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Description: In This Issue: EFA Outlook 2018, Supply Innovation, Healthy Blood Sugar, and Herbs & Botanicals

A VRM Media Publication www.niemagazine.com November December 2017 Don t miss a single issue of NIE ... go online to renew your free subscription today NIEmagazine.com NovDec17 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com nowpl for info about this advertiser TableofContents Proud Supporter of VOLUME 22 NO. 9 NOVEMBER DECEMBER2017 F E A T U R E S 36 EFA Outlook 2018 Omega-3 essential fatty acids both marine- and terrainsourced continue to be quite the vibrant evolving category. Consumers are invested--here s what the category looks like for 2018. 40 Blood Sugar Focus Whether they have diabetes or not consumers are increasingly interested in keeping healthy blood sugar levels and natural ingredients are becoming part of the plan. 36 A L S O I N S I D E 55 Supply Innovation The Science of Ingredients section highlights the research supporting the ingredients that can help finished products stand out. C O L U M N S 10 20 27 28 29 30 34 52 67 67 Industry News Ingredient News AHPA Update Conventions & Meetings SupplySide West Wrap Up Association News Science Update Equipment & Packaging Advertiser Index Industry Events Supplier of the Month 4 First Word 6 Legalities 46 Nutraceuticals 48 Marketing Innovation 50 Functional Foods 6 68 FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.niemagazine.com Copyright 2017. Nutrition Industry Executive (ISSN 2331-2602) Volume 22 Number 9 November December 2017. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and November December) by VRM Media 431 Cranbury Road Suite C East Brunswick NJ 08816 USA Phone (732) 432-9600 Fax (732) 432-9288. All rights reserved including the right to reproduce in whole or in part. Not responsible for unsolicited material. Opinions expressed in by-lined articles or advertisements are not necessarily those of Nutrition Industry Executive or its owners. Publisher is not liable for advertiser product claims or representations. Advertisers assume total responsibility for the contents of their advertisements. Printed in U.S.A. Basic annual subscription rate is 50.00. Periodicals Postage Paid at East Brunswick NJ 08816 and additional mailing offices. POSTMASTER Send address changes to Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026. Subscription Customer Service Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com. Back Issues & Single Copies For order information contact (732) 432-9600 or info niemagazine.com. March issue is 25.00. All other issues are 8.00 each. 2 Nutrition Industry Executive www.niemagazine.com November December 2017 Go to www.niemagazine.com plt for info about this advertiser FirstWord Engaging Millennials Industry Groups Want Your Participation re younger generations participating enough in professional industry groups Suzanne Shelton of the The Shelton Group whose company holds memberships in AHPA (American Herbal Products Association) CRN (Council for Responsible Nutrition) and UNPA (United Natural Products Alliance) and who has been involved with the CANI (Consultant Association for the Natural Industry) board and was on the founding board and executive committee of the Natural Products Foundation said she would like to see more. I noticed decades ago that many of the same people have been on trade association boards for multiple terms and it s mostly men in senior management positions Shelton observed. Although it makes sense that companies would designate one person to look out for their interests on association boards it means less diversity in who fills board seats. Experienced board members are probably more efficient as well ... the downside is that a particularly aggressive board member of multiple associations can drive policy that favors companies similar to their own over the needs of others. Shelton noted that some organizations have a junior board in addition to the actual board with the express purpose of nurturing future leadership. It is probably very healthy for the trade associations to initiate similar programs with less senior staff of member companies she said. Another established industry professional James Gormley was a member of the NNFA NPA s (Natural Products Association) communication committee as well as its education committee for several years. He agreed that there is a status quo with industry leadership. However Just as corporations (especially public corporations) are expected to or required to have a succession plan we as an industry should have a succession plan too he noted. Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com Associate Russ Fields Publisher RussF VRMmedia.com Advertising Gary Pfaff Sales Associate GaryP VRMmedia.com Editor-in-Chief Janet Poveromo JanetP VRMmedia.com A Getting Noticed There are advantages to participating in industry professional organizations which go beyond LinkedIn or other social media platforms that a tech-driven generation may prefer for professional networking. Younger people in the industry should be reaching out to the trade associations said Steve Mister Esq. CAE president and CEO of CRN. Many times their companies have a corporate membership to the associations and we re out there and we re able to provide them with services and benefits and they should take advantage of them. One reason is because it is important to their career development to get involved in organizations like CRN and build their reputation in the industry. In case they decide they don t want to stay in the company forever it s a good way to get your name known and have people in the industry know who you are. Managing Editor Shari Barbanel ShariB VRMmedia.com Associate Editor Nicholas Saraceno NicoS VRMmedia.com Contributing Writers Satya Jonnalagadda Todd Pauli Lisa Schofield Marc Ullman Art Director Robert Certo Production Manager RobertC VRMmedia.com Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com Circulation Manager Rosie Brodsky Important Opinions Overall Mister said he has been happy with the level of participation he sees with younger industry members noting that the participants at CRN s 2017 Conference and Workshop represented a diverse range of ages. From an industry standpoint it s important to get the perspective of younger people Mister added. We know that Millennials are a big user of supplements ... so I think it s important in these industry organizations that that perspective gets represented in our committees as such as well as the Boomer perspective. And according to Michael McGuffin president of AHPA Having younger industry members participate in a trade association benefits the organization and contributes to the long-term success of the industry. Rosie StarkServices.com A PUBLICATION OF VRM MEDIA President Daniel McSweeney VRM Media 431 Cranbury Road Ste. C East Brunswick NJ 08816 Phone (732) 432-9600 Fax (732) 432-9288 Email info VRMmedia.com Website www.niemagazine.com VRM Media publishes Nutrition Industry Executive Vitamin Retailer Natural Practitioner and FitnessTrainer magazines. Subscription Customer Service To order a subscription or manage your account please contact us at Nutrition Industry Executive P.O. Box 15026 North Hollywood CA 91615-5026 USA Phone (818) 286-3170 Fax (800) 869-0040 niecs magserv.com www.niemagazine.com Back Issues See the Table of Contents page for price and order information. P.S. The VRM staff would like to wish our readers a very happy and healthy holiday season and a prosperous New Year. Connect With Us www.twitter.com www.facebook.com www.linkedin.com www.instagram.com www.pinterest.com vitaminretailer vitaminretailermagazine company vrm-media vitaminretailermagazine vrm_media 4 Nutrition Industry Executive www.niemagazine.com November December 2017 Go to www.niemagazine.com jiaherb for info about this advertiser Legalities FDA and the Slowing Pace of Ingredient Innovation By Marc Ullman Esq. O ne of the more noticeable trends of the past few major supplement industry trade shows has been a seeming lack of really interesting new ingredients. For years (even decades) a stream of new and innovative ingredients was one of the primary driving forces that allowed the industry to thrive while many others struggled. It has however felt like a long time since we have seen a truly exciting new ingredient such as astaxanthin zeaxanthin or krill oil burst upon the market. While the causes of this trend are certainly multi-faceted it seems apparent that FDA (U.S. Food and Drug Administration) shares a large part of the responsibility for the slowdown of innovation. The NDI Guidance New dietary ingredients (NDIs) are those ingredients that have were not already on the market in October 1994 when DSHEA (Dietary Supplement 6 Nutrition Industry Executive Health and Education Act of 1994) was signed into law. These ingredients cannot be brought onto the market unless there is sufficient evidence to conclude that they satisfy the standard of a reasonable expectation of safety and that FDA has been given 75 days advance notification demonstrating that this standard has been satisfied. Notification is not needed if an ingredient has not been previously used in dietary supplements but is nevertheless present in the food supply in a form not chemically altered. In July 2011 nearly 17 years after DSHEA became law FDA put forward a guidance document purporting to provide information that would allow industry to understand what had previously been considered a confusing opaque agency review process of new dietary ingredient notifications (NDINs). This guidance was almost universally decried as unduly burdensome confusing and an inappropriate effort to impose the strict standards applicable to food additives to dietary supplements. Ironically it was FDA s failed efforts to attempt to force supplement ingredients into the same category as food additives that ultimately led to the passage of DSHEA. Following harsh criticism of this document by Senators Orrin Hatch (R-UT) and Tom Harkin (DIA) the primary authors of DSHEA FDA withdrew the guidance. On August 12 2016 some six years after its first effort to provide clarity to industry FDA published its second attempt at a NDI Guidance. This document was also flatly panned by industry. Among other things it was critiqued as an effort to again impose burdensome food additive standards on supplement ingredients attempting to create a new dietary supplement (as opposed to ingredient) notification requirement failing to provide clear guidance as to the nature of scientific evidence FDA looks for when reviewing a NDIN (new dietary ingredients notification) contradictory statements on the treatment of www.niemagazine.com November December 2017 Go to www.niemagazine.com olcott for info about this advertiser Legalities esterified ingredients failing to provide a valid scientific or legal basis for disparate treatment of natural and bioidentical synthetic ingredients and failing to provide any meaningful guidance on the concept of chemically altered. Nearly a year after the comment period closed on this guidance no formal response or follow-up has been provided by the agency. At this point it is not hard to imagine that 23 years after DSHEA was enacted the lack of a clear statement from FDA of the standards that it applies to its reviews of NDINs would give pause to any company considering investing in the development of a new ingredient for the supplement market. Absent clarification of its approach to NDINs and acknowledgement that DSHEA inarguably intended for the agency to treat these ingredients differently than food additives regulatory uncertainty will inevitably act as a drag on innovation. lack of coordination between the Office of Dietary Supplements and the Office of Food Additive Safety (which reviews GRAS [generally recognized as safe] notifications for conventional food ingredients) has allowed follow-on ingredients to enter the marketplace under questionable circumstances. These cases involve synthetic copies of pioneer NDIs that rely primarily on safety data generated with the pioneer ingredient but bypass or circumvent the NDIN process and enter the supplement market as GRAS ingredients even though they have never been present in the food supply and should be subject to the same agency scrutiny as NDINs. ket. Not long thereafter however it returned to the market at virtually the same low price--having incredibly passed through FDA s GRAS notification process without so much as a question being raised by the agency. A Freedom of Information Act request querying the process by which this occurred revealed two alarming gaps in procedures surrounding the NDI and GRAS notification process There was no actual communication between the NDI and GRAS group concerning this ingredient despite its having twice faced significant questions concerning identity and potential safety issues following NDI submissions and There are no mechanisms in place for FDA to allow the NDI group to flag ingredients of concern that might later be the subject of a GRAS notification and vice versa. A subsequent request to the FDA Ombudsman s Office seeking follow-up on the apparent lack of communication between the two groups charged with reviewing the safety of new ingredients in supplements and foods has gone over a month at the time of this writing without a substantive response. Compounding the uncertainty problem is a relatively new issue suggesting that the left hand at FDA does not speak with the right hand and that neither is in communication with the brain. The most egregious example of this problem involves an ingredient that FDA reviewed and had voiced no concerns with in 2008. The pioneer company and its marketing partners devoted substantial efforts to grow demand for the ingredient over the next five years. Once real demand for the ingredient was established a synthetic follow-on copy appeared on the market without any NDIN being submitted and at a much lower price. The follow-on was eventually submitted for NDI review after significant questions were raised about the potential presence of unidentified impurities in the synthetic copy. Following two ill-fated NDI submissions--one of which featured FDA s questioning the presence of lesions on test animal kidneys--this knock-off seemingly disappeared from the mar- More FDA Incoherence Compounding the uncertainty problem is a relatively new issue suggesting that the left hand at FDA does not speak with the right hand and that neither is in communication with the brain. Companies that develop a truly new ingredient obviously invest the time and resources into the endeavor in the expectation that they will be able to see a real profit when they finally submit a successful NDIN. One of the ways this expectation should be met is by FDA applying the same rigorous standard of review to follow-on ingredients that try to take advantage of any success in the market by the developer of the pioneer of the NDI. FDA has repeatedly stated that any copy of an NDI is also considered an NDI subject to the same 75 day premarket notification process as the first NDIN. In theory this process ensures that any follow-on NDI undergoes the same rigorous product development process and safety review and the pioneer thus requiring a similar investment. Any sensible application of this process would help protect the public health by ensuring that the follow-on ingredient is also truly safe as well as protect the pioneer s market viability by limiting the opportunity for the follow-on to be sold at a steeply discounted price. The problem however is that this is not what is happening. Unfortunately there have been at least two prominent ingredients where 8 Nutrition Industry Executive Conclusion The absence of any clear guidance from FDA that it understands the distinction between ingredients intended for use in supplements and those intended for use in conventional food that it will be transparent in the criteria it requires for NDINs and that it has the capacity to protect pioneers position in the market place (not to mention the public health) presents a clear disincentive to ingredient innovation. Until this regulatory uncertainty is lifted slow pace of innovation seems destined to continue. NIE Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration and Drug Enforcement Administration matters regulatory issues Federal Trade Commission proceedings and litigation. He practiced with one of New York s leading white collar criminal defense firms for ten years where he represented clients in both federal and state prosecutions as well as numerous related civil matters and other litigations. www.niemagazine.com November December 2017 Go to www.niemagazine.com gcinutrients for info about this advertiser IndustryNews FDA Holds Meeting on the Development of a Pre-DSHEA Dietary Ingredients List n October 3 the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the development of a list of pre-Dietary Supplement Health and Education Act of 1994 (DSHEA) dietary ingredients. According to a release from Washington D.C.-based law firm Keller and Heckman LLP the meeting featured two stakeholder panels that presented on two distinct issues the standard of evidence required to show a dietary ingredient belongs on the pre-DSHEA list and the process by which dietary ingredients should be added to the list. The first panel included representatives from the National Institutes of Health (NIH) Harvard Medical School the United Natural Products Alliance (UNPA) the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA). The panelists proffered the following as potential forms of pre-DSHEA evidence shipping documents bills of lading records from contract manufacturers catalogs trade association lists monograph standards set by the United States Pharmacopeia (USP) the Peterson Field Guides the Farmer s Almanac field books (i.e. boy scout field book) the U.S. Dispensatory ingredient or supplement marketing materials analyst worksheets and research published on PubMed.gov among others. Affidavits would be accepted if accompanied by verifiable data. Additionally industry stakeholders suggested the pre-DSHEA list could include ingredients that are generally recognized as safe (GRAS) and listed in FDA s Everything Added to Food in the United States (EAFUS) database however this recommendation was met with some opposition. Several stakeholders argued for the creation of a comprehensive list of all ingredients to include the preDSHEA ingredients NDIs (new dietary ingredients) notified to FDA and ingredients already in the food supply. It was argued that this comprehensive list would provide a significantly more meaningful resource for industry and FDA. The panelists discussed the means to define identity of an ingredient with a focus on processes that alter an ingredient s identity. Although no conclusions were reached the panelists considered the idea of an abbreviated notification for the new processing of an ingredient with the same or similar profile. AHPA President Michael McGuffin stressed that the FDA must make some significant changes to previous positions on NDIs in order to successfully create an authoritative list of old dietary ingredients (ODIs) in a statement delivered at a public meeting held by FDA to discuss the development of a list of O pre-DSHEA dietary ingredients. AHPA and its members will need to see a significant shift in the agency s thinking if we are to embrace the current effort McGuffin said. The effort by FDA to create an authoritative list of ODIs or pre-DSHEA ingredients as previously described in FDA s revised draft NDI guidance issued in 2016 is unlikely to be successful in actually compiling a list of these ingredients. During the second panel the discussion focused on the process by which ingredients should be added to the pre-DSHEA list. Panelists included the Natural Products Association (NPA) The Pew Charitable Trusts Center for Science in the Public Interest Consumer Healthcare Products Association (CHPA) and the Consumers Union. The panelists floated process ideas including an expert panel to generate the pre-DSHEA list subject to FDA review a method to delist ingredients found to be unsafe and to rely on information from the FDA s Adverse Event Reporting System (AERS) or the industry-created lists which were argued to already have the necessary pre-1994 marketing evidence. One panelist suggested the process of a public docket for stakeholders to submit ingredients with the requisite supporting documentation. The FDA would then compile the nominations into a list but would have the discretion to remove ingredients. In addition to process recommendations much of the second panel discussion detailed the importance of the public s health and safety. The panelists urged the FDA to clarify that the list would not be a safe harbor for unsafe ingredients to continue to be sold. Panelists reiterated FDA s statement that the inclusion of an ingredient on the list does not guarantee its safety or efficacy. Further FDA stated that a listed ingredient may be removed should the ingredient be found unsafe. Finally FDA discussed creating a preDSHEA list that would be authoritative but not comprehensive meaning ingredients that satisfy the pre-DSHEA requirements could be continually added to the list. McGuffin also questioned if developing a list of pre-DSHEA ingredients was the best use of resources. If FDA and especially the Office of Dietary Supplement Programs has resources to spare AHPA believes these resources might be bet- ter addressed to improving a mutual agencyindustry understanding of the FDA s current good manufacturing practice regulation for supplements and to assisting manufacturers especially small entities to comply with this complex rule McGuffin said. The NDI provision of the law only establishes that old dietary ingredients are old it does not establish that every old dietary ingredient is safe in any quantity for any person McGuffin reminded meeting attendees. Whether a supplement is made with preDSHEA ingredients or new dietary ingredients it is held to the same standard under the adulteration clause of the Food Drug and Cosmetic Act (FDCA) and is adulterated if it presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or under ordinary conditions of use. On Hyman Phelps & McNamara s official FDA Law Blog A. Wes Siegner Jr. who provides counsel on FDA and Federal Trade Commission (FTC) regulation of foods and dietary supplements OTC drugs and cosmetics devices and animal drugs and feeds commented As FDA s focus should be ingredient safety the obvious conclusion is that FDA should turn its attention from ODIs and instead work with industry to identify any ingredients for which safety concerns exist and then using the existing adulteration provisions of the FDC Act as well as an appropriate interpretation of the NDI provision either remove these ingredients from the market or require NDI notifications. As this change in focus will require an abandonment of FDA s long held but ill-conceived views of DSHEA the necessary change will not likely occur without guidance from FDA s new leadership under the watchful eye of Congress. Duffy MacKay CRN s senior vice president scientific and regulatory affairs also made the following statement We thank FDA for giving industry the opportunity to participate in discussion surrounding the planned development of a list of pre-DSHEA ingredients. We have consistently advocated for collaboration between industry and FDA to establish this list and hope the agency will continue to include us in future conversation. We thought it was a valuable meeting. FDA the dietary supplement industry and consumer groups have the shared value of consumer safety and establishing a list of pre-DSHEA ingredients would allow FDA to then spend more of its time focus and resources on other crucial areas of work such as cGMP (current good manufacturing practice) inspections and going after bad actors who tarnish the reputation of the industry and its products. 10 Nutrition Industry Executive www.niemagazine.com November December 2017 Go to www.niemagazine.com balchem for info about this advertiser IndustryNews FDA Issues Warnings to CBD Companies Over Product Health Claims n November 1 The U.S. Food and Drug Administration (FDA) issued warning letters to four companies it said are illegally selling products online that claim to prevent diagnose treat or cure cancer without evidence to support these outcomes. According to the FDA selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food Drug and Cosmetic Act but also can put patients at risk as these products have not been proven to be safe or effective. The FDA issued warning letters to four companies--Greenroads Health Natural Alchemist That s Natural Marketing and Consulting and Stanley Brothers Social Enterprises LLC--citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages online stores and social O media websites. According to the FDA s website the agency has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case the illegally sold products allegedly contain cannabidiol (CBD) a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types such as oil drops capsules syrups teas as well as topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing reversing or curing cancer killing inhibiting cancer cells or tumors or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer s and other serious dis- eases the FDA stated. Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we re not going to look the other way on enforcing these principles when it comes to marijuana-containing products said FDA Commissioner Scott Gottlieb MD. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven anti-tumor effects that could extend lives. For more information visit www.fda.gov. FTC Complaint Against Quincy Bioscience is Dismissed n September 29 Judge Louis Stanton of the U.S. District Court in the Southern District of New York dismissed the Federal Trade Commission and the New York Attorney General s (NYAG) complaint against Wisconsin-based Quincy Bioscience the makers of Prevagen. In January the Federal Trade Commission (FTC) and the NYAG charged the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory provides cognitive benefits and is clinically shown to work. The federal court complaint alleged that the defendants enticed consumers to spend anywhere from 24 to 68 for bottles of 30 supplement pills by touting the product s active ingredient--a protein derived from jellyfish--to improve memory and reduce memory problems associated with aging. The complaint noted that the supplement is widely available at major retailers such as Amazon CVS the Vitamin Shoppe and Walgreens and is also sold directly on Quincy Bioscience s websites. The company s product sales have topped 165 million according to the complaint. John Villafranco partner at Kelley Drye and counsel representing Quincy Bioscience in the complaint released the following statement We are very pleased with the Judge s decision today he said. We continue to believe that Quincy Bioscience has presented substantial evidence in support of its claims about Prevagen. For more information visit www.quincybioscience.com. Kemin Launches Bakery and Snack Resource Guide emin Industries (Des Moines IA) a provider of shelflife extension and food safety solutions that help manufacturers keep food and beverage products safe high quality and appealing has recently developed a bakery and snack resource guide. The guide illustrates key aspects of the oxidation process including the antioxidant mode of action to show bakery and snack manufacturers how antioxidants can help protect their brands. We are pleased to share this at-a-glance resource guide with the baking and snack industry said Courtney Schwartz senior marketing communications manager for Food Technologies. With this guide we ve created a helpful resource that simply illustrates the complex process of oxidation how it affects product quality and how antioxidants and plant extracts can delay oxidation to lengthen shelf-life and help maintain consumer loyalty. The bakery and snack resource guide uses visually appealing infographics to Highlight how lipid oxidation negatively impacts bakery and snack products with three modes of failure color flavor and quality. Illustrate antioxidants mode of action and their role in significantly delaying or preventing oxidation. Consider how formulation changes can affect brand goals of price label and transparency as well as consumer loyalty. To view or download the baking and snack guide visit www.kemin.com en north-america markets food-technologies market-segments bakery-snack sensory-appeal. O K 12 Nutrition Industry Executive www.niemagazine.com November December 2017 Go to www.niemagazine.com alkemistlabs info about this advertiser IndustryNews FDA Warns Against Using SARMs in Bodybuilding Products he U.S. Food and Drug Administration (FDA) recently released an In Brief statement along with warning letters to Infantry Labs LLC (O Fallon MI) IronMagLabs (Henderson NV) and Panther Sports Nutrition (Garfield NJ). The warning brief states that bodybuilding products known to contain selective androgen receptor modulators or SARMs have not been approved. FDA will continue to take action against companies marketing bodybuilding products that contain selective androgen receptor modulators. According to the FDA life-threatening reactions including liver toxicity have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke and the long-term T effects on the body are unknown. FDA stated that consumers should stop using these bodybuilding products immediately and consult a health care professional if they are experiencing any adverse reactions that may be associated with their use. The companies that received a warning letter must respond to the FDA identifying how the problems noted by the FDA will be corrected within 15 working days. Companies that do not correct the problems risk additional enforcement action such as seizure injunction or prosecutions. We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that contain selective androgen receptor modulators or SARMs have not been approved by the FDA and are associated with serious safety concerns including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage said Donald D. Ashley JD director of the Office of Compliance in the FDA s Center for Drug Evaluation and Research. We will continue to take action against companies marketing these products to protect the public health. FDA noted that health care professionals and consumers should report any adverse events related to the use of these bodybuilding products to the FDA s MedWatch Adverse Event Reporting program. For more information visit www.fda.gov. MeriCal Acquires Global Health Industries to Create Probiotics Leadership eriCal LLC an Anaheim CA developer manufacturer and packager of probiotic and other nutritional supplements owned by Linden Capital Partners has announced it has signed a definitive agreement to acquire Ogden UT-headquartered Global Health Industries (GHI). GHI is a respected player in the industry best known for its highly specialized approach to probiotic manufacturing and packaging including bacteria spores and yeast products. GHI also boasts strong multi-level marketing and branded manufacturing and sales expertise. MeriCal CEO Brian Smith said the acquisition is MeriCal s next step in its strategy to become the leading developer and manufacturer in the probiotic segment of the vitamins minerals and supplements industry. We are excited at the prospect of combining our respective resources. Among other benefits Global Health Industries will gain access to our industry leading R&D capabilities which we are confident will lead to expanded demand for our innovative products said Smith. GHI s unique spore manufacturing and packaging operation will add to MeriCal s existing capabilities. Together we will continue to strive to become the clear leader in probiotic and supplement contract manufacturing--one of the goals we set out to achieve after last year s acquisition of MeriCal by Linden. Added GHI s CEO Kim Wheelwright Though both companies have demonstrated success in their respective MLM customer bases the combination of MeriCal s No. 1 market position in the private label retail space for large blue chip customers combined with our broad branded customer base make the combined company extremely powerful. The collective organization will employ nearly 550 individuals at six sites across the U.S. For more information visit www.merical.com or www.globalhealthindustries.com. Draco Announces Strategic Partnership With Givaudan raco Natural Products Inc. a manufacturer of bioactive natural ingredients headquartered in San Jose CA has announced the formation of a strategic partnership with Swiss flavor giant Givaudan for the development of a new proprietary line of bioactive botanical ingredients. Draco specializes in the manufacture of full-spectrum standardized extract ingredients made from herbs fruits vegetables and mushrooms and is known for its expertise in creating formulas using the principles of traditional Chinese medicine (TCM) combined with modern science. Its innovative ingredients are popular in products ranging from dietary supplements and functional foods and beverages to skin and hair care. Started in France in 1895 as a perfumery Givaudan is the world s largest flavor and fragrance company with 4.7 billion in sales and more than 10 000 employees worldwide. Under the new strategic partnership the two companies will jointly work on research and development of the new proprietary product line. It will develop functional botanical ingredients featuring TCM principles. These unique ingredients will primarily be used for producing topical products to improve and enhance skin and hair health. We are very excited about this partnership said Jerry Wu president and CEO of Draco. Givaudan is a top notch company with a long history of innovating in fragrances and cosmetics and our combined expertise will allow us to bring natural solutions for customers brands. With this strategic partnership we will introduce to the market unique products that have been designed using natural extracts that follow the principles of traditional Chinese medicine and that use all the knowledge of modern science added Laurent Bourdeau head of Givaudan s Active Beauty business. It is a very exciting moment for us as it opens a new world of possibilities. For more information visit www.draconatural.com or www.givaudan.com. M D 14 Nutrition Industry Executive www.niemagazine.com November December 2017 Go to www.niemagazine.com nutrasolutionsusa for info about this advertiser IndustryNews Verdure Sciences Celebrates 20 Years and a New Campus erdure Sciences (Noblesville IN) recently celebrated its 20-year anniversary and unveiled details of a new corporate campus during the Supply Side West show in Las Vegas NV. An independent and privately owned company Verdure Sciences has evolved over the years along with the natural products industry. Founder and CEO Ajay Patel began the business as GENI Inc. in Indianapolis IN shortly after graduating from Purdue University with a chemical engineering degree. In 1997 Patel saw an opportunity to sell garcinia with his familiarity knowing that the botanical was native to his homeland India. Patel s reflections upon initial sales coincides with frustrating accounts of botanical extract color as a prime quality indicator many times superseding chemical analysis. These early frustrations helped outline Patel s vision to deliver V high-quality botanical extracts based on chemical identity and traceable initiatives balanced with innovation and conservative management principles. Although GMPs (good manufacturing practices) were under DSHEA (Dietary Supplement Health and Education Act of 1994) specific guidelines were not finalized for over a decade. Patel stayed true to his vision and worked with industry associations to ensure quality standards and efficacy became leading requirements. In early 2002 the next chapter of branding and clinical initiatives began the first of which was on the efficacy and tolerability of Boswellia serrata branded as WokVel (Phytomedicine. 2003. 10 37). Feedback and acknowledgement regarding the integrity and appreciation of the investment into human clinicals encouraged Patel to proceed with further investments and to rename the company in 2005 to Verdure Sciences Inc. At this same time Verdure began to license and develop intellectual property resulting in Pomella Pomegranate Extract. Over the next decade Verdure launched numerous branded ingredients including well-known ingredients such as Longvida Optimized Curcumin Bacognize Tinofend and Calzbone along with VBATS Verdure s Botanical Active Testing System. Next year Verdure will be in a new seven-acre corporate campus including office laboratory product development greenhouse and warehouse spaces. The campus will encourage healthy living with a wellness building and outdoor walking trail surrounded by native fauna and flora. For more information visit www.vs-corp.com. DSM UNICEF and Sight and Life Partner to Deliver Better Nutrition in Nigeria oyal DSM (Heerlen The Netherlands) a global science company active in health and nutrition UN children s agency UNICEF and Swissbased humanitarian nutrition think tank Sight and Life have announced a new partnership to deliver better nutrition to at-risk children and mothers in Nigeria. The partners will also advocate on a global scale for micronutrient supplementation. Guided by the Sustainable Development Goal s target of ending hunger and improving nutrition everywhere the partnership will focus on reaching mothers and children with nutrition interventions during the crucial first 1 000 days of children s lives from conception to age 2. Good nutrition during this period plays a vital role in supporting children s physical and cognitive development with lifelong benefits. Less than 20 percent of children in Nigeria are fed diets that meet the minimum adequacy for health growth and development and nearly 40 percent of children under 5 have stunted growth a condition caused by malnutrition. Good nutrition is a human right. DSM is proud to partner once again with UNICEF and Sight and Life to improve nutrition in Nigeria and across Africa especially for vulnerable populations like women and children. It is an important step toward achieving a world without R hunger and a world in which people everywhere can reach their full potential said Feike Sijbesma CEO and chairman of the DSM Managing Board. DSM offers essential vitamins nutrients and fortification solutions as well as expertise that complements the research programs and global reach of UNICEF and Sight and Life. Nutrition is one of the most effective and cost-effective investments we can make -- in children s lives and futures and in the long-term strength of their societies said UNICEF Executive Director Anthony Lake. Every child has a right to grow up healthy and strong and this new partnership with Royal DSM and Sight and Life will help more children in Nigeria to realize that right. Together the partners will develop scalable models and drive innovation to improve the quality of food and nutrition in Nigeria with the goal of spurring similar action in other countries where malnutrition is a critical concern. The part- ners will also advocate on a global scale for best practices in micronutrient supplementation. The new partnership builds on joint activity by DSM and UNICEF from 20132015 that supported micronutrient powder (MNP) programs in Madagascar and Nigeria. Together the organizations already improved nutrition for about 400 000 children in Nigeria through the MNP pilot program. For more information visit www.dsm.com www.sightandlife.org or www.unicef.org. Pharmtech Relocates to New Facility harmtech International has announced its relocation to a new facility in East Hanover NJ with new additional and upgraded equipment. The company continues to be an industry resource with more than 30 years of experience in the food cosmetic and pharmaceutical industries and are a complete source for all material processing needs. Pharmtech s personalized services include compaction granulation milling and blending with a prompt turnaround. The new location is 13 West St. East Hanover NJ 07936. The company s phone number is (973) 535-3000. P 16 Nutrition Industry Executive www.niemagazine.com November December 2017 New Quality Testing and Certification Services for Dietary Supplements Brands abdoor (South San Francisco CA) has announced the launch of Labdoor Testing Services a new testing and certification business that helps dietary supplements brands develop high-quality products and reach consumers looking for them. Established in 2012 Labdoor has become a leading consumer resource for expert guidance on how to shop for supplements. Six million visitors per year use Labdoor.com s product rankings and independent testing results to make informed purchases more than any other supplements certification provider online. The launch of Labdoor Testing Services (LTS) comes at a time when gaining competitive market advantage is especially challenging for supplements brands. While the industry is seeing low product adoption and customer retention rates Labdoor engages consumers and compels purchasing decisions by reporting objective facts about L a product s quality at the point of sale the company stated. With LTS brands can now take advantage of Labdoor s testing expertise and trusted online marketplace to expedite product development reduce liability and drive sales. Currently LTS offers two routes to laboratory testing services. First brands can opt for custom testing services which support manufacturers with R&D and quality control. Then there s the LTS Certifications Program which certifies products for label accuracy purity and the absence of substances banned from competitive sports. LTS most powerfully differentiates through its Membership Program which gives brands access to wholesale testing prices certifications and notably a dedicated brand page on Labdoor.com which displays their certified products alongside full testing results and options to buy them. These features allow brands to continuously certify their products at a low cost and ensures that consumers can easily shop for them. Labdoor said that LTS gives brands the security of a proven conversion funnel so they can focus on creating great products. Results so far are promising. Usage of the certification logo gave our customers confirmation and confidence that what we say is in our products has been independently verified said Kim Shafer CEO of Daily Body Restore. We personally use and recommend Labdoor s Certification Programs. For more information visit www.labdoor.com. BASF to Enter U.S. Medical Foods Market With DIEM Labs ASF Corporation (Florham Park NJ) and DIEM Labs LLC (Buffalo WY) have entered into a distribution agreement to commercialize BASF s first U.S. medical food product for the dietary management of patients with non-alcoholic fatty liver disease (NAFLD). As part of this agreement BASF will use its scientific expertise and state-ofthe-art manufacturing capabilities to provide a first-to-the-market medical food product to patients with NAFLD. DIEM Labs will market the product to health care professionals in the U.S. and sell it through an online hub. The product will be available to U.S. patients who are under the supervision of a physician for NAFLD management. NAFLD is defined as fat accumulated in the liver representing more than 5 percent of its weight. This condition has an estimated prevalence of 20 to 30 percent in the western population and is closely linked to obesity and metabolic syndrome. Diagnosis often starts with abnormal liver function test results or detection of hepatic steatosis during incidental imaging. If the condition is not managed it can progress to more severe liver damage such as fibrosis and B throughout the U.S. in the first half of 2018. For more information visit www.basf.com or www.diemlabsllc.com. cirrhosis. By managing the condition at an early stage called simple steatosis the disease can be controlled. Currently there is no dedicated product available on the market specifically targeting patients with NAFLD and patients are left with no solution to improve their condition other than undergo extensive lifestyle changes. BASF acknowledged the significant unmet need and developed a new medical food product for the dietary management of patients with NAFLD. A product-specific human intervention trial including more than 170 patients has been conducted by BASF to show that the product is effective and safe in the dietary management of patients with NAFLD. The to-be-launched product will therefore add to the current standard of care for NAFLD. It is anticipated that it will be commercially available NattoPharma USA Moves Offices attoPharma USA Inc. has announced that it has moved its New Jersey office from Metuchen to a new facility in Edison. N According to the company due to its current growth--and future growth expectations-- NattoPharma has selected a bigger better-equipped space that will allow the company to improve its service levels. NattoPharma USA Inc. s new address is 95 Newfield Ave. Ste. C Edison NJ 08837. The company s phone number remains the same at (609) 454-2992. For more information visit www.nattopharma.com. Nutrition Industry Executive 17 November December 2017 www.niemagazine.com IndustryNews Lycored Calls for Focus on Education as Consumers Fail to Spot Bad Cholesterol ost consumers do not know which kind of cholesterol is considered bad for health new research by Lycored (Be er Sheva Israel) has shown. The global wellness company surveyed 329 dietary supplement users. More than eight in 10 (82 percent) said they were aware that there are two main forms of cholesterol one considered good and one considered bad. However when they were asked which was considered good 58 percent named LDL rather than HDL. In fact high levels of oxidized-LDL cholesterol in the blood are associated with risk of cardiovascular disease. By contrast HDL is often known as good cholesterol. Lycored said the findings highlight the responsibility of manufacturers to support consumer education. Too M often nutrition marketing is about making claims for products without considering how much the user really knows said Zev Ziegler head of global brand and marketing health at Lycored. Most consumers understand that there s good cholesterol and bad cholesterol but beyond that things get a bit hazy. Our research highlights the importance of educating consumers not just selling to them. Commenting on the research in a blog post consumer nutrition expert Amie Valpone said There is so much noise out there and if we don t educate ourselves about what we re putting in our body we re giving our power away and we re lost. People want to live and eat healthier but they need support and proper education on the subject to increase their understanding. Cardiomato Lycored s cardio-grade tomato extract has been shown to reduce levels of oxidized LDL. The company has worked with distributors nutritionists and clinicians on initiatives to help educate people on the role of nutrition in cardiovascular health. Earlier this year Lycored launched Lycopedia an interactive educational hub which explains the health benefits of lycopene at different stages of life. For more information visit www.lycored.com. Survey of 329 U.K. consumers (160 men and 169 women) carried out online in June 2017. All respondents took dietary supplements at least once a week. Graminex LLC Expands Partnership With IDIPharma After Clinical Study Publication raminex LLC (Saginaw MI) producer of NonSolvent Graminex Flower Pollen Extracts has announced the expansion of its partnership with IDIPharma. After completion and publication of clinical studies supporting the use of Graminex Flower Pollen Extract for prostate pain and chronic pelvic pain (CCP) IDIPharma and Graminex have agreed to expand clinical research on Graminex Flower Pollen Extract. Graminex looks forward to expanding its relationship with IDIPharma producer of DEPROX 500 containing NonSolvent Graminex Flower Pollen Extract. IDI Pharma has proven its outstanding commitment to quality by delivering substantiated products to its customers stated Justin E. Ritter regulatory affairs Graminex. IDIPharma is committed to solving gynecological urological and andrological problems by its continued scientific collaboration within the medical community. Deprox 500 which contains Non-Solvent Graminex Flower Pollen Extract was the first Italian supplement strongly focused on prostatitis. Deprox is supported by clinical studies that underline the distinctiveness of its formulation and its real effectiveness in regards to the long standing problems of prostatitis stated Dora Arena PhD. For more information visit www.graminex.com or www.idipharma.com. BIO-CAT Microbials Announces Retirement of Steve Lamb PhD IO-CAT Microbials (Shakopee MN) has announced that Steve Lamb PhD will retire after more than 40 years devoted to biotechnology. In the last 20 years Lamb worked to optimize production processes for enzyme-producing microbes and to develop proprietary Bacillus-based solutions for human probiotic crop science aniSteve Lamb mal feed bioremediation and waste treatment applications. As the technical director at BIO-CAT Microbials Lamb was instrumental in establishing an industry leading Bacillus-based research team. He was the driving force in selecting recruiting and retaining qualified research scientists along with securing state-of-the-art equipment for the R&D lab. His passion for Bacillus contributed significantly to helping employees understanding. With Steve present in discussions you knew biochemical equations and chemical structures would end up on the whiteboard it was impossible not to learn at least one new thing with every interaction said Senior Scientist and Quality Assurance Manager Jessica Spears PhD. Lamb had tremendous success in finding creative solutions for customers and thoroughly answering their technical questions according to the company. He was an invaluable sounding board for inspiring new ideas and troubleshooting setbacks said Spears. Lamb earned his PhD in microbial biochemistry from the University of Wisconsin in 1974. He has worked for various companies in the chemical pharmaceutical and food industries. G B 18 Nutrition Industry Executive www.niemagazine.com November December 2017 Frutarom to Acquire Full Ownership of Enzymotec rutarom (Israel) will acquire full ownership of Enzymotec (Israel) at a net investment of approximately 210 million. Frutraom will acquire the balance of shares at USD 11.9 per share. The transaction will be done via full merger of Enzymotec into a subsidiary of Frutarom. We are delighted at having signed a definitive agreement for the acquisition of Enzymotec and its merger with Frutarom said Ori Yehudai president and CEO of Frutarom Group. This acquisition will provide additional reinforcement to our growing activity in natural specialty fine ingredients based on innovation which is expanding at a rapid pace. Following our announcement of the acquisition of Enzymotec shares and our intention to make a tender offer we conducted friendly and professional negotiations with Enzymotec s board of directors and F reached an agreement on acquiring 100 percent ownership. This amicable transaction offers significant advantages to both parties including a further boost in value for our shareholders along with providing a quick and efficient implementation of a growth strategy and profitability for Enzymotec s operations as well as a rapid and effective realization of the significant synergies between the companies. The merger will enable full integration of the companies activities in the fields of R&D sales marketing production supply chain and logistics while accelerating joint growth through many cross-selling opportunities inherent in the acquisition and the expansion of the product portfolio to both Enzymotec s and Frutarom s existing customer bases. For more information visit www.frutarom.com or www.enzymotec.com. You reHired (UNPA) has joined the AAK has added Emile Henein Leadership Council for the to its team. Henein will manage Institute for Natural Medicine AAK s Special Nutrition seg(INM). Rick L. Cox founder and ment as business development president of Cave Creek AZmanager and will be based out based Specialty Process Labs of AAK s Edison NJ office. has been appointed to the NSF International is adding Emile Henein organization s board of direcnew sports nutrition experts to tors. its NSF Certified for Sport team. To better serve its growing customer Dana Leenheer joins the NSF team in base in North America New Jerseythe United States and Terence O Rorke based BENEO Inc. has announced an is based in the U.K. Leenheer is the additional expansion of its NAFTA sales technical scheme manager for NSF and support team with the appointment International s Certified for Sport proof Mary Karpati to serve as the compagram based in Ann Arbor MI. O Rorke ny s Southwest region sales is NSF International s regional manager. manager for the Certified for Naturex strengthens its senior Sport program in Europe the management team with the Middle East Africa and Asia. appointment of Sarah Martin as ChromaDex Corp. (Irvine CA) its new chief scientific officer. has announced that it has Martin who has high-level appointed Kevin Farr as new experience in the food science chief financial officer effective Mary Karpati and nutrition industry joins immediately. Farr is joining Naturex s executive committee. Taking ChromaDex from Mattel Inc. where he global responsibility for Naturex s scienwas executive vice president and chief tific and innovation programs Martin financial officer since 2000. Frank Lampe vice president commu- will operate out of the company s corporate headquarters in Avignon nications and industry relations for the France. United Natural Products Alliance November December 2017 www.niemagazine.com Nutrition Industry Executive 19 IngredientNews Probi s Probiotics Show Promise for Gluten Intolerance in Children randomized double-blind placebo-controlled intervention trial has evaluated the effect of probiotics from Probi (Sweden) in children genetically predisposed for gluten intolerance (celiac disease). The results show that the probiotics have a suppressing effect on celiac autoimmunity and may delay the onset of the disease. Celiac disease (CD) affects up to 3 percent of the population and currently the introduction of a lifelong gluten-free diet is the only available treatment. The randomized double-blind placebo controlled intervention study was performed by Daniel Agardh MD PhD and his research team at Lund University with the objective of evaluating the effect of Probi s probiotic strains Lactobacillus plantarum Heal 9 and Lactobacillus paracasei 8700 2 on celiac disease (CD) autoimmunity. Seventy-eight asymptomatic children (3-7 years old) with an increased risk for developing CD were randomly allocated to a daily consumption of either the probiotic product or a placebo for a total period of six months while on a gluten-containing diet. The 78 children were identified as a subpopulation in a multinational and multiyear autoimmunity study with thousands of children. The study results show that the consumption of the probiotics is associat- A Study Shows Bilberry Extract www.probi.com. to be an Ally for Eye Discomfort Management new randomized double-blinded placebo-controlled clinical study published in European Review for Medical and Pharmacological Sciences highlighted that Mirtoselect the Indena (Italy) proprietary standardized bilberry extract containing 36 percent anthocyanins may have an important role in preserving adequate acqueous levels in people possibly experiencing dry eye conditions. A ed with suppressing effects on celiac autoimmunity in the children. The levels of the disease-related antibodies were significantly reduced in the probiotic group and significantly increased in the placebo group during the course of the study. In addition several significant differences were observed between the groups on a cellular level indicating that the probiotic may counteract CD-associated ongoing immunological and inflammatory response. This is an excellent example of a well working collaboration between academia and the industry said Peter N hlstedt CEO of Probi AB. We see a growing interest in children s probiotics and these results enable Probi to build a product platform for children. For more information visit Natural Sustained-release Caffeine ipofoods SLU (Spain) launched NEWCAFF microcapsules a natural slow-release caffeine formulation for athletes and others living an active lifestyle. The company introduced NEWCAFF microcapsules at SupplySide West Las Vegas NV in September. NEWCAFF microcapsules is a novel delivery system designed to mask the bitter taste of caffeine and ensure controlled release making it more affordable for food and beverage products targeting the active lifestyle. Stauber is Lipofoods distributor for North America handling NEWCAFF microcapsulesand LIPOPHYTOL (a palm-free water-dispersible phytosterol) L as well as other advanced Lipofoods ingredients. NEWCAFF microcapsules are available in two caffeine concentrations of 60 percent and 75 percent providing different release profiles depending on customer preferences. The formula is ideal for food supplements powders bars gels chewables milkshakes and other food products. For more information visit www.lipofoods.com. The aim of the study was to investigate the ability of bilberry extract to maintain adequate tear levels and to confirm its antioxidant potential. Twenty-one healthy subjects experiencing dry eye have been enrolled and randomly assigned to receive Mirtoselect supplementation (two tablets corresponding to 160 mg) daily or placebo for four weeks. The results of Schimer s test--indicating the volume of tear secretion--before and after the four-week period showed significant improvements in the mean values for right eye ( 71 percent p 0.009) and both eyes ( 55 percent p 0.019) as well as a beneficial tendency for the left eye ( 43 percent p 0.062) in the supplemented group. In the placebo group the mean values of Schimer s test at the end of the treatment were not significant. For more information visit www.indena.com. 20 Nutrition Industry Executive www.niemagazine.com November December 2017 Novel Ingredient Improves Constipation Symptoms onsumption of natural immune strength ingredient EpiCor (Iowa) fermentate results in beneficial modulation of the gut microbiome and improvement of gastrointestinal comfort and constipation a new study finds. The research was recently published in BMC Complementary and Alternative Medicine. The positive results with EpiCor in this study are very encouraging since an ingredient of this kind has never been evaluated for its role in gut microbiota shifts and effects on common constipation-associated symptoms said Massimo Marzorati PhD PostDoc at Ghent University (Belgium) and cofounder of ProDigest the contract research organization that conducted the trial. It s a remarkable finding to see compelling prebiotic effects in a human study at a dose of only 500 mg per day. EpiCor is a natural whole food fer- C mentate made through a proprietary fermentation process researched developed and manufactured by Embria Health Sciences LLC of Ankeny IA. EpiCor is self-affirmed GRAS (generally recognized as safe) and has a new dietary ingredient notification (NDIN) on file with the FDA (U.S. Food and Drug Administration). It is widely known that prebiotic fibers feed beneficial gut bacteria but can also cause bloating and gas which can make staying on these products difficult for many people. This new research shows EpiCor balances healthy gut microbiota levels leading to an actual reduction in bloating and distention while improving stool consistency. The randomized placebo-controlled study was conducted in Europe over six weeks and included 80 healthy adult subjects reporting moderate to severe constipation. A validated questionnaire recorded the improvements in constipation-associated symptoms and quality of life. A general stress survey showed EpiCor positively impacted perceived stress. Finally stool samples taken from the subjects demonstrated healthy shifts in gut microbiota. Specifically members of the families Bacteroidaceae and Prevotellaceae two groups of bacteria that have been previously reported to be deficient in constipated patients were found to increase with EpiCor in the severe constipation subgroup. In the moderate subgroup researchers observed a significant increase in Akkermansia muciniphila a potentially beneficial species. For more information visit www.epicorimmune.com. BCM-95 Study Reveals New Mechanisms in Anti-Chemoresistance new clinical study investigated the mechanism of BCM-95 a high-potency turmeric extract in treating pancreatic cancer. The study revealed evidence that indicates BCM-95 could help overcome some cases of chemotherapy resistance. The study using a mouse model was conducted by researchers Kazuhiro Yoshida MD et alia at the Baylor University Medical Center at Dallas and published in the July 2017 issue of Carcinogenesis. In both normal and chemo-resistant pancreatic ductal adenocarcinoma (PDAC) cell cultures the curcumin essential oil complex was tested for its ability to inhibit self-renewal and differentiation also known as stemness. It had been proposed that a curcumin-induced reduction in stemness could resensitize PDAC cell cultures to the commonly prescribed--but often resisted--Gemcitabine chemotherapy regimen. The study demonstrated that BCM-95 turmeric extract was able to re-sensitize pancreatic cancer cells to the effects of Gemcitabine. This was further confirmed by a reduction in tumor size. BCM-95 also prevented hallmark signs of chemotherapy-induced stemness and down regulated several of the genes that drive this process. For more information visit www.dolcas-biotech.com. Natreon Debuts One Sports Nutrition Platform ew Jersey-based Natreon debuted its Natreon One sports nutrition platform to provide formulators and brand owners with ingredient solutions that achieve consumers preference for natural and scientifically studied ingredients. Natreon is centered on the idea of trusted science naturally and the development of the Natreon One ingredient portfolio delivers this ideal while providing enhanced performance outcomes to athletes. Natreon is proud to lead the industry in patented scientifically validated botanicals with optimal levels of bioactives said Natreon President Bruce Brown who joined the company in early 2017. Natreon One is bridging the gap between botanical solutions and sports nutrition. This is an important yet underserved category for our industry and the announcement of Natreon One signals our continued investment in clinical research around our sports nutrition products as well as our commitment to developing next-generation ingredients to enhance sports performance. When I started with Natreon I was impressed with the family of products and inspired to bring our researchedbacked ingredients to a new level. With Natreon One the company plans to build on its portfolio of top customer partners who formulate with its ingredients. Natreon One botanical solutions deliver natural sports nutrition benefits as only Mother Nature can provide said Brown. For more information visit www.natreoninc.com. A N November December 2017 www.niemagazine.com Nutrition Industry Executive 21 IngredientNews Sabinsa Granted U.S. Patent For Synbiotic Composition of Lactospore abinsa (New Jersey) has been granted a U.S. patent on the company s shelf stable probiotic LactoSpore in combination with cranberry seed fibers. The granted patent (US9717766) discloses a method of increasing the viable colony count of Bacillus coagulans MTCC 5856 in a synbiotic composition containing natural plant fibers from Vaccinium oxycoccos (cranberry). The cranberry fibers in this composition were observed to increase the viable count of Bacillus coagulans MTCC 5856. This combination product is sold under the name LactoCran with the cranberry seed fiber components supplied by Fruit d Or Nutraceuticals of S Quebec Canada. LactoCran provides support for healthy gut and digestive health. The nonlactose diary-free nonGMO (genetically modified organism) combination works well in sports nutrition supplements as it contains a rich composition of 16 essential amino acids and eight branch chain amino acids. This patent along with the previously granted patent for the management of irritable bowel syndrome is expected to boost LactoSpore s popularity and market value. LactoSpore is a GRAS (generally rec- ognized as safe) probiotic containing Bacillus coagulans MTCC 5856 which is lactose-free and nonGMO. This probiotic is room temperature stable and does not require refrigeration ensuring a long product shelf life. Because of its ability to withstand high heat LactoSpore has been included in functional baked goods. Clinically studied LactoSpore can be used in a variety of food and dietary supplements for maintaining gut health and good microbiota. For more information visit www.sabinsa.com. Bayir Announces Patent for New Applications of Curcumin ayir Inc. a New Jersey-based manufacturer of ingredients for the dietary supplement functional food and beverage and nutraceutical industries recently announced the approval of a process patent for synthesizing curcumin nanoparticles. The nanoparticles are developed using Bayir s in-house technology. This patent approval holds promise for formulators offering more versatility in applications of curcumin. The new patent offers ground-breaking applications for formulators said B.G. Bairy chairman and managing director of the Bayir Group. We have been testing nanoparticle applications for a number of years the impetus being the increasing demand from the consumer market for innovative applications of curcumin. The market has really pressed on the need for more bioavailable and readily soluble forms. The new nanoparticle formulation along with the micronized product variants technology allows for more diverse and user-friendly applications including food beverage and over-the-counter formulations. For more information visit www.bayirinc.com. Frutarom to Launch Frutaceuticals rutarom BU Health (U.S. location in New Jersey) announced the launch of Frutaceuticals a new fruit-based delivery system combining great flavor enhanced with the benefits of Frutarom s branded health ingredients. The new nutrition delivery concept is based on URC (ultra rapid concentration) technology from Taura Natural Ingredients Ltd. (a Frutarom company) and Frutarom s extensive expertise in bringing together taste and health to create a new form of supplement snack that will appeal to consumers suffering from pill fatigue. Frutaceuticals is made from real fruit and designed to deliver the taste texture and goodness of true-fruit chews. The fruit pieces flakes shapes and pastes are produced using Taura s URC process to quickly evaporate moisture from heat-sensitive fruits and maintain the raw material s integrity says Peter Dehasque CEO of Taura. The fully automated system creates stable products that do not need added sugar bulking materials or preservatives. For more information visit www.frutaromhealth.com. B F Insea2 Gains Self-affirmed GRAS Status nnoVactiv a Canadian company that develops science-based specialty ingredients announced that InSea recently obtained a self-affirmed generally recognized as safe (GRAS) status. Following a comprehensive evaluation an independent panel of experts has declared the ingredient safe for various food and beverage applications includ- i ing nutritional bars meal supplement drinks and dietary supplement products. This certification comes following a positive conclusion of the expert panel s comprehensive review of the safety aspects of InSea2 intake under the conditions of use as a food ingredient. This self-affirmed GRAS status is yet another indication of our strong commitment to continuously improve our ingredient s scientific foundations both on the efficacy and safety aspects said Jocelyn B rub executive vice president scientific and regulatory affairs for innoVactiv. For more information visit www.innovactiv.com. 22 Nutrition Industry Executive www.niemagazine.com November December 2017 Organic AstaPure Astaxanthin is Now Non-GMO Halal and Kosher Certified srael-based Algatech (Algatechnologies) Ltd. announced its 100 percent organic Haematococcus pluvialis microalgae powder and astaxanthin oleoresin have been granted non-GMO (genetically modified organism) verification by the Non-GMO Project. Algatech is the first and only astaxanthin manufacturer to have achieved these verifications according to the company. Consumers are actively seeking nonGMO products so having the NonGMO Project verify our line in accordance with its strict standards provides I Kemin and Valensa Partner to Introduce Algae-sourced Betaglucan Ingredients emin Industries (Iowa) and Valensa International (Florida) announced a partnership to jointly supply and market BetaVia ingredients immune-supporting beta-glucans sourced from a proprietary strain of algae (Euglena gracilis) in the U.S. dietary supplement and functional foods and beverages markets. our partners added value on top of the existing USDA (U.S. Department of Agriculture) organic GMP (good manufacturing practice) kosher and halal certifications said Hagai Stadler CEO of Algatech. For more information visit www.algatech.com. K Helhetsh lsa Sverige AB Introduces Citikolin Cognizin Supplement for Swedish Consumers wedes looking for ways to boost mental energy concentration focus and overall cognitive health now have a new daily supplement for their nutritional regimens Citikolin Cognizin. Helhetsh lsa Sverige AB is offering Citikolin Cognizin in 250-mg capsules. Cognizin acts as a catalyst to produce phosphatidylcholine (phospholipids) which are important for prop- S er brain function. Phospholipids make up approximately 30 percent of brain tissue aid neural communication and provide essential protection for neurons. Clinical research has shown that citicoline has multiple applications and is able to improve various aspects of the brain s physiological activity. For more information visit www.helhetshalsa.se english or www.cognizin.com. GanedenBC30 Probiotic Wins Inaugural IFT FoodTech Summit Innovation Award he results are in and GanedenBC30 Ganeden (Ohio) s patented and shelf-stable probiotic strain has been announced as the winner of the first annual IFT FoodTech Summit Innovation Award. The award was developed by the Institute of Food Technologists (IFT) and Encumex to acknowledge innovation in the food science industry. A panel of six judges with a variety of backgrounds reviewed almost 40 entries that were submitted for the inaugural year looking for the best examples of T commercial innovation in the science of food. According to IFT entries were judged based on degree of innovation technological advancement and benefits to both food manufacturers and consumers. The panel unanimously selected GanedenBC30 (Bacillus coagulans GBI-30 6086) celebrating it as a breakthrough ingredient that answers the growing consumer demand for food and beverage products with enhanced health benefits and natural ingredients. For more information visit www.ganedenprobiotics.com. The new microalgae ingredients [use marketed under wereAlgaeHealth here] the brand names BetaVia Complete (whole cell Euglena gracilis) and BetaVia Pure (Paramylon Linear beta-1 3-glucan). The pro-immunity ingredients will be offered as stand-alone ingredients and as part of Valensa s proprietary synergistic combinations. The BetaVia product line offers a new patented standard in immune support using Euglena gracilis microalgae. BetaVia ingredients are naturally sourced GMO-(genetically modified organism) and gluten free for functional applications. Both in vitro and animal studies show that algae-sourced BetaVia ingredients can prime key immune cells to strengthen the body s immune defenses. This partnership creates a twoarmed sales approach to the U.S. [use DDW here] dietary supplement and functional foods and beverages markets. The Kemin sales team will service the functional food and beverage customers while Valensa s sales team will service customers producing dietary supplements. For more information visit www.kemin.com betavia or www.valensa.com. Nutrition Industry Executive 23 November December 2017 www.niemagazine.com IngredientNews Study Shows How Pycnogenol Helps Osteoarthritis ccording to the Centers for Disease Control and Prevention (CDC) osteoarthritis is the most common joint disorder in the U.S. affecting more than 30 million Americans. A new peer-reviewed published study shows that the polyphenols found in the French maritime pine park extract Pycnogenol are absorbed directly into joints supporting the vast catalog of research on Pycnogenol for osteoarthritis symptom relief. Pycnogenol is a powerful super- A antioxidant shown in decades of research to reduce inflammation in patients experiencing osteoarthritis symptoms. The new study published in the MDPI Journal of Nutrients is the first to measure the polyphenol distribution of Pycnogenol in joint synovial fluid. The double-blind study examined 33 individuals diagnosed with severe osteoarthritis scheduled for knee arthroplasty. Participants supplemented with 200mg of Pycnogenol daily over the course of three weeks leading up to the scheduled surgeries. Synovial fluid samples were collected during surgery to detect and measure the presence of polyphenols. Results from the synovial fluid samples show that the polyphenols found in Pycnogenol including taxifolin ferulic acid and catechin were distributed throughout the synovial fluid in the Pycnogenol-tested group. Taxifolin and ferulic acid were not detected in control group serum samples. For more information visit www.pycnogenol.com. Sunfiber Earns Low FODMAP Certification aiyo (Japan) a nutritional ingredient company announced that its premium branded ingredient Sunfiber is the first fiber and first stand-alone ingredient to become a Monash University Low FODMAP Certified product. Sunfiber made from guar bean is also one of the only soluble fiber ingredients approved by the FDA in 2016 to be listed as a dietary fiber. FODMAPs (fermentable oligo-saccharides disaccharides mono-saccharides and polyols) are a group of dietary sugars which are poorly absorbed in the small intestine. They are known to cause excess water retention gas related pain and intestinal distention in people suffering from functional gastrointestinal disorders (FGIDs) and irritable bowel syndrome (IBS). Low FODMAP foods and ingredients help to reduce these symptoms. Because many high-fiber foods are also high in FODMAPs IBS sufferers typically have difficulty getting the recommended daily intake of 25 to 30 g of fiber in their diets. That means they may not get enough soluble fiber which is essential for gut health as regularity. Even more problematic many of the shortchain dietary fibers such as inulin wheat and corn dextrin and IMOs are high FODMAP fibers and should be avoided by those looking to minimize FODMAP in their diet. To alleviate symptoms Monash University has developed a diet to help people cope with IBS and avoid foods that could breed FODMAPS and offers two certification programs that translate the science of a low FODMAP diet into practice one for food and beverage products the other for recipes. Now with Sunfiber Monash University has established a certification program for therapeutic ingredients and has confirmed that Sunfiber meets the low FODMAP criteria. For more information visit www.sunfiber.com. T NattoPharma & Ortho Molecular Products Form Exclusive Partnership attoPharma (Oslo Norway) has announced that it has been selected by Ortho Molecular Products a leader in practitioner-specific nutraceuticals as its exclusive vitamin K2 supplier partner. The company will transition the seven products in its line currently featuring vitamin K2 to MenaQ7 PRO a line extension available only to Ortho Molecular. For more than 25 years Ortho Molecular Products has researched and manufactured nutraceuticals sold exclusively to thousands of health care professionals nationwide and in Canada. With headquarters in Chicago IL the company has U.S. Food and Drug Administration (FDA)-audited current good manufacturing practice (cGMP)-certified manufacturing facilities in Stevens Point WI where the company will work to transition the following products to include NattoPharma s MenaQ7 PRO Vitamin K2 Vitamin K2 with D3 Vitamin K2 180 mcg Liquid Vitamin D3 with K2 K-FORCE Pro Bono Alpha Base Capsules without Iron Alpha Base Capsules with Iron The reformulated Ortho Molecular Products will be available in 2018. For more information visit www.nattopharma.com www.menaq7.com or www.orthomolecularproducts.com. N ChromaDex Announces Top-line Results of its Second Clinical Trial alifornia-based ChromaDex Corp. announced that the initial results of its second human clinical study of NIAGEN nicotinamide riboside chloride (NR) have confirmed NR significantly and sustainably raises the co-enzyme nicotinamide adenine dinucleotide (NAD ) in 140 healthy human volunteers over eight weeks. C In this study participants in the active group received 100 300 or 1 000 mg per day. Results from the randomized double-blind placebo controlled parallel-arm trial demonstrated that NR produced statistically significant increases in blood NAD compared to placebo that were related to the dose of NR consumed demonstrating a dose response. Levels remained elevated throughout the duration of the study thereby establishing an efficacious range for daily consumption. The study confirms not only efficacy in raising NAD but also definitively documents the safety of daily use of NR. For more information visit www.chromadex.com. 24 Nutrition Industry Executive www.niemagazine.com November December 2017 DuPont Debuts Plant-based 90 Percent Protein Nuggets uPont Nutrition & Health (Delaware) announced an expansion of its 90 percent protein nugget product range. The new SUPRO 90 percent protein nuggets are unique not only for their exceptionally high level of protein but also because they are label friendly. Nutritionally robust with a neutral flavor and crispy crunchy texture these plant-based nuggets are ideal for use in snacks cereals and nutrition bars. Food manufacturers can now differentiate their products with SUPRO 90 percent protein nuggets. With their D high protein level these nuggets can help formulators achieve desired protein levels while using liberal amounts of nuts seeds and fruit to add visual appeal. Available in a range of textures shapes and sizes the 90 percent protein nuggets offer endless possibilities to create innovative and great-tasting products. DuPont Nutrition & Health offers the widest selection of high-protein nuggets in the industry delivering nuggets with crunch nutritional value and taste experience. DuPont was the first supplier to offer a 90 percent protein nugget with the initial introduction of SUPRO Nuggets 570 a light crispy textured nugget with a barrel shape. Three new 90 percent protein nuggets have now been added to the portfolio each featuring a unique shape size and texture. For more information visit www.dupont.com. IN Ingredients Receives Cinnamon Patent N Ingredients (Tennessee) a global supplier of branded nutraceutical ingredients has been granted U.S. patent 9 700 590 by the U.S. Patent and Trademark Office (USPTO) for methods and materials related to cinnamon extract and metabolic syndrome X. This newly issued cinnamon patent compliments IN s current IP portfolio and continues to strengthen Cinnulin PF as the leading cinnamon extract available on the market said Gus Romero president of IN Ingredients. Cinnulin PF is a water-soluble cinnamon extract standardized to doubly I linked type-a polymers. It was the first cinnamon extract to be clinically tested and proven to have benefits supporting blood pressure and body composition. In a 12-week randomized doubleblind placebo-controlled clinical trial Cinnulin PF statistically lowered body fat and enhanced lean body mass while showing it supports blood sugar and blood pressure. Cinnulin PF has multiple published clinically tested studies--more than any other cinnamon extract. Research shows it has a strong synergistic effect with a probiotic improving its use over the probiotic tested alone for the gastrointestinal tract. For more information visit www.in-ingredients.com. CoreFX Ingredients Earns Organic Certification onsumer demand for organic food continues to increase with organic food sales forecasted to grow 6.7 percent annually in the U.S. until 2025 according to RaboResearch. To meet the needs of this changing marketplace CoreFX Ingredients (Illinois) manufacturers of custom dry dairy cheese and lipid ingredient solutions has earned organic certification under the USDA National Organic Program (NOP). The certification was awarded by accredited organic certifying agency Midwest Organic Services Association (MOSA) following rigorous on-site inspections of CoreFX Ingredients facility materials processing and handling. To maintain its organic certification CoreFX must continue to adhere to the strict national standards of organic products as outlined by the NOP. For more information visit www.corefxingredients.com. C Frost & Sullivan Recognizes OmniActive for Product Leadership ased on its recent analysis of the eye health ingredient market Frost & Sullivan recognizes OmniActive Health Technologies with the 2017 North American Product Leadership Award. OmniActive s R&D culture vertically integrated manufacturing and quality control systems (cGMP and HACCP systems) in all of its FDA (U.S. Food and Drug Administration) CFR110 cGMP (current good manufacturing practice) audited facilities has positioned the company as a market leader with Lutemax 2020. This is a unique eye health ingredient that has demonstrated efficacy and safety through extensive clinical trials and university partnerships. We are honored to receive this award which is a true testament to the B uniqueness of Lutemax 2020. Sustainably sourced from a fully integrated supply chain Lutemax 2020 delivers all three macular carotenoids for a more complete formulation said Lynda Doyle senior vice president of global marketing at OmniActive Health Technologies. Supported by strong science including the B.L.U.E. (Blue Light User Exposure) study Lutemax 2020 is the first and only macular carotenoid ingredient which showed beneficial effects on vision health and performance sleep quality as well as reducing eye strain and fatigue during long-duration exposure to blue light which addresses the needs of modern lifestyles. For more information visit www.omniactives.com. November December 2017 www.niemagazine.com Nutrition Industry Executive 25 IngredientNews Ingredion Launches Versasweet Low-sugar Glucose Syrups I ngredion Incorporated (Illinois) a global provider of ingredient solutions to diversified industries introduced in the U.S. and Canada a new line of low-sugar glucose syrups. Versasweet low-sugar glucose syrups enable manufacturers of confectionery dairy ice cream and baked good products to achieve reduced grams of sugar on the Nutrition Facts panel by formulating with low-sugar corn- or tapioca-based glucose syrups that compared to standard glucose syrups have a lower percentage of monoand disaccharides also called DP1 DP2. In a proprietary Ingredion study 61 percent of consumers said that added sugar on the nutrition label would negatively impact their purchase intent. In response to heighted awareness of sugar on labels especially in the face of changing sugar regulations in the U.S. and Canada manufacturers can give consumers the taste and sweet experience they expect with Versasweet lowsugar glucose syrups said Afrouz Naeini Ingredion s senior marketing manager of sweetness and beverage North America. For more information visit www.ingredion.us. Deerland Enzymes & Probiotics Earns Non-GMO Project Verification for ProHydrolase Euromed USA Launches ABAlife uromed USA (Pennsylvania) has brought a new standardized extract to the global ingredient marketplace ABAlife from the fig fruit. Coming out of Euromed s headquarters in Barcelona Spain the company has an exclusive license agreement with BioTherapeutics Inc. for the patented technology to create absiscic acid (ABA). The patents licensed by Euromed are entitled Method of using abscisic acid to treat diseases and disorders (Patent numbers 7 741 1367 and 8 367 727) and the inventors are Josep Bassaganya-Riera Raquel Hontecillas and Amir Guri. The invention relates to biologically active compounds (ABA) that treat and prevent insulin resistance and impaired glucose tolerance. The patents provide protection for structure-function claims related to ABA and maintenance of healthy blood sugar levels and similar statements. For more information visit www.euromedusa.com. G eorgia-based Deerland Enzymes & Probiotics an international enzyme and probiotic-based dietary supplement formulator and contract manufacturer has earned Non-GMO Project verification for ProHydrolase the company s branded enzyme blend for protein digestion. ProHydrolase is the third of Deerland s branded products to earn verification the company s DE111 probiotic and PreforPro prebiotic were verified earlier this year. Consumer demand for non-GMO (genetically modified organism) supplements is on the rise and Deerland is responding in order to provide added value for our customers said Scott Ravech CEO of Deerland Enzymes and Probiotics. We re pleased to work with the Non-GMO Project the leading verifier of non-GMO products in the United States. For more information visit www.deerlandenzymes.com. E THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights Jan. Feb. March 12 14 17 ad closing Heart Health Engredea at Expo West Show Issue Longevity and Aging Supplyside East Show Issue 2 2 18 ad closing Our 2018 Media Planner Is Available At NIEmagazine.com 2018-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF VRMmedia.com Gary Pfaff at (732) 432-9600 ext. 103 or e-Mail GaryP VRMmedia.com 26 Nutrition Industry Executive www.niemagazine.com November December 2017 AHPAUpdate Leading Industry Association Speaks Directly to Nutrition Industry Executive Readers Recent AHPA Board Actions T he American Herbal Products Association (AHPA) board of trustees took several actions at its Sept. 26 meeting held in conjunction with the SupplySide West trade show in Las Vegas NV. Among other issues the board addressed limits on foreign matter in herbal ingredients organic dietary supplement labeling ethanol identity testing methods and efforts to educate state attorneys general about the supplement industry. detection and mitigation of foreign matter and recommends good agriculture and collection practices such as those outlined in the AHPA Guidance for Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials to minimize foreign matter in raw herbal materials. If a cosmetic body care product or personal care product contains or is made up of agricultural ingredients and can meet the USDA NOP organic production handling processing and labeling standards it may be eligible to be certified under the NOP regulations. Organic Dietary Supplements The AHPA board authorized additional communications to the U.S. Department of Agriculture s (USDA) National Organic Program (NOP) to clarify that there are no regulatory differences between conventional foods and dietary supplements sold as organic. In 2004 NOP asserted that supplements and body care products were not under its jurisdiction and therefore not eligible to seek [NOP] certification. After persistent input from AHPA and a few organic supplement and body care brands--and a lawsuit filed against USDA (U.S. Department of Agriculture) by Dr. Bronner s--NOP reversed its position to communicate that its regulations could apply to all agricultural products irrespective of the end use of the product. However there continues to be con- Foreign Matter Limits The AHPA Board authorized development of industry guidance titled Limits of Foreign Matter in Herbal Ingredients which outlines maximum quantitative limits on foreign matter in various herbal raw materials. The guidance recommends plant parts of the same herbal raw material species other than those named in specifications should not exceed 5 percent (by weight) and all other foreign matter should not exceed 2 percent (by weight). It is natural for herbal raw materials to contain some foreign matter which may consist of Plant parts of the herbal raw material other than those named in its specification and description for example the European Pharmacopeia Hawthorn Leaf with Flower monograph limits lignified branches with a diameter 2.5 mm to not more than 8 percent Any organism part or product of an organism other than those named in the specification and description of the herbal raw material for example grass clippings in mint leaves Mineral admixtures present in the herbal raw material for example soil stones metal sand and dust. Official pharmacopeias worldwide recognize quantitative limits of foreign matter as part of monograph specifications for herbal raw materials. Limits of foreign matter for the same herbal material may differ in various pharmacopeias. Although not specific to foreign matter as defined here the U.S. Food and Drug Administration (FDA) establishes maximum levels of natural or unavoidable defects in foods that present no health hazards for humans. The guidance offers an overview of standard industry practices for the fusion in the marketplace and the AHPA board acted to provide more clarity for industry. A document on the NOP website titled National Organic Program Cosmetics Body Care Products and Personal Care Products states If a cosmetic body care product or personal care product contains or is made up of agricultural ingredients and can meet the USDA NOP organic production handling processing and labeling standards it may be eligible to be certified under the NOP regulations. In a meeting with NOP staff in January AHPA staff pointed out there is no such document regarding organic dietary supplements and requested that this be corrected. AHPA is also working with the Organic Trade Association and Quality Assurance International (QAI) to update a document issued jointly by AHPA and QAI in 2006 titled Guidance on Formulation and Marketing of Organic Dietary Supplements Under the National Organic Program. State AG Representation The board authorized AHPA to fund ongoing advocacy efforts to educate state attorneys general (AGs) about the dietary supplement industry in 2018. AHPA has contracted for Maryland Attorney General Doug Gansler of Buckley Sandler LLP to engage and build relationships with state AGs since early 2016. Funding to date has relied on the generous support of individual member companies which contributed 30 000 in 2017. In addition to the AHPA funds authorized by the board AHPA will continue to seek financial support for these ongoing efforts from individual members. Stevia and Philadelphia s Sugar Tax The board directed AHPA to contact Philadelphia Department of Revenue officials to correct inaccurate information posted online about stevia in relation to the city s recently enacted tax on sweetened beverages. A webpage that describes the Philadelphia beverage tax states that drinks considered diet or zero calorie are also taxed and provides as examples any non-alcoholic beverage syrup or other concentrate used Nutrition Industry Executive 27 November December 2017 www.niemagazine.com AHPAUpdate to prepare a beverage that lists any form of artificial sugar substitute including stevia aspartame sucralose neotame acesulfame potassium (AceK) saccharin and advantame. AHPA has submitted a letter stressing that stevia is not artificial and that ingredients used as sugar substitutes are derived from the leaf of the Stevia rebaudiana plant. The letter urges the city s Department of Revenue to correct the inaccurate information on this webpage to make it consistent with the regulation and other webpages. applicable components specifications are met. To fulfill these requirements manufacturers need to conduct appropriate tests or examinations or rely on certificates of analysis from suppliers of these components provided that the criteria listed in 21 CFR 111.75(a)(2) are satisfied. This AHPA resource will be useful for companies that receive a clear liquid labeled ethanol said AHPA Chief Science Officer Maged Sharaf PhD. It will help them verify the identity of the liquid in order to satisfy dietary supplement manufacturing requirements enforced by the Food and Drug Administration. The document was developed with extensive input from AHPA members and will help member companies conduct appropriate testing to identify ethanol. It covers a number of physical chemical spectrometric and chromatographic methods for the identification of ethanol. The document is not an exhaustive collection of test methods for ethanol and other methods not included in the document may be equally suitable. Ethanol Identity Test Methods The AHPA board authorized publication of a resource document that describes test methods that can be used to identify ethanol. Dietary supplement operations are required to confirm the identity of nondietary components used in their products and determine whether other Michael McGuffin President and Board of Trustees American Herbal Products Association (AHPA) Conventions&Meetings Vitafoods Asia 2017 Strategic Move to Singapore Makes Positive Impact itafoods Asia an event dedicated to the nutraceutical functional food and beverages and dietary supplement industries concluded its seventh edition on a high note for the first time in Singapore this past September. Held in the Sands Expo & Convention Centre at Marina Bay Sands the seventh edition of Vitafoods Asia welcomed a total of 5 067 industry professionals (representing a 113 percent increase over its 2016 edition) V from 62 countries to discover a remarkable showcase presented by 260 global exhibitors from 40 countries that cover the entire nutraceutical supply chain. The event also enabled trade visitors to learn from over 40 world-class industry expert speakers who shared deep insights from their wealth of experience. The strategic relocation of Vitafoods Asia saw the show double--both in size and attendance revealed Chris Lee managing director at Informa Exhibitions Global Health & Nutrition Network Europe. The quality of visitors who came through and the meaningful connections made at the event have been phenomenal. While it s never just about the numbers we re very heartened by the industry s response. The eighth edition of Vitafoods Asia will be held September 11-12 2018 in the Sands Expo & Convention Centre at Marina Bay Sands Singapore. For more information visit www.vitafoodsasia.com. S Influencers to Gather at Mexican Healthy Products Summit ShiftCon Social Media Conference to be Held in Puerto Vallarta hiftCon is an eco-wellness influencer conference focusing on food wellness health sustainability and platform growth. Shifters are part of an online influencer community that seek healthier and more sustainable lives promote brands that mirror their values and help causes that speak to their soul according to the official event website. Influences span between newbies light and deep green. Held February 1-3 2018 at the Hotel Irvine in Irvine CA the exhibitor hall will include more than 50 brands and organizations that want to work with influencers. The fourth annual conference also offers fitness events and non-GMO (genetically modified organism) meals. For more information visit www.shiftconmedia.com. T he Sheraton Buganvilias Resort and Convention Center in Puerto Vallarta Mexico will be home to the Mexican Healthy Products Summit which will be held January 2628 2018. This is an invitation-only business-to-business trade show and conference linking healthy products suppliers with key retail buyers and distributors. There will be a variety of networking opportunities including a welcome reception evening cocktail gatherings meals (breakfast lunch and dinner) and entertainment. Expert speaker session will be in the morning with topics ranging from the Latest Healthy Lifestyle Trends in Mexico & Research in Mexico and Globally to Best Export Practices. For more information visit www.healthyproductssummit.com. www.niemagazine.com November December 2017 28 Nutrition Industry Executive SupplySideWestWrapUp SupplySide West Closes its 21st Year With Record Attendance upplySide West has been the industry s gathering point where science and strategy intersect since 1997. Now in its 21st year the event continues to offer scientific innovation and strategic educational programming plus networking opportunities that help participants form mutually beneficial business relationships. According to show organizers this year s event hosted more than 16 000 attendees from more than 68 countries. It was held September 25-29 at the Mandalay Bay in Las Vegas NV bringing together more than 1 200 exhibiting companies including more than 185 first-time exhibitors. The energy and buzz at SupplySide West 2017 exceeded past years as did industry participation said Jon Benninger vice president of Informa s Global Health & Nutrition Network. From the recordbreaking expo hall to the packed education sessions participants were ready to connect and talk about the science and strategy driving the healthy products indusSteven Tave try. Education programs saw record engagement this year as well with a packed room for featured speaker Steven Tave director of the Office of Dietary Supplement Programs in the FDA s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition. Tave discussed the importance of safety product integrity along with the con- S cept of transparency and the 2016 NDI (new dietary ingredient) Revised Draft Guidance. He addressed the specifics of submitting an NDI notification which involves notifying the FDA of dietary ingredients marketed in the U.S. after October 15 1994. Over the five days of education attendees actively engaged with experts from across the globe all of whom were tackling the prime issues--from regulatory compliance and product formulation to market trends and demographics--that will drive product development into the future. As always we appreciate the engagement of our industry in truly leading the dialogue around how a transparent supply chain dedication to quality and emphasis on science and efficacy will benefit consumers health and wellness said Heather Granato vice president of content for Informa s Global Health & Nutrition Network. Attendees also found learning and networking opportunities at SupplySide Central. Offering a variety of interactive programming designed to delve into some of the hot topics facing the industry SupplySide Central featured topics from the Ingredient Launchpad where exhibitors highlighted their new products to the sixth Annual CPG Editor s Choice Awards where SupplySide West recognized the most innovative product launches in supplements and food & beverage. Industry Trends On the show floor at the USP booth John B. Atwater senior director Verification Programs who presented on the importance of testing standards during an education session at the show noted that one of the trends is an overall industry interest in the self-regulatory initiatives such as CRN s OWL supplement labeling initiative the Supplement Safety & Compliance Initiative (SSCI) and the American Botanical Council s Botanical Adulterants programs. This trend is in line with USP s focus on ensuring quality through development of standards and USP s Verification Programs for dietary supplements and ingredients Atwater said. SupplySide West wrapped up its successful show with a 36 395 donation to Vitamin Angels. This year s SupplySide Cares program donated to support this impactful non-profit that is dedicated to bringing vitamin supplementation to at-risk populations in need--specifically pregnant women new mothers and children under five. The next SupplySide will be Supplyside East which will return to the Meadowlands Exposition Center in Secaucus NJ April 10-11 2018. SupplySide West 2018 will be held at Mandalay Bay November 6-10. For more information visit west.supplysideshow.com. Nutrition Industry Executive 29 November December 2017 www.niemagazine.com AssociationNews Supplement Caucus Shines Light on Nutritional Intakes of U.S. Adults he best way to improve dietary intake is diversification fortification and supplementation said Regan Bailey PhD RD MPH associate professor Department of Nutrition Science Purdue University (Indiana) at the 31st Congressional Dietary Supplement Caucus briefing held in September on Capitol Hill. Speaking before an audience of more than 60 Congressional staffers and guests Bailey discussed dietary supplement use and nutrient intakes in U.S. adults as well as ways to improve nutritional habits and access to products that will help them achieve their health and wellness goals. We always recommend food first advised Bailey. However research shows that overwhelmingly adults fail to exceed the recommended daily value of any vitamin or mineral from foods alone. For this reason we must find ways to incorporate these vital nutrients into our diets--and taking a dietary supplement like a multivitamin is a great step to take. T At the briefing Bailey presented research on dietary supplement usage across the spectrum of specific American populations. She noted that adults who use dietary supplements differ from those who do not in a number of ways including age gender race and socioeconomic status. A clear pattern that always emerges in almost every cohort that I have ever seen is that the use of dietary supplements increases with the amount of money a person or family has said Bailey. Many Americans live in communities that lack accessible affordable healthy food options. By increasing access to dietary supplements among those most at risk for micronutrient deficiency especially those of lower socioeconomic status we can ensure all Americans are getting the nutrients they need to live healthier lives. Bailey s presentation dovetails with legislation recently introduced in Congress the SNAP Vitamin and Mineral Improvement Act (HR 3841) which allows for the inclusion of a multivitamin under Supplemental Nutrition Assistance Program (SNAP) benefits. Dietary supplements such as the multivitamin are useful in providing nutrients that otherwise may be consumed in less-than-recommended amounts and HR 3841 would empower SNAP recipients to make the choice to purchase the dietary supplements they need to live healthier more nutrient-rich lives. The educational event was sponsored by the bipartisan bicameral Dietary Supplement Caucus with help from trade associations representing the dietary supplement industry--the American Herbal Products Association (AHPA) the Consumer Healthcare Products Association (CHPA) the Council for Responsible Nutrition (CRN) the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA). For more information visit www.ahpa.org www.chpa.org www.crnusa.org www.npainfo.org or www.unpa.com. Delaying Food Labeling Rules is Consistent With Trump s Pledge to Overhaul the Regulatory System and Grow The Economy Says NPA he Natural Products Association (NPA) has submitted a formal request to U.S. the Food and Drug Administration (FDA) for an extension of the comment period by 90 days regarding the opportunity to comment on the newly proposed compliance dates published on October 2 for both Nutrition and Supplement Facts and Serving Size Final Rules. President Trump has successfully cut hundreds of burdensome and costly regulations to protect taxpayers and grow the economy said Dan Fabricant PhD president and CEO of NPA. Providing small and medium sized businesses more time to comply with the FDA s food labeling rule is consistent with the President s promises to overhaul the regulatory system and grow the economy. Given the complexity and technical nature of this final rule the obvious need for more empirical research by the agency to support their changes the significant economic burden to industry to implement these changes quickly T more time is needed for the industry to prepare a response and ensure the best outcome for consumers of dietary supplement conventional foods and other natural products. added Fabricant. An extension of the implemented compliance dates will allow the Executive Branch to assess these regulations under the lens of President Trump s Regulatory Reform Agenda as to whether these changes are even warranted. It will also give time to FDA to conduct empirical consumer research studies that support changes to the Nutrition and Supplement Facts labels and a proper analysis of the economic and regulatory impact to industry. The industry and FDA are familiar with NPA s Citizen s petition to stay the implementation of the Nutrition and Supplement Facts final rule. We are asking FDA to extend the comment period of this notice for 90 more days to allow for additional stakeholder comment to increase their newly proposed compliance dates from 1.5 years to three years reopen the comment period up for these final rules amendments and all guidance documents associated with these two rules and conduct reasonable empirical studies with transparent methods that are publicly available that support their findings to mandate the changes proposed in these two final rules Fabricant continued. We would also like the economic impact analysis to represent true costs to the industry including the costs of adopting their dietary fiber substantiation guidance which was borne out of the Nutrition and Supplement Facts final rule. Extending the comment period here is a necessary first step to collect the diverse opinions from across the industry and ensure that consumers continue to have access to safe healthy and affordable foods dietary supplements and other natural products. For more information visit www.npainfo.org App_Themes NPA do cs press Documents NPA%20Comment s%20-%20extension%20of%20compliance%20dates%20for%20NFL%20and% 20SFL%20-%20final.pdf. 30 Nutrition Industry Executive www.niemagazine.com November December 2017 AHPA Issues New Guidances on Ethanol Foreign Matter T he American Herbal Product Association (AHPA) has published multiple new guidances. The first is a resource document that describes test methods that can be used to identify ethanol. Dietary supplement operations are required to confirm the identity of nondietary components used in their products and determine whether other applicable components specifications are met. To fulfill these requirements manufacturers need to conduct appropriate tests or examinations or rely on certificates of analysis from suppliers of these components provided that the criteria listed in 21 CFR 111.75(a)(2) are satisfied. The document was developed with extensive input from AHPA members and will help member companies conduct appropriate testing to identify ethanol. It covers a number of physical chemical spectrometric and chromatographic methods for the identification of ethanol. The document is not an exhaustive collection of test methods for ethanol and other methods not included in the document may be equally suitable. This document is an AHPA member benefit and members can log into www.ahpa.org to download the guidance. AHPA also published new industry guidance titled Limits of Foreign Matter in Herbal Ingredients which outlines maximum quantitative limits on foreign matter in various herbal raw materials. The guidance recommends plant parts of the same herbal raw material species other than those named in specifications should not exceed 5 percent (by weight) and all other foreign matter should not exceed 2 percent (by weight). Official pharmacopeias worldwide recognize quantitative limits of foreign matter as part of monograph specifications for herbal raw materials. Limits of foreign matter for the same herbal material may differ in various pharmacopeias. Although not specific to foreign matter as defined here the FDA (U.S. Food and Drug Administration) establishes maximum levels of natural or unavoidable defects in foods that present no health hazards for humans. The guidance offers an overview of standard industry practices for the detection and mitigation of foreign matter and recommends good agriculture and collection practices such as those outlined in the AHPA Guidance for Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials to minimize foreign matter in raw herbal materials. Lastly AHPA has updated Proposition 65 guidance to inform the herbal products industry about legal liabilities related to nat- urally occurring substances in some natural products sold in the state of California. Under Prop 65 consumer goods sold in the state generally must provide a clear and reasonable warning if chemicals listed by the state as carcinogens or reproductive toxicants are present above specified limits. California amended Prop 65 warning requirements in August 2016 and the changes are scheduled to be effective in August 2018. AHPA s Guidance on California Proposition 65 and Herbal Products provides detailed information about these changes and options for implementation. Several chemical constituents that naturally occur in certain botanicals used in teas and dietary supplements are included on the Prop 65 warning list. Recently two processed botanicals were also added to the list. The document includes Prop 65 guidance on heavy metals naturally occurring constituents pulegone and -myrcene goldenseal root powder and aloe vera (nondecolorized whole leaf extract). Over the last decades numerous brand marketers contract manufacturers retailers and other companies that sell or manufacture herbal products have been the targets of Prop 65 complaints and the allegations can be costly. For more information visit www.ahpa.org. Identification of Medicinal Plants A Handbook of the Morphology of Botanicals in Commerce a manual that addresses the macroscopic assessment of 124 medicinal plants used in North America and Europe. The book was originally co-published in 2006 by ABC with the Missouri Botanical Garden in St. Louis. It was written by Wendy Applequist PhD associate curator at the Missouri Botanical Garden s William L. Brown Center and illustrated with botanically accurate blackand-white line drawings by artist Barbara Alongi. ABC is pleased to be able to make this important book available to its members particularly those in academic analytical research and in the herb industry noted ABC Founder and Executive Director Mark Blumenthal. Because many botanical raw materials used in the current herb industry are either cut plant parts (e.g. for use as teas) or powders (to be made into capsules or tablets) many companies never receive and process whole plants or whole plant parts. In such cases microscopy chemical analysis and or genetic (DNA) testing are required analytical methods. But for growers wildcrafters collectors processors and others who deal with whole plants and their whole parts this manual is a highly valuable quality control resource. The Identification of Medicinal Plants will be available online to ABC members at the Professional level and above. For more information visit www.abc.herbalgram.org. November December 2017 www.niemagazine.com T ABC Publishes Online Version of The CRN Announces Dates Identification of Medicinal Plants Book for 2018 The Workshop he American Botanical Council (ABC) announces a new benefit for and The Conference its members around the world the online publication of The he Council for Responsible Nutrition (CRN) has announced that CRN s annual educational networking events--The Workshop CRN s Day of Science and The Conference CRN s Annual Symposium for the Dietary Supplement Industry--will be held October 17-20 2018 at The Ritz-Carlton Laguna Niguel in Dana Point CA. The Workshop is a full-day scientific symposium on October 17 convening expert speakers for highly relevant scientific discussions on dietary supplement and nutrition topics including forward-looking research and closing with an evening reception that also marks the start of The Conference. CRN s conference features thought-provoking sessions spanning a range of topics including business and marketing regulation government affairs and more and lasts through Saturday morning with a popular Breakfast With ... session and additional content. CRN s events also offer prime opportunities to connect with industry colleagues and meet new people. Additional details and registration for The Workshop and The Conference will be available mid-2018 at www.crnusa.org 2018events. T Nutrition Industry Executive 31 AssociationNews UNPA Announces In-house Education and Training for Food and Supplement Companies n an effort to assist its members and the broader natural health products industry in improving and maintaining regulatory compliance the United Natural Products Alliance (UNPA) is now offering onsite education and training courses for food and dietary supplement companies. UNPA s onsite education and trainings provide a host of efficient and cost-effective staff trainings that can save companies time money and travel costs plus they allow for confidential proprietary discussions and solutions with staff and trusted suppliers as they develop policies and procedures to ensure regulatory compliance. These onsite in-house trainings allow UNPA to further its mission to help companies reach and maintain compliance with ever-evolving federal regulatory requirements said UNPA President Loren Israelsen. The onsite trainings have been met with universal approval as a smart efficient way to I accomplish staff education and raise the bar for quality initiatives in the dietary supplement category. UNPA s onsite training program is led by Larisa Pavlick UNPA s vice president of global regulatory an compliance a 20-year industry veteran who most recently served as an investigator for the U.S. Food and Drug Administration s (FDA) Denver CO district office. As an FDA investigator Pavlick has been in more than 200 facilities and she is a lead instructor for the standardized coursework for Preventive Controls Qualified Individual (PCQI) part of the require- ments under the Food Safety Modernization Act (FSMA). She will shortly become a lead instructor to teach standardized training for Foreign Supplier Verification Programs (FSVP) also a requirement of FSMA. Pavlick has previously completed onsite training for companies in Oregon Texas Italy Norway and Canada. Many of the onsite training courses especially the overview courses can be combined during a single visit by UNPA staff making it easier for companies to meet their regulatory obligations. For more complete training session descriptions including who should attend each session visit www.unpa.com ABOUT EducationTraining Onsite-Training. For more information about the UNPA onsite trainings contact Kira Olsen UNPA s director of membership services and events at (801) 474-2572 or kira unpa.com. SENPA Breaks With NPA Announces Branding Initiatives NPA Responds With Cease and Desist ENPA a non-profit trade association located in New Port Richey FL and producer of SOHO Expo Strategies for Success Road Shows and providers of Comprehensive Continuing Education programs has announced new branding initiatives for the association. SENPA has been a long chartered regional member of Natural Products Association (NPA) and on September 19 2017 President Michelle DuFresne announced SENPA will no longer charter with NPA. SENPA and the Board of Directors believe we can better serve our membership with this change and align the association with additional groups that serve the natural products industry and foster the growth of SENPA membership said DuFresne. The Board of Directors has unanimously adopted a new mission and vision statement for the association to include supporting the industry through education networking and advocacy for the right to buy and sell natural products by empowering healthy choices and business develop- S ment. Our focus has always been serving the natural products retailer and the companies that serve them said DuFresne. In response the NPA has released the following statement regarding the cease and desist letter it sent to SENPA for trademark infringement and unfair competition NPA will not permit unaffiliated organizations to trade on its reputation and goodwill and harm its national and state advocacy efforts. The actions-- taken by SENPA--to open up their membership to those outside its region and infringe on NPA s trademarks--while they were still serving on NPA s Board of Directors is an undisclosed conflict and breach of duties owed to NPA. It s unclear how such activities would ever be envisioned as helping to strengthen the industry or to help NPA the oldest and largest Association that has been fighting for the industry for over 80 years. NPA is as strong today as we have ever been and we are confident that we will continue to grow stronger as an association as natural products continue to gain popularity with our customers in the U.S. and across the globe. Our membership is at a very healthy level which we believe is a result of our dedication to strong advocacy whether it s federal state local or internationally NPA s premier industry education programs and our commitment to individual member service. We are also encouraged by the success of our modernization and reorganization plan as we work to maintain our preeminence as the industry s largest and most influential trade association in the natural products and dietary supplement spaces. State legislatures and state attorneys general are becoming increasingly active on issues related to our industry and NPA is responding in kind with smart timely and effective strategies to ensure that our collective interests are represented both nationally and in all states. For more information visit www.senpa.org or www.npainfo.org. 32 Nutrition Industry Executive www.niemagazine.com November December 2017 CRN Announces Supplement OWL Advisory Board he Council for Responsible Nutrition (CRN) has announced the creation of an Advisory Board for the Supplement OWL (Online Wellness Library) the dietary supplement product registry. Eight individuals have been appointed to serve on the Board including representatives from dietary supplement companies (CRN members and non-members) and other representatives of the industry along with two technical advisors. According to CRN President and CEO Steve Mister The Advisory Board brings together stakeholders from all corners of the supplement industry and provides a forum to discuss the forward progress of the Supplement OWL. The goal is to take a critical look at the registry and continually find ways to improve upon the successes already actualized and find new ways to optimize the experiences of both users and participants. Appointees to the Supplement OWL Advisory Board are Jeff Brams general counsel and vice president science & international T Garden of Life Michael Cleary PhD director of research and development SmartyPants Mike Devereux CEO Nature s Way Randy King senior vice president governance & compliance New Chapter Inc. Carlotta Mast executive director of content & insights New Hope Natural Media Steve Mister president & CEO CRN Guru Ramanathan PhD chief innovation officer and senior vice president GNC Pam Walker head of global sales materials & ingredients UL Non-voting Technical Advisors to the Board are Duffy MacKay ND senior vice president scientific & regulatory affairs CRN Alec Miller director of software development UL The majority of the appointees have been involved with the Supplement OWL since its inception said Mister. Having an intimate knowledge of the roots of the registry the members of this Board will be able to offer insight and constructive feedback that speaks to the OWL s past present and future. As the Supplement OWL continues to gain momentum throughout the industry it s crucial that the registry evolves to accommodate increased demand and participation Mister continued. Though just six months old the registry already contains an appreciable amount of product labels and is being noticed by regulators retailers and other target audiences. Through its work and regular meetings the Supplement OWL Advisory Board will ensure the registry lives up to its potential. For more information visit www.supplementowl.org. CRN Welcomes Six New Companies Website Honored With 2017 Communicator Award he Council for Responsible Nutrition (CRN) recently announced six new companies have joined the association s membership ranks. These companies include Voting Members--Catalent Jigsaw Health LLC RoundTable Healthcare Partners Santa Cruz Nutritionals Vitabiotics and Associate Member--Debevoise & Plimpton LLP. CRN recently also received a 2017 Communicator Award for the redesign of CRN s website from Balance Interactive a Northern Virginia-based full-service digital agency the redesign of CRN s website. According to the Academy of Interactive & Visual Arts (AIVA) the Communicator Awards is the leading international awards program recognizing big ideas in marketing and communications. Each year the Communicator Awards receives more than 6 000 entries from companies and agencies of all sizes. T We re pleased to see our new site honored with this prestigious award and thank AIVA for its recognition said Judy Blatman senior vice president communications CRN. Partnering with Balance Interactive enabled us to create a website that is visually appealing and technically improved allowing us to more easily showcase responsible industry and the important work CRN and its member companies do. CRN publicly launched its redesigned website this past January establishing a fresh modern virtual home base for the association. Enhancing the user experience and simplifying navigation the new CRN website is designed to grow with the industry and provides visitors with easy to access information about CRN and the industry in the areas of science regulation and self-regulation legislation and consumer trends. In addition to its public-facing features the website also features a dynamic members-only section that permits access to exclusive alerts announcements and documents. The interactive new website can viewed from a desktop computer tablet or mobile phone and features a strong search engine. Websites are often the first impression people get of an association and we wanted to create something that reflected the professionalism the industry knowledge and the innovation that are hallmarks of CRN and its member companies added Blatman. We hope that as industry continues to grow the CRN website will serve as a key resource for those inside and outside the industry. For more information visit www.crnusa.org. Nutrition Industry Executive 33 November December 2017 www.niemagazine.com ScienceUpdate Black Tea May Help With Weight Loss CLA researchers have demonstrated for the first time that black tea may promote weight loss and other health benefits by changing bacteria in the gut. In a study of mice the scientists showed that black tea alters energy metabolism in the liver by changing gut metabolites. The research is published in the European Journal of Nutrition. The study found that both black and green tea changed the ratio of intestinal bacteria in the animals The percentage of bacteria associated with obesity decreased while bacteria associated with lean body mass increased. Previous studies indicated that chemicals in green tea called polyphenols are absorbed and alter the energy metabolism in the liver. The new findings show that black tea polyphenols which are too large to be absorbed in the small intestine stimulate the growth of gut bacterium and the formation of shortchain fatty acids a type of bacterial metabolites that has been shown to alter the energy metabolism in the liver. U It was known that green tea polyphenols are more effective and offer more health benefits than black tea polyphenols since green tea chemicals are absorbed into the blood and tissue said Susanne Henning the study s lead author and an adjunct professor at the UCLA Center for Human Nutrition which is part of the David Geffen School of Medicine at UCLA. Our new findings suggest that black tea through a specific mechanism through the gut microbiome may also contribute to good health and weight loss in humans. The results suggest that both green and black teas are prebiotics substances that induce the growth of good microorganisms that contribute to a person s well-being she said. After four weeks the weight of the mice that were given green or black tea extracts dropped to the same levels as those of the mice that received the lowfat diet throughout the study. The researchers also collected samples from the mice s large intestines (to measure bacteria content) and liver tissues (to measure fat deposits). In the mice that consumed either type of tea extract there was less of the type of bacteria associated with obesity and more of the bacteria associated with lean body mass. However only the mice that consumed black tea extract had an increase in a type of bacteria called Pseudobutyrivibrio which could help explain the difference between how black tea and green tea change energy metabolism. For more information visit www.uclahealth.org. Zinc Can Halt the Growth of Cancer Cells Study Says Z inc supplements can significantly inhibit the proliferation of esophageal cancer cells according to a new study co-authored by a University of Texas (UTA) at Arlington researcher. In the study a team led by Zui Pan an associate professor of nursing at UTA s College of Nursing and Health Innovation and a noted esophageal cancer researcher discovered that zinc selectively halts the growth of cancer cells but not normal esophageal epithelial cells. The finding was published in The FASEB Journal. Esophageal cancer is the sixth leading cause of human cancer deaths around the world according to the National Cancer Institute. The institute estimates that there were almost 16 000 esophageal cancer deaths in the United States in 2016. The average five-year survival rate is less than 20 percent. Pan said this study could provide a pathway for better esophageal cancer prevention and treatment. Zinc deficiency has been found in many cancer patients said Pan whose study was funded in part by a research grant from the National Institutes of Health--National Cancer Institute. Both clinical data and animal studies have shown that this mineral is very important for overall body health and for cancer prevention. Zinc is an important element in many proteins and many enzymes and the absence of zinc makes it impossible for cells to function she added. But previously we didn t know why the same physiological concentrations of zinc inhibit cancer cell growth but not normal cells. Our study for the first time to our knowledge reveals that zinc impedes overactive calcium signals in cancer cells which is absent in normal cells and thus zinc selectively inhibits cancer cell growth. said Pan. It now appears that zinc and calcium can have a cross talk meaning that they can be linked. An insufficient amount of zinc can lead to the development of cancers and other diseases Pan said. That s why it is important to have a good diet she added. Zinc enriched foods include spinach flax seeds beef pumpkin seeds and seafood like shrimp and oysters. Pan said that in the future they will study how these two signals link how they impact each other and how researchers can take advantage of what they know. Such a step will guide them in developing a better prevention and treatment strategy she noted. For more information visit www.uta.edu uta . 34 Nutrition Industry Executive www.niemagazine.com November December 2017 By Lisa Schofield F or years more American adults were proclaiming I want my EFAs And for good reason popular health media continue to tout the benefits of docosahexaenoic acid and eicosapentanoic acid--DHA and EPA. In the past five years the market has seen dips and gains after years of growth. According to Ellen Schutt communications director of Utah-based GOED (Global Organization for EPA and DHA Omega-3s) recent indicators show that the U.S. market for omega-3 EFAs which is currently stabilized is returning to growth after a decline that began in late 2013. In 2015 the global EPA and DHA market tallied at 88 600 metric tons (mT) of ingredient oils worth 1.16 billion and the global volume was flat. According to GOED s preliminary estimates the global ingredient volume in 2016 grew at a rate of 1 to 2 percent. In the U.S. early estimates indicate that the volume remained relatively flat in 2016 and appears poised to 36 Nutrition Industry Executive return to modest growth in 2017 Schutt reported. Factors impacting a return to growth include ongoing scientific developments and more crucially continuing positive media. In agreement is Katrin Berntsen director of communications for Norway-based Aker BioMarine who observed that in the past couple of years the omega-3 market has been flat but most recently it has started to pick up the pace and head toward new and exciting areas. Innovation and new product launches she noted have been the key drivers to consumer excitement and growth in the omega-3 market and krill oil is now an increasingly popular option in the omega-3 space. There have been other impacts in the market. For example said Ben Kelly cofounder of Algarithm Saskatoon SK Canada there has been a significant shift in consumer preference of omega-3 sources consumers he noted prefer to obtain these nutrients from functional foods over pills. Many consumers are part of a plant-based movement currently led by food tech companies such as Beyond Meat Hampton Creek and Impossible Foods which are replacing animal-sourced proteins with plants he said adding that Algarithm is extending the trend to lipid ingredients. Higher EPA and DHA concentrations are now beginning to enter the mass market observed Anne Healy senior marketing manager DSM Nutritional Products North America in New Jersey. The company she reported recently launched 3C Technology a radically efficient process technology that makes high concentrations of omega-3s more accessible. Further 3C Technology isolates and separates EPA and DHA for greater nutritional precision assisting formulators to potentially be more innovative. Innovation in this space has been focusing on the changing paradigm from intake to uptake from dosage to delivery which will www.niemagazine.com November December 2017 transform R&D and product development strategies described Abhijit Natu global marketing manager North America BASF Nutrition & Health based in New Jersey. He added Scientific evidence links an improved omega-3 index to enhanced health especially cardiovascular health. We ve learned from past mistakes in study designs and have a better understanding of the importance of omega-3 bioavailability and the implications for dietary supplement innovation. Innovation in any market and the ability to achieve consistent growth are not without challenges to overcome. Some in the omega-3 space involve consumer habits. For example said Healy consumers are confused at point-of-sale due to such a variety of choices they have not been educated as to how to select what s most suitable for them. Brand marketers should educate more assertively about how it is important to choose by amount of EPA and DHA in each serving instead of amount of total fish oil. Berntsen agreed asserting that the multitude of products on store shelves makes it more important than ever for consumers to understand more comprehensively what they are buying and why. To that end she said Aker Biomarine has created The Omega-3 Index Project to help increase awareness about EPA and DHA insufficiency and to encourage consumers to regularly measure their omega-3 levels and seek suitable sources. Another challenge in consumer knowledge Natu pointed out is that they still don t quite grasp the importance of bioavailability among other factors. Citing GOED research he said nearly half of Americans are not trying to get omega-3 in their diet. Additionally the omega-3 status in 95 percent of Americans is below levels associated with cardio-protection. Without education these figures will not improve he warned. In tandem although physicians are trusted sources for consumer education even they can be confused he added. The industry must collaborate cohesively to educate health care practitioners to communicate accurate information about this vast category. BASF is a part of GOED s Executive Council for Education and Outreach an ongoing campaign focused on educating physicians. Clinical study outcomes and related research can be confusing to consumers and this is compounded by the fact that EPA and DHA have a vast number of studies some conflicting. The biggest challenges continue to be confusion about the science supporting omega-3s and questions about oxidation of omega-3 oils observed Schutt. Regarding research GOED has been funding new science on omega-3s to fill the research gaps and has published two meta analyses during 2017. The first reinforced the link between omega-3 intake and reduced risk of coronary heart disease and the second clarified the connection between omega-3s and a reduced risk of cardiac death. Oxidation is another issue often misunderstood not just by consumers but by industry as well Schutt added. Oxidation is incorrectly described as a safety issue when there are no studies that show that consuming oxidized omega-3 oils is unsafe she said. Also most omega-3 oils are within oxidative limits and far below oxidation levels for oils like olive oil which are more broadly consumed in much higher serving sizes. The biggest challenges continue to be confusion about the science supporting omega-3s and questions about oxidation of omega-3 oils. -- Ellen Schutt GOED GOED recently completed a study that independently tested the top 50 omega-3 products in the United States and found high compliance levels Schutt said these findings will be published soon. Relatedly GOED also recently published Best Practices for Oxidation Control to help the industry understand the steps to take to minimize oxidation throughout the production process and improve quality product overall. Oil freshness is always a challenge for manufacturers pointed out Steve Dillingham global director AlaskOmega Ingredients Organic Technologies of Ohio. Once the oxidation process begins it cannot be stopped only curtailed which is why it is critical for manufacturers to have control over the supply chain and production process to help reduce oil oxidation. Dillingham added that Organic Technologies is able to manufacture its AlaskOmega omega-3 concentrates to such high freshness and purity standards. Raw oil is extracted from the trimmings of Marine Stewardship Council (MSC)-certified wild Alaska pollock sourced from the Bering Sea within a few hours after catch and then transported to the company s NSF-certified GMP (good manufacturing practice) manufacturing facility and gently processed through a proprietary purification and concentration process to extract and purify EPA and DHA concentrates to very high purity levels (80 percent EPA DHA). Products are kept under inert gas and away from oxygen throughout the entire process to ensure that AlaskOmega oils have the utmost freshness and quality. AlaskOmega omega-3 concentrates have a maximum TOTOX limit of 5 more than a five-fold reduction from the limit of 26 set by GOED he explained. Typical AlaskOmega TOTOX values range between 0-3 Fresher oil translates into better product stability longer shelf life and optimal sensory characteristics. Helping consumers properly distinguish alpha linolenic acid (ALA) another omega-3 EFA is another challenge. Further there are opposing views as to the efficacy of ALA as an omega-3 EFA. Kelly asserted that many people believe you can get the same nutritional benefit from flax as from algae or fish when the reality is that most ALA will not convert to EPA and DHA in the body due to a variety of reasons. This issue in particular is going to require ongoing education at the consumer level that organizations like GOED are conducting. An opposing viewpoint is offered by Sandra Gillot CEO of Benexia Santiago de Chile a supplier of chia seed ingredients. A study published in Nutrients has shown that women who consume Benexia chia oil transferred high levels of DHA to their infants during breast-feeding she said. It is the first published study of its type involving pregnant and lactating women. The authors measured the transfer of fatty acids (ALA DHA EPA) to the fetus (blood phospholipids) and breast milk in women who supplemented with chia oil during pregnancy and lactation. The authors said Gillot explained that through a series of enzymatic reactions of elongation and desaturation which occurs mainly in the liver ALA is first transformed into EPA then to DHA. The values of ALA EPA DHA suggest a higher bioconversion of the omega-3 precursor ALA from consumption of chia oil and that it could be a valuable addition to the diets of pregnant and lactating women she commented. According to Schutt there are now more sources of omega-3 EFAs coming online. In Nutrition Industry Executive 37 November December 2017 www.niemagazine.com SGS Germany GmbH which confirmed BASF established a sustainable sourcing process for its omega-3 products. BASF s approach to omega-3 sustainability consists of three principles sustainable sourcing operational excellence and more sustainable omega-3 end products according to Natu. Sustainable sourcing starts with choosing addition to an explosion in algae offerings partners that practice sustainability princifrom various strains with varying amounts of ples he said. Unregulated fishing can EPA and DHA there are now offerings from damage fragile marine ecosystems and vulcalamari oil hoki oil and herring roe just to nerable species which in turn may reduce name a few. Also under development are future productivity and biodiversity and creseveral genetically modified (GM) plants that ate imbalances in the ecosystem. can express EPA and DHA. Once these are Operational excellence Natu described commercialized they should have a major is critical to reduce waste save resources influence on the market of tomorrow she and create synergies. BASF works to minisaid. mize emission and bio-diversity impact. Waste reduction and recycling are key focus Sustainability areas as well as energy efficiency. We focus No matter the source--plant or marine-- on the optimal use of side streams of the omega-3 EFAs are derived from natural main production line allowing to extract resources and due to the very high volume almost all of the valuable omega-3 (EPA and demanded by consumers sustainability is a DHA) components from the fish oil. primary concern. Finished product sustainability minimizes BASF sources its fish oil from sardines and oxidation which increases shelf life. anchovies from Peru and Chile and said Additionally Natu said smaller products Natu its sustainable sourcing approach was with highly concentrated omega-3s require reviewed by the global auditing company less volume for packaging material fewer soft gels to achieve an effective dosage and less weight for transportation. Algarithm s product said Kelly has longchain DHA that is similar to authentic fish oil but is also contaminant free and vegetarian making it more sustainable and equally nutritious. We like to think of it as a fish-free fish oil. You can t get much more sustainable than that. DSM is ranked second on Fortune magazine s 2017 Change the World list an annual publication of companies that have a positive social impact through activities that are part of their core business strategy according to Healy. DSM sources fish for MEG-3 oils from regulated wild fisheries where equipment practices and proceGo to www.niemagazine.com somalabs for info about this advertiser dures are in place to 38 Nutrition Industry Executive protect fish stocks. We also turn fish oil processing waste into biofuel to operate our state-of-the-art fish oil production facility in Mulgrave Nova Scotia she described. Schutt asserted that there is a huge misconception that marine-based sources of DHA and EPA are being overfished and depleted. This is not the case she stated. In almost all cases omega-3 fisheries are managed sustainably and with third-party oversight. The Arctic cod fishery the Alaskan pollock fishery and the Antarctic krill fishery are all MSC-certified. The Peruvian anchovy fishery where most fish oil supplements are sourced is overseen by IMARPE (Instituto del Mar del Peru) a governmental scientific body that organizes sonar surveys of the fish biomass at least twice a year to ensure there are enough adult fish available to harvest. In the last several years Schutt reported the fishery has been closed twice for a fishing season twice due to the presence of too many juveniles. Berntsen noted that Aker BioMarine received an A rating for sustainability from the Sustainable Fisheries Partnership (SFP) for two consecutive years. Sustainability is something that we take very seriously especially given the delicate nature of where krill comes from she added. What s New With these challenges in mind and the notion that science continues to explore impact of omega-3 EFAs in humans (and in some cases companion animals as well) there are some developments that may prove exciting for the category for 2018. BASF s Pronova Heritage said Natu offers a high concentration of omega-3 EFAs (60 to 90 percent). Its 46 38 EPA DHA product is he said the most clinically studied omega-3 composition. BASF donated omega-3 concentrates for the largest omega-3 study in the U.S. the ongoing VITAL trial (VITamin D and OmegA 3 Trial). VITAL is being conducted at Harvard with 25 000 participants and is expected to be completed in 2018. Udaya Wanasundara PhD principal scientist POS Bio-Sciences Saskatoon SK Canada explained that just this year (2017) Algarithm was created as a spinout from POS Bio-Sciences (which introduced canola oil). In the supplement market Algarithm plans to launch several combination products with partners algal DHA concentrates (60 and 80 percent DHA) and high active ingredient powders to allow for delivery of more DHA per serving. A few supplement products have already launched with our algal oil in it and we expect with more time (Continued on page 44) www.niemagazine.com November December 2017 FAMILY OF PRINT AND DIGITAL MEDIA Branch Out With VRM s NIEma gazine .com VitaminR etailer.com Fitnes sTrain erMag .com NaturalPr actitionerM ag.com NIE s Upcoming Issue Highlights Jan. Feb. Heart Health 12 14 17 ad closing Engredea at Expo West Show Issue March 2 2 18 ad closing Longevity and Aging Supplyside East Show Issue Our 2018 Media Planner Is Available At NIEmagazine.com 2018-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 e-Mail RussF VRMmedia.com Gary Pfaff at (732) 432-9600 ext. 103 e-Mail GaryP VRMmedia.com Whether they have diabetes or not consumers are increasingly interested in keeping healthy blood sugar levels and natural ingredients are becoming part of the plan. By Janet Poveromo A ccording to the World Health Organization (WHO) the number of people with diabetes has increased considerably from 108 million in 1980 to 422 million in 2014. By 2040 one in 10 adults will be affected. Virginie Codran product manager with Frutarom (based in Belgium) pointed out that consistently high blood glucose can lead to serious complications including damage to the heart and blood vessels eyes kidneys and nerves. With 12 percent of global health expenditure spent on diabetes and its complications the disease also brings about a substantial economic loss Codran said. Given this burden alternative lifestyle management approaches and cost-effective dietary interventions such as plant-based diets are a focus of increasing attention. In a survey released by market-research firm Nielsen earlier this year 22 percent 40 Nutrition Industry Executive of respondents said they already restrict their sugar intake noted Guy Woodman general manager with Pennsylvaniabased Euromed USA. In 2016 U.S. Dietary Guidelines recommended for the first time that people consume no more than 10 percent of their daily calories from added sugar he said adding that the onset of blood sugar disease or diabetes is insidious. We get our glucose tolerance test results from the physician when it is reported to be high we know we should lose weight improve our diet and increase our exercise level. However lifestyle changes are not easy and longerterm compliance with these recommendations is low. Woodman said that in April 2017 the Centers for Disease Control and Prevention (CDC) reported that the incidence of diagnosed diabetes went from 1.5 million people or less than 1 percent of the population in 1958 to 7.4 percent or 23 million in 2015. Estimates in the scientific literature project increases from 9 percent of the current population to 23 percent by 2050. In addition 86 million U.S. adults (35 percent of the population) have pre-diabetes which puts them at an over four times greater risk of progressing to diabetes compared to those with blood sugar within the normal range. Medical experts have advocated that these individuals should be more aggressively treated to avoid moving into the type 2 diabetes category. In regard to avoiding sugar many factors work against us. The avoidance of hidden processed sugar in our diet is difficult Woodman noted. The food industry uses sugar to enhance flavor and as a bulking and browning agent to absorb moisture and reduce spoilage. Also the U.S. Department of Agriculture www.niemagazine.com November December 2017 (USDA) supports low prices for processed sugar through government subsidies for corn and sugarcane. The prohibitive cost and potential side effects of pharmaceutical treatments are motivating people to seek alternative health options to maintain healthy blood sugar levels Woodman added. There are numerous options for botanical products that assist with blood sugar regulation but they require large daily doses that are difficult to consume. that more and more persons are concerned about their blood sugar mostly because of the overwhelming presence of carbs and sugar in our food but also because research is showing that glucose in our blood can induce direct damages by triggering oxidative stress and glycation of proteins. One way for these people to take action now is to look for natural solutions or ingredients to help them alleviate the effects of glycemic stress. Ingredients Cautiously Seeking Alternatives Historically patients with blood sugar management issues typically follow exactly what their doctor recommends and prescribes leaving little room for the exploration of a nutraceutical alternative said Bill Levi vice president of operations with New York-based Nutrition 21. Typically this could have a negative impact on demand narrowing the products ingredients individuals even consider when it comes to addressing blood sugar. He noted that more often than not individuals with blood glucose issues were unaware or uneducated about the benefits of adding a nutraceutical into their daily regiment. However more recently this demographic has taken to proactively educating themselves on what to look for in specific nutritional supplements Levi said. Additionally over time there has been some turn over in the traditional medical community allowing for an upsurge of homeopathic or more naturally inclined physicians who are open to exploring nutraceuticals as a recommended option for their patients. This then expands on the types of products these patients can look to incorporate in their day-to-day regimen. And although addressing blood sugar management requires daily care nutraceuticals are showing significant promise in boosting human health and preventing disease through their ability to fill in nutritional gaps in everyday diets. New research and scientific studies are also fueling the demand for new more advanced and efficacious nutritional supplements that specifically address blood sugar management issues to satisfy patient demand--so it seems as though the market is evolving. In addition the market for blood sugar ingredients has been influenced positively by growing press coverage surrounding the toxic effects of sugar. Not long ago only persons with diabetes or with a family history of diabetes expressed concerns about blood sugar said Jocelyn B rub MSc executive vice president scientific & regulatory affairs with Canada-based InnoVactiv. Today we see Ingredients that support the balance of glucose metabolism and insulin resistance are the goal for healthy blood sugar management. Here flagship products and new launches in this category are described The prohibitive cost and potential side effects of pharmaceutical treatments are motivating people to seek alternative health options to maintain healthy blood sugar levels. -- Guy Woodman Euromed USA Salsulin--Dr. Mohamed M. Rafi CEO of New Jersey-based Bioactives American Corporation noted that for blood sugar management the Salacia oblonga root extract is well known in ayurvedic medicine for its ability to treat diabetes and obesity. Salacia oblonga extract contains many phytochemicals and we have used a proprietary extraction technique to isolate and characterize the active principle (salacinol) and standardized the extract with salacinol 1 percent with our trademark name Salsulin. Salsulin inhibits the alpha glcosidase enzyme (AG) in the intestine and by doing so starch is not hydrolyzed into glucose Rafi explained. The extract is standardized to mangiferin and polyphenol 20 percent which acts as a GLUT-4 activator and as an antioxidant. InSea2--InnoVactiv produces and markets InSea2 a self-affirmed GRAS (generally recognized as safe) organic and non-GMO (genetically modified organism) polyphenolic extract coming from two wild-crafted brown seaweeds. InSea2 induces an immediate relief from glycemic stress coming from starchy and sugary meals by slowing down alphaamylase and alpha-glucosidase enzymes responsible for the quick conversion of starch and sugar into glucose. By acting inside the intestine InSea2 reduces postmeal blood glucose and insulin responses to food intake as well as supporting insulin sensitivity. The effect of InSea2 on blood sugar also induces some interesting ancillary benefits. For example subjects consuming InSea2 prior to a starchand sugar-rich breakfast saw a significant improvement in post-meal cognitive tasks and reduced their error rate by an impressive 15 percent over placebo. Pycnogenol--With U.S. offices in New Jersey Horphag Research s flagship ingredient Pycnogenol has been shown in numerous studies to support healthy blood sugar levels to manage the symptoms related to diabetes. A 2013 study found Pycnogenol to reduce metabolic syndrome factors including waistline obesity high cholesterol high blood pressure and high blood sugar. Another study published in 2015 in the Journal of International Angiology found that Pycnogenol naturally improves circulatory and endothelial function while improving fasting glucose levels in individuals with borderline high glucose levels. Pycnogenol has also been found to naturally reduce cardiovascular risk factors in diabetics like blood sugar levels LDL (low-density lipoprotein) cholesterol and blood pressure. Research shows that Pycnogenol naturally improves kidney function in patients with metabolic syndrome. This study showed Pycnogenol s benefits for managing blood pressure reducing blood sugar and lowering body mass index (BMI) due to weight loss. SUSTRA--Patrick Luchsinger marketing manager nutrition with Illinoisbased Ingredion noted that at SupplySide West 2017 the company introduced SUSTRA 2434 slowly digestible carbohydrate a clean label starch-based solution for manufacturers of energy-focused nutritional products including bars shakes mixes snacks and supplements to help meet the evolving need for sustained energy. SUSTRA 2434 is an easy-to-formulate ingredient that has been scientifically shown to affect a lower glycemic index and steadier blood sugar levels over an extended period leading to balanced and long-lasting energy. This is especially helpful when strategic snacks are needed to bring back that alert energized state of mind. Nutrition Industry Executive 41 November December 2017 www.niemagazine.com Having a nutrient-rich snack that s low in sugar and saturated fat a slowly digestible carbohydrate such as SUSTRA 2434 can help ensure the body has the fuel to keep going. HI-MAIZE--This resistant starch is Ingredion s flagship ingredient for blood sugar management. The science behind HI-MAIZE has demonstrated three ways that help maintain blood sugar levels. They include Reduced glycemic response HIMAIZE resistant starch lowers the shortterm glycemic (blood sugar) and insulin response in foods. Improved insulin sensitivity HIMAIZE resistant starch increases longterm insulin sensitivity in healthy people and in individuals with insulin resistance and type II diabetes. Improved metabolism HI-MAIZE resistant starch facilitates healthy fat storage within the adipose tissue and pancreatic function both of which contribute to long-term glycemic health. In December 2016 the U.S. Food and Drug Administration (FDA) authorized a qualified health claim for HI-MAIZE citing limited evidence that it may reduce the risk of type 2 diabetes. Ioniplex--Richard Hunsaker business development manager with Arizonabased Mineral Biosciences said that clinical studies have shown that Ioniplex can reduce glycation and glycative damage (damage that occurs with the formation of AGE s--advanced glycation end products) which can not only damage cells but cause a spike in blood sugar levels. Glyde D is unique in both ingredient and expected results Hunsaker explained. Ioniplex is the main ingredient in Glyde D and the only ingredient in IoniCell a cellular health product which enhances cells protects cells and helps manage healthy blood sugar. The differences between products with Ioniplex and products with the more traditional remedies are numerous 1. Glycation reduction 2. As a result of this anti-glycation action Ioniplex can help lower postprandial blood sugar levels (postprandial blood sugar elevation occurs after eating a large carbohydrate laden meal) 3. Ioniplex is highly bioavailable so it can absorb into our system quickly and penetrate our cells. 42 Nutrition Industry Executive ABAlife--EuroMed s Woodman said according to a recent U.S. dietary survey 90 percent of Americans do not obtain an adequate amount of abscisic acid (ABA) a natural metabolite found in fruits and vegetables in their diet as they do not consume 4.5 servings of these foods per day necessary to obtain it. These people would benefit through supplementation with ABAlife. This ingredient is the world s first standardized extract of ABA Woodman noted. It is a highly concentrated extract from Spanish fig fruit one of the richest sources of ABA found in nature. Unlike other herbal products where a large dosage is required ABAlife only requires 200 mg per day for efficacy. A recent study from the University of Sydney Glycemix Index Research Service (SUGIRS) found supplementation with 200 mg ABAlife reduced blood sugar levels by 25 percent and insulin levels by 24 percent after a reference dose of glucose was administered. Many of the botanicals that lower blood sugar levels do so by raising or increasing production of insulin something that can be problematic in the long run particularly for those with pre-diabetes type 2 diabetes and metabolic syndrome. -- Mark Kaylor Radiant Health Project Mushroom Wisdom ABAlife will be used in a ready to drink product by the firm Pervida to be launched in 2018. Other products containing ABAlife in capsules and tablets are planned for development. Sunfiber--Taiyo s premium branded ingredient Sunfiber soluble fiber is commonly known as guar fiber which is derived from guar gum (guar bean) splits. However unlike guar gum Sunfiber does not cause any viscosity. It is a non-viscous soluble dietary fiber approved by the FDA. It dissolves completely without giving any taste texture or color. Several vitro animal and clinical studies suggest that Sunfiber can reduce the absorption of sugar and delay the onset of diabetes. A recently published clinical study suggests that the daily intake of Sunfiber with every meal may reduce the absorption of glucose by an average 40 percent in normal and pre-diabetic people. Also an animal and a preliminary clinical study suggest that Sunfiber has the ability inhibit the biomarkers responsible for the initiation of diabetes. These studies suggest that Sunfiber is not only effective in reducing the absorption of glucose but also in delaying the onset of diabetes. Maitake SX-Fraction--Mark Kaylor with Radiant Health Project and consultant for New Jersey-based Mushroom Wisdom said that while there are a number of remedies that assist with lowering blood sugar one of the key differentiating points for the Maitake SX-Fraction is that it helps balance both blood sugar and serum insulin. Many of the botanicals that lower blood sugar levels do so by raising or increasing production of insulin something that can be problematic in the long run particularly for those with pre-diabetes type 2 diabetes and metabolic syndrome Kaylor explained. Raising insulin levels can actually exacerbate issues with insulin resistance the condition at the root of these health issues. In clinical trials the SX-Fraction was shown to lower blood sugar as well as serum insulin levels by way of improving insulin sensitivity. In fact in a comparison study the Maitake mushroom was found more effective than a leading pharmaceutical. The improvement in insulin sensitivity was seen in the cardiovascular benefits that were found in the research including lowering blood pressure total cholesterol and triglycerides with moderate increases in HDL cholesterol Kaylor continued. With Maitake being a relatively newcomer to the world of medicinal research there is continuing research confirming Maitake s blood sugar actions as it uncovers other possible mechanisms as well. Chromax--With 60 patented uses Nutrition 21 s Chromax chromium picolinate is the only form of clinically efficacious dietary chromium that has been reviewed extensively for safety and efficacy according to the company. Chromax is supported by more than 50 human clinical studies is GRAS affirmed at clinically substantiated doses and has 35 nonrejected DSHEA (Dietary Supplement Health and Education Act of 1994) claims. Our ingredient has been supplied to leading manufacturers marketing effective products designed to promote and support glucose metabolism and insulin resistance as well as appetite control and weight management Levi said. Chromium (Cr) is a trace element which www.niemagazine.com November December 2017 Go to www.niemagazine.com nutrition21 for info about this advertiser preclinical and clinical studies. Diabetic subject consuming purslane seeds for instance displayed significant reductions in fasting and postprandial glucose insulin body weight together with a normalization of the lipid profile. is essential for carbohydrate lipid and protein metabolism. Low chromium status can adversely affect blood glucose insulin total cholesterol and triglycerides. Chromium is also an insulin cofactor. It increases insulin-stimulated glucose metabolism by enhancing glucose transporter trafficking enabling excess blood glucose to enter cells. This means that chromium helps insulin function more effectively. Portusana--With Portusana Frutarom has developed a scientifically supported and unique purslane herb extract that captures the health benefits of an ancient weed and helps to keep blood glucose concentrations on track. Rich in valuable nutrients purslane is known as a healthy culinary weed throughout the world and is treasured for its anti-diabetic properties in Near Eastern folk medicine. Today the beneficial effects of purslane on glucose homeostasis have also been confirmed in Healthy Blood Sugar for the Long Haul No one becomes diabetic simply because of one single bad meal or for skipping one training session. Rather it is the accumulation of bad meals and decline in physical activity that gradually alters our metabolic capacity to effectively handle glucose noted InnovActiv s B rub . In fact once fasting glucose starts to rise it means that years before other more subtle changes in blood glucose control could have been noticed including excessive glycemic responses to food intake. It is now increasingly recognized that high post-meal blood glucose is an independent risk factor for subsequent development of diabetes and for cardiovascular complications. Improving how the body reacts to dietary carbohydrates is achievable today by using -amylase and -glucosidase inhibitors. Such ingredients offer great promises to induce long-term health ben- efits to users. Ultimately while supplements offer benefits ingredient suppliers confirm that lifestyles must change to make substantial health improvements. While supplements can certainly assist in re-establishing healthy blood sugar and insulin levels said Kaylor it all needs to start with the necessary dietary and lifestyle changes such as a plant-based lowglycemic whole food diet with plenty of movement and exercise. NIE Extra Extra Visit www.niemagazine.com to read about a study on the benefits of cocoa for diabetes. FORMOREINFORMATION Bioactives American (732) 253-7750 Euromed USA Inc. (412) 279-8808 Frutarom 32 52 319 532 Horphag Research (201) 459-0300 Ingredion (800) 713-0208 InnoVactiv (418) 721-2308 Mineral Biosciences (623) 932-1522 Mushroom Wisdom (800) 747-7418 Nutrition 21 LLC (914) 701-4500 Taiyo (763) 398-3003 (Continued from page 38) we will see more food applications finalize and launch as well he said. Expect to see higher concentrations of EPA and DHA and more tailored solutions in the future predicted Healy noting that DSM s portfolio of plant-based omega-3 products life sDHA is a vegetarian and sustainable source of DHA while its life sOMEGA is a plant-based omega-3 containing both EPA and DHA. Also expecting to grow heartily is personalized nutrition and omega-3s are set to be a significant part of this trend. Said Natu Personalized nutrition will continue to be an important factor in the future of omega3 science and marketing. No longer is it a one dose fits all. Consumers will be encouraged to check their omega-3 levels before 44 Nutrition Industry Executive and during supplementation. Berntsen agreed elaborating The idea is to get people more motivated to act when it comes to omega-3 intake particularly because EPA and DHA are so essential to everyone s diets. Using a simple nutritional tool called The Omega-3 Index Test everyone will be able to measure their omega-3 levels and then take steps to devise an omega-3 regimen that works for them. Additionally the company recently launched Superba Boost a krill oil concentrate that features several enhancements over typical krill oil including higher amounts of phospholipids choline and omega-3s. According to Dillingham AlaskOmega added two new DHA omega-3 concentrates to its line in September of this year a high DHA concentrate and a medium strength DHA (non-tuna) tuna oil alternative. AlaskOmega s high DHA concentrate he explained offers a minimum 460 mg g DHA 100 mg g EPA in triglyceride (TG) form (TG100460). The tuna oil alternative is made from wild Alaska Pollock and provides the same EPA DHA content typically found in tuna oil (min. 50 mg g EPA 250 mg g DHA in TG form). Both DHA oils are MSCcertified and well suited for formulators looking for a fully sustainable DHA oil source that is extremely low in oxidation and offers excellent sensory characteristics. EPA DHA and ALA will continue to be sought out by consumers and recommended by more physicians. As such innovations for easy consumption bioavailability and utilization will continue and older characteristics attached to these supplements notably fish burp are dwindling quickly in the rearview mirror. NIE Extra Extra Visit www.niemagazine.com to read about how EFAs may benefit people with dry eye syndrome. FORMOREINFORMATION Aker BioMarine (732) 860-0137 AlaskOmega Ingredients (740) 622-0755 Algarithm www.algarithmdha.com BASF (800) 527-9881 Benexia www.benexia.com DSM www.dsm.com GOED (801) 746-1413 www.niemagazine.com November December 2017 Go to www.niemagazine.com innovactiv for info about this advertiser Nutraceuticals One of the most challenging issues with combination products is being able to include therapeutic levels of key ingredients while keeping the daily serving of tablets or capsules to a minimum -- Marci van der Muelen National Sales Manager Nordic Naturals A better understanding and appreciation of herbs and botanicals by consumers is leading to more use and innovation in nutraceutical products. By Nicholas Saraceno ccording to the World Health Organization the worldwide annual market for herbal medicinal products is approaching 60 billion. These herbal medicinal products refer to herbs and botanicals. As Dr. Josh Axe a certified doctor of natural medicine doctor of chiropractic and clinical nutritionist referenced in his article Herbal Medicine Benefits & the Top Medicinal Herbs More People Are Using practices such as ayurvedic medicine and traditional Chinese medicine which focus on overall health as opposed to disease have been around for thousands of years written records of herbal medicine use dates back over 5 000 years. As for today s herb and botanical marketplace news if the phrase numbers never lie is correct there is an optimistic story. Dan Lifton president of the Proprietary & Branded Ingredients division of New York-based Maypro pointed A to several promising market reports A Mintel Herbal and Homeopathic Remedies report from November 2016 noted that the overall homeopathic and herbal market increased nearly 30 percent between 2011 and 2016 up to about 5.4 billion in the United States which is an upward trend that Mintel predicts will continue through at least 2021. The HerbalGram Herb Market Report for 2016 showed total retail sales of U.S. herbal dietary supplements rising past 7 billion for the first time ever with SPINS and IRI data noting retail outlet sales alone of about 944 million. In 2005 the American Herbal Products Association calculated the global herb market to be 83 billion including 11 billion in herbal dietary supplements and 14 billion in herbal functional foods and beverages. Although she does not discount the impact of other extracts Deanne Dolnick science director with TR Nutritionals (Georgia) said she believes there are promising signs due to two specific botanicals Ginkgo biloba and turmeric. The quality of these botanicals all depends on finding the right manufacturer. The botanical market has continued to grow she noted. TR Nutritionals is one of the largest suppliers of Ginkgo biloba extract to the dietary supplement industry. We believe that our business has continued to soar because we purchase our extract from the most reputable ginkgo manufacturer in the industry. When you can promote an extract based on its quality and show that it is not adulterated it will sell. We are also seeing significant growth with Turmeric 95% Extract. This is another botanical that is having serious issues with adulteration ... Overall TR s extracts sales have seen huge growth over the past year. The consumer continues to seek out natural products backed by scientific research and many extracts fall into this category including Ginkgo biloba 46 Nutrition Industry Executive www.niemagazine.com November December 2017 resveratrol green tea and many of the Indian extracts. Lifton also added that market-wise at least globally herbal penetration in the functional market is strong however what can be claimed for functional ingredients in foods and beverages while theoretically great news--such as for oats where the FDA (U.S. Food and Drug Administration)-authorized health claim allows May reduce the risk of heart disease or for calcium for which the FDA allows Adequate calcium throughout life may reduce the risk of osteoporosis --is generally speaking a minefield and very limited in terms of what is allowed in the U.S. Popularity Uses & Preparation When it comes to adding herbal and botanical ingredients to nutraceutical products there are several popular candidates. Sendhil Pani president of New Jerseybased Bayir Inc. noted three trending ingredients Curcumin-- Has led the way with a wide body of scientific research and validation behind its anti-inflammatory and anti-oxidant properties. Curcumin hold[s] great promise in the treatment of conditions such as Alzheimer s dementia etc. which will also impact its popularity. Green Coffee-- A non-caffeine extract which acts as a stimulant often used for weight management. The extract also acts as a chlorogenic acid. The market for green coffee is now equivalent to garcinia really gaining market relevance in the past 10 years. Bacopa-- As the market for cognitive health increase[s] so has the interest in bacopa. Bacopa is a memory enhancer. Bayir s high potency bacopa has numerous benefits outside of cognitive function including stress [the] treatment of Alzheimer s etc. In an on-the-go society where stress is at an all-time high consumers are becoming more interested in adaptogens. Adaptogens botanicals that are thought to help people adapt to the stresses of everyday life are becoming a popular category noted Alison Raban certified food scientist with BI Nutraceuticals in California. Ingredients that fit this category like maca Gingko balboa ginseng St. John s wort and also familiar spices like ginger and turmeric especially are experiencing lots of consumer attention. Blends of botanical ingredients are certainly popular as some have similar benefits or work synergistically with each but single ingredient supplements still have lots of potential for popularity with consumers. However incorporating these ingredients into functional products can present a challenge for manufacturers successfully covering the taste with one that appeals more to consumers. Masking the taste of these herbs and botanicals can be achieved by adding flavors sugars or other ingredients said Kevin Kilcoyne vice president and general manager Welch s Global Ingredients Group (Massachusetts) but these can compromise the manufacturers ability to meet consumers needs for authentic clean label products. Kilcoyne said utilizing Welch s grape juice-related ingredients can help solve this dilemma. of FSMA [FDA Food Safety Modernization Act] regulations Radio Frequency Company s RF Pasteurization system can often provide these suppliers and manufacturers a validated kill-step that doesn t negatively impact their product s organoleptic properties or quality said Lisa Mitchell the company s marketing manager. Since the Macrowave RF system can volumetrically and evenly heat all the product on the conveyor belt in bulk or in bag we can often achieve a 5Log reduction at temperatures around 185 degrees Fahrenheit because the RF is instantly heating the product and offers no opportunity for the pathogens to acclimate to the temperature rise. With conventional heating often higher temperatures are required to heat the internal layers of the product and to obtain that same reduction because the heat is traveling from the outside in. Therefore if there is an interest in utilizing an RF pasteurization system it is important for manufacturers to be aware of the heating temperatures that are used. The Wonders of Tomatoes Grapes & Scientific Research Lycored a New Jersey-based ingredient manufacturer works extensively with tomatoes its main botanical. The fruit s various benefits including in the skin health and beauty department is what makes it essential. This super fruit is responsible for some of the most innovative ingredients currently used in nutraceutical products said Golan Raz PhD Lycored s vice president of health & nutrition. With its powerful natural active molecules lycopene phytoene and phytofluene tomatoes extract is known for its benefits for ingestible skin health and beauty as well as cardiovascular and prostate health. We also produce marigold extract for standardized lutein as well as rosemary extract that is being combined with tomatoes in our ingestible skin care flagship Lycoderm. When it comes to research Kilcoyne noted that manufacturers seek ingredients that are both authentic and produce a science-backed benefit. He referenced Welch s Concord grape one that reportedly contains more polyphenols than other juices--about two decades of research even support that the company s grape juice is beneficial toward heart health. Integrating Concord grape juice into a functional beverage formulation or using FruitWorx real fruit pieces as a natural delivery system for wellness ingredients are effective solutions to this problem. Not only do Concord grape ingredients taste great but they re also free from added colors flavors and preservatives and contain only natural fruit sugars. Also they deliver beneficial polyphenols which means they ll add to the functional ingredients in the product. Process System When it comes to preparation Radio Frequency Co. Inc. a Massachusetts corporation that specializes in high tech radio frequency process heating systems helps prepare herbs and botanicals for use in nutraceutical products via its Macrowave RF (radio frequency) system. With the advent of the enforcement (Continued on page 54) Nutrition Industry Executive 47 November December 2017 www.niemagazine.com MarketingInnovation Influencer Marketing REACHING CUSTOMERS FOR REAL By Todd Pauli The Shelton Group ve always admired golfers. I m not one nor will I likely ever be one. I already have too many hobbies to ever justify spending a few hours a week on a golf course. Plus I assume it costs somewhere in the tens of thousands of dollars to acquire the clubs pay the greens fees and purchase the synthetic fabric shirts that repel both sweat and beer. No it s not the game itself that leaves me inspired every time I find myself making small talk with a golfer. It s the answer to that inevitable question How s your game these days The most common answer It s awful or typically a more colorful version of it needs work. Press a little further and most golfers will talk about the need to fix a slice or buy a new putter or whatever new approach they re willing to try in order to make a small improvement. When it comes to marketing in the nutrition industry some things require a golfer s state of mind. It s easy to run the same media program as last year or give away the same tradeshow trinkets but it s time to ask What can I try in 2018 to gain an edge There s still plenty of room for tried and I true marketing practices like advertising but consumers and the companies serving them have changed the way we think about promotion and selling. It s time to stretch our idea of what it means to market be it direct to consumers or through B2B supplychain relationships. We have to try new methods to reach customers in ways they find meaningful--meaningful enough to stop for a second and give your brand some thought amid the thousands of other promotional messages forced upon them daily. Who are the people consumers will make time to stop and hear what they have to say People they trust. Marketing influencers can technically be anyone from a neighbor recommending a particular supplement to a world-renowned superstar grinning next to a bottle of vitamins. For most of us the real value in using influencers when you consider both scalability and campaign costs lies somewhere in between those two extremes. The idea is to leverage an influencer s audience and the trust they ve built with that audience to communicate the value of your brand. Like so many things in our industry run- ning a successful influencer marketing program depends on being genuine by telling true stories about your brand. Some of the same tenets of quality that resonate when communicating the value of nutritionfocused brands like transparency clean label and responsible sourcing are the very things influencer audiences care about when it comes to their own lifestyles. The similarity makes sense because influencer audiences are often built around a common lifestyle choice. Be it working out eating healthier caring for our children or any other positive lifestyle interest we are all looking for answers. Successful influencers provide the examples the instructions the encouragement and the personality to offer those answers gain trust and build unmatched loyalty among their followers. In an interconnected world of blogs social media posts and live online events influencers grant brands the opportunity to join a conversation among trusted friends to genuinely offer value instead of trying to interrupt with promotional messages. Sounds a little too rainbows and unicorns to be real I know. There are caveats. For all of this magi- 48 Nutrition Industry Executive www.niemagazine.com November December 2017 cal brand interaction to work most marketers will have to trust for themselves that the hard sell isn t the club they should pull out of the bag to make this shot. Instead it s time to stretch a little and try something new. It s All About the Quality of Influencer Interaction For many marketing professionals in our industry tapping into influencer marketing in a meaningful way still seems new and emerging like electric cars in 2012. This is not the part where I go into detail explaining that influencer marketing has actually been around for ages. We can all guess that. What you might not guess is that the very type of influencer marketing involving social media blogging etc. has evolved tremendously in just the last couple of years. Kelly Olexa CEO and founder of FitFluential a network of more than 7 000 fitness health nutrition and wellness influencers put it this way Brands that are most successful with influencer marketing today really become part of the conversation. It s not enough to simply sponsor a post or create a piece of content and then promote it to millions of people one time. It s not always about the most eyeballs said Olexa I think what we re now seeing in social media is that it s more about the marathon not the sprint. People seeing a brand several times over the course of a year and saying I keep hearing about [a particular brand]... is much more effective. Influencer campaigns have shifted from just a couple of years ago when a brand would pay to sponsor a post about its product. Today it s more about embedding a brand in the day-to-day lives of the influencers. People want to hear influencers naturally talking about products as part of their lives not a separate sponsored post said Olexa. They want education conversations over time not an infomercial. According to Olexa the most important social media platforms to reach audiences right now are Facebook and Instagram particularly their video and real time features. Each platform offers a live option for delivering spontaneous content to followers. Brands holding longstanding marketing agreements with influencers gain the flexibility to become part of the day-to-day conversations and live posts influencers share with their audiences. This flexibility makes the endorsement genuine in the sense that the influencer brings the product into his or her daily routine. What does this look like in practice It s a fitness influencer sharing via Facebook Live a quick look at the smoothie she blends each morning. She adds spinach kale a banana and the sponsor s protein. She might say a quick word about how she loves the flavor or the clean label ingredients but she doesn t go into full commercial mode. She s just doing what she does every morning and her audience is watching. She doesn t need to oversell the protein because when her audience goes online or walks into the store and stares at a shelf of protein powders which one will they trust You guessed it. Influencing With Ingredient Brands The influencer marketing applications for finished goods manufacturers are fairly easy to see. For ingredient companies and other organizations deeper into the supply chain there is typically one more step involved. For B2B brands it s imperative to help consumers find your products through brands they can actually purchase. Co-marketing is nearly a part of every conversation I have with ingredient brands as we develop marketing strategies together. Everyone wants to do it yet it can seem hard to know where to start. Co-marketing in itself is far too big of a topic to cover here in-depth but one rule to always keep in mind the easier you make it for a consumer brand to participate the more successful a co-marketing program will be. As a former marketing manager working on the brand side of the equation there is much time wasted when suppliers come forward with a great co-marketing campaign idea and then expect you to execute. There s just no time given the brand is likely supporting several skus and can t afford to turn all of its attention to a single product that supports the ingredient in question. As a supplier find influencers ahead of time that support your ingredient. If your ingredient supports pre-natal health like choline seek out influencers focused on new mothers. If you are a sports nutrition supplier align yourself with a few up-andcoming athletes. You ll be surprised how far free product will go in supporting athletes not yet at the elite level but who still command large social audiences. Be sure to abide by any legality regarding gifts etc. Build the campaigns to hand over to your brands using smart white-labeled content they can readily share including influencer videos profiles etc. Help the brands tap into the social community the influencers have curated. your budget Olexa suggests the first step should be simply becoming part of the social media conversation. Find people mentioning your brand and interact. You re selling in that moment but most brands don t realize it. From there she suggests hiring an influencer or two to discover product trends and ways to incorporate your product. The most successful brands ask the blogger or influencer how to approach working together. Instead of dictating the tactics to the influencer she suggests giving the influencer an overview of what your brand is all about and let them devise a suggested plan from a consumer s perspective. There are several blogger networks you can turn to for influencers that align well with your brand. FitFluental is one of the largest networks focused on the fitness community. You can also develop an in-house brand ambassador program and incentivize existing customers to become influencers on your behalf. If you go the in-house route it s vitally important to make sure you bring on ambassadors that have large active social media audiences that align with your brand s objectives. Whichever way you go to build an initial influencer community it must be able to scale quickly. Throwing social content and brand mentions into an abyss is just a waste of time. Perhaps the most important thing to remember is that influencer marketing can build brand loyalty in an authentic sustainable way like few other tactics especially those that promise a large one-time audience. The price for that level of brand awareness and trust is sustained effort and patience. That sounds a bit like golf or so I m told. 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 sheltongrouppr.com. Nutrition Industry Executive 49 How to Get Started Depending on the size of your brand and your marketing budget getting started could look a bit different. No matter what November December 2017 www.niemagazine.com FunctionalFoods Prebiotics & Probiotics Digestive Health Food for Thought By Dr. Satya Jonnalagadda Director of Global Nutrition Kerry A n increasing number of consumers today are looking for ways to stay healthy rather than get healthy. One of the key nutrition trends of 2017 resonating with proactive health consumers is Digestion 2.0 (New Nutrition Business 2017). This was a claim that years ago may have carried a stigma but has now become trendy. Before scientists knew about the complexities of the gut microbiome digestive health was a niche claim limited to the GI (gastrointestinal) tract and appealing only to those suffering from intestinal issues and constipation. However recently with increasing evidence demonstrating the far-reaching benefits of gut health the task of hosting an optimal microbiome for the sake of general wellness has become mainstream amongst consumers. A new market for digestive health foods has emerged as consumers look for secondary benefits ranging from immunity to stress reduction. Probiotic products such as yogurt kimchi kombucha and even fermented cultured items have gained widespread popularity. However while pro50 Nutrition Industry Executive biotic foods are crucial for populating the gut with beneficial bacteria consumers seemed to have overlooked the other piece of the digestive puzzle prebiotics the very fuel on which the microbiota thrive. According to a Mintel report while 31 percent of U.S. consumers agree on the importance of probiotics only 12 percent of these consumers are aware that prebiotics are needed to keep the cultures alive (Mintel 2017). With the digestive health market growing at 4.4 percent over the next few years there is a great deal of opportunity for prebiotics (Euromonitor 2016). However as the FDA (U.S. Food and Drug Administration) definition of fiber evolves consumer education will be paramount when it comes to understanding the mechanism sources and benefits of prebiotics. What Are Pro- and Prebiotics With digestive health growing words like prebiotic and probiotic are becoming more and more common in the marketplace. What are they One way to think of them is by breaking down the words into their components. Biotic can refer to the ability of these ingredients to impact our microbiome which is the bacteria that grows inside our large intestine (or our gut ). These bacteria can use some fibers carbohydrates that our bodies cannot digest for fuel. When the bacteria metabolize these fibers they can create byproducts our body can use like short chain fatty acids that are used for energy by our intestine cells or vitamins like vitamin K2. As science evolves we are learning that the types of bacteria we have in our gut can impact many aspects of our health from bowel-related health like regularity or irritable bowel syndrome (IBS) to effects that reach far beyond our gut such as our immune system or brain (www.ncbi.nlm.nih.gov pmc articles PM C4566439 ). More than half of all of our body s immune cells are in our digestive tract A microbiome made up of the right types of bacteria can improve our health. There are a few different ways we can impact our microbiome through our diet. We can add more good bacteria directly to our gut by consuming it which is done through probiotics. www.niemagazine.com November December 2017 You can think of pro as adding more good bacteria to the colonies living in our gut they have the ability to directly affect our health. Prebiotics on the other hand are the food our microbiome use to live. These are mostly types of fiber that bacteria can use for energy. They can help the good bacteria that live in our gut grow. If probiotics were the equivalent of planting flowers prebiotics would be the fertilizer. Types of Pre- and Probiotics According to Gibson et al. 2004 a prebiotic is a selectively fermented ingredient that allows specific changes both in the composition and or activity in the gastrointestinal microflora that confers benefits (www.amazon.com Handbook-Prebiotics-GlennR-Gibson dp 0849381711). Many fibers are able to positively impact our microbiome via fermentation and would be considered prebiotics but the most well-studied prebiotic fibers are galacto-oligosaccharides (GOS) fructooligosaccharides (FOS) oligofructose and inulin. Although these are long complicated looking words when you see them on a food package s ingredient label the word oligosaccharide just refers to a carbohydrate chain that s generally short in length (2-20 units long). Prebiotics are common in a lot of the foods we eat every day like bananas onions garlic asparagus whole grains and more. You can also find prebiotics added to foods for health benefits. For example chicory root is one of the most common sources of inulin the prebiotic fiber source often added to foods such as nutritional beverages snack bars or breakfast cereals. When it comes to probiotics the bacterial strain and the amount found in a food ( colony forming units ) are the most important issues to consider. A familiar probiotic Lactobaccilus acidophilus found in fermented dairy products. There are numerous strains of probiotics each with different biological effects but Lactobacilli and Bifidobacterium are the most studied strains (www.ncbi.nlm.nih.gov pmc articles PMC4053917 ). In foods probiotics are found in cultured foods like yogurt kimchi sauerkraut and kefir. ways. Studies have shown intake of these prebiotic fibers may reduce risk of diarrhea caused by bacterial infections such as traveler s diarrhea. By helping the good bacteria in our gut grow prebiotics can reduce the ability of harmful bacteria to grow and proliferate in our intestine. Prebiotics like FOS or inulin have also been shown to improve other measures of digestive health that are more related to our day-to-day quality of life like stool consistency bloating and gastric discomfort (www.ncbi.nlm.nih.gov pmc articles PMC3705355 pdf nutrients-05-01417.pdf). have health benefits in our digestive system and beyond. Potential benefits include improving immune health preventing infection reducing irritable bowel syndrome symptoms improving oral health among others. The important thing to remember is that each strain behaves differently in our bodies so clinical trials demonstrating health effects using a specific strain and dose are the best way to ensure the benefits of that strain. A Hidden Benefit of Sugar Reduction When we see ingredients like fructooligosaccharides in foods it s not always included for a prebiotic health benefit. Consumer backlash against sugar in foods seems ever increasing leading many food manufacturers to reduce sugar in products. Sugar is used not just for making things sweet though it also provides bulk and mouth feel in foods and beverages. Soluble fibers including prebiotic fibers like FOS GOS and inulin are commonly used to replace the structural properties sugar provided before it was removed and can even contribute a slight sweetness to products. This means that the industry-wide quest to reduce sugar in foods may also have the hidden benefit of providing people with prebiotic fiber. Fiber is a nutrient that few people get enough of--the average intake of fiber in the United States ( 17 grams per day) is around half of what should be consumed daily. Soluble and prebiotic fibers provide a solution to increase fiber intake and reduce sugar intake at the same time. Prebiotics like FOS or inulin have also been shown to improve other measures of digestive health that are more related to our day-to-day quality of life like stool consistency bloating and gastric discomfort. Prebiotics have been shown to have effects beyond just the digestive system though demonstrating the importance of gut health on our overall health and wellness. For example prebiotic intake may protect against colorectal cancer (www.ncbi.nlm.nih.gov pmc articles PMC3669163 ) through a variety of mechanisms such as protecting the health of our intestinal cells via the short chain fatty acids produced from prebiotic fermentation. Prebiotics have also been shown to Improve absorption of certain vitamins and minerals like calcium Improve satiety by stimulating production of satiety-inducing hormones Improve markers of glucose metabolism Probiotics have also been shown to Claims and Regulations Like most nutrition-related benefits in food products the question for manufacturers becomes What can I say about prebiotics on a package When it comes to digestive health the impact of our microbiome on our health is still being defined. This makes it difficult for regulatory bodies like FDA and EFSA to approve health claims related to prebiotic content of food (http advances.nutrition.org content 7 1 1.full.pdf). As a result there are no prebiotic- or probioticspecific claims related to digestive health that can be used on foods or beverages. However this is an area of active research and as the scientific Not Just for Digestive Health Prebiotics have been shown to improve digestive health in a few different (Continued on page 54) Nutrition Industry Executive 51 November December 2017 www.niemagazine.com Equipment&Packaging Packaging Machinery Manufacturer Unveils Line of Automated Turntables Automated rotary turntables in the Pharmafill line from New Jersey-based packaging machinery manufacturer Deitz Company Inc. enable packaging engineers to feed transfer and accumulate bottles or other containers for extra control over the filling and packaging processes and improved line efficiency while maximizing the speed and production capabilities of each individual machine. The rotary turntables meter the feed rate of empty bottles into the filling line accumulate filled bottles at the end of the line for cartoning and case packing and may be set at multiple points within the line to stage bottles for slower machines or to transfer bottles from one stage in the process to another without stopping or disrupting the automated process. Developed for filling and packaging foods beverages pharmaceuticals nutraceuticals and other products the rotary turntables feature sanitary all stainless-steel construction with companion stainless-steel loading trays and dead plates. The packaging turntables are designed and manufactured at the company s Wall NJ headquarters in a choice of top plate diameters from 12 inches to 48 inches as standard and in custom sizes as needed and come set on casters for easy rolling to a conveyor. The turntables may be adjusted on the fly to rotate at a faster or slower speed and in either clockwise or counter-clockwise directions. For more information visit www.deitzco.com. Sustainable Low-cost High-performance Cold-chain Packaging In its mission to eliminate the destructive environmental impact of EPS Styrofoam packaging materials California-based Vericool announced that it has launched an expanded line of its patents-pending Vericoolers providing sustainable low-cost high-performance and safe thermal packaging for the pharma life sciences and food kit meal subscription industries. A company s product should be its legacy--not its packaging pollution. EPS Styrofoam is not responsible not sustainable and not safe--it is the dinosaur of the packaging industry said Darrell Jobe CEO of Vericool. It s time for a change and our Vericoolers are defining the future of sustainable cold chain packaging today. For 60 years EPS Styrofoam the branded name for expanded polystyrene (EPS) coolers have provided a cheap and easy way to keep products cold but that convenience has come at a major environmental cost. Each year millions of pounds of EPS are dumped into landfills and end up in marine ways--polluting the environment and jeopardizing the wellbeing of people and wildlife. Now lawmakers around the world are banning its use. Businesses and consumers want sustainable packaging that makes financial and environmental sense. For more information visit www.vericool.com. Mondi Highlights Solutions for Key Packaging Trends Austria-based Mondi the global packaging and paper group offers Water Soluble Film a convenient and biodegradable solution for packing and easy dosing of powders tabs and granulates. It is a more environmentally friendly solution compared to other packaging as it helps reduce waste. Whether ready-to-use doses of household dishwasher or laundry detergents or chemicals for industrial applications Mondi Water Soluble Film provides excellent barrier properties to protect the product and the end-user making it safe and easy to use. For more information visit www.mondigroup.com. ProcessPro Now Offers Expanded Financial Features in Global ERP Solution ProcessPro (Minnesota) a mid-market ERP software solution company introduced the extended functionality of ProcessPro Global the next generation of batch process manufacturing software. ProcessPro Global is built on the world s most accepted Microsoft technologies--.NET SOA and SQL Server spanning the broadest set of functional capability and providing the ability to customize without the penalties commonly experienced with other software vendors. Global is the most recent addition to the ProcessPro product line available on-premises and as a SaaS or cloud solution. The financial needs of process manufacturers are universal with ProcessPro Global we offer solutions to stay abreast of industry trends and changing demands. From tracking costs to vacation accruals our client base will experience increased accuracies through utilization of this expansive financial features suite stated Joe Blauert general manager of ProcessPro. The new ERP solution provides a comprehensive set of financial tools to help manage every aspect of accounting and payroll for today s manufacturers and is completely integrated with the core functionality of the ERP system manufacturing inventory quality and sales. Extended financial functionality includes project costing fixed assets payroll and human resources and muti-currency. For more information visit www.processproerp.com lp global-erp . 52 Nutrition Industry Executive www.niemagazine.com November December 2017 Equipment&Packaging Oracle Packaging Offers Push-through Blister Lidding Foil Oracle Packaging (North Carolina) a provider of flexible packaging solutions for the health care consumer tobacco and industrial sectors offers a selection of blister lidding foil for both over-the-counter and prescription pharmaceutical products. Providing exemplary protection against moisture and oxygen infiltration the high-barrier substrates are available in thicknesses of 20 and 25 microns. Of note the sealant layer utilized by Oracle Packaging yields excellent heat seals to PVC PETG PP HIPS and PE. Here Oracle s high-speed wide-web coating capabilities lead to unsurpassed converting cost effectiveness for blister lidding products. Oracle Packaging s push-thru blister foil products provide customers with outstanding barrier protection efficient machinability and ease of opening said Andrew Starr director of Oracle Packaging. Also the significant investments we have made in high-efficiency foil coating capabilities allow Oracle to deliver exceptional value on a delivered cost basis to customers. For more information visit www.oraclepackaging.com. Nutraceuticals (Continued from page 47) The natural products and pharmaceutical worlds are actually bonded by herbs and botanicals through science. With the dated history mentioned previously consumers are looking to learn more about them. Research has evolved away from more traditional applications toward scientific substantiation similar to what s being done in pharmaceuticals Pani observed. This seems to be a natural segue as herbs and botanicals have always been an inspiration to pharmaceuticals in development of drugs that have naturelike properties. One thing that s definite is the increased understanding and appreciation from consumers with regard to herbs and botanicals. Consumers have sought understanding with regard to their qualities and benefits. It s natural to see this interest contribute to the growing body of scientific evidence evolve including safety toxicity bioequivalence and efficacy testing. effects in a functional product. It may be great as a single herb but is lost in a food formula. So regulatory matters and marketing goals well aside there are many many considerations that must be addressed ideally at the planning and formulation stage as to whether and why to include any given botanical or any ingredient for that matter in a functional application. NIE Advice However it is important to keep in mind that manufacturers should not forcefully try implementing these ingredients for the sake of creating a trendy product. Just because a botanical or herbal extract is interesting doesn t mean we can or should add it into supplements foods or beverages Lifton advised. The research especially human clinical research needs to be taken into account because otherwise you cannot truly know how it will work in the human body. It also may not play well with proteins sugars or other ingredients. Other actives or active-acting incidental ingredients could counteract mask or improperly boost its FORMOREINFORMATION Bayir Inc. (609) 524-9505 BI Nutraceuticals (310) 669-2100 Lycored (877) 592-6733 Maypro (914) 251-0701 Radio Frequency Co. (508) 376-9555 TR Nutritionals (404) 935-5761 Welch s Global Ingredients Group (978) 371-1000 FunctionalFoods (Continued from page 51) body of evidence builds regulations may change to reflect new science. All prebiotics are types of fiber so previously were eligible for claims related to fiber in most cases. However fiber is going to become more complicated in the near future as the FDA reevaluates what is considered a dietary fiber for the purpose of nutrition labeling (www.fda.gov food ingredientspackaginglabeling labelingnutrition ucm52858 2.htm). This re-evaluation of scientific evidence is to ensure ingredients being labeled as dietary fiber actually have the physiological health benefits we expect them to have in our bodies especially in lieu of so many new fiber extracts being added to the food supply. Although seven isolated non54 Nutrition Industry Executive digestible carbohydrates have been approved under the FDA s new definition FDA is still evaluating the scientific evidence for 26 non-digestible carbohydrates at the time of this writing meaning the future is uncertain for claims for many prebiotic fibers. What s On the Horizon There is still much to understand about the human microbiome its effect on health and how we can positively impact it through our diet. The number of scientific studies on this topic is constantly growing meaning the future holds quite a bit of potential for ingredients like pre- and probiotics. For now ingredients like prebiotic fibers and probiotics are great additions to products if you re looking to deliver digestive health benefits. NIE Satya Jonnalagadda PhD MBA RD is currently the director of Global Nutrition at Kerry. She is responsible for leading Kerry s nutrition function strategic nutrition research internal and external nutrition positioning and scientific communications while staying up-to-date of proposed food regulations and identifying new nutrition opportunities. Jonnalagadda leads the Kerry Health and Nutrition Institute (www.kerryhealthandnutritioninstitute.com) a leading resource for health nutrition and general wellness science and policies in food and beverage product development. www.niemagazine.com November December 2017 Supply Innovation F or more than a decade Nutrition Industry Executive (NIE) has strived to cultivate relationships between ingre- Following is the list of companies participating in this year s Supply Innovation section Albion Laboratories Inc. ...............................56 Alkemist Labs.................................................57 GCI Nutrients Inc. .........................................58 Healthco .........................................................59 innovactiv .......................................................60 Jiaherb Inc......................................................61 NutraGenesis .................................................62 Nutrition 21 LLC ...........................................63 PLT Health Solutions Inc. ..............................64 Sabinsa Corporation ......................................65 U.S. Pharmacopeial Convention (USP) ..........66 Nutrition Industry Executive 55 dient suppliers and finished product manufacturers by providing Science of Ingredients sections to highlight the research supporting ingredients that can help finished products stand out. In the interest of furthering that cause and providing greater insight into suppliers efforts NIE offers its Supply Innovation section. NIE has given companies a chance to highlight their latest most innovative offerings. NIE has also provided ample company information to foster immediate connections with parties interested in learning more. November December 2017 www.niemagazine.com Supply Innovations Albion Laboratories Inc. 67 S. Main St. 100 Layton UT 84041 Phone (800) 453-2406 Fax (801) 773-4633 Email tjohnson albionminerals.com Website www.albionminerals.com Balchem Offers Proven Albion Minerals and the Essential Nutrient Choline T he Balchem Human Nutrition and Pharma business unit manufactures and sells Albion Minerals the company s brand of scientifically validated chelated minerals and VitaCholine its brand of the essential nutrient choline. Both brands provide premium ingredients that offer superior delivery of health benefits and are built on strong science and innovative technologies recognized worldwide for their quality efficacy and safety. The company has expertise in delivering nutrients across dietary supplement infant formula and food and beverage applications. Albion Minerals Minerals are essential to life but cannot be manufactured by the body. With Albion science and patented technology have been combined to create an organic molecule in a form the body can readily assimilate. These organic forms of mineral elements are mineral amino acid chelates. Inorganic sources of minerals can cause irritation of the gastrointestinal tract toxicity with larger doses and mineral interactions that may suppress rates of absorption. Albion minerals chelated with amino acids have shown greater bioavailability and utilization in humans. Less irritation has been indicated in human studies from ingesting these minerals as metal amino acid chelates. Albion pioneered the use of FastFourier Transforming Infrared spectroscopy (FT-IR) to identify bonds between the ligand and mineral and to verify the molecular structure is that of a true chelate. With more than 150 patents Albion is continuously working on ways to improve mineral delivery systems. Albion builds a better mineral in six steps 1. Start with high-quality raw materials 2. Use patented chelation technology 3. Select quality ligands 4. Use proven manufacturing processes 5. Test for quality using FT-IR 6. Continue lab and clinical research Albion chelated minerals offer the fol56 Nutrition Industry Executive lowing unique advantages Calcium is an essential mineral for a wide range of health-promoting functions including supporting colon health maintaining healthy blood pressure building dense healthy bones and teeth and supporting healthy weight management. With Albion chelated calcium products less dietary interaction means greater absorption and increased bioavailability. Additionally the Albion line of calcium compounds has the chemical and physical properties to fit most fortification and supplement needs. Iron deficiency is the most prevalent nutritional disorder in the world. Iron is an important component of hemoglobin which carries oxygen to tissues and helps fight fatigue. Iron is also essential to healthy cell function and helps form many of the proteins and enzymes that maintain good health. Ferrochel is a unique fully chelated more bioavailable iron product formed by binding iron to two organic glycine molecules. It is safer than typical iron salts and has less interaction with other nutrients. This is especially important in multivitamins for pregnant and nursing mothers and for children. Magnesium is a crucial macro mineral involved in more than 300 physiological processes. Research studies have shown that magnesium supports bone health cognitive health energy production cardiovascular health muscle strength and relaxation. There are several forms of Albion magnesium amino acid chelates which have been clinically demonstrated to be among the most bioavailable stable and well-tolerated forms of magnesium available. Other offerings include organic salts of aspartic acid and a patented dimagnesium malate as well as Creatine MagnaPower a magnesium creatine chelate ideal for sports nutrition applications. Zinc is a trace mineral needed by more than 300 enzymes to repair the body and support the immune system. It also helps synthesize proteins helps cells reproduce and helps maintain fertility. Strenuous exercise depletes zinc stores and low zinc levels in the muscles correlate with reduced endurance capacity. Zinc manufactured by Albion is a totally reacted nutritionally functional zinc bisglycinate chelate. In a clinical study comparing the oral bioavailability of zinc bisglycinate chelate to zinc gluconate Albion s chelated form increased absorption more than 43 percent. In addition Balchem has Albion mineral offerings in boron copper chromium manganese potassium selenium and vanadium. VitaCholine Choline is essential for single carbon metabolism neural function and cognitive health. After many years of study an RDI (recommended daily intake) for choline was established this year recognizing its essentiality. Today a large part of the population does not consume enough choline in their diets necessitating supplementation. Choline plays a key role in cholinergic memory function and is essential during natal development and throughout life. Choline also contributes to cell membrane integrity as part of the phospholipid membrane. Balchem is the leading manufacturer of choline and offers its branded Vitacholine as a premium quality ingredient. Contact Balchem Human Nutrition and Pharma to learn how the company can combine its premium ingredients to provide consumers with proven benefits in cognition vitality and a healthier metabolism. www.niemagazine.com November December 2017 Supply Innovations Alkemist Labs 1260 Logan Ave. B2 Costa Mesa CA 92626 Phone (714) 754-4372 Fax (714) 668-9972 E-mail sales alkemist.com Website www.alkemist.com Alkemist Labs Why Reference Standards Matter T he many phytochemicals contained in herbs are responsible for their activities. Being able to measure the presence or content of these substances in herbal products in order to assess safety quality and potency is an essential component of GMP (good manufacturing practice) compliance and producing quality products. With herbal products supply chain traceability and the detection of adulteration in the forefront of industry concerns analytical methods that address these concerns have been developed using phytochemical standards to assist in the quality process. Reference standards are used in the measurement of content or presence of phytochemicals contained in natural products and have direct impact on the ability to assess safety quality and potency of raw materials and finished products. They are pure substances existing in and mostly derived from plants for which chemical structure has been determined and for which purity has been accurately measured. They can be made by extraction chemical synthesis or through a combination of these approaches. Because they can be complex and fragile materials their pro- duction requires advanced skills in extraction organic chemistry and purification techniques. Once isolated these purified substances need to be accurately qualified in order to be used as standards using specific analytical techniques to determine their absolute purity and the content of by-products like water other solvents or inorganic materials. This purity determination absolutely requires scientific rigor and careful analytical technique. Because the results of analytical quality control testing are calculated directly against the reference standards chosen these reference standards have direct impact on the ability to accurately assess quality and potency of the raw materials and finished products that have been tested. It is critical that companies understand and correctly incorporate reference standards as part of their increased commitment to valid fit for purpose product testing. Unlike other industries such as petrochemical or metallurgy the production of standards for herbal products is not yet seriously regulated so sourcing them carefully is vital. In the pharmaceutical industry the FDA (U.S. Food and Drug Administration) and EMEA (European Medicines Evaluation Agency) have started to issue guidelines and have developed a collection of official standards. For the herbal products industry the use of standards is at this point still voluntary yet their use says everything about how serious a company is about rigorously testing their products. For the last two years Alkemist Labs has been the U.S. distributor of Extrasynthese phytochemical standards developed specifically for use in the quality control of dietary supplement ingredients and finished products. Extrasynthese s mission is to manufacture qualify and sell phytochemical markers reference materials and analytical standards. Based in Lyon France the company has 30 years of experience in extraction separation purification and analytical technologies from which it has developed a catalog containing more than 1 000 substances. Alkemist Labs is an ISO 17025 accredited contract testing laboratory specializing in plant authentication botanical ingredient identification and quantitative analytical services to the food & beverage nutraceutical and cosmeceutical industries. Alkemist Labs offers clients a wide range of specialty research services to evaluate the identity purity and quality of botanical raw materials dietary ingredients and finished products. Nutrition Industry Executive 57 November December 2017 www.niemagazine.com Supply Innovations GCI Nutrients Inc. 375 Beach Rd. Burlingame CA 94010 Phone (650) 697-4700 Fax (650) 697-6300 Email info gcinutrients.com Websites www.gcinutrients.com www.gcinutrients.com liposerine LipoSerine Stress Management and Cognitive Enhancement T he World Health Organization declared chronic stress the health epidemic of the 21st century. 1 Recent research has shown that there is a nutraceutical solution for managing stress and also improving memory and other aspects of cognitive function. This solution is a complex of phosphatidylserine (PS) and phosphatidic acid (PA).2 3 It is sold under the LipoSerine brand by GCI Nutrients Inc. Health experts have shown that stress is linked to the leading causes of death in America heart disease cancer lung disease accidents and suicide. Stress is also known to be a major source of memory and cognition impairment depression sleep deficit sleep disorders and more. All these set off metabolic chain reactions that can culminate in physical disorders as well as obesity metabolic syndrome and its accompanying disease states.4 5 PS is a well-studied phospholipid previously notable for its role in memory and cognitive health. It is in particularly high concentration in brain and nerve tissue.6 7 In addition PA not only supports mechanisms of brain function but actively participates in reduction of stress. As with PS itself further scientific research has indicated that anti-stress capacities of PS PA are effective across a broad demographic spectrum of age groups. Also there is a high level of overlap between stress level and cognition. The ability of PS to act as an ingredient for brain health and cognition encouraged further research of its potential to alleviate stress response and support stabilization of the internal hormonal secretion. PS as a single-ingredient was not adaptable as a natural stress reliever due to the need to apply high dosages (and thus high costs) per serving (800 mg). However when 400 mg PS is combined with 400 mg PA the blend becomes a cost-effective solution to support both a healthy stress response and 58 Nutrition Industry Executive healthy cognition.2 Research is pointing to the PS PA acid complex (PSPA) as perhaps being greater than the sum of the parts for affecting stress mitigation. One landmark study conducted last summer showed that supplementation with PSPA was able to normalize stress-induced dysregulations of the hypothalamic-pituitary-adrenal axis (HPAA).8 The randomized doubleblind placebo-controlled study of 75 healthy male volunteers was published by Hellhammer et al. in the peer-reviewed journal Lipids in Health and Disease July 2014. The researchers examined effects of daily oral supplementation of PSPA 400 (PAS 400) a complex containing 400 mg PS and 400 mg PA for a 42-day period (six weeks). This six-week period of supplementation was followed by an acute stress test (Trier Social Stress Test or TSST) to determine the effect of the complex on exogenously induced psychological and social stress. Researchers looked at endocrine stress response--specifically Adrenocorticotropic hormone (ACTH) as well as both saliva and serum cortisol--to a psychosocial stressor. In the chronically highstressed subjects supplementation with daily PSPA 400 proved effective at normalizing the ACTH and both cortisol responses following the TSST compared to the placebo. Results indicate that in chronically stressed subjects supplementation with PSPA 400 can normalize the hyper-responsivity of the HPAA to an acute stressor. Formulating with LipoSerine involves the following considerations GRAS (generally recognized as safe) status allowing for use in functional beverages and foods in additional to use in dietary supplements Soybean derived Non-GMO (genetically modified organism) Kosher The U.S. Food and Drug Administration (FDA) allows the following claim for Phosphatidylserine Phosphatidylserine (PS) may reduce the risk of cognitive dysfunction in the elderly and supports cognitive function in healthy individuals in the general population. References 1 The World Health Report 2008--Primary Health Care (Now More Than Ever) (2008). 2 Effects of Soy Lecithin Phosphatidic Acid and Phosphatidylserine Complex (PAS) on the Endocrine and Psychological Responses to Mental Stress Stress. 2004 Jun 7(2) 119-26. J. Hellhammer E. Fries C. Buss V. Engert A. Tuch D. Rutenberg and D. Hellhammer. 3 Soybean-derived phosphatidylserine improves memory function of the elderly Japanese subjects with memory complaints. J Clin Biochem Nutr. 2010 Nov 47(3) 24655. Kato-Kataoka A. Sakai M. Ebina R. Nonaka C. Asano T. Miyamori T. 4 Centers for Disease Control (CDC) and National Institute on Occupational Safety & Health (2011). 5 Our Health At Risk 2011 American Psychological Assn. (2011) 6 Phosphatidylserine (PS) A Remarkable Brain Cell Nutrient (Second Edition). Parris M. Kidd PhD (Totalhealth Press 2007) 7 A soy-based phosphatidylserine phosphatidic acid complex (PAS) normalizes the stress reactivity of hypothalamus-pituitary-adrenal-axis in chronically stressed male subjects a randomized placebo-controlled study Lipids in Health and Disease 2014 13 121. Juliane Hellhammer Dominic Vogt Nadin Franz Ulla Freitas and David Rutenberg. 8 Effects of phosphatidylserine on the neuroendocrine response to physical stress in humans Neuroendocrinology 52(3) 243 248. (1990). Monteleone P. Beinat L. Tanzillo C. Maj M. and Kemali D. www.niemagazine.com November December 2017 Supply Innovations Healthco 244 Knollwood Dr. Ste. 300 Bloomingdale IL 60108 Phone (800) 477-3949 (630) 545-9095 Fax (630) 545-9080 Email info healthco-intl.com Website www.healthco-intl.com Stevia FSE Enzyme-modified Stevia for a Superior Aftertaste Profile S tevia (Stevia rebaudiana Bertoni) leaf extract has become a popular non-caloric alternative sweetener. Several types of stevia ingredients have obtained GRAS (generally recognized as safe) status and are used in food products ranging from baked goods and cereals to yogurt and beverages. However formulating with this popular ingredient often presents a challenge due to the inherent bitterness of steviol glycosides the class of compounds responsible for the distinctive organoleptic profile of stevia extracts. Stevia FSE an innovative enzyme-modified steviol glycosides food ingredient was created to address this problem. The process of producing Stevia FSE starts with high-quality whole leaf extracted using food-grade ethanol. Next the stevia extract undergoes the step of controlled enzymatic glycosylation. During this phase steviol glycosides are extended to incorporate additional sugar-type molecules. Next the material containing glycosylated steviol glycosides is filtered and spray dried to produce a fine powder. The chemical structure of the enzyme-modified steviol glycosides in Stevia FSE has been thoroughly studied. For example rebaudioside A (Reb A) the primary steviol glycoside found in stevia contains 4 glucose units (attached to two different carbon atoms). Research demonstrated that the enzymatic glycosylation treatment augments this compound to have 1 to 3 additional glucose units thus creating mono- di- and tri-glycosyl Reb A found exclusively in Stevia FSE.1-3 This augmentation is believed to be responsible for the more pleasant taste. Overall sweetness intensity of Stevia FSE relative to sucrose has been evaluated in volunteers using a set of blindlabeled samples. In aqueous solution 0.055 g of Stevia FSE was shown to exhibit the same level of sweetness as 6 g of sucrose which indicates that at the given concentration it is about 100 times sweeter than sucrose.4 Metabolism of Stevia FSE has also been studied in detail.5 The research shows that in the body enzymatically modified steviol glycosides are hydrolyzed to ste- Several types of stevia ingredients have obtained GRAS (generally recognized as safe) status and are used in food products ranging from baked goods and cereals to yogurt and beverages. viol by intestinal microflora through the same mechanism responsible for metabolism of non-enzymatically treated stevia.6 Following hydrolysis steviol from Stevia FSE can be absorbed and then excreted in urine and bile as a glucuronide or it is deconjugated and excreted with feces.7 Stevia FSE has an excellent safety profile and is established as GRAS.4 It has been well recognized that the taste profile of individual steviol glycosides depends on the number of glucose units attached to steviol. For example Reb A a tetraglycoside has been shown to be less bitter than stevioside which contains only 3 glucose units.5 By utilizing controlled enzymatic process and lengthening the glucose chain of steviol glycosides the bitter aftertaste in Stevia FSE is reduced even further. It is also worth mentioning that the glucose chains in the native steviol glycosides are in the form of -glycosides whereas the controlled enzymatic glycosylation adds -glycosides to its structure. It has been suggested that the addition of different glucose stereoisomers might have significant impact on the properties of steviol glycosides including attaining a more favorable overall taste and reducing the bitter lingering effect. Stevia FSE makes it easier to create more desirable more palatable and ultimately more consumer-friendly food recipes. References 1. Waszkuc T Berkman S. Emmel K. Mohammed F. High Performance Liquid Chromatography (HPLC) Characterization of the Enzymatic Glycosylation of Stevia rebaudiana A Comparison of Enzyme Treated and NonEnzyme Treated Stevia Extracts. Poster presented at the 38th Great Lakes Regional ACS Meeting (May 13-16) Lincolnshire Il.2009. 2. Emmel K Waszkuc T. Kraemer-Berkman S. Szczesniewski A. D Antonio S. High-Resolution TOF LC MS Characterization of the Enzymatic Glycosylation of Stevia rebaudiana A Comparison of Natural and EnzymeTreated Stevia Extracts Poster presented at the 57th ASMS Conference on Mass Spectrometry and Allied Topics (May 31-June 4) Philadelphia PA. 2009. 3. Waszkuc T Berkman S. Emmel K. Jordan S. Mohammed F. High Performance Thin Layer Chromatography (HPTLC) Characterization of the Enzymatic Glycosylation of Stevia rebaudiana A Comparison of Enzyme Treated and Non-Enzyme Treated Stevia Poster presented at the 2009 AOAC Int. Annual Meeting (September 13-16) Philadelphia PA.2009. 4. FDA. Agency Response Letter GRAS Notice No. GRN 000337. 2011 www.fda.gov Food FoodIngredientsPackaging GenerallyR ecognizedasSafeGRAS GRASListings ucm262289.htm. Accessed Feb 19 2013. 5. NOW Foods U. GRAS Assessment. Glycosylated Enzyme Treated Stevia. 2009. 6. Koyama E Kitazawa K Ohori Y et al. In vitro metabolism of the glycosidic sweeteners stevia mixture and enzymatically modified stevia in human intestinal microflora. Food Chem Toxicol. Mar 2003 41(3) 359-374. 7. Wheeler A Boileau AC Winkler PC et al. Pharmacokinetics of rebaudioside A and stevioside after single oral doses in healthy men. Food Chem Toxicol. Jul 2008 46 Suppl 7 S54-60. Nutrition Industry Executive 59 November December 2017 www.niemagazine.com Supply Innovations innovactiv 265 2e Rue Est Rimouski QC Canada G5L 9H3 Phone (418) 721-2308 Fax (418) 721-2318 Email jberube innovactiv.com Website www.innovactiv.com Leading the Way in Science-based Ingredients B ased in Canada innoVactiv actively develops and commercializes specialty cosmetic and dietary ingredients meeting the highest scientific and quality standards. Each innovactiv team member commits to make every effort to bring value to your brands doing the extra step that facilitates product development. innovactiv Tackles Glycemic Stress With InSea2 Forty years of low-fat guidelines did not prevent rising rates of obesity diabetes or CVD (cardiovascular disease). This low-fat trend however induced profound changes to our diet leading to ever-increasing intakes of sugar and carbs. Low-fat foods needed carbs to bring additional taste and texture lost in the process of removing fat. Yearly average intake of added sugar now reaches 142 pounds per person meaning that every meal is a threat to longterm glycemic health. InSea2 is designed to address the roots of glycemic stress. After each meal large blood glucose fluctuations induce glycation of proteins and oxidative stress slowly paving the way to degrading glucose metabolism. By acting on digestive enzymes -amylase and -glucosidase InSea2 reduces the magnitude of post-meal blood glucose and insulin responses.1 2 This mechanism of action is not only very safe but can also generate immediate benefits after the first use of the product. Clinical studies with InSea2 showed a favorable impact of a single 500 mg dose taken 30 minutes prior to a starchy (bread) or sugary meal. More specifically blood glucose responses were reduced by 48 percent and 39 percent while insulin levels were reduced by 12 percent and 7 percent following bread or sugar intake respectively. At the same time insulin sensitivity was improved by 8 percent and 5 percent respectively.3 4 Additional clinical research is available and currently pending publica60 Nutrition Industry Executive tion in peer-reviewed journals. InSea2 is generally recognized as safe (GRAS)-affirmed organic and non-GMO (genetically modified organism) certified. It can be positioned in any formula targeting optimal metabolic health or in the blood glucose weight management or cognitive health segments. innovactiv Merges Two Passions With Beauty-from-within Ingredient Myoceram With roots in cosmetic and nutraceutical fields it was a matter of time before innovactiv brings these core competencies together. The company recently introduced Myoceram a range of functional ceramides derived from rice or corn germ. As our body s largest organ skin is a physical barrier preventing intrusions by pathogens toxins and physical agents. Skin is also key in preventing loss of water through evaporation. Across the entire skin s thickness this role is entirely devoted to the layer called stratum corneum. This layer is often disregarded as a pile of dead cells on their way to be peeled off the body. But within these cells highly specialized lipids are being secreted of which ceramides compose more than 50 percent. Ceramides have features similar to phospholipids a lipophilic tail and a hydrophilic head. When ceramide is produced it migrates to the stratum corneum to be organized in fine bilayers within the lamellar bodies. For a molecule to go through this structure it must be able to switch from a water-soluble to a lipid-soluble state repeatedly a feat that very few compounds can achieve (even water). It is this important 3D organization of ceramides that makes our skin so effective at retaining water. Myoceram from rice (Myoceram RPS) and corn (Myoceram CP) have each been clinically tested showing clear support of the skin s barrier function and hydration. Unlike other ceramides Myoceram works not by replenishing skin ceramides that are lost through normal skin turnover. Instead it works by stimulating the body s natural ceramide production (that declines with aging) so that human ceramides reach the skin in greater amounts leading to a stronger skin barrier. This mechanism allows using much lower doses of the ingredient. Clinical trials have shown that healthy subjects saw significant hydration benefits in just four weeks with doses as low as 20 to 40 mg per day. Additionally improvements in skin barrier could be felt at various sites indicating that the from-within use of ceramides can benefit dry skin occurring anywhere on the body.5 6 With its low dose and competitive pricing Myoceram can be included in any beauty-from-within supplement in women s health or even multivitamin formula. It is available in powder or liquid version for more formulation flexibility. References 1. Roy MC et al. Food Res Intl. 2011 Nov 44(9) 3026-9. 2. Gabbia D et al. Mar Drugs. 2017 Feb 15 15(2). 3. Paradis ME et al. App Phys Nutr Met. 2011 Dec 36 (6) 913-919. 4. B rub J et al. L Integratore Nutrizionale. 2014 Jun 17(2) 24-9. 5. Hirakawa S. et al. Jpn Pharmacol Ther. 2013 41(11) 1051-9. 6. Asai S et al. Rinsho Byori. 2007 Mar 55(3) 209-15. www.niemagazine.com November December 2017 Supply Innovations Jiaherb Inc. 1 Chapin Rd. Unit 1 Pine Brook NJ 07058 Phone (973) 439-6869 Fax (973) 439-6879 Email info jiaherbinc.com Website www.jiaherbinc.com Why Did Jiaherb Launch HerbaLink iaherb recognizes that there is much uncertainty among manufacturers and consumers about the integral quality of the botanical products they purchase. As a testament to the company s never-ending commitment to customer satisfaction and to ease customer concerns about the integrity of its products Jiaherb created the HerbaLink program. J HerbaLink is a unique What is HerbaLink HerbaLink is a unique chain-of-custody program offering ultimate transparency in product identification and traceability. The program not only assures best practices in identifying sustainable and socially conscious sources but also the implementation of stringent testing methods that include DNA HPTLC and HPLC throughout the processing and preparation of the finished product--documenting every link of the product s journey from harvest to packaging. chain-of-custody program offering ultimate transparency in product identification and traceability. What is Included HerbaLink consists of three parts Botanical Identification Report which includes an authenticated reference or botanical voucher of the correct plant species from Jiaherb s herbarium. Macroscopic Identification Report that describes the physical characteristics of the plant such as size shape color or texture as well as its organoleptic characteristics such as smell and taste. Chemical Identification Report that includes a detailed method of analysis by HPTLC HPLC or GC which provides both quantitative and qualitative information of the material. November December 2017 www.niemagazine.com Nutrition Industry Executive 61 Supply Innovations NutraGenesis 167 Main St. 208 Brattleboro VT 05301 Phone (802) 257-5345 Fax (802) 251-6981 Website www.nutragenesis.com DygloFit is a Comprehensive Weight Wellness Nutraceutical I con Group is a leading provider of weight-management ingredients in North America. This category continues to be a strong area of growth as the number of consumers seeking healthy solutions to manage their weight continues to rise. More and more of these consumers are seeking dietary supplement products that contain efficacious nutraceutical ingredients such as those offered by Icon Group because Icon Group ingredients provide both healthy weight management and metabolic wellness ( weight wellness ) benefits in a comprehensive manner. Icon Group s latest entry in the weight wellness category is DygloFit a clinically tested selfaffirmed GRAS (generally recognized as safe) standardized extract of Dichrostachys glomerata fruit. The fruit from this exotic botanical has a long history of use as both a culinary spice and for medicinal purposes in its native West Africa. Patented standardized DygloFit D. glomerata extract contains polyphenol bioactives with multifunctional properties. DygloFit s efficacy when taken either once a day or twice a day has been demonstrated in two randomized double-blind placebo-controlled human clinical trials that have been published in peer-reviewed journals. Human Clinical Trial Research has Demonstrated DygloFit s Weight Wellness Health Benefits DygloFit s ability to help promote healthy weight management and metabolic wellness at a 200 mg twice daily dose was evaluated in an eightweek-long trial involving 297 subjects.1 DygloFit or placebo was taken by subjects before lunch and dinner for the duration of the trial. There were significant health improvements at both four and eight weeks observed by researchers in the DygloFit group. By Week 8 subjects taking DygloFit lost an average of up to 24.5 lbs. and up to 11.3 percent body fat. These sub62 Nutrition Industry Executive jects also had significant reductions in waist size (up to 4.2 inches) and hip size (up to 3.5 inches). Factors associated with metabolic function including blood lipids fasting blood sugar insulin sensitivity and blood pressure also improved within their healthy ranges. In the second trial 48 participants consumed 300 mg of DygloFit or placebo once daily for a period of eight weeks. Researchers observed significant similar types of improvements in subjects taking DygloFit as occurred in the twice daily study albeit at reduced levels possibly due to the lower daily dose used (300 mg in the once daily study vs. a total of 400 mg in the twice daily study). For example by the end of eight weeks subjects who took 300 mg of DygloFit once daily lost up to 13.8 lbs. and up to 1.45 inches from their waists while body fat and blood lipid levels were also significantly improved. These combined results demonstrate that DygloFit helps support healthy weight management and metabolic wellness in a comprehensive manner at both once and twice daily dosage protocols. DygloFit Possesses Numerous Structure Function Claims and Can Be Utilized in Diverse Applications DygloFit features structure function claims in several condition-specific areas including healthy weight management metabolic wellness cardiovascular health blood sugar balance and antioxidant. These claims are in accordance with DSHEA (Dietary Supplement Health and Education Act of 1994). DygloFit is soluble in water has confirmed stability and possesses selfaffirmed GRAS status so it can be utilized in both dietary supplement and functional food and beverage products. It is also vegan non-GMO (genetically modified organism) and gluten free. DygloFit provides tremendous versatility for formulators because it can be utilized in various types of dietary supplement applications. These include capsules and tablets as well as liquid delivery systems such as shots stick packs and effervescents. References 1 Kuate D et al. 2013. Functional Foods Health Dis 3(11) 416-427. 2 Azantsa B et al. 2015 Functional Foods Health Dis 5(6) 200-208. www.niemagazine.com November December 2017 Supply Innovations Nutrition 21 LLC 1 Manhattanville Rd. Ste. 104 Purchase NY 10577 Phone (914) 701-4500 Email info nutrition21.com Website www.nutrition21.com Nutrition 21 High-quality Patented Nutritional Ingredients N utrition 21 LLC offers highquality patented nutritional ingredients whose health benefits are substantiated by extensive clinical research. With years of biotechnology and pharmaceutical experience Nutrition 21 s scientific platform has created unique patented products that are both safe and clinically effective. Nutrition 21 conducts rigorous preclinical and clinical trials showing effectiveness of bioactive ingredients designed to optimize human performance which help to ensure product safety and consumer trust. Nutrition 21 has high standards for its products and works strategically to develop NDIs (new dietary ingredients) and conduct clinical and preclinical studies with the goal of acquiring DSHEA (Dietary Supplement Health and Education Act of 1994) non-rejected and CARSE (Competent and Reliable Scientific Evidence) substantiated claims to back the efficacy of its ingredients. Nutrition 21 currently holds more than 100 domestic and international issued and pending patents supporting the claims for its products. The ingredients support unique claims associated with among others glucose metabolism weight management cognition and sports nutrition. and cardiovascular health. Consumer benefits include enhancing key factors for increasing blood flow boosting nitric oxide levels increasing energy quickly improving mental acuity and focus within 15 minutes increasing muscle volume and reducing muscle damage from exercise. Velositol Velositol is a revolutionary ingredient that doubles the power of protein which increases muscle protein synthesis a key to muscle growth. Velositol is a patent-protected complex that is clinically shown to work in a single dose. A single dose of Velositol mixed with a dose of whey protein doubles the increase in muscle protein synthesis versus whey protein alone. The primary benefit of protein is in its ability to stimulate muscle protein synthesis which affects the body s ability to build lean muscle and repair muscle damage due to exercise. Velositol enhances insulinogenic response which increases amino uptake and provides fuel for working muscles. This ingredient is self-affirmed as GRAS for use in protein drinks (including ready-to-drink and powder) meal replacements energy and protein bars. Nitrosigine Nitrosigine is a patented complex of bonded arginine silicate with FDA (U.S. Food and Drug Administration) NDI notification status and affirmed generally recognized as safe (GRAS) at the level of 1 500 mg per day for use in supplements nutritional bars and beverages. Nitrosigine is scientifically engineered to boost nitric oxide levels. Nitric oxide has been shown to be a key factor in generating greater blood flow and vasodilation in working muscles. The Nitrosigine complex bonds arginine and silicate--unlocking powerful synergistic effects. Nitrosigine is a safe non-stimulant effective ingredient that is easy to formulate into new and existing products for sports nutrition men s health Chromax Nutrition 21 supplies Chromax to leading manufacturers who are marketing effective products specifically designed to help support the dietary and nutritional needs of the consumer. More specifically Chromax aids in glucose metabolism and insulin resistance appetite control and weight management supports heart and lipid health energy support and brain health. Chromax is clinically substantiated for both efficacy and safety which provides its customers with marketable claims and numerous health benefits for consumers. Chromax is different from other forms of chromium because of its stable chemical structure and superior absorption. Furthermore Chromax has been affirmed as GRAS for use in food and beverage products and is easy to use in formulations. Chromax is Prop 65 compliant through an independent verification. Nutrition 21 is committed to providing outstanding customer service through co-branding and co-promotional marketing strategies. The company utilizes a multi-faceted program designed to create build and maintain demand for products containing the above mentioned clinically substantiated ingredients. Through direct-to-consumer advertising trade promotion public relations and social media Nutrition 21 is able to build consumer awareness and drive demand for its customer s products. Nutrition 21 is looking to develop long-term business relationships with companies interested in sharing its vision of providing unique high-quality ingredients to consumers. Nutrition 21 is always looking for ways to expand both through the acquisition of products in line with its current portfolio as well as through partnerships that will help further its existing ingredients. For more information visit www.nutrition21.com or contact Jim Kahn vice president of sales at jkahn nutrition21.com. Proposition 65 compliance independently verified for arsenic cadmium hexavalent chromium lead and mercury levels. Nutrition Industry Executive 63 November December 2017 www.niemagazine.com Supply Innovations PLT Health Solutions Inc. 119 Headquarters Plaza Morristown NJ 07960 Tel (973) 984-0900 Fax (973) 984-5666 Email plt plthealth.com Website www.plthealth.com RhodioLife Rhodiola rosea Ingredient Receives Third-party Identity Verification Ingredient Verification Program Motivated by Concerns Raised by Newly Published American Botanical Council Adulterants Bulletin O n October 26th of this year two companies Botanical Liaisons LLC (Boulder CO) and NaturPro Scientific LLC (Carmel IN) announced that they had jointly completed a successful ingredient identity verification program for RhodioLife Rhodiola rosea L. which is marketed in the United States by PLT Health Solutions Inc. (Morristown NJ). Verification of RhodioLife identity was based on a comprehensive set of criteria including supplier verification chain of custody review and identity testing using HPLC and DNA testing. The authenticity of rhodiola dietary supplement products has been called into question by the October 2017 publication of Adulteration of Rhodiola (Rhodiola rosea) Rhizome Root and Extracts by the American Botanical Council (ABC). The report authored by top natural products experts outlined that less expensive rhodiola species grown in China may be commonly added to the intended species resulting in its adulteration. According to Trish Flaster CEO and founder of Botanical Liaisons who led the review team a spike in demand for rhodiola in the U.S. and globally may be responsible for quality and identity issues. The global demand for Rhodiola rosea has rapidly increased which has led to shortages of authentic material. Most harvesting comes from alpine regions and forests where supplies can be depleted quickly without replanting and sustainability efforts said Flaster. I applaud PLT Health Solutions for taking the initiative to develop a sustainable supply by building relationships with rural co-ops in the Altai Mountains she added. The Source--and the Fingerprint --Matter Rhodiola rosea has been marketed to 64 Nutrition Industry Executive support sustained energy mood physical performance and an increased capacity to handle stress. Traditionally grown and consumed in North Asia and Russia the R. rosea species may be often confused with other rhodiola species in global dietary and herbal supplement markets. True R. rosea is believed to be differentiated from other rhodiola species by its yellow flowers and presence of significant levels of unique compounds called rosavins in authentic root extracts. RhodioLife s natural fingerprint composition consistently provides the spectrum of rosavins from the root that are considered responsible for its biological activity such as rosavin rosarin rosin and salidroside. RhodioLife preserves R. rosea s natural phytochemical fingerprint based on both the percent- age and relative ratios of rosavins. According to Blake Ebersole CEO of NaturPro Scientific ingredients like RhodioLife are different from the start. For RhodioLife responsible wildcrafting and sustainable sourcing is managed by a single entity and collection point in the Altai Mountains on the border of Russia Mongolia Kazakhstan and China. A Collection Management Plan (CMP) in accordance with WHO (World Health Organization) Good Agricultural and Collection Practices (GACP) is used to ensure responsible harvesting of material. This plan includes requirements for replanting harvesting of mature plants and ensures fair prices safety and training for workers he said. We appreciate the significant investment in quality transparency and traceability made by PLT and its ingredient partner-- Nektium Pharma in Las Palmas Spain--to develop and verify their source of Rhodiola he added. According to Seth Flowerman executive vice president of PLT Health Solutions the independent verification conducted by Botanical Liaisons and NaturPro Scientific on RhodioLife is in line with the company s PLT360 transparency and trust building initiative that was introduced in 2015. PLT360 is a business-wide commitment by PLT Health Solutions to developing transparent ingredient solutions that our customers can confidently supply to their own customers--knowing that these ingredients are safe of high quality efficacious and harvested and manufactured in a sustainable way he said. Going beyond traditional quality control programs PLT360 examines every aspect of an ingredient that we supply to deliver a best-in-class solution in a program that tracks ingredient integrity quality sustainability and efficacy. www.niemagazine.com November December 2017 Supply Innovations Sabinsa Corporation 20 Lake Dr. East Windsor NJ 08520 Phone (732) 777-1111 Fax (732) 777-1443 E-mail info sabinsa.com Website www.sabinsa.com DigeZyme A Multi-Enzyme Complex as a Sports Nutrient I f the digestive system is not functioning the way it is supposed to be then people can experience health problems ranging from poor nutrient absorption bloating constipation stomach pain and diarrhea to severe conditions like acid reflux irritable bowel syndrome (IBS) immune and neurological problems hormonal imbalance among others. In order to enjoy optimal digestive health one should support this intricate system by following a healthy lifestyle practicing balanced eating habits exercising regularly getting enough sleep and managing stress levels. However in the modernday environment numerous factors can wreak havoc on our digestive systems from lifestyle demands to inconsistent dietary habits causing a number of digestive health-related discomforts thus making the task of getting back the balance and restoring optimal digestive health more difficult. Because disturbed activity of digestive enzymes or enzyme insufficiency are common culprits enzyme supplementation is often recommended to those who experience varied gastrointestinal discomforts. in people who experience chronic gastrointestinal (GI) discomfort or are middle-aged and elderly--thus necessitating enzyme supplementation to balance the digestive process.2 Beneficial Role of DigeZyme as a Sports Nutrient DigeZyme is a proprietary multi-enzyme complex developed by Sabinsa s commitment to research. It is a combination of specific digestive enzymes from microbial source that help in proper digestion and better absorption of foods that eases GI symptoms. An additional benefit that has been clinically shown is efficacy against muscle soreness occurring due to high-intensity eccentric exercise. This off-white to creamy-white powder consists of the following digestive enzymes a-Amylase Starch hydrolyzing enzyme Neutral Protease Protein hydrolyzing enzyme Lipase Fat hydrolyzing enzyme Cellulase Cellulose hydrolyzing enzyme Lactase Lactose hydrolyzing enzyme Importance of Digestive Enzymes in Health and Nutrition In basic terms enzymes can be described as simple proteins found within each living cell where they act as biological catalysts to regulate various biological reactions.1 They play an essential role in chemical reactions that take place in our body such as digesting food cellular energy and the repair process of tissues organs and cells. Each of us as with all living organisms could be regarded as an orderly integrated succession of enzyme reactions said Dr. Humbart Santillo summarizing the significance of enzymes in health and nutrition in his book entitled Food Enzymes The Missing Link to Radiant Health. Digestive enzymes are secreted in the lining of the digestive tract which aid in digestion by facilitating the breakdown of larger molecules present in food for absorption. For example amylase protease and lipase are responsible for the breakdown of starch proteins and fats respectively. However due to poor dietary habits a fast-paced lifestyle and excessive intake of fat and sugars secretion of digestive enzymes may not be adequate particularly Efficacy of DigeZyme in Sports and DOMS Recent Clinical Study Findings Delayed onset muscle soreness (DOMS) is a particular type of muscle soreness often occurring as the result of unaccustomed or high-intensity eccentric exercise within 24 hours post-exercise and lasting for three to four days. In a recently published double-blind placebo-controlled clinical trial efficacy of DigeZyme in reducing pain associated with DOMS induced by standardized eccentric exercise was evaluated. In this study 20 healthy male participants received either placebo or DigeZyme capsule (50 mg) thrice a day for a period of three days. Results suggested that DigeZyme supplementation was able to decrease the associated pain and tenderness induced by standardized eccentric exercise. Data also suggested that DigeZyme was able to improve subjective pain and tenderness significantly. Decrements were also observed in McGill Pain Questionnaire (a multidimensional pain instrument where the final score is a sum of all 10 individual pain questions) showing high significance in the active arm (Figures 1 and 2). A declining trend in the level of pro-inflammatory biomarkers was also observed in the DigeZyme group (i.e. creatine kinase and lactate dehydrogenase). Based on the study findings it was concluded that DigeZyme improved the outcome measures related to DOMS induced by standardized eccentric exercise.3 References 1. Cooper GM. The Cell A Molecular Approach. 2nd edition. Sunderland (MA) Sinauer Associates 2000. 2. Roxas M. The role of enzyme supplementation in digestive disorders. Altern Med Rev. 2008 13(4) 307 14. 3. Majeed et al. Multi-enzyme complex for the management of delayed onset muscle soreness after eccentric exercise a randomized double blind placebo controlled study. Sports Nutr Ther. 2016 DOI 10.4172 2473-6449.1000113. Nutrition Industry Executive 65 November December 2017 www.niemagazine.com Supply Innovations U.S. Pharmacopeial Convention (USP) 12601 Twinbrook Pkwy. Rockville MD 20852-1790 Phone (301) 881-0666 (800) 227-8772 Email mediarelations usp.org Website www.usp.org USP Verified Mark R ecent reports challenging the quality of dietary supplements have prompted industry leaders and health professionals to find ways to distinguish quality products from subpar products as they strive to protect their brands and consumers. A prominent solution that manufacturers health professionals and consumers have relied upon is to look for the USP Verified Mark. Pharmacists Know and Trust USP Verified Pharmacists are strong proponents of the USP Verified Mark primarily because they are familiar with USP s role in establishing quality standards for medicines. Since 1906 Congress has required that medicines sold in the U.S. meet public standards and recognized the U.S. Pharmacopeia and the National Formulary or USP and NF as official compendia of those standards. Pharmacists are accustomed to seeing the letters USP on the medicines they dispense. So when the quality of dietary supplements are challenged it is not surprising that they would look to USP for an assurance of quality. How can we protect patients in this milieu asked Cydney McQueen PharmD in a guest editorial published in the March 2016 issue of the journal Hospital Pharmacy. Her answer Provide education on the problem of quality and practical guidance on how to navigate store shelves. Her top recommendation for both pharmacists and consumers is to look for third-party verification of quality specifically the USP Verified Mark. Sarah Erush PharmD clinical manager of the Pharmacy at the Children s Hospital of Philadelphia took this approach one step further and required her hospital pharmacy to try to only stock dietary supplements that have been independently tested for product quality. She also prefers the USP Verified Mark. this law was that it created a disincentive for what had been an accepted practice adding the letters USP after the product or ingredient name to indicate it was made to USP standards. But many manufacturers still wanted a way to indicate their products were made using USP s rigorous science-based standards. So at the request of industry USP created USP Verified a voluntary independent third-party verification program based on USP standards to help address their concerns. The USP Verification process includes facility audits full document review of quality control procedures and testing products against USP s public standards. Products that meet USP s rigorous procedures are awarded the USP Verified Mark. The USP Verified Mark offers assurance that what s on the label is in the bottle in the right amount has been tested for harmful levels of contaminants and will break down so the body can absorb it. Early participants in the program were NatureMade and Costco s Kirkland Signature brand. The USP Verified Mark makes a participant s commitment to quality visible and helps differentiate their products in a competitive marketplace. ents listed on the label. Although the test methods used by the AG s office were challenged the move garnered negative press for those retailers and the industry. Among the 500-plus quality standards for dietary supplements and dietary ingredients in the USP-NF are standards and test methods for all of the botanical extract products and ingredients targeted by the NYAG. None of these standards currently include DNA test methodology. None of the brands cited in the NYAG s letters were USP Verified. If they were USP would have conducted an investigation to ensure they complied with standards found in the USP-NF and USP would stand by the quality of those products. Media Reports Advise Readers to Look For the Mark Increased scrutiny of the dietary supplement industry did not end with the investigation by the NYAG. Federal enforcement actions against a few manufacturers of products primarily in the sports sexual enhancement and weight-loss segments included product recalls and other events making dietary supplement quality a steady focus of news reports over the past year. Many stories have pointed to USP Verified and other third-party seals as a way to help consumers choose quality products. Demand For Verification Seals is Growing The supplement industry is under unprecedented scrutiny. Reports of poor quality among products in a few segments have called into question the quality of almost all products. And independent verification seals are popular and a useful tool to help distinguish quality products. Pharmacists national brands major retailers and the media rely on these seals to help patients consumers and readers determine quality products. Consumers are learning to look for the USP Verified Mark to ensure what s on the label is what s in the bottle. As a result interest in the USP Verified program is growing. More information about the USP Dietary Supplement Verification Program can be found at www.uspverified.org. Retailers Can Look to USP Verified to Manage Risk In February 2015 the New York attorney general (NYAG) sent cease and desist letters to several major retailers demanding they remove some of their herbal dietary supplement products from store shelves because tests using DNA methodology showed they did not contain the ingredi- Industry Appeals to USP to Help Make Quality Visible When Congress created a separate regulatory category for dietary supplements in 1994 it continued to recognize USP standards as official but made them voluntary. An unintended consequence of 66 Nutrition Industry Executive www.niemagazine.com November December 2017 Advertiser Index Alkemist Labs Balchem Albion GCI Nutrients innoVactiv Inc. Jiaherb Inc. Now Foods PL Nutragenesis Nutra Solutions USA Nutrition 21 LLC Olcott Plastics PLT Health Solutions Sabinsa Corporation Soma Labs Inc. United States Pharmaceopea 13 11 9 45 5 1 C3 15 43 7 3 C2 38 C4 ( 7 1 4 ) 754-4372 (801) 773-4631 (650) 697-4700 (418) 721-2308 (888) 542-4372 (800) 999-8069 (802) 257-5345 (631) 392-1900 (914) 701-4500 (630) 584-0555 (973) 984-0900 (732) 7 7 7 - 1 1 1 1 (732) 271-3444 (301) 230-6361 www.niemagazine.com alkemistlabs www.niemagazine.com balchem www.niemagazine.com gcinutrients www.niemagazine.com innovactiv www.niemagazine.com jiaherb www.niemagazine.com nowpl www.niemagazine.com nutragenesis www.niemagazine.com nutrasolutionsusa www.niemagazine.com nutrition21 www.niemagazine.com olcott www.niemagazine.com plt www.niemagazine.com sabinsa www.niemagazine.com somalabs www.niemagazine.com usp Industry Events November 28-30 Food Ingredients Europe Messe Frankfurt Frankfurt Germany www.figlobal.com fieurope November 30-December 3 SOHO Expo Gaylord Palms Hotel and Convention Center Kissimmee FL www.southeastnpa.org February 6-8 2018 West Pack Anaheim Convention Center Anaheim CA www.westpack.packagingdigest.com March 7-11 2018 Natural Products Expo West Anaheim Hilton & Marriott Anaheim Convention Center Anaheim CA www.expowest.com April 10-11 2018 SupplySide East Meadowlands Exposition Center Secaucus NJ east.supplysideshow.com May 15-17 2018 Vitafoods Europe 2018 Palexpo Geneva Switzlerland www.vitafoods.eu.com Don t miss a single issue of NIE ... go online to renew your free subscription today NIEmagazine.com NovDec17 November December 2017 www.niemagazine.com Nutrition Industry Executive 67 SupplieroftheMonth MeriCal LLC 2995 E. Miraloma Ave. Anaheim CA 92806 Phone (714) 238-7225 Fax (714) 238-7249 Website www.merical.com Brian Smith Operating Partner MeriCal LLC is a recognized industry leader in the production of high-quality probiotic and other nutritional supplement products. The MeriCal company provides value-added contract manufacturing and custom bottling and packaging services along with a broad range of laboratory support services to several of the most recognized retailers and nutritional supplement brands in the industry. At the closing of acquiring MeriCal Linden named Operating Partner Brian Smith as interim CEO. Smith has more than 20 years of experience in health care-focused manufacturing having most recently served as CEO of First Engineering a global provider of finished medical devices with more than 3 000 operating personnel worldwide. NIE Merical recently acquired Global Health Industries (GHI). What was the company s motivation behind the acquisition Where do you see Merical headed in the future Smith GHI is a respected player in the industry best known for its highly specialized approach to probiotic manufacturing and packaging including bacteria spores and yeast products. GHI also boasts strong multi-level marketing and branded manufacturing and sales expertise. The acquisition is MeriCal s next step in its strategy to become the leading developer and manufacturer in the probiotic segment of the vitamins minerals and supplements industry. We are excited at the prospect of combining our respective resources. Among other benefits GHI will gain access to our industry-leading R&D capabilities which we are confident will lead to expanded demand for our innovative products. GHI s unique spore manufacturing and packaging operation will add to MeriCal s existing capabilities. Together we will continue to strive to become the clear leader in probiotic and supplement contract manufacturing--one of the goals we set out to achieve after last year s acquisition of MeriCal by Linden. supply chain from receiving raw materials through the manufacturing process and to the final product requirements. MeriCal holds several certifications with recognized names in the dietary supplement industry (i.e. USP NSF) and complies with all FDA CFR 111 and 211 regulatory requirements. MeriCal strives to exceed compliance by developing a quality system that builds quality in and a philosophy of continuous improvement. We also stay proactive in the industry by attending several conferences with the IPA (International Probiotics Association) which we are a member of and monitor compliance initiatives by the FDA (U.S. Food and Drug Administration) to understand the direction of the dietary supplement industry in order to remain ahead. NIE How does Merical s R&D team work with customers to develop products that suit their needs Smith MeriCal takes pride in our approach to innovation and customer collaboration. Often the norm for contract manufacturers is to work reactively on projects brought to them. MeriCal has created the tools and the team necessary to proactively both develop and deliver innovative ideas and novel formulations to our customer base. Our knowledge of the dietary supplement industry in general the probiotics industry in particular and our comprehensive understanding of the packaging industry have allowed MeriCal to bring full turn-key solutions to customers in a manner unmatched in the industry. MeriCal has been compiling clinical NIE The company is committed to quality. What does Merical do to not only meet but also exceed compliance Smith MeriCal s commitment to quality starts from top senior management down through the organization and is one of our key core values. We ensure quality is built in through the entire 68 Nutrition Industry Executive and technical information on hundreds of branded and clinically substantiated ingredients from numerous ingredient suppliers in order to act as an unbiased source of quality information for our customers. This enables us the ability to offer unique formulations covering a variety of health conditions and consumer demographics while maintaining an objective opinion of comparable ingredients. Our methods allow us to quickly and consistently price link claims substantiation and calculate serving size targets with the ability to adjust on the fly or offer alternatives when requested. To be able to offer these services for probiotic formulations and create condition-specific probiotic products are other examples of what sets MeriCal apart from the competition. The formulation piece is just the first part of the equation expert knowledge in ingredient interactions and overages ensure that the product will maintain clinical relevance through the shelf life of the product and our inhouse flavor team helps create a product memorable for more than just the bioactive ingredients it contains. Finally we help choose the appropriate packaging that will speak to our customer s target demographic while protecting the integrity of the product. The end result for our customers is a turnkey solution customized to their specific requests and needs maintaining flexibility to perform customizations to any aspect of the process they choose. We also encourage our customers to come in and work side by side with our formulators and flavor artists to make real-time adjustments which not only optimizes the process but minimizes their timeline. www.niemagazine.com November December 2017 Go to www.niemagazine.com nutragenesis for info about this advertiser Go to www.niemagazine.com usp for info about this advertiser