boys and 56 percent in girls. Meanwhile strong epidemiological associations exist between decreased bone mineral density (BMD) and increased risk of cardiovascular (CV) disease. For example individuals with osteoporosis have a higher risk of coronary artery disease and vice versa. This problem will be magnified according to the paper if the therapies for osteoporosis (e.g. calcium supplements) independently increase risk of myocardial infarction. Dr. Hogne Vik chief medical officer with Norway-based NattoPharma exclusive global supplier of MenaQ7 Vitamin K2 as MK-7 and sponsor of the three-year studies cited in the paper explained that it is not possible to get sufficient amounts of vitamin K2 through a European or U.S. diet. For more information visit www.nattopharma.com. ent company a specification sheet was created to send to researchers along with the materials. That specification sheet includes the material s entire composition including fiber protein flavonols and proanthocyanidins (PACs) levels. For more information call (888) 472-2275 or visit www.crannaturelle.ca. O FDA Grants the First GRAS Classification for Rice Protein he U.S. Food & Drug Administration (FDA) granted the first GRAS (generally recognized as safe) classification for any rice protein to Axiom Foods (Los Angeles CA) for their clinically studied Oryzatein organic brown rice protein ingredient. Axiom s Vegotein pea protein was also awarded a GRAS classification. According to the company the nation s largest consumer packaged food conglomerates are reformulating their products to eradicate allergen- T charged soy and whey proteins glutenladen wheat and GMO (genetically modified organism)-infested corn. The FDA GRAS nod to Axiom Foods is the specific classification that opens the doors for rice and pea protein to burst into the mainstream of food production. Axiom Food s Oryzatein has been used in multiple studies including the 2013 clinical trial (Nutrition Journal) comparing the muscle building and maintenance ability of animal-based whey protein to plant-based rice protein. The study resulted in showing there was no difference a historical landmark finding in the world of sports nutrition the company stated. For more information visit www.axiomfoods.com. FloraGLO Legacy Continues With New Blue Light Protection Patent he United States Patent and Trademark Office has issued Kemin Industries (Des Moines IA) a patent (U.S. Patent No. 9 226 940 B2) for the role of its products FloraGLO Lutein and ZeaONE Zeaxanthin (distributed by DSM as OPTISHARP Natural) in protecting individuals with three common ocular disorders from blue light or lightinduced damage. Kemin s patent allows vitamin and dietary supplement manufacturers using FloraGLO and or ZeaONE to position their products for blue light protection. T The patent specifically covers products containing ocular antioxidants including lutein and zeaxanthin employed to protect the eye from lightinduced damage particularly the damage caused by the blue wavelengths of light. It targets individuals with presbyopia hyperopia or astigmatism. In these three conditions blue wavelengths of light are focused directly onto the macula creating a higher risk for ocular damage. For more information visit www.floraglo.com. 14 Nutrition Industry Executive www.niemagazine.com October 2016 Sabinsa Europe and HealthSpan Ltd. Enter Into Curcumin C3 Complex Supply Agreement abinsa Europe GmbH (Germany) announced that it has entered into an agreement on undisclosed terms and conditions with Healthspan Limited Guernsey for the supply of Curcumin C3 Complex DC. We applaud those companies that choose to source their ingredients from Sabinsa in order to legally license Sabinsa s Intellectual Property said S Sami-Sabinsa Group of Companies Founder & Group Chairman Dr. Muhammed Majeed. Respect for innovation should be demonstrated by industry leaders and we appreciate Healthspan doing so. We are very pleased to have agreed to a supply agreement with Sabinsa for this high quality science backed turmeric extract. The expertise that Sabinsa pro- vides does give us confidence that we can supply our customers with the very best ingredients in our food supplements said Maarten van Deursen director of procurement for Healthspan. For more information visit www.sabinsa.com. Ingredion Introduces Four Clean-Taste Pulse-Based Protein-Rich Ingredients llionis-based Ingredion a global provider of ingredient solutions to diversified industries and Canada-based AGT Foods announced four new clean-taste additions to its lines of protein-rich pulse proteins and flours--VITESSENCE Pulse CT 3602 faba bean protein concentrate VITESSENCE Pulse CT 1552 pea protein concentrate HOMECRAFT Pulse CT 1203 pea flour and HOMECRAFT Pulse CT 2201 lentil flour. Ingredion s VITESSENCE Pulse CT proteins feature two new proteins that contain 55-60 percent protein on a dry basis and are derived from pea or fava bean. The clean-taste pulse proteins can be used to enrich a wide range of new and differentiated products to meet consumer demand for products that are high in protein and fiber and derived from vegetable-sourced ingredients. The HOMECRAFT Pulse CT flours include two new flours made from pea and lentil. These pulse-based flours offer different levels of fiber starch and protein to meet a variety of food manufacturers needs in a wide array of applications. HOMECRAFT Pulse CT flours are naturally gluten free and offer an alternative to traditional and other gluten-free flours enabling the development of gluten-free bakery products while boosting the protein and fiber levels. For more information call (866) 961-6285 or visit www.ingredion.us. I Study Confirms NEM is an Effective Joint Treatment for Man s Best Friend issouri companies Stratum Nutrition and joint-venture partner ESM Technologies the manufacturer of innovative commercialized eggshell and eggshell membrane wellness ingredients announced that a new canine study has published in the journal Veterinary Medicine Research & Reports evaluating their joint health ingredient NEM brand eggshell membrane. Results showed that supplementation with NEM significantly reduced joint pain and improved joint function rapidly (CBPI one-week) and demonstrated a lasting improvement in joint pain (VCSA six-week) leading to an improved quality of life (CBPI six-week). Moreover a chondroprotective effect was demonstrated following six weeks of supplementation with NEM (CTX-II). There were also clinically meaningful results from a brief responder analysis demonstrating that a significant proportion of treated dogs will benefit substantially from NEM supplementation. This canine study on NEM provides further evidence supporting NEM s ability to modify symptoms of pain and it provides an alternative to the use of pharmaceuticals which have known detrimental side effects mentioned Kenneth J. Kopp DVM the lead veterinarian for the trial. For more information visit www.stratumnutrition.com. M Prinova Offers Clean Label Solution to Protect Favors and Extend Shelf Life rinova a supplier of ingredients flavors and value-added nutrient fortification products with a North American headquarter in Illinois has recently expanded its FlavorArmor line of encapsulated flavors. FlavorArmor is a unique encapsulation technology that allows Prinova to offer more than 130 tonalities with several particle sizes including a new mini rod so that it can be used in unique dry applications. FlavorArmor now extends shelf life up to 42 months and has many P manufacturing advantages beyond flavor protection including clear-cut capabilities in liquids and is clean label-friendly with allergen-free and natural labeling options. Donnie Moran sales and marketing manager Prinova USA said Today food and beverage companies are being challenged to revamp and reformulate their product lines to stay competitive and maintain customer loyalty. Prinova listened to this need and developed a solution that would allow manufacturers to protect flavor and expand shelf life in formats that haven t been possible in the past. FlavorArmor has been a trusted solution for flavor protection now we can offer our customer ways to really think outside the box as they formulate products that consumers will love with a long shelf life that will ease inventory control demands. For more information call (630) 868-0300 or visit www.prinovausa.com. Nutrition Industry Executive 15 October 2016 www.niemagazine.com IngredientNews Valensa Announces Immunity-Enhancing Immunum Chewable Tablets alensa International based in Florida announced that it has initiated production and first deliveries of a pre- and post-workout immunity boosting and recovery chewable called Immunum. Immunum contains 1 3 beta glucan from German brewer s yeast astaxanthin New Zealand manuka honey and an algae-derived lipopolysaccharide packing a one two punch when it comes to immune system health. Immunum is a formulation that activates both the innate and adaptive immune systems. The immune- boosting effects work within one to two hours and continue to work during exercise and recovery. The V sugar and caffeine-free chewable should be taken before exercise and optionally after a workout. According to Dr. Rudi E. Moerck president and CEO of Valensa the Immunum formulation represents a comprehensive approach to stimulating the immune system for optimal performance related to the effects of workouts. People don t realize that numerous studies have shown that the human immune system is only at full strength early in the morning. During the day the immune system actually weakens and reaches its weakest point after exercise he said. Most people don t realize that working out in a gym or other public places actually exposes you to a greater risk of illness because your immune system is compromised during and after exercise and workouts. Immunum has been formulated to help boost the immune response of people who are engaged in intensive training-- but the ingredient can help people of all ages in everyday life he said. For more information visit www.valensa.com. ADM Launches New Onavita Flaxseed Oil llinois-based Archer Daniels Midland Company (NYSE ADM) introduced Onavita a new fully refined non-GMO (genetically modified organism) flaxseed oil that provides a cost-effective solution for customers looking to add an ontrend heart-healthy ingredient to their latest food innovations. Onavita flaxseed oil features non-GMO plant-sourced omega-3s polyunsaturated fatty acids that are essential nutrients for humans. Because the body does not produce omega3s they must be consumed which is driving the trend for food formulators to look for ways to include them in foods and beverages. The FDA (U.S. Food and Drug Administration) considers products containing at least 160 milligrams per serving of alpha linolenic acid (ALA) like what is found in Onavita flaxseed oil to be a good source of omega-3s. Onavita flaxseed oil is suitable for vegetarians and vegans and is also non-GMO. It can be used in a variety of products ranging from supplements to pasta sauces and dressings and much more. By leveraging this portfolio and our deep technical expertise we can help customers transform their products by adding nutrition while maintaining product quality and taste. For more information call (312) 634-8100 or visit www.adm.com. Sensus Co-petitions FDA for Fiber Status lobal specialist in chicory root fiber Sensus (The Netherlands) together with Beneo (Morris Plains NJ) and Cosucra (Belgium) have jointly submitted a citizen petition to support the U.S. Food and Drug Administration (FDA) such that chicory root fiber can be included under the Nutrition Facts label s new definition of dietary fiber. In May this year the FDA announced the new Nutrition Facts labeling regulations that apply to packaged food with aim to make it easier for consumers to make better-informed food choices. The new rules which will take effect as from July 2018 include a new definition for dietary fiber as naturally occurring fibers that are intrinsic and intact in plants or as isolated or synthetic fibers that are determined by FDA to have a beneficial physiological effect to human health. Until now the FDA has awarded dietary fiber status to just a few fibers in this new regulation with chicory root fiber and numerous other fibers under review. The citizen petition requests the FDA to amend the regulation and thereby list inulin type fructans derived from chicory root as dietary fiber. For more information visit www.inspiredbyinulin.com. I G UC-II Joint Health Supplements Outperform Legacy Brands C-II joint health product sales continue to grow double digits for InterHealth Nutraceuticals Inc. located in California. IRI MULO data ending July 10 shows that UC-II keeps gaining an important share of the pie in the high-ring joint health segment. As UC-II continues to gain market share it maintains its 24-week growth of 57 percent. With this substantial growth products containing UC-II are beating all category averages and are significantly U outperforming legacy brands. IRI MULO data also shows that UC-II product lift is largely organic which means UC-II sales have been less dependent on offers and BOGOs and show that people are buying these SKUs more frequently and or more people are choosing UC-II products at retail. Joint Support is among the original segments within Vitamins and UC-II is lifting this very important and highring segment. For more information visit www.interhealthusa.com. 16 Nutrition Industry Executive www.niemagazine.com October 2016 Arjuna s One-Shot High Omega-3 Set to Launch ndia-based Arjuna Natural Extracts Ltd. launched a high-concentrate--90 percent--omega-3 PUFA ingredient produced with latest technology for dietary supplements and functional foods and beverages. The main challenge in providing the daily intake of omega-3 is ensuring the consumer gets high enough content of the nutraceutical. The old solution was to take multiple capsules or a hard-to-swallow horse pill. But consumers demand convenience and of course smaller easy-to-swallow soft capsules. A larger quantity of soft gels or capsules can lead to over consumption and overdoses of unnecessary additives just I High-Potency Turmeric Receives GRAS Status for Medical Foods olCas Biotech LLC based in New Jersey received selfaffirmed GRAS (generally recognized as safe) status for its BCM-95 turmeric extract following a comprehensive review by a panel of qualified experts according to the company. The pure high-potency ingredient is now available for use in foods dietary supplements and medical foods. The food ingredient safety evaluation was undertaken in accordance with U.S. Food and Drug Administration (FDA) safety criteria whereby reasonable certainty of no harm under the intended conditions of use must be established. The GRAS evaluation was based on scientific procedures and substantial corroborative evidence derived from history-of-use considerations for related substances. Information obtained from animal studies metabolism studies estimated human exposure in-vitro studies and refined chemical characterization in the collective provided broad-based documentation of the safety of the chemical components of BCM-95. Since curcumin is not well absorbed by the body it benefits from an enhanced delivery system to increase its bioavailability. With BCM-95 the extracted curcumin is highly bioavailable thanks to the synergism between the curcumin itself and the compound ar-turmerone an essential oil component of turmeric extract. For more information visit www.dolcas-biotech.com. to achieve your daily-recommended dose of omega-3 PUFAs said Benny Antony PhD joint managing director for Arjuna Natural Extracts Ltd. We developed a high-concentrate omega-3 PUFA that enables daily intake in just one capsule or one liquid shot per day. For more information visit www.arjunanatural.com. D Ganeden Earns Non-GMO Project Verification on Probiotic Ingredient hio-based Ganeden has announced that GanedenBC30 has earned Non-GMO Project Verification. The international ingredient manufacturer worked with the Non-GMO Project to put its probiotic strain through rigorous thirdparty evaluation confirming that the ingredient is completely non-GMO (genetically modified organism). The proper labeling of GMOs has been in the spotlight over the past several years said Mike Bush president of Ganeden and executive O board president of the International Probiotics Association. Ganeden wants to ensure that manufacturers and consumers alike are aware that the use of GanedenBC30 ensures transparency compliance with laws and peace of mind. Becoming Non-GMO Project Verified is yet another example of our dedication to the probiotic market our partners and their customers. For more information call (440) 229-5200 or visit www.ganedenprobiotics.com. Natreon s PrimaVie Purified Shilajit Stands Apart From Generic Shilajits atreon s PrimaVie is a high quality multi-patented clinically proven purified Shilajit containing dibenzo--pyrones (DBPs) DBP-chromoproteins (DCPs) fulvic acids and more than 40 different minerals. PrimaVie is prepared by a completely aqueous extraction process and contains very low levels of heavy metals compared to most of the generic shilajits found in the market. This is due to the extensive purification work done by Natreon s R&D team to remove a majority of the N heavy metals found in Shilajit. PrimaVie is the only GRAS (generally recognized as safe) affirmed Shilajit in the market and is backed by multiple clinical studies many of which are published in peer-reviewed journals. In addition PrimaVie meets the strict standards of California s Proposition 65. Studies have shown that PrimaVie is effective in supporting male sexual health mitochondrial energy and healthy aging. For more information visit www.natreoninc.com. Nutrition Industry Executive 17 October 2016 www.niemagazine.com IngredientNews PLT Health Solutions Introduces SLIMVANCE Core Slimming Complex ew Jersey-based PLT Health Solutions Inc. has introduced a new weight-management ingredient that has been clinically shown to deliver statistically significant weight loss starting at two weeks sustained weight loss and a slimming effect on stomach waist and hips. Called SLIMVANCE Core Slimming Complex the ingredient is a patented synergistic formulation of three well-known spices. SLIMVANCE s patented approach works at multiple levels by inhibiting the accumulation of fat into fat cells (lipogenesis) and enhancing the body s ability to break down fat cells (lipolysis). A 2016 16-week double-blind placebo controlled study of SLIMVANCE conducted with a healthy population of overweight men and women sets new standards for communicating N efficacy to consumers and regulatory agencies in the weight management category--because of its size its length its use of non-obese subjects and its design and execution. Consistent body weight reductions were observed throughout the 16week trial--starting with statistically significant weight loss at two weeks with a total weight loss of nearly 12 pounds by the end of the study. These overweight subjects taking SLIMVANCE lost 2 inches in waist circumference in the study. According to Seth Flowerman exec- utive vice president of PLT Health Solutions the search for new weight solutions involves cutting-edge discovery but also quality clinical science to create compelling solutions that consumers can trust. The synergistic combination of three spice extracts that constitute SLIMVANCE were selected from hundreds of different herbs examined using sophisticated screening techniques. They were studied to assess their ability to work synergistically to inhibit fat accumulation and promote the breakdown of fat in mature fat cells. The final combination showed the best potential which were then studied in pre-clinical and clinical trials he said. For more information visit www.plthealth.com. Lipogen Partners with Xenesta for Lipogen PSPA srael-based Lipogen Ltd. granted Xenesta Inc. Texas global exclusive rights for marketing a dietary supplement product based on Lipogen PSPA. PSPA is Lipogen s natural brain ingredient clinically demonstrated to support stress management. It will be marketed through Xenesta s network marketing (MLM) channel. The new dietary supplement will come in packaging that provides a monthly supply of the daily 400 mg PS 400 mg PA serving. These amounts have demonstrated optimal results in clinical research. The new product will be marketed under Xenesta s brand name. Xenesta s PSPA supplement is natural vegetarian and contains no preservatives or artificial colors. Lipogen PSPA is a new patentprotected solution for stress management and brain health support. It is a high-quality veganfriendly blend of phosphatidylserine (PS) and phosphatidic acid (PA). For more information visit www.lipogenbio.com or www.xenesta.com. I EVNol Palm Tocotrienol and Whey Protein Isolates Improve Endurance new study reveals that EVNol (by Malaysia-based ExcelVite Sdn. Bhd.) full-spectrum palm tocotrienol (T3) supplementation and WPI (whey protein isolates) prolongs running time (enhances exercise endurance) in sedentary diet-induced obese rats. In this study 35 rats were randomly assigned to four treatment groups (i) high-fat diet high-fat diet supplemented with (ii) T3 at dosage of 50 mg kg (EVNol supplied by ExcelVite Sdn. Bhd.) (iii) WPI (8 percent of total energy intake) and (iv) both T3 (50 mg kg) and WPI (8 percent of total energy intake) respectively for 10 weeks. Food intake body composition glucose tolerance insulin sensitivity exercise capacity glycogen content and oxidative enzyme activity of skeletal muscle were determined. Tocotrienols being a more potent form of vitamin E (40-60x than tocopherol) has been reported to scavenge ROS-induced muscle fatigue effectively. For more information call 61 (03) 9801 3881 or visit www.tocotrienol.org. A 18 Nutrition Industry Executive www.niemagazine.com October 2016 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Takeaways from AHPA NDI Draft Guidance Webinar Industry experts provided in-depth analysis of FDA s latest NDI guidance. By Haley Chitty H erbal products industry experts analyzed the U.S. Food and Drug Administration s (FDA) 2016 draft guidance for new dietary ingredients (NDIs) during a webinar presented August 30 by the American Herbal Products Association (AHPA). AHPA President Michael McGuffin began the webinar by comparing FDA s 2016 NDI draft guidance with the 2011 draft to highlight the changes FDA made to accommodate recommendations and concerns submitted by AHPA. AHPA and others in the industry were very critical of FDA s 2011 draft McGuffin said. That said I am guardedly optimistic. I think we made some progress between 2011 and now. At the same time a lot of work still needs to be done to pull this guidance back into more strict compliance with the statutory framework and the industry s actual obligations under the law. McGuffin noted that FDA modified the 2016 draft in several ways to address AHPA s concern that the 2011 draft overstated the need for separate notifications for the same NDI without clarifying that a generally described dietary supplement is acceptable in a NDI notification. However McGuffin also noted that additional changes are needed and that AHPA will work to enact those. I think the biggest burden for industry is the idea that every single finished product needs a separate notification McGuffin said. If we push it back to the ingredient companies and the ingredients themselves we don t need the hundreds or thousands of extra notifications. McGuffin also outlined the ways in which FDA did (and did not) address AHPA s concerns that the 2011 draft guidance Placed a burden on companies that market only pre Dietary Supplement Health and Education Act (DSHEA) ingredients where the law places no such burden Failed to adequately acknowledge the value of published and industrysubmitted ingredient lists of pre-DSHEA dietary ingredients Suggested every change to the specifications of a NDI requires submisOctober 2016 www.niemagazine.com sion of a new NDI notification industry s options are limited given Overstated the amount of data FDA s attempt to establish rules required to determine safety. through nonbinding guidance and its Tony Young partner at Kleinfeld intransigence in the face of prior indusKaplan & Becker LLP and AHPA general try and congressional criticism. He reccounsel discussed key takeaways from ommended that the industry consider the latest revision of the NDI draft guid- shifting focus further toward self-reguance and NDI-related legal realities of lation consistent with industry efforts the Federal Food Drug and Cosmetic to address product claims and ingrediAct. Young stressed that the latest draft ent quality issues. Self-regulation proguidance should not cause companies vides an opportunity to disagree with to panic. He reassured webinar attenFDA in a constructive way rejecting dees that the sky is blue continues to FDA s narrow interpretations while be overhead and is not falling. assuring safe and beneficial products Young emphasized that the revised Siegner said. NIE draft means revised draft and that FDA s guidance documents including this Haley Chitty is the direcone do not establish legally enforcetor of communications at able responsibilities. He also advised AHPA. He can be that for a dietary ingredient not on (an reached at official ) list an FDA investigation into hchitty ahpa.org. whether an NDI notification should have been submitted would typically depend on factors relating to public health. These may include potential for risk extent of public exposure to the ingredient and association with adverse events. Wes Siegner director at Hyman Phelps & McNamara PC explored next steps for the industry with respect to the revised NDI draft guidance. He said FDA has established that it is unwilling to embrace the regulatory regime established by DSHEA and that accepting FDA s draft NDI guidance requires abandoning most of the flexibility accorded by DSHEA. Siegner recogGo to www.niemagazine.com somalabs nized that the Nutrition Industry Executive 19 AssociationNews CRN Welcomes Quality and Technical Affairs VP he Council for Responsible Nutrition (CRN) has announced that Gisele Atkinson has joined the association as the vice president quality and technical affairs a new position in the association s science and regulatory department. For the past seven years Atkinson worked as the quality assurance and quality control director for Renew Life Formulas. Prior to that she spent three years as the quality control manager for New Chapter where she was a member of the management team that ensured the overall quality performance of the company and the safe operation of the work place. We are very excited to have Ms. Atkinson on board at CRN. She brings a very specific skill set to our association one that will further enhance our T already strong reputation in the areas served as the primary quality resource of science and regulation said Steve for problem identification resolution Mister president and CEO CRN. As and continuous improvement. our industry continues to raise the bar Earlier in her career as the quality on quality Gisele will be a welcome assurance manager she managed all addition not only to CRN s vitamins and mineral supplemembers but as a leader for ment regulatory activities for the greater good of the SwissCaps Inc. In addition industry. she served as a quality conAtkinson s expertise in qualtrol microbiologist at NBTY ity control quality assurance Rexall Sundown where she performed qualitative and and research as well as her Gisele quantitative analysis on raw hands-on experience at Atkinson materials in-process and findietary supplement and food ished dietary supplements. companies will provide CRN memAtkinson has a degree in microbiolbers with another valuable associaogy with a minor in biotechnology tion resource. She has overseen from University of Guelph in Ontario direct process and product-testing Canada. protocols that ensure quality stanFor more information visit dards developed internal and exterwww.crnusa.org. nal quality control structure and NPA Welcomes New Retail and Supply Members he Natural Products Association (NPA) has added 59 new members to its ranks in 2016 following up on last year s membership expansion. NPA s steady membership growth and expansion demonstrates the value and return-on-investment we bring as an organization to our members their businesses and their bottom lines said Daniel Fabricant PhD CEO and executive director of NPA. We are giving the industry what it needs expert regulatory and legislative support in Washington a strong and effective grassroots operation and exclusive membership tools and benefits like the recently launched NPA Warning Letter Database. NPA has been redoubling its efforts recently to gain and retain new members and increase their involvement in grassroots and legislative campaigns that are important to the industry. The list of new members this year include 1 Life Science Applied Sciences AG Commodities Inc. Anything Liquid Manufacturing Inc. Apothik Nature LLC Aquagenics Technologies Inc. Beauty & Health International Inc. Better For You Foods LLC T Browns Market TCBK Inc. BUICED Inc. Contract In-House Counsel and Consultants LLC D & G Laboratories Inc. DACLAF S.A. DE C.V. Descubra Health Foods Down Under Enterprises Inc. Dr. Dunner Dr. Squatch Soap Co. Earth Supplied Products LLC Elysium Health Ensign Health Envisage Consulting Epstein Becker & Green FDA Compliance Simplified FMC Corporation Fortifeye Vitamins Global Master International Group Inc. Good Earth USA Graminex LLC Grin Natural Products Limited Healthy Me Health Foods Hello Gorgeous LLC Hi-Nutrition (Pvt.) Ltd. Hospitality Consultants Ltd Kate Farms Inc. KML Laboratories Inc. Laboratorios Mixim S.A. DE C.V. Luck Has It Natural Pet Products LycoRed Corp Mayer Brown LLP Monteloeder USA Inc. Nature Labs LLC Nika Consulting Inc. Nutra Solutions USA Pharmachem Laboratories Inc. Premier Nutrition Primus Pharmaceuticals Products on the Go Sarandipity Naturals Siddha Flower Essences SleepDrops International St. Paul Brands St. Santino Sunshine Health Foods USA Golden Vision Inc. Vesta R&D LLC DBA Vesta Nutra Vitamins Plus Vit-Best Nutrition W.R. Grace Wuliang Herb Valley Group Dobel Pharmaceutical Inc. Zelang Group USA For more information visit www.npainfo.org. www.niemagazine.com October 2016 20 Nutrition Industry Executive ScienceUpdate Can Omega-3 Intake Aid in Brain Health Recovery he treatment of concussions and traumatic brain injury (TBI) is a clinical challenge. Clinical studies thus far have failed to identify an effective treatment strategy when a combination of targets controlling aspects of neuroprotection neuroinflammation and neuroregeneration is needed. According to emerging science and clinical experience aggressive intake of omega-3 fatty acids (n-3FA) seems to be beneficial to TBI concussion and post-concussion syndrome patients. This research is presented in Concussions Traumatic Brain Injury and the Innovative Use of T Omega-3s a review article from the Journal of the American College of Nutrition official publication of the American College of Nutrition. Research suggests that early and optimal doses of omega-3 fatty acids (n-3FA) have the potential to improve outcomes from traumatic brain injury. The article reviews preclinical research and cites three brain injury case studies that resulted from a mining accident a motor vehicle accident and a drowning accident. Each instance showcased evidence of safety and tolerability wherein the patients who sustained life-threatening brain injuries recovered brain health with the aid of omega-3 fatty acids (n-3FA). Growing clinical experience by numerous providers is that the brain needs to be saturated with high doses of n-3FA in order for the brain to have the opportunity to heal. Without an optimal supply of omegas healing is less likely to happen. It is well recognized that n-3FAs are not a drug and not a cure and every situation is different. Clinically some patients respond better than others. However there is no downside to providing optimal levels of nutrition in order to give a patient the best opportunity to regain as much function as possible following a TBI. For more information visit http taylorandfrancis.com. Evidence Suggests Vitamin D May Help Reduce Asthma Attacks new review published in the Cochrane Library has found evidence from randomized trials that taking an oral vitamin D supplement in addition to standard asthma medication is likely to reduce severe asthma attacks. Low blood levels of vitamin D have been linked to increased risk of asthma attacks in children and adults with asthma. There has been a growing interest in the potential role of vitamin D in asthma management because it might help to reduce upper respiratory infections that can lead to exacerbations of asthma. Several clinical trials have tested whether taking vitamin D as a supplement has an effect on asthma attacks symptoms and lung function in children and adults with asthma. The team of Cochrane researchers found seven trials involving 435 children and two studies involving 658 adults. The study participants were ethnically diverse reflecting the broad range of global geographic settings involving Canada India Japan Poland the U.K. and the U.S. The majority of people recruited to the studies had mild to moderate asthma and a minority had severe A asthma. Most people continued to take their usual asthma medication while participating in the studies. The studies lasted for between six and 12 months. The researchers found that giving an oral vitamin D supplement reduced the risk of severe asthma attacks requiring hospital admission or emergency department attendance from 6 to around 3 percent. They also found that vitamin D supplementation reduced the rate of asthma attacks needing treatment with steroid tablets. These results are based largely on trials in adults. They also found that vitamin D did not improve lung function or day-to-day asthma symptoms and that it did not increase the risk of side effects at the doses that were tested. The Cochrane Review s lead author Professor Adrian Martineau from the Asthma U.K. Centre for Applied Research Queen Mary University of London said We found that taking a vitamin D supplement in addition to standard asthma treatment significantly reduced the risk of severe asthma attached without causing side effects. This is an exciting result but some caution is warranted. First the findings relating to severe asthma attacks come from just three trials most of the patients enrolled in these studies were adults with mild or moderate asthma he added. Further vitamin D trials in children and in adults with severe asthma are needed to find out whether these patient groups will also benefit. Second it is not yet clear whether vitamin D supplements can reduce risk of severe asthma attacks in all patients or whether this effect is just seen in those who have low vitamin D levels to start with. Further analyses to investigate this questions are on-going and results should be available in the next few months. For more information visit www.wiley.com wileycda . October 2016 www.niemagazine.com Nutrition Industry Executive 21 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 The Participants Are Gretchen DuBeau Esq. Executive and Legal Director Alliance for Natural Health Atlanta GA Mike Greene Vice President of Government Relations Council for Responsible Nutrition (CRN) Washington D.C. Mark A. LeDoux Chairman and CEO Natural Alternatives International Carlsbad CA Neil E. Levin CCN DANLA NOW Foods Nutrition Education Manager Bloomingdale IL Scott C. Tips J.D. President National Health Federation Monrovia CA 22 Nutrition Industry Executive The natural products industry has different views on how to tackle the FDA and the challenges that confront us in 2017. By James J. Gormley W e will have a new U.S. president in office as of January 20 2017 and for both chambers of Congress on November 8 2016. What is the most critical point the natural products industry needs to get across to a new president and to freshmen legislators On July 29 President Obama signed U.S. Senate Bill 764 the Biotech Labeling Solutions Act (known by some as the Deny Americans the Right to Know or the DARK act) into law. This past June a controversial bill Puerto Rico Senate Bill 1599 was defeated. The bill was an effort to codify an order (Administrative Order 346) issued by the PR Secretary of Health that would have imposed a variety of burdensome fees. A revised version of the NDI Draft Guidance (Guidance for Industry Dietary Supplements New Dietary Ingredient Notifications and Related Issues) was issued this past August. What should be the industry s next steps on the NDI guidance assuming the comment period is extended What are the key issues that are being communicated to U.S. legislators What are the most effective ways to advocate for legislative and or regulatory matters What are the biggest challenges or blind spots that the natural products industry has and how can these vulnerabilities be proactively addressed by industry Should companies focus more on state issues where the immediate threats to supplements are potentially greatest (such as New York) or on federal issues NIE We will have a new U.S. president in office as of January 20th 2017 and for both chambers of Congress on November 8 2016. What is the most critical point the natural products industry needs to get across to a new president and to freshmen legislators Levin Our most important message to legislators and regulators is that our products are overwhelmingly safe www.niemagazine.com October 2016 and that our industry has had an extensive expansion of regulation over the past 20 years. Important newer laws and regulations governing the dietary supplement industry include the introduction of mandatory cGMPs (current good manufacturing practices) in 2007 (as authorized by DSHEA [Dietary Supplement Health and Education Act] in 1994) the Food Safety Modernization Act in 2010 the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006 that requires adverse event reporting and the Public Health Security and Bioterrorism Preparedness and Response Act in 2002. Other laws increasing government oversight of our industry include a couple of anabolic steroid control acts (in 2004 and 2014) plus the Food Allergen Labeling and Consumer Protection Act of 2004. The recent NDI Guidance issued by FDA represents a dramatic increase in potential government regulation of our industry despite its apparent conflicts with congressional intent as stated in the law that authorized NDI regulation (DSHEA). Greene The most important points that the Council for Responsible Nutrition will be conveying to the new administration whomever it will be and the freshman legislators of the 115th Congress is that dietary supplements are regulated that significant health care cost savings can be realized through the smart prevention and use of key dietary supplement among high risk populations and that our industry is a major economic engine impacting each state and district successfully employing more than 750 000 Americans. In addition we ll underscore that two thirds of all Americans take dietary supplements many of them are constituents. Lastly CRN will do what we do at the beginning of every Congress--we ll provide information about how dietary supplements are regulated and why DSHEA was passed more than 20 years ago. And if these new legislators want more information we ll encourage them to join the Congressional Dietary Supplement Caucus which holds quarterly briefings and has a robust bipartisan membership of Senators Representatives and staff who want to know more about dietary supplements and natural products. LeDoux This is an interesting question because it is not a political matOctober 2016 www.niemagazine.com ter as much as a fiscal matter. It has become clear that the Affordable Health Care Act also known as Obamacare is probably the most inaptly named piece of major legislation in recent memory. Recent charges by one candidate for president regarding the exorbitant cost of the Mylan Labs EpiPen (ingestible epinephrine) points out that the American system of health care and its costs are unjustifiable and unsustainable. Whoever is called upon to govern must look at our industry as a potential vehicle to helping reduce the overall staggering costs of remedial health care in our country. Natural products should provide a significant value to the country if they are widely utilized to help retard disease states that cost billions of taxpayer dollars a year to manage. America appears to be one of the most overfed but undernourished countries on the planet with soaring rates of obesity and type 2 diabetes. A look at the numbers is downright scary. Natural products offer reasonable and cost-effective solutions and as demonstrated in multiple venues and research articles can help reduce the onset of debilitating diseases and their resultant costs to society. Tips They need to know that ObamaCare has been a complete disaster and will continue to be a major drag on the economy and Americans health. It is nothing but corporatist protectionism package camouflaged as compensation. It is also a means of roping Americans into a disease-care system that is oriented toward drugs and failed medical procedures and in keeping Americans away from natural health care. It must go. NIE On July 29th President Obama signed U.S. Senate Bill 764 the Biotech Labeling Solutions Act (known by some as the Deny Americans the Right to Know or DARK act) into law. By some interpretations the new law has made voluntary labeling for GMO (genetically modified organism) foods the national standard and has stripped away consumers right to know by blocking all state efforts to require no-nonsense labeling of GMO foods. According to Food and Water Watch the law would make the already inadequate approval process for genetically engineered (GE) foods even worse. Agree disagree why By other interpretations we finally have a single federal law regarding the labeling of GMOs rather than a patch-quilt of varying state laws. Agree disagree why Levin NOW Foods has always opposed GMOs because our scientific assessment is that they pose unreasonable risks to the environment and health while encouraging unsustainable farming practices. Our position is that GMOs should be banned until they have been thoroughly tested and proven to be safe which is not the case today. A willful refusal to collect proper evidence is not the same as a record of proven safety though that is what pro-GMO advocates want the public to believe. Mandatory labeling is necessary to allow people to know what their food sources are and to be able to vote their preferences with their wallets. It s also required to track potential issues such as unpredicted food allergies which are completely ignored under current GMO approval processes. We want a single federal standard to avoid having to satisfy conflicting requirements of individual states or even internal trade barriers between states. In this there is general agreement within our industry and this is in concert with the thinking of our founders and the Commerce Clause of the U.S. Constitution. Of course we want mandatory labeling but without the various bounty hunter provisions that were included in some state proposals that would make well-meaning industry companies the targets of aggressive lawyers seeking lucrative settlements to drop nuisance suits. It s a shame that the compromise made to pass a federal bill did not require as much labeling as we think is needed to protect the public and allow us to make informed choices. However there is a clause in the new law that allows the government to assess whether the mechanisms for avoiding direct labeling are effective for the public and to propose changes if they re not. This is an area that pro-labeling forces should focus on as the law is implemented. In any case large food companies and restaurant chains will follow the preferences of their customers and the public. We can still get pledges to label or avoid GMO ingredients from these companies regardless of the law s relatively weak labeling requirements. Consumers have some power to demand labeling from the private Nutrition Industry Executive 23 sector. Greene I don t believe either side of the GMO labeling debate was happy with the amount of time it took to reach compromise and achieve a finalized outcome but I do believe it is the best that either side could have hoped for. Consumers who want to know what is in their products will be able to find out and the manufacturers will have a uniform standard and clear information about how to label if a product contains a GMO or if it is free of GMOs. I m very impressed with the new technology like SmartLabel that is being utilized to provide consumers detailed product information about the country of origin nutrition GMOs and use of natural ingredients. This new technology is being used by many food manufacturers but also by those who make natural products and dietary supplements and I suspect that there will be more transparency from all food companies including dietary supplements as we move into the future. Even though the legislative debate is over it is important to underscore that the consumer was heard and they are getting what they wanted--more information about the products they consume. A stateby-state patchwork of labeling laws would have disrupted commerce and raised food costs for consumers. No one would have benefited. DuBeau This is a phony labeling bill. There aren t even enforcement mechanisms for those who ignore the law. On this issue Congress completely sold out consumers and handed Big Food exactly what it wanted and what many were doing anyway hiding the contents of their food in a scannable code that no one will use. LeDoux I strongly support the right of consumers to know what they are eating and where it comes from. Genetic modifications of cereal grains under one very noteworthy hypothesis identified by medical doctors is directly linked to the growth of type 2 diabetes and obesity in American citizens who consume the recommended diet of complex carbohydrates and whole grains. How this relates to 24 Nutrition Industry Executive GMOs is clear to me--when wheat has been hybridized and genetically modified to yield more drought resistant dwarf wheat and withstand pesticide and herbicide exposure--the net result has been an extraordinary increase in crop yield--but ingesting of these products has also been correlated to the two health concerns mentioned. The answer here is not in having potentially 50 separate state regulations regarding disclosure--but in having a federal standard similar to what is accomplished in other multiparty jurisdictions like the European Union. The legislation is not perfect by any means but with over 3 000 products negatively affected in Vermont alone prior to passage of the Federal legislation one can only imagine the impact if 49 other states came up with their regulatory framework absent the federal pre-emption. genetic engineering so narrowly that it will allow most GMOs on the market to escape from the definition 2. It makes customers go scurrying around having to call 1-800 numbers or else scan QR (quick response) codes just to find out if the food contains GMOs rather than simply putting the words on the label and 3. Because it contains no federal penalties offending companies can ignore it with impunity. In addition the legislation violates the U.S. Constitution and in particular the 10th Amendment through its usurpation of states rights. States rights advocates on this issue alone should be opposed to the DARK Act. NIE This past June a controversial bill Puerto Rico Senate Bill 1599 was defeated. The bill was an effort to codify an order (Administrative Order 346) issued by the PR Secretary of Health that would impose a variety of extremely burdensome fees that would have effectively driven the dietary supplement business out of Puerto Rico and would have thus deprived residents of the commonwealth from a wide range of healthenhancing dietary supplements. To what would you attribute the success of this order s defeat Was this supposed money grab a fluke or a sign of things to come in other jurisdictions Levin The lack of due process in issuing the order and the lack of legal framework to impose new regulations was combined with the strong lobbying of our industry to oppose and defeat the measure. We relied on our trade groups to lead the charge against this bill and are gratified that this was successful. Greene CRN led the charge to defeat Puerto Rico Senate Bill 1599 earlier this summer but similar legislation could return during a special session being planned for early fall in Puerto Rico. The legislation was designed to legitimize Administrative Order (AO) 346 which is still in effect and can only be repealed or revoked by the governor or the secretary of health. CRN is working to stop AO 346 and has retained an expert in Puerto Rican politics to provide counsel. AO 346 would require that natural products and dietary supplements sold on the island register and pay a fee with the Commonwealth. The Puerto Rican legislature and government have been dealing with economic crises Zika outbreaks and govwww.niemagazine.com October 2016 I am not clear that the intent of the legislation was to impact the approval process for genetically engineered foods but rather to provide a mechanism whereby food producers could make information available to the consuming public in a variety of ways. The objective of the legislation was to avoid a patchwork quilt of inconsistent regulations from various states in favor of interstate commerce. Any concerns about the adequacy or inadequacy of the review process is a totally separate matter that needs further attention and dialogue. Tips The new law fails in at least three major respects 1. It defines ernment corruption but a new governor and legislature will be elected in November. However we re not waiting for the new elections. On the federal level CRN has met with the eight member Congressional Task Force created by the Puerto Rican Oversight Management and Economic Stability Act (PROMESA) and chaired by Sen. Orrin Hatch of Utah. LeDoux It never ceases to amaze me how creative politicians can be in extracting revenue from their constituents. This whole administrative order is such an example and frankly I believe it would never stand up in court. That said the efforts of the grassroots and industry trade groups in Washington D.C. and the good folks at NPA (Natural Products Association) and CRN working with Congressional staff and leaders paid off with a temporary win for the industry. I say temporary because until the order is challenged in court I believe the Puerto Rican authorities will still attempt to extract these fees in an effort to bring much needed revenue into the territory. Tips Primarily because of its lessthan-free-market policies Puerto Rico today is an economic basket case. This bill was just another example of Puerto Rico s complete lack of economic sophistication and the heavy lobbying influence of the pharmaceutical industry there. NIE A revised version of the NDI draft guidance was issued this past August. By many accounts if enforcement follows the lines of this guidance a much larger ever-expanding pool of NDIs will be created one which will discourage innovation by effectively limiting process and strainrelated improvements since most manufacturing changes will serve as triggers for the profoundly expensive NDI notification process. Some say that the industry need not be alarmed since this is merely a non-binding guidance. Others say if it walks like a duck [regulation] quacks like a duck and looks like a duck it s a duck--ODI NDI determinations could cost industry tens or hundreds of millions of dollars alone. The nexus of NDIs and GRAS (generally recognized as safe) determinations is not clear. Some estimates are that the industry costs could be billions of dollars all October 2016 www.niemagazine.com The agency s interpretation of what constitutes chemically altered is extremely broad and would encompass everything other than the most basic manufacturing processes. -- Gretchen DuBeau Executive and Legal Director Alliance for Natural Health told and consumers would ultimately suffer due to reduced product choice less innovative products and more expensive products. Agree disagree and why Levin The NDIs appear to be a dramatic departure from previous guidance in the 1990s and from the congressional intent in authorizing NDI regulation in 1994. A different process should not automatically trigger a change of status unless that process introduces a relevant new factor to the ingredient in question. For example if the same ingredient is extracted using various solvents--hexane alcohol CO2 or water--then as long as that solvent is not in the ingredient in significant amounts to present a health hazard or change the way that the ingredient provides a health benefit when we take it and as long as the substance extracted is still measurably equivalent to the original source it should not logically become an NDI. If a carotenoid was extracted with hexane pre-1994 and now is extracted by CO2 that actually is more pure and safer process with less potential for toxicity so it should not become an NDI. As long as the same carotenoid is still retained by the process why should the FDA (U.S. Food and Drug Administration) become involved in what amounts to a neutral or beneficial process improvement Fortunately it is unlikely that Congress would vote to dramatically expand the size and power of the FDA to regulate what it has long defined as foods not drugs absent some compelling safety concern that doesn t seem to exist. DuBeau Agree. The agency s interpretation of what constitutes chemically altered is extremely broad and would encompass everything other than the most basic manufacturing processes. But that s just the beginning of the problems with this document. The guidance imposes safety requirements on new supplements that are not even expected of drugs. In most cases this guidance simply doubles down on what was in the original guidance. When the original guidance was released an economic analysis conducted by an Emory University professor estimated that the guidance would result in the elimination of tens of thousands of supplements from the market an industry-wide cost of between 2 billion and 165 billion in animal and human product safety studies and the loss of tens of thousands of jobs. If finalized as is this guidance will eliminate consumer access to supplements they rely on to stay healthy. LeDoux Twenty-two years have passed since the signing into law the Dietary Supplement Health Education Act. I remain mystified how the issuance of this guidance is a shock especially to many of those expressing this concern--who were at the negotiations and passage of the enabling legislation. Is the new NDI guidance perfect Of course not. There is a lot of effort in providing data without sufficient clarity on what is the real definition of safe. There Nutrition Industry Executive 25 is a paucity of benefit from an intellectual property standpoint. There is the whole subject as yet unaddressed as to how the FDA is going to have resources to address what may be a congested and compressed time frame of multiple filings and of course there remains the real potential for legislative fixes or enhancements especially in light of a new president and Congress in 2017. Just having the guidance out for public comment albeit four years after the first guidance came out is an indication of a positive willingness to have the agency engage with the industry and public on what will be an important matter for our industry. I also think it is time for the industry to show some maturity and leadership in this discussion. We have to stop this nonsense of constantly saying that regulations are killing us and they are excessive. The passage of DSHEA created an industry which has flourished but which has also been a breeding ground for consumer fraud willful criminal activity of illegally spiking supplements with active pharmaceutical agents without disclosure or permission and making a quick buck. Responsible industry needs to partner with government regulators to help clean up the messes learn from them and provide means to prevent further abuses of what has been a landmark piece of legislation. I think this is what the FDA and responsible industry are trying to achieve here and while there is substantial room for improvement within the recently released guidance document we need to stop grousing about the costs of doing business appropriately. Tips I most definitely agree that the revised NDI guidance for supplements that was just issued by the FDA will prove to be a disaster for both the supplement industry and for consumers in that innovation favorable pricing and extensive choice and availability will all be sacrificed on the altar to the false god of consumer safety. Nothing will be gained by the FDA s actions except to greatly jack up supplement prices strangle avail26 Nutrition Industry Executive ability and choice and drive consumers into the greedy hands of the pharmaceutical industry. Notice that the FDA s actions in this regard are cleverly dovetailing with Obamacare s similar effect of driving patients away from natural care and into the death grip of the pharmaceutical and medical industries. I agree with what the others are saying and disagree with those who say we should not be alarmed. Over time the FDA s acts will drive smaller supplement companies out of business and consolidate the industry into maybe 10 top companies. The kind of concentration in the industry will not be good for innovation nor will it be good for the consumers. NIE What should be the industry s next steps on the NDI guidance assuming the comment period is extended Levin While our industry must follow federal regulations we have the right to actively lobby against unreasonable rules. Preventing the implementation of the draft NDI guidance by opposing funding for the massive increase in agency size required to manage the expanding program is the first step. Working with congressional champions and opponents of government expansion--especially in the area of agency rule-making that exceeds congressional intent--should help to block the most onerous parts of the NDI Guidance and guide it back to the intended limits of government power over commerce. LeDoux We need to identify those areas which are of greatest concern to the industry and which could yield unintended consequences of excessive burden without the quid-pro-quo of some economic or market benefit. We also need to understand how the FDA works and how it doesn t. This means we need to have a dialogue with stakeholders in industry the government and the legislative branch to see how funding is allocated on a risk basis to the agency. The definition of adequate standard for safety needs to be codified and priced against the risk profile of the status quo. Finally we need a serious look at the economics of the proposed NDI guidance done by experts in statistics and mathematics as well as life sciences. Tips Legislation and or lawsuits against the FDA and its actions in this regard must be commenced. The FDA could care less about our comments. NIE What are the biggest challenges or blind spots that the natural products industry has and how can these vulnerabilities be proactively addressed by industry to improve itself and enhance consumer confidence in the safety and efficacy of the finished natural products we sell Levin It would be helpful for supply side to join forces to develop quality testing that bears up to external scrutiny to manage claims to avoid those that seem excessive (a claims database ) and to create and manage a reputable NDI database to help avoid excessive federal regulation that isn t needed for product safety. We have sometimes overlapping organizations that sometimes cooperate to great effect such as the Dietary Supplement Caucus briefings. More cooperation in the interest of the industry will encourage our congressional champions and discourage our adversaries. LeDoux The industry needs to demonstrate some adult behavior and step up to more responsible and transparent behavior. This also means that retailers distributors producers and suppliers need to work together to raise the bar on standards and adhere to those standards. While there were some serious concerns with the New York attorney general s methods of evaluating products via DNA testing the resulting impact on the industry has been positive in that it has brought all the stakeholders together to recognize they all share in risk. The establishment of the Natural Products Dietary Supplement registry by the CRN in conjunction with Underwriters Laboratories and the separate finished goods testing programs being created by the Natural Products Foundation of NPA under the Tru-Label program are two benchmarks and I believe seminal events in the past year that signify the recognition by industry leaders that credibility is essential for our continued vibrancy as an industry. Tips The biggest challenge that the natural-products industry has is to recognize that if it is to grow or even to stay intact then it absolutely must fight for its existence now. Appeasement complacency and acceptance of others slow noosewww.niemagazine.com October 2016 tightening around the industry s collective neck will only aid in the demise of our industry. We must fight for our rights now more than ever and not be hesitant at all to leap at the FDA s throat and take it down when the FDA is wrong (which is usually always). It is a huge mistake and utterly na ve to think that the FDA is simply misguided and with the proper advice from us will do the right thing. It must be trapped caged and tied down like the wild animal that it is. NIE Given limited resources for advocacy should companies focus more on state issues where the immediate threats to supplements are potentially greatest (such as New York) or on federal issues Levin While national organizations have a role in both federal and state regulations it is often more effective for regional or local grassroots efforts to help manage state actions. The regional NPA organizations have often proven their effectiveness in those areas and magnify the resources of the national organizations with local activism. Companies with a presence in a state often have a greater ability to be part of the conversation and to impact the results than outside national groups which offer support in terms of financial resources lobbying and scientific expertise and organizational help. Greene If companies aren t already members of a trade association then they should join one and work with the great consumer groups in our industry. It s more important than ever that all of us who care about dietary supplements speak with one voice on key issues and convey similar messages whether it be in Washington D.C. in the states or locally. When we are all in agreement and working together we get things done for the good of our consumer. It all comes down to the many Americans who love and regularly take our products. In addition I would argue that federal and state issues are equally important. CRN has an active state legislative subcommittee that is defending the dietary supplement industry by actively lobbying testifying engaging and opposing bad bills early and first. We defend the industry equally among all 50 states commonwealths and territories and on the federal level. Bad policy is bad policy. Because states move October 2016 www.niemagazine.com While national organizations have a role in both federal and state regulations it is often more effective for regional or local grassroots efforts to help manage state actions. The regional NPA organizations have often proven their effectiveness in those areas and magnify the resources of the national organizations with local activism. Companies with a presence in a state often have a greater ability to be part of the conversation and to impact the results than outside national groups which offer support in terms of financial resources lobbying and scientific expertise and organizational help. -- Neil E. Levin NOW Foods Nutrition Education Manager quickly we need to do more about educating state legislatures about the benefits of dietary supplements and natural products to preempt future problems. And we need to be present in states like New York California Massachusetts New Jersey and others where issues come up quickly but can be stopped quickly too. The best way to address limited resources is to join a trade association like CRN a company shouldn t have to make a choice between federal or state. Both are necessary. LeDoux The first part of the question you raise is troubling namely given the limited resources for advocacy. If this is truly the way our industry approaches advocacy then we have a fundamental problem. Advocacy should be a significant and visible component of any company s business plan. Failure to invest in the future will yield very poor results indeed. I think companies should step up their involvement with their trade groups with their local regional and national legislators and get serious about contributing real money into the world of political action committees that undertake the heavy lifting of educating the folks in power. The time for letting others do it is over. NIE What are other issues of great importance you would like to discuss the definition of natural The growth of the cannabis market Food safety scares What should industry be doing right now in these and other important areas Levin The definition of natural is not legally defined by the FDA and has been the subject of litigation. We support the concept of a federal standard but would want that definition to match that of our broad industry. GMOs and artificial food chemicals cannot be natural though others will push to dilute the standard to include those ingredients. It would be wise for our industry to adopt a voluntary standard that we agree on and lobby to match that with a federal one. Greene I believe we must be vigilant about protecting and promoting DSHEA and following the outcome of the revised draft NDI notification guidance. The older DSHEA gets the more attacks and concerns will be raised that it is not capable of appropriately regulating the dietary supplement industry. We must continue to defend the law but recognize when it is time to update change or improve upon the great work that was done in 1994. Tips Frankly the natural products industry should be supporting those health-freedom organizations such as the National Health Federation and others that are out there fighting at international and national levels and on meager funds to defend the industry s very future against the much larger pharmaceutical and commercial agriculture businesses. The natural products industry s failure to adequately insure its own future through such funding is one of the largest blind spots in the industry s vision. NIE Extra Extra Visit www.niemagazine.com to read about the effects of petition drives and lobby days. Nutrition Industry Executive 27 By Nicholas Saraceno W ith the world being just recently removed from the Summer Olympics in Rio de Janeiro Brazil the memories are still fresh. The August spectacle witnessed athletes competing in their respective sports facing the best the globe had to offer. Some individuals triumphed while others were defeated. Those in the nutrition industry are undoubtedly left with countless questions. What tactics did these men and women use to successfully prepare for competition Did they ingest certain vitamins and supplements What nutrition trends are being followed The answers not only affect elite athletes but also garden-variety sport players and exercise enthusiasts. Remedies When one participates in a physical activity whether it is weight lifting or 28 Nutrition Industry Executive playing a sport professionally the body is burning energy. Just like anything else it requires fuel for recovery. In fact when it comes to the nutritional marketplace shoppers realize the importance of this issue. Consumers are interested in energy recovery and performance so they can continue to train and stay in the game of their choice said Marianne McDonagh regional director at Minnesota-based Bioenergy Life Science Inc. manufacturers of ribose for dietary supplements. Recovery from muscle ailments is very common. Consumers should look at Bioenergy Ribose to help with muscle recovery reducing muscle aches and stiffness and for sustainable energy so they get more out of their training and compete better. However fitness does not entirely revolve around taking the correct supplements needed for recovery. It is also heavily reliant upon a functional immune system as noted by Hilde Raa scientific manager with NutraQ a Norwegian specialty ingredient vendor whose materials are found in sports nutrition products. When amateur or professional athletes engage in intensive exercise they put their whole body under stress-- from their muscles to their immune system said Raa. They damage tissues at the micro level and use their energy stores as fuel. This is why athletes exercisers feel sore and tired and may succumb to an infectious illness during the hours following a workout or competition. Raa added A well-functioning immune system is crucial for athletic performance as well as for an active lifestyle but exercise in itself has impact on the immune function. Research has shown that there is a correlation between exercise and respirawww.niemagazine.com October 2016 tory tract symptoms (RTS) (K nig et al. 2000 Nieman 2003). Apparently physical inactivity increases susceptibility of RTS while moderate training seems to have a protective effect (Schwellnus et al. 2010). Furthermore several studies with athletes that engage in strenuous exercise such as endurance sports have shown that this group is particularly prone to upper respiratory tract infections (URTIs) (K nig et al. 2000 Moreira et al. 2009). This has been demonstrated in several different sports disciplines for example running swimming and cycling (Schwellnus et al. 2010) ... As the sports nutrition category overlaps into mainstream consumers are gaining a more holistic view of recovery fuelling their interest for safe and effective solutions to keep their immune system running strong. State of the Sports Nutrition Market In a world where people are beginning to see and experience the ill effects of consuming foods high in sugar a greater incentive to live a healthy lifestyle has formed. Most recently those choosing to take on this new endeavour are not the societal subgroup that the public may expect. According to Dr. John Deaton vice president of science and technology at Georgia-based Deerland Enzymes a contract manufacturer of enzymebased dietary supplements more hobbyists --those pursuing fitness more casually--are entering the fitness realm alongside one s extremists that includes professional athletes and bodybuilders. With 66 percent of Americans active at least three days a week for 45 minutes large numbers participating in sports and just under 20 million hardcore athletes consumers of all ages and backgrounds are increasingly seeking out products that can help them maintain a healthy diet and an active lifestyle said Deaton. This trend isn t isolated to the U.S. consumers across the globe share an interest in improving their physical performance and endurance. As a result manufacturers do not have to find themselves catering to one specific population. Instead they can further expand their outreach to a much more general population which certainly cannot hurt sales. Likewise Chase Hagerman brand director with Chemi Nutra had the October 2016 www.niemagazine.com same optimism when it came to the market s current status. The sports nutrition market has never looked better for both consumers and brands said Hagerman. It used to be an esoteric category of health but the category has really spread its wings into mainstream territory over the years. Granted you won t see hardcore bodybuilder focused brands in mass market retailers but you will see many of the larger category leaders placing well-established products on those store shelves. Hagerman also noted that retailers have not only been able to reach gyms but they have catered to CrossFit boxes as well among other retailers. This demonstrates the flexibility and versatility that this market can offer. Even on a global scale the sports nutrition market is predicted to reach 33.6 billion by the year 2020 which can partly be attributed to consumers starting to use sports nutrition products for everyday activities as opposed to strictly fitness per Aparna Kalidindi PharmD BCPS at Natreon Inc. in New Jersey. Relevant options include beverages and meal replacements among others. Beyond that as Gilbia Portela marketing manager with NutraQ noted the category is expected to have an 8 percent compound annual growth rate from 2014 to 2019. Fascinating Trends In a market striving to innovate new ingredients are coming into the fold. Shilajit for example an Indian biomass is often known in that region as the Destroyer of Weakness due to its energizing dibenzo alpha pyrones or DBPs (lifespa.com). Natreon s PrimaVie Purified Shilajit is now trending due to its numerous clinical studies showing testosteroneboosting effects and now collagen synthesis said Kalidindi. PrimaVie a standardized extract of Shilajit contains DBPs DBP-chromoproteins (DCP) fulvic acid and 40 different minerals with very low levels of heavy metals. PrimaVie increases exercise endurance and overall fitness level by increasing ATP levels. Clinical studies have shown that PrimaVie can boost total and free testosterone levels by 20 percent and 19 percent respectively (p 0.05). PrimaVie also significantly boosts nitric oxide levels. Upon arriving at a fitness center it is apparent that the goal of muscle growth is a normality as many feel that it provides a boost to both physical appearance and overall performance. Today the marketplace offers a plethora of options to cater to this venture including pre- and post-workout proteins from pea to whey. Protein is a necessary nutrient that helps build and maintain muscle mass and for this reason remains the leader in sports nutrition ingredients. Whey a high-quality protein naturally found in dairy is one of the best sources of naturally occurring branched-chain amino acids (BCAAs) said Denton. Whey protein s amino acid profile contains the highest percentage of essential amino acids 25 percent of which are the BCAAs leucine isoleucine and valine the most important for muscle tissue repair. Accelerated repair of tissue damage is key and the use of whey protein can drastically reduce the amount of injuries caused by extended periods of exercise and training. However it is important to note that whey protein contains additional pros besides those intended for weight training. As expanded upon by Denton It s also a rich source of two other important amino acids methionine and cysteine which stimulate the natural production of glutathione one of the body s most powerful antioxidants and a major player in maintaining a strong immune system. This is beneficial particularly for an athlete whose heavy training can have a negative effect on the immune system. From casual fitness enthusiasts to extreme athletes more people are consuming whey protein supplements than ever before. Transparency is a key word when it comes to nutrition on a general note as it can represent organic or nonGMO (genetically modified organism). Manufacturers are continuing to be more conscious of how important this is to consumers. Patented branded scientifically proven functional ingredients are at the forefront of this trend because consumers want to know what they are consuming is natural and safe noted McDonagh. Standard sport nutrition ingredients with no research or quality behind them are fading away. This is why Bioenergy Ribose is so popular and in the majority of sport nutrition products. Essentially manufacturers must continue to ensure that their products are Nutrition Industry Executive 29 clinically tested and proven to yield positive results. This will allow consumers to receive the necessary validation that they will need when shopping for these types of products at health foods stores. Living in the Present Moving Toward the Future If one observes the direction that the sports nutrition market is currently heading in consumers will continue to have the desire to be healthy and be fit especially if it becomes a part of their lifestyle. This requires following the proper portion and serving sizes when it comes to nutrient consumption. Currently the RDA (recommended daily allowance) for protein in healthy adults is 0.8 g kg body weight per day said Mike Smith vice president of California-based Specialty Enzymes and Biotechnologies. For a 150pound person that works out to just under 2 ounces of protein daily. The International Society of Sports Nutrition claims that may be okay for a sedentary individual but the protein intake for healthy exercising individuals is higher. Protein intake of 1.4 2.0 g kg day is recommended for physically active people. Using that example an active 150-pound person can utilize 3.4 to 4.8 ounces of protein per day which in turn should provide the best overall training result. That is results that build muscle reduce catabolism and enhance recovery. That is where digestive enzymes come into play. As Smith added athletes in general consume far more protein than their bodies can digest. The reason of course is a hedge on loss of muscle due to catabolism. To counter this many athletes especially bodybuilders and endurance athletes utilize enzymes particularly protease enzymes to aid with digestion and utilization of protein. Being aware of how proteins are stored and digested is just as important of knowing which ones will properly benefit the body in the first place. An immune health ingredient that is attracting a lot of interest in the sports nutrition category is the beta1 3 1 6-glucan from baker s yeast (Saccharomyces cerevisiae) said Raa. This beta-glucan primes the innate immune system improving the body s ability to protect itself (Raa 2015). Yeast beta-glucan in its purified form is not available through conventional food. Yeast-derived beta-1 3 1 6-glucan has been studied by independent research groups worldwide as well as by commercial companies and is recognized as a safe and effective immune-supporting component. Clinical trials have shown that the infection rate in physically-stressed individuals as well as in individuals particularly prone to URTI is lowered after oral intake of yeast beta-glucan (Samuelsen et al. 2014) suggesting that yeast beta-glucan can improve immune function in these groups of people. Another factor that will influence consumers choices and eating habits revolves around their life choices. Is the individual a meat eater Is he or she vegetarian vegan Depending on one s diet this can open up the door for alternatives to whey for instance. It s also worth noting that the popularity of plant-based proteins especially pea is on the rise. An increasing number of people are moving to vegetarian or vegan diets and some studies have shown pea protein may be equal to whey in muscle building said Deaton. Although pea protein has existed for years it has been receiving extra exposure and attention as of late. Besides the hobbyists and extremists that Deaton referred to this additional form of protein could offer interest to an entirely new demographic of consumers who were hesitant in pursuing fitness due to a lack of supplements that could cater to their needs. Keeping this in mind perhaps new concepts will turn into major factors when the 2018 Winter Olympics kick off in Pyeongchang South Korea. NIE FORMOREINFORMATION Go to www.niemagazine.com morretec 30 Nutrition Industry Executive Bioenergy Life Science Inc. (763) 757-0025 Chemi Nutra (512) 823-2500 Deerland Enzymes (800) 697-8179 Natreon Inc. (732) 296-1080 NutraQ AS 47 21 95 12 00 Specialty Enzymes and Biotechnologies (909) 613-1660 www.niemagazine.com October 2016 Go to www.niemagazine.com natreon for info about this advertiser Americans are more stressed and sleep-deprived than ever here s how to help provide some relief. By Lisa Schofield M arch 10 is National Sleep Awareness Day. But approximately 70 million Americans want to be more than simply aware--they want to do it at night. Every night. According to sleepeducation.org 30 to 35 percent have brief symptoms of insomnia 15 to 20 percent have a short-term insomnia disorder which lasts less than three months and 10 percent have a chronic insomnia disorder occurring at least three times per week for at least three months. Sleep problems are often caused by stress but now says the Centers for Disease Control and Prevention (CDC) are exacerbated by 24 7 access to technology and work school schedules. This in and itself is often considered a stressor. Practitioner Holly Lucille ND RN founder of Inherently You believes that stress-induced insomnia is caused by the overwhelming confounded compounded stressors of our modern day that are effecting the hypothala32 Nutrition Industry Executive mus-pituitary-adrenal axis and neurotransmitters affecting sleep. She explained The traditional definitions of stress summarize the entity as a physical event for example an injury or a mental state like anxiety that disturbs the body s normal state of functioning and or requires the body to respond. In its most refined and simple definition stress is a disruption that causes a reaction. The typical stress reaction she described is the release of a surge of chemicals in the body following an event perceived as dangerous the fight or flight reaction. During this reaction the body switches on all crucial functions for survival and movement. These functions include accelerated heartbeat and blood pressure dilated pupils release of fats and sugars for fuel and muscle tightening digestion and libido however are non-crucial during this moment and are not as highly functioning. This primal method of responding to stress has not evolved with our modern-day society yet our stress response is still thought to be firing at an estimated 60 times per day without much chance for recovery Lucille noted. We tend to feel stress when it is more acute--more instant irritability sore muscles brain fog fatigue confusion. An American Psychological Association survey reported that onethird of American adults feel they are living with extreme stress while 48 percent asserted that their stress levels have increased steadily within the past five years. Stress and the fight or flight response is also triggered very often by thoughts and this can cause poor quality sleep. Guy Woodman director of sales for California-based Euromed USA pointed out that The National Sleep Foundation (NSF) recommends between seven and nine hours of sleep per night for adults 18-64 years of age however unfortunately many people experience fewer hours of sleep due to employment demands www.niemagazine.com October 2016 for longer hours urban living in noisy environments constant attention to electronic devices like cell phones computer tablets and family commitments to children and aging parents. for example one may experience an inability to cope with issues feel tense and nervous. This can elevate heart rate increase rate of breathing cause muscle tenseness in the neck and potentially contribute to headaches. Sleepless Nights Sleep difficulties in many cases pointed out Yannick Capelle product technical manager health Frutarom Switzerland arise from unhealthy lifestyle. And it isn t just the middleaged or older populations mostly experiencing stress and sleep deprivation as younger generations are now experiencing an increasing level of stress in their daily lives he said. Another important cause is the increasing consumption of stimulants such as coffee and energy drinks. In agreement is Jackson Zapp vice president of innovation Applied Food Sciences Inc. Texas who explained that research from the Center for Economic and Policy Research says that Americans get the fewest number of work days off in the world many other nations require up to 40 paid days off for workers while the U.S. has no such requirements. Add to this over-worked culture he said is the constant need of being connected or switched on. Therefore he observed Americans chase one stimulant after another to tackle their day. According to the FDA (U.S. Food and Drug Administration) report Caffeine Intake by the U.S. Population Americans consume on average 300 mg of caffeine per person per day-- equivalent to three cups of coffee or two 16-oz. energy drinks. It is increasingly more difficult to switch off when the day is done. This inability to relax and recover from the day is likely one of the biggest caveats for sleep-related issues. Lucille added that environmental factors influence stress and poor sleep more than ever--these include the EMFs (electromagnetic fields) emanating from Wi-Fi and cellphones all in constant use pesticide- and chemicalladen foods and chemicals in the air and water. Chronic and acute stress often create and or exacerbate other symptoms that likewise degrade sleep quality. And said Woodman chronic and acute stress engender myriad symptoms that are both physiological and psychological. In the short-term October 2016 www.niemagazine.com Symptoms of stress anxiety and sleep deprivation are some of the most commonly known feelings and it is clear that it impacts the American public greatly. -- Jackson Zapp Vice President of innovation Applied Food Sciences Inc. Longer term stress he countered may cause sleep loss fatigue and potentially increased bouts of cold and flu due to a stress-impaired immune system. In addition it can cause nervous behaviors such as nailbiting bruxism (teeth-grinding during sleep) hair-twisting accelerated speech and attention difficulties to become more pronounced. The consequences of stress and resulting sleeplessness are work-related accidents poor job performance and potentially automobile accidents. Chronic stress has also been implicated in aggravating a number of disease states Woodman stated. Everyone confirmed Zapp can relate to common feelings of muscle tension (especially in shoulders and neck) headaches insomnia anxiety and lack of productivity at work which are often attributed to stress. According to recent information from the Mayo Clinic long-term consequences of stress can contribute to high blood pressure heart disease obesity and even diabetes. Symptoms of stress anxiety and sleep deprivation are some of the most commonly known feelings and it is clear that it impacts the American public greatly he said. In fact mental health problems associated with anxiety disorders and stress are the most common mental illness in the U.S. affecting over 40 million adults and costing the U.S. more than 42 billion a year almost one-third of the country s 148 billion total mental health bill. Stress can also activate autoimmune conditions and digestive dysfunction (constipation diarrhea flatulence appetite swings). And said Capelle stress may cause or exacerbate depression and anxiety degrade selfesteem and also cause skin problems. Stress and sleep problems are at the heart of many health issues annoying symptoms and even potential risk of disease. Since we cannot banish stress from our lives formulating supplements that help a wide variety of individuals manage stress in a healthy way may be the foundation of increased quality of life and wellbeing which anchors sound health. Ingredients to Consider A condition gaining more understanding in the medical community is burnout intensified stress symptoms and attendant sleep disorders said Mitch Skop senior director new product development for Pharmachem Laboratories New Jersey. The more people ignore mounting stress and continued sleep deprivation without giving themselves a break the more this condition can take hold. Our ingredient Lactium a patented hydrolysate of milk proteins that contain a bioactive peptide has been studied and shown to have beneficial affect when this condition exists. According to Skop Pharmachem s Lactium has been the subject of several research studies for both stress and sleep. In a study published in the Journal of International Medical Research Target 1--a formula featuring Lactium--helped significantly decrease symptoms of burnout. The double-blind randomized placebocontrolled clinical trial looked at the effects of the formula on participants with burnout syndrome and followed study subjects symptoms of burnout using different evaluation instruments for the 12-week study period. In the placebo group 14 participants still presented with a high level of burnout at the end of the trial compared with 26 on the first day whereas in the supplement group only two participants had a high level of burnout at the end of the trial compared with 33 Nutrition Industry Executive 33 on the first day. Study participants came from a wide range of professional backgrounds across several economic sectors. Another 30-day study of 63 women who showed at least one stress symptom demonstrated that those who took Lactium (150 mg day) reported a significantly greater improvement in stress symptoms (vs. placebo) in the following areas digestive intellectual social cardiovascular and emotional. Sleep improvements from Lactium was the goal of another study of 44 adults with sleep difficulty who took 150 mg of Lactium per day for four weeks. Results showed that Lactium improves sleep duration and efficiency especially in those individuals with a moderate anxiety or depression profile. Lactium was also shown to reduce daytime sleepiness. And a new study has shown that Lactium is capable of facilitating and promoting sleep with no or minimal sedative properties. These results show that Lactium naturally enhances sleep without the groggy side effects that can be attributed to drugs said Skop. Lactium is positioned as an ideal sleep aid for natural products marketers. According to Capelle Frutarom offers a broad range of botanical extracts well known for supporting healthy sleep and stress resistance. For natural sleep onset promotion the supplier provides lemon balm valerian passionflower linden flower hops and chamomile extract. In the category of healthy sleep we noticed a growing interest in the market for lemon balm extract with several new product launches with this extract in the last months he observed. Frutarom s lemon balm extract utilizes a specific process where the essential oil is carefully extracted by steam distillation and then combined with the extract. We also offer a high quality valerian extract fulfilling the strict requirements of the new E.U. regulation related to polycyclic aromatic hydrocarbons. For stress resistance Capelle added Frutarom provides extracts 34 Nutrition Industry Executive Sleep is one of the most historically researched benefits of kava showing it to influence cerebral information processing providing sedative effects without product dependency. -- Jackson Zapp Vice President of innovation Applied Food Sciences Inc. from adaptogenic plants such as ginseng schisandra or Neuravana a patented extract from a selected green oat variety with five clinical studies showing efficacy in supporting increased concentration and performance in stressful situations. Zapp noted that Applied Food Sciences Inc. is introducing its newest branded ingredient KAVOA kava root (Piper methysticum) extract. While there have been no clinical studies conducted on the company s specific ingredient he noted the active compounds in kava kavalactones have been studied in more than a dozen human clinicals for their temporary benefits in calming anxiety and stress as well as promoting sleep. The etiology of stress and other anxiety-related mental illness is not yet fully understood Zapp pointed out but current evidence suggests mood disorders are heavily influenced by changes in gamma-aminobutyric acid or GABA a substance in the central nervous system that inhibits nerve transmission in the brain by calming neurons that have become overexcited. Kava uses complex neuronal communication where specific plant metabolites bind to neurotransmitters and alter neurotransmitter synthesis having a damping effect on stimulatory pathways he explained. Research demonstrates that kava indirectly affects GABA neurotransmission which ultimately can provide an overall calming effect on the brain benefiting mood and a relaxed state of mind. According to Zapp a recently published analysis of the evidence for kava demonstrated that there is a statistically significant reduction in anxiety and stress scores with kava supplementation. This evidence was supported by the positive results in the Kava Anxiety Depression Spectrum Study (KADSS) a three-week double blind crossover study involving 60 subjects with elevated anxiety. Another study conducted by the same research team also demonstrated in 75 subjects a statistically significant reduction in anxiety scores in the kava group relative to the placebo. Aside from stress reduction Zapp explained the study yielded a secondary mental health benefit from kava--improving sleep quality without impairing REM. Sleep is one of the most historically researched benefits of kava showing it to influence cerebral information processing providing sedative effects without product dependency he said. Further research specifically on the active lactone compounds found within kava substantiated these mental health benefits associated with a reduction in stress tension or restlessness and improved quality of sleep. NIE Extra Extra Visit www.niemagazine.com to read about the vicious cycle some people are facing by constantly utilizing energy and sleep products. FORMOREINFORMATION Applied Food Science (855) 885-2399 Euromed (925) 935-0334 Frutarom (951) 734-6620 or (513) 870-4900 Pharmachem (800) 526-0609 www.niemagazine.com October 2016 Go to www.niemagazine.com afs for info about this advertiser Research&Development By Lisa Schofield mericans are finicky and taste matters instant gratification is expected to be fulfilled-- and we need to consume liquids (beverages) every single day and often in order to maintain healthy hydration. So of course the beverage industry is hopping. And with the continually growing desire among American adults of all ages who are actively governing their own health and wellbeing beverages with nutraceuticals and specific health advantages--that taste great--will fly off shelves. William J. Ludlum chief operating officer MORRE-TEC Industries Inc. of 36 Nutrition Industry Executive A New Jersey said he has seen an evolution in the functional beverage category in only five years. Millennials are becoming a huge part of the market and will soon replace the Baby Boomers he noted. The water and juice market has exploded over the last five years. Soda markets are being reduced for a healthy no-sugar benefit. In addition technology has tried to keep pace on an application basis but also by allowing the introduction of a widening variety of functional beverages. The water dairy and yogurt markets have been seeing nonstop introductions. Formulators are searching for the proper minerals vitamins fibers proteins and other special ingredients to nutritionally fortify beverages and other foods. Most technology challenges need to focus on the path into the product. Ludlum added that taste and solubility are the two chief concerns among consumers selecting beverage products to support health and well being. Buzzwords he said include clean label bone health (with calcium absorption vehicles) heart health and blood health. Minerals fibers proteins bioflavonoids phytosterols and vitamins are all products that consumers desire to ingest in beverages to get the desired result he stated. www.niemagazine.com October 2016 Alix Hoskins research and development manager with Pharmachem Laboratories in Utah said she sees the functional beverage market moving toward general health. Consumers want a more naturally made product versus a synthetic product. Organic gluten free allergen free and all natural (no preservatives artificial sweeteners or colors) have become more predominant in the market over the past couple years and will continue to rise as consumers strive for a healthier lifestyle she noted. Hoskins characterized the growth of the functional beverage market to accommodate increasingly busy and active lifestyles by offering quick and easy ready-to-drink products. The market has expanded to include products such as meal replacements energy products sports nutrition fruit and greens digestive probiotics as well as a variety of beverages formulated to promote health and overall wellness. Undeniably she asserted The growth of this market will continue to rise as health awareness increases. The ease of having ready-to-drink products containing needed essentials makes it more convenient for the consumer. When developing a product said Hoskins there are several factors to consider. Who is the target market and where will the product be sold This information is pertinent in determining what kind of product to develop. Many countries have different regulations and restrictions for ingredients that are accepted into their market. Next she said define the message being presented to consumers heart health weight loss beauty enhancing joint health etc. Will the beverage also be non-GMO (genetically modified organism) allergen free and organic This kind of information makes it easier to formulate a suitable product. Then she advised select a delivery system and artwork. The type of delivery system could determine how well a product does in the marketplace. There are a variety of choices from a bottle canister stick pack or stand-up pouch. Artwork is the final face of the product. Make sure the label fits the message being portrayed and completes the final package. There are several challenges involved in formulating a nutraceutical October 2016 www.niemagazine.com beverage that appeals to taste buds and delivers the nutrients intact through shelf life. Key among them according to Ludlum is solubility. He noted that MORRE-TEC had acquired Vitacyclix (New York) which is a developer of water-soluble solutions for liquid vitamins bioflavonoids and phytosterols. Solubility is a key issue along with exposure. We have a wide range of water-soluble powders and liquids he said. There remain millions of health-con- scious Americans who cannot swallow tablets capsules or soft gels and providing them with the choice of obtaining their dietary supplements in beverage form will not only get your brand noticed it will likely garner immediate loyalty. NIE FORMOREINFORMATION MORRE-TEC Industries Inc. (908) 922-4388 Pharmachem Laboratories Utah (801) 612-2223 Nutrition Industry Executive 37 FoodTechnology THE CHANGING LANDSCAPE OF FUNCTIONAL FOODS Increased knowledge of functional food ingredients will expand product variety. By Nicholas Saraceno F or companies who create goods to be sold to retailers worldwide there are constant challenges and questions that they must ask themselves. Among them which products will perform better in a specific region of the country world What color should the product label be How large or small should the product s container be These only represent a microcosm of the dilemmas they encounter on a daily basis as they become even more difficult when talking specifics especially when the goods are broken down to their most basic form--ingredients. Health Benefits Functional food and beverage ingredients are plentiful and the same is true for their plethora of benefits. For one a concern that consumers often monitor is sugar intake which has resulted in many individuals switching to other sweeteners. As Thom 38 Nutrition Industry Executive King president of Oregon-based Steviva Ingredients noted the company produces sweeteners that are safe for diabetics through weight loss and a reduction in obesity which allows for diabetics to manage their sugar levels more smoothly. On a more in-depth level Wisconsinbased Wellmune (part of Kerry Group s portfolio) is an ingredient that targets the immune system enhances key immune functions improves overall physical health helps maintain healthy energy levels keeps consumers healthy (especially when stressed) and provides immune support as people age according to Donald Cox PhD R&D director. Cox added that beyond Wellmune we see an opportunity and trend for product manufacturers to create innovative stand-alone or dual functional benefit products focused on health and wellness which can allow producers to create multi-purpose products items that will appeal more to retailers and buyers alike. State of the Ingredient Market Although the idea of incorporating these beneficial ingredients into everyday foods is not a new concept its potential for growth and overall success is still extremely promising. This positive correlation between ingredient production and sales is due to several factors such as the occurrence of health conditions and an average person s standard diet which can be a roller coaster especially during a hectic workweek. The global market for functional foods will continue to grow in the coming years said Jon Peters president of BENEO Inc. a natural food ingredient product manufacturer out of New Jersey. According to Leatherhead Food Research the global market for functional foods is estimated to reach 54 billion by 2017 representing a 25 percent increase from 2013. The fastest growing markets will be North www.niemagazine.com October 2016 America and Asia. The main drivers for the increase will be consumers increased awareness and prevalence of adverse health outcomes worldwide including obesity and diabetes (Markets and Markets 2015). Peters added that next to price and taste health benefits are key criteria for consumers when purchasing food and beverage products. They are increasingly aware that a balanced and healthy nutrition plays a crucial role for a better and active lifestyle. Even more than in previous years consumers are looking for natural products as well as products with a clean(er) label as they are regarded as better and healthier. BENEO s research shows that nearly two-thirds of the consumers in the Americas are checking the label before they buy while other figures highlight that seven out of 10 consumers are interested in foods that contain only ingredients they recognize. However in order for innovations to become innovative they must first be accepted by society. As Wayne Lutomski vice president of International and Global Ingredients at Welch s Global Ingredients Group in Massachusetts mentioned the world s demands influence the types of products that are sold and created in the marketplace. Over the years the functional food and beverage category has evolved beyond its niche to become more integrated into the mainstream market said Lutomski. As this has happened the emphasis has shifted from highly specialized products to everyday concepts that deliver inherently functional health benefits in a convenient and enjoyable way. Functional Food Ingredient Trends In order to please retailers and ultimately consumers manufacturers are oftentimes pushed to think outside the box when it comes to creating these product ingredients. After all if one wants to establish a loyal support system confidence is necessary. For Lauren Williams marketing manager of Beverage Flavors North America at Illinois-based Sensient Flavors taste is essential. Product developers are challenged to deliver the necessary nutritional profile with a desirable taste profile noted Williams. Clean label ingredients with taste modulation properties October 2016 www.niemagazine.com like sweetness enhancers or masking technologies can provide a solution here. Clean label or transparent labels are sets of words that have held different meanings from time to time referring to the principle that food is presented in a way that is understandable for people to read it can also refer to foods containing natural ingredients without any article ingredients and chemicals (clean-label.de). There are a number of factors impacting shifts in consumer behaviors including smart living conscientious consumption and multi-cultural influence. Never before has there been greater awareness of the impact food has on one s overall health and happiness and we see this manifest itself in clean label initiatives sugar reduction platforms and year-after-year doubledigit growth in organics said Alan Owen director of marketing Sweet Flavors North America at Sensient Flavors. Additionally consumers want to know from what region ingredients are sourced if they were procured through from companies practicing social responsibility and those demonstrating environmental stewardship. It is important to keep in mind that although consumers aim to achieve a healthier lifestyle that does not necessarily mean that they want to do so without sweets or sweet-like texture at least. In fact prebiotic chicory root fibers such as those found in BENEO s Oligofructose can provide the best of both worlds. Prebiotic chicory root fibers (inulin and oligofructose) are highly successful in the arena of weight management and we have ongoing research into this area ... said Peters. Additionally technical trials confirm that BENEO s chicory root fiber oligofructose reduces sugar by 20 percent and added sugar by 35 percent while providing a sugar-like sweetness and taste when used in fruit-flavored dairy products. While less calories and fat are important to U.S. consumers they don t want to forego the creamy indulgent experience of a rich and premium dairy texture. In fat-reduced products chicory root fiber inulin forms fat-like granules in water-containing systems under high shear. With neutral and balanced flavor it doesn t affect the taste of the product yet delivers in terms of a similar mouthfeel texture and creaminess. Inulin and oligofructose are easily incorporated into a variety of food and beverages. Evolving Research for the Future As noted the vast amount of available ingredients provides a long list of benefits but proper research must continue to be conducted for those to be discovered. This means evidence that is backed by science along with thoroughly conducted studies that support findings. We believe that while there is no shortage of ingredients that claim to have immune boosting properties product manufacturers and marketers will need to source functional ingredients that support benefit claims on an efficacious level said Cox. Taking into account the need for science and efficacy a strong research approach is essential and should be considered when choosing functional ingredients. Welch s for instance followed this process with its new Concord grape powder that reportedly contains more polyphenols (which according to The American Journal of Clinical Nutrition are micronutrients that help prevent degenerative diseases) when compared to other juices. It s important that ingredient and product manufacturers work with experts in the nutrition field to continue to advance the science behind the benefits their ingredients and offerings provide and in turn ensure the health and wellness claims they use are backed by credible research mentioned Lutomski. For more than 20 years Welch s has invested in nutrition research to better understand the health benefits associated with Concord grapes and grape juice and we continue to partner with thirdparty independent researchers to understand the benefits of our grapes and ingredients. Manufacturers have endless factors to consider when making and implementing new ingredients. The question is Will they be able to keep up with the ever-changing landscape NIE FORMOREINFORMATION BENEO Inc. (973) 539-6644 Kerry Group (Kerry Ingredients & Flavours) (608) 363-1200 Sensient Technologies Corporation (800) 558-9892 Steviva Ingredients (310) 455-9876 Welch s Global Ingredients Group (978) 371-3692 Nutrition Industry Executive 39 FinancialConcepts This flexible financial tool should not be overlooked by executives of smalland medium-size dietary supplement companies. By Chuck Slotkin t s always useful to have some sense for the value of your private nutrition products company. Insights into valuation will help you to (a) illuminate strengths and weaknesses (b) develop a capital raising strategy (c) create incentive compensation programs and or (d) plan for an eventual exit transaction. Public company executives and sophisticated investors typically monitor stock price for these reasons on a regular if not daily basis. Three methods exist for valuing a privately held nutrition products company 1. Comparison to a similar group of publicly traded companies 2. Comparison to a group of similar merger and acquisition transactions and 3. Discounted cash flow net present value analysis. These methods are mutually supportive and are commonly used together by valuation professionals and investment bankers. On the other hand each method provides a unique perspective about the factors that contribute to company value. This article focuses on I how you may use the comparison to similar public traded companies method to begin to understand the valuation of your company and even determine if becoming a public company is a path to pursue. Valuation Methodology The publicly traded valuation methodology has its benefits and weaknesses. Primary benefits include access to company information in the form of (a) the availability of current and historical financial statements that are prepared in accordance with generally accepted accounting principles (GAAP) and show long performance and current financial condition (b) the earnings estimates of financial analysts if the company has enough trading volume to support such coverage (c) company filings with regulatory agencies and (d) presentations to the investment community. Relevant qualitative information as well as quantitative information may be gathered. The primary weakness of this method as it applies to nutrition product companies is that most of the recent hot brands have either raised capital from private equity firms and or sold to another company. One cannot look to the public markets today to find close comparisons to nutrition product company stars of recent vintage such as Vega Megalife and New Chapter among others. This is in contrast to the 1990s and 2000s when high-growth companies such Natrol Twin Labs Atrium and Nutraceutical International were publicly traded. Another concern is that publicly traded companies that are thinly traded may not reflect the intrinsic or real value of the company since relatively few trades in the stock could create an artificially high or low value. Comparability In order to ensure comparability the applicable universe of publicly traded nutrition companies were split into four categories 1. branded product compawww.niemagazine.com October 2016 40 Nutrition Industry Executive nies primarily selling to retail stores ( Branded Retail ) 2. ingredient suppliers and contract manufacturers ( Ingredients ) 3. multi-level marketers ( MLM ) and 4. branded product companies primarily selling online and or through other direct channels ( Branded Direct ). The number of companies in each are as follows Branded Retail 5 Ingredients 7 MLM 8 Brand Direct 3. A fifth category was added for one company that investors are valuing on the basis of its strong intellectual property position ( I.P. company ). Two measures of growth and performance--revenue and EBITDA (earnings before interest taxes and depreciation)--were compiled for all of the com- panies in the four groups. In order to gauge long-term and current performance financial data was gathered for the three most recent full fiscal years. Median values vs. average values were used so as to eliminate the effects of both outlier performances and the larger companies vs. the smaller companies within each group. To measure current performance trailing 12 months ( TTM ) financial information was compared to the most recent full fiscal year. Compound annual growth rates for revenue and EBITDA growth the EBITDA margin (Revenue EBITDA) were calculated for each company and group. The results are found in Tables I and II. consumer level like other retailers as opposed to the other public companies that sell at the ingredient or wholesale levels. Group Performance Highlights Each group had its stellar performers and laggards. Branded Retail--Nutraceutical Corp. (NUTR) and Freshpet (FRPT) were the top performers in this group as well as the two largest companies. FRPT was the fastest growing public nutrition products company with a three YR.CAGR of 22.5 percent and NUTR had the highest EBITDA margin of 18.0 percent. FRPT is riding the fast growth rate in natural pet foods while NUTR is expert at acquiring and integrating other nutrition brands. ProPhase Labs (PRPH) and Integrated BipPharma (INBP) also reported significant increases in EBITDA in their current fiscal years. Ingredients--The three smallest companies in this group have the highest TEV Revenue multiples due to near term revenue growth even though Oragenics (OGEN) and Neptune (NEPT) are unprofitable and Chromodex (CDXC) is essentially breakeven. These companies are depending upon their respective I.P. portfolios for future growth. The largest members of the group had strong profit margins despite falling or choppy profitability through 2015. Looking ahead three companies have raised profitability over the last 12 months while two companies have significantly reduced their losses. MLM--In a group where seven out of nine companies had sales decreases over the historical time periods measured Natural Health Trends (NHTC) stands out with fastest CAGR of 71.5 percent of any public company and the highest profit margin of 18.7 percent in the MLM group. On the other hand both of its valuation multiples lag the group median where the three biggest companies generally have higher profit margins than the smaller companies and for the most part the best valuation ratios. Branded Direct--This group consists of three very different companies even though they sell directly to consumers. While Medifast (MED) has had decreases in sales and EBITDA profit margins are still strong. In contrast Fit Life Brands (FTLF) has had accelerated sales and profits growth in 2016 after declines in 2015. Innovus (INNV) is a small company that is both developing Nutrition Industry Executive 41 Overall Performance In general the long-term performances of the four groups were weak. The Brand Direct group was the only cateMedian The mid point in a series of numbers gory to meet or exceed the three-year growth rate of the nutrition products TTM Trailing 12 Months market. On the other hand group EBITCAGR Compound Annual Growth Rate DA fell during this timeframe. The NM Not Meaningful Ingredients group had the best EBITDA margin at 10.9 percent while only the Def. Company losing money. MLM group had a positive EBITDA marTEV Total Enterprise Value gin (5.6 percent). Fortunately current performance Table l. was superior to the historical perPerformance Measures formance. All four categories had similar or stronger current growth Revenue EBITDA rates vs. the historical medians. (3 Yrs. Except for MLM s EBITDA growth CAGR) Growth Growth Margin was also stronger now than in the past for the other groups and EBITRetail Brand 2.3% NM -2.3% DA margin rose significantly in Ingredients 4.6% -8.6% 10.9% Branded Retail and Ingredients and fell modestly in the other two MLM -2.9% 5.6% 8.4% groups. Other Direct I.P. Company 11.9% NM -5.3% NM 10.5% NM Group Valuation Multiples The valuation multiples of each group are strong and are a reflection of the best performers in each group on an historical and or current basis (See Table II). The Ingredients group had the highest TEV Sales of 3.2 due to both current EBITDA growth and long-term margin performance and the perceived value of various companies I.P. The Brand Direct group s TEV EBITDA of 13.3 was the result of superior sales growth and stout EBITDA margins. MLM s lag the other groups because of lower sales growth challenges average profit margins. Its TEV Revenue ratio of 0.9 is also lower than the other groups because MLM revenue consists of sales made at the Table ll. Performance Measures (Recent Growth) Revenue EBITDA (TTM vs. last FY) Retail Brand Ingredients MLM Other Direct I.P. Company Growth 3.5% 4.3% 1.1% 41.3% NM Growth Margin 12.4% 25.8% -5.9% NM NM 5.8% 12.2% 7.5% 10.0% NM October 2016 www.niemagazine.com FinancialConcepts and acquiring proprietary products. As a result sales in the first half of 2016 have more than doubled to 1.6 million vs. 736 000 in all of 2015. I.P. Company--The fifth category includes only one company FlexPharma (FLKS) a biotechnology company focused on muscle cramps and related neuromuscular disorders. It has one drug prospect in Phase II clinical trials and has begun marketing dietary supplements as a consumer brand that is specifically formulated to treat athletes suffering from muscle cramps. FLKS s stock market value is currently 200 million. With revenues of only 110 000 investors are betting on its prescription drug potential. Table lll. Total Enterprise Valuation Multiples Revenue Retail Brand Ingredients MLM Other Direct I.P. Company 1.5 3.2 0.9 1.3 NM EBITDA 11.1 11.3 10.3 13.3 Def. EBITDA Valuation Observations The compilation of comparable financial performance and valuation is an excellent first step in using this method to value a private company. An executive employee or stockholder with access to a private nutrition (Recent Growth) Revenue (Two most recent FY s) Retail Brand Ingredients MLM Other Direct Science Growth 12.6% 7.0% -9.9% -10.2% NM Growth -8.6% -32.0% -20.8% -18.6% NM Margin -2.3% 9.2% 8.4% 7.7% NM product company s financial statements can begin to develop a ballpark valuation range by taking this step. Other steps must follow in order to refine the valuation range for a specific goal such as capital raising or an exit transaction. For example since valuing a private company involves numerous assumptions and estimates studying the public filings and other publicly available information about the members of the comparison group their products market segments quality of the management teams and competition is essential in order to truly prepare an authoritative valuation range. Also valuation experts will apply a discount to the valuation range of a private company since such ownership is less liquid than the shares of a publicly traded company for which a trading market exists. NIE Sources Yahoo Finance Google Finance MarketWatch Chuck Slotkin founded Nature s Equity LLC more than 20 years ago specifically to work with natural products companies to raise capital execute mergers and acquisitions prepare valuations and business plans and advise entrepreneurs and CEOs on building equity value. For more information contact chuck.slotkin naturesequity.com. www.niemagazine.com October 2016 Go to www.niemagazine.com comar for info about this advertiser 42 Nutrition Industry Executive Nutraceuticals Handled with a mindful approach to the environment the ocean offers a new frontier for ingredients with nutritional benefits. By Janet Poveromo or ingredient suppliers in the natural sector marine-sourced ingredients are providing an opening for innovation and growth. Market awareness for marine ingredients continues to increase said David O Leary commercial manager of Marigot Ltd. the creators of Aquamin Strand Farm in County Cork Ireland. New research and growing awareness at producer and consumer levels about the benefits of marine derived ingredients and marine-based bioactives has never been as high. The extent of nutritional products that are available from marine sources as alternatives to land based offerings continues to increase. This is evidenced by marine origin alginates algal DHA EPA omega-3 seaweed minerals spirulina hydrolyzed fish proteins and peptides to seaweed polyphenols. The list is growing. O Leary added that often these marine derived ingredients offer a cleaner alter- F native from a CO2 footprint standpoint in that they are increasingly more sustainable and renewable. They are also easier to process according to Jim Titus CEO with Newgen Biotech USA in Texas who said that globally the company has seen a nice increase in demand for marinesourced ingredients. Marine source material offers an option for both improvement of ingredients as well as being much more economical. If we use beta glucan as an example oat 1 3 1 4 is difficult to extract lacking the 1 6 branch which is beneficial. Yeast is more expensive and in 2015 when mushroom beta glucan arrived costs increased yet again. The process to make marine- sourced beta glucan produces an improved ingredient at a much lower cost than any of the other three. As manufacturing processes have improved recently better options from marine source become more appealing. Key Trends Becky Wright marketing and communications director Superba with Aker BioMarine Antarctic U.S. based in Washington said innovation is key in the marine ingredients industry and companies such as Aker BioMarine are producing new products and different oil grades to help meet the needs of consumers around the world. Wright pointed out that in terms of purchasing decisions (of both heavy and light users of supplements in general) NMI s (Natural Marketing Institute) most recent Consumer Trends report points out that consumers are choosing products based on Price Ease to swallow Ease to digest Clinical proof Made in the USA No taste or smell issues Non-GMO (genetically modified Nutrition Industry Executive 43 October 2016 www.niemagazine.com Nutraceuticals organism) 100 percent traceable and sustainable Only products that meet most of these criteria will have success in today s marketplace she noted. O Leary added that proven marine bioactives are on trend currently as are products that meet with the continuous demand for protein outside of the traditional dairy-based offerings. As the search for other protein sources continue including plant-based so too does the interest in marine and fish based products--chlorella fish protein hydrolysates and seaweed derived minerals to name a few. The wide coverage and clean-tasting options now available from marine-based ingredients allow them to be considered for a wide range of food systems. Gone are the days of bad tasting marine tainted off notes associated with these ingredient types O Leary said. Innovation and product development has improved taste texture and enhanced acceptability for the consumer. This has also been helped by a strong focus on clean technologies for harvesting and processing to deliver quality ingredients that consumers can enjoy in a wide range of finished food products. In line with Wright O Leary agreed that sustainability and awareness about renewability has a vital role to play as companies in this sector embrace clean technology and sustainable practices designed to safeguard their raw materials with minimal impacts to surrounding ecosystems. This is something that food producers can be assured of when sourcing marine-based ingredients he added. Other trends in this area include Ecklonia cava collagen and new possibilities according to Titus. What we have seen is that marine-sourced beta glucan is a hot commodity. We just received a 2016 innovation award in China for a facemask because of it. Beta glucan can be used both topically and internally. The trending part is that it deals largely with anti-aging and immune health both topics that are trending and a marine source option only seems to show an improvement over the current options in the market. While we will always learn new things on the earth s surface we have clearly studied earth surface ingredients a lot more than the ocean. The ocean is a vast and in many ways unexplored inventory of future possibilities in the area of nutraceutical cosmeceutical cosmetic and personal care areas to name just a few. Research Investments The Newgen Biotech Lab in China is the national marine microorganism research center for all of China Titus pointed out. What is developed there is commercialized through Newgen Biotech Ningbo and Newgen Biotech USA. The owners have invested a lot in collaborations with U.S. universities Fortune 500 companies as well in developing further in-house science advances. We are a company open to partner with other companies in exploring marine microorganisms and the potential they offer. At Marigot science-based research supports the flagship product Aquamin O Leary said. We have pioneered the development of this product range over many years but always with a view to gaining an understanding for the unique efficacy of marine minerals for healthier nutrition. This research has grown from early years where the focus was heavily in mineral for bone health. Over time we have found that our product has unique scientific properties which we felt were worth investigating for other important areas such as joint digestive and heart health. For Aker BioMarine omega-3 insufficiency is a major area of interest. To that end said Wright the company is collaborating with several partners to launch The Omega-3 Index Project to help bring more awareness to the ramifications of low omega-3 EPA and DHA consumption globally. The Project also encourages consumers to regularly measure their omega-3 levels using the Omega-3 Index test which is a nutritional tool that measures omega-3s EPA and DHA in the blood and then correlates that with cardiovascular risk Wright explained. Once consumers have established their Omega-3 Index level they can take steps to raise it. Some of the options for raising your Omega-3 Index level include consuming more fatty fish or taking omega-3 EPA DHA supplements such as krill oil or fish oil. Only EPA DHA will have a significant impact on the Omega3 Index. www.niemagazine.com October 2016 Marine Oil Challenges and Capsule Solutions S tan Glab senior formulator with Capsugel in South Carolina said scientists at Capsugel s Liquids Formulations Centers in Greenwood and Colmar France have identified several formulation challenges with marine and krill oils that different delivery dosage forms struggle to address in order to improve the consumer experience and by extension consumer usage. One top challenge is to minimize or eliminate burp-back of the marine oils when consumed without additives. Enteric coating methods address this issue but this might not be appealing to the healthy lifestyle market consumers because coatings polymers are synthetic often non-GRAS (generally recognized as safe) approved chemicals. A most obvious approach is to incorporate natural flavors in the formula--such as peppermint oil spearmint oil or lemon oil-- to mask the taste of the burp-back. A formulator could also pre-emulsify marine oil to minimize the production of gases produced during the natural digestion in the body. Fortunately for consumers and manufacturers the burp-back issue is not a concern with krill oil. The presence of emulsifiers in the form of naturally occurring phospholipids improves the absorption within the gastrointestinal tract thus eliminating burping. A second key challenge is managing the pungent smells within the bottle. This odor issue is more likely to occur if the fish oil is 44 Nutrition Industry Executive delivered in soft gels. Soft gels contain plasticizers that create micro channels in gelatin structure that allows oxygen and odors to penetrate the shell. Soft gel manufacturers might add fragrances or flavors to mask the odor but they can change over time due to high oxygen permeability to smell like another unpleasant odor such as old chocolate. A fragrance canister within the bottle is another way to help cover the smell. A more effective dosage form delivery solution however is a two-piece hard gelatin (fish porcine or bovine) capsule like Capsugel s Licaps capsule. It is less permeable--eradicating migration of oxygen--and thus eliminating the odor within the finished product bottle. A third challenge is minimizing oxidation of the marine omega-3 oils. Oxidation will produce the smell affect stability and ultimately reduce therapeutic efficacy of the ingredient. Again the potential for oxidation is greater if the ingredient is delivered in the higher permeable soft gels. Oxidation can be minimized by incorporating natural antioxidants in the formula such as rosemary extract (carnosic acid) vitamin E (tocopherol) and vitamin C (ascorbyl palmitate). But delivering the ingredients in a low-permeable two-piece hard gelatin polymer like the nitrogen-flushed hermetically sealed Licaps greatly cuts the chance of oxygen getting into the capsule in the first place. Go to www.niemagazine.com msc for info about this advertiser Nutraceuticals According to a May 2016 study published in Progress in Lipid Research most consumers worldwide have a low or very low Omega-3 Index putting them at significantly higher risk of cardiac death and chronic disease in general Wright pointed out. containing higher amounts of phospholipids choline and omega-3s. Omega-3s EPA and DHA are so important from a public health standpoint Wright said. They reduce the risk of so many chronic diseases globally. This category while not experiencing the double-digit growth rates it enjoyed for more than a decade is not going away and will continue to thrive. As for plant-based marine ingredients O Leary said Marigot Ltd. envisions a bright and strong future. We feel that the marine derived offering certainly has a role to play. The growth in the last years alone of new ingredient offerings is testament to this as consumers look for healthy clean label plant-based options that are proven to be efficacious and sustainable. As more companies and the market itself set up to embrace the potential added Titus the future posture should only be rewarded by the lifetimes of innovation and bounty. NIE Future of Marine Ingredients With the future in mind Aker BioMarine has spent the past few years focusing on new product innovation. Most recently the company unveiled two new products Superba 2 which features improved smell taste and visual appearance and Superba Boost a new krill oil concentrate FORMOREINFORMATION Aker Biomarine (206) 855-6736 Capsugel (864) 942-3063 Marigot Ltd. 353-21-4378727 Newgen Biotech USA (972) 524-6664 Equipment&Packaging New Tablet Counter Automatically Counts Tablets Capsules Caplets with 99.95 Percent Accuracy at Full Speed The new Pharmafill TC3 Tablet Capsule Counter from packaging machinery manufacturer Deitz Co. based in New Jersey automatically counts tablets capsules caplets soft gels lozenges and other solid oral dose products with 99.95 percent accuracy. To be introduced at the Deitz Pack Expo booth S-1415 on November 6 2016 in Chicago IL the TC3 automatically counts opaque translucent or transparent solid oral dose products at up to 2 500 per minute. Developed for nutraceutical pharmaceutical cosmeceutical and other companies that are outgrowing their manual and semi-automatic counting and filling methods the TC3 electronic tablet counter features fully PLC-controlled operation with no product change parts for easy setup usage and breakdown without tools. Product changeovers may be completed in less than five minutes including testing. The new TC3 automated tablet counter offers a durable heavy-duty body with stainless steel in product contact areas on a compact footprint spanning 24-1 2 inches x 39 inches deep. Requiring only 36 inches of conveyor line the mobile TC3 automatic pill counter may be rolled up to a companion Pharmafill conveyor or to an existing conveyor and easily positioned for smooth integration. An integral lift platform allows the versatile counter to be raised or lowered by hand crank or by optional motorized system to suit the height of the bottle and conveyor. For more information call (732) 681-0200 or visit www.deitzco.com. Go to www.niemagazine.com hsus for info about this advertiser 46 Nutrition Industry Executive www.niemagazine.com October 2016 Advertiser Index Albion Laboratories Inc. Applied Food Sciences Inc. Comar LLC GE Nutrients Inc. Healthco Herbally Yours HSU s Ginseng Enterprises Inc. Jiaherb Inc. Marine Stewardship Council MORRE-Tec Industries Inc. Natreon Inc. Nutragenesis Icon Group PLT Health Solutions Sabinsa Corporation Savesta LifeSciences Inc. Soma Labs Inc. United States Pharmacopeia 11 35 42 7 1 12 46 5 45 30 31 C3 3 C2 9 19 C4 (801) 773-4631 (855) 885-2399 (856) 507-5402 (949) 502-5760 (800) 477-3949 (480) 892-8220 (800) 388-3818 (888) 542-4372 (206) 631-2498 (908) 688-9009 (732) 296-1080 (802) 257-5345 (973) 984-0900 (732) 7 7 7 - 1 1 1 1 (800) 994-2987 (732) 271-3444 (301) 230-6361 www.niemagazine.com albion www.niemagazine.com afs www.niemagazine.com comar www.niemagazine.com gencor www.niemagazine.com healthco www.niemagazine.com herballyyours www.niemagazine.com hsus www.niemagazine.com jiaherb www.niemagazine.com msc www.niemagazine.com morretec www.niemagazine.com natreon www.niemagazine.com nutragenesis www.niemagazine.com plt www.niemagazine.com sabinsa www.niemagazine.com savesta www.niemagazine.com somalabs www.niemagazine.com usp Industry Events October 4-8 SupplySide West Mandalay Bay Expo Hall Las Vegas NV (866) 230-2311 www.supplysideshow.com October 20-23 The National Association for Holistic Aromatherapy (NAHA) Salt Lake City UT www.nahaconference.com November 15-17 Advanced Manufacturing Expo & Conference Centro Banamex Mexico City Mexico www.manufacturingmx.com October 2016 www.niemagazine.com Nutrition Industry Executive 47 SupplieroftheMonth Oreste Cesco Fieschi Chief Commerical Officer Naturex U.S. Headquarters 375 Huyler St. South Hackensack NJ 07606 Phone (201) 440-5000 Naturex sources manufactures and markets natural specialty ingredients for the food health and cosmetic industries. As the Natural Maker the company actively supports the global shift to natural by directly addressing key consumer expectations through an offer built on two main focus areas My Natural Food and My Natural Selfcare. Naturex s portfolio includes colors antioxidants specialty fruits and vegetables phytoactives as well as numerous other plant-based natural ingredients designed to help its customers create healthy authentic and effective products. Oreste Cesco Fieschi Naturex s chief commercial officer is a chemical engineer with post-grade in marketing (ESPM--Sao Paulo) and a master s degree in business administration (BSP--Toronto University Sao Paulo). Fieschi has more than 20 years of experience with the food ingredient industry. NIE What is Naturex s Pathfinder Program Fieschi At Naturex sustainability isn t just part of our work it s a guiding principle in everything we do. Nature nurtures all our current and future developments and we are fully aware that preserving the environment is vital to our business. The Sustainability Pathfinder program is designed to provide a framework in which Naturex can explore new and sustainable roads without applying a rigid model. We define sustainability in a way that brings responsibility and accountability into every activity and process. Accordingly Naturex is committed to implementing practices for integrating sustainability and social responsibility throughout its overall organization. These actions are structured around four pillars sourcing operations people and innovation. Whether it s ensuring employee safety helping growers to produce crops more sustainably developing green extraction technologies or improving our factories each of Naturex s departments works to deliver concrete actions in these areas. Manufacturers need reliable partners to inspire and help them innovate providing them with responsibly sourced solutions and technical support. Naturex s botanical expertise is rooted in nature and enables its customers to push the boundaries of creativity. Throughout the world our expert teams cover every aspect of the subject from idea generation to laboratory formulation and sensorial analysis. Because we work in several markets we re able to go beyond color and offer customers complete solutions for their products addressing needs such as stability texture and taste. Helping our customers to overcome their challenges and set their products apart with unique highperformance natural ingredients is our greatest source of motivation. ing agreement with EPC Natural Products Co. Ltd. for enhancing the stability and bioavailability of blueberry anthocyanin compositions. The agreement was created under the leadership of Ingenium Naturex s recently launched global Open Innovation initiative. We understand the importance of extending our botanical portfolio in order to keep pace with growing market demand for natural health care alternatives. We are continuously working to develop new technologies that enhance the function bio-efficacy bioavailability and delivery of plant phytoactives. NIE Please talk about the Naturex Foundation and some of the projects it is currently funding. Fieschi Attentive to living conditions in the communities where we conduct our business the NaturexJacques Dikansky Foundation supports numerous initiatives to promote health environment education and economic development. In 2015 the Naturex Foundation supported many projects around the world. For example in India the foundation is launching a social development program for 500 children living in disadvantaged communities in the Maharastra region near the Group s factory in Roha. The program is designed to help the children out of poverty and focuses and the basics of education (such as gender equality hygiene and social interaction) through sports. www.niemagazine.com October 2016 NIE The company recently signed a patent license for enhancing anthocyanins. What does this mean for Naturex s botanical portfolio NIE Naturex featured natural colors at IFT 2016. How does the company help manufacturers switch to natural coloring Fieschi Nobody questions the fact that natural food coloring is no longer a future trend but a current reality. 48 Nutrition Industry Executive Fieschi Laboratory research as well as scientific studies suggest that anthocyanins have a wide range of biological activities including antioxidant anti-inflammatory antimicrobial and anti-carcinogenic properties. Thanks to their potent antioxidant properties red and purple berries and vegetables may play important roles in helping reduce the risk of cardiovascular disease cognitive decline diabetes and obesity. This is why Naturex has recently signed a licens- Go to www.niemagazine.com nutragenesis for info about this advertiser Go to www.niemagazine.com usp for info about this advertiser