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Description: In This Issue: Contract Manufacturing, Immune Health, Yeast Beta Glucans

Don t miss a single issue of NIE in 2017...go online to renew your free subscription today NIEmagazine.com September17 SU S BO PPL EE OT YS US H IDE AT S W A VRM Media Publication S1 ES 76 T www.niemagazine.com September 2017 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 22 NO. 7 SEPTEMBER2017 F E A T U R E S 47 Encapsulating Expertise Why contract manufacturers are a critical core of success and innovation for natural brands and marketers today. 54 Impact on Immune The immune system is complicated--natural ingredients for immune health have evolved to provide a more integrative approach. 54 A L S O I N S I D E 60 Product Quality A Measurable Distinction The word quality is used (and abused) so frequently to many consumers it has lost its value of persuasion. C O L U M N S 16 26 36 38 40 46 71 74 75 75 Industry News Ingredient News AHPA Update Conventions & Meetings Association News Science Update SupplySide West Booth Preview Equipment & Packaging Advertiser Index Industry Events Supplier of the Month 4 First Word 6 Condition Specific 12 Legalities 66 Marketing Innovation 68 Functional Foods 70 Ingredient Technology 12 76 FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.niemagazine.com Copyright 2017. Nutrition Industry Executive (ISSN 2331-2602) Volume 22 Number 7 September 2017. 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 September 2017 Go to www.niemagazine.com plt for info about this advertiser FirstWord Something to Chew on ve been obsessed for a long time with finding the best toothbrush toothpaste floss mouthwash and dentist. My reasons are more practical than cosmetic fending off dentist visits and bills. Also a study published online in the Journal of Alzheimer s Disease in 2013 that found people with poor oral hygiene or gum disease may be at a greater risk of developing Alzheimer s disease is quite alarming. More recently I ve become interested in probiotics role in oral health. That s due to other research findings. A study published in the Swedish Dental Journal discovered a probiotic that reduced gum bleeding in patients with moderate to severe gingivitis. The cavity-fighting effects of probiotics were also seen in an investigation published in Caries Research which found the use of a mouth rinse containing the friendly bacteria reduced the formation of dental plaque by 20 percent. Other studies show probiotics can inhibit bacteria that produce sulfur compounds the odorous substances that cause bad breath. Probiotics may even help prevent oral cancer according to Cancer Prevention Research. The evidence on probiotics benefits for oral health are piling up. Nena Dockery technical services manager for Stratum Nutrition said As research support uncovering the relationship between periodontal health and overall health continues to mount it is becoming increasingly I more obvious that protecting our teeth and gums is essential for maintaining overall health lightening the load on the immune system so it can work efficiently and effectively. Probiotics continue to be one of the foremost ingredient categories for immune support and one of the newest and most noteworthy recent trends in probiotic supplementation is the use of probiotics that support immune health beginning in the oral cavity she noted. Most pathogens enter the body through the mouth and nose. Therefore if protection can begin at these key sites fewer undesirable microbes make their way into the rest of the body and less stress is put on the entire immune system. Stratum Nutrition offers two probiotics that are specifically designed to colonize and function in the oral cavity. You can read more about them in my article on immune health that begins on page 54. Though the biological interactions between oral conditions such as periodontal disease and other medical conditions are still under investigation it is increasingly clear that major chronic diseases namely cancer and heart disease share common risk factors with oral disease. Recognition that oral health and general health are interlinked is essential for determining appropriate strategies for care. The fact that the mouth and body are integral to each other underscores the importance of the integration of oral health into holistic general health. To that end probiotics are promising as well as immune supporting vitamins and herbs. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Gary Pfaff Sales Associate GaryP VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com Managing Editor Shari Barbanel ShariB VRMmedia.com Associate Editor Nicholas Saraceno NicoS VRMmedia.com Contributing Writers Donald Cox Anne S. Cruz James J. Gormley Ronie M. Schmelz Lisa Schofield Suzanne Shelton Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Rosie Brodsky Rosie StarkServices.com A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and FitnessTrainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com Back Issues See the Table of Contents page for price and order information. Connect With Us www.twitter.com 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 September 2017 Go to www.niemagazine.com jiaherb for info about this advertiser ConditionSpecific Being able to perform at a top-tier level mentally while reducing stress are a must for well-being. B Y N ICHOLAS S ARACENO O ne has often heard that there is a correlation between stress and mental health. Since 2007 the American Psychological Association (APA) has conducted the Stress in America survey which examines how stress affects both the health and well-being of U.S. adults. According to the 2015 survey money and work were found to be the top two sources that caused very or somewhat significant stress at 67 and 65 percent respectively. Family responsibilities rounded out the top 3 at 54 percent. Interestingly enough on a scale of 1-10 (one meaning little or no stress 10 meaning a great of stress ) Millennials have an average stress level of 6.0 which is the greatest among the three generations before them (Generation Xers Baby Boomers and Matures). Manufacturers and suppliers utilize mental performance and stress reduction ingredients in a variety of ways 6 Nutrition Industry Executive as they are influenced by technology market status trends and scientific research. Behind the Scenes When it comes to formulating ingredients that can help combat stress and mental performance issues the root of the problem starts with G or gaba-aminobutyric acid. What causes stress and other anxiety-related mental illness is not yet fully understood but current evidence suggests mood disorders are heavily influenced by changes in g-aminobutyric acid or GABA (Sarris 2009) noted Brian Zapp director of marketing with Applied Food Sciences Inc. (AFS) in Texas. GABA is a substance in the central nervous system that inhibits nerve transmission in the brain by binding to and subsequently calming neurons that have become overexcited. Herbal medicines used for the treatment of brain health like kava for instance use certain mechanisms of action involving complex neuron communication. This involves specific plant metabolites binding to neurotransmitters to alter neurotransmitter synthesis (Spinella 2001 and Sarris 2007). In the case of kava research demonstrates that it indirectly affects GABA neurotransmission having a damping influence on stimulatory pathways which can provide an overall calming effect on the brain ultimately benefiting overall mood disposition and relaxed state of mind (Sarris 2009 Baldwin 2005). The ability to concentrate and be productive in various environments is essential. Kyowa Hakko s Cognizin is able to help with brain health as a result of one key nutrient. Citicoline a brain chemical that naturally occurs in the body affects conditions such as Alzheimer s disease stroke attentiondeficit hyperactivity disorder (ADHD) and glaucoma among others (via www.niemagazine.com September 2017 Go to www.niemagazine.com afs for info about this advertiser ConditionSpecific WebMD). There are a wide array of ingredients on the market for focus and mental performance with different scientific processes said Elyse Lovett MS MBA marketing manager with Kyowa Hakko USA in New York. Some work great alone as a signal ingredient while others work well to form a synergistic effect. Kyowa Hakko s Cognizin a branded form of citicoline which is a nutrient found naturally in the brain increases phosphatidylcholine which is critical for healthy brain function. Cognizin citicoline also helps maintain normal levels of acetylcholine. The success of the production portion of the process relies upon an effective production team and a team that handles regulatory items as well. Kemin Human Nutrition and Health (Iowa) combines these ideas in Neumentix which is a water-extracted natural ingredient sourced from spearmint that supports cognitive performance according to Kim Colletti the company s global cognition product manager. Besides the extensive science supporting Neumentix two aspects of technology that Kemin Health uses to set Neumentix apart are the use of our specialty crops team in using a plant as mother nature s factory and our regulatory team in terms of patents she added. We look for the molecule that can deliver the cognitive benefits we desire for the ingredient. Through a thorough literature search it indicated that there would be cognitive benefits with rosmarinic acid and other polyphenols. Kemin plant biologists worked for five years and invested over 3 million to develop our cognitive performance ingredient Neumentix that supports focus and working memory without disrupting sleep at night. This involved screening over 5 000 plant lines using traditional plant breeding techniques developing patent-pending drying technology and partnering with local farmers to name a few of the pieces. The result of these efforts is a new non-GMO (generally modified organism) purpose-grown plant rich in phenolic molecules and tested in human clinical studies. These types of processes can help provide a preview as to what the market holds. Market Status As modern-day life moves what feels to be faster and faster tension and nerves run high as the brain faces more pressure. The result a greater demand for ingredients in the mental performance and stress reduction categories. The market is indeed robust Americans are feeling more acutely stressed than ever said Karen Hecht PhD technical marketing specialist with Washington-based AstaReal USA Inc. College students and young people are stressed to become independent and to succeed middleagers are stressed to ensure financial security and of course older folks are feeling the stress borne from agerelated decline as well as maintaining financial security. As Hecht touched upon stress can www.niemagazine.com September 2017 Go to www.niemagazine.com igy for info about this advertiser 8 Nutrition Industry Executive Go to www.niemagazine.com natreon for info about this advertiser ConditionSpecific take a toll on all age groups. Yannick Capelle product technical manager with Frutarom Switzerland Ltd.-- W denswil also sees the potential of the cognitive market to be quite large due to the same reason. Specifically Capelle noted there is potential in the market due to students seeking to keep their minds sharp during exams working professionals in stressful jobs looking for support to maintain concentration alertness and mental performance during long days and Golden Agers who want to keep 100 percent of their cognitive performance. Capelle also added that herbal extracts benefit from the natural halo effect and are becoming more and more popular in the market for cognitive health but focus is currently mainly on the most known botanicals such as Ginkgo biloba for mental performance and lemon balm for stress reduction. In Europe one of the biggest challenges is the regulation on health claims which makes it difficult to communicate on health benefits to consumers. Trends When it comes to the use of mental performance and stress reduction ingredient trends adaptogens are continuing to grow in popularity. A growing body of research is confirming usage of popular adaptogens such as maca rhodiola ashwagandha ginseng and eleuthero which will contribute to the global growth of the herbal supplements and remedies market projected to reach 115 billion by 2020 (Global Industry Analysts Inc.) noted Zapp. Another trend in the category is a letter vitamin. AFS recently launched its PurC organic vitamin C extract which is a fully water-soluble 25 percent vitamin C extract that is 100 percent organic certified and stable in formulation according to Zapp. The company finds itself in the middle of a market where demand for vitamin C is high especially since this vitamin can help battle stress. According to Mintel 38 percent of consumers believe that stress impacts the appearance of their skin and in that area 85 percent of consumers are seeking products with vitamin C which is more than any other active ingredient. (Mintel Interest in Natural Formulations 2016) Zapp added. The use of ingredients for cognitive health is also being explored for other uses including the field of sports nutrition. Kemin Health recognizes that cognitive ingredients could be utilized in sports nutrition as well as Go to www.niemagazine.com somalabs nootropic markets said Colletti. Growing interest in connecting nootropic (cognition-enhancing) benefits to physical performance improvements inspired our researchers to examine whether Neumentix s cognitive benefits could also support physical performance. In fact she referenced a study with active subjects ages 18-50 that were supplemented with 900 mg of either Neumentix or a placebo at breakfast for 90 days. Participants who were given Neumentix demonstrated an improved choice reaction performance after seven and 30 days along with an improvement in both focus and agility after 30 days.1 Research According to Capelle the cognition ingredient market is looking more and more for ingredients with proven efficacy so many companies invest in research to sustain the cognitive benefit with proprietary data. Along with efficacy proper dosing is another concern during ingredient research. Mostly research that of course shows efficacy and interest is always keen on showing efficacy in dosages that are easy to take (one pill versus six say) to promote longer duration of compliance said Hecht. AstaReal pioneered the natural astaxanthin industry in the 80s and provided the research and product innovation that formed the foundation for natural astaxanthin as a supplement for human health Hecht added. AstaReal continues to invest in research to understand the benefits of natural astaxanthin in cognitive health. NIE Reference 1 RDBPC 12-week study (Makoto Study (2017)) in healthy men and women 18-50 years of age with daily supplementation of Neumentix over the course of the study. Cognitive and physical performance improvements were observed after 30 and 90 days of continued use. FORMOREINFORMATION Applied Food Sciences Inc. (512) 732 8300 AstaReal USA Inc. (877) 227-8287 Frutarom Switzerland Ltd.--W denswil 41 44 782 63 20 Kemin Human Nutrition and Health (800) 777-8307 Kyowa Hakko USA (800) 596-9252 www.niemagazine.com September 2017 10 Nutrition Industry Executive Go to www.niemagazine.com daiwa for info about this advertiser Legalities Regulatory Oversight of Supplement Industry Continues By Ronie M. Schmelz and Anne S. Cruz Tucker Ellis LLP T he new administration has hardly hidden its disdain for regulation and disinterest in regulatory oversight. Nonetheless year-to-date activity by federal regulators signals that agencies have no intention of letting up on their policing of the supplement industry. By mid-July 2017 the U.S. Food and Drug Administration (FDA) had issued nearly the same number of warning letters to supplement companies as it had for all of 2016. The warning letters cite numerous claim labeling branding and current good manufacturing practices (CGMP) violations as discussed more fully below. Last spring scores of businesses including numerous companies in the supplement industry received letters from the Federal Trade Commission (FTC) calling out their failure to disclose relationships with influencers used to market their products. Recently the FDA and FTC joined forces to solicit consumers help in overseeing the supplement industry and asked them to report adverse events safety concerns and improper or overstated product claims (see Dietary supplement concerns Tell the FTC and FDA July 25 2017 FDA Voice). And wherever regulators tread plaintiff class action lawyers 12 Nutrition Industry Executive are typically not far behind as evidenced by the fact that this year in California alone more than 45 consumer class actions have been filed against supplement companies. We ll discuss those class actions in a future article. For now this article focuses on what has attracted the attention of regulators. Misbranded Products The FDA continues to crack down on supplement companies that claim their products are intended for use in the cure mitigation treatment or prevention of disease (e.g. cure cancer treat heart problems and promote sexual health). Some of the claims that drew the FDA s attention are not remarkable others a bit more surprising. Here s a sampling. Product Claims As it has done for decades the FDA has called out companies that claim their products can treat medical conditions including Activate numerous anabolic pathways Increase muscle mass Explosive muscle & strength gains Highly anabolic Blood sugar lowering effects [Listed ingredients] ... have very specific roles to play in ... cancer prevention Reduces brain inflammation Milk thistle--used as a natural treatment for liver problems ... helps repair liver cells damaged by alcohol and other toxic substances N-acetyl L-cysteine...plays a role in white cell production which may help repair damaged tissue All natural formula that ... attacks obesity The main focus of the herbs within [supplement product] is blood sugar balancing ... [Supplement product] is an all-natural formula that ... attacks obesity ... [Supplement product] with bitter melon is an amazing botanical that acts as a mediator between the body s cell and insulin thereby decreasing resistance to proper insulin function. This unique formula may block excessive formulation of glucose in the blood and enhance tolerance for blood sugars ... There are many well designed studies that have been published in legitimate journals that state garlic has a distinct effect on www.niemagazine.com September 2017 Go to www.niemagazine.com olcott info about this advertiser Legalities the reduction of cholesterol ... Natural relief of pain & irritability from ... Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to ... Helps reduce gum redness and pain cGMP The FDA continues to cite supplement companies that fail to adhere to cGMP (current good manufacturing practice). The focus is typically on a company s failure to maintain appropriate manufacturing records and perform adequate quality control. Here are examples of some of the circumstances that triggered warning letters determine whether specifications were met Failure to follow test procedures Failure to collect and properly preserve reserve samples of each production lot FTC Testimonial Crackdown In April 2017 the FTC cracked down on companies using social media influencers to tout their products. It issued more than 90 letters to companies that failed to adequately disclose any relationship including financial between the influencer and the company. A broad range of industries was caught in the sweep including supplement companies. The FTC focus on this increasingly prominent marketing tool is a reminder to all that when using influencers to promote products companies must adhere to the FTC s Guides Concerning the Use of Endorsements and Testimonials in Advertising. The foregoing confirms that neither the FDA nor the FTC have any intention of slowing down their regulatory oversight of the supplement industry. And as we will discuss in a future article wherever regulators tread consumer class action lawyers are never too far behind. NIE Ronie M. Schmelz is counsel with Tucker Ellis LLP in Los Angeles CA. Schmelz represents clients in broad-based commercial litigation. She regularly counsels clients on litigation-avoidance strategies and ensuring compliance with regulations enforced by the FDA FTC and other regulatory agencies California Proposition 65 and advertising labeling and claim substantiation. Schmelz has deep industry knowledge of and particular expertise in representing domestic and international cosmetic personal care and nutritional supplement companies in formulating best practices for pre- and post-market activities. She can be reached at ronie.schmelz tuckerellis.com. A partner with Tucker Ellis in Los Angeles Anne Swoboda Cruz practices in the areas of commercial disputes antitrust and products liability litigation. As a member of the Trial Department she has extensive litigation experience skillfully maneuvering clients through complex cases to successful resolutions. She has represented a wide range of clients including manufacturers telecommunications companies financial institutions food companies and retailers. She can be reached at anne.cruz tuckerellis.com. www.niemagazine.com September 2017 Consumer Testimonials A company that posts testimonials on its website is deemed to have adopted those statements as if they were made by the company itself. Any company that posts a testimonial that touts its products ability to treat a disease or medical condition is likely to see a warning letter as evidenced by the following testimonials Prostate and Bladder Cancer ... I was diagnosed with prostate and bladder cancer ... I chose to bypass surgery and started my own research to find alternate treatment. In my search I found an article that explained the effects of [Supplement Product] on cancer cells. I started a daily regiment [sic] of [Supplement Product] about two years ago and low and behold the mass has been steadily shrinking. Arthritis ... I used to have arthritic pain in my legs and since I started using the [Supplement Product] I am now pain free. High Cholesterol and High Blood Pressure ... My high cholesterol and high blood pressure ailments are now normal after drinking the [supplement product]. Manufacturing Records Failure to provide sufficient documentation to assure that products received from a supplier for packaging or labeling were adequately identified and consistent with the purchase order Failure to maintain product specifications for each supplement manufactured for the purity strength and composition of the finished batch Failure to maintain a written master manufacturing record (MMR) whether for lack of documentation describing manufacturing processes and product specifications written instructions for various aspects of the manufacturing process or corrective action plans for when a product specification is not met Written procedures for holding and distributing operations Scientific Articles In some cases website references to academic articles that discuss the medical benefits of particular ingredients found in a company s products has prompted a warning letter. Referring to the ingredients and referencing the article gave rise to the implied claim that the products containing the ingredients could provide the stated medical benefit. Adulterated Products Warning letters were issued for adulterated products including products containing Any herbs or botanicals that are new dietary ingredients Acacia rigidula In the absence of a history of use or other evidence of safety establishing that A. rigidula when used under the conditions recommended or suggested in the labeling of your product will reasonably be expected to be safe [Supplement Product] is adulterated ... because it contains a new dietary ingredient (NDI) for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. 14 Nutrition Industry Executive Quality Control Failure to ensure that water that could become a component of a finished batch of dietary supplement complied with applicable federal state and local requirements Failure to reject a component and dietary supplement for which a specification was not met Distribution of products that were superpotent for dietary ingredients Failure to follow written procedures for laboratory operations including written procedures for the tests and examinations to Go to www.niemagazine.com certifiednutraceuticals for info about this advertiser IndustryNews Rep. Mia Love Named Co-chair of the Congressional DSC epresentative Mia Love R-Utah has taken on a new leadership role as a co-chair of the Congressional Dietary Supplement Caucus (DSC). Love replaces Rep. Jason Chaffetz formerly a DSC cochair who retired from the House of Representatives this summer. The DSC is a bipartisan congressional group of legislators who promote discussions among lawmakers about the benefits of dietary supplements provide tips and insights for better health and wellness and promote research about the health care cost savings these products provide. In her new role Love joins Senators Orrin Hatch R-UT Martin Heinrich DNM and Rep. Jared Polis D-CO as DSC co-chairs. I m excited to begin work on behalf of the more than 68 percent of Americans who take dietary supplements every year Love said. The industry is also a crucial part of Utah s economy. Not only do dietary supplement companies provide jobs and opportunities in my state they give consumers the opportunity to make educated choices to fill critical nutrient gaps and achieve better health. R Rep. Love s ascension to co-chair of the DSC drew praise from the major trade associations representing the dietary supplement industry. We greatly appreciate Rep. Love volunteering her valuable time and expertise to lead this Caucus in representing the regulated dietary supplement industry on Capitol Hill said Michael McGuffin president of the American Herbal Products Association. Rep. Love s leadership will help the Caucus continue to educate policymakers about this growing industry s significant and positive impact on consumer health and the U.S. economy. Congresswoman Love deeply understands the value of dietary supplements and the important role they play for the millions of Americans who use them to support their overall health and wellness said Scott Melville president and CEO of the Consumer Healthcare Products Association (CHPA). We look forward to working with her and the rest of the DSC to educate Congress about the policy issues that impact the supplement industry. As more than 170 million Americans take dietary supplements each year the Dietary Supplement Caucus serves as an important resource to ensure legislators and their staff learn more about the wellness benefits of dietary supplements and the regulatory complexities of our booming industry said Council for Responsible Nutrition (CRN) President and CEO Steve Mister. CRN welcomes Rep. Love to her new position and is eager to see how her voice and fresh perspective will further the Caucus crucial work. Loren Israelsen president of the United Natural Products Alliance (UNPA) said UNPA is thrilled that Rep. Love is taking on this important new leadership role. We look forward to working with her to help grow the 41 billion national dietary supplement industry which includes more than 13 billion in supplement business activity in Utah. The dietary supplement industry is a positive and powerful economic engine that creates thousands of jobs while helping Americans support their healthy lifestyles. For more information visit www.ahpa.org www.chpa.org www.crnusa.org or www.unpa.com. Aker BioMarine and Neptune Close 34 Million Agreement N eptune Technologies & Bioressources Inc. (Laval QC Canada) and Aker BioMarine Antarctic AS (Lysaker Norway) have announced that they have concluded an agreement whereby Aker BioMarine acquired Neptune s krill oil inventory and IP for a cash consideration of 34 million (U.S.) paid at closing. This transaction marks an important step in Neptune s next phase of development. Neptune believes strongly in the health benefits that krill oil provides and will remain actively involved in this sector via our investment in Acasti Pharma Inc. and also through finished form soft gel capsules from our Solutions Business said Jim Hamilton president and CEO of Neptune. The proceeds from this transaction allow Neptune to accelerate its efforts to position the company in attractive growth segments such as cannabis oil extraction as well as support further acquisitions consistent with our strategy. 16 Nutrition Industry Executive In the last two fiscal years we have significantly grown revenues and improved the bottom line. We are excited about the opportunities that this transaction will enable for the future and the value creation for our shareholders on a long term basis. Neptune has made a strategic decision to withdraw as a bulk krill oil supplier while Aker BioMarine wants to increase investment in the category so this agreement is a perfect fit for both parties added Matts Johansen CEO of Aker BioMarine. This acquisition will allow us to increase investments in science and product innovation sustainable krill-harvesting practices and marketing support for our customers which in turn will build excitement and accelerate growth in the omega-3 market. Neptune s customers and products will be integrated into Aker BioMarine including Neptune s popular NKO brand. These customers will continue to receive the products they are used to and at the same time benefit from the additional products and support Aker BioMarine will offer to drive growth in the omega-3 market. Neptune will exit its bulk krill oil manufacturing and distribution activities and support Aker BioMarine with the transition of its customers krill oil inventory and intellectual property for a total cash consideration of 34 million (U.S.). Some of the proceeds will be used to reduce debt with high interest rates and the balance will be allocated to innovation projects such as the Green Valley medical cannabis oil extraction project and to acquisitions in line with its growth strategy. For more information visit www.neptunecorp.com or www.akerbiomarine.com. www.niemagazine.com September 2017 Go to www.niemagazine.com innovactiv for info about this advertiser IndustryNews NSF International and DYT Partner to Develop Product Standard in China SF International a global public health organization and a leading certifier of dietary supplements met with Diao Yu Tai Food Biotechnology Company (DYT) in Beijing recently to sign a cooperative agreement and discuss development of a functional product standard and certification program in China. An established name brand for more than 800 years DYT is a leading developer and provider of organic food and Chinese medicine-based functional products in China. We recognize NSF International as the leading global standard developer and certification body for public health especially in the dietary supplement industry said Xu Wenhai chairman of DYT. This is why we have established a N strategic partnership with NSF to develop a functional product standard and certification program. NSF International operates in more than 170 countries including China where it has multiple locations and an accredited testing laboratory in Shanghai. A recent strategic discussion between DYT senior management and NSF International included presentations from Kevan Lawlor president and CEO of NSF International Dr. Lori Bestervelt executive vice president and chief technical officer of NSF International Yu Sulian chief advisor to NSF China and Dr. Laura Liu NSF s health sciences division manager China. Topics ranged from NSF International s history and mission to the importance of good manufacturing practices (GMPs) dietary sup- plement testing technologies and NSF s standards development processes. As a global public health organization we are committed to protecting and improving human health and the environment said Lawlor. From our discussions it is clear that Diao Yu Tai is committed to quality and helping ensure the safety of consumers as well. According to DYT introduction of the functional product standard and certification program will help ensure functional product quality throughout the supply chain. With the cooperative agreement signed the two organizations expect to issue the first functional product standard and certification program by 2018. For more information visit www.nsf.org. DuPont Expands Synergy Flavors Breaks Ground on New Corporate Campus Building Probiotics Facility ynergy Flavors (Wauconda IL) a global supplier of flavors extracts and essences is expanding its business due to its continued growth and success in the food and beverage industry. The company will be adding a 40 000-square-foot building to its corporate campus which is expected to be completed in June 2018. The building will include additional office and lab space to support the additional workspace needed to foster the company increase in size data and materials. Key highlights of the expansion Campus to grow to 260-plus employees in three years Silver LEED certification Campus expansion to 200 000 square feet total upon completion of addition Potential for up to 50 new jobs locally in Chicago IL area Our rapid growth is a testament to our dedication to our customers our employees and our shareholders and we are excited to continue that growth in Wauconda. We are looking forward to expanding our facilities and continuing to hire new team members to further our robust growth and continue on a path of leadership in our industry said Rod Sowders chief executive officer of Synergy Flavors. The new state-of-the-art building aligns with our company s vision and future growth plans and will help ensure the company has the people technology and tools in place to take Synergy Flavors in to the future. For more information visit www.synergytaste.com. S Executives from Synergy Flavors commemorated the companys continued business growth by breaking ground on a new corporate campus building. uPont Nutrition & Health has announced a substantial upgrade to its probiotics pilot facility in Madison WI. The 10 million investment strengthens and emboldens DuPont s current position as a leader in the probiotics industry allowing for increased pace of new product development and significantly improved delivery times on pilot material for clinical trials and customer evaluations. Construction on the Madison probiotics pilot area completed in phases over the last six months provides increased capacity and speed for new product development. This in turn improves overall scale up capability and a more seamless transition to commercial scale production. Given the explosive rise in demand for probiotics products all around the globe this project allows us to aggressively pursue our goal to be the No. 1 probiotics supplier in the world said DuPont Nutrition & Health President Matthias Heinzel. These expansion efforts show our commitment to becoming bigger and stronger with our capability to meet demand and our facilities and qualified staff to handle the significant growth we foresee in this sector. The pilot area features new state-of-the-art equipment data collection laboratories instrumentation and specialized workspace for probiotic development and scale up. The upgrades that quadrupled the pilot area have already increased bandwidth to simultaneously run more development projects while improving scale up efficiency and time to market. With all the enhancements we are better able to meet customer demand for new probiotics at a much faster pace said Kurt Fenster BioProcess Development group manager Culture Manufacturing Technology at DuPont Nutrition & Health. Moving forward we expect to substantially increase our speed to deliver products to customers. For more information visit www.food.dupont.com. D 18 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com infiniti for info about this advertiser IndustryNews Lycored Announces Launch of Lycopene Lycopedia ycored (Orange NJ) has announced the launch of its Lycopedia an interactive educational hub that tells the narrative journey of lycopene and its effect on the body during different stages of life. By creating the Lycopedia Lycored hopes it will act as a timeless resource that showcases the incredible health benefits of lycopene the red-hued tomatoderived carotenoid used in food and beverage and oral supplementation. From early life younger adult midlife adult and older adult the Lycopedia guides visitors through an interactive journey on lycopene expanding on the various benefits this carotenoid provides to the body during each phase of life. Health concerns covered throughout the timeline include preeclampsia lung health skin health fertility cardiovascular health vision health osteo- L porosis and prostate health. We have focused a large part of more than 50 clinical studies on exploring lycopene s different beneficial roles in our wellness at every stage of life which resulted in us taking our Lycored Nutrient Complex range for specific indications mainstream yet we are only scratching the surface on what our hero carotenoid is capable of for our wellbeing said Rony PatishiChillim Lycored president and CEO. With further research we have been able to unearth a multitude of health benefits and as a result we want to also make consumers and our industry aware of the significance of lycopene not just for wellness benefits but as a lifelong ally. The launch of the Lycopedia showcases both the depth of research and undeniable commitment Lycored has to the wellbeing and education of creating wellness from within. Through the belief that nature holds a wealth of knowledge just waiting to be unearthed Lycored plans to continue to introduce education tools to their community including a link to its Lycopedia on their un-branded consumer facing website lycopene.com and via wide ranging partnerships including its brand ambassador network. For more information visit www.lycored.com lycopedia. Lonza Acquires Micro-Macinazione onza (Basel Switzerland) has acquired Micro-Macinazione one of Europe s leading contract manufacturers providing micronization of active ingredients for the pharmaceutical and fine chemical industries. Micro-Macinazione which had sales of approximately CHF 20 million in 2016 has 120 employees and is based in Monteggio Switzerland. Micro-Macinazione was purchased from Cross and the acquisition was completed on July 26 2017. Financial details of the deal were not disclosed. The acquisition of MicroMacinazione creates the global leader in the field of micronization services by building on Lonza Capsugel s existing micronization clinical and commercial manufacturing capabilities that are based in Quakertown PA (USA). Lonza Capsugel strengthened its micronization offering to customers in January 2016 when it acquired Powdersize and has since invested in significant additional capacity at this site which came on stream in early 2017. With the acquisition of MicroMacinazione Lonza becomes the largest and most diversified provider of micronization services to the pharmaceutical industry said Lonza s Pharma&Biotech COO Marc Funk. L Micronization is an attractive technology for Lonza given its applications across many of the high growth areas of the pharma market. MicroMacinazione provides micronization technology and expertise that complements our existing U.S. capabilities and provides significant additional capacity to support our growth. Its micronization technology can also add value to other areas of Lonza business including health and nutrition ingredients and excipients enhancing the appeal of this bolt-on acquisition which strengthens our position across the health care continuum. Lonza s Pharma&Biotech customers are increasingly looking for external partners to help them assess earlystage compounds and to improve product design by using micronization and sub-micronization to address key challenges of active pharmaceutical ingredients (API) development. A key focus for the new combined business will be highly potent APIs (HPAPIs) where Micro-Macinaziones s pilot to commercial scale HPAPI offerings and Lonza s recent HPAPI capacity expansion at Quakertown provide the capacity and expertise needed to serve this growing area of the pharmaceutical market. Micro-Macinazione was founded in 1970 and has been a pioneer in the development of jet mill equipment and contract micronization services said Markus Arigoni CEO of MicroMacinazione. We operate in a niche market with high growth expectations. Micronization is often seen as key to improving the bioavailability of the growing number of highly potent and complex APIs which an increasing number of pharma and biotech companies are looking to develop. By combining with Lonza we are creating a global leader with the ability to provide customers both in the U.S. and Europe with access to the micronization technologies and manufacturing capabilities that they need to bring novel drugs to market faster and more efficiently. For more information visit www.lonza.com or www.micromacinazione.com. 20 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com gcinutrients for info about this advertiser IndustryNews Bill Brevoort Chinese Herb Pioneer Dies at 75 conic Chinese medicinal herb pioneer Bill Brevoort 75 passed away at his home in Kona HI on July 28. He had been recently diagnosed with metastatic melanoma. Brevoort was a truly remarkable man--intelligent intrepid focused and highly spiritual as noted by the American Botanical Council (ABC). He and his wife Peggy Brevoort founded East Earth Herb in 1971 the first company to educate and market to the natural food community about the healing and vitality-empowering aspects of traditional Chinese herbs. The East Earth Herb booth was a popular location at many natural food trade shows and alternative medicine conferences in the 1970s 1980s and 1990s where Bill Brevoort would often listen to a person s pulse look at their tongue and frequently perk them up with one of his special blends of Chinese herbal tonic elixirs teas and other creatively blended for- I mulations. East Earth s Dragon Eggs line of Chinese herbs was most likely the first Americanmade line of Chinese herbal formulas. The Brevoorts are also largely credited with creating the initial interest in the Pacific herb kava with their popular after-conference kava parties in the 1990s. A practicing Buddhist most of his adult life he was also an avid amateur astronomer and dedicated vegetable gardener. ABC Founder and Executive Director Mark Blumenthal recalled his 43-year relationship with Brevoort Bill was a truly amazing brilliant spiritual one-of-a kind man. He and Peggy are true pioneers of the American herb movement particularly with respect to Chinese herbs having imported and distributed Chinese herbal patent medicines in the early 1970s and later their own Chinese herbal dietary supplements. They were one of my first suppliers when I owned Sweethardt Herbs (1974-1986) my former herb wholesaling company in Austin TX. When I first started ordering from them they were living in Reedsport OR and I had to call them on a ship-to-shore radiophone line to order Chinese Ginseng Bee Secretion (which Bill probably received by submarine from Vancouver FDA was not letting such products into the U.S. in those days except for sale in ethnic Chinese stores in San Francisco and a few other cities.) In addition to introducing me to many Chinese herbs and kava Bill is also my first introduction to the fabled Chinese Pu-erh tea. American River Nutrition Launches New Brand Identity & Website merican River Nutrition (Hadley MA) has unveiled new branding ranging from logos to a new website for the company and its DeltaGold tocotrienol vitamin E ingredient. Having spent many years focusing on the science of annattoderived tocotrienols we felt it was time for American River Nutrition to move to the next level in marketing our DeltaGold said Anne Trias MS American River Nutrition product director. With our new look and website in place and an exciting new clinical study on DeltaGold that adds significantly to the existing body of science publishing shortly we re enthusiastic about future growth. Todd Pauli of The Shelton Group (Illinois) a boutique marketing and PR firm working in the dietary supplement industry since 1990 led the rebranding effort. It was an honor to work with the people who not only introduced tocotrienols but also maintain such dedicated focus on the science that supports DeltaGold said Pauli Shelton Group Partner. Inspired by the particular shape and color of the annatto plant from which DeltaGold is derived we sought to tell American River s unique story of being both leading scientists and U.S.based ingredient manufacturers. Founded by Dr. Barrie Tan notable expert in the field of vitamin E tocopherols and tocotrienols American River Nutrition has exclusive focus on tocotrienols from the annatto plant as the purest source of delta- and gamma-tocotrienols which emerging research has proven to contain some exceptional benefits that are not shared by their tocopherol counterparts. For more information visit www.americanrivernutrition.com. Wellnext Expands Portfolio of Brands With NeoCell ellnext LLC (Florida) a vertically integrated developer manufacturer and marketer of dietary and nutritional supplements announced the acquisition of NeoCell a collagen supplement company based in California. For nearly two decades NeoCell has specialized in collagen-based supplements for joint bone and muscle health using advanced formulas based on ingredients such as collagen biotin and hyaluronic acid. We are very excited to partner with Wellnext and gain the support of its operational and commercial capabilities to further expand NeoCell said Sarah Quadri NeoCell s chief operating officer. We are confident that Wellnext will provide unique manufacturing product development and market expansion capabilities to support NeoCell s next phase of growth. NeoCell represents the fourth acquisition made by Wellnext in the last two years. NeoCell complements Wellnext s portfolio of brands expanding it into the fast-growing collagen category while diversifying the company s product category focus Jose Minski CEO of Wellnext stated. We are excited to work with NeoCell s industry-leading products for beauty bone and joint health. For more information visit www.wellnexthealth.com. A W 22 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com balchem for info about this advertiser IndustryNews Captek Softgel International Acquires J D Labs alifornia-based Captek Softgel International Inc. (CSI) a contract manufacturer of custom dietary supplements announced its acquisition of California-based J D Labs Pharma Manufacturing Inc. Captek Softgel International is a portfolio company of Swander Pace Capital and the acquisition of J D Labs is a continuation of SPC s focus on investing in and growing industryleading vitamin mineral and supplement companies. For decades J D Labs has been recognized in the nutraceutical industry as a first-class manufacturer of health and wellness supplements producing more than 1 000 unique formulations. More recently J D Labs has brought NutraStock to the market more than 250 bulk stock dietary C supplements manufactured in the USA. Captek CEO David Wood said this union will result in a greater diversity of offerings and services within the supplement channel. We have long regarded J D Labs reputation and the significance of what they bring to the table as a leader in the industry he said. J D Labs extensive experience manufacturing a wide-range of soft gels specialized tablets capsules and powder formulations was a perfect complement to Captek s offerings. The newly joined companies will continue to produce products in both Cerritos and Vista CA. This will give customers the business continuity by having the ability to have their products manufactured at either site. As a result more than 300 000 square feet of manufacturing warehousing and analytical testing labs will immediately bring to market greater capacity expertise comprehensive turnkey packaging the benefits of enteric coating and more according to the companies. For more information visit www.capteksoftgel.com www.spcap.com or www.jdlabs.com. You reHired Shaheen Majeed has been promoted to president of Sabinsa Worldwide (East Windsor NJ) with responsibility for manufacturing marketing strategies and other operational matters. Majeed s first job was in the Sabinsa warehouse when he was 17 years old and over the past 23 years he has held a variety of positions representing the company s substantial portfolio of proprietary nutritional and cosmeceutical ingredients. NattoPharma (Oslo Norway and Metuchen NJ) has named Jeff Lind as its vice president of sales Americas. Lind comes to NattoPharma from Natreon Inc. where he served as the vice president of sales and marketing. Prior to Natreon he led Frutarom US Inc. s North American Health Business Unit and served as the CEO with Sabinsa Corporation. SPINS (Chicago IL) has announced Patrick Kelly as senior vice president of customer soluShaheen Majeed tions and AJ Rivera as principal of global enterprise sales. Kelly will activate SPINS assets to deliver insights and actionable solutions to SPINS retail partners improving the health & wellness shopping experience and driving consumer loyalty. Rivera will work with CPGs to align to these enterprise-wide solutions and create custom wellness frameworks. Virginia-based BIO-CAT is expanding its team. The company has hired Stephen Schuler as its newest member to the sales team and Debbie Jackson as regulatory affairs associate. In her new role Jackson will help develop BIO-CAT s support of those customers and business efforts by providing information and support as it pertains to BIO-CAT s line of enzymes and probiotics. In addition Christopher Penet vice president of BIO-CAT assumed the role of committee Jeff Lind chair for the IFT Biotechnology Division. Penet spent the previous year as chair-elect. His new position as committee chair is to develop and implement activities in support of the IFT overall mission and to engage members by providing education on the impact that biotechnology can have on the various roles within the food industry. Oregon State University has named Richard van Breemen as the director of the university s Linus Pauling Institute. Van Breemen professor of pharmacy at the University of Illinois at Chicago will succeed Balz Frei as director and endowed chair of the institute which studies the role of vitamins and other micronutrients in enhancing health and preventing disease. Biova LLC (Johnston IA) has added Amanda Orloske as director of marketing to the management team. Orloske has more than 10 years of experience in marketing and sales in the nutritional industry and has covered all different aspects of marketing including graphic Amanda Orloske design web development and CRM management. 24 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com onceagain for info about this advertiser IngredientNews Embria Partners With LEHVOSS Nutrition Division owa-based Embria Health Sciences LLC manufacturer of EpiCor fermentate has partnered with the nutritional division of LEHVOSS UK - Gee Lawson (England) to distribute its flagship ingredient to key countries in Western Europe including United Kingdom Italy France Germany and Spain along with Scandinavia and Benelux regions. EpiCor is a natural whole-food fermentation ingredient made from a proprietary process. EpiCor s metaboliterich composition includes proteins fibers polyphenols vitamins amino acids polysaccharides (including beta glucans) and many other beneficial I bioactive metabolite compounds that work together to support a strong immune and digestive system. Eight human clinical studies covering hundreds of subjects show EpiCor supports wellness by strengthening the immune system and supporting gastro-intestinal health. As a complex ingredient EpiCor has many documented modes of action including increasing sIgA antibodies activating certain white blood cell activity (natural killer cells) and boosting antioxidant power. For more information visit www.embriahealth.com or www.geelawson.com. Longvida Exhibits Significant Improvements to Neuroprotective Biomarkers esearchers at Central Michigan University have taken a closer look at Longvida Optimized Curcumin. Previously these researchers conducted amyloid binding work in vitro with promising results. Recently published in the International Journal of Alzheimer s Disease Maiti P et al have compared standard unformulated curcumin more closely to Longvida with SLCP Technology. The present study was designed to compare the neuroprotective effects of [unformulated 95 percent curcumin equivalent to 80 percent free curcumin] and or SLCP [Longvida with 20 percent free curcumin] in vitro after exposure to A 42. It is important to note that the accumulation of amyloid beta (A ) proteins and phosphorlayted tau (p-tau) are key pathological hallmarks of AD. The researchers go on to explain that the maintenance of cell survival protein markers as well as decreasing oxidative stress are vital factors in the delay of neurodegeneration or neuronal loss. In this study Maiti and team brought a fresh perspective to the question how does Longvida s free curcumin compare to unformulated free curcumin With that in mind the results are even more exciting to see Longvida s free curcumin outperformed the unformulated 80 percent free curcumin in all tested parameters. Longvida showed greater permeability than 80 percent in vitro decreased reactive oxygen species (ROS) production and prevented apoptic death. Next researchers examined cell death and cell survival markers after exposure to A 42. They indicated that with A 42-treatment whereas SLCP but not curcumin was able to decrease these protein levels. Longvida was also shown to mediate p-tau after exposure to A 42 as they showed that without Longvida A 42 exposure significantly increased (p 0.01) p-tau. For more information visit www.vs-corp.com. R Publication of a Safety and Tolerance Study for Probiokid Strains team from Madrid University (Spain) has just published a multicentre randomized double-blind placebo-controlled intervention study regarding the safety and tolerance of three of LHS probiotic strains in healthy infants. The strains tested individually are Lactobacillus helveticus Rosell-52 Bifidobacterium infantis Rosell-33 and Bifidobacterium bifidum Rosell-71 all part of the ProbioKid formula previously shown to help prevent the reoccurrence of winter infections in children. The eight-week intervention study involved a large population sample as 221 healthy infants (3-12 months of age) A were recruited in total divided between four groups (placebo and each of the three probiotic strains). No serious adverse events were reported and the Spanish authors concluded that the use of the three probiotic strains in infancy is safe and well tolerated. The safety study contributed to the GRAS (generally recognized as safe) status recently obtained in the U.S. for both ProbioKid formula and its individual strains for infants and children and the approval by Health Canada of the formula for children from 3 months old. For more information visit www.lallemand-health-solutions.com. MenaQ7 Expands Brazil Presence With New Partner attoPharma (New Jersey) announced a new partnership with Nutriangels (Brazil) a pioneering nutraceutical brand with highly innovative products that include chelated minerals further expanding the presence of MenaQ7 Vitamin K2 as MK-7 in Brazil. Nutriangels launched K2 featuring N MenaQ7 in Q2 2017 and has already been well received. Because of NattoPharma s extensive clinical substantiation and awarded patents K2 is positioned to support both bone and cardiovascular health. For more information visit www.nattopharma.com www.menaq7.com or www.nutriangels.com.br k2-mais p. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose treat cure or prevent any disease. www.niemagazine.com September 2017 26 Nutrition Industry Executive Frutarom Helps to Empower Women Increase Annatto Crop rutarom Natural Solutions BU (Israel) offers local women farmers and growers in Latin America a secured income and versatile collaboration to ensure a safe sustainable and consistent supply of natural annatto coloring. Women are playing a big role in changing the food system to create a well-nourished world said Danielle Nierenberg president of FoodTank. They are taking on larger and more defined roles in food and agriculture globally. On average women represent 43 percent of the world s agricultural labor force according to the U.N. Food and Agriculture Organization (FAO) and the World Bank. In Peru Brazil Guatemala and other countries women are the primary keep- F ers of the household but are struggling with basic subsistence. In light of this challenge and with the growing demand for natural annatto coloring Frutarom has initiated a collaboration with a local agriculture partner to encourage local women to become independent farmers and grow annatto in their fields. Together Frutarom and its partner support the local farmers from mother plantation to education and training including technical support on how to grow and harvest high quality annatto. Frutarom is committed to buying all the fresh annatto harvested at a fair price. The outcome of this collaboration is providing a safe stable income to the growers working directly with local farmers. Annatto is an oily seed from the Achiote tree (Bixa orellana). Natural pigments present in the seeds are the carotenoids bixin and norbixin. It has a wide color range of yellow to orange tones with mid to high stability against light heat and oxidation. Frutarom s advanced extraction of the seeds also enables recovery of high-antioxidant vitamin E while significantly minimizing fruit waste explained Glickman. Suppliers of natural colors are in a race to provide sufficient supplies of natural annatto coloring. For more information visit www.frutaromnatural.com. Less Sodium for Plant-based Meat Analogs srael-based Salt of the Earth Ltd. completed a series of trials of plant-based vegan and vegetarian meat alternatives. The trials successfully demonstrated the ability to create tasty meat analogs with less sodium. For developers seeking to meet the growing demand for meat alternatives Salt of the Earth s Mediterranean Umami clean-label sodium-reduction ingredient can be a key ingredient in creating meatless products. Increasing consumer concern over sustainability and the global food chain alongside the rise of veganism plant power and clean eating trends has facilitated diverse new product innovation in the global meat substitutes market according to Innova Market Insights. For the U.K. market specifically meat analog launches tracked by Innova registered a 4.9 percent CAGR (2011-2016) while the U.S. market recorded even higher growth at 8.7 percent CAGR in the same period. As part of this trend even major meat companies have recently invested in start-ups and companies making plant-based and vegan meat substitutes. For more information visit www.saltoftheearthltd.com. I DuPont Nutrition & Health Increases the Appeal of Dairy-free Drinks uPont Nutrition & Health (Denmark) announced that it has made it easier for beverage manufacturers to produce stable soy almond and other plant-based drinks with a refreshing texture and a clean label. Utilizing a new ingredient in the DuPont Danisco range manufacturers can obtain all the functionality they need without mixing in other additives. The gelling ingredient is Grindsted Gellan Mas 100-- otherwise known as gellan gum--and is the label-friendly stabilizer for non-dairy beverages made with pulses grains nuts and plant-derived protein. Previously produced by DuPont for ingredient systems it is now available as a single ingredient for the first time. Grindsted Gellan Mas 100 provides reliable stabilizing functionality with a low cost in use regardless of raw material fluctuations. No other additives are required-- supporting the consumer preference for clean-label plant-based drinks that are free of artificial ingredients. For more information visit www.dupont.com. D Fit for Purpose Fruit d Or Cran Naturelle is a Game Changer in Cranberry Research or the first time researchers have linked the structure of specific soluble cranberry proanthocyanidins (PAC) found in Canada-based Fruit d Or s Cran Naturelle whole fruit cranberry powder with a mechanism of action and efficacy. The in-vitro study conducted using Fruit d Or s Cran Naturelle whole fruit cranberry powder F demonstrates the value of using stateof-art C-PAC reference standard in research. In the study conducted by Complete Phytochemical Solutions (CPS) a thirdparty consulting and contract research company researchers used scanning electron microscopy to capture images of extra-intestinal pathogen Escherichia coli (ExPEC) agglutinated in the presence of proanthocyanidins from Fruit d Or Cran Naturelle. C-PAC reference material developed by CPS was used to authenticate and quantify the soluble and insoluble PAC from Cran Naturelle whole fruit cranberry powder. For more information visit www.crannaturelle.ca. Nutrition Industry Executive 27 September 2017 www.niemagazine.com IngredientNews Curcumin C3 Complex With Bioperine Shows Protective Role in Lipid Profile Modification in Type 2 Diabetes study that further consolidates the ameliorating role that Sabinsa s C3 Complex BioPerine combination plays in the context of diabetes has just been published in Complementary Therapies in Medicine. The study demonstrated the protective role the C3 Complex BioPerine combo play in maintaining HDL functionality reducing non-HDL-C and for the first time in curcumin research improve- A ments in Lp(a) [Lipoprotein(a)] a structural component of LDL. The results of a 12-week randomized double-blind placebo-controlled trial on subjects with type-2 diabetes showed promising outcome of using a combination of Sabinsa s proprietary branded ingredients Curcumin C3 Complex (1 000 mg day) and BioPerine (10 mg day). Fifty subjects in the active group and an equivalent number in the placebo group successfully completed the trial. The analysis of the results showed that the Curcumin C3 Complex BioPerine combination reduced the atherogenic lipid indices including non-HDL-cholesterol and Lp(a) while showing an increase in HDL-levels and improving HDL-functionality. For more information visit www.sabinsa.com. Nutrition 21 Presents Studies on Velositol at ISSN Gains GRAS Status ames Komorowski MS CNS vice president of scientific and regulatory affairs at Nutrition 21 presented the results of three preclinical studies on New Yorkbased Nutrition 21 s patented amylopectin and chromium combination ingredient Velositol at the ISSN (International Society of Sports Nutrition) this summer in Phoenix AZ. The study results presented showed the positive effects of Velositol on increasing muscle protein synthesis when combined with branched-chain amino acids (BCAA) pea protein and increasing doses of whey protein. In a previous human study published in Journal of the International Society of Sports Nutrition Velositol was shown to double the muscle J protein synthesis (MPS) rate by 48 percent from baseline when combined with whey protein (6 grams) as compared to a 24 percent increase from baseline shown with whey protein alone. The purpose of the three additional preclinical studies presented at ISSN was to evaluate and examine further effects of Velositol when added to a different protein source (other than whey protein) such as BCAAs pea protein and increasing doses of whey protein. The study results were also used to determine if the Velositol benefits seen in the clinical study could also apply to higher doses of whey protein and potentially raise the ceiling effect seen in MPS with increasing doses of protein. Velositol has also attained GRAS (generally recognized as safe) status after an extensive and rigorous review of the scientific dossier and safety data conducted by Intertek Health Sciences Inc. Velositol was determined to be GRAS at the recommended serving of 2 grams per day in protein drinks (including ready-to-drink and powder) meal replacement bars energy and protein bars with the consideration that these products can be taken up to three times a day. For more information visit www.nutrition21.com. Study Shows Capsicum Extract Helps Increase Metabolic Rate s we age managing healthy weight may become more difficult due to a slowing metabolism however help may come from a fiery source--the capsicum pepper. A recent paper Capsaicinoids Enhance Metabolic Rate in Normal Healthy Individuals Using a Novel Metabolic Tracker Breezing Device--An Open Label Placebo Controlled Acute Study published in the journal Obesity Open Access discussed the findings of the Metabolic Rate (MR) Study which demonstrated that an extract from red hot peppers boosted metabolic rate (Chen et al. 2017). The MR Study was a placebo-con- A trolled crossover open label study with 40 healthy adults examining the effects of either 2 mg capsaicinoids from 100 mg of Capsimax or placebo on resting energy expenditure heart rate and blood pressure. Resting energy expenditure is the amount of energy required by the body during resting conditions and accounts up to 60 percent of the calories you burn each day and so increasing this amount can aid in managing weight. The study showed that supplementing with this low dose of Capsimax increased metabolic rate which calculated to an equivalent to burning an extra 116 calories per day. Moreover though resting energy expenditure varies with each individual this increase would yield almost 1 lb. of fat lost over 30 days. For more information visit www.omniactives.com. www.niemagazine.com September 2017 28 Nutrition Industry Executive Go to www.niemagazine.com alkemistlabs for info about this advertiser IngredientNews Balchem Applauds AMA Recommendation for Increased Choline Levels in Prenatal Vitamins alchem Corporation (New Hampton NY) maker of the VitaCholine branded choline product line commends the American Medical Association (AMA) for taking action to ensure that pregnant women get adequate levels of choline an essential nutrient needed to support neural development of the fetus and reduce the incidence of birth defects. A resolution passed by delegates at the 2017 AMA Annual Meeting supports evidence-based amounts of choline in all prenatal vitamins to make B sure pregnant women maintain adequate choline levels. In 1998 the Institute of Medicine established a Dietary Reference Intake (DRI) of 450 mg for pregnant women and 550 mg for adults in general. A recent study showed that only eight of the top 25 prenatal vitamins contain choline and none provide more than 55 mg per daily dose which is just 12 percent of the DRI for pregnant women. Additionally data from the most recent National Health and Nutrition Examination Survey (NHANES) indicates that women aged 20 and above consume just 278 mg of choline on average from both food and supplements far below the recommended levels. For more information visit www.balchem.com. Lesaffre Organic Certified Nutritional Yeast Now Gluten-free esaffre Human Care (France) supplier of ingredients from yeast and bacteria fermentation for the global human care markets announced that Lynside Nutri Organic is now certified gluten free. Although some believe that the gluten-free market is about to slow down recent research is showing that consumers are still demanding gluten-free products and brands are delivering. Indeed Allied Market Research predicts the gluten-free food market will increase from 3.13 million in 2015 to 5.28 million by 2022. To ensure the total absence of gluten in its organic nutritional yeasts Lesaffre Human Care per- L Prova Launches New Line Of Allergen-free Nut Flavors illiam Graham PROVA (Massachusetts) s vice president sales North [use America AlgaeHealth announced the immediate and ongoing availability of new nut flavors especially suited to consumers who suffer from tree nut allergies. Three million of the more than 15 million consumers who have food allergies need to avoid nuts to prevent allergic reactions that can be quite severe. Beyond understanding that nut allergies pose a serious medical concern there s the economic impact of children s allergies--presently about 25 billion dollars a year. PROVA technology has found the solution to the nut allergy challenge in a new line of 30 allergen-free natural type nut flavors that are well suited to a wide range of products. Peanut [use DDW here] pecan pistachio coconut pine nut almond cashew and hazelnut are among the allergen-free natural type nut flavors now available from PROVA. These flavors capture unmistakable good taste without imparting the effects of troubling components that trigger allergic reactions. For more information visit www.prova.fr. W forms a series of tests on all batches which includes Sandwich Elisa and competitive Elisa tests. The latter being the most efficient and reliable to quantify hydrolyzed gluten which is the most common form of gluten in organic yeasts. When identified in Lynside Nutri Organic quantities are always well below 20 ppm which is compliant with gluten-free labeling regulations. For more information visit www.lesaffrehumancare.com. Barrington Nutritionals Reaffirms Representation of Algatech arrington Nutritionals (Harrison NY) a North American distributor of ingredients to the nutraceutical pharmaceutical and functional food industries reaffirmed its continued loyal representation and exclusive North American distribution of AstaPure Oleoresin Powder and all other non-beadlet product forms from Algatechnologies Ltd. (Algatech). Barrington has partnered with Algatech over the past eight years as its official distributor of AstaPure in North America. The company s commitment B in offering new technologies with Algatechnologies continues and it is working to introduce Organic Oleoresin Fucoxanthin and other product forms in the year ahead. Barrington Nutritionals has been an ingredient distributor to the North American nutraceutical industry for more than 25 years partnering with manufacturers from around the world to offer science-based ingredients such as AstaPure astaxanthin. For more information visit www.barringtonnutritionals.com. 30 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com dpl-us for info about this advertiser IngredientNews Probiotic Strain ProDURA Found to Survive in Beverage Products he patented probiotic ProDURA a lyophilized strain of Bacillus coagulans has been found to survive at different pH and storage conditions. Currently there are only a few beverages on the market containing probiotics due to their lack of resistance to lower pH levels for an extended period of time. A recently conducted study examined ProDURA in four different experiments in order to evaluate its stability in beverages. ProDURA was exposed to different storage conditions (refrigerated and room temperature) at different pH levels (3.5 4.0 4.5 5.0 5.5 6.0 and 8.0) in order to evaluate its potential application in beverage products. The strain was applied to a variety of beverage products including coconut water a dairy-based protein T drink (Muscle Milk) almond milk and apple juice. The study conducted suggests that even in these settings ProDURA is still viable in an aqueous solution over a wide range of conditions. The study found that the spores are able to survive in a pH range of 3.5 to 8.0. The study also shows promising data on the potential use of ProDURA as a probiotic in self-stable products as well as refrigerated products. For more information visit www.maypro.com. These statements have not been evaluated by the Food & Drug Administration. These ingredients are not intended to diagnose treat cure or prevent any disease. New Study Shows IgY Max Mediates Initial Inflammatory Response Following Muscle Damage n a randomized doubleblind placebo controlled study 25 healthy active male and female participants were randomly assigned to an IgY (Nutrition based in Oklahoma) or placebo (PL) group. After supplementing with either IgY or PL for 14 days muscle soreness was induced through exercise and participants continued to dose for 48 hours while rating delayed onset muscle soreness (DOMS). After 48 hours subjects were post-tested for CK and completed a final DOMS rating. Analysis revealed that post exercise serum CK levels were significantly less for the IgY group than the placebo group. The IgY group also noted significantly less soreness than the placebo for observations at 36 and 48 hours. These results suggest that IgY Max mediates the initial inflammatory response following muscle damage as reflected by reduced serum CK. The beneficial effect of IgY Max was also demonstrated by the subjects perceived reduction in muscle discomfort and pain. This study supports that by mediating DOMS following an acute bout of exercise IgY Max allows athletes to continue training and competing at a high level without compromising strength power or technique. By reducing DOMS IgY Max helps muscles recover more quickly providing a competitive advantage for athletes by allowing them to train at a higher intensity with less time between gym visits. For more information visit www.igynutrition.com. I Valensa Offers Free Saw Palmetto Analysis ix saw palmetto suppliers were found to have little-to-no actual saw palmetto extract according to scientists at Valensa International based in Eustis FL in a recent report that summarizes the study findings and methodology. To help the industry battle for legitimacy Valensa will provide a free analysis of any commercial grade ingredient claiming to be saw palmetto regardless of the source. Saw palmetto extract is among the best-selling ingredients in the world for normalizing prostate function and relieving lower urinary tract issues. The saw palmetto plant is known to grow and produce fruit (called berries ) pri- S marily in the southeast United States and Florida but not all of the saw palmetto extracts on the market are legitimate as the Valensa lab study found. In addition to the six competitive suppliers Valensa tested its own USPlus Saw Palmetto which is the only sample to comply with both the USP (United States Pharmacopeia) monograph and the Valensa-developed authenticity protocol. The results showed that four of six extracts appeared to be adulterated (engineered) and the remaining two appeared to be outright imitation. For more information visit www.valensa.com. Cactus Botanics Introduces Two Plant Protein Powders he consumer demand for plantbased proteins has inspired Cactus Botanics (California) to launch two vegetal proteins--Pumpkin Protein Powder and Hemp Protein Powder. When keeping fit protein powder is the popular choice for people to help recover strength and build up muscles to promote a leaner more effective body mass observed Carol Cheow CEO of Cactus Botanics. She added that in both brick-andmortar and internet retail it is common to find whey proteins and soy- T bean proteins the two leading protein powders. However whey protein is not suitable for vegans Cheow explained. Additionally whey may cause indigestion abdominal distention or lactose allergy in people with sensitivity issues. Meanwhile soybean protein is suitable for vegans but it is also a common allergen and can also cause indigestion and flatulence. Additionally soy contains phytoestrogens--genistein and daidzein--which men may want to stay away from. For more information visit www.cactusbotanics.com. 32 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com nutragenesis for info about this advertiser IngredientNews BIO-CAT Microbials Announces Allergen-Free Protocol for Probiotic IO-CAT Microbials (Minnesota) announced a new protocol in the manufacture of OPTI-BIOME Bacillus subtilis MB40. This new process eliminates all materials from the fermentation currently listed on the FDA s (U.S. Food and Drug Administration) known allergen list including soy. Removing materials like soy a long standing common fermentation ingredient from our process is a significant step forward in our ability to meet the demands of the consumer said Christopher Schuler president of BIO-CAT Microbials. He added customers and formulators will not see any difference in appearance performance or physical characteristics with the new process. OPTI-BIOME is a unique and innovative food grade probiotic that offers supplement manufacturers and food formulators a naturally stable safe and effective probiotic. OPTIBIOME can be added to a variety of food systems and decrease overage in capsules. Clinically tested for safety and improvement in digestive health this probiotic may reduce bloating and gas as well as improve quality of life parameters. For more information visit www.bcmicrobials.com. B Arla Foods Ingredients to Unveil Extensively Hydrolysed Whey Protein rla Foods Ingredients (Denmark) is now offering extensively hydrolysed whey protein for sports nutrition. Developed for serious gym goers and athletes the highly advanced ingredient is a premium quality whey protein with a degree of hydrolysis (DH) of 20. This means it is classified as an extensively hydrolysed protein--a protein that has been cut into small pieces and in which the majority of amino acids are present as small di- and tri-peptides. As a result of this the body absorbs it significantly more quickly than other forms of protein providing outstanding muscle building and recovery benefits. Ideal for formulating in powder shakes the new ingredient is made from 100 percent extensively hydrolysed whey protein and contains as much as 10.3 g of leucine per 100 g and only 3 percent fat. For more information visit www.arlafoodsingredients.com. A CarnoSyn Launches Loading & Dosing Education Initiative alifornia-based Natural Alternatives International Inc. (NAI) the patent holder of CarnoSyn beta-alanine a sports nutrition ingredient announced a commitment to educating consumers and manufacturers about the scientifically proven loading period and correct dosing of beta-alanine. As the sole U.S. patent holder of the ingredient NAI has an obligation to ensure that CarnoSyn is being taken correctly and that consumers are reaping the musclebuilding benefits. There are more than 55 scientific studies on the benefits of beta-alanine but in order to achieve performance benefits it must be properly loaded and dosed. Consumers need to load a minimum of 90 grams over a period of 28 days. For advanced or maximum benefits 179 grams over 28 days is needed. This proper dosing regimen works out to an average of 3.2 to 6.4 grams per day. For more information visit www.nai-online.com www.carnosyn.com or loading.carnosyn.com. C 34 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com nutrasolutionsusa for info about this advertiser AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers AHPA Resource Helps Ensure High-quality Herbal Ingredients Free tools help ensure quality at every step of the supply chain. A Go to www.niemagazine.com ayushherbs 36 Nutrition Industry Executive HPA has developed free guidance and an accompanying set of assessment tools to help the herbal products industry implement and assess policies and procedures that ensure high-quality herbs and herbal ingredients throughout the supply chain. AHPA s guidance on good agricultural and collection practices (GACP) and good manufacturing practices (GMP) for botanical materials and assessment tools provide an easy-to-follow road map to implement and appraise best practices for most botanical operations. Adopting these practices will help companies demonstrate their commitment to quality to their customers. Agricultural and collection practices have wide-ranging impacts on product quality native and regional communities and the environment. This tool provides templates that growers harvesters and processors can adapt to their operations to ensure that herbal raw materials used in consumer products are accurately identified not adulterated with contaminants that may present a public health risk and fully conform to all quality characteristics for which they are represented. The resources are gaining traction in the industry and were recently endorsed by the Council for Responsible Nutrition (CRN). There has been a need for best practices that are easily adaptable for growers harvesters and processors to improve their operations for the cultivation wild collection and processing of botanical crops and we commend AHPA for filling this gap said CRN President Steve Mister. Creating standards such as these provides companies of all sizes an equal opportunity to succeed in the marketplace and strengthens the overall supply chain. Ultimately adherence to these guidelines will help to assure our consumers of consistently high-quality botanical supplements that deliver on their health benefits every time. AHPA has launched a web center where the industry can download the guidance and nine assessment tools that cover an array of operations from cultivation and harvesting to assessing botanical identity and quality. A guide is also provided to help companies select sections of the GACP-GMP document that are relevant to their specific botanical operations. Companies can also use the assessment tools to document adoption of relevant GACP-GMP practices by suppliers. Companies can work with suppliers to identify the sections of the practices that the suppliers must adhere. Suppliers that complete the assessment tools will help companies identify and document all quality practices in the supply chain. It also encourages adoption of a common set of best practices. AHPA encourages the industry to review the guidance and assessment program and determine how to best apply it to relevant operations. AHPA welcomes questions and feedback on the assessment program which can be directed to jwilson ahpa.org. As the industry continues to grow and innovate efforts to increase adherence to legal ethical and safety standards becomes increasingly important. Widespread adoption of the practices outlined in this guidance helps the industry demonstrate its ongoing commitment to meaningful self-regulatory initiatives. NIE Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) www.niemagazine.com September 2017 Go to www.niemagazine.com fccproducts for info about this advertiser Conventions&Meetings Sixth Annual Botanical Congress Food Ingredients Europe T he American Herbal Products Association (AHPA) will hold its sixth annual Botanical Congress on Friday September 29 from 7 30 a.m. to 5 p.m. at the Mandalay Bay Convention Center during SupplySide West in Las Vegas. This year s Botanical Congress will explore the emerging challenges and opportunities for herbal product companies. The Botanical Congress is a unique one-day forum that features a wide-array of herbal industry experts and leaders offering first-hand experience education and information to help companies comply with laws and regulations take advantage of market opportunities and tackle industry challenges. Attendees will participate in interactive discussions about legal and regulatory issues supply chain management best practices industry self-regulation and financial trends. For more information visit www.ahpa.org. F rom November 28-30 at Messe Frankfurt in Frankfurt Germany four halls spanning 65 000 square meters of exhibition space will give more than 1 500 suppliers a stage to showcase food and beverage ingredients sourced from all over the world including a range of functional and organic raw ingredients. Traditionally suppliers use the global industry s event to introduce their innovations to the market. Exhibitors and visitors will also benefit from the new Expo FoodTec Content Hub in the Expo FoodTec pavilion focused on ingredient processing and packaging solutions for the Food & Beverage industry. The Expo FoodTec Content Hub is the hotspot where speaker sessions presentations and videos from leading experts and associations will offer priceless insights into new developments in F&B processing and ingredients packaging. It is co-located with Natural ingredients (Ni). For more information visit www.figlobal.com fieurope. Natural Health and Nutrition Expo N atural Health and Nutrition Expo (NHNE) helps the global manufacturer of health food and nutrition to promote brand and develop business channels in China. With more than 100 000 distributors and retailers it s been the most effective platform for participants to search new products and get deep insight into the market. It will run November 28-30 at the China Import and Export Fair Complex in Guangzhou China. For more information visit www.nhnexpo.com homeen.jhtml. Go to www.niemagazine.com apl for info about this advertiser 38 Nutrition Industry Executive www.niemagazine.com September 2017 Go to www.niemagazine.com rousselot for info about this advertiser AssociationNews CRN Announces Agenda for The Workshop CRN s Day of Science 2017 he Council for Responsible Nutrition (CRN) has announced the agenda for The Workshop CRN s Day of Science taking place October 18 at The Ritz-Carlton Dove Mountain Marana AZ--outside of Tucson. The Workshop presents a full day of focused high-level scientific sessions on some of the timeliest topics in the dietary supplement and nutrition ingredient arena and precedes The Conference CRN s Annual Symposium for the Dietary Supplement Industry held this year October 18 21. The Day of Science brings together top industry executives who have a keen interest in learning more about the latest science and innovation related to dietary supplements and nutritional ingredients said Duffy MacKay ND senior vice president scientific and regulatory affairs CRN. This year s agenda includes robust scientific sessions facilitated by leading experts in nutrition science exploring industry trends and key issues impacting our industry and is sure to uphold The Workshop s top-tier T reputation. The event will commence with a keynote address delivered by Rachel K. Johnson PhD MPH RD FAHA professor of nutrition and pediatrics University of Vermont. Johnson will speak to the audience on improving the nutrient status of American women and children by way of balance and choice in the Women Infants and Children (WIC) supplemental nutrition program. The Workshop will feature speakers from academia government organizations and abroad covering topics such as nutrition policy personalized nutrition and optimal health and advances in botanicals. One session will focus on cuttingedge clinical research for botanicals led by Stephan K hler MD PhD director clinical research Dr. Willmar Schwabe GmbH & Co. KG in Karlsruhe Germany. Another session featuring Ahmed El-Sohemy PhD professor department of nutritional sciences at the University of Toronto will explore advances in personalized nutrition. Chris McGlory PhD ESPEN postdoctoral research fellow in the department of kinesiology at McMaster University will discuss protein requirements beyond the recommended dietary allowance (RDA) while Giulio Maria Pasinetti MD PhD director basic and biomedical research and training program James J. Peters Veterans Affairs Medical Center will give an overview of the nutritional bioactives for the promotion of cognitive and psychological health. Additionally a session on nutritional genetics epigenetics and dietary supplementation will be led by Chris D Adamo PhD assistant professor department of family and community medicine department of epidemiology and public health and director of research Center for Integrative Medicine University of Maryland School of Medicine. Additional speakers are being confirmed and will soon be added to the official agenda. For more information visit www.crnusa.org 2017events. Legislation Would Provide Relief for Americans Living in Food Deserts ew legislation introduced by Congressman Dave Brat (R-VA) would expand access to multivitamin dietary supplements for purchase as part of the special supplemental nutrition program for women infants and children (WIC). The effort led by the Natural Products Association (NPA) could help provide relief to the 25 million Americans currently living in areas without access to fresh and nutritious foods. Why should you be able to buy Dora the Explorer cereal but not a Nature s Way Children s Chewable vitamin said Dan Fabricant PhD president and CEO of NPA. Expanding WIC to include multivitamins would create an oasis for the 25 million Americans living in food deserts and make it easier for people to provide healthier lives for their families. The United States Department of Agriculture (USDA) defines a food desert as parts of the country vapid of fresh fruit vegetables and other healthful whole foods usually found in impoverished areas. As part of an effort to bring awareness to this grow- N ing problem the USDA created an interactive map to show the areas most impacted which can be viewed at www.ers.usda.gov dataproducts food-access-researchatlas go-to-the-atlas . Since 1978 the WIC Supplemental Food Program has served low-income at risk pregnant breastfeeding and postpartum women infants and children up to age 5. The WIC program provides Federal grants to States for supplemental foods health care referrals and nutrition education. The program has grown significantly in its nearly 40-years of existence and it now serves approximately eight million participants. The WIC Improvement Act H.R. 3529 will expand WIC to give these low-income families equal opportunity for access to low-cost high nutrient alternatives like multivitamins. Multivitamins are proven to have the following health benefits especially relevant to those the WIC program intends to help Classic nutrient deficiency diseases (scurvy pellagra and iron deficiency anemia) Improve appetite and growth rates Prevent neural tube birth defects Protect against heart disease and stroke Build bone mass in the young NPA recently launched a grassroots campaign calling for Congress to support multivitamins to be eligible in the WIC special supplemental nutrition program. Visit www.saveoursupplements.org to write Congress to tell them to support H.R. 3529 for multivitamin dietary supplements to be eligible under WIC. www.niemagazine.com September 2017 40 Nutrition Industry Executive AssociationNews AAHP Highlights Expanded Homeopathic Drug Manufacturing Best Practices he American Association of Homeopathic Pharmacists (AAHP) recently hosted a webinar on 2017 improvements to the Homeopathic Pharmacopeia of the United States (HPUS). Highlighting new manufacturing best practices in the HPUS--which more than tripled to 175 from 40 in the prior version--the webinar underscored how this extensive resource can help manufacturers produce safe and effective homeopathic drug products. Recognized by the United States Federal Food Drug and Cosmetic Act the HPUS is the official compendium of homeopathic active ingredients and manufacturing guidelines. AAHP s webinar covered two major areas in the document good manufacturing practices (GMPs) and drug stability guidelines. Eric Foxman senior scientist with the Homeopathic Pharmacopoeia Convention of the United States (HCPUS) the organization that publishes and updates the HPUS facilitated the session. Foxman first covered manufacturing T best practices. The result of five years of deliberations the expansions are designed to be consistent with modern pharmaceutical manufacturing and drug GMP. Additions include new facilities controls around temperature and humidity in manufacturing plants as well as documentation guidelines for supplier and vendor management. The HPUS also saw expanded rules for the sourcing handling purity testing and storage of both botanical and chemical raw materials. The product of about 2 225 hours of work between the more than 30 members of the HCPUS the new HPUS covers more than ever before said Foxman. It is a testament to the homeopathic industry s dedication to continual improvement. New drug stability guidelines in the HPUS aim to ensure that drug products will remain in their intended form over the entire period of their use. Foxman explained that manufacturers are now required to identify and document the individuals who are responsible for assessing stability. The expanded stability section also includes guidelines for material usage risk analysis expiration dating and retesting of product stability. The importance of the HPUS in guiding homeopathic manufacturing and marketing organizations cannot be overstated said Mark Land AAHP president. And that s why AAHP continues our educational programming around this and other topics that help our industry set a high bar in manufacturing excellence and product safety and effectiveness. The webinar is the first of AAHP s 2017 Compliance Thru Education series which aims to help AAHP members and nonmembers alike keep abreast of the latest in regulatory compliance and manufacturing trends affecting the homeopathic industry. Other webinars will cover key issues such as over-the-counter (OTC) labeling and product recall procedures. For more information visit www.aahp.info. Sabinsa Joins Global Curcumin Association as Founding Board Member he Trust Transparency Consulting has announced that Sabinsa Corporation (East Windsor NJ) has become a founding board member of the Global Curcumin Association (GCA) established through Trust Transparency s incubator program of single ingredient trade associations. Sabinsa is a highly regarded global ingredient supplier with a broad scientific and intellectual property platform to support its products including Curcumin C3 Complex C3 Reduct and Uc3 Clear. With Sabinsa s leadership role in advocating best practices their decision to be a Founding Board Member of GCA validates our conviction that visionary companies see value in banding together with like-minded businesses to promote and protect a significant category said Len Monheit Trust Transparency co-managing partner. We are eager to begin executing the programs we have developed to support the rapidly growing curcumin category even as we build out the rest of the membership with other companies T committed to solid science adherence to intellectual property law and quality systems. As part of Trust Transparency s single ingredient trade association incubator program the GCA will work to establish a best practice recognized third-party baseline for ingredient quality identity and appropriate category definitions and standards. The association will also serve as a voice and supporter of science and education through all supply chain levels and customer consumer and influencer communities. Sabinsa has worked very hard to promote and protect the integrity of the curcumin market from adulteration and IP infringement while fostering research and promoting benefits and can thus attest to the efforts it requires said Shaheen Majeed president of Sabinsa Worldwide. When presented with the opportunity to work together with other legitimate curcumin suppliers to protect the market the decision was easy. We are very proud to be the initial Founding Board Member of the Global Curcumin Association and intend to be active participants in the association becoming a proactive category voice. The 2015 NBJ Supplement Business Report listed curcumin as one of its Top 5 Growth Ingredients and it has been in the top 10 for the past six years. The 2017 NBJ Raw Materials Report comments curcumin is the fourth bestselling herbal product. Emerging science and ongoing marketing education and effectiveness of the ingredient has provided consistent double-digit annual sales growth over the past decade. For more information visit www.sabinsa.com or www.trusttransparency.com. www.niemagazine.com September 2017 42 Nutrition Industry Executive AssociationNews Supplement OWL Honored With ASAE Power of A Silver Award he Council for Responsible Nutrition (CRN) has announced that the Supplement OWL (Online Wellness Library) the dietary supplement product registry is the recipient of a 2017 Power of A Silver Award. The Power of A Awards presented by the American Society of Association Executives (ASAE) showcase association initiatives that leverage their unique resources to solve problems advance industry and professional performance kick-start innovation and improve world conditions. We thank ASAE for honoring the Supplement OWL with a Silver Award said Steve Mister president and CEO CRN. This award is something the entire industry can be proud of as the registry is the product of our collective collaboration and desire to improve ourselves from T within. Proactive effective self-regulation deserves to be acknowledged and we appreciate ASAE for recognizing this important industry-wide program. The Supplement OWL was one of 32 Power of A Silver award winners this year out of a total 149 submissions. Winning entries include programs from all corners of the association world and are evaluated on reach how the initiative embodies the power of associations and the overall objective and outcome. The Power of A Awards were first launched by ASAE in 2009 to increase awareness about issues pertinent to associations and to spotlight the expertise and resources available for policymakers and other key audiences. As the Supplement OWL gains momentum within the industry and among stakeholders I hope this award further motivates companies to participate in the registry Mister said. Despite having only just launched in April the Supplement OWL is already being recognized for its merits and potential benefits. The OWL is still maturing but this award speaks to its great potential and the impressive progress it has made in only a few months. For more information visit www.crnusa.org. NPA Adds 34 New Members he Natural Products Association (NPA) continues its strong membership growth during the second quarter of 2017 welcoming 34 new members to the organization. NPA s robust modernization and restructuring program has strengthened the entire organization opening up membership to a more diverse group within the industry bringing in members representing an evolving industry that strengthens and solidifies the industry s voice as NPA interacts with regulatory agencies and our legislators to protect consumers access to natural products said Dan Fabricant PhD president and CEO of NPA. NPA s industry tools and resources along with pro-active advocacy efforts continue to attract new members who T know that the industry s well-being requires that they become involved. New NPA members include American Association of Chinese Herbs AstaReal Boston Nutraceutical Science LLC Central Valley Nutrition Colorcon Copperhead Chemical Company Inc. Custom Collagen Inc. DuraScience Institute LLC ExeGi Pharma LLC GLOHE Group Good Idea Inc. Homeo-Health Inc. Integra Medical JW Nutritional Ken Seguine Consultant Lifeway Foods Inc. Marealis Micro Quality Labs Inc. NFP Holdings LLC NutraBio Labs Inc. Nutrabolt ONNIT Labs Paam Nutravite Post Holdings RIBUS Inc. Rotex Pharma Philippines Surya Herbal Limited The Kroger Company The Retro Company Group LLC ThermoLife International Tucker Ellis VidaLine Nutrition Inc. Vitacost Vitalpax Inc. For more information visit www.npainfo.org. Don t miss a single issue of NIE in 2017 ... go online to renew your free subscription today NIEmagazine.com September17 44 Nutrition Industry Executive www.niemagazine.com September 2017 ScienceUpdate Zinc May Hold Key to Fighting Liver Disease ew research from the Westmead Institute s Storr Liver Centre (Australia) in collaboration with the Centre for Virus Research and Kirby Institute has shown that serum zinc may benefit liver disease in a way we never expected. The study led by Dr. Scott Read and Associate Professor Golo Ahlenstiel demonstrated that zinc naturally inhibits the inflammatory and antiviral effects of interferon lambda 3 (IFN-3) a protein strongly associated with tissue damage in chronic liver disease. Lead author of the study Read said the study provides the first evidence that zinc can act as a potent and specific inhibitor of IFN-3 in the context of viral infections such as hepatitis C and influenza. We have demonstrated that zinc inhibits numerous facets of the liver s immune response to viruses that may be N mediated by IFN-3. Zinc interferes with IFN-3 binding to the interferon lambda receptor which results in decreased antiviral activity and increased viral replication both in vitro and in vivo. Interestingly zinc also blocks the inflammatory activity of IFN-3 which has been strongly linked to accelerated progression to liver cirrhosis in viral and non-viral liver disease explained Read. Our data suggests that serum zinc levels in patients with chronic hepatitis C are genetically predetermined by the IFN-3 polymorphism confirming the inhibitory role of zinc in vivo. The data highlights the potential for zinc to be used as a simple and effective treatment against acute and chronic inflammation in the liver. Ahlenstiel and his team are now working towards a therapeutic intervention for IFN-3-mediated chronic disease. For more information visit www.westmeadinstitute.org.au. Increase in Use of High-dose Vitamin D Supplements F Olive Oil Nutrient Linked to Processes That Prevent Cancer in Brain compound found in olive oil may help to prevent cancer from developing in the brain a study shows. Research into oleic acid--the primary ingredient in olive oil--has shown how it can help prevent cancercausing genes from functioning in cells. The oily substance--one of a group of nutrients known as fatty acids--stimulates the production of a cell molecule whose function is to prevent cancer-causing proteins from forming. The study team says it is too soon to say whether dietary consumption of olive oil may help prevent brain cancer. Their findings however point towards possible therapies based on the oil to prevent brain cancer from occurring. Scientists from the University of Edinburgh analyzed the effect of oleic acid on a cell molecule known as miR7 which is active in the brain and is known to suppress the formation of tumors. They found that oleic acid prevents a cell protein known as MSI2 from stopping production of miR-7. In this way the olive oil component supports the production of miR-7 which helps prevent tumors from forming. Researchers made their discoveries A in tests on human cell extracts and in living cells in the lab. The study published in the Journal of Molecular Biology was funded by the Medical Research Council and the Wellcome Trust. While we cannot yet say that olive oil in the diet helps prevent brain cancer our findings do suggest that oleic acid can support the production of tumor-suppressing molecules in cells grown in the lab said Dr. Gracjan Michlewski of the University of Edinburgh s School of Biological Sciences who led the study. Further studies could help determine the role that olive oil might have in brain health. For more information visit www.ed.ac.uk. rom 1999 through 2014 the number of U.S. adults taking daily vitamin D supplements above the recommended levels increased and 3 percent of the population exceeded the daily upper limit considered to possibly pose a risk of adverse effects according to a study published by JAMA. A 2011 report concluded that vitamin D was beneficial for bone health but noted possible harm (e.g. abnormally high levels of calcium in the blood soft tissue or vascular calcification) for intakes above the tolerable upper limit of 4 000 IU daily. The recommended dietary allowance for vitamin D is 600 IU d for adults 70 years or younger and 800 IU d for those older than 70 years. Using data from the nationally representative National Health and Nutrition Examination Survey (NHANES) Pamela L. Lutsey PhD MPH of the University of Minnesota Minneapolis and colleagues assessed trends in daily supplemental vitamin D intake of 1 000 IU or more and 4 000 IU or more from 1999 through 2014. The analysis included 39 243 participants. The researchers found that the prevalence of daily supplemental vitamin D use of 1 000 IU or more in 20132014 was 18.2 percent in 1999-2000 it was 0.3 percent. In 2013-2014 prevalence of daily supplemental intake of 4 000 IU or more was 3.2 percent this figure was less than 0.1 percent prior to 2005-2006. Trends of increasing supplemental vitamin D use were found for most age groups race ethnicities and both sexes. In 2013- 2014 intake of 4 000 IU or more daily was highest among women (4.2 percent) nonHispanic white individuals (3.9 percent) and those 70 years or older (6.6 percent). A limitation of the study is that data were self-reported however participants were asked to bring supplement bottles to aid in reporting. Characterizing trends in vitamin D supplementation particularly at doses above the tolerable upper limit has important and complex public health and clinical implications the authors wrote. For more information visit http jamanetwork.com journals jama. 46 Nutrition Industry Executive www.niemagazine.com September 2017 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 Why contract manufacturers are a critical core of success and innovation for natural brands and marketers today. By James J. Gormley The Participants Are John Altenberg Vice President of Sales and Client Services Vit-Best Nutrition Tustin CA Sally Gagan Vice President Beehive Botanicals Hayward WI T Emek Blair PhD Founder Valimenta Labs Fort Collins CO Dan Lifton CEO Quality of Life Labs Purchase NY he question is not Why are you engaging a contract manufacturer but Why aren t you With world-class plants many outfits also boast their own range of proprietary technologies and processing methods versatile pre-mixes and semi-finished formulas. We spoke with a group of natural products industry experts about what to consider when thinking about going with a contract manufacturer. Kenny Flores Vice President of Sales Reliance Private Label Supplements Edison NJ Jan Thoele Executive Vice President SternMaid America Aurora IL NIE Aside from not having the huge capital expenses and high operating costs of building and running respectively one s own manufacturing plant what are the main advantages that finished product brands should consider when thinking about using contract manufacturers Flores Focus--allows for [the] main concentration to be on the sales and marketing elements required to grow Nutrition Industry Executive 47 September 2017 www.niemagazine.com a brand. Expertise--the knowledge and experience gained over many years of manufacturing dietary supplements and in navigating in an increasingly difficult regulatory environment is invaluable to a brand. Economies of scale--raw materials and componentry can sometimes be difficult to obtain with the larger users getting preferential order in terms of availability in cases of shortages. Blair The entire idea is that the brand owners are allowed to focus on their strengths that is building a brand and sales and [letting] the majority of the product manufacturing responsibility be in the hands of a company that specializes in manufacturing. Go to www.niemagazine.com nutraceutix for info about this advertiser 48 Nutrition Industry Executive Thoele Outsourcing creates elbow room contract manufacturers release capacity so that customers can focus on their own core competences-- such as research and development or marketing and sales--and thus ultimately grow their brands. Other reasons for using contract manufacturers include cost-savings rapid growth or better quality as well as the additional know-how acquired through working with specialist partners. By outsourcing processes customers also benefit from the technologies project experience and expertise of the external service provider. In most cases expertise in particular is difficult to build up or maintain at the required high level and it takes a long time. Sometimes the production process also requires special technologies that are not available to a company or cannot be introduced quickly enough at its own facility. By outsourcing companies can make use of the latest technologies without having to invest in it themselves. The installation of [a] large commercial-scale plant needs a lot of consideration these days. Faster innovation cycles are shortening the life of products Who knows whether the production line for a particular dry beverage base or food supplement will still be working to capacity in a few years time Specialization and the grouping of orders often enable contract manufacturers to produce at [a] lower cost than a company could achieve in-house. Lifton Finished product manufacturers should be focused on developing and marketing clinical sciencebacked innovative formulas for consumers. Marketers should not be spending their time on being manufacturing plants. High-quality brands should be devoting their time and resources to identifying the channels in which their products will make the most sense. They should also actively think about a unique brand story to tell around each of their products in addition to the niche and categories in which each of them belong. What challenge or problem does the product address What retail need or consumer demand does the product satisfy Brands need to be obsessively focused on their brands the science the quality and the value. Contract manufacturers need to take into consideration the marketer s problems while also focusing on manufacturing. www.niemagazine.com September 2017 NIE That being said brands cannot wholly shift their responsibilities for product quality to the contract manufacturers. Do you agree If so please explain. Thoele Correct. Today s safety requirements in the food industry are stricter than ever before. Ultimately the brand owner is responsible for selling a safe product to the market and it would also be the first party to be contacted in the case of a product claim or recall. This makes it even more important to work with reliable partners only partners who have established and certified quality management systems of the highest level. We are aware of this responsibility and with rigorous quality control and quality assurance we take every precaution to ensure the greatest possible safety for our customers. Altenberg I would never advocate that brands can shift the quality entirely. Transparency is a two-way street. To draft a culture of quality the brand must provide among other requirements detailed raw material specifications including preferred vendors. Clarity must also ensue that manufacturing and packaging specs are clear. Test requirements and methods frequency of tests and lab location must also be vetted. Flores Yes ultimately the contract manufacturer shoulders a certain responsibility to [ensure] that the regulatory and efficacy requirements for each product are met. However the basic parameters with which each product is created are dictated by the companies who they service. Understanding the quality issues that affect our industry falls on both sides to [ensure] adherence. Blair Absolutely brands must set specifications and ensure the finished products quality. These steps are straightforward and can include testing the product for identity strength and purity and may include collecting some other information which will vary according to the relationship with the manufacturer. Lifton Completely agree. It is the responsibility both ethically and legally for finished product brands to always do their due diligence to ensure that their contract manufacturers labs and suppliers are adhering to cGMPs (current good manufacturing practices) and a variety of other quality safety and efficacy benchmarks. Gagan I agree but manufacturers [do] hold the majority of the responsibility of manufacturing even the customer-supplied labels being applied to product. NIE What are the key questions finished product brands and house labels should ask a potential contract manufacturer And what should acceptable answers be Altenberg Ensure detailed correspondence and direct site visits to determine the transparency commitment of a prospective contract manufacturer. The brand owner should investigate the R&D capabilities control of production processes employee training on equipment and quality functions. How versed is senior management in the daily details of the business to effectively intervene when needed Gagan Have you been inspected by the FDA (U.S. Food and Drug Administration) in the last three Go to www.niemagazine.com beehivebotanicals for info about this advertiser September 2017 www.niemagazine.com Nutrition Industry Executive 49 years Do you have any third-party auditing What specifically will you be testing my product for Are you willing to provide batch production records If they will not provide information I would find a new manufac- turer. Thoele There is actually nothing you should not ask. Everything comes down to food safety and product quality and ultimately your company s and your brand s reputation. Above all our customers must be able to trust us. So all aspects of safety quality and production should be discussed openly and 100 percent transparently. Blair The main questions are straightforward What is the process for specifications to be set how are those specifications guaranteed and what is the timeline for manufacturing Flores What quality certifications do you carry (GMP NSF ). Do the labels and marketing materials go through a review process to [ensure] regulatory compliance (Yes). Can you accommodate all raw material and finished product testing required by our brand (Yes) What are your lead times and what are your minimum order quantities (This answer will vary from manufacturer to manufacturer. Ingredients componentry and scope of testing requirements will play a factor here). Go to www.niemagazine.com adh for info about this advertiser 50 Nutrition Industry Executive NIE Contract manufacturers must be cGMP compliant should potential customers ask to see their certification documentation If not why not What should potential customers ask to see Should a same-day or unannounced site visit ever be done Thoele Absolutely. Being GFSI (Global Food Safety Initiative) certified does not mean being compliant on audit days only. It means being compliant 24 7. Contract manufacturers who decline to share their documentation or certification or who do not allow unannounced or same day audits probably have something to hide. Blair On Valimenta.com we post our third-party cGMP certification for review. Our assumption is that every company that wants to partner with us will want to see our certification. Same-day or unannounced site visits can be tricky if none of the manufacturer s staff are available for a tour it will likely not occur. There are also some issues in regards to confidentiality we don t like to run brands that are not openly associated with our factory while tours are occurring. Lifton Yes GMP certification documents should be an integral part of mutual transparency in business dealings. The days of just trusting a photocopied COA are over. Gagan I think it s hard to just show up to a contract manufacturing facility but you should always be welcome to a site visit. Yes certification should be available kosher organic NSF NPA (Natural Products Asociation) etc. Flores Agreed. Contract manufacturing companies plan schedules out many days or even weeks in advance to meet the needs of their customers. A disruption such as an unannounced www.niemagazine.com September 2017 visit audit causes delays to the manufacturing process. It is best to provide notice so the proper time can be allocated for such a visit. NIE Should finished product companies ask potential contract manufacturers how they deal with testing problems raw material supply issues FDA inspections auditor inspections Lifton Yes the best way to see how professional a contract outfit truly is to see how they handle contamination and adulteration problems supply outages FDA inquiries and auditor requests. If they are evasive or dismissive about cases or examples such as this then you know you need a different contract manufacturer. Gagan Absolutely We see many warning letters that continue to say identity testing not performed as well as there not being [potency] and composition testing. You can t compare contract manufacturers that are doing the appropriate testing against a manufacturer that is a cheap price but in the end not compliant. Flores Yes all contract manufacturers deal with issues from time to time and it is important to know if such an event occurs that they are capable of maneuvering through the issues and resolving them to the mutual satisfaction of everyone involved. Altenberg Both parties should answer these same questions. To formalize the relationship a detailed quality agreement that clearly spells out roles and responsibilities is essential. NIE If developing a powered supplement to be dissolved in water what steps should a contract manufacturer be willing to take sure until the customer is pleased with the taste color and other properties of the product Flores With all products that involve taste color etc. a thorough understanding of the goals the customer has for the product (such as sweetness bitterness color serving size and so forth) is established. Samples should then be provided and modified until the desired effect is achieved. However it is also incumbent upon the manufacturer to indicate when a certain desired effect cannot be achieved based on raw material limitations or restrictions. Blair This has to do with a good development agreement and open communication. I do believe that the customer must be happy with the flavor color and other properties without compliance the product will not benefit anyone. However this is always a compromise between time and 100 percent approval of the flavor. Thoele Trial runs are an essential part of the development of new products. A pilot blender for small batches in order not to waste resources and materials should be standard equipment for contract manufacturers. Altenberg Organoleptic results can be subjective. It is reasonable that the contract manufacturer develop and modify formulations. The contract manufacturer should insist on written comments and ensure the target audience is also involved in tasting. It is also reasonable that the manufacturer recover its cost of development including labor and machine time. NIE Some so-called testing outfits that get a good deal of media play Go to www.niemagazine.com vit-best for info about this advertiser September 2017 www.niemagazine.com Nutrition Industry Executive 51 don t actually have their own labs but get finished products tested by outside labs and reviewed. Often the methods of analysis are chosen incorrectly and the tests conducted are otherwise not appropriate for the materials being tested. What role can contract manufacturers play in helping finished product brands with adversarial or gotcha testing done such as this Lifton While nobody including contract manufacturers can predict all potential cases of adversarial attention such as this they should have verifiable systems and processes in place that address and are responsive to ingredient and supply chain questions that could be raised. Flores A quality contract manufacturer will easily connect you with a quality lab to ensure [the] proper test- ing method is used and results are accurate. Blair This type of testing is unethical at best. Companies look for ways that the testing will make their brand look superior while avoiding actual quality markers. In this respect contract manufacturers can provide the correct test methodology and data to show the product is manufactured to specifications. I firmly believe that brands need to stand on their strengths rather than go negative. NIE Transparency is all the rage but for good reason. In the interests of full disclosure and transparency what specific information and documentation should finished product marketers and contract manufacturers share with each other for their mutual benefit Gagan If your contract manufacturer will not share production documentation I would question why. Are they not manufacturing to your specifications or are they not doing the required testing Thoele Without exception all information related to product quality and required to provide and sell a safe product should be shared. Contract manufacturing is a matter of trust. We have very close contacts with our customers right from the start. Our offer begins with consultancy where we explain the most efficient ways of integrating our services into the customer s production process. Activities should be regularly coordinated even at the planning stage. This creates the basis for a good long-term business relationship. Blair Testing results must obviously be shared however other documents depend on the brand and their level of sophistication. Here is a situation to consider A brand has the manufacturing paperwork from the contract manufacturer and the brand is audited by the FDA. The brand must have the skill set to properly review the documents and be able to accept or reject them If not the FDA will view that as a serious issue. Even worse if there are glaring mistakes on the manufacturing paperwork and the brand owner did not catch them the brand owner has now taken on addi- Go to www.niemagazine.com generexlabs for info about this advertiser 52 Nutrition Industry Executive www.niemagazine.com September 2017 tional liability. This is not to say that ignorance is the answer this is a simple example of how more paperwork is not necessarily better. Flores Any claim substantiation needs to be shared between brands and contract manufacturers to ensure regulatory requirements are being met. NIE Should one primary (or master) contract manufacturer be chosen On what basis In what cases should testing or specialized manufacturing work be farmed out to sub-contractors Lifton Having one master manufac- turer can make sense if they produce a wide variety of ingredients complexes and pre-mixes especially those associated with unique extraction or processing methods. Sub-contractors may focus on nano ingredients or other more specialized offerings. Altenberg If you are representing a contract manufacturer of course exclusivity provides volume and overhead absorption. If a brand owner has multiple suppliers to protect the supply chain for large volume products it makes sense. If a sub-contractor is needed the same qualifications should be conducted by the primary contract manufacturer with direct input from the brand owner. Thoele Small brands may not have the resources to be able to afford a second and or multiple contract manufacturers but they should at least have a plan B. Especially when growing a brand a company doesn t want to upset its customers by being on back order for whatever reason. NIE Extra Extra Visit www.niemagazine.com to read the rest of the article. THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights Oct. Nov. Dec. 9 7 17 ad closing Washington and the Natural Industry Sports Nutrition Supply Innovation Healthy Blood Sugar 10 25 17 ad closing 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 September 2017 www.niemagazine.com Nutrition Industry Executive 53 Impact on Immune The immune system is complicated--natural ingredients for immune health have evolved to provide a more integrative approach. By Janet Poveromo O ne of the most critical support systems in a living organism the immune system serves as a preventative and defensive mechanism against injury and infection for the body. And it is difficult to quantify the status of immune health in Americans noted Guy Woodman general manager with Euromed USA in California. Cases of colds and flu are tracked throughout the winter season by Centers for Disease Control (CDC). Woodman also pointed out that access to fresh fruits and vegetables is associated with level of socioeconomic status and the financial ability to purchase foodstuffs for the family. In addition he said excessive long-term use of antibiotics prevalence of pesticides in the food supply stress of a fastpaced technologically advanced socie54 Nutrition Industry Executive ty has been shown to influence negatively the health of our immune system. Our immune system is comprised of our spleen thymus lymph nodes and bone marrow Goodman said. These tissues produce the cells that work together to protect us from microbial attack. It is difficult to establish a prevalence for poor immune health as it is not a clearly defined phenomena agreed Susan Hewlings PhD RD and chief science officer at IgY Nutrition in Oklahoma. Immune system balance is a complex process involving many systems and markers. We do know that there are several things that can influence immune health--aging obesity poor nutrition lack of physical activity and an imbalance of bacteria in the gut called dysbiosis can all alter immune function she noted. Michael Bush president and CEO of Ohio-based Ganeden noted that there are a variety of external internal and environmental factors that can contribute to poor immune health. Our main focus is on causes that originate in the digestive system. Seventy percent of the body s immune cells are located there--meaning that immune health is directly affected by digestive health. These immune cells come into contact with hundreds of species of naturally occurring bacteria--some beneficial and some harmful. When the levels of good and bad bacteria are out of balance digestive health and immune health are affected. In addition Tim Hammond vice president of marketing and sales for Bergstrom Nutrition in Washington noted that a relatively high number of www.niemagazine.com September 2017 Americans are battling slight immunological issues today. The primary causes stem from chronic inflammation and stress-related factors. Chronic inflammation can arise from environmental factors such as toxins or lack of physical activity and from dietary factors such as high levels of sugar or toxins. Stress itself whether physical or psychological can also have an immunosuppressing effect. These causes are not isolated issues but rather are interrelated Hewlings explained. Meaning that obesity may be associated with a poor diet and lack of physical activity which all influence microbial diversity and may lead to dysbiosis. Most of the diseases that have been linked to dysbiosis such as diabetes metabolic syndrome inflammatory bowel disease and more are characterized by immune alterations especially chronic inflammation which affect not only the gastrointestinal (GI) tract but also impacts the systemic circulation and potentially any system in the body. The impact involves alterations in cytokine levels and significant changes in the frequency function and trafficking pattern of immune cells affecting the immunological environment in the human. One way to gauge the immune status of Americans is to monitor the sales of immune enhancing products Woodman added. of the factors that can compromise immune system functioning are within our control but our fast-paced lives impede our willingness or ability to sufficiently alter these habits. This provides an open market for supplements that help strengthen immune system functioning. Trends in Immune Health Ingredients Consumers are used to evaluating the efficacy of herbal supplements they consider on the internet. Resources Beneficial Ingredients S State of the Immune Health Market Echinacea-containing supplements the traditional remedy against cold and flus increased 10 percent in the natural channel from 2014 to 2015 Woodman pointed out. Olive leaf extract another popular supplement well recognized for immune stimulation increased almost 10 percent in this period. This sales data is found in the American Botanical Council report on Top Selling Herbal Supplements 2016. According to Nena Dockery technical services manager for Stratum Nutrition in Missouri The general immune health segment of the dietary supplement market is currently more than 100 million and is projected to continue steady growth. If cold and flu supplements are included the numbers are much higher she said. Many individuals recognize the need to support their immune systems and there is also the realization that many September 2017 www.niemagazine.com uppliers provided a description of their company s most beneficial immune health ingredients Bergstrom Nutrition It s necessary to support the immune system year round Hammond noted especially during times of stress. Recognized and trusted as a joint health supplement OptiMSM displays broad utility with a variety of health benefits. Clinical research has displayed MSM s ability to reduce oxidative damage and expression of inflammatory markers. OptiMSM could be added into products that reduce acute cold or flu symptoms as well as into those that modulate chronic symptoms. Euromed There is a large body of research showing that use of olive leaf extract in a dietary supplement can be beneficial for immune health according to Woodman. He explained that olive leaf extract has been evaluated for antimicrobial activity against a variety of organisms. It has been shown to have activity against Listeria monocytogenes Candida albicans E. coli and Staphylococcus aureus he said. Ganeden In addition to the traditional immune health ingredients GanedenBC30 is also used frequently for its immune health benefits. The company recently launched Staimune which provides immune benefits through interaction with immune cells in the gut. While both ingredients offer immune health support they are beneficial in their own ways. The benefit of GanedenBC30 is consumers receive both digestive and immune support along with enhanced protein utilization. Staimune provides the same immune benefits as GanedenBC30 (without the digestive or metabolic benefits of the living probiotic) but is capable of being used in any food or beverage product--regardless of manufacturing processes. IgY IgY Max is a polyvalent antigen specific IgY product targeting 26 of the most common human-relevant pathogens. IgY Max is a unique digestive and immune function ingredient that promotes GI health by increasing gut wall integrity improving bowel function and reducing non-beneficial bacteria adherence. In addition to favorably altering the composition of the microbiome it supports the digestive tract lining pro- motes proper microbial adhesion supports immune system health supports the body s natural defenses and promotes proper cytokine balance. IgY Max works along with probiotics in that it helps to change the composition and activity of the microbiome. IgY antibodies contained in IgY Max help the body eliminate only the harmful bacteria and leave the good microbes intact. They work by significantly reducing harmful bacterial adhesion and growth in the GI tract helping to minimize inflammation by decreasing cytokines and HSCRP. Stratum Nutrition The company offers two probiotics that are specifically designed to colonize and function in the oral cavity. Both probiotics are strains of Streptococcus salivarius a bacterial species that is common in the oral cavities of healthy individuals. S. salivarius K12 was first isolated from a child with exceptional upper respiratory health. It is a rare strain found naturally in about 2 percent of the population. As a probiotic BLIS K12 colonizes on the back of the tongue but can migrate up through the nasopharynx. K12 not only competes with less desirable oral cavity strains but it also produces bactericin-like-inhibitory-substances or BLIS. BLIS are produced by a variety of beneficial bacteria and provide natural protection by targeting and destroying specific pathogenic strains. BLIS K12 targets strains that cause upper respiratory and middle ear complaints and it is also effective in controlling many of the bacteria that cause bad breath. A sister strain to K12 is M18. M18 was first isolated from an adult who did not have cavities or other dental or periodontal issues. The BLIS in M18 target specific bacteria that contribute to dental caries. But M18 has a couple of additional unique characteristics. It produces two enzymes in response to its environmental conditions. One is a urease. This enzyme helps buffer the area around it which is extremely helpful since many bacteria that cause tooth decay produce acid as part of their metabolism. This acid helps erode the tooth enamel providing an easy access point for tooth decay. The second enzyme is a dextranase. This enzyme breaks down dextran a polysaccharide that is one of the main components in dental plaque. Nutrition Industry Executive 55 Impact on Immune like the National Institutes of Health (NIH) Pubmed search site allow people to quickly verify those natural products that are scientifically substantiated Woodman observed. For example he noted olive leaf extract (OLE) is known to be an antimicrobial that also has antioxidant activity. It has been used to reduce bacteria levels in shrimp and leafy greens and enhance the quality and shelf life of meat products. Research groups like the USDA (U.S. Department of Agriculture) have evaluated olive leaf extract (OLE) and found it effective against Listeria monocytogenes Escherichia coli and Salmonella enteriditis. USDA s goal is to determine if OLE would be a suitable antimicrobial for use by the food industry. USDA found it influenced gene expression by the bacteria and reduced Listeria bac- teria motility. According to Bush another trend in the category is using probiotics not only for digestive health benefits but for immune health benefits as well. In fact of the consumers who are familiar with probiotics 82 percent associate them with immune health support. One of the most popular strains for this use has been our patented probiotic GanedenBC30 (Bacillus coagulans GBI-30 6086) due to its ease of fortification and science-backed immune health benefits. Recent news in the immune health category also includes the introduction of new immune-focused ingredients. Bush noted that earlier this summer Ganeden officially announced Staimune the company s newest immune-focused ingredient. Staimune is unique to Ganeden and utilizes the inactivated cells of GanedenBC30 which have been shown to support immune health. Hewling also noted consumers strong interest in probiotics for immune health. Because of the increased awareness between gut health and immune health several products have reached the market to address gut health she said. Perhaps the best known are probiotics and prebiotics. Systemic immune response has been shown to be modified by changing the microflora through supplementation of probiotics. Probiotics have also been shown to regulate the host immune response. Indeed probiotics have been found to enhance the innate immunity and modulate pathogen-induced inflammation via toll-like receptor-regulated signaling pathways. There are three to four main types of probiotics that aid in regulating the immune system Hewling said. Lactobacillus Acidophilus which produces vitamin K and lactase and is most commonly found in the upper digestive tract. L. Acidophilus has been shown to improve digestion blood pressure and cholesterol reduce lactose intolerance increase absorption of calcium and B vitamins help the body fight viral bacterial and fungal infections decrease allergy symptoms and decrease the likelihood of developing kidney stones. Bifidobacterium Lactis inhabits the Go to www.niemagazine.com mackflavor for info about this advertiser 56 Nutrition Industry Executive www.niemagazine.com September 2017 intestines and colon and its main job is to break down waste and absorb various vitamins and minerals. B. Lactis has been shown to improve digestive conditions by decreasing intestinal permeability and relieving general digestive discomfort improve oral health by fighting dental caries and enhance immunity by reducing the frequency and severity of respiratory diseases. Lactobacillus Bulgaricus is one of the lesser known probiotics but it has significant benefits for immune health. Inhabiting the intestinal mucosa L. Bulgaricus helps to reduce intestinal infections by adjusting the pH of the GI tract to promote healthy flora growth increase immunity by releasing natural antibiotics and fight infections by blocking pathogen adhesion sites within the intestinal mucosa. factory the recipient of seven industrial certifications. The olive leaf extract is produced according to its Phyto-Proof process. Each batch of certified organic olive leaf extract undergoes a minimum of 20 laboratory tests starting with the leaves that are organically cultivated and harvested in Southern Spain. Euromed obtains an organic certificate from CCPAE in Spain and also provides a National Organic Program (NOP) equivalence statement. Organic olive leaf extract is well controlled during cultivation as it does not use pesticides and interestingly the organic leaves provide an excellent oleuropein content Woodman explained. This is the most prevalent and active phytochemical in olive leaf extract. In the past most immune support ingredients stimulated the immune system often by causing an increase in production of certain white blood cells Dockery pointed out. It is now known that constant stimulation of the immune system is not best she said. More products now use ingredients that are designed to work alongside the body s immune processes and Too Tired to Fight An exhausted immune response toward infection may result in a worse outcome. Hammond noted that exercise may boost immune function but strenuous training can exhaust the immune system and hinder the innate immune response. Viruses and bacteria may gain a foothold during this window of altered immunity and lead to potential illness or downtime away from training. Recently published data from a Bergstrom Nutrition sponsored study in the Journal of Sports Medicine by Mari van der Merwe and Richard Bloomer of the University of Memphis s School of Health Studies suggests that the OptiMSM brand of MSM can blunt tissue damage and result in inflammation which prevents leukocyte apoptosis following strenuous exercise. Based on these results the authors stated MSM taken during intense bouts of exercise reduces post exercise immunosuppression. By supplementing with OptiMSM athletes can continue to train at high levels while preserving an active immune system. Immune Health Ingredient Innovations The natural product industry community is aware that transparency and traceability are big concerns for consumers these days. They want to know where their herbs come from and information on how are they grown Woodman said. Euromed recently manufactured its first production of certified organic olive leaf extract at its Barcelona Spain September 2017 www.niemagazine.com Go to www.niemagazine.com mushroomwisdom for info about this advertiser Nutrition Industry Executive 57 Impact on Immune ciencies. Consumers are looking for broader solutions to a complicated issue Hammond added. When Considering Ingredients Suppliers manufacturers and distributors are often interested in research that supports claims that they want to make in marketing their products said Dockery. In addition research that supports safety is usually a top priority as is research in a selected demographic. Conscientious manufacturers and distributors are also interested in a strong support of efficacy for the ingredient or product. The research into the immune system effects resulting from poor dental and periodontal health is still in its infancy but as more information comes to light it is likely that suppliers and manufacturers will expand research on ingredients into their effects on the body s long-term immunity against both infections and chronic diseases she added. Bush agreed that when selecting an immune health ingredient it s important for manufacturers to confirm the ingredient has science backing its specific health benefit offerings. He also recommends that the ingredient is providing efficacious amounts at the time of consumption so that consumers are receiving the health benefits. Testing should be done to ensure survivability and efficacy. And now that we are approaching cold and flu season manufacturers need to be aware they can only make structure-function health claims and not state that their products are intended to diagnose treat or prevent any disease Woodman advised. These statements are limited to drugs. Therefore product health claims need to be described as supporting normal immune health and maintenance. NIE products that stimulate the immune system bear cautions for short-term use only. In addition immune support ingredients were predominantly botanicals at one time. Now they are mostly probiotics she added. Adding to that fact Hewlings explained The innovations are the identification of the connection between gut health and immune health where in the past the market only offered products that directly supported immune health. This evolves from an overall understanding of a more integrative approach to health and well being rather than looking at the various physiological systems as acting independently. I think the evolution in the marketplace has reflected this awareness. IgY Max is one of those products that supports both immune and digestive health at once. Unlike a probiotic or prebiotic IgY Max helps reduce the attachment of 26 humanrelevant bacteria to promote healthy digestive function. By targeting the source of dysbiosis in the gut IgY Max helps reduce occasional gastrointestinal discomfort reduce excess inflammatory stress and support an efficient immune response to restore and maintain peak digestive health. Regarding probiotics the biggest innovation Ganeden has seen is immune health benefits being offered in everyday foods and beverages said Bush. There s been a shift from consumers taking supplements and pills for immune health benefits to a new demand for these benefits in more consumer-friendly products. Consumers want immune health benefits but pill fatigue dietary restrictions and busy lifestyles can all affect their ability to be consistent in getting daily servings of immune ingredients. Fortifying functional immune-health ingredients such as Staimune and GanedenBC30 into everyday foods and beverages provides easy options that fit into any daily routine. The market has moved beyond vitamins and minerals associated with the immune system and into products with benefits beyond addressing defi58 Nutrition Industry Executive Extra Extra Visit www.niemagazine.com to read about a new report on plant hormones effects on human health. FORMOREINFORMATION Bergstrom Nutrition (888) 733-5676 Euromed USA (925) 935-0334 Ganeden Inc. (440) 229-5200 IgY Nutrition (405) 242-5382 Stratum Nutrition (800) 970-4479 www.niemagazine.com September 2017 Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS NIEmagazine.com VitaminRetailer.com FitnessTrainerMag.com NaturalPractitionerMag.com NIE s Upcoming Issue Highlights Oct. 9 7 17 ad closing Washington and the Natural Industry Sports Nutrition 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 By Lisa Schofield The Participants Are David Trosin Director Of Global Business Development Dietary Supplements NSF International Ann Arbor MI Randal Kreienbrink Vice President of Marketing BI Rancho Dominguez CA T Elan Sudberg CEO Alkemist Labs Costa Mesa CA Anna Lykkeberg Research Associate Beta Analytic Miami FL Jennifer Cooper Vice President R&D and Quality Twinlab Consolidated Corporation Boca Raton FL 60 Nutrition Industry Executive he word quality is used (and abused) so frequently to many consumers it has lost its value of persuasion. Further skepticism is at the forefront consumers are hesitant to fully believe something is high quality when they want to know exactly how the brand defines that term. What are the facts that support that opinion--and to consumers quality is opinion-based. And this is what needs to change--quality as defined in scope should be transformed from marketing buzzword opinion to facts about the processes that create that quality. A lot of what creates and defines levels of quality is compliance to ever-tightening regulations and the technological advances allowing for such attainment. Industry experts weigh in on what constitutes quality in the natural product world--how to attain it and what challenges remain and are forthcoming. NIE What do you feel are the most sigwww.niemagazine.com September 2017 nificant strides in the past 10 years in regulations philosophies and technologies that allow for more reliable quality and compliance Trosin We are seeing more acceptance and compliance with good manufacturing practices (GMPs) in the dietary supplement industry. In recent years the industry has come together to establish the Global Retailer and Manufacturer Alliance (GRMA) and focus its efforts on supply chain transparency and quality. It s encouraging to see the dietary supplement industry moving in the right direction in both thought and action. Sudberg More reliable quality and compliance comes with an increased cost of doing business. The industry has accepted this idea which can be seen by the growth in the lab sector. We have also done a great job of weeding out the bad players (from the standpoint of a lab that knows all the bad players). Transparency has become more than just another buzzword and we re seeing it exemplified throughout the industry. From a regulatory standpoint unimpressive strides have been made toward clarifying fit for purpose test methods in response to the turbid vagueness for which cGMPs were forged. We ve spent the last 10 years debating which methods we should all be using and for what samples based upon demonstrated scientific validity and then from the sidelines technologies such as Infrared spectroscopy (IR) Near-infrared spectroscopy (NIR) Fourier transform infrared spectroscopy (FTIR) and DNA have emerged as disruptors to the progress made in agreeing on best testing practices. All technologies might have a purpose in our industry once their strengths and weaknesses are understood and widely accepted. However and unfortunately premature application of technology as we have seen with DNA and IR technology has distracted industry from focusing on actual quality. Cooper The most important issue facing the industry today is a philosophical one. Is our quality strategy as an industry to get ahead of the regulators or is good enough good enough for now We have an unfortunate reputation as an industry of doing just enough to get by and waiting for the next shoe to drop. Some of that may be well deserved and some of it is due to ambiguity in and the evolution of regulatory standards and enforcement activity. Shockingly the industry waited with bated breath for more than a decade for September 2017 www.niemagazine.com the supplement GMPs. Among the next shoes to drop are NDIs (new dietary ingredients) raw material GMPs SAERs (Security Access Eligibility Report) and finished product market registrations. There are six key factors as follows 1. Advances in testing (eg DNA) has very real limitations and has met with much controversy in the industry. We can accept that this tool for better or worse is coming. Regulators and watch groups are likely to use it whether we embrace it or not. We can either keep bemoaning it or we can participate in improving the technology and developing the standards for its use. In recent years the industry has come together to establish the Global Retailer and Manufacturer Alliance (GRMA) and focus its efforts on supply chain transparency and quality. It s encouraging to see the dietary supplement industry moving in the right direction in both thought and action. -- David Trosin NSF International 2. Claims challenges class-action lawsuits involving claims or product descriptions are increasing in frequency. More worrisome plaintiffs are winning huge settlements. The standard for competent and reliable scientific evidence has been a hot topic from the day DSHEA (Dietary Supplement Health and Education Act of 1994) was passed and continues to evolve based upon case law and consent decrees. While we may debate the definition of competent and reliable science we should acknowledge that whatever the standard the industry needs to be more committed to supporting scientific endeavors and to elevating science behind dietary supplements. We should not lose sight of the big picture while we debate the nuances. 3. The industry has taken a very proactive role in trying to shape the final guidance document on NDIs. If your company is not involved you should be. Based upon the pending draft the extremely broad definition of NDI will impact every company and has the potential to create a quasi pre-market approval paradigm. 4. SAER reporting is actually dropping rather than increasing while sales are up. The industry is growing and social media makes it easier than ever for customers to voice their complaints but reporting does not keep pace with these trends. SAER under-reporting is going to precipitate a cataclysmic event. Companies with a proactive quality strategy should get ahead of the regulatory crisis that is looming. 5. We have better testing methods and more agreement on their standardization lower detection limits increased specificity expanded reference libraries more precise standards and the school of hard knocks to thank for smarter faster and more accurate testing of ingredients and products. We still have more we can do here and as new ingredients or forms of ingredients come into the market we need to invest in the best practices for ensuring their quality. The ability to test the identity of most ingredients using various LC and GC technologies (including MS and MS-MS strengths) has facilitated a different level of detail available to us for monitoring purity potency and identity. (Both TLC and HPTLC technologies are still heavily used.) 6. Philosophies and practices such as SQF (Safe Quality Food) and HACCP (hazard analysis and critical control points) have guided cleanliness and practices in manufacturing that help protect the quality of the products being sold to the customer and ensure safety. They can help in designing processes as well as redesigning them when failures occur in formulation production or testing. Kreienbrink Both FSMA (Food Safety Modernization Act) and GFSI (Global Food Safety Inititative) have made strides on food safety quality and standards. FSMA has shifted food safety measures from responsive to preventative while GFSI has created consistent food safety standards across the industry. Trade organizations--ABC (American Botanical Council) AHPA (American Herbal Products Association) CRN (Council for Responsible Nutrition) NPA Nutrition Industry Executive 61 (Natural Products Association)--have also had great impacts on quality and standards as well as safe unadulterated products. Lykkeberg While Carbon-14 natural source testing is not a recent development it has been gaining traction in the supplement industry in line with the changes in consumer perceptions and priorities and businesses implementing stricter quality controls for natural ingredients and rising demand for botanical extracts. to the lack of clarity in some of the provisions. The lack of clarity applies to areas such as fiber for example will the FDA allow other fibers besides the seven designated fibers to make claims Fibers such as inulin aren t currently on the list. Another area that is murky is added sugars. Fruit concentrates are currently labeled as added sugars but fruit pumices are not. Will this change And finally there are questions regarding portion sizes. Who will define what constitutes a reasonable amount Will this be the FDA consumer or manufacturer NIE What are the most significant challenges brand marketers now face for compliance when formulating new products Cooper Claims claims claims. The substantiation standard for claims is one that continually plays out in the court system. Natural product claims are on the radar of the National Advertising Division FTC (Federal Trade Comission) FDA (U.S. Food and Drug Administration) CRN state attorneys and others. It is marketing s job to create the most compelling story for a product and its ingredients. Label claims are so much more than just the front panel structure function claims. Claims also come in the form of how we describe the ingredients in the supplement facts panel and any additional language about their sourcing origin or certifications. It s Quality s and R&D s job to make sure that we haven t created an ingredient mythology where all the bells and whistles have limited our ability to source this magical ingredient to less than 2 percent of all the material available on the planet. I like to refer to this as sourcing from the dark side of the moon. Basically we have over spec-ed the ingredient to where it is not realistically commercially available on a consistent basis or where its sourcing will have dire environmental consequences. Kreienbrink Label claims health and wellness claims ingredients that match specifications and certifications all pose challenges when formulating with new products but the new Nutrition Facts label regulations though postponed are proving to be especially difficult due 62 Nutrition Industry Executive Lykkeberg When formulating new natural products a big challenge is becoming familiar with the supply chain and QA (quality assurance) of any new ingredients. With the ever-burgeoning variety of natural ingredients on the market and the corresponding adulteration techniques it is important to understand how the natural raw material is sourced and what measures are in place to assure its authenticity throughout the increasingly complex supply chains. There are no specific regulations on the use of the term natural in many industries including dietary supplements however claims must not mislead consumers. Understanding natural ingredient sources and ensuring their authenticity when formulating new natural products is crucial to prevent any legal ramifications from any claims used. The cosmetics industry also sees similar issues with natural product claims and the U.S. Federal Trade Commission has acted on misleading natural labels. There have been settlements with several companies that used 100 percent natural or all-natural claims on products containing synthetic material. An additional concern here is the complexity of regulatory restrictions. For example raspberry ketones are permitted in small amounts as flavoring in the E.U. However for use as a dietary supplement it is classified as a Novel Food meaning its use as a supplement was unauthorized in the E.U. until a review later permitted the use of a specific extract sourced from raspberries. In this case the above considerations of the supply chain and QA have added regulatory implications. Extracting them from raspberries is expensive and gives a low yield whereas the synthetic version manufactured from petrochemicals is a much cheaper option. Trosin You might think qualifying a contract manufacturer is a challenge but NSF International s GMP Registration lists hundreds of manufacturing facilities packagers and distributors that are verified to comply with the FDA s GMP requirements. NSF International evaluates thousands of dietary supplement products and we ve found that contamination adulteration and a lack of claimed ingredients or stated level of ingredients are the biggest challenges for brand marketers. Sudberg We have evolved as an industry to where the increased cost of identity testing is no longer that new liability on the balance sheet getting people fired. Most of the industry has taken that big gulp and swallowed it down identity testing is essential. The industry s next big challenge that must be addressed sooner than later is new product method development. Once a formulation has more than just a single ingredient there is a need for fit-for-purpose methodology. Test methods simply don t exist for blends of ingredients until they are developed by a lab. Ginger in ginger powder testing is quite routine. Testing Gingerols in ginger is also quite routine. Gingerols from ginger in a ginger blend with all of ginger s close colleagues is not routine it requires specifically developed test protocols. Some companies choose not to spend the money but that s foolish the FDA has been hunting for labels that make constituent claims without scientifically valid methods to back up the data. The resulting fallout is far far more expensive than doing it right in the first place. www.niemagazine.com September 2017 Go to www.niemagazine.com nsf for info about this advertiser We see this as the next major challenge for the dietary supplement industry which is why we re strongly recommending dealing with it now. NIE There are hundreds of thousands of natural ingredients sources for dietary supplements--and still a high potential for adulteration or use of the wrong material. How do you believe adulteration prevention has potentially improved--and what needs to be done to make it even more foolproof Cooper One of the best and worst things about the natural products industry is that there is literally an infinite number of possibilities when it comes to raw materials. The same ingredient could be grown in multiple regions of the world fluctuating seed stock sprayed with different kinds of herbacides and pesticides exposed to varying weather patterns pests and pollution picked during different seasons and at different times during the plant life cycle. It can be harvested and processed immediately or languish in silos or bales. It might be sterilized extracted dried granulated and stored under diverse conditions. The same mega lot might be sub-lotted and sold under different lot numbers for many months or longer. Even with all this uncertainty legally this could all be the same ingredient--and we haven t even discussed how it might be adulterated contaminated or misidentified. It is not the same thing to do quality control for a pure substance like ascorbic acid as it is for an agricultural commodity. Just like there are fat juicy brightly colored oranges there are also green hard stubby oranges. They are all still oranges but not really the same thing. Certainly if you ask the consumer what he wants his expectation is definitive. There is also an endless number of things that can go wrong in the global complex supply chains that are now prevalent. It is impossible to spec your way to quality. The first step to getting high quality ingredients is having a rigorous specification but unless your specification is a doctoral dissertation for each ingredient you can t define or 64 Nutrition Industry Executive anticipate everything that could go wrong. Specifications are constantly evolving to consider new threats better sourcing options and improved testing techniques. Even when you have great relationships and solid specifications nothing can take the place of testing. So many different grades of materials are available and the bottom line is that you get what you tolerate. Every time I reject a lot I know the likelihood that it will be sold to someone else is very high someone who didn t do as aggressive testing and whose tolerance is higher than ours for accepting variation and risk. Using a third-party ISO 17025 accredited laboratory to confirm any in-house testing can detect any fraudulent claims along the supply chain. -- Anna Lykkeberg Beta Analytic Trosin Adulteration prevention starts with raw material and finished product testing. It s also important to know the likely adulterants for different ingredients and product categories. NSF offers two levels of certification for dietary supplement and functional foods. NSF product certification verifies regular GMP compliance and product content while also making sure the product is free of common contaminants. At a higher level of certification products that are NSF Certified for Sport are tested on a lot-by-lot basis for over 270 athletic banned substances. That s why NSF Certified for Sport is recognized by major professional sports leagues including the NFL NHL MLB PGA and LPGA. Lykkeberg One form of adulteration in the industry arises from the fact that many natural raw ingredients can be expensive to extract and low in supply with prices fluctuating significantly depending on harvests while petrochemicals are plentiful and cheap with comparatively stable supply chains. This difference means that many natural products are subject to economic adulteration with a variety of cheaper additives including petrochemical sourced synthetics. A prominent example of this in the supplement industry is curcumin. There have been legal cases brought against suppliers selling petrochemicalderived synthetic curcumin as natural indicative of businesses taking the problem of adulteration increasingly seriously. A Euromonitor survey found that consumers associated products labeled as natural with being plant-based and free of artificial additives. Businesses with verified natural claims and stringent quality controls for natural ingredients can use this to their advantage in marketing their products. There have also been issues with suppliers providing falsified testing certificates. Using a thirdparty ISO 17025 accredited laboratory to confirm any in-house testing can detect any fraudulent claims along the supply chain. Carbon-14 testing offers a definitive answer to whether any natural products have been adulterated with any petroleum-derived synthetic ingredients and is able to detect adulteration of curcumin as described above providing assurances to consumers that the product is 100 percent plant based. Sudberg Cheaters will cheat. They have since the beginning of trade-- there is clear evidence that olive oil adulteration was a major problem in ancient Rome. The industry has resources available that can help such as AHPA s tireless efforts to guide the industry toward quality products and ABC s Botanical Adulterants Program. By deploying a testing regimen that strategically uses these resources to engineer an internal or external testing program that will minimize adulteration risk and optimize product efficacy a company can make something we shouldn t have to worry about foolproof. If testing is not part of a company s internal operations incorporating high quality standards into their buying power such as only buying from the top providers with demonstrated quality standards will do its part. NIE Clean label has rocketed to the forefront of consumer demand--what types of challenges does this place on www.niemagazine.com September 2017 the brand marketer and its supplier contract sources What are more recent developments in achieving this as expediently and effectively as possible Sudberg Clean label is a fancy way of saying that consumers increasingly opt for products with simple ingredients are ethically produced and with nothing to hide. Many supplements have complex production that isn t easy to describe and some products can t honestly make such a claim. To claim clean label for supplements requires demonstrating ethical sourcing conscientious manufacturing and robust fit-forpurpose testing to both retailers and consumers. For legitimately high-quality ingredients marketers are telling the stories behind their products but are missing the boat in an important way. One way of demonstrating quality that the industry has not yet caught onto is being transparent about testing. Testing is crucial to product quality and good testing labs are quality gatekeepers so why are we kept secret Cooper Clean label ingredient options are now more commercially available than ever making clean label more the rule than an exception for many brands that are willing to pay a premium. Organic non-GMO (genetically modified organism) allergen free animal product-free actives and excipients are commercially available and more functional than ever. The challenge of changing a traditionally formulated product to clean label product is always how to mitigate the cost increases and how to decide what the consumer is willing to pay for such a change. Lykkeberg The push for clean label has seen a rise in demand for plantderived ingredients and phasing out of artificial additives and flavors. Making clear and verifiable claims is a key aspect of clean labels and with the term natural not being regulated or having a harmonized definition across the industry authenticating natural claims is one of the key considerations. The aforementioned Euromonitor survey noted that while many consumers seek natural products and trust the natural label the majority are also aware that the term is not regulated. Being plant-based and free of artificial additives are attributes that consumers associated with the label. The use of the natural claim for vitamins that contain more synthetically sourced ingredients than natural ones is an example of an instance where this label has caused September 2017 www.niemagazine.com concern and left consumers feeling misled. Being able to verify natural claims is an important step for a clean label and the Carbon-14 method provides an easily communicable result for consumers and QA. By distinguishing between biomass-derived and petrochemical-derived material Carbon-14 testing substantiates claims that natural products are free of petrochemicalderived synthetics in line with consumer perceptions of the natural claim. Your best plan is to focus on quality and genuine regulatory compliance so whatever happens your business should be on solid quality and regulatory ground. -- Elan Sudberg Alkemist Labs NIE What is on the horizon in the area of compliance and quality control eg. regulations and technology Trosin FSMA compliance requirements for dietary supplements are on the horizon. Shortly after that we hope to see finalization of the GRMA dietary supplements standard. With that said it is not about what is new but about perfecting what we have. Lykkeberg Many natural product industry stakeholders and consumer segments are calling for a more defined and restrictive definition for use of the term natural and we are beginning to see regulatory bodies respond to this. Other industries have been facing similar challenges to nutraceuticals and supplements with natural claims and the clean label trend. In the personal care industry the FTC has taken action against several businesses using all-natural or 100 percent natural claims for products that also contained synthetic ingredients. Additionally the E.U. has recognized the problems of misleading marketing that the lack of a regulated and harmonized definition for natural has on the cosmetics industry. And the FDA has also shown an interest in the use of the natural label in foods and requested comments on the topic. As supply chains become increasingly complex and consumers demand more clarity the use of more standardized tests to substantiate claims verifiable by third-party laboratories is a logical step toward increased accountability of any natural claims. Along with QA for the ingredients themselves any third-party laboratories used should themselves also hold accreditation confirming their technical competence ISO 17025 is the recognized benchmark for testing and calibration laboratories. Sudberg Expectation that regulatory scrutiny would decrease with Republicans winning Congress and the White House was silly because it s not like industry critics such as state AGs (attorneys general) the media and other fault finders were abducted by aliens. With the administration so chaotic anything can happen. Your best plan is to focus on quality and genuine regulatory compliance so whatever happens your business should be on solid quality and regulatory ground. While there are always people drawn to the latest shiny ball of new technology when it comes to testing new technology often gets dilettantes in trouble. Experts spend years being nerdy together to agree on what methods work best and you don t throw that over lightly. The fact is that if it isn t fit for purpose and reproducible it s not good science. There is no single technique to be utilized for plant identity (extract or not). DNA HPTLC microscopy and good old-fashioned organoleptic techniques can t be beat when combined. As you remove one from that mix you add risk to your quality. NIE Extra Extra Visit www.niemagazine.com to learn more about the importance of quality assurance. FORMOREINFORMATION Alkemist Labs (714) 754-4372 Beta Analytic www.betalabservices.com BI (310) 669-2101 NSF International www.nsf.org Twinlab Consolidated Corporation www.twinlab.com Nutrition Industry Executive 65 MarketingInnovation PR in the Age of Transparency By Suzanne Shelton The Shelton Group few years ago as if by magic suddenly everyone was talking about transparency. Then clean label joined the conversation. While the two are not the same they are closely related in terms of meeting consumer expectations. In the handful of years since entire issues of trade magazines and multiple educational programs at trade shows have been dedicated to these ideas which are in essence marketing terms. All of these to this day still include the question what is it The answer has always been simple follow best practices in producing healthy products and tell the story of how you do that thoughtfully authentically and accurately. Let s look at that process. The first step is determining when a campaign based upon transparency is a good decision because transparency that reveals shortcomings is not advantageous. I heard a trade show speaker from another marketing agency advise companies to decide what they want to be transparent about and what they don t. I d take a different approach to A this and say if your practices won t bear scrutiny transparency isn t for your company. Buying the cheapest ingredients you can find doing minimal testing if any or even worse relying on a suppliers certificate of analysis and putting the tiniest amounts of ingredients into a product that you can get away with and still have them on the label isn t going to win customers if they know about those practices. A company doesn t have to be perfect but they do have to demonstrate their quality and integrity. Here are the ideal types of companies that would benefit from campaigns based upon transparency Ingredient suppliers that source raw materials ethically grown or produced process them with minimal solvents and attention to environmental impact have science to support safety and efficacy and a robust testing program to confirm identity purity and potency. Finished product companies that buy high-quality ingredients with any botanical raw materials ethically grown then have them tested by a competent lab knowledgably formulate ingredients and use therapeutic doses in their finished products made by strict adherence to cGMP (current good manufacturing practice) requirements. One other component of producing quality products very few companies are including in their marketing and PR campaigns is transparency in testing which I think is a mistake. Product testing is complex. Even the average dietary supplement company executive probably doesn t understand it very well let alone consumers however describing who does your testing and why they are the best gatekeeper for quality is not an overly confusing story to tell. If testing is at the heart of product quality then good testing labs are the gatekeepers and they should not be kept secret. So once you have determined that your company is a good candidate for being transparent what are the best tools and tactics to use All of them. Today the line between PR and other www.niemagazine.com September 2017 66 Nutrition Industry Executive marketing tactics has been blurred by the many and varied content marketing opportunities offered by publishers and trade shows companies. While it has always been important to have consistency between the different tactics and information vehicles with today s overlap it s more crucial than ever. Again transparency is revealing your best practices telling the story clearly and honestly whenever you talk about your company and products. This is a great time to freshen up your website copy. Look at your FAQs and see if you have current information there that tells your quality story and talks about your sustainability efforts and other business practices that consumers have come to expect. Do the same with your About Us page and the rest of your website. Then check your company description on social media in your catalog and everywhere else you make information available to customers. Once you have added that information to the basic places people check you out then begin using new ways to telling your story. Why Because if you have new ads or press releases touting your quality and none of that is on your website your credibility is imperiled. viewed that is an opportunity to include clear descriptions of your best practices. Many of them are also open to publishing an article that you write so ask editors about it. This is another opportunity to pull back the curtain and reveal your best practices although it has to be done with an educational approach rather than as an advertorial or they won t print it. Other opportunities to tell your story can be speaking slots at trade shows web seminars video tours on your website infographics and bringing in editors writers and bloggers for media tours of your facility. This latter tactic can be expensive but the return on your investment is incredible. content well presented. Don t clutter the graphics do list references for studies mentioned and don t promote your company until after you talk about the substance of the product. Some trade magazine publishers will distribute materials you produce to their subscribers for a fee with others you have the option to sponsor fresh content they produce usually but not always with some input from you. Every publisher s content marketing program is a little different so talk to them all to figure out what is the best fit for your specific needs. What Consumers Expect The information that you reveal within the industry can be a lot more detailed and specific than that presented to consumers but that doesn t mean you can t explain your best practices to them. You absolutely should. The number of consumers shopping their values has grown along with their access to information about companies who s products they might or might not buy from wherever they are. Because consumers are interested in how you demonstrate shared values describe to them for example how you are working to eliminate GMOs (genetically modified organisms) from your products with occasional updates on your progress. Use this on your website and on social media platforms. Keep your website updated with messages from management and even various departments involved in the manufacturing process. Use these on social media as well. Once you have begun telling the story of your best practices you might find that it inspires you in your work which is not an unusual reaction to authentic transparency. It s a side benefit but a very good one. NIE The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Suzanne Shelton has provided public relations services to both international and domestic dietary supplement and natural products manufacturers suppliers and associations. Nutrition Industry Executive 67 Content marketing engages potential customers with more substantial information than advertising allows in an effort to increase likelihood they will eventually purchase your product. Content Marketing 101 Content marketing engages potential customers with more substantial information than advertising allows in an effort to increase likelihood they will eventually purchase your product. Flagrant product pitches are not effective in good content marketing but telling your story with all the substance behind it in detail is what they are designed to do. Your content should be authentic and informative providing detail that is consistent with your other marketing messages. Content marketing works best over time consistently reinforcing your quality message and willingness to be open about your business practices. Because we are all overwhelmed with content to stand out make it valuable B2B Visibility A major transparency initiative is worthy of a news release but that s not your only opportunity to tell this story. Whatever news you are announcing you can and should reiterate your best practices and how that fuels quality and ethical business practices. When was the last time you freshened up the boilerplate paragraph at the end of your news releases Take a look now and make sure describing your commitment to best practices is in there (while you are at it change any references to X number of years to the actual date so it s always accurate that s one of the most common mistakes in those paragraphs). People who don t have much experience with public relations sometimes think PR is just sending out news releases. While that s certainly part of it I spend far more of my time on other tactics. Check all the industry trade publications editorial calendars to see what upcoming topics you could provide expert input to and send them an email offering your expertise. If they are able to include you in their list of companies interSeptember 2017 www.niemagazine.com FunctionalFoods By Donald Cox PhD R&D Director--Wellmune S imply put the functional products market is large and growing. Euromonitor reports the functional food and beverage market is estimated to be 247 billion globally growing at a compound annual growth rate (CAGR) of 3.6 percent through 2021. Additionally the vitamins and dietary supplement category are an estimated 91 billion with a CAGR of 3.3 percent through 2021. What s driving this growth in the functional products category For one consumers are taking a long-term approach to their health moving from reactive short-term fixes to a more proactive preventative approach. Because of this functional foods beverages and supplements are becoming an important tool for self-accountable consumers in reaching their health and wellness goals. As a proof point GlobalData reports that 60 percent of consumers say they actively use foods and beverages to improve their health and 73 percent of con68 Nutrition Industry Executive sumers report taking supplements at least once per week or more. This progressive approach to health and wellness is bringing long-term immune health to the forefront of consumer concerns. For example according to a GlobalData report immune health is the second most desired functional benefit consumers want in food or beverage--second only to general health and wellness. Product Availability Whitespace Even though consumers look for more immune health-focused foods beverages and supplements consumption remains low. Here is where we find the whitespace and thus the open opportunity for product manufacturers. GlobalData also reports only 48 percent of consumers are actively buying immune health products yet 87 percent of consumers are interested in purchasing foods and beverages with immune health benefits. High interest yet low consumption indicates a few issues in the marketplace including a lack of ingredients that help communicate the benefits of an immune health product and the lack of naturally functional nutrition that is clinically proven to address the immunity needs of targeted consumer groups safely. As manufacturers look to create products that meet demand immune health ingredients that are safe natural and clinically proven will lead to stronger innovation and resonate with consumers. Innovation Starts With Building Trust While immunity is top-of-mind health messages are becoming more involved. This can be an issue for product manufacturers because people want to quickly understand and feel good about the benefits of the immunity products they are consuming. Addressing consumer skepticism and confusion by utilizing www.niemagazine.com September 2017 immune health ingredients backed by clinical research is an important factor to consider. Products supported by science and research can help cut through the noise and provide opportunities to build trust and transparency. Immune health ingredients that are clinically proven can reduce the fear of the unknown. Research can demonstrate the safety of the ingredient and its ability to strengthen the body s natural immune mechanisms. In certain markets it also gives manufacturers the ability to utilize marketing claims which can capture consumer attention and help consumers better understand the value of the product. ing lifestyle stress. Ultimately consumers want to know that they are getting the right immune health benefits for their current or future needs. Targeted nutrition will be a key trend and will require formulating products by benefit demographics and or lifestyle needs. proprietary baker s yeast beta 1 3 1 6 glucan Wellmune is the solution for product manufacturers that want to create produce and sell a variety of functional food beverage and supplement products with immune health as a core benefit. Look for Research That Matters When it comes to finding immune health ingredients with clinically proven benefits not all research is created equal. The key here is to look for multiple high-quality clinical studies with consistent outcomes. Scientific and regulatory interest in biomarker outcomes and physical health outcomes must have a demonstrable positive benefit for people. Also ingredients that have safety data published in a peerreviewed journal and been reviewed by the appropriate leading regulatory agencies are by far the best way to differentiate your product. Products supported by science and research can help cut through the noise and provide opportunities to build trust and transparency. Product Applications Need an Innovative Touch Finally manufacturers will need to consider how different consumer groups are consuming their product. The desire for both traditional supplements and more convenient product formats are blurring the lines between functional foods beverages and supplements in the immune health market. And consumers are looking for immune health products that will easily fit into their lifestyles throughout their day. Because of this consumers will continue to seek immune health products such as bars chews gummies powders and nutritional beverages and manufacturers will need to find immune health ingredients that can easily be incorporated into such products. Yeast Beta Glucan Beta glucans are naturally found in foods such as baker s yeast shiitake mushrooms and cereal grains like barley oats rye and wheat. But beta glucans vary with respect to branching structure and the understanding of that structure s health benefits. And while beta glucans have long been utilized for targeted health benefits what differentiates Wellmune is its proprietary extraction process its 1 3 1 6 structure and the proven research supporting its ability to help improve immune health across all ages. For example the scientific understanding of Wellmune s mechanism of action in the body is well documented in published peer-reviewed research. Clinical studies have consistently demonstrated Wellmune s health benefits including its ability to help maintain overall physical health protect against the harmful effects of stress and promote healthy energy levels and mental clarity. In general innovation in the functional food beverage and supplement markets is something to track. Capturing demand will require safe natural and clinically proven ingredients. It will also require targeting the right benefits for the right consumers. This starts with understanding what health benefits consumers want and what functional ingredients can meet those demands. NIE Donald Cox PhD leads Kerry s technical efforts for the Wellmune ingredient. Areas of responsibility include clinical research regulatory filings product development and technical services. Cox has significant experience with the commercialization of natural products in the industry. He has worked exclusively in the natural products industry during his career and has held positions with Biothera DKSH North America Cargill and Diamond V. Cox has a PhD in food microbiology from Cornell University and an MBA from the University of Iowa. Back to Natural Nutrition Beyond the importance of sourcing ingredients that are backed by science consumers are seeking products with natural functional ingredients to better their health. GlobalData reports 94 percent of consumers are interested in food and beverages with a natural claim. What this tells us is great opportunities exist using nutrition to build immunity naturally but ingredients also need to be effective. The challenge here is that more often than not natural functional immune health ingredients can lack compelling scientific proof of efficacy. Targeted to the Consumer While immune health is important for everyone consumers are also seeking personalized and tailored products for their specific age groups and need states. And though immune health is important for everyone it is especially critical (and in high demand) for consumer groups including families and children athletes and weekend warriors older adults and those experiencSeptember 2017 www.niemagazine.com Immune Health Technology Led by R&D Kerry is focused on providing innovation through R&D and one of the best examples of that is our natural immune health ingredient Wellmune. Wellmune is a natural food beverage and supplement ingredient clinically proven to help strengthen the immune system. A Nutrition Industry Executive 69 IngredientTechnology Big Performance is Delivered in Many Tiny Spheres Through Lipid Multi-particulates Technology The benefits are as numerous as the particles themselves from helping to launch new products to freshening up a brand with a new delivery look. By Glenn A. Guadi Senior Global Product Manager Capsugel Health & Nutrition here pharmaceutical delivery forms have travelled the health and nutrition industry has often followed. Take antibiotics for example. A normal dosing regimen for an antibiotic was 10 to 14 days but by creating the modified release version of the product patients could get the same efficacy in only five days. This long-standing multi-active timerelease concept is being repurposed and repositioned for the delivery of nutritional actives with a new formulation technology called Lipid MultiParticulates (LMP). The technology offers modified release taste masking and the potential for enhanced bioavailability along with a novel and visually appealing dosage form for fresh product presentation with a marketing edge. LMP are spherical in shape and are characterized as microspheres. Each particle is formulated to contain a measured micro-dose of active nutritional ingredients including botanicals vitamins and amino acids. Particle sizes range from 50 to 300 microns. The ability to precisely deliver a metered dose of actives combined with controlled particle size of LMP can lead to improved gut distribution. The combination of size and specific formulation can affect the various timing of the controlled dissolution after ingestion. Using a continuous spinning-disk process developed by Capsugel the ingredient is uniformly distributed within a carrier--typically a lipid. The liquid active is pumped into a tank and then sprayed onto a rotating disk. The centrifugal force of the spinning wheel shapes the microspheres that are blasted with temperature controlled air to congeal them. Although similar to the beads-in-acapsule technology for combination products and timed release LMP technology provides advanced precision dosing and floating microspheres that feel smooth in the mouth rather than crunchy to the teeth. Because LMP microspheres have excellent flow properties they are versa- W tile and can be included in a broad range of finished dose formats including textured powder blends via sachets and sticks for reconstitution in liquids powder-filled capsules liquid-filled capsules sprinkle capsules and capsuleswithin-capsules. They can even be compressed in tablets. LMP technology can improve the performance of nutritional actives in three areas modified release taste masking and bioavailability. Performance Advantages Following are examples from the sports nutrition platform often the earlier adopters of new technology. Other applications will arise as solutions are created for capsule convenience without the need of added packaging and as ingredients in other platforms. Modified Release Phosphatidic acid has been studied for the development and maintenance of muscle mass. In a sports nutrition product modified release of phosphatidic acid has been touted as a value for building muscle and recovering from exercise. LMP has been combined in a bulk powder blend that can be mixed in water. The microspheres in varied dosages reflect neutral buoyancy properties--meaning they float in the water--and dissolve after ingestion the smallest particles fairly quickly and the largest spheres hours later. This over-time dissolution profile releases the active periodically when you want it or when you need it rather than all at once for longer enduring effect. Taste Masking Theacrine is an alkaloid closely related to caffeine and is often incorporated into sports supplements connected to energy mental sharpness and focus. Formulators use it synergistically with caffeine to help prevent the crash when the caffeine hit wears off. Theacrine is extremely bitter and a recommended dose can taste terrible if it dissolves before ingestion. The delayed-release like property of LMP technology for a beverage application contributes to taste masking because it stops dissolution of microspheres until after consumption when the active is no longer in contact with the palate. Bio Enhancement Lipid multi-particulates were designed to improve bioavailability especially when the ingredients are fat-soluble. The active ingredient is solubilized in a stable lipid solution that is converted to a solid but acts like a lipophilic micelle to promote absorption through the brush barrier of the gut. These three illustrations discuss the performance advantages of LMP technologies that can help launch an entirely new product. Supplement manufacturers and marketers are also drawn to the technology for numerous marketing benefits and competitive advantage with consumers within their own brands. Free-floating spheres in liquid suspension in clear capsules or water can be attractive even cool to view. The unique appearance can be tapped to create standout product extensions and premium offerings within categories. The versatility of LMP--from performance enhancement to dosage form options to presentation edge--is a true testimony to how big things can come in small packages. NIE Glenn A. Guadi Senior Global Product Manager is a 22-year veteran of the 500 billion Global Consumer Healthcare Market. He is responsible for developing and implementing the global strategy at Capsugel to expand the use of novel drug delivery technologies to enhance the efficacy of oral consumer health care products. Guadi holds an MBA from the NYU Stern Graduate School of Business with specializations in corporate finance and corporate strategy. He is an active member of the famed Central Park Track Club and will compete in his seventh NYC Marathon this fall. www.niemagazine.com September 2017 70 Nutrition Industry Executive SupplySideWestBoothPreview September 25-29 2017 Mandalay Bay Expo Hall Las Vegas NV The following companies advertising in this issue have submitted information describing their plans for SupplySide West--product launches show specials and special services are all included below. Booth numbers are provided with each listing to encourage in-person meetings to learn more. ADH Health Products Inc.--Booth OO175 ADH (Congers NY) has and continues to be relied upon as a trusted manufacturing partner by some of the most prestigious and well-renowned brands in the industry. The company understands what it takes to ensure that its clients succeed. ADH manufactures in a state-of-the-art 70 000-square-foot facility based in New York. The company provide its clients with a plethora of dietary supplement options within the following dosage forms tablets capsules liquids and powders. Of course modifying a traditional dosage is our specialty--if you re looking to match a desired flavor profile alter a release pattern or develop a proprietary process ADH is your partner. For more information call (845) 268-0027 or visit www.adhhealth.com. Ayush Herbs Inc.--Booth LL150 Founded in 1998 Ayush Extracts (Redmond WA) marries ancient ayurvedic principles with the latest scientific technology providing the highest quality uncontaminated unadulterated standardized extracts and raw powders. The company has full knowledge and confidence in every facet of all its products. That is just one of the many reasons that Ayush Extracts is a name that represents quality and purity. And now the company is proud to provide more than 100 NOP certified extracts to its product lineup. For more information call (425) 637-1400 or visit www.ayushextracts.com. Balchem Corporation--Booth CC155 The Balchem (New Hampton NY) Human Nutrition and Pharma unit manufactures and sells Albion Minerals the company s brand of scientifically validated chelated minerals and VitaCholine its brand of the essential nutrient choline. These premium ingredients offer superior delivery of health benefits and are built on strong science and innovative technologies recognized worldwide for their quality efficacy and safety. Balchem s SensoryEffects unit develops customized food and beverage solutions via the company s novel microencapsulation powder flavor and cereal systems delivering enhanced sensory attributes and nutritional benefits. For more information call (845) 326-5675 or visit www.balchem.com human-nutrition-and-health. Alkemist Labs--Booth R121 Industry leader Alkemist Labs (Costa Mesa CA) is an ISO 17025 flexible scope accredited contract testing laboratory specializing in plant authentication botanical ingredient identification and quantitative analytical services to the food and beverage nutraceutical and cosmeceutical industries. Alkemist Labs offers a wide range of specialty research services to evaluate the identity purity and quality of botanical raw materials dietary ingredients and finished products and an array of critical tools for botanical identity verification. For more information call (714) 754-4372 or visit www.alkemist.com. Applied Food Sciences Inc.--Booth EE176 Try Guaysa at booth EE176. This emerging ingredient patented exclusively by Applied Food Sciences Inc. (AFS Austin TX) is featured in this year s SupplySide West Survival Kit AFS is an international ingredient supplier that provides solutions to the industry for creating the healthiest natural and organic products imaginable in beverage food and nutritional supplements. With its newly opened innovation center AFS develops novel ingredients that are highly scientifically qualified water-soluble sustainably and ethically sourced non-GMO (genetically modified organism) and GRAS (generally recognized as safe). For more information call (512) 732-8300 or visit www.appliedfoods.com. Beehive Botanicals--Booth D136 Since Beehive Botanicals (Hayward WI) founding in 1972 the company has strived to give its customers a quality product in a timely manner at a fair price. Beehive Botanicals holds kosher organic and NSF GMP (good manufacturing practice) certifications as well as Canadian site license. The company welcomes third-party review and audit of its facility and SOPs to demonstrate our compliance. Beehive Botanicals 44 years in this industry enables it to manufacture your product to meet FDA (U.S. Food and Drug Administration) compliance. For more information call (800) 227-0651 or visit www.beehivebotanicals.net. Daiwa Health Development--Booth 130 Visit Daiwa Health Development (Gardena CA) at booth 130 at SupplySide West. The company will be offering a show discount of 20 percent off. For more information call (866) 475-4810 or visit www.dhdusa.net or www.dhdmed.com. September 2017 www.niemagazine.com Nutrition Industry Executive 71 SupplySideWestBoothPreview September 25-29 2017 Mandalay Bay Expo Hall Las Vegas NV DPL-US--Booth R165 DPL-US (Islandia NY) a division of Dr. Paul Lohmann is a leading manufacturer of specialty mineral salts for food dietary supplements personal care and pharmaceutical industries. With more than 130 years of manufacturing the company offers more than 400 different mineral salt varieties. DPL-US high-value quality minerals are manufactured according to FSSC 22000 ISO 22000 GMP certification and are GMO free. Superior service and quality has been DPL-US long history. For more information call (631) 851-8810 or visit www.dpl-us.com. IgY Nutrition--Booth Q138 IgY Nutrition (Oklahoma City OK) is the foremost authority on the development and production of hyperimmune egg supplements. The company s ingredient IgY Max captures the capabilities of IgY immunoglobulins delivering targeted immune support to the digestive system for improved gastrointestinal and immune function. This unique IgY-based prebiotic supplement supports the body s natural detoxification process to reduce bacterial competition in the gut and promote the growth of pre-existing probiotics. IgY Nutrition s mission is to provide a naturally pure safe and effective dietary supplement for comprehensive digestive and immune protection as an ingredient in other health products or to be used directly by consumers. For more information call (405) 242-5382 or visit www.igynutrition.com. ExcelVite Inc.--Booth Q126 At SupplySide West 2017 PIC S GMP-certified ExcelVite Inc. (Edison NJ) will share recent research updates on palm mixed-carotene EVTene (vision and weight loss) and bio-enhanced full spectrum tocotrienol complex--EVNol SupraBio (preliminary findings of on-going and completed clinical trials). Natural ingredients like EVTene and EVNol SupraBio are being sought after for their non-GMO status wildlife-friendly commitment and scientific substantiation. Both EVTene and EVNol SupraBio are self-affirmed GRAS with no objection letters by the FDA and are halal and kosher certified. For more information call (732) 906-1901 or visit www.excelvite.com. Infiniti Nutraceuticals--Booth MM182 Infiniti Nutraceuticals (Lake Forest CA) is proud to offer an alternative its new clinically proven SCP-II Complex Undenatured Type II Salmon Collagen with Proteoglycans. SCP-II Complex contains perfectly balanced 40 percent Undenatured Type II Collagen and 30 percent Proteoglycans. Missed the last harvest The company is also a quality supplier of Saw Palmetto Oil 85 percent CO2 super critical extraction and Saw Palmetto Powder Extract 25-50 percent native to the USA. Ask about Infiniti Nutraceuticals special on 100 percent Peruvian Maca Root Powder Conventional & Organic. For more information call (949) 455-9708 or visit www.infinitinutraceuticals.com. GCI Nutrients--Booth QQ178 GCI Nutrients (Burlingame CA) will feature its latest scientifically validated health brands that produce results. Meet Othmane Aqallal and learn about Olivie the unique organic antioxidants coming from suffering olive trees planted in a harsh desert environment which has five clinical trials realized. Meet Endre Nagy and find out about PrebioSure the latest in microbiome discovery and improved digestive health. Visit the booth to meet Fred Castro and learn about SilicSure the most potent orthosilicic acid for the cosmetics industry. Also meet Dr. Jit Nag and find out more about GCI s new Herbalyn Life Science Venture. For more information visit www.gcinutrients.com. InnoVactiv--Booth F136 InSea2 by innoVactiv (Rimouski QC Canada) is the best science-based ingredient for glucose metabolism optimization. Supported by several clinical studies InSea2 promotes healthy blood sugar control maintains cognitive functions and is the perfect companion to manage carbs absorption in weight management formulations. innoVactiv also features Myoceram Juventide and VivenSea a unique cosmetic ingredients portfolio that achieve eloquent results for skin rejuvenation wrinkle reduction improvement of firmness hydration and elasticity. Come meet innoVactiv at booth F-136 For more information call (418) 721-2308 or visit www.innovactiv.com. Jiaherb Inc.--Booth LL151 Jiaherb (Pine Brook NJ & Anaheim CA) is the industry s premier NSF-GMP certified manufacturer of natural ingredients. The company s commitment to its customers is to provide reliable high quality ingredients supported by our superior customer service and competitive pricing. Jiaherb knows that the ingredients you choose to put into your products are a reflection upon your standards of quality and excellence. The company guarantees its customers consistent efficacy and efficiency through fast delivery large inventory of products 100 percent traceability complete regulatory documentation and uncompromised service and support. For more information call (973) 439-6869 or visit www.jiaherbinc.com. 72 Nutrition Industry Executive www.niemagazine.com September 2017 Mushroom Wisdom Inc.--Booth KK175 For more than 25 years Mushroom Wisdom (East Rutherford NJ) has been producing the finest mushroom extracts grounded in tradition and supported by science. Mushroom Wisdom uses only mushroom fruiting body the part that was always used traditionally and is your source for wellresearched standardized proprietary mushroom extracts. For a high quality researched-based immune blood sugar or brain supporting ingredient stop by booth KK175 and learn about the trademarked Maitake D-Fraction SX-Fraction and Amycenone from Lion s Mane For more information call (800) 747-7418 or visit www.mushroomwisdom.com. Probi USA Inc. dba Nutraceutix--Booth X159 Nutraceutix (Redmond WA) is one of the largest manufacturers and suppliers of probiotics in North America. Nutraceutix offers proprietary delivery technology BIO-tract and provides a wide range of viable and effective probiotic products. Since October 2016 Nutraceutix has been part of Probi. The vision of Probi is to contribute to healthier life by delivering effective and well-documented probiotics with proven health benefits. Probi offers dedicated probiotic expertise and partnership all the way from R&D to finished products. For more information call (425) 883-9518 or visit www.nutraceutix.com. Rousselot Inc.--Booth L143 Rousselot (Mukwonago WI) is a leading manufacturer of gelatin and Peptan collagen peptides and is a supplier to the food pharmaceutical nutritional and technical industries. The company benefits from global sales and production networks in Europe North America South America and Asia. Rousselot Peptan are part of Darling Ingredients. Visit booth L143 for more information Rousselot will participate in a Lunch Brief discussing collagen protein for sports and performance nutrition on Wednesday at 12 p.m. For more information call (262) 363-6060 or visit www.rousselot.com. NutraGenesis--Booth E136 NutraGenesis Icon Group (Brattleboro VT) are leading providers of proprietary branded nutraceuticals for dietary supplements and selfaffirmed GRAS functional ingredients for foods and beverages. NutraGenesis Icon Group s clinically tested patented ingredients feature structure function claims in highly marketable wellness areas Stress Healthy Weight Management Energy Cognition Metabolic Cardiovascular Health Joint Health Anti-aging Antioxidant and Respiratory Immune Support. Visit booth E136 to learn about Q-actin NutraGenesis Icon Group s new clinically tested vegan ingredient that supports healthy joint function. For more information call (802) 257-5345 or visit www.nutragenesis.com. Sabinsa Corporation--Booth DD153 This year Sabinsa (East Windsor NJ) rolls out its superior protein line from Pea to Almond the company has some very unique proteins coming to market. As the official Curcumin sponsor at this year s SupplySide West Sabinsa is also showcasing its uC3 clear water-soluble curcumin ingredient great for baking items to beverages. Sabinsa s Top 10 ingredients will be on display as well. Come visit booth DD153 or make your appointment today. For more information call (732) 777-1111 or visit www.sabinsa.com. Once Again Nut Butter--Booth D137 Visit Once Again Nut Butter (Nunda NY) at booth D137 at SupplySide West. The company has been manufacturing nut betters seed butters and honeys since 1976. For more information call (585) 468-2535 or visit www.oanb.com. PLT Health Solutions--Booth OO133 At SupplySide West PLT Health Solutions (Morristown NJ) will feature a range of branded ingredients--most of which are considered best-in-class solutions--in categories like joint health heart health weight management cognitive health and beauty-from-within. The PLTSports initiative can differentiate sports nutrition formulations and help capitalize on market trends. New z mXR Targeted Release Caffeine ingredients--Delayed Release Extended Release and Extended Release--Liquid Stable will allow supplement and sports nutrition companies to develop predictable energy release profiles for consumers. PLT Health Solutions Ingredients for happier healthier--and more active lives. For more information call (973) 984-0900 or visit www.plthealth.com. September 2017 www.niemagazine.com Vit-Best Nutrition--Booth U121 Vit-Best Nutrition (Tustin CA) provides full-service solutions for contract manufacturing clients. The company s product portfolio includes powders capsules and tablets--with large-scale blending capability. Vit-Best Nutrition s services include ingredient sourcing formulation product development and custom packaging solutions. The company s quality assurance program ensures continuous monitoring of product manufacturing supported by an in-house comprehensive testing laboratory. Sixty-plus years of manufacturing history gives Vit-Best Nutrition the insight to answer today s challenges--from surge demand to new product development. For more information call (949) 293-2247 or visit www.vit-best.com. Nutrition Industry Executive 73 Equipment&Packaging Neck Bander Allows Full Interior Access for Easy Setup Tablet Counter Features Proprietary Sensor The automated Pharmafill NB-1 Series II neck bander from New Jersey-based packaging machinery manufacturer Deitz Co. is designed to permit free unimpeded physical and visual access to the interior of the machine for intuitively easy rollstock setup fast changeovers and safe unobstructed monitoring during operation. Developed to allow entry level line workers to manage the tamper-evident banding process the reliable Pharmafill NB-1 Series II neck banding machine eliminates the cumbersome time-intensive trial and error method required to setup other machines that block or hinder access to the film drive mechanism while a simple menu-driven PLC-based control panel allows quick adjustments to Neck Bander Tablet Counter the parameters for smooth automated operation. In addition the neck bander sets the film roll unwind spool in a space-saving vertical configuration and the film drive mechanism at the front behind a clear plastic safety door that automatically stops operation when opened. The company also provides the Pharmafill TC3 Tablet Capsule Counter which features a proprietary counting sensor that enables opaque translucent or transparent solid oral dose products in a wide range of sizes and shapes to be automatically counted with 99.99 percent accuracy. Devised and developed to bring versatility to high speed counting of tablets capsules caplets gelcaps lozenges and other solid oral dose products the Deitz counting sensor may be quickly adjusted without any tools via PLC control panel to achieve the highest counting speed and accuracy possible for a diverse variety of products while reducing changeover times to less than five minutes--including testing. For more information visit www.deitzco.com. PET Flake Sorting Station Completely Provided by Sesotec Germany-based Sesotec GmbH supplies complete sorting stations for PET flake recycling. Target customers are recycling companies that are looking for a profitable solution for PET flake recycling and wish to have all the components--from air separator to sorting machine--from one source. The FLAKE PURIFIER multi-sensor sorting system has been comprehensively modified and features optimised material infeeding for a more evenly distributed material flow and increased material throughput. It also allows easier maintenance and integration. The system s dust-proof design and integrated dust and label extraction connections provide increased efficiency in the recycling process. All Sesotec multi-sensor sorting systems and the new FLAKE PURIFIER are available with all sensor combinations and in various working widths. For more information visit www.sesotec.com. Keystone Folding Box Co. Adds Digital Printer for Short-run Carton Production Keystone Folding Box Co. (New Jersey) a designer and cGMP (current good manufacturing practice) manufacturer of paperboard packaging solutions for the health care market has added digital printing capabilities by installing a multifunction four-color process system. The new digital press meets the increasing demand for cost-effective short-run package manufacturing. With the addition of the new technology Keystone can rapidly manufacture anywhere from one carton to 18 000 cartons depending on a customer s specific needs. Compared with a conventional offset press digital printing also has significantly decreased set-up times. For more information visit www.keyboxco.com. 74 Nutrition Industry Executive www.niemagazine.com September 2017 Advertiser Index ADH Health Products Inc. Alkemist Labs Applied Food Sciences Inc. Avanti Polar Lipids Ayush Herbs Balchem Albion Beehive Botanicals Certified Nutraceuticals Daiwa Health Development DPL-US ExcelVite Sdn. Bhd FCC Products Inc. GCI Nutrients Generex Labs IgY Nutrition LLC Infiniti Nutraceuticals InnoVactiv Inc. Jiaherb Inc. Mack Flavor Ingredients Inc. Mushroom Wisdom Natreon Inc. Now Foods PL NSF International Nutragenesis Nutragenesis Nutra Solutions USA Olcott Plastics Once Again Nut Butter PLT Health Solutions Probi USA Inc. d b a Nutraceutix Rousselot Inc. Sabinsa Corporation Soma Labs Inc. United States Pharmaceopea Vit-Best Nutrition Inc. 50 29 7 38 36 23 49 15 11 31 37 21 52 8 19 17 5 56 57 9 1 63 33 C3 35 13 25 3 48 39 C2 10 C4 51 (845) 268-0027 (714) 754-4372 (855) 885-2399 (800) 227-0651 (800) 9 2 5 - 1 3 7 1 (801) 773-4631 (800) 233-4483 (951) 600-3899 (877) 434-3633 (631) 851-8810 (973) 535-3300 (650) 697-4700 (239) 592-7255 (888) 998-3763 (949) 455-9708 (418) 721-2308 (888) 542-4372 (951) 683-6245 (800) 7 4 7 - 7 4 1 8 (732) 296-1080 (800) 999-8069 (734) 769-8010 (802) 257-5345 (802) 257-5345 (631) 392-1900 (630) 584-0555 (888) 800-8075 (973) 984-0900 (425) 883-9518 (888) 455-3556 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (301) 230-6361 (714) 832-9700 www.niemagazine.com adh www.niemagazine.com alkemistlabs www.niemagazine.com afs www.niemagazine.com apl www.niemagazine.com ayushherbs www.niemagazine.com balchem www.niemagazine.com beehivebotanicals www.niemagazine.com certifiednutraceuticals www.niemagazine.com daiwa www.niemagazine.com dpl-us www.niemagazine.com excelvite www.niemagazine.com fccproducts www.niemagazine.com gcinutrients www.niemagazine.com generexlabs www.niemagazine.com igy www.niemagazine.com infiniti www.niemagazine.com innovactiv www.niemagazine.com jiaherb www.niemagazine.com mackflavor www.niemagazine.com mushroomwisdom www.niemagazine.com natreon www.niemagazine.com nowpl www.niemagazine.com nsf www.niemagazine.com nutragenesis www.niemagazine.com nutragenesis www.niemagazine.com nutrasolutionsusa www.niemagazine.com olcott www.niemagazine.com onceagain www.niemagazine.com plt www.niemagazine.com nutraceutix www.niemagazine.com rousselot www.niemagazine.com sabinsa www.niemagazine.com somalabs www.niemagazine.com usp www.niemagazine.com vit-best 27 insert (732) 9 0 6 - 1 9 0 1 Industry Events September 13-16 Natural Products Expo East Baltimore Convention Center Baltimore MD www.expoeast.com September 25-29 SupplySide West Mandalay Bay Las Vegas NV west.supplysideshow.com November 30-December 3 SOHO Expo Gaylord Palms Hotel and Convention Center Kissimmee FL www.southeastnpa.org September 2017 www.niemagazine.com Nutrition Industry Executive 75 SupplieroftheMonth Frutarom Industries Ltd. Established in 1933 Frutarom Natural Solutions part of the Frutarom Group is a rapidly growing global flavor and fine ingredients company and numbers among the ten Frutarom Natural leading companies in the world in the field of flavors and fragrances. The company supports development of concepts and products that Product Solutions are at the frontier of consumer desires addressing the growing demand in healthy and natural categories. Frutarom Natural Solutions offers flavor and color food protection and health benefits all naturally. Based on years of expertise Frutarom provides high-quality ingredients to the food beverage functional food flavor pharmaceutical nutraceutical and cosmetic industries. The company s regulatory and formulation support comprehensive market knowledge and combined capabilities place Frutarom in an optimal position to help its customer gain tomorrow s competitive edge through integrated solutions. Yoni Glickman currently serves as president of Frutarom Natural Product Solutions a global business encompassing Frutarom s solutions in natural colors food protection and health ingredients. Glickman has worked in leadership roles within the natural ingredients industry for more than 15 years in C-level positions and as a board member in innovative startup companies. Yoni Glickman President Hamanofim 2 Herzelia Israel 4672553 Phone 972 9 9603800 Website www.frutaromnatural.com NIE Frutarom has made several acquisitions in 2017. What companies has Frutarom acquired and what is the strategy behind this rapid growth the EFLA product line. NIE Frutarom s Food Protection Business Unit recently expanded its organic oxidation management solutions line with an organic rosemary extract. What was the purpose of expanding the line Glickman Frutarom has acquired Unique Flavors (South Africa) Rene Laurent (France) Western Flavors Fragrances Production (WFF)--Vietnam and SDFLC (Brazil). The acquisitions are part of Frutarom s long-term strategy to increase our footprint and dramatically grow our market share in the developing world--Africa Asia and Latin America. The Rene Laurent acquisition brings with it a strong presence in France with its long established heritage of more than 100 years in the sweet flavoring market. industry best practices. We are in the process of a long-term program that allows us to process significant botanicals at source therefore reducing our carbon footprint through savings on the global supply chain and lastly sourcing our key botanicals in a sustainable manner through partnerships with local growers. Glickman Answering the rising demand for natural and organic oxidation management solutions that replace synthetic solutions in line with growing consumer demand. Not only has Frutarom introduced organic antioxidants we have started partnerships with Spanish growers to provide our own specific species of organic rosemary that is extremely high in naturally occurring antioxidants. NIE Frutarom Natural Solutions has initiated a collaboration with a local agriculture partner to encourage local women to become independent farmers and grow annatto in their fields. What was the company s motivation behind this collaboration NIE What does the company do to ensure quality and product safety NIE The company is committed to sustainable and responsible environmental health policies. What does Frutarom do to ensure that the company and its employees hold up this commitment Glickman Frutarom has global procedures to ensure product quality and safety at the highest attainable levels. Our facilities are audited by relevant third-party auditors including ISO BRC GMP (good manufacturing practice) and more. Frutarom s HyperPure technology originally used in the company s Swiss pharmaceutical-grade facility gently processes botanical nutraceuticals without impairing their bioactivity or health benefits. This sustainable ecogreen technology maintains the nature of the ingredient while achieving improved solubility and preventing contamination and ensuring the safety of 76 Nutrition Industry Executive Glickman Through this partnership we create a sustainable source of supply for Frutarom and its customers and at the same time a sustainable source of income for small farmers in the geography where the plant naturally occurs. We ensure safe high-quality all-natural color supply while supporting local communities in developing countries. Glickman In our plants we carry out a wide range of activities to minimize our environmental footprint such as reconverting facilities that we have acquired in the last years to use of natural gas use of plant by products in further downstream value processing and ultimately returned to agricultural use. Furthermore we track on a monthly level solvent recovery in all our facilities to ensure that recovery is at or above NIE Is there anything else you would like to add Glickman Frutarom believes that our positioning across the whole value chain from agriculture to finished solutions are tailored for our customers specific F&B products. It is important for us to meet the desire of people globally who wish to consume natural great-tasting products at affordable price points. www.niemagazine.com September 2017 Go to www.niemagazine.com nutragenesis for info about this advertiser Go to www.niemagazine.com usp for info about this advertiser