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Description: In This Issue: 20th Anniversary Issue, Heart Health, Digestive Health, Global Supply Chain Management

w w w. N Ne V w isi W tO IE e m bs ur ag i az te in e. co m A VRM Media Publication www.niemagazine.com January February 2015 Go to niemagazine.com gcrieber for info about this advertiser Go to niemagazine.com sabinsa for info about this advertiser Go to niemagazine.com nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 20 NO. 1 JANUARY FEBRUARY2015 F E A T U R E S 24 Heart on the Line Suppliers and manufacturers seek heart health ingredients that address prevention and even damage reversal. 30 Digesting the Right Ingredients Consumers look for easy-to-take natural digestive health products that don t compromise their day-to-day lifestyle. 34 Acting Globally The natural products supply chain has a global footprint unlike any other. Following quality standards and guidelines help manage it. A L S O I N S I D E 8 10 16 20 21 22 23 49 49 50 Legalities Industry News Ingredient News Association News AHPA Update Science Update Conventions & Meetings Advertiser Index Equipment & Packaging Supplier of the Month 38 Celebrating 20 Years To celebrate Nutrition Industry Executive s 20th anniversary we asked industry insiders to reflect on the impact challanges and evolution of natural product industry since the magazine s inception. C O L U M N S 4 6 First Word Condition Specific 43 Production Line 45 Marketing Innovation 47 Functional Food FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.NieMagazine.com Copyright 2015. Nutrition Industry Executive (ISSN 2331-2602) Volume 20 Number 1 January February 2015. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by Vitamin Retailer Magazine Inc. 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 432-9288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Application to Mail at Periodicals Postage Prices is Pending at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com. Back Issues & Single Copies For order information contact (732) 432-9600 or info vitaminretailer.com. March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Go to niemagazine.com plt for info about this advertiser FirstWord Happy New Year Readers and Happy Anniversary NIE his year marks a very special occasion for NIE magazine--its 20th anniversary. A year after entrepreneur and publisher Daniel McSweeney launched the very successful Vitamin Retailer magazine he saw an opportunity where no one else had and started up his second publication Nutrition Industry Executive (NIE) magazine setting the standard for business coverage of the supplement and nutraceutical manufacturing industries. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Roy Kieffer Sales Manager RoyK VRMmedia.com Advertising Gary Pfaff Sales Associate GaryP VRMmedia.com Independent Sales Glenn Dulberg Representative GlennD VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com T Legitimizing an Industry It has been a significant 20 years for the natural products industry after the passing of DSHEA. Since then there has been continued steady growth due to the strong consumer demand for access to herbal products and supplements. But one of the biggest differences from the pre-DSHEA time period is that the law helped legitimize the dietary supplement industry in the minds of many consumers as it set down specific rules and regulations that manufacturers had to follow in order to be in compliance. That legitimacy was only strengthened by the passage of the Serious Adverse Event Reporting (AER) law in 2006 and the release of final regulations for good manufacturing practices (GMPs) in June 2007 (fully in effect 2010). Steve Mister president and CEO of the Council for Responsible Nutrition (CRN) called the AER law a watershed event because it was the one thing missing from DSHEA. AER passage brought post-market surveillance to both supplements and OTC drugs he said. Defending supplements requires reporting these things and the FDA has used these reports in a number of cases--from the Hydroxycut recall to DMAA and caffeine. While supplements and natural 4 Nutrition Industry Executive products have had a tremendous impact on the population s health with its affordable preventative strategies one cannot ignore the economic impact the industry has had on the nation. The industry has been at the forefront of the movement to improve the health and well-being of U.S. citizens. At the same time the industry has significantly contributed to the U.S. economy by producing more jobs and creating taxable revenue said Michael McGuffin president of the American Herbal Products Association (AHPA). Moving forward there is every indication that the industry will continue to grow and contribute to the health and success of U.S. citizens and the U.S. economy he added. Managing Editor Shari Barbanel ShariB VRMmedia.com Assistant Editor Cristina Goodwin CristinaG VRMmedia.com Contributing Writers Linda M. Dougherty Todd Pauli Lisa Schofield Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Yoko McSweeney General VRMmedia.com Looking Back Moving Ahead This month NIE celebrates these achievements in its anniversary coverage where you can read more details about the news and evolution in the past 20 years. NIE was the leader for thinking beyond retail and product news and setting the standard for coverage of the manufacturing and supply side. Its 20 years of success is a testament to the parallel achievements of the natural products industry and its impact on health and well being. Looking ahead the magazine will continue to move forward--with both online presence and in print-- featuring new voices and expert contributors to cover technology association news and health research as well as tackling the big issues currently facing the industry--in other words the information that is most vital to its readers. The NIE staff looks forward to working with you in 2015 and beyond and wishes you all a joyous healthy and prosperous New Year. May your journey be wonderful A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Gluten Free Retailer and Natural Practitioner 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. Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Go to niemagazine.com jiaherb for info about this advertiser ConditionSpecific Energy B Y C RISTINA G OODWIN Enhanced The functional food and beverage market continues to turn to natural energy ingredients. A ccording to Energy Drinks and Shots Market Trends in the U.S. a report from Packaged Facts the total sale of energy drinks and shots exceeded 12.5 billion back in 2012 with sales growing a whole 60 percent between 2008-2012. And like a caffeine-fueled rocket sales continue to soar. Joseph O Neill president and general manager of New Jersey-based BENEO Inc. said he believes that the functional beverages category is one of the strongest categories on the market for consumers looking to promote a healthier lifestyle with the help from nature that is low-glycemic lower-calorie and balanced without the crash effect associated with sugar or caffeine. Natural energy drinks with plant extracts are alternative sources for non-stimulating caffeine and other energy enhancing energy beverages he said adding that natural energy products are being used by just about anyone who is concerned about maintaining a healthier lifestyle for themselves and their families. Carol Cheow general manager of California-based Cactus Botanics added that both the social progress and economic development are catalysts for consumers to understand the health benefits from natural energy products. According to Cheow in a recent study 56 percent of primary household shoppers in the United States are worried about tiredness and lack of ener6 Nutrition Industry Executive gy which is why it is no surprise the demand for functional food and beverage products that address energy are sky high. However it is found that taking natural energy enhanced products are not only for sleepy heads but also for those who are physically active and are in need an extra physical energy. An overall healthy lifestyle is what enlightened consumers are seeking O Neill agreed including energy-related issues. With work and stress a main focus of today s lifestyle fatigue is a major health concern. People may feel fatigued in body or mind because of physical exertion poor eating habits lack of sleep etc. he explained. Benefits Functional food and beverage ingredients can help relieve tiredness and these nutritional natural energy products offer an array of other benefits such as boosting the immune system enhancing muscle strength and heightening one s metabolism. There are a variety of ingredients including vitamins and herbals such as vitamins B and C yerba mate green tea American ginseng powder and astragalus powder extracts Cheow explained. The ingredients play an important role in keeping our bodies running like well-oiled machines. In most cases the molecular structure and elemental composition are the determinant factors for natural energy products beneficial to people Cheow added. For example the B vitamins help the body convert food into fuel and play an important role in the nervous system in helping to make the neurotransmitters or chemical messengers in our brain vitamin C helps your body absorb iron is important for immune system is an antioxidant and is also needed for building strong muscles American ginseng powder extract contains chemicals called ginsenosides that seem to affect insulin levels in the body and lower blood sugar and astragalus has astragalus root which contains a high amount of polysaccharides with potent immune enhancing properties. Cheow said that Cactus Botanics which has been in business for more than 10 years specializes in extracts from natural plant sources such as American ginseng powder used to reduce stress and as a general tonic and stimulant and astragalus powder which strengthens the primary energy of the body and has metabolic respiratory and eliminative functions. American ginseng powder and astragalus powder extracts have become our star ingredients that have been strong sellers for dietary supplement brand marketers she said. In the future we are devoted to becoming an expert and pioneer in developing and marketing natural energy products with reasonable prices she explained. The Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 company s natural energy products address the most common health concerns of active middle-aged and older populations. In Addition New Jersey-based Hill Pharma which produces dietary ingredients and sweeteners from natural energy sources to ensure increased energy provides functional food manufactures with ac-11 formerly known as C-MED100. The energy-efficient ingredient is bioactive and water soluble and stems from Uncaria tomentose a medicinal herb that can be found in Peru and Brazil. As for finished products product developer Inno-Bev Ltd. (Tel-Aviv Israel) provides their target audience which they believe are overworked employees with the all-natural energy drink WakeUp. The newly developed beverage contains herbal ingredients made up of guarana Ginkgo biloba elderberry and Fruit Up a patented fructose that helps prevent fatigue. According to the company s peerreviewed article in the Israeli Medical Association Journal the combination of ingredients as apposed to caffeine did not result in adverse hemodynam- Sugar Alternatives Sugar replacement is another big issue when it comes to natural energy enhancing ingredients. Due to reduced sugars as compared to other energy-enhanced sweeteners the relative sweetness of sucromalt is 70 percent as compared to sucrose said Pam Stauffer global communications manager at Minnesota-based Cargill. Compared to other carbohydrates such as sucrose or some starches which break down under acidic conditions sucromalt is stable over a wide pH range Stauffer explained. Cargill s energy-efficient functional food and beverage ingredient Xtend sucromalt is a liquid sweetener with 4 cals g of energy. Unlike caffeine and sucrose Xtend provides a steady source of balanced energy. It is also low-glyemic and is easy to use in formulations. All Cargill s products including Xtend have undergone primary consumer research which the company shares with their customers to ensure success. BENEO s functional food ingredient Palatinose is a natural sweetener for use in a variety of beverages from dairy to tea and sports drinks. The product has 4 kcal g of energy and is digested up to four to five times more slowly than regular sucrose. Also it is low-glycemic and insulinemic and supplies the body with extended energy for muscles and brain over an extended period of time. Aside from energy BENEO s Palatinose has added benefits for weight management and longterm metabolic control. New York-based G3 Labs Inc. by Kyowa Hakko USA has created an amino acid and vitamin-based supplement called minoTOR a functional beverage using the company s patented Sustamine. The blend includes 4.2 g of amino acids vitamins and minerals for natural energy and is only 50 calories per serving. The new ingredient is a dipeptide of L-alanine and Lglutamine and is effective for functional food and beverage products in regard to energy. It works by replacing electrolytes and fluids repairing damaged muscle proteins and refilling the body s energy stores. ic effects. The ingredient formulation was shown to counter the body s system of slowing down every six to seven hours but without the detrimental effects of increased blood pressure blood glucose fluctuations mild drops of temperature and hormonal change. Ultimately manufacturers are hoping to expand the natural energy category. According to Inno-Bev Ltd. the market is on a steady incline for new ingredients for natural energy and there is increased interest to expand these products across numerous market segments from health food stores to direct sale (web TV radio) to massmarket retail. NIE FORMOREINFORMATION BENEO (973) 538-6644 Cactus Botanicals (562) 219-2167 Cargill (800) 344-1633 Inno-Bev Ltd. 972-544-822998 Hill Pharma Inc. (973) 521-7400 Kyowa Hakko USA (800) 596-9252 THE NUTRITION INDUSTRY S ONLINE NEWS & INFORMATION RESOURCE 1995 20 Y ars Celebratingellence e of Exc 2015 NIE s Upcoming 2015 Issue Highlights March April 2 5 15 ad closing Annual Sourcebook Engredea at Expo West Show Issue Ingedient Marketplace Show Issue 3 11 15 ad closing Our 2015 Media Planner Is Now Available At NIEmagazine.com 2015-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF niemagazine.com Roy Kieffer at 719-358-9838 or e-Mail RoyK niemagazine.com Gary Pfaff at 732-432-9600 ext. 107 or e-Mail GaryP niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 7 January February 2015 www.niemagazine.com Legalities IP Basics to Consider Before the Launch of a New Brand By Linda M. Dougherty L aunching a new brand of product or ingredient can be an intensive and lengthy process. Research and development regulatory compliance business development funding and the other many aspects of this process may consume your thoughts and energy. It is essential however to remember to consider intellectual property and branding issues in the very early stages well ahead of launch time. The success of your new product or ingredient may hinge largely on your ability to successfully brand it. Choosing a name for the product or ingredient entails more than ensuring that no one else is using a confusingly similar name it is also important to choose a name that is capable of operating in a trademark fashion (e.g. that will identify and distinguish your company as the source of the goods) and ideally be eligible for registration as a trademark with the U.S. Patent and Trademark Office (USPTO). Although it is not mandatory to have a trademark registration from the 8 Nutrition Industry Executive USPTO in order to use a name (and in fact a registration is not a prerequisite to having common law trademark rights) a registration is a powerful tool for putting other parties on notice that you have rights in the mark and for enforcing those rights if others infringe your mark. There are many factors the USPTO considers when determining whether a mark is eligible for registration. Generally speaking marks that are merely descriptive are not eligible for registration on the USPTO s principal register (unless and until such marks have met the USPTO s standard for having acquired distinctiveness which subject is beyond the scope of this article). A name is considered merely descriptive if it describes an ingredient quality characteristic function feature purpose or use of the specified goods or services. (Trademark Manual of Examining Procedure (TMEP) Section 1209.01(b)). For example a supplement company located in New York wishing to brand its product under the word mark NY SUPPLEMENTS will not (assuming there is no acquired distinctiveness) be likely to succeed in obtaining a registration on the principle register. It is possible for a mark to contain some merely descriptive terms as well as some non-descriptive terms (for example an application by the same company for NY BOWTIE SUPPLEMENTS ). In such a case the USPTO will require the application to include a disclaimer of the merely descriptive wording within the mark. In the previous example the applicant might be able to get a trademark registration for NY BOWTIE SUPPLEMENTS but would have to disclaim NY and SUPPLEMENTS within the application. Disclaiming these terms means that the company would not have the right to exclude others from using those terms on the same types of products. Names that are deceptively misdescriptive will generally be refused registration. For example a supplement company located in California that has Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 no connections with New York may receive a refusal based on geographic misdescriptiveness if it applies for the mark NY BOWTIE SUPPLEMENTS. The USPTO will of course also conduct a likelihood of confusion analysis comparing your proposed mark to preexisting registrations and prior applied-for marks and will refuse registration if it determines that registration of your mark is likely to cause consumer confusion. These are just a few examples of the types of objections the USPTO might raise when examining an application for registration. Before receiving a final refusal from the USPTO an applicant will receive an Office Action in which the USPTO sets forth any such objections which can potentially be overcome by legal arguments. However it is often wiser to consider the likely registrability of your mark prior to investing in the name. Many companies engage legal counsel to conduct and or review a trademark search prior to committing to a mark. Trademark attorneys skilled in conducting preliminary trademark searches and reviewing full comprehensive searches will likely not only provide you with a list of potentially conflicting marks but also provide you with a practical assessment of the risk level associated with your registration and or use of the mark. Such an examination will often involve more than a review of the USPTO s records of trademark registrations and applications in its database (which may only tell you the likelihood that the USPTO will approve the mark for registration) but also an investigation of common law uses of potentially conflicting marks that have not necessarily been applied for at the USPTO. Users of such marks may have rights that give rise to actionable claims of common law trademark infringement. Assessing the level of risk associated with using a proposed mark will involve among other things analyzing the similarities between the proposed mark and potentially conflicting marks and comparing the respective goods or services and channels of trade. This may also involve investigating how actively the owner of the potentially conflicting mark markets its goods or services under the relevant mark whether they use the mark widely across various SKUs whether they have registered or applied to register the mark and whether they arguably have a family of formative marks similar to the potential conflict and or the proposed mark. This may also involve legal research as to whether the owner of the potential conflict has sued before to protect this or other intellectual property (i.e. how litigious they are). A company known to be vigilant and aggressive in policing and enforcing its trademark may be more likely to send a cease and desist letter file an opposition proceeding with the USPTO and or file a federal trademark infringement lawsuit. In summary it is best to be aware of potential conflicts and their associated risks prior to moving forward with a brand name. A valid objection by another trademark owner received after your brand has been launched the labels have been ordered and domain names purchased could be extremely damaging to your business. NIE Linda M. Dougherty is an associate in Kane Kessler s Intellectual Property practice group. She can be reached at ldougherty kanekessler.com or (212) 519-5144. www.kanekessler.com David Biderman Michael McGuffin Suzanne Shelton Celebrating 20 Years of Excellence 1995-2015 Todd Pauli January February 2015 www.niemagazine.com Nutrition Industry Executive 9 IndustryNews VRM Media Acquires Fitness Trainer Magazine RM Media (East Brunswick NJ www.vrmmedia.com) a leading provider of business magazines websites and e-newsletters for the health and natural products industry has announced its acquisition of Fitness Trainer magazine from the Mallarina Sales Corporation. Fitness Trainer (www.fitnesstrainermag.com) founded in 2012 by Robert B. Rose is a digital business magazine for personal trainers and other professionals within the 78 billion global fitness and health club industry. The magazine is distributed on a six-time per year basis to more than 90 000 personal trainers plus bonus distribution to more than 100 000 active fitness consumers including top athletes coaches physical therapists and nutritionists. We are thrilled to welcome Fitness Trainer into the VRM Media family of health and wellness business publications said Daniel McSweeney president of VRM. Fitness Trainer is the No. 1 business magazine for personal trainers and with its focus on health and fitness is a perfect addition to VRM s existing portfolio which includes Vitamin Retailer Nutrition Industry V Executive and Natural Practitioner. Fitness Trainer is at the forefront of today s publishing industry technology with its digital interface providing a number of unique and beneficial user tools McSweeney added. Also readers and advertisers are able to immediately connect with just a click of a mouse or tap of a finger. VRM announced that Rose would continue to oversee the publication as consulting editor working alongside current Editor-in-Chief Amy Kierce and Graphic Designer Jesse Radford. The magazine s advertising sales efforts will now be directed by VRM s Roy Kieffer assisted by Russ Fields and Gary Pfaff. Fitness Trainer grew in popularity beyond my imagination in just two years noted Rose. In order for it to reach the next plateau a full staff of professionals was needed and VRM was a perfect fit in every way. I am pleased to join the VRM team and to continue to help produce Fitness Trainer for the benefit of our many loyal readers and advertisers. Fitness Trainer is for trainers by trainers with articles written by worldrenowned fitness experts including regular contributions from leading certification and training organizations such as the National Strength and Conditioning Association the National Council for Certified Personal Trainers the International Association of Resistance Trainers and the National Academy of Sports Medicine. Note To view the Fitness Trainer 2015 Media Kit visit http fitnesstrainermag.uberflip.com i 429560. For more information contact Daniel McSweeney VRM Media President DanM VRMmedia.com (805) 646-2921 Roy Kieffer Fitness Trainer Associate Publisher RoyK VRMmedia.com (719) 358-9838 Bob Rose Fitness Trainer Founder Consulting Editor Brexercisegroup aol.com (914) 739-0214 President Obama Signs Sunscreen Innovation Act n November 26 President Obama signed the Sunscreen Innovation Act (SIA) into law after is was passed in the House of Representatives on November 14. The bill is designed to address a regulatory backlog that is preventing U.S. consumers from having access to advanced effective sunscreens that are widely available in the rest of the world. The U.S. Senate passed the bill in September. SIA will help the U.S. catch up to other countries in sunscreen technology by expediting the U.S. Food and Drug Administration s (FDA) review process for active ingredients in sunscreens that have long been approved for use in places like Europe and Canada. Some of these sunscreen ingredients have been safely used overseas for years but have had their applications pending before the FDA for more than a decade. SIA also seeks to shed some O light on the FDA s review process by requiring the agency to periodically report to Congress on the progress of this effort. The signing of the Sunscreen Innovation Act by President Barack Obama is the culmination of persistent bipartisan work by Congress and stakeholders to provide Americans with access to the latest sunscreen products to help curb future cases of skin cancer particularly melanoma said Michael Werner Public Access to SunScreens (PASS) Coalition policy advisor. We are confident that the new law will enable Americans to have greater choice when it comes to protecting their skin from the sun s harmful UVA and UVB rays. The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002 eight new sunscreen applications have been filed and are still awaiting review 12 years later. With President Obama s approval of the bipartisan SIA FDA must now work with applicants Congress and stakeholders to implement the new law. FDA must render a decision on the eight pending sunscreen applications according to statutory timelines created by the legislation with some decisions expected as quickly as six months from enactment. The President s approval of the Sunscreen Innovation Act demonstrates that the White House and Congress agree that FDA should ensure all sunscreens receive a transparent review within a predictable timeframe Werner said. With this law Congress has helped answer the U.S. Surgeon General s Call to Action to Prevent Skin Cancer. The PASS Coalition and other stakeholders will now focus on working with FDA to guarantee the new law is implemented as quickly as possible. 10 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 NPA and UL Partner for Expanded Industry Education he Natural Products Association (NPA) and UL a leading global independent safety science company are working together to offer increased educational opportunities to NPA members. The education provided through joint NPA and UL efforts will provide online and in-person education for NPA members. The new education partnership which will incorporate NPA s regulatory and compliance seminars web-based education and personalized on-site training along with top-notch training modules from EduNeering the online regulatory training division of UL is designed to better inform dietary supplement manufacturers distributors auditors retailers and other industry stakeholders on a variety of vital issues via various training platforms. These training platforms include but are not limited to How to Prepare for a current Good Manufacturing Practices (cGMP) Inspection How to Prepare for a Safe Quality Food (SQF) Audit cGMPs for Manufacturing Plants and Equipment cGMP Requirements for Quality T Control Introduction to Part 111 cGMPs Packaging Labeling Holding and Distribution Production and Process Control System for Manufacturing Operations Dietary Supplements-- Requirements for Records and Recordkeeping How to Write and Qualify Claims as Structure Function Claims How to Write Standard Operating Procedures (SOPs) Label Labeling Requirements Prior Notice and Labeling Requirements for Imports Given the combined reputation and expertise of both NPA and UL our collaborative efforts to bring elevated education to the natural products industry is the logical next step for both organizations said NPA CEO Daniel Fabricant PhD. Our combined vision is to see one program the industry can turn to for dietary supplement education and we see this being that program. We anticipate this to be the start of a lasting relationship between NPA and UL that will reflect this shared vision and impact our industry in a very profound and meaningful way. Additionally through this partner- ship we seek to educate those who inspect the facilities of dietary supplement manufacturers so we can demonstrate transparency in how auditors are qualified and provide consistency in the certifying process to elevate the standard for the entire industry he continued. A GMP education system for third-party certifiers and auditors has never been done before. NPA brings a level of regulatory expertise in Dr. Fabricant and Dr. Corey Hilmas that is unmatched in the dietary supplement industry and UL is very pleased to be partnering with them in this new endeavor. Through this alliance the industry and consumers will undoubtedly be better served said Mike O Hara general manager of Global Nutraceuticals for UL. The UL educational library includes courses that can be part of a company s learning and compliance culture. The end result is a more knowledgeable productive and effective organization that delivers bottomline improvements through improved manufacturing quality and compliance with regulatory requirements. For more information visit www.uleduneering.com or www.npainfo.org. Healthy Nation Coalition Details Persistent Failures of DGA n an open letter to government officials the Healthy Nation Coalition described the Dietary Guidelines for Americans (DGA) as a failed policy. The letter from concerned scientists nutrition professionals and consumers is addressed to the Secretaries of the U.S. Departments of Agriculture and Health and Human Services. The letter asserts that these recommendations contribute to worsening health outcomes for the nation and should be replaced with guidance focused on essential nutrition (see full text and downloadable PDF at http forahealthynation.org healthynation-coalition-letter .) On December 15 the 2015 Dietary Guidelines Advisory Committee which reviews the DGA finished deliberations. The committee is expected to issue guidelines perpetuating 35 years of advising consumers to reduce their intake of eggs meat and full-fat dairy. While the consumption of these foods has decreased in past decades rates of obesity have doubled and rates of dia- I betes have tripled. Critics maintain the DGA which directs all federal nutrition activities are not sufficiently grounded in science not compatible with adequate essential nutrition and do not respect the diversity of food traditions in America. The narrow focus on plantbased nutrition ignores unique dietary needs of growing children older adults athletes and ethnic minorities. Furthermore this focus has prevented federally funded research into dietary approaches not in line with the DGA including the use of low-carbohydrate diets to treat diabetes. More than 70 clinicians and academics have joined farmers and ranchers as part of the 600 signatories to the letter. These include several notable voices on nutrition Robert Lustig MD of the University of California Paul Jaminet PhD author of The Perfect Health Diet Mark Sisson blogger and author of numerous books on fitness and health Richard Feinman PhD of SUNY Downstate Medical Center Sean Lucan MD of Albert Einstein College of Medicine and co-author of textbooks on nutrition and public health and Sally Fallon Morell founder of the nutrition education nonprofit The Weston A. Price Foundation. Spokesperson for the coalition is Adele Hite a registered dietitian PhD student at North Carolina State University and former health educator at Duke Lifestyle Medicine Clinic. Our way forward doesn t have to emphasize dietary extremes she explained. We propose recommendations that provide clear concise food-based guidance that helps Americans meet essential nutrition needs according to their own food traditions. We cannot justify guidelines that restrict nutritious whole foods like meat eggs and butter discriminate against farmers who produce them and confound efforts of Americans who recognize their health benefits. For more information visit www.forahealthynation.org. Nutrition Industry Executive 11 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 IndustryNews Company Owner Pleads Guilty to Adulterating Supplements he owner and president of a dietary supplement manufacturing company in Flanders NJ pleaded guilty to conspiracy to commit wire fraud in relation to a scheme in which he directed the sale of diluted and adulterated dietary ingredients and supplements sold by his company U.S. Attorney Paul J. Fishman announced. Barry Steinlight 69 of Hackettstown NJ pleaded guilty to a one-count information charging him with conspiring to commit wire fraud. As part of his plea agreement Steinlight admitted that Raw Deal s gross sales during the scheme were between 7 million and 20 million. Steinlight has agreed to forfeit more than 1 million in profits from the scheme. Barry Steinlight diluted his products cheated his customers and lied to the Food and Drug Administration (FDA) when they came to inspect his company said U.S. Attorney Fishman. This scheme went on for four years and essentially became the business model at his company. People who sell and use dietary supplements have the right to expect that the ingredients are listed and they get what they paid for. This dietary supplement company owner ignored his basic obligations in his pursuit for profit said Acting Assistant Attorney General Joyce R. Branda for the Department of Justice s Civil Division. American consumers have a right to know that the dietary supplements they purchase are safe to consume and that the ingredients listed on the label are actually in the bottle. This case demonstrates the Department of Justice s commitment to ensuring that those who deal products affecting the health and safety of consumers are law abiding and that wrongdoers will be held accountable. According to documents filed in this case and statements made in court Steinlight was the president and owner of Raw Deal Inc. a dietary supplement manufacturing facility. From at least 2009 through November 2013 Steinlight instructed Raw Deal employ- T ees to add fillers including maltodextrin viobin cocoa replacer and rice flours to the dietary ingredients and supplements packaged for and sold to Raw Deal s customers. These fillers were added without customer consent or knowledge. Steinlight also directed Raw Deal employees not to list the fillers as ingredients on the certificates of analysis (COAs) issued to its customers as proof of the identity of the ingredients contained in the products. In addition to directing the dilution and adulteration of Raw Deal s products Steinlight also directed Raw Deal employees to create COAs that falsely certified that certain Raw Deal products were kosher or organic. Further during an FDA inspection of Raw Deal in February 2012 Steinlight instructed Raw Deal employees to alter a document before providing it to the FDA. U.S. Attorney Fishman credited special agents of the FDA s Office of Criminal Investigations under the direction of Acting Special Agent in Charge James J. Royal who investigated the case. When a company distributes adulterated and misbranded dietary supplements they put consumers at risk said Acting Special Agent in Charge Royal. Today s plea agreement should serve as a reminder that FDA s Office of Criminal Investigations will continue working with the Department of Justice to protect consumers from public health risks and fraud. The conspiracy charge carries a statutory maximum sentence of five years in prison and a maximum 250 000 fine or twice the gain or loss caused by the offense. Sentencing is scheduled for March 30 2015. 12 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Glanbia Expands Collaboration Center lanbia Nutritionals has nearly doubled the size of its customerfocused Collaboration Center in Twin Falls ID adding a new bakery lab and a culinary applications kitchen. The Glanbia Collaboration Center is a codevelopment and process optimization facility designed to accelerate successful product introductions for customers from initial ideation to product completion. The first Glanbia Collaboration Center building opened in April 2009 in Twin Falls with extensive pilot and lab capabilities for bar beverage and dairy application development. A second Collaboration Center building has now opened adjacent to the first building with comprehensive baking kitchen and lab capabilities for bakery development and culinary applications development. At the Collaboration Center customers are able to work side-by-side G with Glanbia scientists and commercialization professionals in developing producing and testing of new product prototypes that use Glanbia s growing portfolio of whey and milk proteins whey peptides functional ingredients flavors and next generation grain ingredients to provide a range of functional and nutritional solutions. From basic science to applications expertise Glanbia has steadily made significant investments in people facilities and equipment that provide the scientific and creative backbone our customers seek in a product development partner said Eric Bastian vice president of R&D. The new addition to our Collaboration Center demonstrates our commitment to helping bakery customers and prepared foods customers achieve the same benefits already available to our bar beverage and dairy product customers with solutions tailored to customers individual needs. As one example the equipment within the new building replicates common bakery functions with commercial artisanal and in-store bakeries. Customer bakers can work together with Glanbia s bakers to formulate bake and review prototypes faster to help more quickly take advantage of consumer s seemingly insatiable interest in more healthful products such as gluten-free cleanlabel or higher-fiber products. The new Collaboration Center building is part of the newly named Glanbia Research Campus a three building R&D site in Twin Falls hosting basic research labs application labs analytical labs pilot processing facilities and offices. For more information call (608) 316-8500 or visit www.glanbianutritionals.com. Deerland Enzymes Receives Canadian Site Reference Number eerland Enzymes (Kennesaw GA) has announced that the company has received a notice of acceptance from Health Canada Natural and Non-prescription Health Products Directorate (NNHPD) for a Foreign Site Reference Number (FSRN). Deerland Enzymes is among a select group of companies located in the United States chosen to participate in the NNHPD s pilot program that aims to replace the current foreign site application process with an onsite third-party audit. The company s quality system was audited earlier in the year and was assessed by the NNHPD against Canadian Natural Health Products Good Manufacturing Practices (NHP GMP) requirements. As a result Deerland Enzymes was found to be in compliance as an approved foreign manufacturer packager and labeler. We are extremely appreciative to NNHPD for allowing Deerland to participate and for the manner in which the program was implemented. The FSRN assures our customers that the products we manufacture for them meet the GMP requirements for import and sale in Canada said Hope Hanley Deerland Enzymes vice president of quality assurance and regulatory affairs. This new program of onsite audits for certification expedites the approval process which is a D huge benefit and time savings for our customers who sell products in Canada. For more information call (800) 697-8179 or visit www.deerlandenzymes.com. Go to niemagazine.com herballyyours for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 13 January February 2015 www.niemagazine.com IndustryNews Naturex Opens Chilean Subsidiary aturex (Avignon France) is strengthening its position in Latin America in response to growing local demand for natural ingredients. Following the January 2014 acquisition of Chile Botanics and its factory in Linares the group is now opening a sales office in Santiago Chile. The Chilean branch provides current and future customers with the full product portfolio and the latest innovations from Naturex combined with exceptional local service. Part of a network of three sales offices and two factories in Latin America the Chilean office is fully in line with the group s expansion strategy in emerging markets. Guillaume Levade sales director--Latin America is heading the sales office which will support N the development of three strategic markets food & beverage dietary supplements & pharmaceuticals as well as cosmetics. Chilean customers will benefit from Naturex s manufacturing expertise and global and local capabilities. Chile is a very dynamic country with one of the highest GDPs per capita within the Latin America region. This indicator confirms the potential of the country. Combined with the fact that Chile has the most free-trade agreements in the world we think there is an exceptional opportunity for Naturex to grow our business in this country and facilitate the development of our presence in neighboring countries said Levade. The Latin American market remains a top priority for Naturex and the company continues to invest in the area in order to strengthen ties to its customers. The richness of Chile s natural environment also offers an opportunity for Naturex. The company sources Quillaja saponaria a native tree rich in saponins from the Chilean forest. Sustainably harvested in partnership with local authorities the wood is extracted to obtain quillaia extracts with different levels of purity. These specific extracts address different markets according to their final applications by either reinforcing natural foaming in beverages or by acting as a natural emulsifier in flavor or color emulsions and beverages. For more information visit www.naturex.com. OmniActive Subsidiary Receives Rural Innovation Award O mniActive Health Technologies (Morristown NJ) subsidiary OmniKan Earth Science Pvt. Ltd. was recently notified that they have been honored with the Rural Innovation Award from Sahaj e-Village Ltd. for their work in deploying technology and software to support and uplift farmers. The award is given to companies in recognition of their innovation ideas that have made a sustained impact on the quality of lives and contributed to the development of people society or industry in rural parts of India through technology. OmniKan has further solidified OmniActive s position as a reliable and quality source of lutein from marigold for human consumption made under food-grade standards through a vertically integrated process said Sanjaya Mariwala managing director of OmniActive Health Technologies. While doing so it has also allowed us to realize our vision of operating with social stewardship and sustainability for the betterment of the environment and future generations. Since its official inception in February 2012 OmniKan Earth Sciences operations not only facilitated the production of premium lutein using high quality marigold flowers for the human nutrition industry but also benefited the lives of more than 10 000 local farmers and more than 30 000 agricultural workers. For more information call (866) 588-3629 or visit www.omniactives.com. 14 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 You reHired development and regulatory compliSharon Peek a former vice president BrandHive (Salt Lake City UT) has ance. of Nutra Manufacturing the manufacannounced that Andy Yorkin joined the Albion Human Nutrition (Clearfield turing division of General Nutrition team as account director while 14-year UT) has announced Dennis Centers (GNC) has joined Novel BrandHive veteran Gail Frankoski has Goodman MD FACC as the Ingredient Services (West been promoted to account director. most recent addition to its Caldwell NJ) as vice president of Frutarom Switzerland Ltd. Health Scientific Advisory Board. manufacturing innovation. Business Unit announced the appointDSM (The Netherlands) has Daniel H. Rosenbaum has ment of Matthias H. Kreuter PhD as its appointed Ilona Haaijer as presbeen appointed chief operating new global chief scientific officer effecident and CEO of DSM Food officer of NattoPharma USA Inc. Ilona Haaijer tive January 1. Specialties one of the five based in New Jersey. Biova LLC (Johnston IA) has named global divisions of Royal DSM Rosenbaum s role will help drive Matt Stegenga president of the compaNV. Haaijer will succeed Hans and realize the next commercial ny. He succeeds Dennis Casey PhD Christian Ambjerg who is movphase of NattoPharma and its who will continue with Biova as a meming to the Nutritional Products signature ingredient MenaQ7 ber of its board of directors. Stegenga division to lead innovation on and to add strategic capabilities will continue Biova s global market Holly Johnson January 1 2015. to enable further business development focusing on Holly E. Johnson PhD has joined the growth. expanding applications for staff of Alkemist Labs (Costa Mesa CA) J.G. Pizzey Inc. (Russell MB Biova s patented technoloas senior analytical chemist leading Canada) has announced the addigies and branded ingrediproject teams in analytical testing and tion of Julie Pizzey Faber Esq. to ents. Dr. Craig Rowles also R&D as well as performing specialized its business development team. joins Biova in January as chief Julie Pizzey research. Pizzey Faber brings her expertise in operating officer overseeing UAS Laboratories (Wausau WI) has the culinary arts and legal fields to J.G. multiple operations in Iowa and Kansas. announced the appointment of Michele Pizzey enhancing the company s ability Nutegrity (Irvine CA) has added Rickard to vice president--quality and to provide sound guidance to its cusMark Smith as Eastern regional sales tomers regarding issues such as product continuous improvement. manager. SourceOne Moves to New Headquarters ourceOne Global Partners LLC has announced the relocation of its offices still in downtown Chicago IL. Thanks to the loyal support of our domestic and international customers and partners SourceOne has grown in staff strategic partners and customer base. Therefore after more than 10 years at our previous address we have moved into larger offices that are better suited to accommodate our growing staff and diverse product line explained Jesse Lopez SourceOne founder and CEO. The new offices allow for more sophisticated communications such as high-definition iCam technology and larger screens to enhance virtual face-to-face meeting experiences. This is a strategic part of our growth strategy to better serve clients and strengthen functional collaborations between our corporate headquarters and technology partners product manufacturers and brand marketers to create next-generation patent-protected ingredients innovative formulations and delivery systems Lopez added. The company s new mailing address is 400 W. Erie Ste. 200 Chicago IL 60654. SoureOne s phone numbers have not changed. For more information call (312) 321-8222 or visit www.source-1-global.com. S Go to niemagazine.com uckele for info about this advertiser Nutrition Industry Executive 15 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 IngredientNews Food Funktions Combines East Ingredient With Setria Glutathione F ood Funktions (St. Lucie FL) launched a new dietary supplement that combines Japanese raisin extract with Setria Glutathione to help reduce the damaging effects of alcohol consumption. Their new product Intox-Detox uses ingredients including Setria Glutathione to help enhance the body s ability to detoxify alcohol. Taken before drinking alcohol IntoxDetox is designed to offset damage to the liver brain and other organs. Setria Glutathione a branded form of glutathione nature s master antioxidant replenishes the body s supply and protects against toxins such as alcohol. Intox-Detox is the culmination of more than 10 years of research by Food Funktion s founder Andrew Bennett. It includes Korean red panaxg ginseng and green tea leaf powder. For more information call (772) 236-4443 or visit www.intox-detox.com. Almega PL Launched in Consumer Products Shown to be Effective Carrier of EPA ualitas Health (Imperial TX) has launched the first consumer products based upon Almega PL marking the company s transition from research and development into successful commercialization of the company s premium algal omega-3 oil. These first two products demonstrate the wide range of possibilities available with Almega PL--from a standalone Almega PL product with a vegetarian EPA-only offering to blends of Almega PL with other algal ingredients to create a vegetarian and sustainable alternative to fish or krill oils said Yuri Shoshan CEO of Qualitas Health. The initial consumer products include Almega PL that contains EPA and polar lipids from Almega PL sourced from Nannochloropsis oculata a non-GMO (genetically modified organism) strain of microalgae select- Q ed for its high level of EPA omega-3 and unique polar-lipid structure Almega PL contains omega-3 fatty acids with phospholipids and glycolipids that provide superior digestibility and incorporation into tissues and membranes. In other news Qualitas Health performed an animal study recently published in the journal Food and Function proving that total omega-3 uptake into tissues and plasma is equivalent between krill oil and the microalgae-sourced Almega PL (Nannochloropsis oculata). In the study rats were fed for seven days an omega-3 dosage of either Almega PL (7.3 g total omega-3 all of it EPA) or krill oil (7.24 g of total omega-3 4.8 g EPA 2.4 g DHA). The polar lipid content of the Almega PL was 15 percent polar lipids (phospholipid glycolipid combination) while the krill oil polar lipid content was 40 percent phospholipids. While the uptake of total omega-3s in plasma brain liver and gonadal adipose tissues was similar between Almega PL and krill oil in retroperitoneal adipose tissues the levels were statistically significantly higher in the Almega PL group. There was an average three-fold differential in EPA content of retroperitoneal adipose tissue between groups which is much greater than the difference in EPA content in the two oils. Tissue availability of Almega PL containing 9 percent glycolipids and 6 percent phospholipids is similar to that of krill oil containing 40 percent phospholipids. Researchers hypothesized that glycolipids may be a more effective carrier for omega-3s and specifically EPA. For more information visit www.qualitas-health.com. Nippi Collagen Studies the Effects of TrueMarine Collagen for Aging ippi Collagen (Tokyo Japan) announced the results of a 2014 clinical randomized placebocontrolled double-blinded study on the effectiveness of TruMarine Collagen on skin parameters related to cutaneous aging. Researchers examined the effects of marine collagen peptide ingestion on the skin of healthy women aged 35-65 years. As early as our 30s collagen production begins to decrease and our skin s natural reserve of collagen begins to diminish gradually collapsing the skin s dermal layer and creating an ideal opportunity for wrinkle development stated Greg Nielsen N vice president of the company. Eighty-eight women were given 5 grams of TruMarine Collagen peptide or placebo daily after dinner for 8 weeks. Before treatment and at 7 and 8 weeks of treatment digital images of the face were analyzed by VISIA Complexion Analysis with multiple end points for facial skin parameters related to cutaneous aging. At 0 4 and 8 weeks wrinkles pores age spots (brown and red skin lesions inclusive of hyperpigmentation melasma acne spots vascular lesions and lentigines) and texture (variation in tone and smoothness on the skin surface) were objectively measured. In addition a daily diary and a subjective selfassessment questionnaire of facial skin condition were recorded at 0 4 and 8 weeks. Additional results from the trial showed improvements in facial skin condition (68 percent increase) including minimizing fine lines wrinkles and uneven appearance of skin. The results support the large body of clinical research previously undertaken by Nippi and underpin the tremendous growth potential that collagen supplements offer Nielsen explained. For more information call 1 604-205-5955 or visit www.nippicollagen.com. 16 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Ganeden Biotech and Grupo Saporiti Launch GanedenBC30 in South America aneden Biotech (Mayfield Heights OH) announced that GanedenBC30 (Bacillus coagulans GBI-30 6086) patented probiotic ingredient will be available through a distribution agreement with Grupo Saporiti S.A. in Argentina Bolivia Brazil Chile Colombia Ecuador Paraguay and Venezuela. The South American population continues to be increasingly concerned with health and wellness said Michael G Bush senior vice president of Ganeden Biotech while leveraging Saporiti s 80-plus years of education and experience. Unlike most other probiotic strains GanedenBC30 is a spore-former which makes it highly stable and allows it to remain viable through most manufacturing processes up to three years of shelf life and the low pH of stomach acid. The efficacy of GanedenBC30 is backed by 20 published studies show- ing digestive and immune support and has an exceptional safety record with FDA (U.S. Food and Drug Administration) GRAS (generally recognized as safe) status. It can be formulated into virtually any product food or beverage product and will not change the sensory characteristics of the product according to Ganeden Biotech. For more information call (440) 229-5200 or visit www.ganedenbiotech.com. Sabinsa s LactoSpore Now Used in Cosmeceutical Products L actoSpore the proprietary Bacillus coagulans strain MTCC 5856 manufactured by Sabinsa Corporation (East Windsor NJ) is for the first time included in cosmeceutical products with the launch of Massey Medicinals Candida Freedom Soap and Candida Freedom Bath Salts. While use of probiotics orally for improving gut health and microflora is well known the use of probiotics on skin is a relatively new area of interest. Microbes play an important role for our skin and such pathogenic bacteria in skin conditions such as acne atopicdermatitis psoriasis seborrheic dermatitis is well known said Sabinsa s Marketing Director Shaheen Majeed. Candida Freedom Soap is an all-natural handcrafted soap and provides B. coagulans topically for supporting healthy skin. This eco-friendly soap contains no synthetic fragrances color or preservatives and is 100 percent biodegradable. LactoSpore provides probiotic support to skin in addition to the oils of tea tree lemon and lemongrass which additionally provide anti- fungal cleanser benefits. Candida Freedom Bath Salt formula is free of fragrances dyes and essential oils for those with sensitive skin or low immunity. The skin is not only a barrier between the human body and environment but also contains an ecosystem on the surface of a wide variety of microbes that must be in balance said Bryan Massey ND founder of Massey Medicinals. For more information call (732) 777-1111 or visit www.sabinsa.com. Krill Oil is Primary Ingredient in NKO Focus eptune Technologies & Bioressources (Laval QC Canada) introduces NKO Focus to support brain and vision health. Utilizing Neptune Krill Oil (NKO) as the core ingredient NKO Focus offers proven brain health support including up to seven times more astaxanthin than other krill oils as well as 3 percent of the daily value of choline--a precursor of acetylcholine a neurotransmitter for memory. When combined with NKO a clinical trial showed Lutein s absorption improved N by as much as eight times than a generic counterpart. NKO Focus contains DHA and phospholipids known to support healthy brain function in addition to vitamin A thiamine (vitamin B1) and lutein esters which help maintain eye health normal vision and cognitive function. We took the original NKO and gave it a boost targeting brain and vision health said Jacqueline Khayat Neptune s sales director. This is the first krill oil blend to offer such a pow- erful delivery mechanism to support brain and vision health. NKO is the perfect vehicle to increase bioavailability of other ingredients. Aside from enhancing lutein uptake NKO Focus contains the heart-healthy omega-3 polyunsaturated fatty acids EPA and DHA in a phospholipid form which supports more efficient digestion absorption and utilization. For more information call (450) 687-2262 or visit www.neptunekrilloil.com. Rainforest Awards Will Spotlight 2014 s Best Performing Ingredient s 2014 has come to a close Ecuadorian Rainforest (Belleville NJ) has chosen to spotlight the year s best performing ingredients at the company s inaugural Rainforest Awards. These ingredients have all performed exceptionally well in 2014 and are poised to grow in popularity. Ingredients will compete in six categories ranging from best newcomer of the year and best functional sup- A port ingredient of the year to the lifetime achievement award given to an ingredient that has had a major impact on the nutraceuticals world. Each ingredient in every category was carefully selected added to the category through careful vetting. An ingredient nominated is guayusa a heavily used tea leaf in South America. Guayusa earned its nomination through its known energy- supporting characteristic. Guayusa was offered in 2014 as an alternative to coffee. Other ingredients include maca a natural energy booster that may also help lower high blood pressure and beet root an ingredient that may help heighten endurance levels. For more information call (973) 759-2002 or visit www.intotherainforest.com. Nutrition Industry Executive 17 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 IngredientNews Next Pharmaceuticals Introduces New Relora Website ext Pharmaceuticals (Salinas CA) has launched a new Relora website www.Relora.com targeting its consumer audience to provide the type of information consumers want in an easy to understand format. The new website features one-click access to purchase Next s Relora products accessible explanations of the product and how it relates to consumers health and a blog for ongoing updates on new research that relates to stress and its many causes. The site also highlights the numerous N videos that have been made about Relora. We developed this website with the intention of it helping both the consumer and the customer. On the consumer side it will enable them to be more knowledgeable on the products they are ingesting and the potential health benefit said Regan Miles president of Next Pharmaceuticals. On the customer side we make it as simple as possible for consumers to purchase customers products with just a click from our site. The consumer- oriented language and other aspects of our new site are available for customers to integrate into their own marketing materials and sites. Relora is a proprietary blend of Magnolia officinalis and Phellodendron amurense bark extracts that alleviates stress curbs stress-related eating and promotes weight management by quieting the HPA axis without causing drowsiness according to the company. For more information call (604) 552-3077 or visit www.relora.com. Study Suggests Kyowa s Oxidized Glutathione May Brighten Skin study of healthy adult women showed topical application of oxidized glutathione may regulate melanin production resulting in brightening or whitening of the skin. Thirty healthy women aged 30 to 50 applied a lotion containing Kyowa s Oxidized Glutathione (GSSG) to one side of their face for 10 weeks. A placebo was applied to the other side. Researchers found that A skin treated with the 2 percent KYOWA oxidized glutathione location had significant whitening over the placebo group said Ryusuke Nakagiri senior director of strategic science at Kyowa Hakko USA (New York NY). Kyowa s Oxidized Glutathione is a clinically studied form of glutathione that when used topically has been shown to reduce aging effects caused by overexposure to ultraviolet radia- tion mainly from the sun. Called the master antioxidant glutathione helps protect cells in the body from the damaging effects of oxidative stress and toxins. Kyowa s Oxidized Glutathione is manufactured through a patented fermentation process and is preservative-free allergen-free and contains no artificial flavors or colors. For more information call (800) 596-9252 or visit www.kyowa-usa.com. G3 Labs New minoTOR Combines Sustamine and Glutamine rizona-based G3 Labs has launched minoTOR a ready-todrink sports supplement that combines Sustamine L-Alanyl-LGlutamine with a blend of vitamins and other amino acids. minoTOR provides a break-through in the functional beverage industry according to the company. It is a refreshing non-carbonated convenient premium sports drink designed for A the athlete in all of us. A precise blend of 4.2 g of amino acids vitamins and minerals provide energy sustained endurance substantial lean muscle gain and accelerated recovery. With only 50 calories per serving it integrates perfectly with training regimens and nutritional meal plans by promoting increased oxygen utilization lactic acid buffering and an overall improved rate of perceived exertion so activities feel easier. Sustamine is a dipeptide of glutamine that infuses minoTOR with several substantial benefits such as enhanced recovery immune system support and increased metabolic rate. Research also suggests that Sustamine is absorbed 240 percent more than standard L-glutamine. For more information visit www.g3.com. LactoSpore Meets Fruit d Or Nutraceuticals Cran Naturelle abinsa (East Windsor NJ) now offers the combination of its shelf-stable LactoSpore probiotic brand of Bacillus coagulans (MTCC 5856) combined with Cran Naturelle cranberry seed powder from Fruit d Or Nutraceuticals of Quebec Canada. This patent-pending combination is distinguished as a synbiotic blend for use in foods beverages and dietary supplements. It will be marketed and sold as LactoCran by Fruit d Or. Cranberry seed powder in this combination showed remarkable potential S as a prebiotic food for growth of LactoSpore compared to commonly used prebiotics such as fructooligosaccharides (FOS) said Shaheen Majeed marketing director of Sabinsa. We know that our cranberry seed powder contains over 50 percent fiber and as much as 25 percent natural protein therefore this new combination could be the complete synbiotic solution for gut health and beyond said Stephen Lukawski director of business development and sales of Fruit d Or. LactoCran provides support for healthy gut and digestive health while its prebiotic function also provides a source of tocopherols and tocotrienols thus benefitting heart and circulatory health. LactoCran s non-lactose diaryfree non-GMO (genetically modified organism) combination also works well in sports nutrition supplements as it contains a rich composition of 16 essential amino acids and eight branch chain amino acids. For more information call (732) 777-1111 or visit www.sabinsa.com. 18 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 NattoPharma Launches MenaQ7 VitaminK2 Down Under attoPharma ASA (Hovik Norway) in collaboration with Complementary Medicines Group (CMG) Australia announced successful penetration into the Australian and New Zealand markets including supplying major sponsor brands. Blackmores Australia s leading natural N T health brand will utilize NattoPharma s MenaQ7 Vitamin K2 in a soon-to-be released product throughout Australia. BioCeuticals supplier of high-quality practitioner- specific nutritional and therapeutic supplements has also signed on to use its MenaQ7 Vitamin K2 in an upcoming product as well as Essential Nutrition Vitamin K2 a standalone bone health product featuring NattoPharma ASA s MenaQ7 Vitamin K2 as MK-7 the only clinically validated and patented vitamin K2 as MK-7. For more information call ( 47) 40 00 90 08 or visit www.nattopharma.com. NHPD Grants Frutarom Product License for Benolea he Canadian Natural Health Products Directorate (NHPD) granted Israel-based Frutarom a product license for its Benolea a cardiovascular health support ingredient that is manufactured in Wadinswil Switzerland. A recent clinical study by Endang Susalit PhD et al showed that extract of olive leaf (Olea europaea) was effective in patients with stage-1 hypertension demonstrating that Benolea can lower blood pressure. As of December Benolea using Frutarom s proprietary HyperPure process will be available to local dietary supplement manufacturers in Canada. We are excited to receive the product license for Benolea from NHPD said Yannick Capelle product manager for Frutarom Health. Benolea is already marketed successfully as dietary supplements successful sold in the U.S. Germany Finland and Bulgaria. We are confidant Canada may now also benefit from the introduction of similar products. For more information call 972 4 9877600 or visit www.frutarom.com. Capsugel Announces New Licaps Fusion Technology apsugel (Morristown NJ) recently announced that its Licaps Fusion Technology liquid-filled hard capsule technology has been chosen by Healthy Directions a direct-to-consumer supplement retailer and wholly owned subsidiary of Helen of Troy Limited. For decades physicians have recommended marine-based oil supplements as a way to increase intake of omega-3 fatty acids essential nutrients for optimal heart skeletal and brain health. C The high-quality easy-to-swallow Licaps capsules mask the taste and odor that can be a common concern for fish oil products all while allowing the body to absorb the benefits of this form of omega-3. These attributes help make Krill Omega Defense stand out in a competitive marketplace said Connie Hallquist president of Healthy Directions. The delicate nature of krill oil requires a tailor-made natural encapsulation technology to ensure proper delivery and consumer satisfaction and designed for secure containment of liquids and semi-solids. Capsugel s Licaps Fusion Technology creates a hermetically bonded capsule without banding that mitigates the risk of leaks and effectively masks the strong taste and odor of supplements such as krill oil. For more information call (862) 242-1700 or visit www.capsugel.com. PLT Gains Product License to Support Cognitive Function LT Health Solutions Inc. (Morristown NJ) announced that it has received a license from the Natural Health Products Directorate (NHPD) of Health Canada to market its Zembrin Sceletium tortuosum to support cognitive functioning in healthy adults the company said. In the U.S. Zembrin has been marketed to nutraceutical and functional food and beverage producers interested in incorporating the innovative evidence-based ingredient in products that experientially support stress relief enhanced mood and improved P cognitive function. In Canada the approved claim is Helps support cognitive function in adults. PLT Health Solutions worked with Dicentra Regulatory and Scientific Solutions in the development of documentation for the Canadian license. According to Dr. Barbara Davis director of medical & scientific affairs at PLT Health Solutions the granting of an NHP license by Health Canada is a significant milestone for Zembrin as an ingredient--both because it opens up the Canadian market for this unique ingredient and for what it says about the scientific support that backs Zembrin. In Canada like the United States PLT has seen a dramatic increase in interest in cognitive health. We see this both in the aging population as they look to learn and function as they did at a younger age but also in a younger demographic who look to achieve peak performance throughout their lives she said. For more information call (973) 984-0900 or visit www.plthealth.com. Study Shows Pomella Phenolics Inhibit AGE Formation A 2014 University of Rhode Island Kingston study provides statistical data showing that Verdure Sciences (Noblesville IN) Pomella phenolics inhibit the formation of a biologically relevant oxidative stress marker called advanced glycation endproducts or AGE. AGEs are formed when a sugar molecule attaches to DNA or other proteins and prevents their proper function. Accumulation of AGE plays a key role in aging and some agerelated chronic human diseases like type-2 diabetes and Alzheimer s. Authors stated Our study suggests that pomegranate may offer an attractive dietary strategy for the prevention and treatment of AGErelated diseases. For more information call (317) 776-3600 or visit www.pomextract.com. Nutrition Industry Executive 19 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 AssociationNews Online Tool Helps Industry Monitor and Learn From Violations he Council for Responsible Nutrition (CRN) announced a free online tool that compiles U.S. Food and Drug Administration (FDA) warning letters sent to dietary supplement companies into a searchable database to help the industry achieve better regulatory compliance. The database can be used to evaluate FDA s warning letter allegations of good manufacturing practices (GMPs) violations products making impermissible claims and products tainted with illegal ingredients reported the council. According to Steve Mister CRN president and CEO the council s goal is to help companies in the supplement industry better understand the types of transgressions that will trigger a warning letter from FDA so that all companies can learn from others mistakes and identify priorities in FDA enforcement thereby raising the level of compliance with the law. The database is searchable by key criteria including product name company ingredient issue date potential violations and regulations cited and FDA district office issuing the warning. The database includes almost 300 warning letters publicly released by FDA from January 2008 through August 2014 to companies that the agency claims have violated dietary supplement GMPs and are illegally marketing a dietary supplement that T contains undisclosed pharmaceutical ingredients or are making impermissible claims to prevent treat cure or mitigate a disease. Monitoring violations cited in FDA warning letters is one of the best ways to understand the agency s current enforcement priorities and expectations said Mister. When companies have compliance questions they can search previous warning letters for similar circumstances and review the contents of those letters to consider the positions taken by the agency in those situations and avoid these mistakes. The database also has value for consumers according to the administration. While all warning letters are serious in their indication that a regulation has been violated not all warning letters are considered equal said Mister. If you look at the three main categories that these letters cover the most egregious--and the one that consumers should pay special attention to--are the warning letters that address products that are marketed as dietary supplements when in fact they contain undeclared drug ingredients. Mister said he is also concerned by the products in this category and urges consumers to avoid those products. We d further urge FDA to quickly escalate its enforcement action for these products beyond the warning letter stage as these products could be dangerous to consumers said Mister. Council officials further advised that because FDA does not always issue warning letters for products it has found to be adulterated--in some cases the agency instead uses other regulatory tools such as consumer advisories or product seizures--CRN recommends that consumers also check out a website created by the American Herbal Products Association Keep Supplements Clean which lists public notices of tainted products. A second category of violations included in the database is letters alleging improper statements made in labeling or websites that claim to prevent treat cure or mitigate diseases. According to Mister consumers need to be skeptical about these product claims and to talk with a health care practitioner before relying on these claims that could inappropriately raise expectations as to the product s benefits. Lastly the third category addresses more technical GMP violations that are discovered during FDA inspections ranging from minor technical issues to serious gaps in quality according to the administration noting the category would likely be of little use to consumers but would be of great interest to manufacturers trying to ensure they don t receive an FDA warning letter following an inspection. For more information visit www.crnusa.org. NPA Welcomes New Retail and Supply Members he Natural Products Association (NPA) has continued to track a rise in membership numbers since naming Daniel Fabricant PhD as executive director and CEO in April reported the association. More members for NPA means a larger benefit to the industry in the form of advocacy and education efforts as well as networking opportunities offered by our association Fabricant said. We ve had many new initiatives come out this year from NPA which we re only looking to increase in 2015 and we look forward to working with all new and current members as we advance the NPA mission of securing natural products for all. Every member has an equal voice--one member one T vote--bringing our diverse membership together to protect natural for current and future generations. The list of new members from September and October are Archon Vitamin Corp. Barksdale Organic Products LP Betty Lou s Inc. BioNeutra North America Inc. CA Botana International Candlewood Stars Inc. Caprico USA LLC Country Home & Health Store Dinescu & Dinescu Organics EcoNugenics Inc. Gabriel Organics Inc. Gluten Free By Beverly Gmp Global Marketing Inc. H2 for Life Holistic Farmacy Homeolab USA Inc. Iovate Health Sciences International Inc. Live Ultimate LLC LiveLeaf Inc. Marketing & Change LLC DBA Southwestern Cedar Oil.com Masta Corporation Murphy s Health Foods Natural Foods Market Nature s Vitamin Spot Pacific Naturals Healthbuy.com Pacific Power Brokerage Package Solutions LLC Porzio Bromberg & Newman P.C. Pulver Packaging Raw Elements LLC SBE Farms Enterprises Inc. Select Quality dba Assure Consulting Shanghai Jiaoda Onlly Co. Ltd. Sirio Pharma Co Ltd. Sisterna B.V. Spring Life USA LLC Stephanie Raffelock Inc. SVB Consulting Twinlab Corporation Universal Nutrition Wellements Wellpod Collective LLC Wellspring Custom Pharmacy Zebra Organics LLC. For more information visit www.npainfo.org. 20 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers 114th Congress Presents Industry With New Opportunities and Challenges J anuary marks the start of a new Congress after the 2014 election significantly changed the congressional landscape and created new opportunities and challenges for the supplement industry. A historic level of turnover in Congress now provides an opportunity for the supplement industry to forge relationships with the new federal representatives that can influence a widerange of issues that impact the industry from labeling products with genetically modified organisms (GMOs) to guidance on new dietary ingredients (NDIs) and substantiation of claims. Nearly half (48.8 percent) of the 114th Congress has only been in office for four years or less. Going back a little further Fair Vote data shows that 63 percent of the new Congress have been elected in 2006 or after. There are more than 60 newly elected officials in the 114th Congress. Perhaps the biggest change for the supplement industry is the departure of Sen. Tom Harkin (D-IA) a longtime supplement advocate and coauthor of the Dietary Supplement Health and Education Act (DSHEA). Sen. Harkin was the chairman of the influential Senate Committee on Health Education Labor and Pensions (HELP) and retired after serving three decades in the Senate and 10 years in the House. Throughout his career Sen. Harkin sought to change the debate about the U.S. health care system to focus on prevention wellness medical research and supplement food and drug safety. He consistently focused on many supplement industry-related issues including better nutrition in school lunch programs attention to complementary and integrative medicine support for organic agriculture and unending advocacy for properly regulated dietary supplements. While there is no way to replace Sen. Harkin Sen. Martin Heinrich (DNM) is emerging as a strong ally for the industry. In December Sen. Heinrich was recognized by Sen. Harkin and DSHEA coauthor Sen. Orrin Hatch (R-UT) as the next Democratic leader to safeguard access to dietary supplements. Sen. Heinrich was elected as the junior Senator of New Mexico in November 2012 and served in the U.S. House of Representatives for New Mexico s First Congressional District from 2009 to 2012. Shortly after being elected to the Senate the American Herbal Products Association (AHPA) invited Sen. Heinrich to attend Expo West and introduced him to the herbal supplement and natural products industry. The relationship fostered by AHPA and AHPA s New Mexico members over the years helped inform Sen. Heinrich about the important role that the supplement community plays in his home state and across the U.S. In 2013 Sen. Heinrich became the first Senator to join the Congressional Dietary Supplements Caucus since Sens. Hatch and Harkin founded it. On the House side vocal supplement critic Rep. Henry Waxman (DCA) retired leaving an opening for the top Democrat on the House Energy and Commerce Committee. House Congressional Dietary Supplement Caucus co-chair Rep. Frank Pallone (D-NJ) was narrowly elected to replace Waxman as the ranking Democrat on the committee which oversees the Food and Drug Administration (FDA). The other Caucus co-chair Rep. Jason Chaffetz (R-UT) won his bid to be the chairman of the House Oversight and Government Reform Committee which has broad oversight over all federal agencies. The most significant outcome of the 2014 elections was Republicans taking control of Senate with a 54 to 46 majority. Senate Democrats can still filibuster because Republicans don t have the 60 seats needed to give them the supermajority. Republicans also strengthened their control of the House by adding an additional 13 seats to their majority. With a ratio of 247 to 188 the House Republican majority is the largest since 1928. The 114th Congress will signify the first time that the Obama White House works with a Congress that is completely under Republican control. Only time will tell if the next two years will be marked by President Obama using his veto pen--which has been relatively dormant through his first six years--or if the White House and Congress will compromise to enact significant legislation. Most pundits are predicting more vetoes. The new Republican-controlled Senate is expected to maintain an anti-regulatory bent that should provide a more favorable climate for private industry. However the supplement industry cannot afford to let its guard down. There is no indication that the industry s primary critic Sen. Richard Durbin (D-IL) will ease his attacks and he continues to be well positioned to insert amendments that hamper consumer access to supplements into legislation. Moreover the Senate is still occupied by a number of members who share Sen. Durbin s desire to amend DSHEA. Sens. Richard Blumenthal (DCT) Ed Markey (D-MA) Claire McCaskill (D-MO) and Elizabeth Warren (D-MA) all serve on committees that oversee either the Federal Trade Commission (FTC) (Senate Commerce Committee) or FDA (Senate HELP Committee). AHPA encourages supplement industry stakeholders to join its advocacy efforts to help the industry leverage new opportunities and overcome the challenges presented by the 114th Congress. All the new faces in Congress provide a unique opportunity for the industry to make new allies by highlighting how supplements contribute to healthy lifestyles and to the U.S. economy. Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) Nutrition Industry Executive 21 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 ScienceUpdate Mushroom Extract AHCC Helpful in Treating HPV J apanese mushroom extract appears to be effective for the eradication of human papillomavirus (HPV) according to a pilot clinical trial at The University of Texas Health Science Center at Houston (UTHealth) Medical School. The results were presented at the 11th International Conference of the Society for Integrative Oncology in Houston by principal investigator Judith A. Smith PharmD associate professor in the Department of Obstetrics Gynecology and Reproductive Sciences at the UTHealth Medical School. Ten HPV-positive women were treated orally with the extract AHCC (active hexose correlated compound) once daily for up to six months. Five achieved a negative HPV test result--three with confirmed eradication after stopping AHCC--with the remaining two responders continuing on the study. Currently there is no effective medicine or supplement to treat HPV which is associated with more than 99 percent of cervical cancer cases. According to the Centers for Disease Control and Prevention (CDC) several other cancers are related to HPV including 95 percent of anal cancer 60 percent of oropharyngeal 65 percent of vaginal cancer 50 percent of vulvar cancer and 35 percent of penile cancer. AHCC is a readily available nutritional supplement that works to improve the innate immune system. Human and preclinical studies have shown that AHCC increases the number and or activity of natural killer (NK) cells dendritic cells and cytokines which help the body fight off infections and block tumor growth. The results are very encouraging Smith said. We were able to determine that at least three months of treatment is necessary but some need to extend that to six months. Since AHCC is a nutritional supplement with no side effects and other immune modulating benefits we will be planning on using six months of treatment in our phase II clinical study to have consistent study treatment plan. This confirms our earlier preclinical research. Smith is director of UTHealth s Women s Health Integrative Medicine Research Team which focuses on the safe and effective use of nutritional and herbal supplements with pharmacologic modalities as it relates to women s health and cancer. This research is proceeding to a randomized double-blind placebocontrolled Phase II clinical trial which has just begun at UTHealth Smith said. For more information visit http go.uth.edu judithresearch. Nothing Fishy About Plant-based Omega-3 Fatty Acid Health Benefits I ncreasing the amount of omega-3s in your diet whether from fish or flax will likely decrease your risk of getting heart disease according to Penn State nutritionists. A substantial amount of evidence exists supporting the heart-health benefits of eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA) marine-derived omega-3 fatty acids. However much less evidence exists to demonstrate the positive effects of alpha-linolenic acid (ALA) a plantbased omega-3 fatty acid. The benefits reported for EPA and DHA are stronger because supplements of EPA and DHA were tested and EPA and DHA was the only difference between the treatment and control groups said Jennifer Fleming instructor and clinical research coordinator in nutritional sciences. In contrast in the ALA studies there were diet differences beyond ALA between the treatment and control groups. 22 Nutrition Industry Executive EPA and DHA can be found in seafood and fish oil and are often consumed in the form of dietary supplements. ALA is found in flaxseed and its oil vegetable oils and some nuts and is now available in supplement form. EPA and DHA have been available for much longer. Other sources of ALA EPA and DHA are fortified foods such as orange juice eggs peanut butter margarine and bread among others. While there are many other omega-3 fortified foods in the marketplace most are relatively low in omega-3 fatty acids. Omega-3 fatty acids are considered essential for human health but the body does not produce them--therefore they must be consumed in order to maintain appropriate levels. In reviewing existing literature on the subject the researchers have come to the conclusion that ALA is likely just as effective in preventing cardiovascular disease (CVD) as EPA and DHA have proven to be as they reported in the journal Advances in Nutrition. Our understanding of the cardiovascular disease benefits of ALA has advanced markedly during the past decade said Penny Kris-Etherton distinguished professor of nutrition. Based on the current evidence ALA decreases CVD risk. Fleming and Kris-Etherton believe that dietary recommendations should be amended to increase the amount of ALA consumed but note that randomized controlled clinical trials need to be conducted in order to determine the amount recommended. Heart disease is the leading cause of death in the country said Fleming. Learning what you can do to prevent heart disease is important and relevant for everybody. The California Walnut Commission supported this research. For more information visit www.psu.edu. Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Conventions&Meetings PMMI Brings PACK EXPO to the North East P MMI the Association for Packaging and Processing Technologies brings the only processing and packaging event to the East Coast at PACK EXPO East (Philadelphia PA). The two-day trade show will focus on processing and packaging technologies top-tier exhibitors and a customer-centric approach to operational needs to help many markets such as confectionery baking snack pharmaceutical and medical devices food beverage electronics and more PMMI announced. Attendees will gain insight on the industry s challenges regarding sustainability and food safety through Innovation Stage sessions on-floor edu- cation at exhibitor booths and activities led by packaging and processing experts. Exhibitors will also have the opportunity to network while learning about the latest and trending issues. The expo will be held on February 16-18 at the Pennsylvania Convention Center. For more information visit www.packexpoeast.com. China s 4th Functional Food Summit and Technical Expertise Exhibition C hina s functional food industry will host the 4th China International Nutraceutical and Functional Food Summit 2015 & Technical Expertise Exhibition at Crowne Plaza Beijing Chaoyang UTown Beijing China January 12-13. Some of the world s top functional food manufacturers such as Amway GNC and Herbalife will host discussions or act as delegates. In addition associations including China Health Care Association and China s central government will continue to support and participate in the event by providing experts and officials from the China Food and Drug Administration (CFDA) the Department of Legislation AQSIQ and the Department of Food Safety Supervision. Attendees will be informed of new safety regulations registration processes and other key points in relation to the market. The summit will also explore enhancing insight through publicity strengthening the interaction and cooperation between companies to promote sustainable development and more. For more information call 86 21 55800330 or visit www.duxes-events.com ff4 . Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS www.VitaminRetailer.com www.GlutenFreeRetailer.com 1995 20 Y ars Celebratingellence e of Exc 2015 www.NaturalPractitionerMag.com www.NIEmagazine.com www.FitnessTrainerMag.com Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF niemagazine.com Roy Kieffer at 719-358-9838 or e-Mail RoyK niemagazine.com Gary Pfaff at 732-432-9600 ext. 107 or e-Mail GaryP niemagazine.com January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 23 Heart on the Line As cardiovascular disease remains the leading cause of death in the U.S. suppliers and manufacturers seek heart health ingredients that address prevention and even damage reversal. By Shari Barbanel A ccording to the Centers for Disease Control and Prevention (CDC) cardiovascular disease (CVD) is the leading cause of death for both men and women in the United States and approximately 600 000 Americans die of heart disease each year. Further The Heart Foundation noted that not only do more people die of heart disease than of AIDS and all cancers combined but by the year 2020 heart disease will be the leading cause of death throughout the world. These figures can startle just about anyone into paying attention to the health of their heart. Couple that with the fact that Americans are now taking the time to educate themselves on healthy lifestyles and that many are also becoming increasingly unhappy with the side effects that prescription drugs have--the heart health segment of the natural health category is expanding. The life extension category in general is growing every day as awareness of utilizing supple24 Nutrition Industry Executive ments instead of drugs become a more popular choice among the educated consumer said Pete Maletto president and senior scientist of PTM Food Consulting Inc. in New Jersey. New ingredients such as citrus bergamot not only perform better to change cholesterol levels than statin drugs they often do so with no side effects. While support nutrients are helpful the response to this relatively new dietary supplement is nothing short of amazing. Inflammation Nation According to the American Heart Association inflammation is common for heart disease and stroke patients and is said to be a sign on atherogenic response. George Tardik ND key research contributor for Pennsylvania-based Pharmax added that inflammation is involved with atherosclerosis from inception to development of thrombotic complications. There are multiple mechanisms. On a macroscopic level poor diet high in certain fats smoking obesity insulin resistance and hypertension are at the core of the process he explained. One well-established effect of inflammation is on endothelial cells that form the innermost surface of the artery wall. Normally the artery wall resists adhesion by leukocytes. However consuming a high-saturated-fat diet smoking hypertension hyperglycemia obesity or insulin resistance can initiate the expression of adhesion molecules by endothelial cells facilitates the attachment of leukocytes to the arterial wall. In addition chronic inflammation is a large contributor to developing chronic diseases which have become the health challenge of the 21st century. Chronic disease can lead to health issues such as diabetes and cardiovascular disease. Further The National Heart Lung and Blood Institute and American Heart Association have identified metabolic syndrome as a multiplex risk factor for cardiovascular disease that is Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 deserving of more clinical attention. 1 The link between inflammation and heart health has a name it is called the metabolic syndrome (MetS). MetS is a cluster of cardiometabolic risk factors that are most often found together in one individual explained Pierre Lemieux COO of Acasti Pharma a subsidiary of Neptune Technologies & Bioressources (Laval QC Canada). Based on the NCEP-ATPIII (U.S.) set of criteria people can be diagnosed for the MetS when at least three out of the five following criteria are met high triglycerides abdominal obesity low HDL-C high blood pressure and abnormal fasting glucose. The MetS is recognized beyond traditional factors such as bad cholesterol as a metabolic condition that put people at increased risk for heart disease and type 2 diabetes. It is estimated that more than 50 million Americans (around one out of three) suffer from the MetS. panthehine and slow release niacin yields results nothing but short of incredible. Omega-3s According to the American Heart Association omega-3s especially EPA and DHA are heart healthy nutrients that help the heart function optimally. Further research has shown that omega-3 can help lower blood pressure and triglycerides as well as reduce the risk for both coronary heart disease and sudden cardiac death. In fact according to a study that was published in 2013 in The FASEB Journal showed that naturally derived compounds from polyunsaturated fatty acids (omega-3s) may reduce the inflammation associated with these procedures to help arteries more fully and completely heal from procedures like angioplasty stenting and bypass surgery. And according to a 2014 study published in the journal Advances in Nutrition researchers found that increasing the amount of omega-3s in a person s diet will likely decrease the risk of getting heart disease. Neptune introduced Neptune Krill Oil (NKO) in 2003 and according to Lemieux the company published one of its first studies on cardiovascular health in 2004 comparing NKO to fish oil and a placebo. NKO was proven significantly better than fish oil to support normal cholesterol levels at a low daily dose of 1-1.5 g per day. And in 2014 Neptune launched condition-specific formulations including NKO Beat for heart and circulation health which offers a wider management of cardiovascular health. NKO Beat features all the proven heart health benefits of NKO plus coenzyme Q10 (CoQ10) Lemieux said. When combined with NKO a clinical trial showed the antioxidant CoQ10 levels are greatly increased--demonstrating up to 25 times better absorption as compared to a generic USP CoQ10. Aker BioMarine Antartic US offers Superba Krill which is a pure natural source of phospholipids the omega-3 fatty acids EPA and DHA and the naturally occurring antioxidant astaxanthin according to the company. Superba Krill is backed by a growing evidence base. In fact the majority of Celebrating 20 Years of Excellence 1995-2015 Heart Healthy Ingredients Some of the long-standing natural ingredients for heart health include omega-3 fatty acids CoQ10 vitamin K2 among others. Research has also found that ingredients such as astaxanthin olive oil and citrus bergamot also benefit the heart. Further there are a number of aspects of cardiovascular health in which different ingredients may be beneficial. PTM Food Consulting s Maletto noted that depending on the issue of focus each individual requires careful consideration and what supplementation strategy could be used for the specific area of cardiovascular concern. Each ingredient has its own strengths and weaknesses related to the condition that affects the other he said. For instance if a blood pressure related issue is a concern then using nitric oxide inducing amino acids such as agmatine citrulline and arginine with high dose potassium and magnesium tend to work wonders for reducing blood pressure. If the area of concern is circulation than high dose omega-3 fatty acids nattokinase turmeric bromelain and garlic work well to keep blood platelets from sticking together and thereby increasing healthy circulation. And if the issue is cholesterol related then the combination of citrus bergamot Go to niemagazine.com gcrieber Nutrition Industry Executive 25 January February 2015 www.niemagazine.com Heart on the Line clinical trials conducted on krill during the last several years have featured Superba Krill said Becky Wright marketing director for the Washington-based company. A study published in the February edition of Nutrition Research researchers investigated Superba Krill s ability to lower triglycerides without raising LDL the bad cholesterol (which has been the case in some fish oil trials) in those who have borderline high or high triglyceride levels. Three hundred subjects participated in this random- ized double-blind placebo-controlled multi-center U.S. study. The five treatment groups included a placebo group (olive oil) as well as four groups taking 0.5 1 2 and 4 grams of krill oil daily. Vitamin K2 Vitamin K2 is not only beneficial for bone health but greatly benefits cardiovascular health as well. In fact a number of studies have found the benefit of vitamin K2 for cardiac health including decreasing calcification and reducing the risk of death from heart disease. For instance according to 2006 study in which 16 000 people were followed for 10 years researchers found that found that each additional 10 mcg of K2 in the diet results in 9 percent fewer cardiac events. Herbs Spices Enhance Flavor as Well as Heart Health Spices and herbs are rich in antioxidants which may help improve triglyceride concentrations and other blood lipids according to Penn State nutritionists. Sheila G. West professor of biobehavioral health and nutritional sciences and Ann C. Skulas-Ray research associate in nutritional sciences reviewed a variety of research papers that focused on the effects that spices and herbs have on cardiovascular disease risk. The findings were published in the journal Nutrition Today. The metabolic effects of spices and herbs and their efficacy and safety relative to traditional drug therapy represent an exciting area for future research given the public health significance of cardiovascular disease the researchers wrote. West and Skulas-Ray looked at three categories of studies--spice blends cinnamon and garlic. They reviewed several cinnamon studies that looked at the effect of the spice on both diabetics and non-diabetics. Cinnamon was shown to help diabetics by significantly reducing cholesterol and other blood lipids in the study s participants. However cinnamon did not appear to have any effect on non-diabetics. The garlic studies reviewed were inconclusive but this is likely because the trials had a wide range of garlic doses from 9 milligrams of garlic oil to 10 grams of raw garlic. The reviewers noted that across the studies there was 26 Nutrition Industry Executive an 8 percent decrease in total cholesterol with garlic consumption which was associated with a 38 percent decrease in risk of heart problems in 50-year-old adults. In addition the researchers prepared meals on two separate days for six men between the ages of 30 and 65 who were overweight but otherwise healthy. The meals were identical-- consisting of chicken bread and a dessert biscuit--except that the researchers added two tablespoons of a high-antioxidant culinary spice blend to the test meal. The researchers followed the participants for three hours after each meal drawing blood every 30 minutes. Antioxidant activity in the blood increased by 13 percent after the men ate the test meal when compared to the control meal which may help prevent cardiovascular disease and other chronic diseases. West and colleagues are currently working on a study to monitor study participants for eight hours after eating a meal with a high-antioxidant spice blend. They want to know what happens to the fat in such a meal. If (the fat) isn t being absorbed when spices are included in the meal it might be excreted instead said West. We will examine whether spices affect how rapidly the meal is processed through the stomach and intestines. For more information visit www.psu.edu. New Jersey-based NattoPharma USA Inc. offers MenaQ7 Vitamin K2 as MK-7 (menaquinone-7) which not only offers bone health benefits but vitamin K2 offers cardiovascular benefits as well particularly as vitamin K2 activates the matrix gla protein (MGP) the most potent inhibitor of vascular calcification. Our newest innovation is MenaQ7 PURE an all-trans nature-identical synthetic vitamin K2 menaquinone 7 (MK-7) that contains no cis-isomers said Eric Anderson NattoPharma s global vice president of marketing. A patent-pending synthesis process produces an unprecedentedly pure vitamin K2 molecule that provides a much more desirable outcome for stability efficacy and safety resulting in a greater than 98 percent purity of active product. It is produced exclusively by NattoPharma in a pharma cGMP (current good manufacturing practice) facility on a dedicated line. PURE may be used directly in dietary supplements premixes and in food and is also naturally stable in omega-3 EFA products. What is important to understand is that MenaQ7 PURE is not a racemic form of vitamin K2 as MK-7 he continued. Racemic means a product contains a mixture of both cis- and trans-isomers. Research has established the efficacy of the trans-form of menaquinione-7 isomers while the cis-isomers benefit and activity in the body is unknown. And MenaQ7 PURE is the only nature-identical MK-7. Astaxanthin Astaxanthin is a powerful antioxidant and research has shown that it benefits the heart--specifically cholesterol levels. In a study published in 2010 in the journal Atherosclerosis researchers found that 12 and 18 mg per day of astaxanthin reduced triglyceride levels while 6 and 12 mg doses increased HDL-cholesterol (good cholesterol). According to Janice Brown technical sales support for New Jerseybased AstaReal Inc. astaxanthin is superior to many other antioxidants because of the unique role it may play in protecting the cell membrane due to its unique chemical structure and corresponding orientation within the living cell. Its unique chemical structure is comprised of polar ends which are held together by lipid soluble double bonds she said. This allows astaxanthin to span the cellular mem- Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Go to niemagazine.com kyowa for info about this advertiser stroke or dying of heart disease. One of the most dramatic developments that has occurred in the area of heart health in recent years was the 2013 PREDIMED Study that was published in the New England Journal of Medicine on the heart healthy benefits of what has come to be known as the Mediterranean Diet said Barbara Davis PhD RD brane protecting both the inside and director of medical and scientific affairs the outside of the cell giving overall for New Jersey-based PLT Health better antioxidant protection. Solutions Inc. This study showed a relBrown noted that AstaReal natural ative risk reduction of approximately 30 astaxanthin has been the company s percent among high-risk persons who most successful heart health ingrediwere initially free of cardiovascular disent. In the near future we expect to ease. As a result interest in The see astaxanthin positioned as one of Mediterranean Diet--and some of its the go to heart health ingredients that consumers reach for without hesi- primary elements--exploded into consumer consciousness. This has been tation she said. AstaREAL astaxanparticularly true of olive oil. thin is the most researched natural PLT Health Solutions offers Hytolive astaxanthin on the market today and Olive Fruit Polyphenol into the heart one of our major areas of focus is health space. Hytolive is a 100 perimproving cardiovascular health. cent natural patented ingredient. It is a solvent-free extraction of olive Olive Oil polyphenols from the by-product According to a 2013 study published in water of olive oil production--the prithe New England Journal of Medicine mary constituent of which is hydroxyconsuming more than four tablespoons tyrosol. The recommended addition a day can significantly lower your risk of rate of Hytolive of 100 milligrams to having a heart attack suffering from a foods beverages and supplements contains hydroxytyrosol equivalent to 10 olives or a half liter of extra virgin olive oil the company stated. According to Davis one of the most interesting compounds in olive oil for researchers is hydroxytyrosol. Hydroxytyrosol is a polar phenolic phytochemical found in olive fruit olive leaf and olive oil as well as by-products of olive processing she explained. Along with tyrosol and their conjugates it represents the main phenolic compounds in olive oil (50 percent). Hydroxytyrosol has a simple structure the highest bioavailability and ORAC of the olive oil. Go to niemagazine.com somalabs for info about this advertiser Heart on the Line Further Davis noted that in 2012 the European Food Safety Authority (EFSA) approved a heart health claim for olive oil based on its content of hydroxytyrosol concluding that a cause and effect relationship has been established between the consumption of olive oil polyphenols (standardized by the content of hydroxytyrosol and its derivatives) and protection of LDL particles from oxidative damage. Standing Out In a sea of ingredients and heart health products ingredient suppliers and manufacturers are looking for ways to set themselves apart from the rest of the pack. According to NattoPharma s Anderson specificity and brevity are key for successful marketing communications. Your supplier(s) should be partners in your efforts to concisely communicate the benefits your product delivers due to their ingredient s inclusion he said. Consumers interested in advanced information should be directed to the supplier s web presence to learn more. And if your supplier has significant educational materials available it is recommended to tie into them and keep the key messaging intact straying from this may cause confusion. In the case of formulas with several ingredients blended together--again keep the supplier s key claims intact in your labeling and promotional campaigns Anderson concluded. When working with quality suppliers that have invested in research there is no reason to re-invent the wheel. NIE Reference 1 Circulation. 2004 109 433-438. Extra Extra Visit www.niemagazine.com to read about how the age of a woman s first menstrual cycle is linked to the risk of heart disease. FORMOREINFORMATION Aker BioMarine US Inc. (206) 855-6736 AstaReal Inc. (609) 386-3030 NattoPharma USA (609) 454-2992 Neptune Technologies & Bioresources (450) 687-2262 Pharmax (888) 737-6925 PLT Health Solutions Inc. (973) 984-0900 PTM Food Consulting Inc. (888) 736-6339 28 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Go to niemagazine.com lonza for info about this advertiser DIGESTING THE RIGHT INGREDIENTS Consumers look for easy-to-take natural digestive health products that don t compromise their day-to-day lifestyle. By Cristina Goodwin 30 Nutrition Industry Executive O ver the years digestive health has become a concern for health-conscious consumers and continues to rise exponentially. In fact ingredient manufacturers are one step behind the industry as a whole according to Dr. John Deaton vice president of technology for Georgia-based Deerland Enzymes. We are encouraged by the increasing demand from our customers to develop more complex products that have scientific validation and human clinical support where appropriate he said. That being said a U.S. Digestive Health Enzymes Prebiotics & Probiotics Market report stated the industry shows huge opportunities for digestive health ingredients manufacturers by educating and drawing awareness to consumers. According to the report The U.S. Digestive Health Ingredients market has been segmented into www.niemagazine.com January February 2015 Celebrating 20 Years of Excellence 1995-2015 prebiotics probiotics and enzymes. The market is in the growth stage and is currently valued to be 265.9 million. It is expected to grow to 495.3 million in 2015 at a compound annual growth rate (CAGR) of 13.2 percent. In addition Scott Ravech CEO Deerland Enzymes said the supplement industry estimates a 3 percent growth or as much as 6 percent growth in 2014. Healthy Digestion The human digestive tract relies upon many different chemicals--and in some cases organisms--to function normally said Kristin Hendrickson contributing writer to Livestrong.com. The ability to breakdown food into normal components is another large concern for consumers searching for functional nutrition for growth development and supporting healthy aging. According to Nigel Plummer PhD key research contributor for Pennsylvania-based Pharmax The gastrointestinal tract forms the body s main immune barrier and at a basic level a healthy digestive system which includes a normal microbiota (gut bacteria) will protect against potential infection from bacteria yeast or parasites. Consumers are paying more attention to the nutrition label and becoming increasingly health conscious so the benefits of functional food and beverages continue to become more clear Deaton added. Consumers continue to look for easy and convenient ways to support their healthy lifestyle and functional food and beverages are a great way to receive the desired health benefits without chancing their day-to-day routine. Michael Bush senior vice president for Ohio-based Ganeden Biotech agreed noting that the target audience--children athletes moms and active seniors--can t digest the idea of downing another pill. Therefore trending functional food and beverage products make it an easy solution to consume your daily does of digestive health ingredients without altering your lifestyle. otic therapy may alter and disrupt the microbial balance in the gut said Kathy McIntee vice president of New York-based Patient One MediNutritionals. She referred to a 2010 review published in the journal of Nutrients that explained the three functions of the human gut (a) it breaks food down to nutrients (b) it facilitates absorption of nutrients into the blood through intestinal walls and (c) it prevents foreign and toxic molecules from entering the bloodstream. Digestive disorders are on the increase. About 38 million Americans suffer from a variety of digestive problems such as gastroesophageal reflux disease (GERD) irritable bowl syndrome celiac disease food allergies diverticulitis ulcerative colitis and Crohn s disease the review noted. Approximately 25 million Americans have daily heartburn and is estimate that 20 percent of the adult population have irritable bowl syndrome. Celiac disease once considered rare is now thought to affect one in 133 people and food allergies Concerns Recent studies have examined unintended health consequences of persistent antibiotic use and how antibiJanuary February 2015 www.niemagazine.com Go to niemagazine.com nutraceutix for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 31 DIGESTING THE RIGHT INGREDIENTS have increased alarmingly. Additionally Plummer explained that ongoing digestive issues can lead to the development of not only food allergies but also bacterial and yeast overgrowth and the production of toxins which can lead to inflammation and systemic illnesses. According to Mclntee manufacturers are looking for ingredients that are documented genetically identified strains and have a natural delivery system to survive stomach acids. The challenge for ingredient manufactures is that bacteria must be stable alive and potent to survive in the stomach acid so they can reach the intestinal tract where the organisms can colonize and replicate as well as ensuring the integrity of the product once it is in the consumers hand she said. Furthermore under the U.S. Dietary Supplement Health and Education Act (DSHEA) of 1994 manufacturers are responsible to ensure that their product s label information is truthful and not misleading. Furthermore Additional items such as cost storage requirements stability in final product and suitability for the target consumer should also be taken into consideration Ganeden Biotech s Bush said. However it is crucial that manufacturers first support their ingredients through scientific studies in safety and efficacy. According to Ravech manufactures are encouraged that their customers are placing the importance more than ever on formulating with ingredients that are backed by science not theory and the responsibility of manufacturers is to ensure that their products are of the utmost safety and purity. Microbes and Food A 2014 preliminary study about microbes in food begs the question do the microbes we eat as part of our normal daily diets contribute to the composition and function of our gut microbiota For the study 15 meals were selected to exemplify an everyday meal consumed as three very different dietary patterns to find out the average amount of microbes digested in food and beverages. One group focused on the American diet specifically on convenience food. The second group was USDA (U.S. Department of Agriculture) recommended to study the pattern in regard to the Go to niemagazine.com nutritional for info about this advertiser Celebrating 20 Years of Excellence 1995-2015 consumption of fruits and vegetables lean meat dairy and whole grains. The third group focused on the vegan dietary pattern excluding all animal products. The conclusion of the study suggested that the microbes we eat as part of normal diets that vary in absolute abundance community composition and functional potential. The variation depends on the specific ingredients in the meals and how the foods are prepared and processed and other potential facts not explored here including the provenance of ingredients. The significance of this variation on the gut microbiota composition and function impacts the human dietary constituents and nutrients polyphenolic compounds and vitamins in the gut. The study suggests the possibility that food microbes modify nutritive molecules. The researchers concluded that future studies need to address key questions about the composition and content of food microbes and how these vary across diets and meals and their impacts on the short-term and long-term composition and function of the gut microbiota. Probiotics & Prebiotics Recently probiotics have become a trending ingredient in the functional food and beverage market and consumers are aware of the importance of digestive health. A popular nutritional trend recently promotes digestive health by fortifying foods with natural probiotics prebiotics that help the digestive tract stay healthy said Ravech. In fact BBC Research estimated that 80 percent of consumers know what probiotics are and associate them with a health benefit. In addition the beneficial ingredient has a variety of functions that changes with the species of organisms Hendrickson explained. They can assist in vitamin and mineral absorption alleviate lactose intolerance and produce vitamin K. However manufacturers should be aware that not all probiotics are created equally and when choosing one to formulate with it is important that the strain (not just the genus and species) that they choose is the 32 Nutrition Industry Executive www.niemagazine.com January February 2015 appropriate probiotic bacteria--for example Lactobacillus fermentum helps digestion and balances bacteria Bush said. Ganeden Biotech s probiotic Ganeden BC30 (Bacillus coagluans GB1-30 6086) is a patented spore-forming organism that has been shown to support digestive health. The ingredient is extremely stable and remains viable through processing shelf life and the low pH of stomach acid he said. Its safety and efficacy is backed by 17 published studies including a doubleblind crossover study by the University of Tampa which stated that with 20 grams of protein the ingredient can help decrease recovery time soreness and blood kinase reduce swelling and increase power. In addition BC30 was granted FDA (U.S. Food and Drug Administration) GRAS (generally recognized as safe) approval. Prebiotics on the other hand increase the benefits of probiotics although there is a list of drawbacks such as temporary gastrointestinal issues or in some cases prebiotics support the growth of unhelpful bacteria. Deerland Enzymes research team created a prebiotic that was not a fiber or starch yet is very effective in 15 mg doses. The company s prebiotic product PreforPro has scientific evidence by both in-vitro and in-vivo studies which revealed the ingredient s impact on digestive health. The new product supports the growth of beneficial bacteria in the gut said Bush. Cold processed foods offer an ideal environment for both prebiotics and probiotics due to the cool temperatures from the time of production all the way to consumption he added. Enzymes Unlike probiotics enzymes are not living organisms Hendrickson wrote because enzymes are proteins which means that they are large molecules made up of long chains of smaller molecules amino acids. The industry as a whole is investing more than ever in support for enzyme-based products for digestive health Ravech said. According to enzymeessentials.com raw food includes enzymes needed to digest it ment products has never been highand when the food is cooked the er concluded Deerland Enzymes enzymes are destroyed leaving our Deaton. The functional food and body needing to make more in order beverages industry is playing catchto digest our food. However they are up with consumers with the high clinically proven to reduce the effects demand for digestive health ingrediof bloating gas heartburn and acid ents in their products they purchase. reflex. Ingredient suppliers have researched According to Sloan Trends digesand conducted numerous clinical tive enzymes are one of the top supstudies and landed on three key plement ingredients for 2013-2016 ingredients to help ease digestive with projected growth rates of 6.3 which include probiotics prebiotics percent. Ravech said Deerland and digestive enzymes. All three Enzymes is encouraged by the high ingredients have been trending over demand from their customers to crethe past few years and there is no ate more complex and new innovative sign of stopping for the future. NIE products backed by scientific evidence and human clinical support Extra Extra where needed. Visit www.niemagazine.com The company recently released to read about the new their newest products Glutalytic and documentary MicroWarriors. Dairylytic which are known to support healthy digestion of gluten and dairy proteins. These enzyme-based FORMOREINFORMATION products hydrolyze wheat and dairy Deerland Enzymes (800) 697-8179 proteins and break them down into Ganeden Biotech (866) 777-0825 smaller protein constituents so they Patient One Formulas (631) 390-9669 can be more easily managed by the body Ravech said. Glutalytic is one digestive natural product that helps minimize the consequences of gluten consumption and is backed by clinical studies. The company s other new product Dairylytic breaks down lactose associated with dairy foods as well as other proteins that are difficult to digest and cause discomfort to sensitive consumers. The entire supplement industry is going through a time which could be characterized as a clinical revolution in which the demand for clinical validation for dietary suppleGo to niemagazine.com americanlaboratories Celebrating 20 Years of Excellence 1995-2015 Nutrition Industry Executive 33 January February 2015 www.niemagazine.com ACTING Globally The natural products supply chain has a global footprint unlike any other. Following quality standards and guidelines help manage it. By Janet Poveromo F rom procurement of materials to the hands of end users the natural product industry s supply chain for ingredients used in the manufacture of dietary supplements that are sold in the U.S. is certainly global. Dietary supplements and their ingredients cover a wide range of materials many of which originate not only from Asia but also from all the other continents including the krill oil from Antarctica krill said Dr. Nandukumara Sarma director Dietary Supplements U.S. Pharmacopeial Convention. A large portion of dietary supplement ingredients (particularly botanical products) is sourced overseas. Today even a majority of the global supply of vitamin C comes from China. Dr. John Atwater senior director Verification Program with the U.S. Pharmacopeial Convention pointed out that the U.S. has responded in part to the global nature of the dietary supplement supply chain by enacting the Food Safety Modernization Act (FSMA) which was signed into law in 2011. FSMA is expected to have a significant impact on how the dietary supplement industry manages its supply chain he said. The law is intended to help ensure the safety of the 34 Nutrition Industry Executive food supply in a proactive manner by trying to prevent contamination rather than reacting to it. However regulatory expectations of how companies will meet the provisions of FSMA are still in the early stages of development and immediate impacts are yet to be seen. For example FSMA has a proposed rule for foreign supplier verification programs for importers of foods which includes dietary supplements. The extent of verification activities will likely be centered on risk-based approaches rather than end-product testing which for some manufacturers will represent a paradigm shift. Trends in commerce will also play a role in the global supply chain for dietary ingredients and dietary supplements. For example Atwater continued unbeknownst to consumers chondroitin sulfate products can vary tremendously in quality. Although there are reputable ingredient manufacturers that produce chondroitin sulfate sodium of high quality meeting USP (United States Pharmacopeia) standard of content of not less than 90 percent and a limit of nonspecific disaccharides of not more than 10 percent there are several others that manufacture chondroitin sulfate sodium of lower quality and at lower cost. When ingredients such as chondroitin sulfate sodium become more commoditized the cost of the ingredient decreases. Often times this is accompanied by greater variations in quality and a decrease in quality overall. This is especially true for botanicals. Thus a possible result of commoditization could be the appearance of lower-quality products in the market especially in cases in which products are not required to follow a quality standard. Sarma added that a positive development in the global supply chain has been the emergence of major dietary ingredient manufacturers who specialize in ingredients that are commonly used in several dosage forms from multiple manufacturers (beta-carotene) or specific botanical extracts thus enabling quality testing in a consistent and technically appropriate manner for products containing the ingredients. Because the supply chain in this situation is consolidated and more contained problems that emerge throughout the manufacturing chain can be identified and addressed more effectively he said. Tom Kiningham technical manager of NSF International s Dietary Supplement Programs noted that increasing economic prosperity in Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 developing regions such as Brazil Russia India and China have opened up new and enticing dietary ingredient sourcing opportunities for European and American-based dietary supplement manufacturers. In fact he pointed out that China is expected to surpass Western Europe and the U.S. as the largest global producer and consumer of nutraceutical ingredients by 2020. Abundant natural resources and competitive pricing have made foreign ingredient suppliers very attractive for dietary supplement manufacturers looking for an edge over their competition Kiningham said. The reasons for sourcing ingredients from these countries are certainly based on low price but there is also the issue of availability. Some ingredients are just not available anywhere else. For example ascorbic acid many of the B vitamins and certain botanicals are most readily available from China and little elsewhere. Even as labor costs in China are rising there may not be an alternative for sourcing certain ingredients. Competitive pricing and availability are among the many factors that have contributed to the globalization of the supply chain for dietary supplements. Bangalore India-based Indfrag s Chairman and Founder Philip Samuel pointed to popular ingredients and the global chain required for obtaining them. Green coffee extract for weight loss from coffee beans come from Vietnam are processed in India by us and made into capsules by contract manufacturers in the U.S. and sold all over the world to consumers he said. Garcinia fruits come from Sri Lanka Indonesia and India get extracted in India by us and are sold as ingredients to contract manufacturers and brand owners in the U.S. E.U. Japan Korea Australia etc. Valerian root used for sleep management is sourced from Poland and Bulgaria extracted by us in India and is used as an ingredient in products sold in the U.S. E.U. and Australia. There are many other examples like this. Oversight at the very first link in the supply chain is beneficial. Due to this extensive supply chain sourcing is the most complex function of the industry said George Pontiakos president and CEO California-based BI Nutraceuticals. There is a significant increase in the interest of sourcing sur- veillance at the farm level as well as chain of custody control from the farm to BI s receiving dock. We have had this process in place for a number of years and it is highly beneficial to our customers with respect to peace of mind in eliminating identity issues adulteration as well as ensuring organic and non-GMO (genetically modified organism) compliance. Risks And Liabilities Those following the natural products industry know that adulteration of sexual enhancement weight-loss and sports performance products with active pharmaceutical ingredients (or substances with similar molecular structure) is currently a major problem and one USP is addressing. Throughout the industry noted Sarma manufacturers and regulators are struggling to find the best methods for detecting and identifying adulterants. Heightened concern about this issue has motivated USP to form an Expert Panel charged with proposing analytical test procedures for identifying adulterants. The information will be published as a general chapter in the U.S. Pharmacopeia--National Formulary (USP NF) USP s compendia of standards for medicines and dietary supplements Sarma added. The chapter will also be published in the USP Dietary Supplements Compendium a publication of USP standards intended primarily for use by dietary supplement manufacturers. Currently adulteration of sexual enhancement products is the initial focus of USP s Expert Panel which hopes to draft a document for public review and comment by mid-2015. Low-ball pricing from global sources isn t necessarily the answer to achieving trailblazing status in a competitive market. Marketers and manufacturers of dietary supplement products are constantly seeking an economic technological or product breakthrough that will give them an edge in a crowded international marketplace Kiningham explained. Some dietary supplement advertisements dance the line of improbable health benefits and claims that border on being a cure for a disease condition. In this type of competitive environment and level playing field it is important for brand owners to leverage any advantage to their cause and international sourcing can be part of that effort he said adding that global sourcing can give the marketer an edge on controlling costs and having access to a wider variety of dietary ingredients and cutting edge nutritional products. However international sourcing is not always the best choice even if domestic supplies are more expensive up front. There are several reasons for this Lead Times and Unpredictable Availability Not only can lead times be longer but there is always the very real possibility of additional delays at the port of entry caused by regulatory agencies. In this frustrating situation essential raw materials can be a few minutes away and not be released for shipment for weeks. Economic or Other Types of Adulteration Recent episodes of economic adulteration by companies outside of the U.S. (melamine and cyanuric acid) and enzymes from India (through a U.S. distributor) that were contaminated with chloramphenicol a powerful antibiotic illustrate the risk of lower standards in some parts of the world which may have an impact on products manufactured in the U.S. Distributor Reliability Even when distributors are used to hold supplies of key imported raw materials it could be that when the shipment of a critical foreign-sourced raw material arrives that there are several manufacturer s lots in the truck. This can add additional time and expense as each lot must be separately tested and released. Also lot-to-lot variability can affect the quality of production batches and key characteristics of the finished product. Supplier Quality Management Whether a company is managing the quality of an overseas supplier through a distributor or directly there can be serious challenges to assuring that the materials are appropriate for use in the products to be manufactured. Language and cultural barriers can hinder accurate descriptions of what the manufacturer actually needs which can adversely affect the performance quality of the goods. For example if key specifications are not thoroughly communicated and in the quality contract material variability such as density particle size and color variations can adversely affect the finished product quality. Nutrition Industry Executive 35 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 ACTING Globally Economic Unpredictability Even if pricing and transportation are considered and planned for there is always the chance for unusual circumstances to drive up costs and affect the eventual sales of the company s product. These circumstances can include everything from unfavorable exchange rates and rising oil prices which can affect transportation costs and as mentioned above unpredictable and intrusive governmental activities. dioxins Kingham added. The best way to achieve this is to implement a robust supplier qualification program which generally consists of two components. First an auditing program that provides proof (and peace of mind) that your supplier complies with GMPs and is able to consistently produce quality ingredients to your specifications and second an ingredient testing program that verifies the quality and purity of the ingredients you source. Incoming Testing According to USP s Sarma the most important trait of a good protocol is that the test methods used be scientifically validated with respect to analytical parameters such as specificity accuracy precision and robustness. GMPs require that the manufacturer establish product specifications for identity purity strength composition as well as limits for contaminants he said. In the U.S. FDA has established GMP requirements (21 Code of Federal Regulations 111.70) and that the product conform to the specifications (21 Code of Federal Regulations 111.75). In order to ensure that quality ingredients are sourced through the supply chain manufacturers need to ensure that the test methods used by their suppliers are scientifically validated. Sarma added that the FDA GMP rules by nature are generic in their expectations it provides manufacturers with the flexibility to use any scientifically valid method. Consequently the common language between the buyer and the seller can be compromised if each is using a different test method that yields different results. In this context USP s public standards for dietary supplements (known as monographs) provide quality standards for the most commonly used ingredients which can be used to help ensure the quality of ingredients in the supply chain by providing common language for both the buyer and seller he noted. Quality standards from USP provide not only the necessary tests test procedures and acceptance criteria for the results of the tests but also highly characterized and pure chemical reference standards needed to obtain accurate results. Without a common standard determining what passes or fails as a good quality ingredient or supplement becomes the manufacturer s responsibility. Thus it would be difficult to determine if two Safety and Security Having a robust supplier qualification program is essential for any manufacturer and means for companies to be proactive in mitigating the risks associated with a global supply chain. Kingham said implementing an ironclad supplier qualification program is a challenge for companies in every sector. As supply chains spread across multiple countries and vendors the challenge of maintaining control over product quality and safety increases. The U.S. Food and Drug Administration (FDA) requires that manufacturers packagers labelers and warehousers and distributors of nutritional supplements to qualify each of their vendors but do not provide guidance on how a company is to perform this qualification Kingham explained. Supplier qualification principles also apply to subcontracted services affecting cGMP (current good manufacturing practices)--manufacturing steps packaging and labeling testing and or calibration services storage and distribution etc. He noted that any supplier qualification program must include two critical components clearly defined specifications or requirements for all goods or services being purchased and objective evidence to show that your requirements are being consistently fulfilled. In other words you must have a system in place that can demonstrate to an FDA auditor that the ingredients you source meet the certificate of analysis and are free of unacceptable levels of contaminants--for example heavy metals pesticides PCPs and 36 Nutrition Industry Executive ingredients or supplements that are supposed to be comparable do indeed share the same basic characteristics. If two different manufacturers of a similar product follow the same USP monograph then the two products can be compared for adherence to monograph specifications. In the end a public quality standard for a dietary ingredient establishes common expectations about product quality between an ingredient seller and a buyer and ultimately further down the supply chain between the dietary supplement seller and the consumer. Atwater argued that despite the availability of USP quality standards unless all manufacturers use USP standards it becomes difficult for the consumer to expect that their products will be of consistent high quality. Different analytical test methods and acceptance criteria--when independently defined--can yield different results regarding product quality he explained. Use of public quality standards throughout the supply chain provides consumers with assurance that a particular product is of known compendial identity and good quality since it has been manufactured against a known scientifically based quality standard. At Indfrag incoming materials are tested by HPLC high-performance liquid chromatography or other internationally recognized techniques to measure the content of the active ingredient. We insist on pre-shipment samples of the bulk to make sure that we buy the best quality said Samuel. HP-TLC (high performance thin layer chromatography) is used to identify any adulteration or mix up of different plants. With 25 years of experience Indfrag can be sure of the raw botanical. Another important aspect is that Indfrag never buys powdered raw botanicals where other plant can be mixed easily. We only buy whole leaves roots seeds so that inspection is easy. In addition Pontiakos said BI tests for (but is not limited to) Cleanliness extraneous matter Identity BI has a proprietary species genus testing and authentication testing technology known as Identilok Pesticides Heavy metals Residual solvents Aflatoxins Microbial Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 However before testing even begins you have to take a few things into consideration he noted. First do you have an appropriate test method Every method has its advantages and limitations. It is important for suppliers and their customers to agree on test methodologies prior to accepting C of A results. Second do you have the correct reference material or are you comparing apples to oranges For instance the materials should have the same country of origin harvesting method and plant part. better to pack in bags that are breathable and not air-tight. It is better to buy full container loads to avoid our material being in close proximity to other material which may contaminate our goods. BI uses double-wall cardboard boxes with an inner liner closed with a color-coded security zip tie. These boxes are sealed with food grade security tape to insure product integrity. Storage and self-life studies are conducted and results monitored. Outgoing lots are tested using BI s GMPs and SOPs (standard operating procedures). Ensuring Stability Purity and Quality for Storage and Shipping Several systems or programs are needed to ensure the stability purity and quality of dietary ingredients and supplements. First suppliers and manufacturers need a scientifically based quality standard to properly characterize the article the standard would include validated stability-indicating test procedures Atwater explained. Secondly suppliers and manufacturers would need to have a good packaging and labeling systems to ensure that the article is packaged and labeled properly along with a stability study program for assessing the stability of the article under proper packaging and controlled storage conditions. The stability study program would be used not only to establish the expiry date of the article but would also evaluate the stability of the product when placed under extreme conditions of temperature and humidity outside of its labeled storage conditions. Thirdly the supplier and manufacturer need a good means of tracking the chain of custody of the article including who handled it and under what storage or transportation conditions. Material transported under improper storage or transport conditions can cause the material to degrade. However he added with the proper quality standard the supplier or manufacturer would be able to determine whether or not the article conforms to its specification and thus whether or not an article s quality has been negatively impacted by improper handling. For Samuel the most important aspect of shipping is the moisture content. If moisture exceeds 12 percent there is a chance of fungal growth and degradation he said. Our suppliers are strictly instructed to dry the material before packing and shipping. It is Weather Conditions Climate change weather issues sudden increase in demand etc. can impede acquiring certain raw materials and suppliers are taking measures to address those challenges. Sudden demand or the loss of crop due to environmental factors could lead to adulterated or counterfeit raw materials in the supply chain noted Sarma. Adulteration of hoodia is a classic example due to demand exceeding the supply. Many botanicals are complex mixtures and as such their quality can be affected by region where they are cultivated seasonal changes etc. which could result in adulterated ingredients in the supply chain due to high demand. A recent example was the adulteration of ginkgo extract with rutin and quercetin. USP revised the Powdered Ginkgo Extract monograph to provide analytical methods to detect the adulteration. This is a huge problem with botanicals Samuel agreed. Price variations can be as much as five times due to sudden demand and failure of crops due to unexpected rains poor weather etc. He also noted the problem with garcinia which cost about 1 U.S. per kg about five years ago went up to 4 per kg last year and is now down to 3 per kg. The only way to overcome this is to keep large inventories and buy when prices are down he said. This needs a lot of experience and Indfrag has 25 years. Indfrag keeps two years of stock and has large warehouses well ventilated and maintained with GMP standards to ensure that the goods are in good shape. improving the bottom line and even the state of the world. But expanding quality operations globally would require consideration of limited technical capabilities and resources of the labs in less developed countries said Sarma. For example if the seller is unable to test the materials for meeting specifications from the buyer before they are shipped the buyer would have a hard time to return the shipment to the country of origin he noted. For these reasons when USP develops standards we take into account input from manufacturers and regulators around the world regarding the feasibility and suitability of tests and whether or not they can be performed by manufacturers around the world. Thus manufacturers who expand globally can benefit greatly from the use of USP s public quality standards. If a company is expanding globally added Atwater it is most important that the firm operate under the same GMPs with the same quality management system in place at all of its sites in order to ensure consistent product quality he said. While vertical expansion (single-manufacturer control over the entire product supply chain starting from the raw material source all the way to final product) is the best way for a company to control the quality of its product it is typically not economically feasible for companies to do so. Thus having robust GMPs that includes consistent monitoring of the quality of supplier s ingredients plays a large role in the production of consistently good quality products. NIE Reference 1 Global Sales for Nutraceutical Ingredients to Reach 24 Billion by 2015. Nutraceuticals World. 2 Jan. 2012. Web. 27 Mar. 2012. www.nutraceuticalsworld.com issues 201201 view_industry-news global-sales-for-nutraceuticalingredients-to-reac . Extra Extra Visit www.niemagazine.com for more information on the global supply chain and the benefits of NSF GMP registration. FORMOREINFORMATION Best Practices for Global Growth Dynamic high-growth companies are considered trailblazers shapers and innovators that are committed to BI Nutraceuticals (310) 669-2100 Indfrag 91-80-25285365 NSF International (734) 827-6850 U.S. Pharmacopeial Convention (800) 227-8772 Nutrition Industry Executive 37 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Celebrating Years 20 Jeff Hilton To celebrate Nutrition Industry Executive s (NIE) 20th anniversary we asked industry insiders with a few years of experience under their belts to reflect on the impact challenges and evolution of the natural product industry since the magazine s inception. By Janet Poveromo Our Participants Are Paul Dijkstra CEO InterHealth Nutraceuticals Paul M. Flowerman President & CEO PLT Health Solutions Inc. Bob Green Chairman Novel Ingredient Services Jeff Hilton Partner & Co-founder BrandHive Joe Kuncewitch National Sales Manager Fuji Health Science Shaheen Majeed Marketing Director Sabinsa ulated like drugs. Only a few products would be available and they would be extremely expensive. In addition to the rules and regulations implemented in DSHEA and other acts and enforced by the FDA and FTC (Federal Trade Comission) responsible companies in the industry adhere to a strong code of ethics and provide high-quality efficacious products to consumers. Green DSHEA completely changed the natural products industry. Its framework allowed us to go from a cottage trade to a burgeoning billiondollar industry. After DSHEA it became clear that consumers want to take greater ownership of their health and they want natural alternatives to do it. Before DSHEA dietary supplements were considered food. We couldn t talk about their functions in the body. And if you wanted to talk about the benefits of dietary supplements you had to invest in years of research as companies must do for pharmaceuticals. The DSHEA laws recognized that dietary supplements are not food--nor are they pharmaceuticals. DSHEA defined our unique industry and set up new rules labeling laws etc. so we could finally discuss how supple- Paul Dijkstra Paul M. Flowerman Bob Green Joe Kuncewitch Shaheen Majeed N IE In 1995 DSHEA (Dietary Supplement Health and Education Act) was enacted for less than a year. How has the natural products industry changed since that time Flowerman Passage of DSHEA formalized the legal legitimacy of the dietary supplement industry enabling major investment and innovation. Hilton Tremendous growth in most industry sectors increased profitability exciting product innovation and an explosion in consumer interest and trust in supplementation as a critical 38 Nutrition Industry Executive part of maintaining good health. Dijkstra The industry has become more cognitive of how supplements are defined. DSHEA is now a more common point of reference amongst conversations with industry professionals. DSHEA provides FDA (U.S. Food and Drug Administration) with appropriate regulatory authority while allowing consumers access to a variety of affordable high quality safe and beneficial dietary supplement products. Consumers would not have the access to dietary supplements like they do today if dietary supplements were reg- Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 ments work in the body. Consequently dietary supplement manufacturers--as well as ingredient suppliers like Novel--could publicly discuss specific structure function applications of the hundreds of nutrients we marketed at that time. This changed the dynamic in which we presented our products and ingredients especially branded ingredients to both trade and consumers catapulting consumer marketing and sales to new heights. Majeed On October 25 1994 DSHEA was signed into law clarifying what supplement companies can and cannot state about supplements they market. The industry has grown enormously since then due to this clarification and the fact that the FDA cannot regulate supplements as they do with drugs which is entirely appropriate given the safety record of supplements. This allows responsible supplement manufacturers and distributors to have the security and financial wherewithal to investigate the properties of supplements in terms of their chemistry and their effects on human health. Sabinsa has used this opportunity to conduct research to clearly define the chemistry of ayurvedic herbs all the way to conducting human trials on nutraceuticals and human health the world over. This has also contributed to publication and contribution to the scientific understanding of complex herbal mixtures and single natural substances on complex biological systems including cell studies animal models and human trials. This focus on science had the unintended side effect of some companies borrowing the science other companies produced and claiming it was applicable when for proprietary versions of products it actually was not. That also contributed to the commoditization of ingredients which meant quality and purity was often thrown out the window in favor of cheap prices. Over the last few years though we have seen the pendulum swing back over to focus on quality and branded ingredients backed by applicable science. We are very pleased about this because the ultimate goal is to provide health benefits to consumers which requires higher quality products. NIE How has your company evolved in those years Flowerman PLT s supplement business initiative increasingly becomes the most significant platform for carrying out our health and wellness mission. Hilton BrandHive was founded in 1996. Since then we have grown to 20 employees partnering with industry companies around the globe to educate and promote awareness for health solutions. We have moved into new offices in 2014 and work actively in the supplement food beverage and personal care sectors. Kuncewitch AstaReal Inc. continues to grow along with the dietary supplement industry and DSHEA has been a guiding force for us. Most recently we were granted an NDI (new dietary ingredient) up to 12 mg per day for AstaREAL Astaxanthin the highest daily dose allowed for this antioxidant. Additionally in 2014 we have constructed a new state-of-the-art algae manufacturing facility in Moses Lake WA to help us meet the growing demand for natural astaxanthin. Dijkstra InterHealth Nutraceuticals was founded in 1987 seven years before the enactment of DSHEA. For over 20 years InterHealth has provided safe and effective ingredients to the natural products industry. InterHealth supported industry leaders in leading the way to DSHEA s enactment. Since then we have worked closely with industry groups such as the American Botanical Council and Council for Responsible Nutrition regarding regulatory issues pertaining to our industry--ensuring consumer s rights to safe and effective dietary supplements. Green The past 20 years have changed how ingredients suppliers function in the natural products industry. At my first natural products company Nutratech Inc. (now Advantra Z Inc.) we launched Advantra Z shortly after DSHEA had been enacted. It was probably one of the first branded ingredients to launch under the context of the new laws. So we were able to discuss Advantra Z s thermogenic mechanism of action and how it supports diet fitness and energy. This was key to the launch growth and endurance of this branded raw material which 20 years later is the industry s leading thermogenic ingredient. But even before I became involved with my second ingredient supply company Novel Ingredient Services it was clear to me that everybody up and down the industry supply chain would have to evolve and offer a whole new level of business and technological sophistication. That s why Novel while still a preferred supplier of high-performance botanical and nutraceutical raw materials known for its global sourcing expertise and delivering value beyond price per kilo is really a provider of business solutions offering a full range of technical services custom ingredient manufacturing rigorous QA QC and regulatory intelligence accompanied by world-class customer service. We have distribution facilities on the East and West U.S. coasts as well as an office in China. Novel also maintains ISO 9001 1008 certification and registration to the NSF International Dietary Supplement Ingredient Good Manufacturing Practices program. In fact we were the first U.S. dietary ingredient supplier and the second in the world to receive this supplier-specific facility registration. As the industry has evolved we have positioned Novel to cater to a host of different manufacturer needs with in-house experts who can work quickly and cost-effectively adding significant value to the supplier manufacturer partnership. Majeed Sabinsa was founded in 1988 and now employs 1 000 people in seven world-class manufacturing facilities with sales and marketing operations spanning several countries with a primary focus on dietary ingredients. Throughout the years Sabinsa has pioneered bringing classic ayurvedic herbs into the mainstream as proprietary ingredients supported by science and often identifying health benefits previously unknown by ayurvedic practitioners. Industry rock star herbs such as Garcinia cambogia piperine curcumin and coleus are just a few of the herbs Sabinsa put on the dietary supplements map. The company now has nearly 100 patents on its products and the company s curcumin C3 Complex is the most studied proprietary curcumin in the world. The company has grown from a handful of researchers to over 100 scientists on staff. A drought in India around 15 Nutrition Industry Executive 39 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 Celebrating Years 20 years ago taught us to get involved in cultivation and now Sabinsa has a robust program of working with farmers to insure a sustainable supply of high quality raw materials. NIE What impact has NIE magazine had on the industry over the years Dijkstra NIE magazine has been able to maintain fresh insight over the last 20 years. Executives in the industry such as myself greatly appreciate the targeted content and practical information in all areas of the industry. NIE has been a great communication tool for me during my meetings and conversations over the years. I know that this magazine will remain an indispensable asset to our industry. Green NIE was an industry pioneer. Twenty years ago our trade journals were focused on finished products and retail--with only occasional coverage of issues important to the supply side of our industry. The publishers at NIE were the first to recognize that the ingredient sourcing and manufacturing side of our growing industry had its own specific challenges and very different business issues than the retail side of the business and that these could not be thoroughly addressed by the retail trade publications that existed at the time. And for two decades now NIE has focused on covering the issues that directly impact ingredient suppliers like Novel as well as finished goods manufacturers on a daily basis. Flowerman NIE has consistently and courageously lazered in on the most commercially important or contentious issues of the day. I still consider it a worthwhile read when I no longer have time to personally review most industry publications. Hilton NIE has been a great media partner in helping us credibly educate manufacturers and industry leaders about new technologies products and clinical research. Majeed The launch of NIE was an important development for the industry. The majority of the trade coverage at that time was directed to retailers but there was increasing need for suppliers and manufacturers to have both 40 Nutrition Industry Executive a forum and a source of information targeted to their separate issues and needs. Think about it back then the regulatory climate for most of the industry s products was still evolving from organic to supplements. Having a forum to stay on top of developments was essential to industry growth and development. NIE What impact has the industry had on the health and well being of U.S. citizens Dijkstra The industry has made U.S. citizens a more informed consumer. Nevertheless the industry has to continue to educating the public and build awareness of how even a small lifestyle change such as supplementing with efficacious and safe products may greatly impact lifelong health. Many of InterHealth s branded ingredients provide steps manufacturers can take to help consumers maintain their weight blood sugar and insulin levels. InterHealth s ingredients help make a difference and improve the quality of life for millions of Americans. Flowerman The paradigm of preventive health and wellness grows more credible and well characterized every year. Healthy aging supplementation to postpone the need for harsh pharmaceutical intervention and supplementation to overcome nutrient deficiencies have become mainstream consumer objectives for which supplement plays an important part. Green The natural products industry has made an entire generation of health-conscious consumers healthier. We ve brought natural products to the masses. We opened the door on new ways to lead healthier lives--and provided the ingredients products and solutions to help people get there. Twenty years ago only a fraction of the population had been exposed to these alternatives. Today a vast majority of Americans consume dietary supplements and partake in alternative health care modalities. Without DSHEA--if for example dietary ingredients supplements were to have been regulated as food or pharmaceuticals--none of this would have happened. Would there be a successful national chain of natural products like Whole Foods Market Would mass-market merchandisers like Walmart see the value in carrying a wide selection of dietary supplements and organic products Would vitamin- only retailers like VitaCost be as popular as they are today I don t think so. DSHEA opened the marketing and sales floodgates enabling dietary supplements to become a hit with the masses and a multi-billion dollar industry. Hilton It s impossible to measure or overstate. While obesity is still a huge issue our industry has helped fuel the self-care trend that is causing consumers to adopt a more preventive health mindset than ever before. We should all be so proud of those accomplishments. That said there is so much more to do. Kuncewitch The health and wellbeing of all people including U.S. citizens is what drives our industry. AstaReal Inc. has invested a tremendous amount of resources time and effort to the investigation of natural algae based astaxanthin. We are world leaders in studying the safety and tolerances for natural astaxanthin using different doses treatment periods research design and demographic variables including age gender and ethnicity. Majeed One the appropriate regulatory framework was in place the industry was able to expand product offerings to provide health benefits to consumers as well as fund research into those health benefits. Looking at important studies commissioned by first the Natural Products Foundation and later the Council for Responsible Nutrition billions of dollars in health care savings can be realized by the use of supplements. And you can t put a price on the quality of life when for example a senior citizen can stay independent when their vision stays good and their bones strong. NIE Overall what is the current state of the industry What are its biggest challenges Dijkstra The current state of the industry is change and evolution. Our biggest challenge currently is overcoming the negative publicity of the media. It is unfortunate that a few bad apples have overshadowed more positive discussions about healthful products that are designed to help people support a healthy lifestyle. Unscrupulous companies selling lowquality products drag down the reputation of the industry and the responsible companies that offer safe scientifically backed supplements. Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Reputable manufacturers can counteract bad publicity by complying with regulatory manufacturing and quality standards providing correct labeling and ensuring that sufficient research has been done to support product claims and safety. Unfortunately because of the few companies that continue to put marketing before research the industry is coming under growing scrutiny by Food and Drug Administration Federal Trade Commission and Congress. Flowerman We are experiencing the highest levels ever of investment and attention to our industry. There is also the highest level of government oversight and intervention which enforces a needed higher standard of performance but also often confuses and limits both the industry and the consumer with confusing guidance. Green More than half of Americans take dietary supplements regularly. So vitamins are no longer considered a small cottage industry. They have become a staple of American alternative and preventative health care. Twenty years ago you had to go to a health food store to buy dietary supplements. Now new channels-- including the mass market and especially the internet--are dissecting the business. Health food stores used to be able to distinguish themselves by having educated personnel to help consumers address their specific nutritional needs. That wasn t available in the mass market. But with the rise of the internet all of this information is at your fingertips along with supplement prices that undercut virtually every other distribution channel. So while it s wonderful that our industry has grown and become attractive to the masses it has created challenges in some distribution channels. Competition is fierce. Consumers are becoming more and more price-conscious and price-driven rather than value-driven. Manufacturers need to make products cheaper so everyone is squeezed-- all the way down to the ingredient supplier. Oddly enough this has been an opportunity for Novel to differentiate its ingredients and services. Since the beginning Novel has cultivated strong relationships with the very best Asian suppliers. Long before it was mandatory we worked exclusively with suppliers who were willing to collaborate with our regulatory experts and adopt the proposed U.S. cGMPs (current good manufacturing practices). The suppliers we use have a good understanding of the high standards required by manufacturers in today s rigorous regulatory environment. These long-term relationships have enabled us to consistently deliver the ultimate in value premium quality ingredients and value-added services at extraordinarily competitive prices. Hilton The industry is healthy and poised for continued growth I believe. Our biggest challenges in 2015 will be 1) maintaining and increasing consumer confidence 2) bringing continued innovation in product development and 3) maintaining consistent quality and safety of our products. Majeed Growth continues particularly in categories that address concerns of aging Baby Boomers in sports nutrition and in the ever-strong weight management sector. We ve been encouraged by newfound interest in clean label and even more so by those companies who interpret that to mean sourcing quality ingredients backed by science and formulating products with efficacious amounts of ingredients marketed with transparency. It was also encouraging to see industry reaction to the POM Wonderful Supreme Court decision with industry leaders advising companies to closely examine their labels and visible discussion of the pitfalls of fairy dusting. The industry continues strong albeit with sales slumps when the media picks up on a negative study and scares people away from specific supplements with alarmist headlines while failing to report the inevitable study design flaws. The biggest challenges to the industry is reaching a consensus on many things--on standardizations of herbs testing protocols and what constitutes sufficient scientific evidence. This includes guidelines in making structure-function claims. The industry is in a state of flux where proper protocols are being put in place for others in the industry either to follow or to be left behind. It is a very challenging yet hopeful time. The introduction of cGMP rules for supplement manufacturers to follow was a wonderful development both for the benefit of the consumer and the manufacturer from a safety standpoint so he can rely on his fellow manufacturer s procedures with confidence. The cGMP regulations ensure safe manufacturing procedures are followed from quarantine of incoming material until confirmation testing to cleaning machines to prevent cross-contamination and final analysis of finished product before it leaves the facility. NIE What has the industry achieved and how can it best move forward Dijkstra I believe the best way for the industry to move forward is to keep being at the forefront of safety and evolution. Flowerman The extraordinary growth in revenues and public visibility document our industry remarkable growth and the popular awareness. We are involved in very important national controversies over our food supply and the consumers right to be well informed about the composition of what they ingest. The only winning strategy is taking the high road which includes greater investments in quality science and reasoned public advocacy. Hilton As an industry we can continue to tell the good news story about our products and the legitimate health benefits they provide. We should consistently raise the bar on quality manufacturing. We should seek to support our products and ingredients with science and clinical research. We should reach out to new customers and new younger demographic groups who are just now forming their attitudes and usage patterns around natural products. Majeed The industry has achieved increased credibility with consumers due to enormous leaps in knowledge of plant chemistry and pharmacology which has improved human health in many areas from the supplement arena to functional foods to nutraceuticals. We ve got nearly 70 percent of consumers using our products and we stand to make a positive contribution to human health and well being. The industry can move forward by making a point for this latest trend of clean label to actually mean products made with the best ingredients in the right amounts transparently marketed. It can move forward by more businesses that make their livelihood in the dietary supplement world supporting the trade associations that advocate for our industry. Nutrition Industry Executive 41 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 20 Years of Natural Products Industry News Coverage T he dietary supplement industry has gone through a number of changes since Nutrition Industry Executive s (NIE) debut in 1995. A year earlier the Dietary Supplement Health and Education Act (DSHEA) was passed and Pearson Shaw and the American Preventative Medical Association (APMA) filed comments with FDA to authorize a folic acid health claim that would later lead to the landmark Pearson v. Shalala case both in 1994. Both set the stage for tremendous growth in the natural products industry. In honor of the magazine s 20th anniversary we look back at some of the industry s major milestones over the years. on the benefits of fish and fish oil supplements for cardiovascular disease (CVD) is published in Circulation. sizes are required to by GMP compliant. 2011 President Obama signs the FDA Food Safety and Modernization Act (FSMA). FDA announces that it has issued draft guidance clarifying agency expectations on new dietary ingredients (NDI) as required by the FSMA. 2003 Dietary supplements containing ephedra are banned December 20. 2004 The Miller meta-analysis published in the Annals of Internal Medicine concludes that high doses (400 IU) of vitamin E daily could do more harm than good. 2012 AHPA CHPA CRN NPA and UNPA join together to call for an overhaul of the FDA s Draft Guidance for Industry Dietary Supplements NDI Notifications and Related Issues. The U.S. Senate votes against amendment SA 2127. If passed the amendment would have set new requirements for dietary supplement manufacturers to register all products and their ingredients with FDA within 30 days of introduction reformulation or discontinuation. Senators Orrin Hatch and Sheldon Whitehouse introduced the Designer Anabolic Steroid Control Act of 2012. The vitamin celebrates its 100th anniversary. The FDA announced plans to reissue a revised draft guidance NDIs used in dietary supplements. 2005 Androstendione is moved to the Controlled Substances List in 2005. 2006 The adverse event reporting (AER) law is passed requiring that companies submit serious AERs to the FDA. Life...supplemented is a consumer wellness campaign presented by the Council for Responsible Nutrition (CRN) and dietary supplement ingredient suppliers and product manufacturers. Life...supplemented is managed and funded through the CRN Foundation the 501(c)(3) educational affiliate of CRN. 1996 The White House Commission on Dietary Supplement Labels issues its report on future regulation of this product category. 1999 D.C. Circuit Court of Appeals handed down its decision in Pearson v. Shalala. A federal appeals court ruled in January that the FDA must allow qualified health claims on supplements--that is claims that include qualifying language to prevent them from being misleading to consumers. 2007 The final GMPs rules specific to dietary supplements are published. CRN launches its consumer wellness campaign Life...supplemented with the support of dietary supplement ingredient suppliers and product manufacturers. The multi-year multi-million dollar public relations campaign focused on helping individuals create a healthier lifestyle by offering actionable suggestions and educational information about the three pillars of a smart wellness regimen healthy diet supplements and exercise. 2013 Representative Ed Markey and Senators Richard Durbin and Richard Blumenthal release a report they state shows inconsistencies in the labeling and classification of energy drinks. Senator Barbara Boxer and Congressman Peter DeFazio introduced the Genetically Engineered Food Rightto-Know Act. Scientists at NSF International and the U.S. Army Research Institute of Environmental Medicine publish a research paper confirming that 1 3 dimethylamylamine (DMAA) is not present in geranium and pelargonium. 2000 FDA s final rule on structure function claims. Seen in general as a victory for the supplement industry the FDA increased the number of claims that could be made for supplements and narrowed its definition of disease rather than broadening it as the agency originally had intended. 2001-2002 Following the 9 11 terrorist attacks internet marketers and a few branded manufacturers touted supplements as remedies for bioterrorism. A coalition of industry groups issued a statement warning members to refuse to stock or sell products that were presented as anthrax treatments. 2008 On April 17 the FDA receives a Citizen Petition from a pharmaceutical company demanding that all weight-loss support claims be re-classified as disease claims which was strongly condemned by consumers and natural products industry organizations. A three-year rollout of the Federal cGMPs (current GMPs) for dietary supplements begins. 2014 Pom Wonderful vs. Coke Even with FDA-compliant labeling companies can still be sued for false advertising under the Lanham Act. Senator Tom Harkin announces retirement. Dr. Oz testifies scolded by congress over natural weight-loss aid claims. GMO labeling debated state by state. Dr. Daniel Fabricant leaves dietary supplement role at Food and Drug Administration to return to Natural Products Association. NIE 2002 FDA issued a draft of proposed GMPs for dietary supplements. FDA finalized the mandate of Pearson v. Shalala that would allow qualified health claims on foods as well as supplements. Fish oil supplements garner serious consumer interest after the American Heart Association s scientific statement 42 Nutrition Industry Executive 2010 NPA (The Natural Products Association) announces that more than 300 natural personal care products have been certified through its two-year-old natural standard certification program. Dietary supplement companies of all Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 ProductionLine Test By Lisa Schofield Passing the NQA QC testing continues to evolve. E very second of the day someone is consuming a dietary supplement whether in pill form beverage chew etc. Consumers automatically take two things on faith--that the supplement will work as the label claims and that it is safe it won t make them sick. As new ingredients are being launched and others are refined or combined this increasing ingredient inventory necessitates a wide variety of testing to ensure a host of factors. According to the U.S. Food and Drug Administration s (FDA) cGMP (current good manufacturing practices) interim rule Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled and The rule will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity purity strength and composition. Product quality problems that the rule will help prevent include Dietary supplements that contain ingredients in amounts that are greater than and less than those listed on the label Wrong ingredient(s) Contaminants Foreign material in a dietary supplement container So you can see how crucial it is for your supplier and contract manufacturer to ensure testing facilities operations and processes are up-to-date and are followed literally to the letter of the law. Anurag Pande PhD vice president of scientific affairs with Sabinsa Corporation in New Jersey emphasized Testing is a crucial component of GMP compliance and providing consumers with safe and effective products which is the ultimate goal. If a facility does not have a well-designed testing lab with well-trained personnel manufacturers can build the delay needed for third-party testing (and they need to make sure it s a very good lab) into the production schedule. Is inhouse more efficient Absolutely. But every manufacturer must put emphasis of solid testing practices no matter where it s done. Analytical capability Pande believes serves as the backbone of product quality. The role of analytical testing is not limited to quality analysis of finished product but it starts right from the selection of the raw material hence in-house testing capability is important in order to provide a good quality material. Although many manufacturers operate compliant testing labs there is growing reliability on third-party testing as well. Joseph E. Mitchell Jr. PhD senior vice president corporate quality with New Jersey-based Pharmachem Laboratories Inc. said he believes that when possible it s best to utilize a contract manufacturer that has qualified cGMP laboratory testing instead. The use of third-party laboratories is fairly common in the industry he said. These labs are frequently chosen for several reasons for smaller manufacturers brand marketers that do not have any in-house testing capabilities to avoid purchase of expensive analytical equipment that is needed for only a few sample analyzed infrequently and or for short-term use to handle significant workload caused by increased customer demands. The use of these laboratories however is generally more expensive then in-house testing he noted. Additionally support of production may be delayed due to routine turnaround time. Expedited samples may double the routine costs normally incurred. Further methods used by third-party labs are generally not verified for the submitted sample matrix which can lead to inaccurate results. Pande agreed noting that a thirdparty or outsourced testing lab can not only delay the qualification process for raw material but also the finished goods. Further in absence of robust in-house analytical testing facilities Nutrition Industry Executive 43 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 ProductionLine production may not be able to put sufficient check points at critical steps of the processes leading to failure of batches. An in-house analytical laboratory has a significant role in processing raw materials through finished goods. Raw materials especially of botanical origin undergoes identification testing and then raw material needs to be tested for actives residual pesticide heavy metal and microbial contaminants before it can be qualified for further processing. Once in production each processing step is qualified as complete only after successful analytical tests. All these processes are critically analyzed using the analytical tools. Deviations at any stage may affect the quality of the finished product he described. And those that are dedicated to the industry would have the knowledge of the process the materials and at what point any material should be rejected. specifically formulations--can represent significant challenges. The use of HPTLC TLC ICPMS and more sophisticated HPLC equipment is now a must he said. the biggest challenge. The use of HPTLC and TLC has long replaced the FTIR test for identity required by GMPs. The use of authenticated botanical reference standards (BRM) and specific country of origin plant part and species are required. Economic adulteration has been reported for many botanical materials. If information is available for specific adulterants testing for these contaminates is now a must he reported. Failures do occur for whatever reason. When a material fails to meet an established specification Mitchell said it is required that the failure be subject to a very specific out of specification (OOS) investigation to determine the root cause and eliminate testing into compliance. As testing continues to evolve there are new analytics that are exciting. Recently said Pande Sabinsa acquired LC-MS MS and GCMS MS to estimate pesticide residues residual solvents and other impurities in herbal raw materials as well as finished products. Using the latest model of LC-MS MS Sabinsa was able to authenticate its enzyme product (Digezyme) to be free from chloramphenicol contamination. Comparable work is in progress for method development for analyzing other contaminants such as ochratoxin aflatoxins and other naturally occurring toxins in plant raw materials he reported. Similarly we developed the methods for estimating Poly aromatic hydrocarbons (PAH) in the raw materials using the latest model of GCMS MS. For Mitchell at Pharmachem Laboratories Using UPLC UFLC with a new ELSD (evaporative light scattering detector) one can analyze compound ingredients without derivatization for amino acids many carbohydrates and those where UV detection is not applicable. This results in time and cost savings and replaces the refractive index detector. Of course Sabinsa and Pharmachem are only two of many suppliers and contract manufacturers that are deeply engaged in QA QC analytical testing. When launching or reformulating with new ingredients or improved ingredients always ask about how the ingredient and final formula is qualified for safe human consumption and meets your desired label claims. NIE Keeping Up With Demands Sabinsa s analytical labs are capable of performing not only the routine testing procedures for quality control but also serve as analytical R&D according to Pande. Its analytical R&D lab is capable of identifying isolating and characterization of new chemical entities identifying and quantifying the active components of raw materials derived from nature. Plant extracts are frequently complicated and require analysis of active compounds present in a complex matrix which demands a robust analytical system using modern hyphenated techniques such as HPLCMS (high pressure liquid chromatography-mass chromatography). In the last few years keeping in pace with the developing technology and emerging knowledge about natural products we have invested heavily in increasing analytical capabilities and continuous training of our analytical team to provide top quality extracts that marketers and their consumers expect from today s marketplace. Testing procedures for materials and formulations are not static they evolve and often do so to overcome challenges that may be present. One example is Sabinsa s R&D and analytical R&D have worked together to unravel an age-old myth of Saberry. Indian gooseberry (Saberry) is one of the oldest fruits used in ayurvedic formulas like triphala. Pande explained that earlier studies suggested it to be very rich in vitamin C which thus became used as the marker compound. Scientists at Sabinsa investigated the fruits from various sources and found that vitamin C may not be the predominant active constituent. During related investigational work Sabinsa s team using medium pressure liquid chromatography was able to isolate fractions showing maximum antioxidant potential these fractions were later studied for the active constituents. The isolated compounds were identified using advanced spectroscopic techniques such as LCMS MS and NMR as beta glucogallin and mucic acid gallate unique compounds occurring in Indian gooseberry fruits. Botanicals Mitchell agreed represent Testing in House On the flip side Mitchell said there are several benefits of in-house testing the costs are generally lower the lab analysts are aware of production demands and familiar with in-house verified methods that have been developed for specific formulations and respective matrices and these analysts as employees have an ownership philosophy versus those at a third-party lab. And Mitchell warned as a brand marketer you are ultimately responsible for the quality of the product for sale. He explained that from a compliance perspective third-party labs are considered an extension of the manufacturer submitting samples and therefore they must to be viewed and treated as an internal laboratory. The company submitting the samples inherits the responsibility for qualifying any third-party laboratory for the sample it submits. Robust industry growth characterized by new materials new companies and new loyal consumers creates the need for in-house labs to evolve and keep up. Into this mix said Mitchell is the increasing regulatory scrutiny of the FDA as the result of Part III GMPs. We are finding that the technical competence of our customers is also continuing to increase he observed. Additionally the once-common practice of relying only on COAs is now no longer allowable and COAs are required to be verified via testing. Testing of ingredients--and more 44 Nutrition Industry Executive FORMOREINFORMATION Pharmachem (800) 526-0609 Sabinsa (732) 777-1111 Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 MarketingInnovations Fostering Customer Loyalty for Long-Term Growth B Y T O D D PA U L I PA R T N E R S T R AT E G I C M A R K E T I N G T H E S H E LT O N G R O U P C ustomer loyalty every company needs it for growth and long-term sustainability but some are better than others at earning it. Let s examine what it is and the best ways to obtain and nurture that loyalty. Customer loyalty is part logic and part emotion. A customer s ability to logically evaluate product quality and value is the first factor in growing a long-term relationship while treating them well and providing a reason for customers to believe in your brand goes a long way in establishing an emotional connection with customers. Consumer-facing brands work hard to appeal emotionally to consumers and examples of their efforts can be seen across television print ads and through social media. While it may seem difficult to establish an emotional connection with customers purchasing your ingredients or considering stocking your finished products it s not as tough as you may think. Companies that convey honesty and a deep connection to their products and the manner in which those products are produced drive customer loyalty on an emotional level no matter what type of products they sell or in what channel. mote a product build a brand and entice customers to take notice come after the countless hours of work that go into making a great product. Whether you make finished goods or ingredients the process used to produce a product that simply performs as promised is the most important element in building a loyal customer base. No matter what your marketing strategy entails customers won t return if they re unsatisfied with the quality of a product. Customers aren t surprised or impressed that a product works. They expect it. In fact gaps in product quality can lead to the antithesis of customer loyalty compelling one-time customers to share their bad experiences very publically. The hard work that goes into producing safe and effective products consistently becomes the foundation of your customer loyalty program and ultimately the most important reason your customers will return to your brand despite a highly competitive marketplace. ity-driven purchase customers are willing to compromise on many other product aspects even quality to chase the cheaper alternative. Price is just one factor in a purchase decision especially in the nutrition industry where effectiveness and safety play such a critical role. In terms of building customer loyalty it is often the non-price driven factors that make the difference in maintaining existing customers. Trust Leads to Loyalty While offering a safe effective product is the first step in building customer loyalty finding ways to build a deeper connection between your customers and your brand will build the emotional connections necessary to foster long-term brand loyalty. Customers who appreciate a product s quality are more likely to suggest the product when they are asked for input but true brand advocates the people who actively spread the word about a great brand because they re genuinely enthusiastic about it usually connect with the brand on a deeper level. They are the customers who bring up your product in conversation with colleagues not because they were asked for their opinion but because they feel good about being connected with the brand. A great example of a company actively Nutrition Industry Executive 45 Price Doesn t Create Loyalty While being price competitive is important don t expect to build long-term customer relationships by being the most inexpensive offering available. Price-based purchasing is primarily transactional with customers viewing products as commodities. In a commod- Loyalty Starts With Product All the extra things you may do to pro- January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 MarketingInnovations building brand advocates is Zappos the popular online shoe retailer. The now legendary customer service approach adopted by Zappos requires all new employees to spend time answering customer calls to gain a true understanding that every position in the company is ultimately in support of its customers. Its policies make it easy for customers to order several products to try on at home and return what they don t want without a high price. Easily accessible reviews help shoppers make informed purchasing decisions. The company also surprises customers with upgraded next-day delivery from time to time. This customer-centric approach has made them the go-to website for many online shoppers and a website its customers are quick to recommend to their friends and their friends online. Zappos builds loyalty by making it easy and pleasant to buy from them and that s something every kind of business can do. The entire experience builds loyal customers who actively promote the brand. The aspects of your brand that will help make customers feel great about doing business with you often go back directly to your company s mission statement and the very reason the brand was created in the first place. Providing customers with an inside look at how products are produced and what principles guide the business helps build trust and ultimately loyalty. We all know that loyalty is important to retain customers especially in the midst of a competitive environment. Putting in the extra effort to consistently provide great products and to finding ways to build an emotional connection with customers takes work but the result are customer relationships that endure. business meetings still exist despite a myriad of other cost-saving ways to meet including Skype email and screen-sharing software like Join.me. Inperson meetings facilitate a connection and resulting bond that goes deeper than online alternatives. While it s impossible to meet every visitor that comes to your website you can tell your story in an engaging way that aspires to offer more than just product information. Your website should clearly convey your company s mission and the care that goes into serving customers. Your story should also provide customers a peek at your production process and the quality measures taken to ensure effective finished goods and pure ingredients. Remember an effective story engages its audience and keeps their attention. Look to short video clips or graphics-driven methods to tell your story to get the attention of your audience. A short video is a good example of a story telling device that can be produced once and used on your website at tradeshows and in email marketing campaigns. Yes you can make your cGMP (current good manufacturing practice) compliance interesting and even entertaining The purpose of telling your story is to ultimately demonstrate that the care put into your products and the support you provide will help customers succeed. 2. Use Email to Build a Loyal Customer Community Loyalty means communication beyond that required during a purchase cycle. As you make contact with customers and prospects begin building an email list and use it to reconnect with information your list finds useful. Helpful information is a world apart from advertising or spam. Since you are already thinking constantly about customer needs reaching out on a regular basis with the intention of helping your customers demonstrates an understanding of their business and a willingness to help them succeed. Emails to customers can highlight industry best practices and showcase some of your best clients. If your products are sold directly to retailers product training information and ideas to help promote your products to retail customers are especially effective. You can also use your emails to frame industry issues and provide a perspective to help your customers understand new developments. If done correctly the emails will demonstrate your industry expertise become a valuable knowledge resource for customers and keep your company top of mind among your clients. As valuable as this information may be to your customers growing a loyal community through email marketing also requires incentives. Rewarding your customers occasionally with an exclusive product discount or an industry-related drawing or giveaway like a free pass to a popular tradeshow event will keep your email community engaged. 3. Listen to Customer Feedback and Act Perhaps the most important factor in maintaining customer loyalty is listening to customer needs. Every company should strive to listen and act accordingly when a customer approaches with a complaint or an issue that needs resolution. The opportunity to build loyalty lies in actively approaching customers to solicit feedback and improve processes. Having an open dialogue with customers and taking real steps to evolve your business based on feedback goes a long way in deepening the customer relationship. Gathering feedback starts with being focused on your customer s idea of success. Companies selling ingredients or services to finished goods manufacturers can schedule check-ins at regular times to align goals and think about the partnership on a long-term level. Finished goods manufacturer s can use their email list and sales force to contact retailers and build a list of initiatives that will help stores sell more units. Growing customer loyalty is ultimately about partnership and mutual success. Customers who engage with their suppliers beyond price and product specifications come to see the supplier as a provider of safe effective products as well as a resource to help them succeed. NIE Todd Pauli works with clients in the natural products industry to develop comprehensive marketing strategies that integrate social media advertising and content marketing. Prior to joining The Shelton Group Pauli led marketing communications efforts for several well-known businesses including NOW Foods one of the largest supplement manufacturers in the natural channel. He has 15 years of experience in helping businesses develop digitally focused marketing strategies. The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Customer Loyalty in Practice In a business-to-business environment building brand trust and prompting your customers to establish an emotional connection to your brand is not so much about launching fancy advertising campaigns and influencing customer opinion across social media as it is with consumer brands. Fostering customer loyalty in our industry is more about being transparent and helping customers. A straightforward approach to showing customers why they can believe in your products and going the extra mile to help them succeed as part of the relationship will go a long way in establishing trust and loyalty. Three Ways to Create Loyal Customers 1. Tell Your Story There is a reason why face-to-face 46 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 FunctionalFoods Marine Fortifications As with supplements quality stability flavor and digestibility remain among the top concerns when it comes to marine nutraceuticals for foods. B Y S H A R I B A R B A N E L T he ocean covers approximately 70 percent of the earth s surface but much of it is still a mystery. What we do know is that marine ingredients offer a number of health benefits. According to Chong Lee a University of Rhode Island researcher and professor emeritus of food sciences while nutraceuticals provide health benefits above and beyond traditional nutrients the nutraceutical market is dominated by terrestrial sources like cranberries that provide antioxidants he said. Marine nutraceuticals are something new and now they are getting a lot more attention. I think most people feel a natural affinity for the ocean and marine ingredients--most consumers know and or perceive that healthy benefits from fish seaweeds and especially omega products which creates a halo effect and a positive impact that spills over into botanical and or nutraceutical ingredients that are of marine origin said Maider Gutierrez marketing manager for Frutarom Health (Haifa Israel). Marine nutraceuticals have been a part of the company s program for about a decade. Marine nutraceuticals provide potent health benefits. Recent research has shown that health conscious people have begun to understand the health benefits they may derive from consuming marine nutraceuticals especially chondroitin sulphate fucoidan and astaxanthin all which support a healthy lifestyle added Carol Cheow general manager of California-based Cactus Botanics. This is why from our point of view both fucoidan and astaxanthin can occupy segments of the dietary supplement market for quite a while notably because research into these ingredients is growing. Cactus Botanics offers high-quality chondroitin sulphate from marine sources as well as shark powder for joint support. The company also provides omega-3 powder extracted from algae as well as fucoidan and astaxanthin. The most successful and innovative marine nutraceuticals Cactus Botanics provides are fucoidan and astaxanthin Cheow noted. Our fucoidan is extracted from kombu which contains more fucoidan than other types of seaweed. And our astaxanthin exists abundantly in algae and it also can be obtained by fermentation. While the market for marine nutraceuticals is still growing the essential fatty acids (EFA) category slowed after a July 2013 study published in the Journal of the National Cancer Institute linked omega-3s to prostate cancer. It is no secret that the EFA category saw some softening this year but we believe that this is not the long-term direction and are looking to stronger sales in 2015 said April Lewton category director-- lipids for Nutegrity in California. Our company in particular is committed to this category and fully believe in not only what we are doing but the science that drives this category and the marketing companies that have a vested interest in seeing fish oil succeed long term. We work closely with our partners to develop their lines and garner more share. According to Becky Wright marketing director for Washington-based Aker BioMarine Antarctic US globally most consumers are deficient in omega-3s particularly EPA and DHA. And because the body can t produce EFAs on its own it must be obtained through food sources and supplementation. This among a number of other reasons is why the EFA category is bound to bounce back. The omega-3 category is gaining more momentum. Sales are on the rise partly due to a new omega-3 campaign initiated by GOED and industry partners she said. As consumers continue to demand new delivery methods and options the omega-3 market will have to continue to evolve. Broadening Usage Beyond dietary supplements marine nutraceutical ingredients are being incorporated into functional foods. For instance while some people do not enjoy the taste of fish foods such as cereal pasta and oatmeal have been fortified with EFAs to help ensure that people get the required amount in their diet. According to Gutierrez fish oil in a powder form Nutrition Industry Executive 47 January February 2015 www.niemagazine.com Celebrating 20 Years of Excellence 1995-2015 FunctionalFoods provides a novel way to incorporate the benefits into a wider variety of products. Sea-derived ingredients for both beauty from within as well as for cosmetic products have been and will continue to grow as market segments he said. And as consumers look for different delivery methods in the market companies are working on new formulations. To that end Aker BioMarine Antarctic US now offers a Superba Krill oil gummy bear product that provides the same omega-3 dose in a single serving as a traditional capsule of krill oil. Krill contains mostly phospholipidbound omega-3s which is a key differentiator when you compare it to triglyceride-bound omega-3s such as those found in fish oil said Wright. Phospholipid-bound omega-3s are immediately incorporated into cell membranes and delivered to the places in the body where they are needed most (i.e. heart brain joints). Triglyceride-bound omega-3s on the other hand have to be converted in the liver before they are available to the body s cells and then distributed to key tissues and organs in the body. Challenges & Concerns While the category continues to grow and change major concerns remain-- scent flavor and digestibility--especially when it comes to functional foods. According to Gutierrez a fishy smell or flavor will always be a turn off no matter how good the ingredient is. Deodorized omega oils and powders are very popular since they are easier ingredients to incorporate into a finished product and have less concern about odor and taste he explained. Beyond the taste scent and flavor issues there are a number of other challenges that suppliers and manufacturers must consider when it comes to marine nutraceuticals with quality credibility sustainability and efficacy at the top of many lists. The EFA category is impacted by some of the same macrotrends that are seen throughout the industry. Consumers are concerned about taste convenience sustainability non-GMO (genetically modified organism) and the source of their food among other things said Nutegrity s Lewton. Consumers are more knowledgeable than ever with regard to choosing which product is right for them and their families. The decision process involves wanting a product that is not only great tasting and an easy way for to get their omega3s but one that they feel good about purchasing without concerns of quality or sustainability. Frutarom s Gutierrez explained that quality can be addressed with careful harvest processing and competent laboratory work while efficacy should be supported with clinical data. While in-vitro data is useful products supported by human clin- ical studies along with safety and tolerance data will typically gain the most traction with customers he said. Human clinical studies to demonstrate efficacy and safety are almost required at this point. Companies and their customers are more savvy than ever and there needs to be strong points of differentiation in a crowded market. Wright agreed that sustainability is a major concern in the marine omega-3 market adding that Aker Biomarine addresses the issue in several ways including third part research environmental partnerships and technological developments. In terms of research we ve partnered with several outside institutions to monitor the krill biomass in the Southern Ocean and investigate the animal populations that depend on krill as a food source she said. As far as partnerships go we have a close relationship with the World Wildlife Fund for Nature (WWFNorway) which helps us establish best practices and go above and beyond traditional sustainability requirements. Lastly we have developed an eco-friendly harvesting technology (e.g. Eco-Harvesting) which helps us minimize environmental impact and eliminate by-catch. Last but not least this gentle harvesting method helps us protect the nutritional integrity of the krill. And as suppliers and manufacturers look to expand the category it is imperative that they remember that consumers rely on them to produce only reliable quality products. As an industry we must do everything we can to keep the high manufacturing standards expected of us. There is nothing more important than consistently producing quality material which is safe for consumption concluded Lewton. For omega-3s that starts with the manufacturer and ends with the brand on the shelf. We must be good stewards for the category as a whole and we have come a long way in defining what the quality standards should be globally via various industry and governmental bodies. NIE FORMOREINFORMATION Aker BioMarine Antartic US (206) 855-6736 Cactus Botanics (562) 219-2167 Frutarom North America (201) 861-9500 Nutegrity (888) 992-9839 48 Nutrition Industry Executive Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Advertiser Index American Laboratories Inc. Herbally Yours Jiaherb Inc. Kyowa Hakko Lonza Inc. Novel Ingredient Srvcs GC Rieber Now Foods PL Nutraceutix Inc. Nutritional Engineering Inc. PLT Health Solutions Inc. Sabinsa Corporation Soma Labs Inc. 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Over the past 26 years this science-based ingredient producer has brought to market more than 100 standardized botanical extracts and privately funded clinical studies in conjunction with prestigious institutions in support of these products. With more than 100 full-time scientists conducting ongoing research in India and the United States Sabinsa and sister company Sami Labs Ltd. continue to develop patent and manufacture phytonutrients for the world market. All products intended for human consumption are certified kosher and halal. Shaheen Majeed knows Sabinsa from the ground up. Son of the company s founder when he was just 17 years old he began working in the warehouse. Now he is helping to spearhead the company s expansion of its functional foods offerings while being actively involved in Sabinsa s extensive cultivation program interacting with farmers to ensure sustainability of quality raw materials from which Sabinsa manufactures the company s high quality proprietary ingredients. Here Majeed discusses the company s most recent endeavors. Shaheen Majeed NIE Sabinsa recently announced the formation of a new division focused on animal nutrition called Vetvitals. Why did the company decide to venture into animal nutrition Majeed We see our products contributing to improved health in many different ways. While every ingredient we have manufactured patented and commercialized has been focused on human health care we could not ignore the science on our ingredients and the benefits it could give to our pets. After a few years of research and part of 2014 dedicated to understanding the animal nutrition regulatory environment we decided to launch VetVitals to offer the science and innovation that only our ingredients could bring to market. The animal nutrition sector is one that is dear to many people and knows that people who consume supplements to better their lives would ultimately want the same for their pets. We see a major gap in how people offer nutrition to their beloved pets and what is available to those pets from manufacturers we want to bring added value to this segment and we feel our clinically backed ingredients can make a difference. NIE Research and development seem to be of major importance to Sabinsa. Talk about some of the company s recent studies about Curcumin 50 Nutrition Industry Executive C3 Complex and Bioperine. Majeed This has been a really exciting time especially when it comes to this combination. The Batman and Robin of joint-care supplements Curcumin C3 Complex and BioPerine have inspired us this year with two focused studies on osteoarthritis using this combination. Researchers at the University of Medical Sciences Mashhad Iran conducted the studies and their conclusion states curcuminoids can effectively reduce the symptoms of osteoarthritis (OA). A significant takeaway from the studies also has to do with how OA is more like a condition associated with local rather than systemic inflammation--our combination positively showed results in improvement. Another notable study was the effect C3 Complex plus BioPerine had on metabolic syndrome. The study results showed significantly greater effect of curcuminoids in reducing the serum concentrations of LDL-C non-HDL-C total cholesterol triglycerides and Lp(a) in comparison to the placebo group. This research indicates additional benefits of curcumin beyond inflammation giving increased value to C3 Complex as the body of science grows. Once again the C3 Complex and BioPerine combination has been shown to be a safe and effective supplement blend that can help keep people healthy. All studies carried the gold standard of being double-blind placebo-controlled either in parallel groups or randomized with the number of trial subjects ranging from 40 to over 100. We re excited for more research coming out soon on our combinations which can offer consumers real efficacious and safe benefits. NIE Sabinsa s sister company Sami Labs Ltd. recently acquired KCP Biotech. What was the purpose of this acquisition Majeed The timing of this purchase is in line with our growth strategy as we progress further into the biotech world. While the purchase gives us land for future expansion as we continue our robust growth the facility has equipment we can use right away with few modifications for our existing line of products which helps increase our productivity outflow. In addition the colors market has been one that we have been eyeing for some time. Though in the past Sabinsa has supplied colors this will help strengthen our portfolio of natural colors coming from ingredients that we re already extracting from for nutritional and cosmeceutical benefits. Extra Extra Visit www.niemagazine.com to read the rest of the interview. Celebrating 20 Years of Excellence 1995-2015 www.niemagazine.com January February 2015 Go to niemagazine.com usp for info about this advertiser