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Description: In This Issue: Supplements & Food Safety, Weight Management, Functional Food & Beverages, and Content Marketing Opportunities

VI S SO IT UR OU em ag CE R O az ine BO NL .co OK IN A VRM Media Publication E m so AT u ww w. ni rc eb oo k June 2016 Go to sabinsa for info about this advertiser Go to healthco for info about this advertiser TableofContents Proud Supporter of VOLUME 21 NO. 5 JUNE2016 F E A T U R E S 28 Winning the Losing Battle Weight gain and subsequent loss is not a one-size-fits-all solution. Here s how to formulate for specific reasons why individuals want to slim down. 32 Perfecting Functional Foods and Beverages Consumer expectations for cleaner healthier and tastier products are changing the category. 28 A L S O I N S I D E 38 Supplements and Food Safety As the food industry lurches from scare to scare the dietary supplement industry waits for the dust to settle on the FSMA and maybe thinks it s time to feel good about itself. C O L U M N S 12 19 24 25 26 27 47 51 51 52 Industry News Ingredient News Ingredient Marketplace Wrap-up AHPA Update Association News Science Update Conventions & Meetings Advertiser Index Industry Events Contract Manufacturer of the Month 4 First Word 6 Condition Specific 43 Functional Foods 48 Marketing Innovation 6 FREE Subscription (Print Digital or BOTH) & E-newsletter Available Copyright 2016. Nutrition Industry Executive (ISSN 2331-2602) Volume 21 Number 5 June 2016. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 4329288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Periodicals Postage Paid at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues & Single Copies For order information contact (732) 432-9600 or info March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive June 2016 Go to plt for info about this advertiser FirstWord The New Supplement Product Registry n April the Council for Responsible Nutrition (CRN) announced its Board had unanimously authorized the creation of an industrywide dietary supplement product registry to be launched by the end of the year. The registry will be developed and managed by a third-party vendor (see news item on page 26). In a phone conversation I asked Steve Mister CRN s president and CEO about the initiation of the database and how it would help retailers and the industry overall. He explained that CRN s members were looking for what they could do as an industry to gain transparency for regulators and consumers and provide a way for people to learn about the products they are buying and to evaluate them and perhaps steer clear of products that are not being completely transparent about what s in the product or where the product is made. That was the genesis of this Mister said. Initially we looked at the Office of Dietary Supplement (ODS)-- the National Institutes of Health has a database of supplement labels. We are now requiring our members to participate in that but we really felt that it didn t go far enough. So the best thing to do was to create a separate registry for the industry overseen by the industry. The ODS database doesn t indicate whether a product is still on the market and only provides limited product information. The new registry he explained will consist of two parts The first will provide basic information about a product. The second tier will allow users to obtain more product information on ingredients NDIs (new I dietary ingredients) structure function claims certification and information about the facility where the product is made. CRN is making the initial investment on behalf of the industry to get the database up and running. Providing information for tier one will be free to the industry and CRN is strongly encouraging all marketers in the space to put their labels in an annual fee will be required to supply information for tier two. I do think down the road that the FDA (U.S. Food and Drug Administration) will make registration some kind of requirement of the industry. If that happens they may take over this database. Publisher Daniel McSweeney Editorial Director DanM Associate Russ Fields Publisher RussF Advertising Gary Pfaff Sales Manager GaryP Editor-in-Chief Janet Poveromo JanetP Managing Editor Shari Barbanel ShariB Assistant Editor Corinne Anderson CorinneA Contributing Writers James Gormley Todd Pauli Lisa Schofield Art Director Robert Certo Production Manager RobertC Production Assistant Bryan Zak Graphic Designer BryanZ Circulation Manager Rosie Brodsky Rosie A Problem Solver The database in and of itself doesn t solve all industry woes Mister said but it creates a platform by which we can address issues because it pulls everybody into the like and says these are the kinds of companies that are out there selling products ... One of the aspects of tier two is whether you had an FDA inspection and whether you have a third-party certify that you re GMP (good manufacturing practice) compliant. I think having that helps FDA target companies that are not being transparent. As for retailers Mister said they were on the hook with last year s attorney general actions. So I think retailers are now looking for ways to ensure that the products on their shelves have quality behind them. One way to find out is to see who is in the industry and what s in products. So [the database] starts to answer those questions and I think retailers should be very excited about having this as an opportunity. 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 Website VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and Fitness Trainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs Back Issues See the Table of Contents page for price and ordering information. Connect With Us vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive June 2016 Go to jiaherb for info about this advertiser ConditionSpecific Consumer education is key to growing the digestive enzymes category. B Y S HARI B ARBANEL et s face it--the standard American diet is not kind to the gastrointestinal (GI) system. And according to the American Nutrition Association approximately 70 million people suffer every day from some form of digestive issues--heartburn acid reflux GERD (gastro esophageal reflex disorder) IBS (irritable bowel syndrome) indigestion constipation diarrhea abdominal pain etc.). To fix their digestive problems consumers often turn to over-the-counter (OTC) proton pump inhibitors (PPIs) such as Nexium or Prilosec. But recent research is showing that PPIs may do more harm than good with two studies published this year linking PPIs to an increased risk for kidney disease and dementia respectively. With reports that these OTC digestive aids are harmful to their health people are often looking for natural options to aid their digestion woes. Enter digestive enzymes. Enzyme supplements continue to gain recognition among consumers for their role in digestive health and bioavailability of nutrients from foods said Scott Ravech CEO of Georgia-based Deerland Enzymes. The ability to break down food into its basic and useful components is of critical concern for consumers interested in functional nutrition for L growth development and supporting healthy aging. Education is the Key When it comes to dietary supplementation those who are truly health conscious educate themselves about what is available and are early adopters. But it can take time for much of the general public to catch on. Our most recent Natural Marketing Institute s Supplement Over-the-counter and Rx Database survey (SORD December 2015) showed that approximately 5.7 percent of those who take supplements consume digestive enzymes said Missy Lowery MS senior manager marketing for Capsugel in South Carolina. That compares with 15 percent for probiotics. We think that as consumers better understand the benefits of the different enzymes the market will grow. The SORD study showed heavy users of dietary supplements report a 15 percent use for the category and interestingly Boomers report 5.9 percent and Millennials report 6.9 percent use. According to Lowery there is little mainstream consumer awareness of the role enzymes play in the digestive process or of their key use in the control and regulation of various intracellular processes. She added that in order to build consumer confidence in digestive enzymes they need to be effective. Consumers are always looking for the latest trends no matter the category of the product. The same goes with digestive enzymes added Amanda Brown sales representative for Nebraska-based American Laboratories Inc. (ALI). More and more people are focusing on products that actually work leading to repeat buyers and particular product lines growing. Benefits Digestive enzymes aid in the absorption of nutrients and assist in the breaking down of food particles so they are beneficial for just about anyone to take. Digestive enzymes are very effective for digestion due to the wide range of optimum pH values and the variety of applications for each specific enzyme explained Brown. Digestion occurs at different points in the body and at different temperatures and pHs. The mouth is the first point of digestion where naturally occurring amylase is secreted to help with the initial breakdown of food. Once food reaches the gastric juice in the stomach an enzyme is needed to withstand the low pH range to continue June 2016 6 Nutrition Industry Executive Go to specialtyenzymes for info about this advertiser ConditionSpecific working further along the digestive track. This is where pepsin or an acid stable protease comes into play. According to Brown Pepsin is able to work in low pH environments and hydrolyze proteins even after the harsh environments of the stomach environment. The end consumer would find these enzymes particularly beneficial in a digestive product. Brown noted that pancreatin and pepsin have been the most successful digestive enzymes for the company. Both are manufactured in our facility in Omaha NE for 50 years with USAsourced starting material. They are allencompassing digestive products that work great by themselves or with other enzymes added she said. They are both naturally occurring enzymes secreted from porcine pancreas similar to the enzymes secreted in the human body. By adding these to a normal diet you are intensifying what your body is already producing to ease overall digestion. In addition ALI offers Panc-Zyme a digestive enzyme complex consisting of protease amylase lipase trypsin and chymotrypsin. According to Brown PancZyme is a systemic digestion formulation that has gained popularity over the last year. While digestive enzymes are useful for everyone people that eat a vegan or vegetarian diet can especially benefit from digestive enzymes. Ravech noted that because the body does not produce cellulase at all (an enzyme that breaks down the cell wall of plants releasing the nutrients for our bodies to absorb) people who follow a vegetarian or vegan diet are likely missing out on key nutrients from the plant-based foods they re eating and would most certainly benefit from an enzyme supplement. In addition to those on plant-based diets the number of people with intolerances to wheat dairy and gluten (among others) continues to increase. According to the Center for Celiac Research and Treatment 18 million Americans believe they have difficulty digesting gluten while the American Gastroenterological Association said that 50 million people report discomfort due to ingestion of dairy products. Maximizing digestion of proteins helps to support overall health and wellness and enzyme-based solutions can help Ravech said. To address the growing demand for products that address food sensitivities Deerland Enzymes latest products Glutalytic and Dairylytic have been designed to optimize digestion of gluten and dairy proteins. These enzyme-based products hydrolyze wheat and dairy proteins and break them down into smaller protein constituents so they can be more easily managed by the body. Glutalytic helps minimize the unintended consequences of inadvertent gluten consumption and is supported by a human clinical study he continued. Dairylytic works to help break down not only the lactose associated with dairy foods but also the proteins that can be difficult to digest and may cause discomfort to sensitive individuals. Fewer dietary restrictions can yield huge quality of life benefits. Delivery & Quality When it comes to digestive enzymes delivery is incredibly important. Because of stomach acid the delivery method needs to ensure that the digestive enzymes will not be destroyed before they are utilized properly. Manufacturers Go to americanlaboratories 8 Nutrition Industry Executive Go to somalabs June 2016 Go to texasbestorganics for info about this advertiser ConditionSpecific need to understand that some enzymes and digestive ingredients may be acidsensitive and may be prone to damage in the digestive process before they reach the small intestine said Capsugel s Lowery. These include amalase betaine hydrochloride bromelain enzidase isolase and lipase enzymes. For this timing reason a dosage delivery form that is protective from early activation and targets release of ingredients close to the intestines is critical for enzyme use. To address these issues Capsugel created DRcaps vegetarian capsules with unique acid-resistant polymer properties that slow down the capsule opening after swallowing and protect ingredients from stomach acids. Made of low-moisture hydroxypropyl methylcellulose (HPMC) that helps keep the ingredients stable in the package before ingestion the capsule also disintegrates more slowly than conventional gelatin or HPMC capsules because of the distinctive polymer Lowery explained. This polymer protects the capsule contents from opening in [the] stomach opening only when the pH rises above 6.8--the average pH level of the entry into the intestines. According to Lowery the capsules delay opening without the addition of synthetic chemicals solvents or other coating ingredients to the capsules. Doing away with the coating step can reduce production time and cost for manufacturers and make it easier for our customers to launch products rapidly. It is also appealing to nutritional health companies whose customers often perceive coatings as unnatural. In addition to ensuring that the digestive enzymes that are ingested into the body are able to deliver there is also a demand for clinical validation of ingredients and finished products. The entire supplement industry is going through a time that could be characterized as a clinical revolution in which the demand for clinical validation for dietary supplement products has never been higher Ravech said. Deerland Enzymes branded products are all developed based on numerous studies and testing of the safety and efficacy of the ingredients Ravech pointed out. Further the company s in-house lab not only has the capability to perform in vitro studies but its alliances with nine highly respected universities allow us to conduct clinical trials as well in order to develop science-backed formulations. Brown added that the credibility of the supplier is very important in the marketplace noting that more than 25 percent of ALI s employees consist of regulatory and quality personal which allows the company to provide the highest standard of ingredients as well as any supporting documentation in a timely fashion. With consumer education and a proven track record the possibilities for digestive enzymes seem to be endless. The digestive enzyme category is an ever-changing and growing product line. We only see this market increasing in the coming years due to the diet of consumers concluded Brown. Poor diets and processed foods make digestive enzymes even more important for the overall breakdown and comfort of the consumer. NIE FORMOREINFORMATION Go to comar for info about this advertiser 10 Nutrition Industry Executive American Laboratories Inc. (402) 339-2494 Capsugel (864) 942-3063 Deerland Enzymes (800) 6997-8179 June 2016 THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights September October Nov. Dec. 8 11 16 ad closing 9 7 16 ad closing 10 25 16 ad closing SupplySide West Show Issue Washington and the Natural Industry Supply Innovation Our 2016 Media Planner Is Available At 2016-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 e-Mail RussF Gary Pfaff at 732-432-9600 ext. 103 e-Mail GaryP IndustryNews Blumenthal Withdraws Amendment to Limit Military Access to Supplements S enator Richard Blumenthal (D-CT) withdrew his amendment to the FY 2017 National Defense Authorization Act (NDAA) that would require supplements sold on military bases to be verified by a third-party amid strong opposition by the supplement industry. Enacted on an annual basis by Congress NDAA legislation establishes budget and policy parameters for the Department of Defense. Sen. Blumenthal a member of the Senate Armed Services Committee stated his intention to offer a dietary supplement related amendment to the Senate version of the FY 2017 NDAA during the Committee s consideration of the bill. The Senate Armed Services Committee is marking up the FY 2017 NDAA bill in a closed session. The American Herbal Products Association (AHPA) and Natural Products Association (NPA) have been in active communication with other industry associations and the offices of senators who serve on the Armed Services Committee to voice opposition to the Blumenthal amendment. Because Sen. Blumenthal withdrew the amendment U.S. military personnel won t face unnecessary restrictions that limit their personal and informed choices to use safe dietary supplements. Sen. Blumenthal and Sen. Richard Durbin (D-IL) who are both long-time critics of the federal regulatory structure for dietary supplements introduced a similar amendment last year when the FY 2016 NDAA measure was being considered by the Senate. However the BlumenthalDurbin third-party verifier amendment was never allowed to come to a vote. AHPA and the regulated supplement industry appreciate Sen. Blumenthal withdrawing this amendment said AHPA President Michael McGuffin. Dietary supplement companies are currently required to comply with a host of federal regulations including current good manufacturing practice (cGMP) requirements that ensure the safety and quality of supplements sold in the U.S. This amendment would have created a redundant and expensive burden for companies to sell products on military bases effectively limiting service members access to highquality supplements. We strongly support the rights of our service men and women to have access to safe products that they feel support their fitness goals added Daniel Fabricant PhD executive director and CEO of NPA. Senator Blumenthal has repeatedly sought to deny access to these safe and healthy products from all Americans and it is unfortunate that he appears to be targeting our men and women in service uniforms first. For more information visit or FDA Recognizes Canada as Having a Comparable Food Safety System he U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other s food safety systems as comparable to each other. The arrangement was signed at a meeting of the FDACFIA Health Canada Joint Committee on Food Safety. This is the second time that the FDA has recognized a foreign food safety system as comparable the first being New Zealand in 2012. A similar system recognition process is underway between FDA and Australia and the European Commission. By recognizing each other s systems FDA CFIA and Health Canada have confidence that they can leverage each other s science-based regulatory systems. For example each partner will consider the oversight of the other when prioritizing inspection T activities but the benefits go beyond inspection and admissibility. Systems Recognition establishes a framework for regulatory cooperation in a variety of areas that range from scientific collaboration to outbreak response. Systems recognition involves reviewing a foreign country s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities including foreign facility inspections import field exams and import sampling. The FDA working with the CFIA and Health Canada conducted a systems recognition review and assessment using the International Comparability Assessment Tool (ICAT). The process includes a comprehensive review of key elements of the country s national food safety control system such as its relevant laws and regulations inspection programs response to food-related illness and outbreaks compliance and enforcement and laboratory support. Systems recognition is voluntary and not required in order for a country to export foods to the U.S. For more information visit June 2016 12 Nutrition Industry Executive Industry Urges FDA to Define Natural he American Herbal Products Association (AHPA) submitted comments to the U.S. Food and Drug Administration (FDA) encouraging the agency to establish through rulemaking a regulatory definition for the term natural (and possibly other terms such as 100 percent natural and made with natural [named ingredient(s)] ) for the labeling of human food products and other products regulated by FDA such as animal foods cosmetics and botanical drugs. Consumers seek such a designation on foods and other products and it is important to some consumers purchasing and consumption decisions said AHPA President Michael McGuffin. Creating a regulatory definition of natural and related terms for product labels will help ensure that consumers are not misled by inconsistent or inaccurate uses of this term. T AHPA also suggested that the term (or terms) be allowed on labeling not only on raw agricultural products but also on multi-ingredient and processed foods. AHPA s comments include ideas about how the term natural should be defined and how FDA should enforce any resulting rule. Natural processed food must be derived only from natural ingredients and must be processed in a manner that retains the natural quality of the starting ingredients McGuffin said. Any food manufacturing process that is a traditional food preparation process should be recognized as maintaining the natural quality of the ingredients used to make a multi-ingredient or traditionally processed food. AHPA has also expressed support for FDA s cooperation with USDA (U.S. Department of Agriculture) to ensure consistent use of natural labeling of all foods irrespective of agency jurisdiction and has also recommended that current regulatory definitions of natural flavor June 2016 and natural flavoring be retained. AHPA isn t alone in their quest for a definition for natural. The Natural Products Association (NPA) has also submitted comments asking that the FDA define natural. Natural should mean natural which in our general view is no chemicals no additives and only should involve minimal processing said Daniel Fabricant PhD CEO and executive director of NPA. A national standard is the best most cost-effective and least-confusing way to deliver on this commitment for American consumers. To have hundreds of different state and local requirements would be counterproductive and expensive. NPA welcomes this opportunity to submit comments to FDA and looks forward to reviewing the final guidance from the Agency when it becomes available. FDA should create a regulatory definition of natural that is reasonably consistent with consumers understanding of the term as shown through market research McGuffin added. AHPA s comments also urge FDA to prohibit use of the term natural on labeling of raw agricultural commodities from crops produced with genetic engineering (GE) include in the definition of natural those ingredients derived from crops resulting from traditional hybridization between closely related taxa. Choline Joins the Nutrition Facts Label beneficial but lesser-known nutrient is making its way onto Nutrition Facts labels choline an essential nutrient associated with heart health improved liver function maternal and fetal health child development cognition and sports performance. In the first update to the Nutrition Facts label in 20 years the U.S. Food and Drug Administration (FDA) called for manufacturers to voluntarily label choline paving the way to help Americans look for and include this essential nutrient as part of a balanced healthy lifestyle. In addition for the first time the FDA established a reference daily intake (RDI) for choline of 550 milligrams (mg) per day which was the adequate intake (AI) amount set in 1998 by the Institute of Medicine (now the National Academies of Sciences Engineering and Medicine s Health and Medicine Division). Despite choline s recognized and well-established benefits for health almost 90 percent of Americans are not getting enough choline every day. Choline is perhaps one of the most underrated nutrients yet a large body of evidence supports a range of benefits at all life stages from maternal health and infant nutrition to healthy aging said Marie Caudill PhD RD and professor in nutritional sciences at Cornell University. By using the Nutrition Facts label to check choline amounts in foods Americans will soon be able to look for this essential nutrient and better meet their daily goals. Food sources of choline include eggs beef chicken fish certain seafood toasted wheat germ Brussels sprouts and broccoli. Some multivitamins and prenatal vitamins contain choline and certain packaged foods such as infant formula may be fortified with choline to boost intake. Foods with at least 55 mg of choline per serving are considered a good source of the nutrient. For more information visit A Background On November 12 2015 FDA issued a Federal Register notice soliciting information and comments on use of the term natural in the context of food labeling. FDA explained in the November 12 Notice that it was taking this action in part because it had received three citizen petitions asking it to define the term for use in food labeling and one citizen petition asking for the term to be prohibited on food labels. The November 12 Notice also referenced litigation between private parties in some Federal courts over use of the term and reported that FDA is working with the USDA Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term natural in meat poultry and egg products and is considering areas for coordination between FDA and USDA. For more information visit or Nutrition Industry Executive 13 IndustryNews NPA Works to Repeal Puerto Rico Rule That Limits Access to Supplements he Natural Products Association (NPA) is meeting with members of the House of Representatives to overturn an administrative order issued by the Commonwealth of Puerto Rico s Department of Health that would raise prices for dietary supplement and natural products consumers and adds requirements for retailers distributors inconsistent with federal law. NPA is seeking to attach the provision to the debt relief package for Puerto Rico which Congress is considering. This rule is arbitrary unnecessary and potentially damaging to consumers and economic growth in Puerto Rico. It will drive consumers to the internet for supplement purchases which we know is a haven for counterfeiters and fly-bynight suppliers said Daniel Fabricant PhD NPA CEO and executive director. It will raise prices on the island for vitamins and natural products which hurts consumers and low income people the T hardest. And it will hurt legitimate highquality supplement providers and distributors here in the continental U.S. who will now have to pay a premium to deliver products to meet growing demand. But most of all it is unnecessary because FDA (U.S. Food and Drug Administration) and FTC (Federal Trade Commission) have adequate tools to regulate the industry. On February 9 2016 the Puerto Rican Secretary of Health issued Administrative Order 346 without any notice and comment period which includes a host of costly and onerous requirements The Order imposed a regulatory scheme in Puerto Rico for all distributors of dietary supplements in Puerto Rico. It requires a burdensome productby-product registration per store requiring 25 fee for every variation of a supplement by size color SKU. All manufacturers must likewise file an application and pay an additional 500 fee. Distributors must also register and pay an additional 100 fee. NPA is encouraging members to visit its grassroots website ( and reach out to Congress and tell them to stop Puerto Rico from creating an arbitrary tax on the industry as the relief package is debated. For more information visit InstantGMP Releases Software Update nstantGMP Inc. s (Cary NC) InstantGMP MES v3.0 electronic batch record software has gone through a transformative aesthetic and functionality update that is designed to make GMP (good manufacturing practice) compliance for dietary supplement manufacturers easier. Our work with dietary supplement producers has helped us design a much more user friendly manufacturing system application for them said Dr. Richard Soltero president of InstantGMP Inc. We are dedicated to helping this industry meet the compliance standards of good manufacturing practices and our latest version is a big leap forward in this effort. Version 3.0 features a calming blue look with brand new icons and buttons designed to make the software more intuitive. In addition to the new hues users have much more customizability including being able to favorite a particular module create and save user preferences and resize the screen for maximum work room. InstantGMP MES has also improved its GMPs workflow by improving the ease of use for users. On screen icons alert the user to errors and signals when the necessary prerequisites have been fulfilled when they are making their master production records and their batch production records. For more information visit I Go to hsus for info about this advertiser 14 Nutrition Industry Executive June 2016 Pulmuone Closes Asset Purchase Agreement With Vitasoy USA ulmuone Foods Co. Ltd. (Fullerton CA) has completed the acquisition of substantially all of the assets of Vitasoy USA Inc. which includes the NASOYA AZUMAYA and SAN SUI brands in North America. This acquisition solidifies Pulmuone s position as the world s leading tofu company while strengthening its operations in South Korea U.S. Japan and China the company stated. Pulmuone had previously announced it had entered into an asset purchase agreement to acquire Vitasoy USA Inc. on March 24 2016. This acquisition provides bicoastal production and logistics capabilities as P well as a national sales and distribution platform said H.Y. Lee CEO of Pulmuone Foods Co. Ltd. We are especially excited about expanding the brand beyond the tofu category through our innovative product development and with our multi-channel business base. We look forward to bringing our customers and consumers more healthy and tasty products. The acquired business now known as Nasoya Food USA LLC joins the Pulmuone family of healthy and nutritious brands and will be a part of the company s significant expansion in the U.S. M&A will continue to drive future growth for Pulmuone in North America and globally. Ross Gatta has been appointed to lead the Nasoya Food USA business as CEO. The acquired operations will remain in Ayer MA with significant investments planned to grow the business. For more information visit Capstone Nutrition Announces Successful Recapitalization and Capital Investment apstone Nutrition has announced the completion of a successful recapitalization and significant capital investment to expand its state-of-theart powder manufacturing capabilities and organic product capabilities in its Ogden UT facility. Capstone s recent capital investments in manufacturing technology and equipment have broadened its extensive product offerings enabling the company to better serve its nutritional supplement and sports nutrition customers with industry leading quality research and development and customer service. As a part of Capstone s recapitalization and recent strategic investments the company will consolidate powder production from its Tennessee facility into its Utah facility to service customers more efficiently. This recapitalization reinforces our ability to pursue our long-term strategic growth initiatives. We are excited by our enhanced manufacturing capabilities which will enable us to deliver high quality powders and other nutritional products to our customers said Jared Leishman Capstone Nutrition s CEO. We appreciate the support we have received from our investors Medley Management Inc. and Business Development Corporation of America and look forward to leveraging their long-term vision and continued confidence in us. Capstone s Utah facility is accredited with several of the most demanding nutritional supplement industry standards including TGA NSF GMP (good C manufacturing practice) and NSF for Sport certifications. This commitment to quality together with Capstone s continued investment in its facilities and product offerings makes it a preferred partner for domestic and global customers seeking a trusted contract manufacturer the company stated. For more information visit Go to herballyyours for info about this advertiser Nutrition Industry Executive 15 June 2016 IndustryNews Brassica Protection Products Adopts Broccoli he nonprofit American Botanical Council (ABC) has announced the participation and support of Brassica Protection Products LLC (Baltimore MD) an innovator in the research and development of nutritional ingredients derived from cruciferous vegetables in ABC s Adopt-an-Herb program. Through its adoption of broccoli (Brassica oleracea) Brassica Protection Products is helping ABC keep its unique HerbMedPro database up to date with the latest scientific and clinical research on broccoli and its nutrients. HerbMedPro is a comprehensive interactive online database that provides access to important scientific and clinical research data on the uses and health effects of more than 250 herbs and medicinal plants. For more than 10 years Brassica has been dedicated to delivering consistently high-quality sources of glucoraphanin from broccoli seeds through our truebroc ingredient brand said Tony Talalay CEO of Brassica Protection Products. We are deeply committed to making the exten- T sive health benefits broccoli can deliver to our bodies including long-lasting antioxidant activity and protection against oxidative stress easily accessible for consumers. We re excited to partner with the American Botanical Council to further educate academic and consumer communities about broccoli and its important phytonutrient glucoraphanin which produces sulforaphane in the body. ABC is pleased to partner with Brassica Protection Productions to recognize the fast-growing science on broccoli and to curate decades of scientific and clinical research into HerbMedPro said Mark Blumenthal ABC s founder and executive director. Broccoli is one of the most extensively studied plants. This program will make broccoli research more easily available to health care professionals researchers consumers and industry members who are hungry to learn about this crucifer s compelling health benefits. For more information visit or NOW Achieves Underwriters Laboratory (UL) Certification OW is one of the first companies to be certified by Underwriters Laboratories (UL) for its dietary supplement manufacturing process. The purpose of the UL R National Brand Certification Program (NBCP) is to assess the extent to which an organization conforms to the applicable regulations and or standards regarding the products being manufactured. This is the most recent certification in NOW s history of commitment to quality. The company was one of the first to be GMP (good manufacturing practice) certified when the Natural Products Association (NPA) pioneered GMP certification in 2000. In 2015 NPA partnered with UL to bring the ACLASS ANAB Accreditation to their third-party cGMP certification program. ACLASS ANAB accreditation by the ANSI-ASQ National Accreditation Board demonstrates UL s technical competence as a monitoring body. From sourcing quality ingredients to comprehensive and sophisticated testing throughout the manufacturing process NOW is committed to industry-leading quality said Aaron Secrist NOW s director of QA QC and R&D. While we had no doubt that UL would find us worthy of certification we re pleased to have that confidence validated. Both NOW s Bloomingdale IL and Sparks NV facilities have been audited and certified by UL. Each facility will undergo a surveillance audit annually prior to renewal. The UL seal is well recognized by consumers as indicating a manufacturer s commitment to quality said Jim Emme CEO of NOW Health Group. While we have always been very transparent about the steps we take to ensure product quality having the UL certification symbol on our website and in other marketing materials is an easily recognizable symbol that tells our customers we have been scrutinized and meet high standards. For more information visit or N 16 Nutrition Industry Executive June 2016 Branch Out and Join VRM Media s FAMILY OF PUBLICATIONS Our 2016 Media Planner Is Available At 2016-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at 732-432-9600 ext. 102 or e-Mail RussF Gary Pfaff at 732-432-9600 ext. 103 or e-Mail GaryP IndustryNews You reHired new role Chappuis will be in for the protein product Ganeden (Mayfield Heights charge of leveraging science lines and will drive OH) has promoted Michael and regulation to consoliachievement of busiBush to president of the comdate existing market posiness targets for prodpany. Previously Ganeden s tions and develop innovative ucts sold by the prosenior vice president Bush s concepts for the company. teins business in the new role will allow him to Essential Formulas Americas region. focus on Ganeden s strategic Incorporated (EFI Irving TX) Andernacht s product business development and recently named Brian Craig help manage the company s Michael Bush management experiBrian Craig as its director of strategic ence includes new massive growth both domestiaffairs. Previously the vice president product development launches and cally and internationally. He will also of business development at Xlear continue to oversee sales and market- initiatives as well as cost savings and Inc. Craig will help steer EFI continenhancement initiatives. ing activities while maintaining his ued growth with a focus on building EAS Consulting Group LLC position as a go-to expert source for brand preference initiating integrated media quotes speaking engagements (Alexandria VA) has hired Bryan J. marketing strategies and advising on Coleman as its new senior director and educational opportunities. regulatory matters. pharmaceutical and Kemin (Des Moines IA) has Algatechnologies (Israel) device consulting servadded two new members to has appointed Professor ices. Coleman s addithe protein and grains group Yuval Heled as scientific tion to the senior leadof the Food Technologies advisor in a move that herership team further division. Amanda King has alds the beginning of a new solidifies EAS as the been named technical servicmulti-year science-based leading consulting es manager and Kyle product development stratcompany in regulatory Andernacht has been named egy. As a renowned internamatters pertaining to product manager--proteins. Yuval Heled Amanda King tional expert in clinical all FDA (U.S. Food and As technical services manager exercise and environmental physioloDrug Administration) regulatKing will provide technical gy Heled has more than 20 years ed areas including OTC support to the proteinexperience in clinical research with (over-the-counter) pharmafocused sales team. King has more than 70 publications in peerceuticals cosmetics dietary a wealth of experience in the reviewed journals. His fields of intersupplements foods medical meat industry with a focus on est include exercise physiology therdevices and tobacco. enabling technologies and moregulation nutrition fluid and Olygose (France) has preservation. And as product electrolyte balance sports medicine announced the recruitment of manager--proteins Kyle genetics and performance and Eric Chappuis as senior nutriAndernacht will provide direcAndernacht health education. tion science manager. In his tion vision and optimization 18 Nutrition Industry Executive June 2016 IngredientNews Harmless Harvest New Multi-step Micro-filtration Process alifornia-based Harmless Harvest a Fair-for-Life-certified organic coconut water--announced a proprietary new multi-step microfiltration process that achieves the highest levels of product safety and quality while preserving optimal flavor fragrance and nutrients of its critically acclaimed coconut water which complies with FDA (U.S. Food and Drug Administration) standards and requirements the company stated. C This process builds upon Harmless Harvest s history as an industry pioneer in the low-acid beverage category and enables the company to introduce a new more environmentally conscious bottle with an average of a quarter less plastic than previous bottles the company stated. According to the CEO of Harmless Harvest Giannella Alvarez the introduction of the Multi-Step MicroFiltration process is a significant advancement for the industry. With our move to our proprietary FDA-compliant Multi-Step Micro-Filtration linked to an aseptic filling and packaging system--as with every step we take as a company--it is our goal to drive the industry forward towards better products better practices and more environmentally sustainable business models. For more information visit World Food Processing s PURISPea receives GRAS isconsin-based World Food Processing LLC the only USA-grown and -manufactured pea protein supplier has announced that it received a letter of no objection from the U.S. Food and Drug Administration (FDA) for PurisPea un-hydrolyzed and hydrolyzed pea protein the company said. The letter of no objection confirms that the FDA does not have question for the generally recognized as safe (GRAS) status of pea protein through the basis of scientific procedures. PurisPea is the first pea protein isolate grown and manufactured in the U.S. Achieving GRAS status adds yet another layer of confidence and another advantage for manufacturers who want to create foods and beverages with mass-market appeal said Tyler Lorenzen president of World Food Processing s proteins and ingredient subsidiary. The GRAS status confirms that PurisPea is safe for use as a protein source in foods such as bakery products cereals snack foods smoothies beverages soups imitation dairy products dry instant milk shake mixes and protein drinks instant powdered nutritional beverages vegetarian products meat analogues and meal replacement bars. For more information visit BIO-CAT Microbials Announces New Probiotic Ingredient innesota-based BIO-CAT Microbials announced the launch of OPTI-BIOME Bacillus subtilis MB40 a highly-concentrated shelf-stable probiotic ingredient for dietary supplements and food products. It is GRAS (generally recognized as safe) via expert panel review and is available for sampling and testing the company said. OPTI-BIOME Bacillus subtilis MB40 is a naturally occurring spore-forming organism which protects itself from extreme pH and heat like the conditions associated with some food manufacturing processes. This proprietary strain can be encapsulated in a dietary supplement to provide a more diverse probiotic product and support label claims with impressive colony forming units (CFU). Formulating with OPTI-BIOME Bacillus subtilis MB40 can raise and stabilize the CFU count of products the company said. This is the best of both worlds according to BIO-CAT Microbials President Chris Schuler. I think our customers will see immediate value in formulating with OPTI-BIOME Bacillus subtilis MB40 as they minimize the need to over-formulate which they had to do in the past because of the limited shelf life of first generation probiotics. For more information visit W M New E.U. Health Claim for Sensus Chicory Root Fiber he new health claim authorized by the European Commission (E.U.) confirms that non-digestible carbohydrates such as chicory root fiber also labeled as inulin or fructo-oligosaccharides contribute to better blood glucose management as they support a lower rise in blood glucose response the company said. Scientific evidence jointly submitted to the European Food Safety Authority (EFSA) by Netherlands-based Sensus together with other chicory root fiber manufacturers prompted the change in regulation. The new regulation which is based on scientific evi- T dence falls under article 13.5 of the E.U. Regulation on nutrition and health claims. After publication of the new claim in the EU Official Journal manufacturers may state the following when their products contain Sensus chicory root fiber Consumption of food and drinks containing chicory root fiber instead of sugars induces a lower blood glucose rise after their consumption compared to sugar-containing foods and drinks. In addition to the authorized 13.5 health claim general health-related wellbeing claims under article 10.3 are also possible along with the main claim such as lower and more balanced blood glucose rise. The authorization is based on a human study led by Sensus followed by a human study jointly funded by the chicory root fiber manufacturers and besides other scientific evidence clearly showed that chicory root fiber has a significant part to play in controlling glycemic response said Elaine Vaughan scientific and regulatory affairs at Sensus. European food manufacturers now have the opportunity to communicate and educate consumers on this health benefit when applying this claim to their new products. For more information visit Nutrition Industry Executive 19 June 2016 IngredientNews BENEO Extends Portfolio With Remypure ew Jersey-based BENEO announced the launch of Remypure the company s first high performance rice starch that qualifies for natural and clean label status worldwide. BENEO s Remypure functional native rice starch has high stability during processing and performs well even under harsh processing conditions such as low pH high temperature or high shear the company said. As a result it is well suited to applications that undergo demanding processing conditions including retorted N sauces baby food jars dairy desserts and fruit preparations. Due to Remypure s new thermal production process which is entirely natural BENEO s functional native rice starch achieves performance levels comparable to chemically modified food starches without using any chemicals. Remypure has a clean taste and improves both shelf life stability and texture of products. It is available in a range of variants meeting customers requirements be they creamy or soft texture. As a result of this new product development from BENEO food manufacturers now have a versatile clean label rice starch available allowing viscosity build-up suitable for both gentle and demanding processing conditions. For more information visit Frutarom Launches Next Generation Antioxidants for Instant Drinks rutarom Health BU announced NutraT the next-generation instant drink powder with all the benefits of a healthy Mediterranean diet. The all-natural antioxidants line was launched at Vitafoods Europe Geneva in May. Extracting the best innovation from the Mediterranean diet is the expertise of Nutrafur S.A. now a member of the Frutarom family. Nutrafur S.A. Alcantarilla Murcia Spain developed NutraT a line of ready-to-use soluble powder formulas that dissolve easily in water soft drinks and dairy products. Once the powders dissolve the beverage stays clear without turbidity and delivers fresh flavor. The NutraT line offers water and soft drink manufacturers the ability to fortify their products with exceptional natural extracts that typically are not water-soluble explained Maria Dolores Garcia product manager for Frutarom Health. This opens new opportunities to develop products with new flavors that include ingredients delivering the essence of a healthy Mediterranean diet. Extracts include OliveT CynaxT RosT and CitroT. OliveT contains ben- F eficial compounds from the olive and provides more than 25 percent olive polyphenol content. Recent studies demonstrated that these olive extracts can help regulate blood pressure and support blood circulation. CynaxT a formulation of artichokes with a 5 percent polyphenol content has been shown to help regulate serum cholesterol levels thanks to the plant s choleretic and diuretic properties. RosT is a high-phenolic compound content combined with via Nutrafur s unique production method guarantees RosT s significant antioxidant capacity and preserves pleasant taste. Products fortified with RosT allows beverage producers to position their products as a beauty from within drink or a better sleep aid. Finally CitroT is a soluble extract with high bioflavonoid content. Citrus bioflavonoids are known to provide a protective effect on the cardiovascular system. All four mixes are produced using sustainable sources are heat stable at up to 70 C and both kosher and halal certified. For more information visit New Organic Cordyceps Mushroom Extracts Available in North America eff Chilton president of Nammex Organic Mushroom Extracts Canada announced that Nammex now has a reliable ongoing supply of genuine organically certified Cordyceps militaris mushroom extracts at an affordable price. Wild-crafted Cordyceps sinensis is a Chinese medicinal mushroom that has traditionally been recommended for a broad range of applications including low energy and fatigue respiratory function and fertility. New scientific research has demonstrated that Cordyceps militaris mushrooms have active compounds and benefits similar to if not better than Cordyceps sinensis. As with other Nammex extracts actual cordyceps mushrooms are being organically cultivated and are supplied in powder form to supplement manufacturers in North America. Nammex organic Cordyceps militaris mushrooms guarantee a higher level of active ingredients than common Cordyceps mycelium grown on cereal grains according to the company. For more information visit J 20 Nutrition Industry Executive June 2016 Omniactive Presents Poster on Capsimax Capsaicinoids r. Stacie L. Urbina presented Capsaicinoids Decrease Appetite Measures--An Open Label Study in Free Living Individuals at Experimental Biology April 2-6 in San Diego CA. This study accompanies the rapidly expanding base of research on OmniActive s innovative sciencebacked ingredients the company said. The data showed that Capsimax Capsicum Extract may be beneficial for decreasing measures of appetite which can support weight management stated Lynda Doyle vice president of global market New Jersey-based OmniActive Health Technologies. The study also demonstrated there was no statistically significant increase in heart rate or blood pressure with one-week supplementation. Authors concluded that future studies should examine the longterm effects of Capsimax supplementation on appetite weight management and body composition using a randomized double-blind placebo-controlled trial. Natural compounds like capsaicinoids from Capsimax are becoming increasingly popular as the demand for clean ingredients fuel a fast-growing market that not only addresses weight management but also a broader category including stimulant-free energy to support a healthy lifestyle through diet and exercise. For more information visit or D Maximum Yield Approach Delivers Bigger Profits and Enhanced Green Credentials for Dairies enmark-based Arla Foods Ingredients launched a new drive to raise awareness of the ways in which whey protein ingredients can enable dairy companies to maximize output increase profits and significantly cut waste. The campaign--called Maximum Yield--will highlight how simply adding whey protein to an existing production process with only small or no processing adjustments can significantly increase a dairy s efficiency and boost its sustainability credentials. The campaign is focusing on two fronts--the elimination of unwanted by-products and the use of by-products as a raw material--underlining that there is an approach available to suit every dairy whatever their circumstances. As well as supplying a wide range of tailored whey protein solutions Arla Foods Ingredients offers the technical expertise to ensure factory managers can get the best out of them with little or no further investment in manufacturing equipment required. Maximum Yield is about emphasising the benefits of whey protein ingredients in terms of either making sure 100 percent of the milk processed ends up in the finished product or alternatively treating any by-products created during production as a valuable raw material said Brian J rgensen business unit director at Arla Foods Ingredients. In both cases dairies will be maximising their productivity and reducing the burden they place on the environment. For more information visit D Naturex and Adamed Sign Licensing Agreement he Naturex group a Francebased leader in specialty plantbased natural ingredients and Poland-based Adamed Consumer Healthcare SA a producer of OTC (over-the-counter) drugs and dietary supplements signed a cooperation agreement to an exclusive global license for Aronox aronia extract. Aronox is an extract of the native North American superfruit aronia. Since 2005 the health benefits of Aronox have been investigated in seven human clinical studies. The outcome of these studies have shown very promising results in a variety of health related areas including the reduction of cardiovascular T risk factors the improvement of blood flow and the decrease of oxidative stress. Aronia also called black chokeberry possesses a unique combination of phytonutrients and is particularly high in polyphenolics that help maintain cardiovascular health. However new research has also shown aronia to hold potential in the areas of anti-inflammation blood glucose management and improved blood flow which could positively impact vision cognitive performance and muscle oxygenation and recovery. As licensee Naturex has been given global exclusive rights to use the Aronox clinical dossier and trademark and to sublicense it to its B2B customers in all territories where the trademark has been registered. Only four eastern European countries and Spain will be excluded from this agreement. This partnership with Adamed is part of Ingenium our new open innovation program said Marc Roller chief scientific officer for Naturex. Aronox will further enhance our global leadership position in the phytoactives market segment one of four key categories highlighted in our Bright2020 strategic plan with various applications that will help our customers reduce time to market fitting perfectly with consumers expectations. For more information visit or Nutrition Industry Executive 21 June 2016 IngredientNews KD Pharma Launches KD Smart DHA ermany-based KD Pharma has announced the launch of its specially formulated KD Smart Omega-3 oil. It was developed to provide the same average ratio of omega-3 EPA and DHA found in mother s milk. KD Smart is an important product for us said Ren Kamminga vice president of nutrition for KD Pharma. DHA G plays a critical role in eye and cognitive health starting right from early development and continuing on throughout life. This particular product is designed to ensure expecting or nursing mothers receive sufficient DHA for both themselves and their growing baby. For more information visit Cepham Announces Release of Furosap ew Jersey-based Cepham announced the release of their new product Furosap. This new product helps to maintain healthy testosterone levels though the use of standardized protodioscin at an affordable price point according to the company. Protodioscin is derived from fenugreek seeds (Trigonella foenum-graecum) and is known to promote healthy testosterone levels. It has been found to support healthy athletic performance as well as balanced energy and mood. These effects are connected to protodioscin s activities in both hormonal and circulatory systems. A study released in March found that Furosap improved free testosterone levels in nearly 90 percent of 50 male subjects. Other results in the study revealed that 85.4 percent of the participants experienced an increase of approximately 150 percent in sperm count and 95.2 percent of the participants reported enhanced reflect erections. Mental alertness mood and overall performance were also noted as improved among the majority of those in the study. For more information visit NECTAR7 Launches NIAGEN alifornia-based ChromaDex Corp. announced that NECTAR7 has released a new product Niagen & Collagen featuring ChromaDex s lead ingredient Niagen. Jeromy Stallings president of California-based NECTAR7 Media said Nectar7 is excited about launching the first and only Niagen & Collagen anti-aging nutricosmetic under the Nectar7 brand. Science has shown that collagen production is NAD dependent. Niagen a major ingredient in the Nectar7 exclusive formula has been shown in a recent human trial to increase NAD . We are proud to add NECTAR7 to the growing list of customers for niagen our branded nicotinamide riboside added Frank Jaksch Jr. founder and CEO of ChromaDex. The ingredient is the first and only commercially available form of nicotinamide riboside (NR) a naturally occurring vitamin B3 metabolite found in milk. In addition to human clinical studies ChromaDex is actively collaborating with numerous leading universities and research institutes studying the health benefits of Niagen. For more information visit N C New Published Study on Weightain Satiety Ingredient he scientific journal Nutrition Research recently published the latest results on Weightain--a satiety ingredient manufactured by Illinoisbased Ingredion Incorporated. The new research clearly demonstrates that Weightain satiety ingredient significantly lowered both post-breakfast and postlunch glycemic and insulin responses relative to the control. While previous research has highlighted the satiety benefit of Weightain satiety ingredient this is the first study to demonstrate a glycemic benefit for the ingredient. The study was also unique in that it showed Weightain satiety ingredient was clinically effective when incorporated into two different food applications. One part of the study compared T glycemic responses in a frozen berry smoothie for breakfast--made with either the control (maltodextrin) or Weightain satiety ingredient--among healthy men and women. The second part of the study was identical to the smoothie study except subjects consumed cold-pressed bars for breakfast with either the maltodextrin control or Weightain satiety ingredient. Both the smoothie and the bar with Weightain satiety ingredient significantly lowered post-breakfast glycemic and insulin responses relative to the maltodextrin control. Over and above this immediate benefit the study demonstrated that Weightain satiety ingredient at breakfast significantly reduced the glycemic response to lunch. This sec- ond-meal effect shows that the metabolic benefits of Weightain satiety ingredient can persist for hours after consumption. There are many negative health consequences that result from not maintaining healthy weight and blood sugar levels said J. Paul Zimmer PhD director of global nutrition R&D with Illinoisbased Ingredion Inc. Including ingredients such as Weightain in food formulations not only help promote a satiety effect making consumers feel fuller for longer periods but also help maintain a healthy blood sugar level--which is becoming of vital importance for future food formulations. For more information visit June 2016 22 Nutrition Industry Executive Welch s Global Ingredients Group New Niagara Grape Juice elch s Global Ingredients Group has strengthened its product portfolio with 100 percent Niagara grape juice--a unique golden American super fruit juice that delivers a sophisticated flavor profile and naturally nutritious polyphenols. Niagara grape juice contains no added sugar colors or flavors. It is available globally to companies and offers bolder and more floral flavor notes than other white grape juices. To preserve this inherent nutrition in the Niagara grape juice Welch s squeezes the whole grape including the skin and seeds to release these plant nutrients or polyphenols straight from the grape W and into the juice. The result is a 100 percent juice. Massachusetts-based Welch s Global Ingredients Group added the Niagara grape to its FruitWorx range of real fruit inclusions for bakery nutrition bar confectionary snack and breakfast cereal applications. The new launch follows the successful introduction of FruitWorx Concord grape inclusions a year ago. FruitWorx inclusions contain the goodness that Concord and Niagara grapes are renowned for. They are created using Ultra Rapid Concentration a unique process that concentrates the taste texture and natural goodness of fruit juices and pur es it into pieces flakes and bites. FruitWorx inclusions can be made using a single type of fruit or in combination with other fruits or blended with other ingredients--including ancient grains such as chia. The pieces can also be enrobed in chocolate to create a delicious and wholesome treat the company said. For more information visit Stevia Ingredients to Offer Powdered Sweeteners in Reduced Particle Sizes o help manufacturers reduce the costs of research and development associated with creating food and beverages made with all-natural sweeteners Oregon-based Steviva Ingredients is now offering reduced particle sizes for its entire line of powdered sweeteners. Having the right particle size affects food and beverage processing methods that require precision such as tempering chocolate said Thom King president and CEO of Steviva Ingredients. We are now able to offer our customers sweeteners and custom blends in particle sizes ranging from 30 mesh to as high as 230 mesh. In addition to precise particle size offerings Steviva s new technology can customize particle shape as well. By being able to control not only particle size but also shape will be a game changer for those working with beverages requiring instant dissolvability uncooked processes such as meringues and confections as well as glazes and coatings on bars and cereals King said. ErySweet Ultra is designed for use in chocolate since it allows for perfect tempering. It folds into any cold or hot process and has an excellent heat tolerance past 250 degrees F. Finer than confectionary sugar ErySweet Ultra can be used for making smooth frostings fillings fondants or coatings. Reduced particle sizing also available for CocoSweet Fructevia MonkSweet SteviaSweet RA98 and XeroSweet . For more information visit Lesaffre Human Care Introduces LifeinU esaffre Human Care supplier of quality ingredients from yeast and bacteria fermentation for the global human care markets introduced its newest proprietary bacterium LifeinU Bacillus subtilis CU1 the most stable probitic for immune support with clinically proven efficacy at Vitafoods Europe in Geneva the company said. Lesaffre Human Care developed LifeinU Bacillus subtilis CU1 to support the whole family in maintaining a powerful immune system at all times. LifeinU BSCU1 has been clinically proven to strengthen the body s natural defenses especially in people with a weakened immune system. LifeinU BSCU1 is made of an exclusive and patented strain of Bacillus subtilis registered as CNCM I-2745. Beneficial effects of LifeinU BSCU1 consumption were demonstrated in a four-month clinical trial conducted in healthy seniors in collaboration with an independent expert in gastroenterology. Findings of this clinical study were recently published in the peer-reviewed journal Immunity & Ageing and showed that consumption of a small daily dosage (20mg day) of LifeinU B. subtilis CU1 significantly boosts natural defenses by increasing SIgA stool and saliva concentrations by respectively 87 percent and 45 percent and reduces the frequency of upper respiratory infections by 45 percent. Being highly stable LifeinU BSCU1 can survive extreme conditions such as exposure to the human gastrointestinal tract and harsh manufacturing processes which allows it to deliver its health benefits through a diverse range of dietary supplement as well as food & beverage applications (e.g. hot tea cereal bar etc.). In addition LifeinU BSCU1 is compatible with all kinds of dietary restrictions (gluten- and lactose free kosher halal etc.) and therefore suited for virtually any healthy individual that wants to boost their natural defenses. For more information visit L T June 2016 Nutrition Industry Executive 23 IngredientMarketplaceWrapUp IM Offers Venue for Quality Networking & Ingredient Insight early 2 400 buyers and suppliers that drive the nutrition health food and beauty industries gathered in Orlando FL for Ingredient Marketplace (IM) April 27-29 to explore what s on the minds of consumers. The three-day conference and expo delivered valuable education and industry trends including the results of its inaugural Mind of the Consumer study high-quality exhibitors and engaged attendees. The results of our Mind of the Consumer study which was conducted in partnership with the Natural Marketing Institute really called out white space opportunities within the health and nutrition space. Seeing the consumers reasons for using ingredients such as omega-3s and probiotics and comparing that against supplier perceptions pointed out areas for market expansion. New delivery formats user-friendly messaging of benefits and an emphasis on safety and efficacy all were highlighted for growth strategies for companies in the finished products space said Heather Granato vice president of content for Informa s Global Health & Nutrition Network. The conference kicked off with Probiotics Marketplace a one-day intensive event that took place the day before IM. The full-day program provided insight into what is driving consumer interest scientific research and market opportunities around probiotics as well as the why and how of developing finished products with probiotics. During his discussion speaker Ralf J ger pointed out that the market for probiotics in sports nutrition is booming with more to come and he sees great potential to help increase tolerance for food allergies as well as opportunities in the healthy aging category. N meaning their goals vs. life. In regard to supplement concerns he noted that clients worry about safety purity and dosage. A believer in marketing through education Roussel said he stresses to his clients that If you re not taking the supplement on a regular basis it s not going to work. He suggested manufacturers consider easy-touse delivery methods that reduces consumer friction such as supplement packs products that are ready to mix or ready to drink. The Storefronts Live sessions in the expo hall gave attendees the opportunity to explore health solutions and ingredients in a live setting. The Healthy Aging Optimizing Well-Being Storefronts Live presentations were sponsored by Gelita & Gencor Bioenergy & Top Health Ingredients. The IM stage in the expo hall offered a variety of quick programming designed to highlight market opportunities. Sessions included Technology & Transparency in Supply Chain Sourcing Trends In Sports Nutrition with market insights from Euromonitor and Mintel and Storefronts Live showcasing solutions around Healthy Aging and WellBeing. A new exhibitor Exhibiting Special Events Keynote speaker Dr. Mike Roussell The Diet Doctor a food industry and nutrition consultant led a discussion on The Mind of the Sports Enthusiast. Roussell discussed how important it is to think about the client-- specifically their concerns goals and friction 24 Nutrition Industry Executive Wayne D. Lutomski vice president International and Global Ingredients with Concord MA-based Welch s Foods Inc. noted it was the company s first time exhibiting at the trade show. Welch s is new to the ingredient business having launched its Global Ingredient Group roughly 18 months ago he explained. We are still establishing ourselves in this space so in that sense participation in Ingredient Marketplace was well received. We had many people come by our booth and ask why we were there. We were able to explain how they should think of Welch s differently--as an ingredient supplier as well as for the iconic and much Dr. Mike Roussell loved consumer brand it is. More importantly we had some products that were well suited as a new delivery system for the nutrition supplement industry that sparked real interest. The company showcased its Niagara grape juice and FruitWorx. They go hand in hand Lutomski said. As we created our FruitWorx product which uses a unique URC process that concentrates the goodness of Welch s grape juices or purees into delicious and versatile real fruit pieces. Also exhibiting Bryan See regional product manager with ExcelVite based in Edison NJ and Malaysia said the response and feedback at IM were good. We met existing customers and friends. At the same time we received a few potential inquiries from new customers and branded international companies. ExcelVite showcased EVTene a natural mixed-carotene complex as well as its flagship tocotrienol branded ingredients EVNol a natural full-spectrum palm tocotrienol complex and EVNol SupraBio a patented and bio-enhanced natural full-spectrum palm tocotrienol complex. Coming Soon Informa s SupplySide West trade show will be held October 4-8 at Mandalay Bay in Las Vegas NV. Next year IM is scheduled to return to the Orlando World Center Marriott April 18-20. June 2016 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Health Canada s Evolving TCM Monograph Incorporates AHPA Recommendations ealth Canada s Natural Health Products Directorate (NHPD) continues to expand a draft monograph used for registering traditional Chinese medicine (TCM) products as natural health products (NHPs) in Canada. Last year Health Canada incorporated the majority of the American Herbal Product Association s (AHPA s) recommendations into its third and latest draft of the TCM monograph now titled Traditional Chinese Medicine Ingredients (TCMI). AHPA has been advocating for improvements to Health Canada s TCMI based on the invaluable and expert input of the AHPA Chinese Herbal Products Committee. The first draft of NHPD s TCMI was introduced in 2012 with a list of less than 300 pre-cleared general medicinal ingredients for use in TCM NHPs. Last year it was expanded to include 137 of 147 additional ingredients AHPA had recommended adding to the list. The current draft now includes more than 500 pre-cleared general medicinal ingredients. Specifically AHPA has advocated for the addition of ingredients that have significant use as individual ingredients or are not easily replaced by other ingredients. Health Canada also accepted AHPA s proposal to remove ephedra from the list of excluded ingredients. Ephedra root is now pre-cleared as a general medicinal ingredient and ephedra stem may be used when prepared according to the specifications outlined by NHPD and are generally based on traditional processing requirements for certain TCM ingredients. AHPA s comments stress that ephedra plays a unique role in TCM and is not easily replaced. AHPA also provided references to large body of evidence that supports the safety of ephedra when used in the traditional manner to provide only a limited quantity of ephedrine alkaloids per serving. H AHPA made several additional specific recommendations concerning toxicity and processing and NHPD accepted all but one of these suggestions. These adopted recommendations include Ginkgo biloba seed was moved from the list of pre-cleared general medicinal ingredients to the list of medicinal ingredients that are only allowable when prepared according to NHPD specifications. This ingredient is considered slightly toxic as an unprocessed herb and now appropriately includes a description of its traditional processing to reduce toxicity. Eighteen ingredients previously identified as diuretics or stimulant laxatives were moved to the list of pre-cleared ingredients. Ingredients identified by NHPD as diuretics or stimulant laxatives are restricted so moving these ingredients to the precleared list allows them to be freely combined with other ingredients. These herbs have no greater diuretic effect and hence cause no greater safety risk than many common foods such as watermelon fruit. Folium Sennae was added to the list of ingredients with stimulant laxative properties as it has been used by TCM for this purpose. Several herbs (Radix Aconiti Lateralis Praeparata Radix Aconiti Kusnezofii Praeparata Radix Arebiae Semen Gingko and Flos Farae) were added to the list of ingredients and ingredient combinations that are required to be prepared according to NHPD specifications. Additionally preparation requirements for several herbs (Semen Cannabis Semen Persicae Radix Aconiti Kusnezoffii and Radix Arnebiae) were modified to reduce toxicity. Aristolochia spp. all species of Aristolochia Cinnabar and Lead oxide were added to the list of ingredients that are excluded from the monograph. AHPA also made several recommendations related to more general issues such as definitions policies on combinations labeling for use in pregnancy and lactation but NHPD did not incorporate these suggestions. However the TCMI monograph is still identified by NHPD as under consideration and the agency does not have an estimate for when the document will be finalized. Although not officially final NHPD staff said that submissions that comply with the current draft could now be submitted under this monograph as it is currently being used for TCM product license applications for NHPs. AHPA and its members appreciate the opportunity to be involved in this important regulatory process and Health Canada s willingness to continue to expand and improve the regulatory framework for traditional Chinese medicine. NIE Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) Nutrition Industry Executive 25 June 2016 AssociationNews AstaReal Withdraws From NAXA to Focus on Advanced Research staReal (Burlington NJ) a leading natural astaxanthin producer and a part of the Fuji Chemical Group of Japan announced its amicable withdrawal from the Natural Algae Astaxanthin Association (NAXA) of which AstaReal was a founding member. NAXA was established in January 2014 for the purpose of educating consumers and industry about the differences between natural astaxanthin sourced from algae and the synthetic form that is produced from petrochemicals. We are extremely proud of the seminal work we have done with NAXA. Especially during the first year of its existence NAXA presented an extremely valuable message to the public about the many concerns and unanswered questions about using synthetic astaxanthin in human nutritional supplements said Kazuyuki Miyakawa chief scientific advisor at AstaReal. AstaReal will continue to independently educate consumers that only natural astaxanthin from A H. pluvialis should be used in supplements and functional foods and beverages. Although all NAXA member companies produce astaxanthin from H. pluvialis there are vast differences in the cultivation technology quality standards and research capabilities of each company according to Joe Kuncewitch national sales manager for AstaReal. NAXA membership may give the false impression that all members are offering astaxanthin of equivalent quality. However NAXA only confirms that member companies are producing astaxanthin from algae. They don t perform extensive quality testing he explained. Kuncewitch emphasized that by withdrawing from NAXA AstaReal will be able to clearly emphasize its advantages over other natural astaxanthin producers We have a truly unique cultivation process that produces the purest and highest potency astaxanthin available. AstaReal is the most studied brand of astaxanthin our material has been used in the majority of human clinical studies. And we are the only producer offering a stable supply of Made in the USA natural astaxanthin produced in Moses Lake WA. Clinical human research remains the cornerstone of AstaReal s operations and the company has pioneered natural astaxanthin research for health. Dr. Arun Nair president of AstaReal s operations in the U.S. revealed AstaReal currently has multiple human clinical studies underway in the United States and Japan. These studies will add to the already strong body of evidence supporting AstaReal astaxanthin s use in nutritional supplements and the emerging area of medical foods. Consumers purchasing products containing AstaReal can feel confident that they are getting the most researched natural astaxanthin available. For more information visit CRN to Launch Industry-wide Dietary Supplement Product Registry he Council for Responsible Nutrition (CRN) has announced its Board has unanimously authorized the creation of an industry-wide dietary supplement product registry to be launched by the end of the year. The registry will be developed and managed by a thirdparty vendor and CRN plans to announce the results of that search later this spring. This is one step we re making to take back our industry from the lawbreakers from the renegades from the companies that spurn regulation said CRN president and CEO Steve Mister. Our member companies have turned a corner and are fully engaged in efforts to separate the legitimate manufacturers marketing healthful products from the hit-and-run fly-by-nighters selling quick fixes and illegal drugs wrapped with a supplement label. We need all companies who care about our consumers and the sustained growth of this industry to join with us in this initiative. According to CRN the initiative is the latest in a growing number of the association s self-regulatory projects and comes at a time when the supplement industry is primed to work more closely together and with regulators to help T solve the problems that have attracted increasing public scrutiny. The days of the regulators sitting on their hands are long gone and we appreciate that we re seeing stronger enforcement action of the law said Mister. Mister noted that the product registry will initially serve the regulators and the retail community with the ultimate goal of providing industry accountability to consumers as well. We re moving in a deliberate step-wise fashion and layering initiatives that when combined will address transparency ingredient verification and GMP (good manufacturing practice) compliance. CRN has formed a working group to resolve the specifics of the product registry which is anticipated will contain multiple tiers of product information-- some public-facing which will be accessible to anyone and will permit participating manufacturers marketers to add their products at no charge and an addon component which will provide more in-depth information about the products to specified audiences such as regulators and retailers. Earlier this year CRN announced what it called a first and necessary step toward improving transparency in the supplement industry by requiring all CRN members as a condition of membership submit their supplement product labels to the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) Dietary Supplement Label Database (DSLD). Said Mister the industry product registry will serve as a companion piece to the ODS Label Database which we understand is an important tool for the scientific research community. CRN continues to support ODS s database and we intend for the product registry to interface in some way with the label database so companies will not have to engage in duplicative efforts. Mister noted the importance of working closely with the other trade associations and both member companies and non-member companies. When it comes to the industry trade associations he said We re cooperating on a number of initiatives that will contribute toward a stronger more accountable industry-- CRN is taking the lead on this one and we will lend support as others take the lead on other initiatives. You can expect more announcements soon. For more information visit June 2016 26 Nutrition Industry Executive ScienceUpdate Chronic Drinking Interferes With Absorption of Critical Vitamins hronic exposure to alcohol interferes with the pancreas ability to absorb vitamin C potentially predisposing the body to pancreatitis and other pancreatic diseases a new study in the American Journal of Physiology-- Cell Physiology reported. The pancreas produces the enzymes used to digest food and the hormones such as insulin that are needed to store energy from food. Pancreatic diseases and damage to the pancreas can lead to digestive problems malnutrition and diabetes. Alcohol-related pancreatitis takes an average of 10 years of daily alcohol abuse to develop and the risk of developing the condition increases with the amount of alcohol consumed said Fred Gorelick MD of Yale University and a collaborator of the study s authors. Earlier studies support that prolonged alcohol exposure weakens the pancreas defense system making it more vulnerable to injury. However less than 10 percent of alcoholics develop pancreatitis indicating that alcohol is a sensitizer but other genetic and environmental factors are also involved. While longterm continual alcohol intake is a signifi- C cant factor in developing pancreatitis little is known about how daily consumption patterns affect the likelihood of developing the disease Gorelick said. To function properly pancreatic cells require a number of vitamins which they take from the blood stream. The research team at the University of California Irvine led by Hamid Said PhD investigated whether the pancreas weakened defense from alcohol exposure could be attributed to poor absorption of vitamins. The researchers reported in earlier studies that chronic alcohol exposure prevented the pancreatic cells from absorbing biotin and thiamin. In this new study the team investigated whether alcohol exposure also interfered with the pancreas s absorption of vitamin C. The research team first identified the protein called sodium-dependent vitamin C transporter 2 (SVCT-2) as the main protein responsible for transporting vitamin C into pancreatic cells. Next researchers exposed mouse pancreatic cells to alcohol levels similar to the blood alcohol concentration of chronic alcoholics. The researchers also fed mice a diet in which alcohol made up 25 percent of the total calories consumed. They found that both pancreatic cells directly exposed to alcohol and pancreatic cells from alcohol-fed mice had lower numbers of SVCT-2 blocking the cells absorption of vitamin C. Reducing the levels of vitamin C and other essential micronutrients will interfere with normal cellular activities in the pancreas Said explained. This may sensitize the pancreas to a secondary insult predisposing it to the development of pancreatitis and other pancreatic diseases. For more information visit http High Prevalence of Vitamin D Deficiency in Kids With Type 1 Diabetes D uring the past two decades vitamin D status defined as serum concentration of 25hydroxyvitamin D has emerged as a predictor of key clinical outcomes including bone health glucose metabolism cardiovascular health immune health and survival. Now a University of Pennsylvania School of Nursing (Penn Nursing) team including senior author Terri Lipman PhD CRNP FAAN the Miriam Stirl Endowed Term Professor of Nutrition Professor of Nursing of Children and Assistant Dean for Community Engagement has examined the association between 25-hydroxyvitamin D and diabetes control in children and adolescents with type 1 diabetes. The results demonstrate the high prevalence of patients with low levels of 25-hydroxyvitamin D specifically in healthy weight and Caucasian children and adolescents with type 1 diabetes--patients previously considered at no or low risk of having low levels of vitamin D. These data underscore the importance of vitamin D screening in all children and adolescents with type 1 diabetes. The team s findings have been published in Diabetes Research and Clinical Practice. To our knowledge this is the first study that has been adequately-powered to examine the association between 25-hydroxyvitamin D and HbA1c (a measure of diabetes control) in children and adolescents with type 1 diabetes said Lipman and colleagues. These data suggest the need for monitoring of vitamin D in all youth with this disorder. The study included approximately 200 children and adolescents from the Diabetes Center for Children at the Children s Hospital of Philadelphia who were recruited during regular follow up visits. Non-fasting blood samples were collected from the participants to measure 25-hydroxyvitamin D and blood glucose levels. HbA1c and other key variables were abstracted from patients medical records. For more information visit Nutrition Industry Executive 27 June 2016 One of the most challenging issues with combination THE products is being able to include therapeutic levels of key ingredients while keeping the daily serving of tablets or capsules to a minimum -- Marci van der Muelen National Sales Manager Nordic Naturals WINNING LOSING BATTLE Weight gain and subsequent loss is not a one-size-fits-all solution. Here s how to formulate for the specific reasons why individuals want to slim down. By Lisa Schofield S ome people think it s as simple as just shutting your mouth to lose weight meaning just stop eating as much. Well if that were the case there wouldn t be a multi-billiondollar weight-loss industry Throughout one s life weight will fluctuate. There are others who continuously gain ballooning up to obesity. For every overweight individual there have been times of failure to lose weight despite the fact that just about everyone understands that eating a healthy diet with portion control and exercise is the way to go. Again because of multiple diet-attempt failures the weight loss industry continues to boom and flourish. According to Bruce Abedon PhD director of scientific affairs for Icon Group LLC of Vermont there are several reasons why people have difficulty losing weight. Many individuals often have difficulty changing their diet to reduce the number of calories consumed and maintaining the newer healthier diet for long periods. Limiting the diet often leads to increased irritability that decreases the joys of life making it difficult to maintain the diet. 28 Nutrition Industry Executive Other people may not have time interest or a commitment to engage in exercise that promotes healthier lean body mass and enhances weight fat loss. That s why consumption of dietary supplements containing clinically tested weight-management ingredients such as Synetrim CQ is so important he asserted. Synetrim CQ helps to inhibit the absorption of dietary fat and starch through a mechanism that inhibits digestive enzymes that break down these nutrients. Research has shown that Synetrim CQ can also help enhance feelings of emotional well-being which may improve a dieter s mood. Weight gain said Lynda Doyle global vice president of marketing OmniActive Health Technologies New Jersey is both biological--and commercial. The body is very good at preserving energy and dieting invariably slows metabolism making weight loss more difficult she explained. Yo-yo dieting also makes subsequent weight loss more difficult. Couple that with the allure of the mythological magic bullet supplements and a glut of weight loss programs all promis- ing fast and easy results and it s apparent why consumers are confused about their choices and the lack of commitment for weight management. Well let s face it and own it-- It s because chocolate cake cheeseburgers and pizza are just so darn delicious emphasized Mitch Skop senior director of product development Pharmachem Laboratories Inc. New Jersey. Some people can eat to live. Others live to eat. Obviously a large percentage of consumers fall into the latter category. These comfort foods coupled with our aging population make losing weight very very difficult and especially once the weight is lost to keep it off. Putting reality into perspective Paul Djikstra CEO InterHealth Nutraceuticals based in California noted that to lose one pound of fat one must burn 3 500 calories more than consumed so you can see how hard it is to exercise your way through a poor diet. Instead you have to watch what you eat and exercise he remarked. Many causes of weight gain are indeed known and understood but there are less June 2016 known factors pointed out Shaheen Majeed marketing director of Sabinsa Corp. dually based in Utah and New Jersey. Factors such as lack of sleep side effects of drugs consumption of foods or beverages high in fructose can increase one s weight. A holistic approach to weight management with a blend of natural extracts can be a safe and effective approach to weight management no matter what the cause of increased weight may be he said. Once the fat forms and is deposited in the body it is very difficult to curb weight increase and to lose the accumulated fat because of the complex nature of fat. Thus prevention is better than cure. Mechanisms that can prevent fat deposition and increase existing fat oxidation may support weight management. A high-fat diet stimulates the endocannabinoid system (ECS) which results in accelerated building of body fat--this creates a truly vicious circle according to Vladimir Badmaev MD PhD CEO of American Medical Holdings of New York. Therefore normalizing the overactive ECS preventing excess fat intake and body fat build-up may prevent metabolic deterioration and obesity. Arguably the stimulation of the ECS starts with excess dietary fatty acids that gradually incapacitate hepatocytes (liver cells) and compromise one of the major functions of the liver which is oxidation and utilization of fat for energy. A liver burdened with accumulated fat can be compared to a vacuum cleaner clogged with excess dirt. As a result nutritional fat is deposited throughout the body leading to a characteristic central or abdominal obesity pattern. prior. Sounding counter-intuitive it is a measure of not only commitment but to see how the individual handles a significantly reduced diet. Can supplements help candidates become successful Based on a 2015 published peerreview study FB3 a proprietary blend of Coleus forskohlii Salacia reticulata and Sesamum indicum from American Medical Holdings supplies a safe effective and synergistic method preventing excess body fat by limiting gastrointestinal dietary fat absorption according to Badmaev. In addition another 2015 published clinical study on FB3 s component Coleus forskohlii indicates that it may improve insulin sensitivity in obese individuals which regulates lipid metabolism in the body. The clinical studies also show FB3 led to diminished food cravings and caloric intake. The Centers for Disease Control tallies the current obesity rate in the U.S. as between 26 and 32 percent accounting for approximately one out of every three individuals who are classified as obese. FB3 addresses the emerging target in dietary intervention to normalize body fat and the ECS Badmaev explained. The endocannabinoid system in the human body operates via one of the oldest structures in the brain the limbic system which regulates most basic functions commanding one s daily life. The ECS regulates metabolic functions satiety and energy homeostasis and also regulates mood memory and pain sensation. Committing to bariatric surgery requires that an individual commit to a healthier lifestyle Doyle said. Basic nutritional requirements are the first priority because bariatric surgery can predispose individuals to certain deficiencies. Doyle believes that supplements can indeed help--naming a multivitamin calcium vitamin D B complex with sufficient levels of B12 and iron as primary. In addi- Specialized Circumstances The Centers for Disease Control tallies the current obesity rate in the U.S. as between 26 and 32 percent accounting for approximately one out of every three individuals who are classified as obese. Concurrently there s been an increase in the number of obese individuals who undergo some form of bariatric surgery. Citing the American Society for Metabolic and Bariatric Surgery the educational website reported that in 2013 there were approximately 179 000 bariatric surgeries performed broken down as follows 34.2 percent of surgeries as Roux-en-Y gastric bypass 14 percent gastric banding 42.1 percent gastric sleeve 1 percent as duodenal switch 6 percent as revisional surgery and 2.7 percent classified as other. Before being labeled a successful candidate for this surgery many individuals are told they need to lose some weight June 2016 tion the candidate should consume adequate levels of protein as an excellent way to start managing weight and also an important requirement both before and after bariatric surgery. Through the process of managing a new healthier diet pre-surgery the ability to limit a portion of carbohydrate absorption is certainly beneficial. Skop mentioned that Pharmachem s Phase 2 Carb Controller helps by safely reducing the digestion of starchy foods like breads rice pasta and potatoes and does so without side effects. The reality is there are indeed some individuals who despite considerable effort to lose weight cannot experience normal loss due to genetics difficulty changing or moderating their diet or lifestyle or other factors according to Abedon. If the decision to undergo gastric surgery is made an initial period of weight loss prior to surgery can be aided through supplementation with products containing proprietary clinically tested Synetrim CQ Cissus quadrangularis extract WellTrim iG African Mango extract and other branded weight management nutraceuticals. In addition to weight loss these ingredients also help promote metabolic wellness in the areas of blood sugar balance and cardiovascular health which helps support overall health he explained. Djikstra agreed. Several clinical studies have shown that adding weight-management supplements to a slim-down routine may provide advantages more than just diet and exercise alone. For instance he said InterHealth s Meratrim clinical findings demonstrate that Meratrim in combination with a standard diet (2 000 kcal day) and moderate daily exercise produces a clinically significant incremental reduction in body weight waist and hip size over diet management and exercise alone. According to Majeed most gastric surgeries principally target reduction in food intake and also focus on education about healthier meal choices to reduce weight. However weight that has already been accumulated may benefit from the intervention of safe and effective weight management ingredients. Sabinsa has three proprietary sciencebacked weight-management ingredients that approach weight reduction in several different ways. ForsLean is a standardized extract from the roots of Coleus forskohlii available with 10 20 or 40 percent forskohlii. There have been several clinical studies showing ForsLean plays a role in promoting lean body mass. Citrin and GarCitrin (Garcinia cambogia) have been demonstrated through pre-clinical Nutrition Industry Executive 29 WINNING LOSING BATTLE THE and clinical studies as a natural weight loss aid. Its bioactive constituent (-) Hydroxy Citric Acid has been evaluated for its three pronged mechanism for weight loss studies show it may inhibit fat formation increase fat oxidation and induce satiety. Sabinsa s LeanGard blends ForsLean GarCitrin and Sabinsa s bioavailability enhancer BioPerine this formula said Shaheen works synergistically to support satiety lean body mass and a healthy body composition. On the seemingly opposite end of the spectrum are the vanity folks--those who want to achieve the perfect body and weight by losing a few pounds for summertime or a major event such as a reunion or wedding. Echoing the one-size-does-not-fit-all idea Abedon explained These groups differ in their initial BMI (body mass index) so it is important that each group takes a supplement that contains one or more ingredients that have been tested and shown to be effective for their BMI class. Often ingredients that may help reduce weight for obese (BMI 30) individuals are not effective for those who are overweight (BMI 25-30). One of the many attributes of Synetrim CQ and WellTrim iG branded ingredients is that they each have been shown to be effective in helping to promote healthy weight management in multiple human clinical trials that included both overweight and obese subjects. According to Badmaev metabolic aging starts at approximately age 25 when adults tend to accumulate fat and lose lean body mass i.e. muscle mass and bone mass independent of lifestyles. Also aging gradually sets us up for the pro-inflammatory processes in the body with lessened regenerative abilities which negatively affect our metabolic rate gradually becoming less responsive and sluggish he explained. After about age 30 the extra 10 or so pounds is not as easy to shed. Doyle observed that there is a common goal across these two categories people want to maintain or achieve a healthy weight. Therefore healthy diet and exercise should be the foundation for any weight management regimen and natural approaches for support such as supplements she said can help achieve any of these goals. OmniActive s 30 Nutrition Industry Executive Capsimax capsicum extract which contains the active capsaicinoids is an example she offered. Capsaicinoids have been well-researched in over 90 human clinical studies. Specific research on Capsimax supports its ability to support weight management by promoting lipolysis--the breakdown of fat--for energy production she reported. A recent presentation at Experimental Biology demonstrated that Capsimax can support appetite control and a healthy body composition at a small dose of only 2 mg. arm in the weight-loss study experienced a statistically significant decrease in their desire as well as in their frequency and strength of food cravings for chocolates and other sweet foods whereas the placebo group experienced a significant increase in the difficulty in resisting particular types of food. While attaining a perfect body is perceived as a matter of only better physical appearance it is more important for one to attain a healthy body composition which means focus on increasing the ration of lean body mass Majeed asserted. Supplements containing natural extracts that are safe and efficacious will benefit those wishing to slim down for the season or an event to have a lean and fit body that can be sustained particularly when accompanied by exercise. Bioactive compounds in natural extracts galvanize effective weight reduction through specific mechanisms such as inhibition of citrate lyase or enhance cyclic AMP or by inducing satiety. The Stress Factor There are also numerous stress eaters who find comfort in food and thus gain a size or two and after the period of distress subsides want to regain their original weight and size. During prolonged periods of stress those who are gaining weight by indulgence may also want to halt the process. Skop noted that when people are stressed they tend to reach for comfort foods typically carbs such as mashed potatoes pasta breads crackers. In this case a carb controller such as Phase 2 can be a valuable weight management tool. Study participants who used Phase 2 lost three times more weight than those on diet and exercise alone. Individuals suffering from stress he noted should also try to determine the cause of their stress and find ways to reduce it including professional help. Abedon agreed explaining that stress eating occurs when people cope with stress by eating high-calorie carbohydrate--and fat-laden foods because consumption of these foods helps lead to an improved mood and a state of relaxation. The best type of supplement for this type of consumer is one that contains a clinically tested mood-enhancing ingredient that helps reduce stress and anxiety he said. Sensoril is a multi-patented clinically tested extract of ashwagandha root and leaf which contains what Abedon noted is the highest levels of ashwagandha bioactives in the industry. In one human clinical trial of 98 subjects OmniActive s OmniLean a proprietary Salacia extract is called a metabolic synergizer Doyle explained. From a dietary perspective effective weight management pivots on caloric consumption and the body s ability to metabolize carbohydrates and lipids effectively. OmniLean is a single ingredient that addresses key areas of metabolic health (carbohydrate and fat metabolism) that play a crucial role in weight management and health. Phase 2 is also highly appropriate for the quick slim down of a few pounds while getting into fighting shape before summer or an event. Carbohydrates are part of everyone s daily diet--it s nearly impossible to avoid this macronutrient. According to Skop in the largest human study conducted on Phase 2 Carb Controller to date those subjects taking a proprietary extract of the white bean PhaseLite (Phase 2 Carb Controller) lost an average of 7 lbs. more than those on placebo after 12 weeks. In addition 73.5 per cent of the participants in the weight management phase successfully maintained their body weight after 24 weeks. Study results were published in the journal Obesity. After 12 weeks the active (Continued on page 51) June 2016 Go to nutragenesis for info about this advertiser Consumer expectations for cleaner healthier and tastier products are changing the category. By Corinne Anderson atural has become the watchword across the whole food and beverage industry said Wayne Lutomski vice president of International and Welch s Global Ingredients Group based in Massachusetts. When the functional food and beverage category first emerged it was viewed as a distinct entity. We saw a lot of products come into the market specifically to deliver health benefits while good taste and pleasure took a backseat. Over the years however the category has evolved to become more integrated into the mainstream. As this happened the emphasis has shifted to everyday concepts that deliver functional health benefits in a convenient and enjoyable way. In addition the regulatory environment has become much tougher noted Oliver Wolf head of advertising print media exhibitions for Germany-based Gelita. Certain expectations in terms of health claim 32 Nutrition Industry Executive N approvals have not come to fruition which has made innovation more complex. As a consequence many producers are looking to develop products with naturally healthy and non-allergic ingredients. I think consumers expectations have changed the category Lutomski said. Shoppers have become skeptical of the claims functional foods and beverage brands make today. So as a product manufacturer and marketer the question you have to ask is am I using ingredients with benefits that are supported by sound science But don t forget it has to taste good too. Market and Trends According to Mark Thurston president of California-based AIDP the market is still growing above 5 percent per annum overall but the nonGMO (genetically modified organism) organic products are in double-digit growth. Tyler Lorenzen president proteins and ingredients at World Food Processing (Minneapolis MN) noted that the future of functional food is clean label non-GMO and organic. Five years ago awareness of nonGMO was on the rise. Today nonGMO is mainstream. And five years ago it was more about energy drinks and not much in the way of functional foods added Suvash Kafley senior director of process and product innovation at Minnesota-based Milk Specialties Global. Everything was loaded with carbs and fats. Now people are asking for reduced sugar options and higher protein. There are three trends I see nutrition convenience and feel good he said. Kafley noted that protein-added ingredients have become popular as well as low carbohydrates and fat. In the convenience sector consumers have shown a noticeable interest in products being shelf-stable portion controlled personalized and having a bold and interesting flavor. Third the June 2016 most important aspects center on clean label organic non-GMO and whether it is naturally flavored. Thurston agreed adding that more vegetable and plant based ingredients minimally processed and a move away from artificial colors preservatives and sweetening systems have been the main trends in the category. We have a full range of plant and vegetable powders plant based proteins plant and yeast based minerals as well as natural sweeteners and plant based prebiotics he said. Protein is King Many new products on the shelf are driving innovations from protein-fortified greens to microwavable muffins to protein bars that taste amazing. The innovation is constant and spreads across all categories protein being the king ingredient overall Lorenzen said. protein isolate and milk protein isolate are targeted toward lactose-free and low-sugar formulations. Both milk and whey protein powder have nondetectable levels of lactose according to Kafley. The company s ingredient Barsoft is produced via membrane filtration process and contains casein and whey in slightly different composition to decrease bar hardening over time. Bar texture can be further enhanced by using high protein inclusions. We have the ability to tailor products using combinations of the following offerings to meet customer needs non-GMO hormone free organic and made with grass-fed Kafley said. In addition Milk Specialties Global also offers proteins for bakery and confectionary uses. crisps ready-to-drink beverages and even dairy products. PurisPea has the ability to be cross-functional Lorenzen said. This is because it has proven to be important for its ease of use in a probiotic drink or a protein crisp and is always delivering on great taste. FutureCeuticals Organic Terasante whole-food plant proteins have become in-demand because consumers are looking for non-isolate or concentrate sources of protein according to Wheeler who added We have seen a lot of interest in natural sources of energy primarily our Organic Coffeeberry energy whole Grape Functions Plant-based Proteins We have been experiencing an increased demand for natural gum replacements in the RTM (ready to mix) space and we meet this with our beverage-ready TRIM family of healthy grains said Andrew Wheeler director of marketing at Illinois-based FutureCeuticals Inc. The mainstream protein shift has also turned to whole food sources of plant-based protein. Some of FutureCeuticals formats include Terasante Whole Food Plant Proteins a legume and also a greens formula Coffeeberry whole coffee fruit baking and meal replacement Coffeeberry energy whole coffee fruit caffeine for healthy energy performance Sproutgarden in house grown America in sprouts organic grasses QuinoaTrim Nutrim beta glucans from oat AncienTrim beverage ready ancient grains and ModCarb Real Fuel from Real Food with protein palatability and slow-burn energy. M Everyone is high on protein Kafley said. It is no longer for bodybuilders or sports nutrition only. It s for kids adults and the aging population. While everyone uses protein differently or for various reasons like growing healthy maintaining lean muscle weight loss and healthy aging this is one ingredient that can help everyone. Protein is widely recognized as a necessary nutrient associated with muscle growth and maintenance. Nutrition 21 s new ingredient Velositol has been shown to double the benefits of protein supporting an increase in muscle protein synthesis. Velositol offers our customers a new way to formulate better protein products said Bill Levi vice president of strategy and business development for New York-based Nutrition 21. Milk & Whey Milk Specialties Global offers various ingredients to help processors and formulators achieve their goals of delivering superior nutrition with high quality products. Lactose-free whey June 2016 PurisPea protein is a U.S.-grown and manufactured pea protein by World Food Processing. It is naturally non-GMO offered as organic and can be found in protein shakes bars and ade from two American super fruits Concord and Niagara grape juices are delicious and deliver natural nutrition--including plant nutrients called polyphenols which act as antioxidants and can also contribute to health Lutomski said. It s the perfect package and totally in tune with what consumers today are looking for. FruitWorx real fruit inclusions is Welch s new ingredient line that uses a unique URC process that concentrates the natural goodness of fruit juices and purees into delicious and versatile pieces flakes and bites. This makes FruitWorx a good addition to snack bars and other on-the-go innovations. According to Lutomski FruitWorx products are easy to work with they do not clump and there is no foreign matter like sticks or stems in them. Welch s Global Ingredients Group also added Niagara grape juice a unique golden American super fruit juice that delivers a sophisticated flavor profile and naturally nutritious polyphenols. It is available globally to companies and offers bolder and more floral flavor notes than other white grape juice Lutomski said. In addition following the success of the FruitWorx Concord grape a year ago Welch s also added Niagara grape to its FruitWorx range of real fruit for inclusion in bakery nutrition bar confectionary snack and breakfast cereal applications. FruitWorx inclusions can be made using a single type of fruit or in combination with other fruits or blended with other ingredients including ancient grains such as chia or covered in chocolate for a delicious and wholesome treat. Nutrition Industry Executive 33 coffee fruit caffeine. In the natural caffeine arena formulators are intrigued by chlorogenic acids from the whole coffee fruit working in concert with natural caffeine. More Focus on Plant Ingredients Minnesota-based Cargill offers CoroWise plant sterols along with Oliggo-Fiber chicory root inulin also known as the invisible root fiber which can be incorporated into products without affecting taste or texture. It also acts as a prebiotic ingredient that supports digestive health and enhances dietary calcium absorption. Cargill s Regenasure glucosamine is the only vegetarian glucosamine produced in North America and Treha trehalose a naturally occurring disaccharide that can be found in mushrooms desert plants and yeast is a functional ingredient that can impact the freshness flavor and texture of the product. Treha trehalose s chemical structure remains stable under a wide range of conditions including high heat low pH freeze thaw cycles and prolonged storage said Pam Stauffer Cargill s global marketing programs manager. California-based Polyphenolics is in the business of extending the beneficial aspects of grapes to the consumer in the form of grape seed and skin extracts said James A. Kennedy PhD president of Polyphenolics. These polyphenolic extracts are produced from California-grown grapes that have undergone a patented extraction and purification process Mega NaturalGold a general grape seed extract with antioxidant properties and MegaNatural-BP a grape seed extract with targeted activities intended to help maintain healthy blood pressure. These extracts have been utilized in functional beverages such as Welch s Essence Sparkling Water Health Transformance a dietary supplement beverage Sobe Lifewater a vitamin enhanced water ThinkitDrinkit Personalized Performance Nutrition supplement mix which can be added to cold hot beverages sports drinks smoothies yogurt and baked goods and Young Living NingXia Red. Less Sugar Many consumers seek to reduce sugar in their diets particularly in their beverages said Stauffer. The USDA (U.S. Department of Agriculture) My Plate Guidelines significantly affect the recommended amount of daily sugar consumption for Americans. Added sugars in particular are under fire. Cargill is seeking to help customers stay ahead of these guidelines with its zero-calorie sweeteners like ViaTech stevia sweetener and Zerose erythritol which can help achieve reformulation options that taste great and reduce added sugars Stauffer said. As a plant-based sugar 34 Nutrition Industry Executive June 2016 allow beverage manufacturers to make reduced zero-calorie beverages that taste more like sugar-sweetened products. Reducing calories from beverages without sacrificing taste is highly desirable by consumers. with calories stevia presents the perfect solution for consumers who are looking for naturally sourced low-calorie sweeteners in their search for a healthy lifestyle and weight management program Stauffer continued. Stevia leaf extract is appealing to the food and beverage industry because they can reformulate their products providing calorie-free alternatives from a natural source. The pressure for lessening the amount of sugar and maintaining great taste is very real for formulators. ViaTech stevia and Zerose erythritol Collagen Due to its multiple health benefits that complement trends bioactive protein such as collagen peptides are set to be one of the biggest beneficiaries of the growing functional ingredients market said Mai Nygaard global director Wisconsin-based Peptan (Rousselot Inc.). Collagen peptides are in the spotlight because of their multiple sports nutritional benefits. Due to the unique amino acid composition they offer added value in terms of sports performance in regards to supporting fast recovery promoting healthy and flexible joints and helping to reduce the risk of injury by protecting joints and connective tissues Nygaard said. Food ingredient offerings have become more specific which has opened up a whole new horizon of opportunities said Wolf. One example of this collagen proteins. Traditionally used as natural stabilizers and emulsifiers for countless products they now owing to intensive research enable manufacturers to add important health benefits to everyday products he explained. Gelita has intensified its R&D investments and offers specific bioactive collagen peptides that are individually optimized to stimulate each of the three different human cell types involved in collagen synthesis. They re all manufactured according to a very precise enzymatic hydrolysis process resulting in unique products with high and consistent quality and stability properties Wolf continued. Being GMO-free collagen peptides are ideal for the development of clean label products and they fit well with the growing consumer interest in products that are pure safe and naturally functional. They can be used to develop innovative solid and liquid products such as fortified gummies beverages and shakes bars gels and all kinds of instant foods Wolf said. Vitamins Fuel Growth T here is a growing trend toward personalized medicines in pharmaceuticals which has developed into personalized consumer-based health treatments supplements diets and food said William Ludlum vice president of administration and special projects of Extracts & Ingredients a division or MORRE-Tech Industries in New Jersey. Extracts & Ingredients provides water-soluble nutrients in several categories including vitamins carotenoids omega-3s phytosterols and bioflavonoids. These ingredients are applicable for creating product groupings for functional foods beverages and nutritional products. These trends will impact day-to-day functional foods and drinks opening up a market for manufacturers to supply personalized ingredient groupings for use at home. The water-soluble B-vitamins and the fat-soluble vitamins omega-3s and phytosterols have been popular ingredients for functional foods and beverages over the past five years. Another is vitamin D because of its medical importance in immune heart brain and muscular functions. Clearly the addition of vitamins to water juices and health drinks have been market success Ludlum said. Fortification of foods and beverages with vitamins and supplements normally fuel the growth of the groups. Addition of different groupings creates new products within each category. 36 Nutrition Industry Executive Beauty From Within Crosses Over As consumer health concerns continue to influence the way food and beverages are produced and positioned previously well-established boundaries between different industries are beginning to blur according to Wolf. One example of crossoverinnovation is the synergy between foods and cosmetics resulting in the emerging market of nutricosmetics-- beauty-from-within products that are delivered as foodstuffs. Another example is the fusion of food and pharmaceuticals. As food becomes healthier and pharmaceuticals enter the supplement and nutraceutical market exciting new product innovation opportunities have been identified. Beauty from within is also a growing trend within the functional products market Nygaard noted. This movement sees consumers tailoring their diet to promote skin health and obtain a more youthful look. Many inner beauty products are based on collagen peptides which have been proven in clinical studies to improve the moisture content of skin to boost collagen and elasticity providing more firm and smooth skin. The special amino acid composition of Verisol s collagen peptides enables Verisol to stimulate the fibroblasts in the dermis. This substantially increases the synthesis of collagen elastin and proteoglycans all of which are essential for providing elasticity. As a result the epidermis is supported from beneath skin sagging is prevented and wrinkle formation is reduced. Verisol is complimentary in many different products from liquids to solids coating tablets to dietary drinks and even foodstuffs like chocolate according to the company. Rousselot s Peptan contains a combination of 18 key amino acids and is highly bioavailable with more than 90 percent of the peptides delivered to the connective target tissues within just a few hours of consumption. It has a neutral taste and odor with instant solubility in cold and warm liquid as well as heat stable. It can be utilized in food dietary and nutriacosmetic solutions. Peptan stimulates cell activity and provides specific metabolic signals to produce more collagen and other matrix components in the local tissue Nygaard explained. Peptan is obtained from natural sources of native collagen type 1 a proprietary enzymatic hydrolysis process that June 2016 produces small bioactive peptides which are optimized to provide multiple health benefits in joint bone and skin health. Peptan is also useful in gummies. In fact the company s prototype My Beauty Cherries are functional gummies that act as an example of how collagen peptides can work synergistically with vitamin C in a delivery format that is easy to incorporate into different consumers lifestyles. Bone Health Everyone knows bones need calcium but they also require collagen for optimum health Oliver explained. Bone comprises a mixture of mineral crystals held in an organic collagen matrix. On their own these crystals would be extremely brittle and prone to breakage so collagen plays a key role in keeping the skeletal system healthy. The Bioactive Collagen Peptides in Fortibone by Gelita stimulate osteoblast cells to increase the production of the extracellular bone matrix the essential framework that supports calcium mineralization. It also regulates certain degenerative processes by reducing protease production in osteoclasts. Fortigel has been scientifically shown to measurably stimulate the synthesis of cartilage tissue thus counteracting the wear and tear on joint cartilage caused by factors such as aging excessive weight bearing or extensive physical exercise. Fortibone and Fortigel can be utilized in dairy products functional food food supplements and beverages and Fortigel can also be used in gummy snacks. Gelita developed the ingredient Bodybalance to fight sarcopenia (the progressive loss of skeletal muscle mass and strength that affects millions of aging adults). These specific collagen peptides were found to further increase the benefits of resistance training in elderly people with sarcopenia in a double-blind placebocontrolled study conducted at the Institute of Sports and Sports Science at the University of Freiburg Germany. The ingredient is a natural source of protein is allergen-free and can be used to develop clean label products such as beverages shakes bars gels and instant foods such as soups. Future of Functional The consumer is becoming increasingly aware that functional foods and beverages can help to maintain a healthy state and perhaps more importantly should be taken to maintain a healthy lifestyle. This growth trend in the market for functional foods and beverages will only continue Kennedy said. The challenge has been to deliver these ingredients in a format that consistently delivers that nutrition in a convenient manner while tasting delicious Lutomski stated. An example of co-innovation for a new nutrient delivery concept Nygaard explained comes from a collaboration between Fortified Food Coatings Rousselot and DSM who together developed a concept which enhances the nutrient content of food by applying a layer of nutrient fortified gelatin to ready meals targeting for example the aged care sector. Ingredient suppliers Nygaard pointed out who offer global expertise and in-house technical experts than can work in close partnership with manufacturers to facilitate the use of ingredients in their applications co-develop new products and get them to market faster will have the most impact on future innovation. NIE Extra Extra Visit to read about the functional benefits of lactic acid bacteria. FORMOREINFORMATION AIDP (866) 262-6699 Cargill (800) 227-4455 Extracts & Ingredients div. of MORRE-Tech Industries (908) 688-9009 FutureCeuticals Inc. (815) 507-1400 Gelita 49 6271 84 01 Milk Specialties Global (952) 942-7310 Nutrition 21 LLC (914) 701-4500 Polyphenolics (866) 308-7678 Peptan Rousselot Inc. (888) 455-3556 Welch s Global Ingredients Group (800) 340-6870 World Food Processing (641) 672-9651 Nutrition Industry Executive 37 June 2016 As the food industry lurches from scare to scare the dietary supplement industry waits for the dust to settle on the FSMA and maybe thinks it s time to feel good about itself. By James Gormley The Participants Are Daniel Fabricant PhD Executive Director and CEO Natural Products Association (NPA) Duffy MacKay ND Senior Vice President Scientific & Regulatory Affairs Council for Responsible Nutrition (CRN) Michael McGuffin President American Herbal Products Association (AHPA) Justin J. Prochnow Shareholder Greenberg Traurig LLP Justin J. Prochnow N Daniel Fabricant Scott C. Tips JD President National Health Federation (NHF) Scott C. Tips Duffy MacKay Michael McGuffin IE The Peanut Corporation of America (PCA) shut its doors in 2009 after a 2008 outbreak of Salmonella typhimurium killed nine people and sickened 714 others making it the deadliest salmonella crisis in recent years and resulting in one of the largest food recalls in American history. In September 2015 Stewart Parnell the PCA s former president was essentially sentenced to life behind bars for knowingly shipping out the contaminated products. A federal magistrate handed Parnell a 28-year prison sentence the strongest penalty ever for a company executive in a food-poisoning outbreak. His brother and food-broker Michael Parnell was hit with a 20-year sentence and the plant s quality assurance head Mary Wilkerson received five years. June 2016 38 Nutrition Industry Executive In 2014 Eric and Ryan Jensen brothers who owned and ran Jensen Farms in Holly CO each received five years probation six months of home detention fines and restitution for their role in a listeria outbreak in improperly cleaned cantaloupe that killed 33 people in 2011. Chipotle Mexican Grill is the most recent food-safety crisis. Two Escherichia coli outbreaks in late 2015 sickened 60 people across 14 states and in December about 140 people in Boston MA reported feeling sick as part of a norovirus outbreak at a Chipotle there. Panera Bread is now investing more in food safety as a result of Chipotle s series of problems. What takeaway do all of these foodsafety disasters offer to the health-food industry Fabricant I think it has put the spotlight on companies to hire micro and food toxicologists. We take them for granted because maybe the focus for a company has been to get their QA QC really tight. When you tally all the numbers from drug adverse events submitted to FDA (U.S. Food and Drug Administration) with numbers reported from outbreaks to CDC (U.S. Centers for Disease Control and Prevention) and the reportable food registry for conventional foods and you compare those to the number of voluntary reports and mandatory serious adverse events reported for dietary supplements people don t realize how much safer supplements are in comparison to the other two. NPA tracks those valuable statistics for its members so that we can combat the negative attacks against our industry by those on the outside who don t really understand that dietary supplements are regulated. What separates the dietary supplement industry from conventional foods at this point is that dietary supplements are the only commodity of food at present to have a mandatory reporting requirements for serious adverse events. When a tox signal lights up I think FDA is ready to do something about it like DMAA (1 3dimethylamylamine methylhexanamine or geranium extract). Foods relies on outbreak data reported to CDC which is already too late to stop it at an earlier point in time and to a lesser degree on their data from the reportable food registry. When you compared GMPs (good manufacturing practices) between conventional foods and dietary supplements there is no comparison. Dietary supplement cGMPs were patterned after the drug industry. The dietary supplement cGMP playbook for part 111 (21 CFR Part June 2016 111. or CGMPs) is 813 pages. The rule for conventional foods pales in comparison. I think that is another major contrast. with people experienced in dealing with such situations is an important facet of the plan. NIE Has consumer trust in prepared foods been grievously harmed What about consumer trust in dietary supplements and functional foods beverages-- any fallout Fabricant You will always have these issues creep up from time to time. I think most people have faith that their food is fine. There are federal regulations to follow. There are the new preventive controls for ingredients in place. Safety is getting better over each decade not worse and that is the expectation of the public. Prochnow No I don t believe that consumer trust in prepared foods has been grievously harmed. While it has probably hurt Chipotle s business short term I would imagine that long term people will forget those issues. I think that most people realize that there are going to be contaminations from time to time. People still eat peanut butter spinach eat at Taco Bell and even have cantaloupe here in Colorado. Ironically while safety issues should be a bigger concern I think people continue to be more skeptical about the claims being made on products. In my opinion actions by the New York attorney general and others have caused people to question more about what is actually in products than being concerned about the safety. Tips Absolutely it has. But I do see that this has been largely limited to prepared foods at specific restaurants such as Chipotle with a lesser degree of fear attaching to other such restaurants. I do not see that it has affected food supplements or functional foods and beverages. Still as with what happened to Jack in the Box when it had its own meat contamination issues some years ago this too will eventually pass for Chipotle if that restaurant s management employs a good damage-control team and implements the correct food-safety measures. NIE What generally and specifically is the industry doing to make safer products comply with government food-safety regulations and regain (or maintain) consumer confidence Fabricant FDA has mandatory recall authority and they have used it for supplements. I was the first to use that authority at FDA. There have been voluntary recalls performed. These are all the same things conventional food companies have been expected to do and you Nutrition Industry Executive 39 Actions by the New York attorney general and others have caused people to question more about what is actually in products than being concerned about the safety. -- Justin J. Prochnow Shareholder Greenberg Traurig LLP Prochnow The recent food-safety scares indicate the continuing need to stay on top of the manufacturing and suppliers of ingredients. And also that you can do all you can and you still may be faced with a recall situation. We have many recall situations of late where a company received an ingredient from an ingredient supplier. The ingredient came with a COA (certificate of analysis) and a clean bill of health from the supplier. The company tested the ingredient and it passed with no contamination. The ingredient was used in products which were also tested before being shipped. Then the company gets notice from its ingredient supplier that another customer of the supplier tested the ingredient and it tested positive for salmonella. Then every company along the chain and companies along other chains using that same ingredient are looked at to recall product. Of course FDA is doing this to ensure consumer safety. But companies that test the product over and over are forced to spend time money and energy and there is really no way to prevent it. So the biggest takeaway is that companies must be prepared. Companies should have SOPs (standard operating procedures) in place and plan of action in case a food contamination issue happens at their own facility or from an ingredient supplier. Companies should be running mock recalls. And companies should have a PR strategy in place. While a company like Chipotle is likely to be able to weather the storm over time smaller companies are unlikely to be able to stay in business. Having a strategy in place can contrast the adverse events [among supplements foods and prescription drugs]. NIE How has the natural products industry been affected since the enactment of FSMA Fabricant I think very little is the answer. NPA has asked FDA on where they are in terms of their inspections of ingredient suppliers. How will FDA enforce the new FSMA (Food Safety Modernization Act) rules When will they roll it out How many inspectors will be tasked to inspect dietary ingredient suppliers domestically and more importantly in foreign governments like China and India No one knows. It is the great elephant in the room that no one is talking about in an open forum. We have asked FDA for a special FSMA session related to dietary ingredients used in dietary supplements. They have held special FSMA engagements in public stakeholder meetings on every other aspect from FSMA except dietary ingredients. I think FSMA also places heavy burdens on the manufacturer once again to verify aspects of their ingredient supplier. It is a passing of the buck onto manufacturers. We will see how this all plays out soon but it seems like a nonlevel playing field. It is crucial for it to be addressed in a meeting with FDA on dietary ingredients. MacKay As the compliance dates for various parts of the law are staggered it s fair to say that it s too soon for the dietary supplement industry to have seen or to evaluate the true impact of FSMA. But our hope is that over time this law will have a major impact on the entire food industry--including dietary supplements--and that impact will benefit both consumers and industry in a positive way. We ve already seen some implementation that should provide increased efficiencies for FDA enforcement. For example the requirement for bi-annual registration of facilities was enacted immediately and we re supportive of that change in the law because it allows FDA to respond to a food-related emergency quickly and efficiently. We also saw FDA use its new authority granted by FSMA for administrative 40 Nutrition Industry Executive detention--this new tool allowed FDA to essentially remove ingredients like DMAA and Kratom [Mitragyna speciosa] from the market. As regulators the agency needs these tools and as industry we should support removal of ingredients from dietary supplement products that don t meet legal requirements and may pose a threat to consumer safety. NIE While the FSMA (Public Law 111353) does provide some improved foodsafety system measures some believe that its over-reliance on recordkeeping and documentation that features a hazard analysis and critical control point (HACCP) algorithmic risk-based approach to food safety and an under-reliance on on-site physical inspections does little to address the core problems in this country s food-safety system filthy factory farms and abysmal slaughterhouses. Agree disagree Why Fabricant Yes I agree somewhat. It can be viewed as a paper shuffle. I think that will address some compliance issues but not all. I think you need to have a balanced approach with actual boots on the ground as they say in the military. FDA inspectors looking at ingredient supplier facilities rather than looking at record keeping is critical. We need to know how they will enforce and hold ingredient suppliers accountable. NIE Does FSMA saddle raw material suppliers with an overly complex and expensive system of paperwork and systems and onerous requirements Yes no Please explain. Fabricant I can t say that it is all is unnecessary. There are certain aspects of FSMA which have merit and have served fish HACCPs well over the years. If FDA has hope of evaluating safety then I think inspections are the way to go. MacKay In principal we know some companies have expressed concerns that there s unnecessary and burdensome paperwork that does not directly transfer to a safer food supply required by FSMA. But the fact is it s too soon to see if that s true because we ve yet to see how FDA will enforce that section of the law. We really appreciated when former FDA commissioner Dr. Mark McClellan publicly pronounced at a press conference about ephedra that FDA should not be claiming that DSHEA (Dietary Supplement Health and Education Act of 1994) didn t work at least until they had tried to make it work. We feel the same way in this situation. In principal FSMA is well designed and we need to see it in practice before we determine it s too cumbersome. What we hope we ll find is that it properly balances ensuring safe food with new record keeping requirements. NIE Does FSMA expose legitimate manufacturers (and classes of products) to baseless allegations of adulteration June 2016 McGuffin The full effects of FSMA on the natural products industry won t be fully known until all of the rules are implemented. The biggest changes including the new food good manufacturing practice hazard analysis RiskBased Preventative Control rule and the Foreign Supplier Verification Program rule will roll out in phases starting in September 2016 for the largest manufacturers. With the implementation of FSMA FDA has taken a collaborative educate then regulate approach by providing significant resources and engagement opportunities before the major rules roll out. AHPA is hopeful this collaborative approach is one that FDA will carry forward the implementation and enforcement of rules agencywide. Prochnow While I think companies have had to make some changes with the enactment of FSMA I think the new manufacturing practices being implemented in 21 CFR 117 are going to have a greater affect than any previous regulations enacted pursuant to FSMA. While FSMA gave the FDA more latitude to initiate mandatory recalls such powers have been used very sparingly. tamination and misbranding Fabricant No because I think manufacturers have GMPs to focus on. I think FSMA shifts the burden of raw ingredients to the manufacturer more than it should. We spent years exempting dietary ingredient suppliers from the final rule for dietary supplement cGMPs. You could argue FDA was creating a clear line of demarcation as to who was responsible for what. I think that same wall should be applied in FSMA. Suppliers of dietary ingredients which have been the subject of much controversy for the industry need to step up to the plate and shoulder the regulatory burden if they are responsible companies. I don t see any companies like that creating industry-setting standards like NPA did in the mid90s when cGMPs were discussed in those early days before there was even a regulation. I think you will see large retailers stepping up to demand that those types of quality systems are in place. NIE What was the FSMA s end result regarding raw milk cheeses Fabricant FDA was testing cheese samples for non-toxigenic E. coli because the thinking was that above a certain level these bacteria could indicate unsanitary conditions in a processing plant. However FDA s surveillance sampling has shown that the vast majority of domestic and imported raw milk cheeses were meeting established criteria. FDA is still going to inspect cheese-making facilities and test for pathogens but they are punting on testing for non-toxigenic E. coli in cheese because their collected data thus far has turned up nothing. NIE According to Section 423 of the FSMA if there is a reasonable probability that an article of food is adulterated under section 402 or misbranded under section 403 the FDA will offer the manufacturer an opportunity to cease distribution and recall such article. The FDA has often called products misbranded based on the flimsiest of bases it has also challenged the GRAS (generally recognized as safe) status of certain ingredients (or the data behind NDI [new dietary ingredient] filings) as arguably a back-door attempt to go after certain combination supplements. For example the FDA has also made clear its regulatory animus regarding raw milk products (milk cheeses). Could the FDA attempt to use its expanded recall authority to effectively go on a witch hunt against certain June 2016 Suppliers of dietary ingredients which have been the subject of much controversy for the industry need to step up to the plate and shoulder the regulatory burden if they are responsible companies. -- Daniel Fabricant PhD Executive Director and CEO Natural Products Association products or classes of products that it cannot hurt through existing law Fabricant I think it will use mandatory recall authority on products with a serious safety concern. It has not used 402(f)(1)(B) when a company has failed to file an NDI notification. Instead they will look for cases which if challenged in court they will prevail. Therefore they will choose cases where there is a safety concern and the company has failed to file an NDI notification. Safety concern may not be only serious adverse event reports in the CFSAN Adverse Events Reporting System (CAERS). It may be a plausible mechanism of action the agency has a concern about. It might be lack of scientific studies in the public domain to assure them there is no safety concern. So if you haven t filed and you don t have any basis as to whether the ingredient is safe for human consumption those are cases the Agency could take a second look at. NDI warning letters are also less resource intensive than GMP warning letters. You may see the agency use 402(f)(1)(B) more in the future as resources reduced by FSMA and part 111 GMP inspections become scarce. Prochnow The FDA s expanded mandatory recall authority is pursuant to Section 423 of the Federal Food Drug and Cosmetic Act which was facilitated by the FSMA. 21 USC 350i indicates that the FDA only has mandatory recall for intentionally adulterated food that could cause serious adverse health consequences or death to humans or animals. So the recall authority is still only when there are serious safety issues. In the five years that it has had this expanded authority it has used it very infrequently. NIE In Section 113 of the FSMA there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids which could be excellent if judiciously applied. The FDA merely needs to suspect that a supplement may contain an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement so doesn t this open the door to potential targeting of legitimate manufacturers along with the fly-bynight operators Fabricant FDA will always target the weight-loss and bodybuilding class of products. That is just an expectation based upon FDA s level of success in finding bad actors not listed on the label or drugs masquerading as dietary supplements. For FDA to take a product to task they must test for the presence of that steroid. They won t take action based upon a whim or that it even made a claim to contain it. DEA is now doing temporary scheduling to keep up with novel ingredients that they have never seen before. It is definitely one area where the synthetic chemists are staying ahead of the analytical chemists and that is what makes this area a challenge to regulators. Responsible companies in this space tend to be members of trade organizations like ours because they are doing the right thing from a compliance standpoint. Their doors are always open for inspections. You know they can be found at the address listed on their products. The bad actors tend not to want to be found. They have addresses which point to USPS (U.S. Postal Service) shipping stores or post offices or the listed address on the product is not legitimate. You can also look at the claims. If the claims are unbelievable and too good to Nutrition Industry Executive 41 be true you might deal with anabolic steroid ingredients and fly-by-night operators. Fly-by-night companies tend to live for the here and now and are not built for the long haul. MacKay A product adulterated with an anabolic steroid or steroid analogue is a significant public health threat. As an industry we must embrace any efforts to keep young athletes away from these dangerous products. We d urge the industry to stop being so suspicious of FDA s motives. We re in a new era and we re moving from being a young industry to a more mature industry and with that comes more responsibility to accept regulation and to help the agency weed out those products or companies that could potentially stunt the growth of the responsible industry. This is why CRN supported DASCA (Designer Anabolic Steroid Control Act of 2014) the law that provides FDA and DEA the ability to remove products adulterated with steroids from the market swiftly and efficiently. We have to trust the intent of the law and the agency s mandate to protect consumers through that law. Anabolic steroids are drugs not dietary supplements. Legitimate manufacturers understand that. McGuffin In 2014 the industry trade associations stood together in support of the Designer Anabolic Steroid Control Act that gave DEA the means and authority to aggressively prosecute those who sell anabolic steroids and their analogs as dietary supplements. FDA and DEA should use their full authority to stop the sale of these misbranded drugs and FSMA s Section 113 mandates the interagency communication necessary to make that happen. NIE In Section 404 of an early version of the FSMA it stipulates that Nothing in this act (or an amendment made by this act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g. General Agreement on Tariffs and Trade [GATT] NAFTA [North American Free Trade Agreement] the Uruguay Rounds Codex). Isn t this dangerous ground 42 Nutrition Industry Executive even if it was intended as a pro forma throwaway As an example of unintended consequences of nations including such language one commentator claims that in Canada s new Bill C-36 Health Canada has proposed that the powers provided to Parliament should be forfeited so that Canada can honor its international agreements and commitments. Did this make it into the final version of the law If so has the FDA provided any explanation as to why sovereign U.S. domestic laws and regulations would need to be consistent or not inconsistent with international treaties and agreements We re in a new era and we re moving from being a young industry to a more mature industry and with that comes more responsibility to accept regulation and to help the agency weed out those products or companies that could potentially stunt the growth of the responsible industry. -- Duffy MacKay ND Senior Vice President Scientific & Regulatory Affairs CRN Fabricant This comes up from time to time. FDA always holds the position that its laws are sovereign. While other countries have unique categories for foods U.S. law is unique in our category of foods like dietary supplements. It definitely makes exporting and importing a challenge to our industry. Some countries accept certain certificates of export and others do not. Some countries don t even know what they want from the U.S. in terms of certification. I think they are looking for harmonization but I don t see that happening any time soon. NIE Section 420 of the FSMA states In the interest of national security the Secretary of HHS in consultation with the Secretary of Homeland Security may determine the time manner and form in which the guidance documents [...] are made public including by releasing such documents to targeted audiences. If the U.S. government does not care to release the very instructions and guidance needed by suppliers and producers in order to properly comply with the requirements the government does not have to if covered by the catch-all blanket of national security. Isn t it true that in this way many food producers would likely fail if the requirements (and related compliance guidance) were a secret until inspection Fabricant I think in some ways it sets companies up to fail. However FDA has released final rules and guidance. What we don t know is when inspections will commence and how FDA will enforce that law. FDA has typically released guidance after formal rulemaking to help stakeholders but they are also not in the business of providing much in the way of training and guidance. FDA does not offer cGMP training for part 111. It enforces the law. I think there will be growing pains with the first few years of implementing FSMA once a plan is in place but that is to be expected. It is something new for companies to deal with and they many have not grasped their responsibilities under that law until proper guidance has been provided to stakeholders. NIE What specific steps should the natural products industry take over and above regulations to provide enhanced safety and increased consumer confidence as to dietary supplements and functional foods beverages Fabricant NPA is at the forefront on these issues. We were the first trade to develop a third-party certification program for dietary supplement good manufacturing practices. We are working with retailers and suppliers on many of these issues in light of FSMA. NPA also urges companies to seek third party certification for dietary supplement GMPs. FDA just released finalized guidance on medical foods which in a way parallels functional foods as a category of food in other countries. NPA sees a greater need for medical foods and for FDA to expand what it consider as medical foods. Nutrition is an important consideration to manage some disease. MacKay The dietary supplement industry should be focusing on industry (Continued on page 50) June 2016 FunctionalFoods Probiotics are mainstream prebiotics are on the rise and synbiotics are the next big thing. By Corinne Anderson D ata from the 2012 National Health Interview Survey (NHIS) shows that approximately four million U.S. adults had used probiotics in the past 30 days. Among adults probiotics or prebiotics were the third most commonly used dietary supplement other than vitamins and minerals and the use of probiotics quadrupled between 2007 and 2012 the National Institute of Health (NIH) reported. In addition the NIH said consumers are searching for probiotics and prebiotics in order to aid in a variety of health problems including digestive disorders allergic disorders oral health liver disease colic in infants and even the common cold. State of the Market The consumer demand for these products is growing rapidly resulting from a combination of media exposure industry marketing of the developing favorable research and physician recommendations said Nena June 2016 Dockery technical services manager of Missouri-based Stratum Nutrition. Probiotics are one segment of the dietary supplement industry for which the benefits are universally accepted by standard medicine especially for use following antibiotic regimens. With the awareness of probiotics on the rise consumer demand appears to be for safe natural remedies which can help in the treatment and prevention of various diseases said Dr. M. Ratna Sudha managing director of India-based Unique Biotech Limited. Consumers are also demanding clinically proven scientifically documented probiotic strains with the promised shelf life he continued. Probiotic foods and beverages are the dominant segments in the global market and are expected to have a compound annual growth rate of 6.8 percent from 2013 to 2018 Sudha said. In addition the food and beverage segment of the probiotic market is estimated to reach 37.9 billion USD in 2018. Growth has been augmented by several factors Dockery said. These factors involve stability and shelf life as well as the introduction of sporeforming bacterial species that can flourish under much wider environmental conditions. Spore-forming Strengths Though [spore-forming] species are not normally indigenous to the human body some do colonize in the gut and provide benefits to human health said Dockery. They are much more tolerable to variations in heat and moisture making them better suited for inclusion in a diverse line of non-refrigerated food products. A stable spore-forming probiotic like Bascillus coagulans Unique IS2 by Unique Biotech is ideal for use in food products as its natural encapsulation makes it a hardy probiotic capable of withstanding a wide range of temperatures and processes. It can withstand boiling baking and freezing temperatures and has a wide Nutrition Industry Executive 43 FunctionalFoods application in the food industry because of that Sudha said. BIO-CAT Microbials based in Virginia harnessed the natural spore state of the Bacillus organism which is stable to a wide variety of environmental factors in the company s product Opti-biome Bacillus subtilis MB40. The applications for OptiBiome are numerous said Chris Penet vice president of BIO-CAT Microbials. Applications include powder drink mixes baked goods confection and dairy. Our product has shown to be synergistic in the lab with other conventional probiotics thus increasing the benefits from multi-strain products Penet said. According to Mike Bush president of Ohio-based Ganeden and executive board president of International Probiotics Association (IPA) the company s GanedenBC30 probiotic ingredient can survive through most of the manufacturing processes without requiring special technologies or changes to manufacturing processes. It is a spore-forming strain of bacteria and the natural protective spore makes it highly stable and allows for viability throughout manufacturing shelf life (up to three years) and the gastric acidity of the stomach he noted. Because of its survivability GanedenBC30 is providing consumers with functional foods beverages and companion animal products that were never available before containing a safe and effective probiotic Bush said. GanedenBC30 is easily integrated into virtually any food or beverage and is one of the only probiotics that can be added to foods and beverages outside of refrigerated dairy. GanedenBC30 is currently found in more than 300 leading food beverage and companion animal products throughout the world. In addition to 60 new probiotic product SKUs presented at Natural Products Expo West 2016 Ganeden has also conducted lab studies on prebiotics showing that GanedenBC30 can help them perform better Bush continued. Processing Advancements Improvements in manufacturing processes that increase both shelf stability and survival through the body s digestive processes have improved the suitability of probiotics for use in products to improve human health Dockery said. Probiotics are living microorganisms that thrive in the body where conditions are warm and moist with ample sources of nutrients. In storage where nutrient sources are not available introduction of heat and or moisture causes the bacteria to grow and reproduce but subsequently die for lack of nutrients Dockery explained. Therefore the preferred storage condition for most probiotics is cool to refrigerated and dry to ensure dormancy until they enter the body. Use in conventional foods is limited to refrigerated products such as yogurt that are a natural growth media for several species of probiotic bacteria. But recently advances in different avenues such as coatings encapsulations packaging and more have extended the shelf stability of probiotics. Manufacturing processes using coatings or microencapsulation techniques have helped ensure survival of June 2016 Go to nutraceutix for info about this advertiser 44 Nutrition Industry Executive probiotics through the acidic environment of the stomach enabling them to provide positive benefits in the intestine. In addition improvements in packaging such as blister packs have helped improve shelf stability Dockery revealed. Spore-forming bacteria as probiotics have also expanded the possibilities for food inclusion. They have their own protective shell (endospore) enabling them to survive the very harsh conditions of heat and moisture Dockery noted. Therefore they can be included in many conventional food products such as cereals and bars. As a result of advances in the spore-forming bacteria as well as improvements in protective coatings the use of probiotics in non-refrigerated foods has increased. There has also been a trend toward emphasizing strain specificity in research and marketing of probiotics for targeted uses Dockery said. The gut microbiota play a very important role in defining our health status Sudha added. Eubiosis or the proper balance of bacteria strongly influences the healthy status and any imbalance leads to dysbiosis and diseases. Sue Hewlings chief science officer at Oklahoma-based IgY Nutrition said It has been suggested that probiotics play a role in correcting the dysbiosis. However they are not strain specific and since dysbiosis can present differently in each person they may not always address the imbalance. Probiotics are not all alike NIH said. For example if a specific kind of Lactobacilllus helps prevent an illness that doesn t necessarily mean that another kind of Lactobacillus would have the same effect or that any of the Bifidobacterium probiotics would do the same thing. health market is the recognition that across generations consumers are utilizing digestive health products and therefore marketing goals have shifted from a primarily older market Hewlings observed. In relation to prebiotics though Hewlings noted that even with increased awareness of probiotics consumers have very little knowledge about benefits of prebiotics or the combination of pre- and probiotics. There is a need for more education from suppliers to customers and it starts with more clinical research she said. IgY Max made by IgY is a polyvalent antigen specific IgY product targeting 26 of the most common human-relevant pathogens. Other IgY products only target one pathogen making them monovalent. IgY Max is a unique digestive and immune function ingredient that promotes GI (gastrointestinal) health by increasing gut wall integrity improving bowel function and reducing non-beneficial bacteria adherence and in doing so Digestive Health Digestive wellness is becoming one of the top global trends in the market 70 million of U.S. consumers are using digestive health products and 44 million are taking a probiotic Hewlings noted. Due primarily to information obtained through new research consumer awareness of the connection between gut health and overall well-being is increasing. An additional trend in the digestive June 2016 Go to biocat for info about this advertiser Nutrition Industry Executive 45 FunctionalFoods functions much like a prebiotic. Made of hyperimmune egg powder it is much like a prebiotic in that it changes the composition and activity of the microbiome Hewlings said. Moreover IgY Max is able to exert its activity within the entire length of the GI tract. Due to its mechanism of action IgY Max is an effective tool to address issues caused by dysbiosis. products designed to feed the body s indigenous microbiota. While the prebiotic market has been dominated by fructo-oligosaccharides (FOS) inulin etc. in recent times the prebiotic market has seen some innovative concepts coming up said Shaheen Majeed marketing director of New Jersey-based Sabinsa. Very recently Sabinsa and Fruit d Or (Quebec Canada) launched a new symbiotic product called LactoCran. This is a customized product containing LactoSpore (Bacillus coagulans MTCC5856) as probiotic and cranberry seed powder as prebiotic. This specific combination was carefully designed to deliver the optimum nutrition to B. coagulans which showed more growth in the presence of cranberry seed powder Majeed explained. While the science of prebiotic feeding probiotics is not new scientists at Sabinsa also focused on using the right prebiotic for its strain to optimize probiotic benefits. Sabinsa zeroed in on a few fibers which provide optimum nutrition to B. coagulans in the gut such as FenuFibers and cranberry seed powder. These fibers have shown better growth of B. coagulans than regular inulins and FOS. Recently Fruit d Or Nutraceuticals launched Choco Cran the world s first cranberry probiotic organic chocolate peanut butter cup. Each Choco Cran contains prebiotic probiotic and protein as well as fatty acids omega 3 6 and 9. Choco Cran contains LactoCran one of the first of its kind symbiotic tailored to suit specific formulation demands Majeed shared. The chocolate presents both the benefits of probiotic LactoSpore and prebiotic benefits of cranberry seeds. Oral Health Another area of use of probiotics for applications beyond gut health is oral health. Research focusing on protection derived from bacteria that colonize in the mouth has led to intense investigation into the supplementation of select bacterial strains designed to complement the microbiome of the oral variety Dockery shared. These probiotics help protect us from a host of invaders that daily try to make our bodies their home. Stratum Nutrition specializes in probiotic strains indigenous to the oral cavity and designed to support health in multiple ways. BLIS K12 is a rare strain of Streptococcus salivarius one of the common species of bacteria found in the mouths of healthy individuals. Studies conducted predominately in children have demonstrated its benefits to throat and ear health. In addition BLIS K12 has also been shown to assist in controlling bad breath caused by the overabundance of volatile sulfur-producing bacteria in the mouth. In addition to BLIS K12 Stratum also markets BLIS M18 another rare strain of S. salivarius found naturally in the oral cavity of about 2 percent of the population according to the company. This probiotic helps decrease periodontal inflammation and protects the teeth and gums from undesirable bacteria that contribute to plaque buildup and tooth decay. Benefits In the not so distant past the foods of many of our relatives consumer came directly from the farm or local markets and naturally contained a wide diversity of beneficial bacteria. However advances in sterilization and pasteurization methods contributed to the removal of the natural microbial content in foods. In addition prebiotic fiber content was much higher before the era of refined foods and advanced processing techniques. June 2016 Synbiotic The growth of prebiotics has been slower than probiotics Dockery noted. Mostly due to the lack of consumer understanding of their purpose. The growth is steady however as companies continue to convey the message of the benefits of prebiotics both as additions to probiotic formulations (synbiotics) and as standalone 46 Nutrition Industry Executive Other factors Dockery continued including the Western fast food diet as well as overuse of antibiotics and antimicrobial cleansers have contributed to the necessity of pre- probiotic supplementation to improve immune and gut health. Oral and upper respiratory health can be detrimentally affects by an unhealthy microbiome in the oral cavity caused not only by poor diet or lack of dental hygiene but also by medications or even antimicrobial mouthwashes Dockery said. Probiotics are generally recognized as safe (GRAS) and have a long history of use with no known toxicity. With so many products adding pre- and probiotics to final products the question some consumers may ask is is there a possibility for over consumption of pre- and probiotics I do not see the possibility of overconsumption happening unless the customer is selectively consuming only foods fortified with probiotics throughout the day Sudha said. There is a limit to the number and kinds of bacteria that would exert a positive effect in the gut. It would be possible to reach a point where more isn t better. Consumption of too much fiber even prebiotic fiber in most cases would be self-limiting because of expected intestinal side effects of gas bloating and discomfort Dockery shared. Bush noted that consumers can take a variety of probiotic products daily without concern for adverse effects. Our safety level is so high that manufacturers have not come close to it. It is important to do your homework though Hewlings warned. For example patients with IBS (irritable bowel syndrome) have shown a reduction in Lactobacillus or Bifidobacterium and may benefit from consuming probiotics containing more of these. Be sure that there is sound scientific evidence that the specific strain being consumed is appropriate for the specific indication. Yes people may benefit from having more of one strain than the other for a specific condition however research on the exact balance needed is still evolving. To the Future Pre- and probiotics cover a wide range of applications from immunity digestive health oral health renal health inflammation diabetes obesity cancer cardiovascular diseases and even in sports nutrition. Topical applications for wound healing acne etc. are also available. Evidence linking the gut to the brain axis has led to the discovery of probiotics as physchobiotics with application in treatment of depression anxiety and autism Sudha shared. Which Bacillus coagulans we have explored a variety of food applications including gummies mixes for frozen yogurts breads cookies cof- fee chocolates health bars candies soups juices ... the possibilities really are endless Majeed said. In our view [the state of the market] is still limited due to stability issues for the traditional probiotics. Growing certainly as supplements but limited in food applications where shelf life claims are still an issue said BIO-CAT s Penet. Overall the market is thriving and continuing to expand as new applications and advancements are made to maintain the pre- and probiotic strains being sent into the body. The global market of probiotic ingredients supplements and foods is growing and expected to reach 36.7 billion in 2018 according to Wellesley MA-based technology markets research firm BCC Research Bush shared. One thing is sure Hewlings said having a diverse microbiome is the key to a healthy gut. So adding good bacteria such as probiotics or nutrients for the bacteria to flourish the prebiotics is very beneficial to your digestive health. NIE FORMOREINFORMATION BIO-CAT Microbials (877) 912-4622 Ganeden (440) 229-5200 IgY Nutrition (405) 242-5381 Sabinsa (732) 777-1111 Stratum Nutrition (888) 403-5039 Unique Biotech Limited 91 40-23751345 Conventions&Meetings Vitafoods Europe 2016 itafoods Europe celebrated its 20th anniversary at this year s annual event in Geneva Switzerland. Vitafoods Europe invited the nutraceutical supply chain to attend covering four key sectors ingredients and raw materials contract manufacturing and private label services and equipment and finished products. Vitafoods provided visitors the opportunity to source ingredients raw materials dietary supplements and services to help grow their business exhibition producers Informa said. Held May 10-12 new features at the trade show included a Vitafoods Centre Stage Life Stages June 2016 V Theatre Optimal Health Testing Centre LaunchPad Vitafoods Venture Den Sports Nutrition Zone Vitafoods Data Centre Springboard Pavilion Regulatory Advice Centre and Spotlights at the Tasting Bar. New findings were also revealed at Vitafoods including an E.U.-funded Full4Health study which has been looking into the psychology of eating habits presented by Professor Julian Mercer from the University of Aberdeen s Rowett Institute of Nutrition & Health. Dr. Angela Bonnema senior nutrition scientist at U.S.-based Cargill and Soraya Shirazi-Beechey professor of molecular physiology and biochemistry at the University of Liverpool presented results from Project SATIN--SATiety INnovation a E.U.-funded project investigating how the bioactives found in food could offer cardiovascular health benefits. Other speakers included Claudio Franceschi from the University of Bologna Katrina Lytton U.K. nutrition lead at KPMG and Inga Koehler senior manager regulatory affairs at Pfizer Consumer Healthcare among others. Next year s Vitafoods Europe will be held May 9-11 at the Palexpo in Geneva Switzerland. Nutrition Industry Executive 47 MarketingInnovations By Todd Pauli The Shelton Group here are all kinds of things wrong with the title of this article. First while the content marketing strategy you may be considering for your business doesn t involve buying media from outside sources it s not really free. It s some of the most laborintensive yet worthwhile work you ll do to promote your business. Second the title itself with its cheap attention getter is everything content marketing is not. A good content marketing strategy that is carried out correctly builds a genuine connection with customers over the long term something all of us in this industry can especially appreciate. Content marketing is the polar opposite of catchy tag lines cheesy advertising and so many things that might have worked before consumers had the ability to skip television commercials or enable ad blocker. T A lot of attention has been paid to the nuts and bolts of content marketing and this column is no exception. In past issues we ve covered aspects of content marketing like email campaigns and effectively using video and infographics but stepping back to evaluate why content marketing makes sense and how to approach it successfully will ultimately help your company run better campaigns that attract a loyal customer base. What is Content Marketing Before we move into brass tacks of how content marketing works let s cover a few definitions. You ve probably heard the terms content marketing and inbound marketing but since they are often thrown around as marketing buzzwords it s important to understand what they are and how they differ from traditional adverting. Content marketing means creating valuable content that engages potential customers in a way that eventually leads them to purchase your product. The key terms here are valuable and eventually. The value of the content is measured in the eyes of your customer. Blatant product pitches rarely fit that aspect of content marketing. Also content marketing is a long-term strategy. It takes time and persistence to build a real relationship with customers by creating content. Digital audiences are flooded with content making it tough for your company s efforts to stand out. Publishing on a regular schedule and offering readers something they truly find valuable is key to being successful. Outbound vs. Inbound Marketing Broadly speaking marketing strategies can be categorized as either inbound or June 2016 48 Nutrition Industry Executive outbound. Inbound refers to using content you produce to gain a customer s attention and move them through different steps in the sales cycle. Outbound is the name for more traditional tactics you use to grab attention like advertising or event sponsorships. With inbound marketing you re not hoping to interrupt your target audience and get their attention with an ad or a direct mail piece. Instead you align your content with the topics your potential customers are actively searching for so your brand is integrated into the customer s search for information as part of the purchasing process. A potential customer might see a blog post you wrote because a connection shared it on LinkedIn. She clicks the headline finds the article helpful and she opts-in to receive emails alerts for future blog posts. She continues to read your content and when she is eventually in the market for a product or service like yours she already knows your brand views you as a thought leader when it comes to the product she is considering and she reaches out to you for an initial sales call. With a successful content marketing strategy the customer s trust in your brand often comes before she even meets someone from your sales team. Building that customer relationship digitally is valuable since the vast majority of buyers begin their B2B product search online and often rule out most companies before they even speak to a sale representative. This is a crucial process to understand because no matter how charming and well informed your sales people are if the information and materials that are searchable online aren t solid you lose a huge number of potential customers that you ll never even know about. prompt a prospect to opt in for further communication from your brand you have earned the right to reach out to that customer in the future for free. Outbound tactics like ads and tradeshows are perfect for initially engaging new prospects. Inbound tactics like engaging email campaigns sustain the relationship with a prospect and move her through the sales pipeline. Melding Traditional Marketing & Content Marketing Both outbound and inbound strategies are an important part of your overall marketing mix. Outbound tactics such as running digital and print ads with trade magazines and participating in trade shows are great ways to access a larger targeted audience you couldn t reach on your own. A good content marketing program furthers those efforts by engaging the audience for the long term. At the center of a great content marketing strategy is the email list. If you produce content worthy enough to June 2016 Consider two possible digital ads-- one that integrates your content marketing strategy and one that doesn t. The first ad consists of a more traditional call to action We offer the best Product X click here to buy Product X. This ad is highly effective if the person who sees it happens to be looking for Product X at that exact moment. The second ad leverages your content marketing strategy. The headline reads more like an article and less like a product pitch Learn Three Best Practices for Evaluating Bulk Nutrition Ingredients. This content appeals to a buyer no matter whether or not she is looking for your ingredient at the moment. The ad links to a blog post on your site and if the content is truly engaging and carries a strong call to action to sign-up for future posts you ve converted that prospect to a contact you can reach out to on a regular basis at no additional cost. The idea is using your traditional outbound methods to rent an audience initially and using your marketing content strategy to convert that rented prospect into an owned contact. genuine manner. The strategy is dependent upon serving up truly helpful authentic content to prospects instead of a veiled advertising bait and switch. Take the previous example involving the web banner ad with the headline Learn Three Methods for Evaluating Bulk Nutrition Ingredients. For this ad to be successful in growing your owned audience of prospects it actually has to deliver on its promise. Making the third method for evaluating ingredients be Buy Product X From Us is disingenuous and those people who spent the time to click your ad and read the content are smart enough to know when they ve stumbled upon a product pitch. Deception is never a good idea when your goal is to build trust in a brand. There s nothing wrong with product pitches as part of a content program but they should come at the right time in the sales cycle and never be disguised as something other than a pitch. Companies are often tempted to push products too heavily as part of the content strategy because in a traditional outbound strategy the goal is to tell prospects you have something to sell and keep telling them until they pay attention. The problem is more and more people are tuning those ads out so you have to make them more effective. Content marketing is a longer-term play. Brands who do content marketing right establish themselves as thought leaders and industry experts. This has wide-ranging benefits for your brand beyond individual sales to the customers you reach. From an industry perspective establishing your brand as a subject matter expert complements your PR efforts that are demonstrating your expertise and can possibly open up opportunities for editorial exposure and industry speaking engagements. Like anything else if you approach content marketing from a standpoint of wanting to genuinely help customers and the industry we are in more people in the industry are likely to trust you and help your brand as well. Arm Your Sales Team With Content Your company s efforts to create helpful content for emails a blog or your website also fit well into your field sales strategy. The idea of building content around a specific theme or aspect of your business and then disseminating it in several formats to reach different Nutrition Industry Executive 49 The Dividends of Honest Content What I love about content marketing is that it only succeeds in building customer trust if you use it in a trustworthy MarketingInnovations aspects of your target audience is central to content marketing. A great white paper contains all of the content needed to make good blog posts and social media posts and email newsletters. Of course you ll adjust the voice length and look of this content to fit each channel but that s the easy part once you have a good foundation to work with. One often-overlooked content channel is your sales team. Good content makes great training materials for your reps (think new proprietary ingredient extraction process boiled down to a quick infographic a sales rep can reference before a key meeting and even utilize to illustrate the process to the customer). This same training material can also be shared with finished goods partners buyers and even retailers. Sharing content through your sales channel empowers your sales team to establish themselves as thought leaders among their customers and provides the tools for a more effective consultative sales approach. One thing to keep in mind is that not all buyers have high levels of technical understanding so having a less complicated version of your technical material will prove useful in ways you may not have anticipated. Good content marketing has the power to build successful long-term customer relationships. The strategy is rooted in being genuine with customers and sharing more than slick campaigns and tag lines making it a natural fit within our industry. As good companies strive to produce quality products in a transparent way extending that same approach to their marketing strategies makes perfect sense. NIE The Shelton Group is a boutique public relations and marketing agency working exclusively in the dietary supplements and natural products industry since 1990. Todd Pauli works with clients 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. Contact him at Todd (Continued from page 42) accountability. First and foremost all companies should be following the laws whether it s ensuring compliance with good manufacturing practices or submitting NDI notifications as required by law. CRN has announced all of our finished product manufacturers will be required to submit product labels to the ODS (operational data store) database and we ve just announced an industry-wide product registry. These are first steps toward providing increased transparency for researchers regulators and retailers to better understand what s in the market. Eventually we hope the registry will also benefit consumers by helping them evaluate product choices. We have to ask ourselves--what s the right thing to do for our consumers. And then do it. Manufacturing safe high quality beneficial products that will help our consumers live healthier lives--that s what will keep our industry growing. McGuffin Natural products marketers and consumers have often been ahead of both legislators and regulators when it comes to setting product expectations. While we will always appreciate the 50 Nutrition Industry Executive leadership of our Congressional allies in crafting the DSHEA in 1994 it was consumer demand for access to herbs and other supplements that led to this Congressional action. In other words DSHEA did not create the supplement market--supplement consumers created DSHEA. Similarly in 2006 a broad coalition of industry trade associations and consumer groups led the Congress to pass the Dietary Supplement and Nonprescription Drug Consumer Protection Act thereby creating a new requirement for supplement marketers to submit all serious adverse event reports received in association with their products and again enhancing product safety. Existing regulations can currently be viewed as completely adequate to ensure that all supplement products and their ingredients are safe. If this view changes recent history suggests the industry will once again lead the way to better regulations. Prochnow I think it is important for the industry internally to address companies clearly operating in violation of the law. Whether it is a trade organization refusing membership companies reporting egregious violators to the FDA or taking action through a number of different channels weeding out the clear bad actors sends a message that the industry isn t going to tolerate companies operating outside the law. Individually companies should be doing more frequent testing of label claims to ensure they are meeting the claims made on the labels so that consumers can confidently expect they are getting what they think they are buying. Tips One part of the industry is ignoring the new food-safety measures and simply continuing to do business as normal hoping that they won t get caught or that when they do that it will result in a relatively painless slap-on-the-wrist punishment. Given FDA s stretched-to-capacity situation many of these companies actually will coast along under the radar for many years. However the more responsible companies are implementing measures to comply with government food-safety regulations. But what I see as the more important trend in food safety here is that some trade organizations have adopted their own food safety certification programs that their members either must adopt or may adopt. The real future of food safety does not lie in coercive governmental dictates which are always subject to political vagaries and corruption but lies in voluntary industry standards and practices backed by strong certification programs that will assure consumers that the products they are buying are safe and healthful. NIE Extra Extra Visit to read about the good news of food safety and supplements. June 2016 WINNING LOSING BATTLE THE (Continued from page 30) consumption of Sensoril resulted in significant reductions in stress and irritability which helped improve mood. This type of response can help provide resistance to stress-related overeating for stress eaters he said. Relora from InterHealth Nutraceuticals is effective for this population as well. According to Djikstra a randomized double-blind placebo-controlled study showed that Relora was able to maintain body weight in stress eaters. In the study subjects who self-identified as eating in response to stress completed the trial. Subjects took 250 mg of Relora or a placebo three times a day for six weeks. Compared to the study baseline there was significant weight gain for the placebo group. But no significant weight gain for the group taking Relora. Natural phytoextracts such as GarCitrin said Majeed may also work here as the naturally occurring content of HCA has been shown to provide a sense of satiety which is an ideal solution for the numerous consumers for whom stress eating is a way of life. Further other groups that place weight loss--or control--include new mothers who want to shed the baby weight and people who gain weight after quitting cigarettes. Marketing weight-control products to these groups and encouraging your retailer network to cross-merchandise your supplements in the women s health and natural smoking cessation categories will serve as reminders and add the convenience of purchase. Overall when an individual commits to getting into better physical shape through losing weight he or she has a specific circumstance. Therefore promotions marketing materials and social media campaigns can be tailored for each group--even for the same supplement. Consumers are more willing to bond with brands that speak to their specific circumstances rather than those that just have a global approach. NIE Extra Extra Visit to read how the weight management category will grow. FORMOREINFORMATION Icon Group (802) 257-5345 InterHealth Nutraceuticals (800) 783-4636 OmniActives (866) 588-3629 Pharmachem Laboratories Inc. (800) 526-0609 Sabinsa (801) 465-8400 (732) 777-1111 Advertiser Index American Laboratories Inc. BIO-CAT Comar LLC Euromed USA Inc. Healthco Herbally Yours HSU s Ginseng Enterprises Inc. Jiaherb Inc. Nutraceutix Inc. Nutragenesis Icon Group PLT Health Solutions Inc. Sabinsa Corporation Soma Labs Inc. Specialty Enzymes & Biochem Texas Best Organics Inc. United States Pharmaceopea 8 45 10 C3 1 15 14 5 44 31 3 C2 8 7 9 C4 (402) 339-2494 (877) 912-4622 (856) 507-5402 (877) 696-3960 (800) 477-3949 (480) 892-8220 (800) 388-3818 (888) 542-4372 (425) 883-9518 (802) 257-5345 (973) 984-0900 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (909) 613-1660 (409) 658-7201 (301) 230-6361 americanlaboratories biocat comar euromed healthco herballyyours hsus jiaherb nutraceutix nutragenesis plt sabinsa somalabs specialtyenzymes texasbestorganics usp Industry Events June 13-16 NBJ Summit St. Regis Resort Dana Point CA June 14-16 EastPack & HBA Global Expo Jacob K. Javits Convention Center New York NY or June 30 - July 1 Nutraceutical and Functional Food Asia Pacific Summit 2016 Novotel Singapore Clarke Quay Singapore July 16-19 IFT 2016 McCormick Place South Chicago IL September 21-22 MinnPack Minneapolis Convention Center Minneapolis MN November 15-17 Advanced Manufacturing Expo & Conference Centro Banamex Mexico City Mexico June 2016 Nutrition Industry Executive 51 ContractManufactureroftheMonth Valimenta Labs Emek Blair PhD Valimenta Labs 216 Racquette Dr. 1 Fort Collins CO 80524 Phone (970) 825-5173 Email emek Website Valimenta Labs is an industry leader in manufacturing custom liposomal and liquid dietary supplements. The company s proprietary liposomal manufacturing process uses no heat no high pressure and no solvents and is clinically proven through double-blind placebo-controlled university clinical trials. Emek Blair PhD earned his undergraduate degree at Occidental College and performed his graduate work in BioAnalytical Chemistry at The University of California Irvine where he received three major awards for his work on enzymes and lipids. More than a decade ago Blair discovered a natural method to form liposomes which Valimenta Labs applies to producing liposomal products. Because this method is derived from nature the process is unique and does not require high pressures high temperatures or toxic synthetic chemicals. Blair has formulated more than 60 unique liposomal formulas that have been brought to market successfully. In 2014 one of his formulas was recognized at SupplySide West as one of the top five antioxidant formulas at the conference. NIE How did you discover a natural method to form liposomes Blair Starting in 2001 I was focused on wrapping lipids and surfactants around enzymes and proteins while performing my graduate research. I would basically make lipid films with proteins inside them in order to better understand how electrons flow through them. At the time I was using standard techniques such as sonication and dehydration rehydration to make stable lipid films. Unfortunately these techniques where far too aggressive and would result in the destruction of the enzymes I was attempting to study. After adjusting my methodology I was able to make lipid enzyme films but noticed that after a short while they would dissolve into solution as liposomes. At the time this caused significant research issues but this happy accident ended up being valuable on its own. From these sets of circumstances I was able to put together a manufacturing system that would naturally form liposomes without pressure heat or solvents. bility without the need for hydrogenated or hydroxylated ingredients (these types of saturated fats increase cholesterol and have other negative side effects). Furthermore this method does not require the lipids to first be dissolved in alcohol which allows us to make alcohol-free products. Overall this allows every ingredient in our product to be health building and as natural as possible. NIE The company recently released a study about liposomal vitamin C. What are the highlights of the study Blair We performed a doubleblind placebo-controlled crossover study on liposomal vitamin C made using our technology for efficacy and bioavailability. From what I can find in the literature this is the first example of liposomal dietary supplements showing improved performance in regards to bioavailability and antioxidant efficacy over standard supplementation. The first part of the study showed significantly higher levels of vitamin C in blood serum levels as compared to powdered vitamin C while circulating in the blood (not clearing from the system) for a significantly longer period of time. The second part of the study showed how liposomal vitamin C prevented oxidative stress during an ischemia-reperfusion event. Ischemia describes any tissue that has been deprived of blood and oxygen. Reperfusion occurs when the blood and oxygen supply is returned. Unfortunately reperfusion can cause massive oxidative stress on your cardiovascular system as the oxygen interacts with metabolites produced by the oxygen-deprived tissues. During the reperfusion for the subjects that took the liposomal vitamin C their oxidative stress was reduced below their normal oxidative stress. We pride ourselves on being a science and data driven company that backs its technology with the appropriate studies. We understand that a liposome is not that interesting to the public but what these products can do is interesting to people. NIE Where do you see this technology going forward Blair Just recently we patented liposome delivery through dissolvable strips. The real advantage is its portability. You can fit a month s supply neatly in your pocket the servings are already measured out and we are the only company in the world with this product. NIE How does your proprietery liposomal manufacturing technology set Valimenta Labs apart Blair Manufacturing liposomes without heat and pressure ensures that our products have extended sta52 Nutrition Industry Executive Extra Extra Visit to read the rest of the interview. June 2016 Go to euromed for info about this advertiser Go to usp for info about this advertiser