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A VRM Media Publication April 2019 www.niemagazine.com Don t miss a single issue of NIE in 2019 go online to renew your free subscription today NIEmagazine.com April19 Go to www.niemagazine.com sabinsa for info about this advertiser Go to www.niemagazine.com certifiednutraceuticals for info about this advertiser Proud Supporter of TableofContents VOLUME 24 NO. 3 APRIL2019 F E A T U R E S 26 Pondering Cognitive Support Young adults are having more senior moments than ever. Stress constant mental and physical activity plus poor diet and sleep-deprived lifestyles necessitate a well-rounded brain-support supplement. 33 A Well-oiled BMJ Machine Bone muscle and joint issues look to disrupt the body but the latest ingredient innovations look to do otherwise. 39 Ensuring Compliance and Improving Quality NIE s panel of industry experts tackles a range of issues that the industry is dealing with including economic adulteration traceability cGMP compliance good agriculture collection practices and even mediocrity. C O L U M N S 33 A L S O I N S 11 Industry News I D E 4 First Word 44 The Pitch 17 Ingredient News 6 Condition Specific 47 Ingredient Technology 22 CRN Update 23 Association News 50 Conventions & Meetings 51 Advertiser Index 51 Industry Events 52 Supplier of the Month 9 Legalities 47 FREE Subscription (Print Digital or BOTH) & E-newsletter Available www.niemagazine.com Copyright 2019. Nutrition Industry Executive (ISSN 2331-2602) Volume 24 Number 3 April 2019. Nutrition Industry Executive is published monthly (except for bimonthly January February and July August and September October) 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 April 2019 Go to www.niemagazine.com bergstrom for info about this advertiser FirstWord It s Time for SSCI hile attending Natural Products Expo West in Anaheim CA this March I sat in on the Natural Product Association s (NPA) committee meeting. As expected the association addressed many of its top priorities at the event such as sports nutrition a new cosmetics safety bill NDI (new dietary ingredient) guidance etc. Also the topic of SSCI (Supplement Safety & Compliance Initiative) came up. I admit I hadn t heard much about it. I wasn t alone however others at the meeting had questions about it as well. But now is the time to get up to speed on the program. According to the NPA the SSCI s vision is to enhance the safety authenticity and regulatory compliance of supplements for consumer use worldwide. Its key objectives are to Create effective global systems to ensure traceability transparency and quality in the supply chain Reduce risks by ensuring equivalence between safety management systems Drive global change through benchmarking of domestic and international standards Eliminate redundancy in certification improve operational efficiency and costs Provide a unique stakeholder platform for collaboration knowledge sharing and networking Major retailers are already embracing the initiative. Recently according to NPA Walmart and GNC want nutritional supplements sold in their stores or on their websites to meet the new guidelines set by SSCI. In fact the new general and technical benchmarking guidance documents were released during a meeting at Walmart s headquarters in Bentonville AR. Dadrion Gaston RPh senior director corporate ethics & compliance with Walmart stated Manufacturing practices vary widely across the dietary supplement industry. Although all of our private label aka store brand suppliers must have a third-party audit and certification. SSCI will ensure they meet our stringent expectations and recognized benchmarking guidance documents W Publisher Daniel McSweeney Editorial Director DanM VRMmedia.com through the supply chain. Associate Russ Fields He added SSCI brings together the best Publisher RussF VRMmedia.com experts from the leading supplement companies to examine everything from auditor Advertising Barry Young training qualification and the way audits are Sales Manager Barry VRMmedia.com conducted. We look forward to having additional retailers and others in the industry join Editor-in-Chief Janet Poveromo JanetP VRMmedia.com our mission to enhance the safety of dietary supplements and promote quality and safety Managing Editor Shari Barbanel for consumers everywhere. ShariB VRMmedia.com Since dietary supplement manufacturers Associate Editor Nicholas Saraceno often rely on third-party auditors to help NicoS VRMmedia.com them verify and comply with GMP (good manufacturing practice) standards SSCI plays Contributing Writers James J. Gormley a role in establishing a minimum set of Lisa Schofield requirements for all certifying bodies and cerBarri Sigvertsen tification program owners with the ultimate Amy Summers goal of harmonization with global requireMarc S. Ullman ments for supplements. Brian Wommack SSCI is the only comprehensive program to provide end-to-end transparency in the Art Director Robert Certo natural products supply chain said Daniel Production Manager RobertC VRMmedia.com Fabricant PhD president and CEO of NPA. We created a system understanding that the Production Assistant Bryan Zak Graphic Designer BryanZ VRMmedia.com FDA can t solve all our problems. We set out to demonstrate to consumers and regulators Circulation Manager Rosie Brodsky that they can have confidence in the industry Rosie StarkServices.com and SSCI is the way we are going to achieve that. A PUBLICATION OF Our new benchmarking guidance docuVRM MEDIA ments will unify and promote supply chain quality and provide a unique stakeholder platform for collaboration knowledge sharPresident ing and networking added Guru Daniel McSweeney Ramanathan PhD chief innovation officer & VRM Media senior vice president for GNC. We are proud of our commitment to increase trans431 Cranbury Road Ste. C parency and safety in the dietary supplement East Brunswick NJ 08816 and natural product industry. Phone (732) 432-9600 SSCI Board member Mark LeDoux explained We received tremendous feedFax (732) 432-9288 back on our new benchmarking guidance Email info VRMmedia.com and we are excited to join the leading supWebsite www.niemagazine.com plement retailers in the world on this project. Our benchmarking guidance documents for VRM Media publishes finished products were developed from a Nutrition Industry Executive Vitamin Retailer broad range of input from manufacturers Natural Practitioner and Fitness Trainer magazines. retailers and a national accreditation board and we are happy to say the results have VRM Media is a proud member of been excellent. Connect With Us Proud Supporter of Vitamin Angels www.twitter.com vitaminretailer www.facebook.com vitaminretailermagazine 4 Nutrition Industry Executive www.linkedin.com company vrm-media www.instagram.com www.pinterest.com vitaminretailermagazine vrm_media go.vrmlink.com youtube www.niemagazine.com April 2019 Go to www.niemagazine.com balchem for info about this advertiser ConditionSpecific Addressing Metabolic Health B Y S HARI B ARBANEL n the U.S. the amount of people that are considered to be metabolically healthy is quite low. According to a study published in February 2019 in the journal Metabolic Syndrome and Related Disorders a person is considered to have metabolic syndrome when they have too high or too low levels of three of the five risk factors increased blood pressure (more than 130 85 mmHg) high blood sugar levels excess fat around the waist high triglyceride levels and low levels of HDL ( good cholesterol). In fact the researchers found that approximately only 12 percent (one in eight) of adults in the U.S. have perfect levels of all risk factors without having to take any medication. These factors have pushed metabolic health into the forefront as consumers are beginning to understand that being healthy is not only about staying in their healthy weight range anymore. This market is fueled by alarming health indicators showing that 34 percent of adult population is predia- I 6 Nutrition Industry Executive betic and 30 to 40 percent of adults (even lean ones) have fatty liver a condition predisposing them to insulin resistance noted Jocelyn B rub executive vice-president scientific & regulatory affairs for the Canada-based InnoVactiv. Consumers understand that these conditions may affect them even when they try to stay fit and have an optimal body weight. We re seeing a growing awareness and people are thus seeking support from natural products supported by sound scientific demonstrations of efficacy and safety. Annie Eng CEO of Florida-based HP Ingredients agreed. Consumers are gaining awareness that metabolic disorders can wreak havoc if unaddressed as they age she said. Metabolic dysfunction is more than just gaining weight it can set the stage for diabetes type II cardiovascular disease hypertension and non-alcoholic fatty liver disease. Clearing Up Confusion While consumers are beginning to understand what metabolic syndrome is because there are so many factors they may not yet have grasped how to address it. Consumers are often confused about how to manage metabolic syndrome (MetS) because it is a cluster of conditions that include elevated blood pressure elevated LDL low HDL excess belly fat and high blood sugar Eng noted. A consumer just told by his her physician that if MetS is present it may be confronted with taking several medications each with side effects. It can be overwhelming physically and mentally. Ideally one would also supplement with an ingredient or product that safely addresses more than one MetS factor. According to Brian Appell marketing manager for OmniActive Health Technologies in New Jersey 35 percent of the U.S. population is predisposed to metabolic health issues of which a considerable number of consumers (more than seven million) are not even aware of their condition. And the problem is only aggravated by the food we conwww.niemagazine.com April 2019 Go to www.niemagazine.com nutrition21 for info about this advertiser ConditionSpecific sume. For example Appell reported 70 percent packaged food contains hidden or added sugar 1 the average daily consumption of sugar is more than 80 gm which is twice the recommended level of 24-40 gm 2 3 and a simple breakfast of 6 oz. low fat yogurt medium bagel with 1 teaspoon of cheese and 8 oz. fresh orange juice packs 46 grams of sugar. Sugar in food both hidden or added is one of the key concerns for consumers regarding metabolic health. Rightly so considering that poor blood sugar management may lead to a plethora of metabolic issues noted Appell. Our focus is to provide natural research-based solutions that target health benefits at their core. We combine our natural branded ingredients our technology and our science to deliver solutions for our customers in an effort to benefit their consumers. Our focus is to provide research-based solutions that target the problem at its core through versatile application options and ease of consumption to increase long-term compliance. the ingredients meeting the highest quality criteria required by today s consumers These are some of the many questions that need to be answered by manufacturers before moving forward with an ingredient. OmniActive s MetaVive is a salacia extract which has been clinically shown to improve glucose metabolism and reduce blood sugar spikes after a meal. We have also invested in conducting multiple clinical trials to prove efficacy at a low dose.4 5 There is a trend toward solutions targeting proactive users to reduce the impact of hidden and added sugar in food said Appell. MetaVive provides a solution that has been clinically shown to support metabolic health allowing consumers to worry less about what they are consuming. Ingredients Longstanding ingredients for metabolic health include gymnema berberine cinnamon chromium green coffee bean and salacia. According to Appell many of the metabolic health ingredients come from ayurveda. Salacia for example a plant native to India and Sri Lanka has been consumed by indigenous people for thousands of years to support blood sugar and metabolic health. While developing metabolic health products manufacturers and suppliers need to think about today s consumer. They are savvy and want products that are clean safe and have research available that back up product claims. These shoppers are unwilling to compromise on quality and will do their research to find what meets their criteria. Safety and efficacy should be at the core of the decision-making process of any manufacturer looking to develop metabolic health products said B rub . Ingredients having a long history of safe use or that are GRAS (generally recognized as safe) should be on top of the list because of their demonstrated safety. Published significant human clinical trials should also be considered. Were they conducted on a diseased population Are they showing benefits in healthy subjects as well Are 8 Nutrition Industry Executive HP Ingredients Bergamonte contains bioactive compounds of extract of the juice and albedo of Citrus bergamia Risso standardized to 38 percent polyphenolic flavanoids consisting of naringin neohesperidin neoeriocitrin 1 percent melitidin and 2 percent brutieridin. Bergamonte is produced using patented extraction technology through collaborative works of various universities and research institutions in Italy. According to Eng these flavonoids are clinically proven to help maintain healthy cholesterol levels healthy blood glucose level increase HDL-cholesterol and promote healthy weight management. HP Ingredients recently launched a new and improved version of Bergamonte (BPE-C). This has been tested clinically Eng said. Researchers found the new Bergamonte to be able to retain its powerful ability to regulate cholesterol and blood glucose levels (as it still has the same flavonoid profile of naringin neohesperidin neoeriocitrin melitidin and brutelidin) and the study also shows it has a significant favorable impact on body weight and metabolic syndrome. The study which is being prepared for journal publication has shown favorable impact on hormones that influence metabolic syndrome specifically a strong increase in leptin (12.30 percent with 650 mg BPE-C and 21.36 percent with 1 300 mg) decrease in ghrelin (6.89 percent 650 mg and 14.90 percent with 1 300 mg) and an increase in adiponectin (18.65 percent with 650 mg) and 21.76 percent with 1 300 mg). InnoVactiv s most successful approach to metabolic health has been with the ingredient InSea2. This ingredient works through a safe and effective way inside the digestive tract by slowing down amylase and glucosidase enzymes responsible for converting dietary carbohydrates into glucose explained B rub . Single use clinical trials in healthy subjects show that InSea2 reduces the normal post-meal rise in blood glucose and insulin so that the body reacts in a healthier manner after each meal. InSea2 is really a superior option to all other natural extracts claiming to have activity on amylase and or glucosidase enzymes and holds several certifications including organic non-GMO (genetically modified organism) and GRAS status. Recently a six-month study was completed with InSea2 showing it can help support long-term glycemic health in challenged individuals. This new study recruited 65 subjects with impaired fasting glucose or impaired glucose tolerance. Glycemic and inflammation parameters were followed over six months of continuous use of the product B rub continued. Treated subjects saw significant improvements in glycated hemoglobin fasting glucose and HOMA index compared to the placebo and also saw a significant (Continued on page 49) www.niemagazine.com April 2019 Legalities FDA Enforcement 101 By Marc S. Ullman he U.S. Food and Drug Administration (FDA) has a broad mandate to protect the public health by ensuring that foods including dietary supplements (except for meat from livestock poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe wholesome sanitary and properly labeled. FDA also ensures that human and veterinary drugs vaccines and other biological products and medical devices intended for human use are safe and effective. It is also responsible for protecting the public from electronic product radiation assuring that cosmetics are safe and properly labeled regulating tobacco products all the while advancing the public health by helping to speed product innovations. Beginning with the Food and Drug Act of 1906 FDA has managed more than 200 laws that have been passed by the Congress that comprise the modern Federal Food Drug and Cosmetic Act (FDCA). The FDCA as we know it today was enacted in 1938 and established the first uniform federal standards for the safety of food drugs and cosmetics. T April 2019 www.niemagazine.com Enacted following the elixir of sulfanilamide tragedy which involved the use of an untested anti-bacterial medicine using diethylene glycol (anti-freeze) as a sweetener resulting in 100 deaths this law included the first preapproval process for new drugs and created the modern definition for products in that category of anything that is intended to treat cure prevent or mitigate disease in man or other animals. FDA s Authority The FDCA provides FDA with the power to enter at reasonable times any factory warehouse or establishment in which food drugs devices tobacco products or cosmetics are manufactured processed packed or held for introduction into interstate commerce or after such introduction or to enter any vehicle being used to transport or hold such food drugs devices tobacco products or cosmetics in interstate commerce for purposes of enforcing the law and any related regulations. The most common reason for an inspection is to monitor compliance with good manufacturing practices (GMP) which for dietary supplements can be found at 21 CFR Part 111. Routine inspections can also take place if FDA has an ongoing compliance program in a specific area such as for sanitation checks pesticide and chemical residue checks or imported acidified and low-acid canned foods. For cause inspections can take place in instances where FDA suspects that there might be an ongoing violative condition in a facility for instance the presence of microbes such as listeria or salmonella or serious GMP failures as indicated by a recall for a manufacturing quality failure. FDA Enforcement Options Under the FDCA the agency is given numerous tools that are used to notify firms of regulatory legal violations and to provide an opportunity to correct those actions or to coerce compliance. These range from administrative actions that alert companies to potential violations of the FDCA and provide an opportunity for corrective actions to criminal prosecutions in conjunction with United States Attorneys across the country. Nutrition Industry Executive 9 Legalities Administrative These are enforcement devices internal to FDA. Form 483 This is also known as a Report of Inspectional Observations and is issued at the conclusion of an inspection when an FDA Investigator determines that significant compliance issues exist that require formal notice and correction. It is basically a list of items requiring corrective action. The initial response to the agency is due within 15 working days and should lay out a detailed corrective action plan for each item cited. If for some reason the investigator has listed an item in error the response should explain the nature of the mistake in great detail and describe the actual compliant conditions at the facility. So 483s while not confidential are generally available to the public by Freedom of Information Act Request only (though they are published on the FDA website in matters of extreme public interest. Warning letter This is the next step up in seriousness of actions FDA can take. It is exactly what it sounds like a formal warning from FDA that there is a matter of serious regulatory concern that requires corrective action in order to avoid potentially much more serious enforcement by the agency. For dietary supplement companies warning letters are most frequently issued following an inadequate response to a 483 or where unapproved drug claims are being made and the agency may decide to skip the 483 and proceed directly to a warning letter Detailed responses describing the cause of the problems identified and a corrective action plan are mandatory in response within 15 working days. Current warning letters are published on FDA s website every Tuesday. Judicial Legal Should FDA determine that a situation is too serious or unlikely to be resolved by an administrative remedy or a 483 or warning letter has proven insufficient to cause a company to come into compliance FDA has a number of much more serious enforcement options at its disposal. These actions will always involve the support of the U.S. Department of Justice. Seizure This is a court order allowing FDA to take possession of property (food supplements drugs etc.) of product that is seriously out of compliance. It is frequently used in matters that the agency views as extremely serious such as food stored in a filthy rodent infested warehouse or where there is a dispute requiring a device to allow a matter to be brought before a federal court. Seizure actions are usually easily recognizable because they are commenced against that offending product such as United States v. 20 Cases of XXXX. In these cases either the company involved enters the case as claimant to defend the products or may 10 Nutrition Industry Executive choose to do nothing which generally results in a court order for forfeiture and destruction. Well-known examples of FDA seizures are the black currant oil cases brought in the late 1980s. In those cases the companies chose to defend the products from seizure and were ultimately able to establish that the FDA had no legal justification to sieze the products in the first instance. Injunction This is another form of court order that is one the most potent enforcement devices at FDA s disposal. It will direct a company and or individual(s) to cease an activity that has been determined or appears likely to be in serious violation of the FDCA. These are most frequently seen where FDA has determined that a company has been given numerous opportunities to come into compliance with GMP regulations and has For dietary supplement companies warning letters are most frequently issued following an inadequate response to a 483 or where unapproved drug claims are being made and the agency may decide to skip the 483 and proceed directly to a warning letter failed to do so. It will then obtain an order requiring the company to cease production until such time as FDA determines that it has come into compliance with the law. Very few companies confronted with such an order are ever able to resume normal operations. Actions described above can become injunction actions if the company does not adequately address the problem that led to the initial seizure. Criminal Prosecution In FDA s discretion every violation of the FDCA is potentially a criminal offense. The power to prosecute while not used very often is the ultimate power vested in the agency. Types of incidents where this power may be brought to bear include where companies or individuals flout FDA authority by ignoring warning letters or injunctions or where there is serious consumer injury. Prominent recent examples include cases against Peanut Corporation of America (nine deaths 714 illnesses five executives and the corporation were prosecuted for felony offenses) melamine contamination of wheat gluten in pet food (hundreds of pets sickened numerous pet deaths company executive pled guilty to misdemeanor offense) and The Real Deal Inc. for falsification of GMP records (guilty pleas by company and responsible executives). Significantly misdemeanor violations of the FDCA can be prosecuted under the principle of strict criminal liability meaning that the government does not have to prove that the individuals in charge had an intent to violate the law. It merely needs to demonstrate that a violation occurred and that the person or company charged was responsible. This principle has been upheld twice the by the U.S. Supreme Court in United States v. Dotterweich (1943) (the general manager of a drug company held responsible for shipments of adulterated and misbranded drugs even though he was not directly involved) and United States v. Park (1975) (the CEO of Acme International prosecuted for failure to follow an FDA directive to clean up the company s food warehouses even though he was not directly responsible) based upon the court s conclusion that individuals and companies take on a special obligation when they enter into business selling FDA regulated products. Conclusion Despite popular perception that FDA s enforcement powers are limited to attempts to persuade companies to comply with the FDCA and applicable regulations the agency actually has a broad array of enforcement options that it is able to deploy as it deems necessary to assist it in its mission of ensuring the safety and efficacy of the United States supply of foods drugs and cosmetics. 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. He can be reached at marc.ullman rivkin.com. www.niemagazine.com April 2019 IndustryNews FDA Gottlieb Resigns Sharpless Named Acting Commissioner n March 5 U.S. Food and Drug Administration (FDA) chief Scott Gottlieb announced his resignation the Department of Health and Human Services (HHS) said. Gottlieb won bipartisan support for his efforts to curb the use of flavored e-cigarettes by youths speed approval times for cheap generic medicines to increase competition and bring down prescription drug prices and boost the use of cheaper versions of expensive biotech medicines called biosimilars. What this could mean in relation to dietary supplement regulatory modernization and the acceptance of hemp-derived cannabidiol (CBD) as a food additive and or nutritional supplement will come into question. Commissioner Gottlieb has been a vocal advocate for ensuring consumer access to safe and reliable self-care options including over-the-counter (OTC) medicines and dietary supplements. His tenure at FDA has been marked by tremendous progress on modernizing the regulatory framework for OTC medicines and beginning similar work for dietary supplements. CHPA will continue to advocate for these important public health initiatives moving forward stated Scott Melville president and CEO of the Consumer Healthcare Products Association (CHPA). O In respose to Gottlieb s announcement Natural Products Association (NPA) President and CEO Daniel Fabricant PhD stated We urge President Trump to consider a new leader for the FDA that will use the agency s enforcement powers to get tough on bad actors and lead on new areas like cannabidiol (CBD) and other promising natural products. A lot of ideas were put in motion on trade NDI (new dietary ingredient) intellectual property protection and NDI enforcement and we need a partner in government who can help bring those home for consumers and small businesses. We commend Commissioner Gottlieb for his service and look forward to working with the FDA during this transition. The U.S. has the safest nutritional supplements in the world because of collaborative efforts between our industry and federal regulators and we are confident that collaboration will continue under new leadership. Following the news of Gottlieb s resignation Norman E. Ned Sharpless MD has been named the acting commissioner of the U.S. Food and Drug Administration (FDA) by Alex Azar the Health and Human Services (HHS) secretary effective April 2019. Dr. Sharpless deep scientific background and expertise will make him a strong leader for FDA said Azar in a statement. There will be no let-up in the agency s focus from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes. Sharpless has been the director of the National Cancer Institute (NCI) since Oct. 17 2017. Before accepting the position at NCI he was the director of the University of North Carolina Lineberger Comprehensive Cancer Center. It will be an honor to advance the FDA s critical public health mission and build on its progress toward the priorities laid out by President Trump Secretary Azar and Commissioner Gottlieb alongside the leadership and staff of the agency Sharpless said. FDA s Request for Supplement Registration Doesn t Follow the Administration s Lead to Unburden Industry Says NPA he Natural Products Association (NPA) recently asked Congress to reject the U.S. Food and Drug Administration s (FDA) budget request for a product registration system for nutritional supplements as it s unclear of what value is added to the agency s mission of promoting and protecting public health. The administration has been clear that they want to unburden industry from unnecessary regulatory requirements and now we have the FDA without a permanent head asking for money and power without any clear reason that their wants will benefit public health which is completely at odds with the administration. The agency currently has access to labels T April 2019 www.niemagazine.com via inspections and other means. Does this mean the agency isn t using that authority or that information Why is that behavior going to be rewarded Any discussion of a national registry for nutritional supplements must start with preemption of state laws otherwise it is a waste of taxpayer dollars will be significantly burdensome to small businesses and will do nothing to protect consumers said Daniel Fabricant PhD president and CEO of NPA. The FDA should also use the resources it already has to act on things like CBD enforcement and NDI (new dietary ingredient) intellectual property protection. The NIH (National Institutes of Health) Office of Dietary Supplements has a voluntary label submission portal in place. Furthermore FDA inspectors routinely collect dietary supplement product labels during good manufacturing practice inspections and log them into the agency s Compliance Management System (CMS) database. Labels are also currently collected by the agency for issuance of certificates of free sale. For more information visit www.npanational.org. Nutrition Industry Executive 11 IndustryNews NSF International to Provide Pre-assessment Audits to New GRMA Standards SF International is now providing interim gap or pre-assessment audits to the recently developed Global Retailer and Manufacturer Alliance (GRMA) standards. In January 2019 the GRMA announced the publication of NSF ANSI 455 a set of consensus-based GMP auditing standards for manufacturers of dietary supplements (455-2 Dietary Supplements) cosmetics and personal care products (455-3 Cosmetics Personal Care Products) and over-the-counter drugs (455-4 OTC Drugs). The new standards are aimed at reducing the number of audits and the associated costs of auditing to multiple independent standards. The new standards will help manufacturers centralize their efforts in continuous improvement and industry best practices while giving consumers greater confidence in the products they choose. It has been rewarding to work with the retailers manufacturers regulators and other stakeholders to address this concern in thirdparty auditing said Casey Coy senior manager training & consulting health sciences at NSF International. Streamlining the path- N way to certification under these new standards helps alleviate the audit burden for manufacturers offers assurance of product quality to GRMA members and supports product safety for consumers. NSF International auditors were recently trained by the GRMA as part of NSF s effort to become an ANSI-accredited certifier of the GRMA standards. While waiting for official accreditation the GRMA is allowing NSF International to conduct interim gap audits. Eventually the GRMA will require ANSI accreditation to the standard for any certifying body that audits to these standards but for now it is accepting unaccredited audits by approved certifying bodies for up to one year in order to get these standards implemented quickly said Coy. NSF International is already working toward achieving ANSI accreditation for certification to these standards and we are currently able to provide interim gap audits. In addition to providing interim gap assessment and eventually certification to the GRMA manufacturing quality system standards NSF will continue providing prod- uct certification to the only American National Standard (NSF ANSI 173) that verifies the health and safety of dietary supplements. The GRMA is a global nonprofit with members from most major retailers manufacturers trade associations and certification bodies. The alliance was formed to develop an auditing scheme that utilizes consensusbased quality system standards for good manufacturing practices (GMPs) in several non-food related industries in the same way the Global Food Safety Initiative (GFSI) audit process was developed within the food industry. As an ANSI-accredited standards development organization NSF International facilitated the ANSI standards development process on behalf of the GRMA membership and other impacted stakeholders. While NSF International is a member of the alliance and has been integral in its structural development and growth the GRMA is now a selfdirected body with an independent governance board. For more information visit www.nsf.org. USPlabs & S.K. Laboratories Plead Guilty to Felony Charges ive individual defendants and two companies pleaded guilty in Dallas TX to felony charges in connection with a scheme to fraudulently sell workout supplements the Department of Justice announced on March 13. All of the defendants played roles in developing manufacturing or marketing the popular workout and weight loss supplements known as Jack3d and OxyElite Pro which were distributed by Dallas-based dietary supplement company USPlabs. Cyril Willson and Matthew Hebert pleaded guilty to introducing misbranded food into interstate commerce with the intent to defraud or mislead. Jonathan Doyle the president of USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce. Sitesh Patel the vice president of S.K. Laboratories a California dietary supplement manufacturer pleaded guilty to conspiracy to introduce misbranded food into interstate commerce and to the introduction of misbranded food into interstate commerce. Jacobo Geissler CEO of USPlabs pleaded guilty on to conspiracy to introduce misbranded food into interstate commerce. In addition S.K. Laboratories pleaded guilty to introduction of misbrand- F 12 Nutrition Industry Executive ed food into interstate commerce and USPlabs pleaded guilty to conspiracy to introduce misbranded food into interstate commerce on. The misbranding charges all relate in part to OxyElite Pro which was recalled in 2013 in the wake of an investigation by the U.S. Food and Drug Administration (FDA) into whether the supplement caused liver injuries in consumers. All of the defendants were charged in a 2015 indictment returned by a Dallas federal grand jury in the Northern District of Texas. The indictment alleged that the defendants participated in a conspiracy to import dietary supplement ingredients from China including the stimulant known as DMAA using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients. According to the indictment the defendants told some of their retailers and wholesalers that USPlabs products contained natural plant extracts when in fact they contained a synthetic stimulant manufactured in a Chinese chemical factory. The indictment also alleged that the defendants sold some of their products without determining whether they would be safe to use. According to the indictment USPlabs products related to the conspiracy brought the company hundreds of millions of dollars. In pleading guilty Doyle Geissler and Patel admitted that they imported substances with false and misleading labeling in part to avoid law enforcement and regulatory agency attention. Willson and Hebert admitted that they helped to cause a dietary supplement to be shipped with false labeling regarding the ingredients it contained. Doyle and Geissler pleaded guilty before U.S. Magistrate Judge Renee Harris Toliver. Patel Willson Hebert S.K. Laboratories and USPlabs pleaded guilty before U.S. District Judge Sam A. Lindsay. Patel faces a maximum sentence of six years imprisonment Doyle and Geissler face up to five years imprisonment and Willson and Hebert face up to three years imprisonment. The individual defendants together with the companies agreed to pay criminal fines and forfeitures totaling about 60 million. The court set sentencing hearings for Willson and Hebert on July 8 2019 for Patel and S.K. Laboratories on Aug. 12 2019 and for USPlabs on Aug. 19 2019. The remaining sentencing dates have not yet been set. www.niemagazine.com April 2019 Alkemist Labs Cuts Identity Testing Turnaround Time to Four Days alifornia-based Alkemist Labs has announced a 20 percent shorter turnaround time for the most common identity tests they provide routine HPTLC and Microscopy testing. Turnaround time for these tests will be four days. We know that rapid turnaround time for identity testing is the biggest need our clients have said Alkemist Labs CEO Elan Sudberg. While we were consistently delivering accurate results in five days we know that one less day is an added advantage for our customers. In a climate of frequent consolidation and restructured labs that can adversely C impact customer service we re proud to meet the needs of our clients. Optimizing the identity departments was an important focus during the development plans for the 2018 facility move which laid the groundwork to decrease turnaround time said Dr. Toto Phoutthavantha lab director. In 2018 we focused on intensive staff training taking quality and safety in testing to an even higher level and implementing lean efficiencies in production. We now have a solid foundation from which to keep this four-day commitment. For more information visit www.alkemist.com. Tenshi and DolCas Announce Joint Venture enshi Kaizen Private Ltd. (Bengaluru India) and DolCas Biotech LLC (Landing NJ) have announced the signing of an agreement for the creation of a joint-venture company. The joint venture between Tenshi a technology-focused specialty pharmaceutical company and DolCas a U.S.based strategic marketing and distribution firm specializing in branded nutraceutical ingredients will be incorporated under the name of its signatories DolCas-Tenshi Bioceuticals Inc. DolCas-Tenshi Bioceuticals (DTB) will focus exclusively on the research development and commercialization of novel nutraceutical lines for key global markets including the U.S. Canada Europe and Japan. The two partners have equal interest and headquarters will be based in New Jersey. The joint venture will allow the new company to create unique positioning for its products in the global nutraceuticals functional food and beverage markets. It brings together the diverse capabilities of the two established partners both with many years of experience in building and scaling innovative businesses. Tenshi brings proprietary technologies in developing and manufacturing highly bioavailable nutraceutical products and DolCas with strong front-end capabilities will spearhead the commercialization and go-to-market efforts. DolCas has a proven 10-year track record in establishing and marketing for two leading nutraceutical brands in the pain management and general well-being cate- T April 2019 www.niemagazine.com gories. Tenshi is delighted to partner with DolCas to build a significant branded dietary supplement business for the global markets said Venkat Iyer cofounder of Tenshi. We strongly believe that DolCas legacy and reputation of bringing to market science-led dietary supplements offers the perfect complement to Tenshi s development platform for its novel ingredients. With DolCas exemplary go-to-market abilities the synergies of the two partners will accelerate the development of and accessibility to affordable high quality nutraceuticals continued Iyer. We are on course with the launch of our first two products at VitaFoods 2019 in May. I am excited about our joint venture with Tenshi an impressive conglomerate of the pharmaceutical industry added K.G. Rao president of DolCas Biotech. At the hallmark of my 27th year in the nutraceutical sector I am looking forward to the positive impact this joint venture will have in the space and the contribution it will make to the end-user. The new company will operate with full vertical integration to ensure maximum transparency for our clients and consumers. Borrowing from pharma s highly standardized manufacturing processes and strict regulatory guidelines and expectations I see this venture contributing to the dietary supplement landscape in a distinctive way. For more information visit www.dtbioceuticals.com. BI Announces Acquisition by Martin Bauer Group I Nutraceuticals (Rancho Dominguez CA) a global fullservice manufacturer and supplier of plant-based ingredients in the United States announced its acquisition by the New Jersey-based Martin Bauer Group a global botanical expert. Effective March 25 2019 the partnership allows both organizations to broaden their portfolio of ingredients while being supported by an expansive manufacturing platform. BI s partnership with the Martin Bauer Group allows the company to expand its food beverage and dietary supplement ingredient offerings. Both companies share a long-standing reputation as experts in quality sourcing and manufacturing processes. This commitment will help further their growth as the demand for safe and responsibly sourced ingredients continue to grow in the domestic market. We are thrilled to be a part of the nature network and the Martin Bauer Group said George Pontiakos president and CEO of BI. This represents a significant move forward for us and our combined customer base. The Martin Bauer Group is a family-owned international company with a long history as a manufacturer and supplier of teas extracts and botanical products going back more than 135 years. BI Nutraceuticals will now have access to the global resources of the Martin Bauer Group in the areas of raw materials sourcing processing technology liquid extract production and research and development. The addition of BI Nutraceuticals to our Group buttresses our commitment to reliable quality safe and clean label raw materials meeting an increasing demand from our customers and consumers stated Ennio Ranaboldo CEO of Martin Bauer Group in North America. The two companies will continue to operate independently and further communications will be issued to ensure seamless integration both internally and for all customers. For more information visit www.botanicals.com. B Nutrition Industry Executive 13 IndustryNews Midwestern BioAg and PURIS Partner to Provide Crop Contracts to Growers isconsin-based Midwestern BioAg (MBA) a company involved with highproduction organic agriculture and PURIS a vertically integrated non-GMO (genetically modified organism) and organic food processing company in Minnesota announced a new partnership to support MBA s focus on helping growers transition to organic by providing financial farm management and agronomic assistance. Through this new partnership PURIS is offering contracts to Midwestern BioAg growers for non-GMO soybean and non-GMO yellow field peas supplying the seed and bridging the gap from farm to market. With those seeds PURIS creates nutritional and great tasting ingredients for food producers that are traceable to the farmers that are growing their food. Achieving sustainability at the farm involves providing solutions to the farm and the food companies to aid in supply chain development said Ben Adolph director of farmland sustainability for Midwestern BioAg. The program allows PURIS and Midwestern BioAg to bring an efficient approach to growing plant-based protein production in the Midwest. For more information visit www.midwestbioag.com or www.purisfoods.com. W Natural Remedies Presented With Platinum Donor Recognition ndia-based Natural Remedies has been recognized by the United States Pharmacopeial (USP) Convention with a Platinum Donor Recognition trophy for its participation in USP s standards-setting activities in 2018. Natural Remedies contribution adds significant public benefit to the standards-setting process in support of the USP mission which is to improve global health through public standards and related programs that help ensure quality safety and benefit of medicines and foods said Ronald T. Piervincenzi USP CEO. Similar to USP our mission is to help protect and improve the health of people around the world noted Anurag Agarwal MD CEO of Natural Remedies. Our seedto-shelf efficiency coupled with innovative production and standardized manufacturing processes make us the best-in-class partner to support the health and wellness industry. For more information visit www.naturalremedy.com. I TraceGains Partners With Ecofibre on Hemp Standards and Compliance olorado-based TraceGains has announced that it s partnering with Australia-based Ecofibre to drive standards and compliance in the hemp industry. Ecofibre has distinct businesses underpinned with more than 20 years of growing and breeding experience. The company owns one of the largest and most diverse collections of genetics with more than 300 land races of cannabis from more than 25 countries. This unique asset combined with deep growing experience gives Ecofibre the ability to work across many latitudes to ensure stability and control of its value chain. Ecofibre has been deeply involved in the development and passing of U.S. hemp legislation from its inception as Chair of the Kentucky Hemp Commission in 2013 to Chair of the U.S. Hemp Roundtable that facilitated the removal of hemp from the Controlled Substances Act in the 2018 Farm Bill. C 14 Nutrition Industry Executive To fully comply with the 2018 Farm Bill manufacturers and distributors must ensure any hemp-derived CBD within their products are grown only by U.S. farmers in states with formal hemp programs. There s a risk that manufacturers and distributors may find themselves unknowingly purchasing and transporting a Schedule 1 substance if they lack full transparency and traceability of the source of CBD products. Although global hemp industry regulations remain uncertain everyone working in hemp today recognizes the need for additional standardization to support imminent compliance requirements TraceGains CEO Gary Nowacki said. Our partnership with Ecofibre represents our joint commitment to helping companies working with hemp avoid risk and easily adhere to current and future legislation. TraceGains has a long history of protecting consumers manufacturers and distributors by ensuring the highest level of transparency in safety and compliance Ecofibre Managing Director Eric Wang said. We reviewed several options but only TraceGains gives manufacturers and distributors the ability to validate that CBD providers are fully compliant with the 2018 Farm Bill. For more information visit www.tracegains.com or https ecofibre.com. www.niemagazine.com April 2019 Water Positive Microalgae Cultivation System Achieves Sustainability Milestone alensa International (Eustis FL) has announced that its parent company EID Parry is the first known microalgae cultivation site in the world to demonstrate they can achieve a Water Positive footprint by actually putting more water into the ground than they take out while operating at-scale. A recent report from the Parry team confirmed the ability to deliver Water Positive cultivation. Despite being located in an arid remote location in India Parry s team created a system that maximizes water sustainability in several ways to push the water-use scale into positive while maintaining the strictest standards for organic production. This water management solution uses rainfall collection careful tracking and monitoring of water drawn from underground aquifers reducing loss during postcultivation processing and re-using filtered and purified water. That s another way of saying Parry s commercial-scale microalgae cultivates the purest forms of organic spirulina and chlorella while replenishing the earth with water. Parry worked with equipment and technology experts around the world V to be able to deliver this milestone said Dr. Margaret Dohnalek chief scientific officer for Valensa. Already the Parry team has been able to improve water filtrate quality which will achieve a savings of 20 percent water usage per day and that is an achievement in just that one part of the operation. The fundamentals of the initiative are less process loss improved productivity and better quality filtered and purified water. And as the Parry operation expands capacity water usage will be optimized so that capacity can double but water usage will only grow by 50 percent. In essence Parry is committed to doing more with less water. This is truly an admirable water conservation initiative. Add to that the rainwater capture system is directly integrated into the production flow to allow for a netpositive water balance from what is drawn from the earth. When you think about environ- mental sustainability you think about using less. The Parry team has flipped the question and asked how do we do more with less and replenish at the same time said Dohnalek. All while quality standards for E.U. Organic for Parry Organic Spirulina and Parry Organic Chlorella are not compromised. In fact Parry is exceeding the standard of many companies by delivering an Organic Spirulina that is below the threshold for polycyclic aromatic hydrocarbons (PAH) established by the E.U. Quality safety and a waterpositive footprint what a tremendous achievement she said. According to Umasudhan C.P. Valensa International s CEO Our goal for our microalgae business is to do more than just talk about sustainability and a commitment to water conservation and the environment. Our commitment is to unlock water sustainability in a way that gives benefit for society and commercial interests in a balanced manner. What we have done noted Uma is to look at water usage and microalgae production technology and be smarter about our approach. For more information visit http valensa.com. Glanbia Nutritionals Acquires Watson lanbia Nutritionals has acquired Watson (West Haven CT) a U.S.based manufacturer and supplier of custom nutrient premix bakery ingredients edible film and material conditioning solutions for the nutrition food and beverage personal care and supplement industries. Watson is a third generation family business with an 80-year history of providing exceptional quality capability and service to its customers. The transaction is highly complementary strengthening Glanbia s capability set with microencapsulation agglomeration micronizing spray drying and edible film technologies. The knowledge and experience of the combined R&D teams will cement Glanbia s position as a leader in the sec- G April 2019 www.niemagazine.com tor with the enhanced ability to create superior premix solutions that address the complex formulation requirements of today s increasingly sophisticated applications. Glanbia Nutritionals custom nutrient premix production footprint now extends coast to coast in the U.S. with facilities in California Missouri Illinois and Connecticut to better serve customers across the region. The U.S. presence is supplemented by facilities in Germany and China to provide global scale and solutions to our customers. We are excited to welcome the 300 employees of Watson with their established reputation of expertise technical capability and commitment to excel- lence said Brian Phelan CEO of Glanbia Nutritionals. The customers of both organizations will stand to benefit significantly from the combined capabilities that the two teams now bring together. For more information visit www.glanbianutritionals.com. Nutrition Industry Executive 15 IndustryNews Kemin Industries Creates New Digital Calculator emin Industries (Des Moines IA) has added a new Oxidation Stability Index (OSI) calculator for its Food Technologies - North America website. The digital slider tool allows formulators to select the desired number of OSI hours then provides shelf-life calculations for various fats and oils. This enables manufacturers to determine the ideal oil and antioxidant solution combination they need to meet cost K targets and shelf-life goals. We developed the OSI calculator so that formulators would have an easily accessible tool to help them maximize the desired shelf life of their food products said Courtney Schwartz marketing director for Kemin Food Technologies. Many manufacturers are seeking to remove traditionally used synthetic ingredients without switching to a high cost high-stability oil which can often reduce the stability of their oil. For example GT-FORT Kemin s oilsoluble green tea extract give manufacturers a label-friendly cost-effective solution to help meet their needs. The GT-FORT product line of plant extracts for fats and oils assists with oxidation control significantly delaying lipid oxidation which lengthens the shelf life of food and maintains brand consistency. For more information visit www.kemin.com. You reHired CV Sciences Inc. (Las Vegas NV) has announced the appointment of Douglas Duffy MacKay ND as senior vice president of scientific and regulatory affairs effective March 18 2019. MacKay will oversee the company s scientific and regulatory affairs department ensuring CV Sciences continues to pioneer the development of hemp-based cannabidiol (CBD) products driven by rigorous science innovation and regulatory compliance. MacKay brings more than 20 years of experience to CV Sciences in nutrition research dietary supplements health sciences and regulatory affairs. He joins CV Sciences following more than 10 years at the Council for Responsible Nutrition (CRN) most recently serving as senior vice president of scientific and regulatory affairs. Nutrition 21 LLC (Purchase NY) has announced that James Komorowski MS CNS the team s chief science officer has been welcomed onto the 2019 Board of Directors of the Council of Responsible Nutrition (CRN) as well as the 2019 Advisory Board for the International Society of Sports Nutrition (ISSN). FoodChain ID has named David Gould as global head of sustainability programs. Gould is currently winding up a seven-year term as senior facilitator for IFOAM Organics International where he has been instrumental in elaborating on best practices in agriculture and its value chains and developing the forward trajectory of the organic movement. PROVA Inc. has announced that Michael Courts has joined the company as Southeast sales manager. In this role Courts will be managing key accounts for PROVA in the Southeast United States as well as developing new accounts within that territory. Sabinsa (East Windsor NJ) has announced that Lori Diez has joined the company as sales manager Texas. Diez joins Sabinsa with 12 years of experience as a diabetes care specialist in spe16 Nutrition Industry Executive Ysabel Davila Leslie Gallo Lori Diez Jeff Langa cialty pharmaceutical sales for a large international manufacturer where she was instrumental in growing product brands as well as building strong business relationships with physicians and members of the primary care industry. The Council for Responsible Nutrition (CRN) has announced four staff promotions. CRN has promoted Jim Griffiths PhD to senior vice president international & scientific affairs Sandra Khouri to senior vice president finance & administration Carl Hyland to vice president membership development and William Dumais to government relations associate. Ysabel Davila has joined FCC Products Inc. as a sales executive for the central region. Davila comes to FCC Products with vast experience in product sales and account management. In her new role she will also spearhead the distribution of the company s products into the cosmetic industry on a national international level. Artemis International (Fort Wayne IN) has announced that Leslie Gallo has been promoted to president of the company. Jan Mills founder of the company will remain as chairman and CEO. Gallo who has been an executive at Artemis International since 2004 was previously vice president of operations. Euromed (Bridgeville PA) has appointed Ray Bonaventura as its new Western regional sales manager for the U.S. and Canada. In this position Bonaventura will be responsible for outside sales and customer service for the ingredient needs of clients throughout the entire Western region from Texas to Washington including western Canada. Fuji Chemical Industries has appointed Jeff Langa as its new director of sales Excipients. Langa brings more than 30 years of expertise in pharmaceutical and nutraceutical manufacturing quality control technical service business management and product management. www.niemagazine.com April 2019 IngredientNews Algatech Delivers Astaxanthin in Whole-food Format aking the whole food approach Algatechnologies Ltd. (Israel) presents AstaPure Arava its clean-label all-natural whole-algae complex. This pure whole-food form contains all of the naturally occurring constituents of healthful Haematococcus Pluvialis algae. This T species of microalgae is also the richest known source of astaxanthin according to the company. AstaPure Arava whole-algae powder containing the whole algae natural astaxanthin and the newly discovered natural complex is backed by research and addresses the needs of consumers seeking pure whole-food plant-based non-GMO (genetically modified organism) nutraceuticals. The results of a new study indicate that Arava Vitamin K2 vs. K1 Paper Published In International Journal Of Molecular Sciences he International Journal of Molecular Sciences has published a new review paper examining the differences between vitamins K1 and K2 showing that based on its very molecular structure K2 is available beyond the liver to support systems like the bone and vasculature through proper calcium utilization. The review paper the result of the INTRICARE and EVOluTION grants awarded to NattoPharma s (Oslo Norway and Edison NJ) International Research Network by the European Union within the Horizon 2020 Marie Sk odowskaCurie research and innovation program is an important step in establishing the need for a vitamin K2-specific recommended daily intake (RDI). According to the authors the paper T Vitamin K Double Bonds beyond Coagulation Insights into Differences between Vitamin K1 and K2 in Health and Disease is the first to highlight differences between isoforms vitamin K1 and K2 by means of source function and extrahepatic activity. Prof. Schurgers states that functions of K2 are proving to be beneficial with regard to cardiovascular diseases and bone metabolism yet there is a growing body of evidence suggesting vitamin K2 is involved in multiple cellular processes and might have a protective role in various organs throughout the human body. To that end it is important to consider an RDI reflective of these additional roles. For more information visit www.nattopharma.com or www.menaq7.com. Valensa Introduces Microencapsulated USPlus Saw Palmetto Extract alensa International (Florida) introduced a new Microencapsulated USPlus Saw Palmetto lipid extract which frees manufacturers abilities to deliver the testosterone and prostate health benefits of saw palmetto extract in wider applications. Using a microencapsulation process Valensa is the first to develop a virtually tasteless powder form maintaining the necessary high profile of fatty acids to deliver the proven health benefits desired by consumers said Valensa s CEO Umasudhan C.P. (abbr. Uma). This is the first-ever water-soluble saw palmetto extract in a powder that does not have the typical strong pungent flavor said Uma who has 20 years V April 2019 www.niemagazine.com in the business studying and commercializing natural-sourced ingredients from botanicals and microalgae. This is a breakthrough in convenient dosage form options to expand applications for an effective product supporting prostate (benign prostate hyperplasia-BPH) urinary tract (lower urinary tract symptoms) and testosterone health and even supporting healthy hair follicles (via inhibition of the 5-alpha reductase enzyme). The potential delivery applications include beverages bars stick packs gummies or chewable tablets as this form of USPlus can create a great-tasting product. For more information visit www.valensa.com. algae powder is highly potent and has synergistic effects of the natural astaxanthin and the whole-algae complex. The research was conducted by Gitte Jensen PhD the head of NIS Labs a U.S. immunity research institute located in Oregon. The study identified a complex found in Algatech s unique Arava strain of Haematococcus Pluvialis cultivated organically in the desert s harsh conditions. For more information visit www.algatech.com. OptiMSM Awarded With InformedChoice Certification ergstrom Nutrition (Washington) announced that shipments of OptiMSM a branded form of methylsulfonylmethane (MSM) will feature the Informed-Choice logo representing the company s continued commitment to the quality consistency and safety of its products. Bergstrom Nutrition began producing and testing material under the Informed-Sport certification in 2014 for distribution exclusively in the E.U. After four years of consistent results the company is now offering OptiMSM under the InformedChoice certification both domestically and to its distributors outside of the E.U. Informed-Choice is a quality assurance program for sports nutrition products raw ingredient suppliers to the sports nutrition industry and supplement manufacturing facilities. The monitoring program certifies that a supplement product and raw material bearing the Informed-Choice logo are skip-lot tested (tested at least on a monthly basis) for banned substances by LGC s world-class sports anti-doping lab. The Informed-Choice raw material certification provides assurance that OptiMSM production lots are regularly tested for substances considered prohibited in sport. In addition InformedChoice also ensures ingredients are manufactured to high-quality standards. Responsible ingredient suppliers are making Informed-Choice part of their existing quality assurance systems to ensure their ingredient is not contaminated before blending. For more information visit www.optimsm.com. B Nutrition Industry Executive 17 IngredientNews Study Shows Neumentix Supports Physical Performance Oil-soluble Green Tea Extract Named GRAS new study published in the Journal of the International Society of Sports Nutrition shows Neumentix the nootropic ingredient from Iowa-based Kemin Human Nutrition and Health can enhance physical performance through cognitive improvements. Neumentix a naturally sourced spearmint extract was shown to improve reactive agility in young adults according to the new randomized double-blind placebo-controlled trial. Researchers assigned 142 healthy young men and women to take either 900 mg of Neumentix or a placebo every day for 90 days. Those who took Neumentix showed improvements in A agility and reaction performance after just seven days of supplementation. The benefits lasted throughout the duration of the 90-day study. The authors of the study assessed subjects abilities with the Makoto Arena II a tool that tracks performance and agility by using lights and tones coming from targets on multiple towers and corresponding footplates. When a light flashes and a tone sounds participants must react quickly to match the correct tower and footplate targets a task that bridges mental and physical performance. In other news Kemin announced that its oil-soluble green tea extract has been named generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA). GT-FORT the Kemin brand of oil-soluble green tea extract is available for use as an antioxidant in a variety of food and beverage products. For more information visit www.kemin.com. Sabinsa Shagandha Ashwagandha Root Extract Verified by Alkemist Labs abinsa (New Jersey) has raised the quality bar for the adaptogen ashwagandha with Shagandha Ashwagandha Root Extract 2.5% USP from Withania somnifera assured to comply with the U.S. Pharmacopoeia-National Formulary (USP-NF) monograph. The company chose botanical specialist Alkemist Labs (California) to test the ingredient to confirm that it meets the USP monograph. We did two tests for Sabinsa s Shagandha Ashwagandha Root Extract 2.5% USP material an identity test by HPTLC and a quantitative test for Withanolides by HPLC confirmed Alkemist Labs CEO lan Sudberg. S The identity testing by HPTLC was performed to show that their material is consistent with Withania somnifera root. The quantitative testing for Withanolides compounds within ashwagandha by HPLC was performed to show the amount of withanolides in their Shagandha extract. This testing was to show that they meet their 2.5 percent withanolide specification they claim on this product. In both testing cases United States Pharmacopeia (USP) methods were used. Essentially the test showed Sabinsa s Shagandha extract is authentic ashwagandha. With ashwangandha sales growing in the double digits in recent years extra caution in sourcing becomes crucial to guard against the adulteration that often follows rapid growth in demand for an herb said Sabinsa founder Dr. Muhammed Majeed. Ensuring identity of the material and that it will meet our specification claims fits with our commitment to combating adulteration in the supply chain while assuring customers we provide quality ingredients. For more information visit www.sabinsa.com. Diana Food Debuts Line of Organic Color Solutions iana Food North America (New Jersey) announced the launch of a new line of organic colors for foods and beverages. These colors represent an extension of the company s existing coloring solutions. The colors are all non-GMO (genetically modified organism) USDA (U.S. Department of Agriculture)-certified organic and were created with natural integrity in mind. Kilgore noted that D 18 Nutrition Industry Executive the concept of natural is the foundational principle of the company that goes back to the very beginning. Diana Food s team of agronomists based in farming areas around the world works closely with local farmers and seed developers throughout the growing cycle to select the best available varieties for maximum color impact those with the most vibrant shade intensity the least color lost and least taste impact. In addition to providing a well-rounded sensory experience for the end consumer this careful sourcing also ensures full supply chain transparency and traceability guaranteeing food safety with ISO FSSC certifications. Diana can map its organic color products back to their farm of origin and can even offer single-ingredient labeling. For more information visit www.diana-food.com organic_colors. www.niemagazine.com April 2019 Seaweed Extract Reveals Anti-cancer Pathways ew research has uncovered the biological pathways by which a seaweed ingredient can combat cancer cells. The ingredient known as fucoidan is a bioactive compound naturally found in brown macroalage. Undertaken at the University of Tasmania the in-vitro research utilized Maritech fucoidan extracts produced by Australian biotechnology company Marinova. Brown seaweeds have a long history of use in complementary medicine with fucoidan in particular holding significance in integrative oncology. It is common for fucoidan-containing supplements and drinks to be administered to cancer patients in many Asian countries today. The anti-cancer effects of Maritech N fucoidan have been demonstrated in preclinical animal and in-vitro studies including reducing tumor growth and enhancing the therapeutic effect of chemotherapy. Yet the specific mechanism of action through which fucoidan promotes these benefits has remained unclear until now. In this latest study researchers identified that Maritech fucoidan beneficially affected a number of anticancer pathways. These include cell cycle arrest DNA damage RNA metabolism and protein synthesis. The findings indicate that fucoidan can limit cancer cells in their ability to make proteins utilize energy and repair damage to themselves. Importantly the research showed that Maritech fucoidan works selec- tively against cancer cells but not against normal healthy cells that were used as a control. This research further demonstrates the safety of fucoidan as an adjunct to cancer therapy. For more information visit www.marinova.com.au. PrimaVie Study Shows Benefits for Muscular Strength and Decreased Hydroxyproline atreon (New Jersey) announced the latest publication on patented PrimaVie shilajit showing benefits of PrimaVie supplementation on maintaining muscular strength and hydroxyproline levels in recreationally active men. This study marks the ninth clinical trial on PrimaVie and is published in the January 2019 edition of The Journal of the International Society of Sports Nutrition by researchers in sports nutrition from the University of Nebraska-Lincoln Dr. Joshua Keller and Dr. Terry Housh. PrimaVie shilajit expands on a rich history of use of shilajit in ayurveda by investing in modern science clinical efficacy and nutrient standardization to achieve a profile consisting of urolithins fulvic acid and micro-minerals. In addition GRAS (generally recognized as safe) affirmed PrimaVie is the only organic and Non-GMO (genetically modified organism) project verified shilajit extract on the market. This U.S.-based study conducted at The University of Nebraska-Lincoln was an eight-week randomized doubleblind placebo-controlled clinical trial to examine the impact of PrimaVie on fatigue-induced percent decline in strength and concentric peak torque and hydroxyproline levels. Subjects were all recreationally active healthy males randomized to receive PrimaVie at 500 mg day 250 mg day or a placebo. In summary the results of the study demonstrated that eight weeks of PrimaVie shilajit supplementation at 500 mg promoted the retention of muscular strength following the fatiguing protocol and decreased baseline hydroxyproline which is a marker for collagen degradation. This suggested that the group supplementing with 500 mg of PrimaVie shilajit was more resistant to fatigue and retained a greater level of maximal muscular strength. For more information visit www.natreoninc.com. N April 2019 www.niemagazine.com Go to www.niemagazine.com pinnaclelabs for info about this advertiser Nutrition Industry Executive 19 IngredientNews DuPont Unveils New Plant-based Protein Nuggets ith plant-based diets protein and healthy snacking as three burgeoning trends in the food and beverage industry DuPont Nutrition & Health (Missouri) has launched a solution for manufacturers of snacks cereals nutrition bars toppings and more. Six new plant protein nuggets from its SUPRO and TRUPRO product range offer options that feature more protein or less sodium than previous offerings in a broader array of formats and textures. Plant protein nuggets or crisps are extruded ingredients that are commonly used in nutrition bars snacks and cereals to increase protein content while delivering crispy crunchy texture. The new offerings include SUPRO NUGGETS 310 LS An oval- W shaped soy protein nugget offering 80 percent protein (dry basis) and less than 120 mg sodium per 100 g is ideal for applications with reduced sodium targets. DuPont also is expanding its popular SUPRO Soy Protein Nuggets with Cocoa range. These new products deliver 82 percent protein (dry basis) and are now offered in a greater variety of shapes and sizes. In applications like snack bars these nuggets resemble chocolate cookie bits flakes or chips. SUPRO NUGGETS 393 has an irregular flake-like appearance. SUPRO NUGGETS 385 is offered in a larger barrel shape. SUPRO NUGGETS 398 is offered in the traditional oval shape. Pea protein is an increasingly popular Study Shows Robuvit Improves Longlasting Symptoms of Mononucleosis ew research shows promising results for those suffering the troublesome fatigue malaise and swollen lymph nodes associated with infectious mononucleosis. Peer-reviewed research published in the journal Minerva Pediatrica shows that daily supplementation with the natural antioxidant Robuvit (distributed by New Jerseybased Horphag Research Inc.) can significantly shorten the duration of symptoms and improve the persistent fatigue associated with a mono diagnosis in just four weeks once fever subsides. Known as mono and the kissing disease infectious mononucleosis is highly contagious and most commonly transmitted through saliva sharing drinks or kissing someone who is infected. Epstein-Barr virus (EBV) is the most common cause of infectious mononucleosis yet other viruses can also cause this condition. Symptoms usually appear four to six weeks after infection with EBV may develop slowly and are known to last for weeks to several months following infection. Each of these participants tested positive for EBV indicating mono and began their standard management regimen which included healthy diet exercise and supplementation with small amounts of zinc and copper and supplementation with Robuvit. Researchers evaluated participant symptoms based on the Karnofsky Performance Scale Index (KPSI) which classifies patients according N 20 Nutrition Industry Executive plant-based protein source. It doesn t require allergen labeling allowing brand owners to appeal to consumers with those concerns. New DuPont pea protein nuggets derived from conventionally grown non-GM (genetically modified) yellow peas boast 70 percent protein (dry basis) and are now offered in a greater variety of shapes. TRUPRO 1670 pea protein nuggets have a firm texture and oval shape. TRUPRO 1673 pea protein nuggets are offered in an irregular flake-like shape that blends seamlessly in formulations with high grain nut or seed content. For more information visit www.dupontnutritionandhealth.com. Ingredion Launches VITESSENCE Pulse 1803 Organic Pea Protein Isolate llinois-based Ingredion Incorporated announced a new certified-organic addition to its line of plant-based proteins for the U.S. and Canada VITESSENCE Pulse 1803 organic pea protein isolate. The isolate provides key formulation functionality while helping manufacturers create in-demand highprotein products that support consumerdesired claims. VITESSENCE Pulse 1803 organic pea protein isolate can be used to formulate a broad range of protein-rich products in a variety of on-trend categories including nutrition and sports bars alternative meat and alternative dairy products powdered and RTD (ready-todrink) beverages and better-for-you baked goods and baking mixes. Ingredion s proprietary research has shown that VITESSENCE Pulse 1803 organic pea protein isolate offers formulators excellent solubility emulsification and water and oil-holding capacity. The sensory profile of Ingredion s organic pea protein isolate is characterized by a smooth creamy texture and a flavor that is lower in raw and green notes than other plant-based solutions. These sensory and formulation characteristics make it a preferred and versatile choice in a variety of plant based products. For more information visit www.ingredion.us. I to their functional impairment and fatigue. Participants in the Robuvit test group supplemented with 300 mg of Robuvit daily for four weeks and reported improvements in most major symptoms of mono including 87 percent of participants reported were free of mono-related fatigue (vs. 69 percent in the control group) 92 percent of participants were free of malaise (vs. 73 percent in the control group) 92 percent of participants were free of long-lasting symptoms (vs. 65 percent in the control group) 62 percent of participants tested negative for swollen nodes in ultrasound exams (vs. 38 percent in the control group) In the study those who supplemented with Robuvit shortened their absence from work or school as a result of their mono illness by 4.2 days compared to the control group which missed seven days on average. Moreover researchers found that oxidative stress levels in the Robuvit test group were normalized in 83 percent of the participants. For more information visit www.robuvit.com. www.niemagazine.com April 2019 AlphaSize A-GPC Earns IGEN Verification as Non-GMO Ingredient hemi Nutra (Texas) announced that its branded patented research validated full GRAS (generally recognized as safe) AlphaSize Alpha-Glyceryl Phosphoryl Choline (A-GPC) has received The International GMO (genetically modified organism) Evaluation and Notification Program (IGEN) verification. We selected the IGEN program because we were very impressed with the testing integrity this organization provides and stands behind and verification assures our customers that our specialty AlphaSize A-GPC ingredient products have been thoroughly tested by a certified third party and that our cus- C tomers as well as final consumers can be assured of our complete transparency demonstrating the lack of GMOs said Scott Hagerman president of Chemi Nutra. AlphaSize A-GPC specialty ingredient products are 100 percent natural (not synthetic) 100 percent water soluble tasteless and odorless and extremely stable and nonreactive and are widely used in dietary supplements sports nutritional and healthy aging finished products as well as in beverage shots bars chewing gum and gummies in conventional foods and pet supplements. Unlike synthetic generic A-GPC can be manufactured using genotoxic raw materials and is likely not a legal supplement under the current regulations of DSHEA (Dietary Supplement Health and Education Act of 1994) and AlphaSize A-GPC in contract is 100 percent natural and no synthetic chemicals are used in its manufacture. In addition it is the only branded A-GPC whose GRAS dossier was submitted to FDA (U.S. Food and Drug Administration) for review and it has been evaluated in dozens of published human studies in providing a variety of profound mental and physical performance benefits. For more information visit www.cheminutra.com. Lycored Secures U.S. Patent for Omega-3 Compositions Lonza Launches Oceanix for Performance and Recovery ycored announced that it has been granted a U.S. patent for its omega-3 compositions. This new patent is a composition comprising of omega-3 fatty acid with a tomato extract lycopene or Lycomato and optionally with carnosic acid and or lutein wherein said combination has been found to be synergistic in balancing general inflammatory processes in the human body. Specifically the compositions could be used to inhibit inflammatory markers by suppressing anti-inflammatory mediators or the secretion of anti-inflammatory mediators from macrophages at a given site. For more information visit www.lycored.com. onza (New Jersey) has announced the launch of its new performance nutrition brand Oceanix in the U.S. and Canada. The phytoplankton ingredient is sustainably sourced from the ocean and meets rising demand for natural non-GMO (genetically modified organism) and vegan supplement products. Containing highly active antioxidant enzymes including superoxide dismutase (SOD) as well as essential fatty acids vitamins amino acids and minerals the Oceanix ingredient offers potential benefits for physical performance and an increased physiological response against oxidative stress to aid recovery in a small concentrated dose. Produced using patent-protected technology the Oceanix brand is suitable for use in a variety of sports nutrition applications including dietary supplements bars drinks and powders. For more information visit www.lonza.com. L L Study Shows Fenugreek Extract Benefits Men s Strength and Endurance new study shows that Trigonella foenum-graecum Californiabased Gencor s unique extract of fenugreek known as Testofen increases strength aerobic endurance and lean body mass in healthy exercising men. Fenugreek is an annual plant in the Fabaceae family and both the leaves and seed are commonly used in various health applications. Fenugreek is frequently associated with increased levels of free testosterone and associated anabolic effects. However this study aimed A April 2019 www.niemagazine.com to examine changes in lean body mass fat mass upper and lower body muscular strength and endurance in response to an eight-week resistance training program with and without daily supplementation of the fenugreek extract Testofen. The double-blind randomized doseresponse clinical trial of eight-weeks was conducted at RDC Global with 138 healthy non-smoking male participants. The findings suggest that Testofen is both effective and acts in a dose- response manner. It concluded that Testofen at a 600 mg per day dose in conjunction with an effective exercise regime has superior positive effects in leg strength aerobic capacity and body composition compared with placebo and a 300 mg per day dose. For more information visit www.gencorpacific.com. Nutrition Industry Executive 21 CRNUpdate Industry Embraces Transparency and Science With Updates to the Supplement Facts Label How CRN Can Help You be Label Wise By Brian Wommack Senior Vice President Communications CRN magine a consumer looking at two similar bottles of a favorite dietary supplement. The bottles look nearly identical. Same product name same manufacturer name same strength and dose information. But when the consumer scrutinizes the supplement facts label each bottle has slightly different information listed. How can this be Which one is right As a member of this industry would you be able to advise this hypothetical consumer Are you aware of what s going on that could cause this hypothetical situation to become all too real Maybe you remember something about the supplement facts label changing but you don t quite remember the phase-in dates. That s fair they ve changed several times. But it s time to key in on the changes and to think about how best to inform consumers about what s going on and to reassure them that this is an expected and welcome improvement in transparency. The most noticeable changes will be in the new percent daily values (DVs) for certain nutrients. These will be updated to reflect the latest in nutrition science and how American diets have changed over the years. For a product that has not been reformulated DVs will change on all nutrients for which new DVs have been established. In some cases products may have been reformulated so that they will continue to provide 100 percent of a DV even if the DV has changed. In some cases the change in DV could appear to be dramatic. For instance the DV for biotin has decreased from 300 mcg to 30 mcg. Therefore if a product previously provided 100 percent of the daily value for biotin and was not reformulated it will now be listed as providing 1 000 percent of the DV on the new label. Other changes will occur in the units of measure. For instance for vitamins A D and E the measure will change from international units (or IU) to more common measures of mil- I 22 Nutrition Industry Executive ligrams and micrograms. While this will require a bit of adjustment from what consumers are used to seeing this should in the long run provide more clarity since these measures are relatable beyond the world of nutrition. Folic acid one of the most important nutrients before and during pregnancy will now be listed as folate and measured in micrograms of dietary folate equivalent or DFEs. The list of nutrients considered under-consumed by Americans has also been updated based on new understanding of requirements and American dietary habits. Calcium potassium dietary fiber and vitamin D are all now considered nutrients of public health concern and will be required on labels. Potassium and vitamin D are newly added to the list. Vitamins A and C have dropped off of the list of under-consumed nutrients and are no longer mandatory on the label. Finally if sugar is added to a product the amount and percent DV will be listed on the label as well. All of these changes are coming to better provide consumers the information they need to make informed choices about their health. These labels have not been updated in many years and it is well beyond time for a refresh. Comply Dates Because the dates for compliance have been changed several times some manufacturers are already complying with the new regulations. But for manufacturers with 10 million or more in sales they aren t required to comply until Jan. 1 2020. And for smaller manufacturers the compliance date is Jan. 1 2021. The compliance date is tied to the date the label is placed on the product not the date that the product appears in stores. So depending on supply chains and quickness of product turnover old labels will appear for a while even after these compliance dates. And as noted in the opening hypothetical it is possible that both an old and a new label could appear on shelves at the same time. When consumers understand the reasons for the change they will recognize that this is just another example of a regulated industry following along with the newest rules put out by a vigilant FDA (U.S. Food and Drug Administration). How can you help consumers become more informed The Council for Responsible Nutrition (CRN) has created a whole suite of materials to educate consumers. A short explainer video a fact sheet and an infographic are all available at belabelwise.org. These resources are free for the taking for members of industry to use not only with their consumers but also with retailers and health care practitioners. CRN hopes that industry will adopt these tools make them their own and share them widely as they communicate with consumers about these changes. After all it is in everyone s interest that we understand and are able to explain these important improvements in the dietary supplement facts panel. So go ahead commit to consumer label literacy and be Label Wise Brian Wommack is the senior vice president communications of the Council for Responsible Nutrition (CRN) a leading trade association for the dietary supplement and functional food industry. www.niemagazine.com April 2019 AssociationNews UNPA Signs Memorandum of Understanding With NASC he United Natural Products Alliance (UNPA) has signed a memorandum of understanding (MOU) agreement with the National Animal Supplement Council (NASC) in an effort to advance the beneficial use of nutritional dietary supplements and dosageform animal health products both nationally and internationally. As part of the agreement the two organizations will cooperate to advance the state of animal health products supplements and food regulation safety and quality standards consumer use and confidence of such products and the establishment of appropriate compliance requirements. Additionally UNPA and NASC plan to cooperate to further develop the Chinese marketplace for animal health products and supplements. We see the companion animal health products category as a vital and growing sector of the natural products industry said Loren Israelsen UNPA president. We have long respected the T work that Bill Bookout and his team at NASC have been doing and felt the timing was right to formalize a relationship with this leading organization. Our partnership can go a long way toward the responsible and sustainable growth of the animal health products and supplements market backed with solid science and standards for quality. In addition UNPA will act as the pipeline for NASC member companies to enter the Chinese market. We could not be more excited about the collaborative relationship with UNPA added Bill Bookout NASC president. Loren is one of the most respected members of the industry and the focus of UNPA has always been one of quality and responsibility with the ultimate objective of increasing consumer confidence. Ultimately our organizations are dedicated to helping our members maximize the opportunities to make a difference in the lives of both people and animals while always looking toward the global marketplace. With new and dynamic developments in China we think UNPA is a great partner to leverage our core strengths which holds great promise for both organizations. The NASC MOU joins 22 other partnerships that UNPA has signed with U.S. and international trade and non-profit organizations academic institutions and other groups that bring expertise influence and trusted reputations. By laying out its joint objectives via an MOU UNPA is able to serve the needs of its members and its industry stakeholders with greatest effect and efficiency. For more information visit www.unpa.com mou-partners.html. NPA Announces Dates for 2019 Big Natural and Natural Products Day he industry will gather in the Washington D.C. area for the third installment of the Natural Products Association s (NPA) official event The Big Natural on Sept. 1112 2019. The two-day event will take place at the MGM National Harbor and will coincide with NPA s annual Natural Products Day advocacy event on Capitol Hill on Sept. 10. If you re interested in meeting with the biggest power players in Washington D.C. and the most influential leaders in the natural products industry this event is for you said Daniel Fabricant PhD president and CEO of NPA. We are lining up hundreds of meetings with members of Congress and the Administration along with a great program of speakers and briefings. The Big Natural will attract the type of industry leaders this new Congress needs to hear from and we are excited to bring it to our nation s Capital. This is the only event in the industry where people T April 2019 www.niemagazine.com can make a direct investment back into the industry with 100 percent of profit going directly to education and advocacy initiatives. Offering two days of industry-driven educational sessions workshop programming case studies and interactive discussions. In addition there will be ample time for networking and benchmarking. The Big Natural will bring together industry leaders innovators and government officials who will share insights that will educate empower and spark innovative ideas to drive the industry forward. Industry-specific educational sessions address attendees most pressing business and regulatory concerns as an industry Executive-level speakers who will provide in-depth discussion of realworld challenges issues as well as practical lessons you can take back to your company and implement across your operations Focus on business innovation finance investment and global market opportunities relevant to the natural products space Breakout sessions that will explore discrete issues faced by business unit and department heads spanning regulatory compliance legal marketing and business functions Open to both NPA members and non-members The Big Natural will attract a diverse cross-section of senior executives spanning the Csuite as well as department leadership within the retail cpg natural health foods supplements and investment sectors with budget and or human capital responsibility. For more information visit www.thebignatural.com. Nutrition Industry Executive 23 AssociationNews GPA Welcomes Six New Members he Global Prebiotic Association (GPA) recently announced six new members including the expansion of its Executive Board. The new board members join Deerland Enzymes and Prenexus Health on the executive leadership team that stewards the organization. We are excited to welcome these new member companies strengthening and adding depth to GPA s membership base and expanding our ability to guide category growth said Len Monheit executive director GPA. This enhances the prebiotic ingredient set we represent adding providers of inulin pectin and pectic oligosaccharides IMO and resistant starch. T New Executive Board Members CP Kelco Intrinsic Organics As a premium ingredients manufacturer focused on enabling our customers to identify and leverage nutritious clean label solutions we are thrilled to be a part of the GPA said Jennifer Mason senior vice president innovation CP Kelco (Atlanta GA). We believe the future of human health will be addressed through nutrition and the microbiome. Many of our products can enable the use of prebiotics in finished goods and some like pectin have benefits in and of themselves. We are committed to helping the GPA further the science and research in this very important area. We are very excited to join the GPA Executive Board. We believe that by joining our efforts with other respected GPA member companies that we can influence guide and expand the market we serve and ultimately help improve the health of our customers added Kyle Griffiths chief marketing officer Intrinsic Organics (Weiser ID). New Members BioNeutra Top Health Ingredients New Associate Members Atlantia Food Clinical Trials MSPrebiotics For more information visit www.prebioticassociation.org. BAPP Publishes Grape Seed Extract Laboratory Guidance Document he ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) has announced the publication of a new laboratory guidance document (LGD) on grape seed extract (GSE). The new guidance document is the 50th peer-reviewed publication from the program. Extracts from the seeds of grapes (Vitis vinifera) have been shown to improve parameters related to cardiovascular health in human clinical trials. Despite promising results in clinical studies GSE dietary supplements are not among the 40 top-selling botanical dietary supplement ingredient in the U.S. (natural food stores drug stores grocery stores etc.) according to the latest American Botanical Council (ABC) HerbalGram herb market report for 2017. Grape seeds are a rich source of proanthocyanidins (PACs) to which many of the commercially available bulk ingredients are standardized. Despite the relative low cost of grape seeds as a byproduct of the juice and wine industries PACs from other plant species are available as economic adulterants. These include for example PACs derived from peanut (Arachis hypogaea) skin or from Masson pine (Pinus massoniana) bark. The availability of these lower-cost T 24 Nutrition Industry Executive PACs combined with the difficulties in unambiguously identifying the source material of PAC-rich extracts has made it easier for GSE adulteration to occur for financial gain of dishonest suppliers. The intricate chemical challenges in the determination of grape seed as the origin of GSE are manifold. Routine analytical methods using chromatography (e.g. high-performance liquid chromatography HPLC) are generally not suitable to separate the larger PAC molecules. High-resolution mass spectrometry (MS) is useful to determine the molecular weight distribution of PACs but such instrumentation is not available in many industry quality control laboratories. Further genetic methods (DNA testing) may not be successful because of the extensive processing leading to DNA fragmentation and the interference of PAC-rich extracts with enzymatic processes such as the poly- merase chain reaction. The new LGD was written by Steve A. Kupina and Mark A. Kelm PhD directors of quality and technology and research and development respectively at botanical ingredient manufacturer Polyphenolics Maria J. Monagas PhD scientific liaison for dietary supplements and herbal medicines at the U.S. Pharmacopeial (USP) Convention and Stefan Gafner PhD chief science officer of ABC and the technical director of BAPP. The LGD provides an evaluation of the usefulness of published analytical methods to detect GSE adulteration and summarizes the main advantages and disadvantages of each method regarding its suitability for use in a quality control laboratory. In addition to the assessment of the analytical methods the document details the chemical composition of grape seed potential confounding species and known adulterants. The GSE LGD has been peer-reviewed by 25 international experts from third-party contract analytical laboratories and the herbal industry. For more information visit http cms.herbalgram.org BAP LGD GrapeSeedExtractLGD.html ts 15536 94205&signature e8aad6be75e8e1fd 6f9a03a8cb400bac. www.niemagazine.com April 2019 AHPA Awards Excellence in the Herbal Industry he American Herbal Products Association (AHPA) presented its 2019 awards to individuals and an organization that have made significant contributions to the continued success of the herbal products industry at AHPA s Annual Member meeting on March 6 at Natural Products Expo West in Anaheim CA. T 2019 AHPA Awards Industry Pioneer Award Sara Katz Herb Pharm Herbal Hero Award Steven Yeager Mountain Rose Herbs Herbal Industry Leadership Award Oregon s Wild Harvest Herbal Insight Award Kelly Kindscher PhD University of Kansas Super Natural Award Mark Blumenthal American Botanical Council Established in 2006 the annual AHPA Awards acknowledge individuals and organizations that help further AHPA s goal of promoting the responsible commerce of herbs and herbal products. Every year AHPA recognizes the hard work and dedication of individuals and organizations that go above and beyond to ensure the continued success of the herbal industry. AHPA and the entire herbal products industry have greatly benefited from their expertise and passion for herbs said AHPA President Michael McGuffin. These awards are a small token of our gratitude for their tireless efforts. For more information visit www.ahpa.org. ABC Celebrates 14th Annual Botanical Celebration t the American Botanical Council s (ABC) 14th Annual ABC Botanical Celebration and Awards Ceremony on March 5 2019 in Anaheim CA the association presented a number of awards. The event for ABC Sponsor Members occurred during the Natural Products Expo West. Aviva Romm MD a midwife herbalist author and Yale-trained physician who is a recognized expert in botanical medicine received the second annual ABC Fredi Kronenberg Award for Excellence in Research and Education in Botanicals for Women s Health. The ABC Mark Blumenthal Herbal Community Builder Award was presented to Linnea and Larry Wardwell a husband and wife team who have been organizing and promoting herb conferences for more than 25 years. Professor Otto Sticher PhD was presented the ABC Norman R. Farnsworth Excellence in Botanical Research Award. A pharmacist pharmacognosist and natural products chemist from A Switzerland Sticher has spent five decades investigating the quality composition and benefits of medicinal plants. Jim Emme CEO of NOW Health Group was honored as the 2018 ABC Champion in recognition of his support of the organization and other non-profit groups focused on the natural products industry. The 2018 ABC James A. Duke Excellence in Botanical Literature Award was presented to Ethnopharmacologic Search for Psychoactive Drugs 50 Years of Research Volumes I and II (ESPD50). This text edited by Dennis J. McKenna PhD and published by Synergetic Press compiles the proceedings from the first ESPD sympo- sium in 1967 and the 50th anniversary symposium in 2017 and contains papers from some of the most well-known and wellregarded experts in the field. Cambridge England-based GW Pharmaceuticals was awarded the Varro E. Tyler Commercial Investment in Phytomedicinal Research Award. Founded in 1998 the company s focus is to bring novel cannabinoid-based prescription medicines to patients in areas of serious unmet need and in which our medicines have the potential to make a real difference to their quality of life according to its website. GW has a U.S. subsidiary Greenwich Biosciences based in California. For more information visit www.herbalgram.org. NPA Demands FDA Action on CBDs he Natural Products Association (NPA) recently submitted comments to the U.S. Food and Drug Administration (FDA) on cannabidiol (CBD). Outgoing FDA Commissioner Scott Gottlieb stated in public comments in February that the agency would hold a public meeting in April to hear from Congress and other stakeholders about its approach to T April 2019 www.niemagazine.com regulating CBD products. The date has not been confirmed. We urge the FDA to schedule a meeting at the earliest possible opportunity to discuss its enforcement strategy for CBD said Daniel Fabricant PhD president and CEO of NPA. (At press time a meeting date had not been announced.) This issue deserves attention and we look for- ward to sharing our views with the agency. According to a recent report issued by New Frontier Data the U.S. CBD industry grew by nearly 40 percent in 2017 reaching 367 million in annual sales across hemp-derived and marijuana-derived markets. For more information visit www.npanational.org. Nutrition Industry Executive 25 Pondering Cognitive Support Young adults are having more senior moments than ever. Stress constant mental and physical activity plus poor diet and sleep-deprived lifestyles necessitate a well-rounded brain-support supplement. By Lisa Schofield T hink about it who doesn t enjoy learning something new There s a momentary flush of self-confidence when the aha hits. It s a great feeling. On the flip side when we forget simple things like where we placed our cellphones or keys or the name of the artist that sang that song we loved in high school or that word we know we know the frustration level skyrockets. And of course these moments do not signify that there s any brain disorder or disease but that we can improve cognitive function and memory through lifestyle modifications and dietary supplements. Shoji Matsukawa chemical engineer for the New York-based Mitsubishi Gas Chemical USA explained the difference between cognition and memory cognition is the mental action or process of 26 Nutrition Industry Executive acquiring knowledge and understanding through thought experience and the senses. Memory is the way the mind stores and remembers information. There are four different types of memory implicit semantic episodic and working. Working memory is one s shortterm memory which includes the ability to recall relevant information in the middle of an activity. This overlaps with cognition the creation of knowledge and thought as they occur simultaneously he said. As we age mitochondrial efficiency decreases communication between neurons diminishes and parts of the brain shrink as much as 25 percent by age 80 he added. As more people become aware of potential for cognitive decline and memory malfunction this category has blossomed. Elyse Lovett MS MBA senior market- ing manager for Kyowa Hakko USA New York has noticed a shift in the cognitive support supplement market with a new demographic emerging over the past five years gearing toward the Millennials and Generation X. This demographic is looking for benefits in focus attention and concentration as there are increases in stress levels in this demographic. The cognitive support supplement market has been growing steadily over the past decade due to the global aging of the population more than 2.1 billion people worldwide will be over the age of 65 in 2050 pointed out Stephanie Prestesacque category director Consumer Health at Diana Food (New Jersey). She added that in a recent study presented at SupplySide West by Natural Marketing Institute analyst Steve French asserted that losing mental capacity is www.niemagazine.com April 2019 Go to www.niemagazine.com aidp for info about this advertiser Pondering Cognitive Support the top health concern across all age groups. Interestingly over the past 10 years cognition and brain health have emerged as the top health concerns for younger people. As a result the market of supplements has broadened the offer to include new products for mental focus stress management and stamina she commented. Aging Baby Boomers are often targeted for cognitive products but more and more Millennials are seeking effective products that support better focus and cognitive mental energy without the jitters or crash associated with caffeine intake observed Mallory Junggren senior director of marketing Nutrition 21 LLC of New York. This uptick in interest in cognitive products by younger consumer demographics is part of an increasing focus on active nutrition she reported. Andrew Wheeler vice president of marketing FutureCeuticals and Van Drunen Farms Illinois said he sees everyone from Millennials and Generation Z-ers to seniors are seeking cognitive health support today. And athletes are also realizing that the performance wall they hit has a cognitive component to it. Despite that younger and middleaged adults are seeking cognitive support for mental performance boosting they are also mindful and fearful of developing dementia type illnesses as they get older pointed out Richard Kozlenko DPM MPH PhD scientific advisor for California-based GCI Nutrients. One of the huge forces is the growing attention fear and anxiety to the epidemic impact of Alzheimer s disease which is terrifying and financially devastating to families. The sense of vulnerability and importance of preserving and protecting our cognitive skills dipped deeper into younger populations. Kim Colletti MBA global product manager-brain health Kemin Foods agreed that there is growing interest among younger healthy adults in natural cognitive-function-enhancing ingredients that help improve focus and also boosts physical performance. Whether it s a 28 Nutrition Industry Executive young professional juggling work home and the gym a gamer wanting a competitive edge for virtual reality play or an athlete focusing on achieving top mental and physical performance consumers are looking for that extra edge and supplementation can be a healthy option. Overall consumers are interested in cognition with their No. 1 concern being staying mentally sharp. She added that research suggests that peak performance in several domains of cognition typically occurs as early as one s 20s. Therefore she emphasized formulators may want to concentrate on offering a more natural and gradual approach rather than a quick fix. In the sector observed Prestesacque while the field of memory improvement remains dominant new products like focus and attention have also been a key trend for sports nutrition and performance (all ages). More specifically observed Kozlenko the cognitive brain health performance category is featuring products to help protect DNA brain and neuron lipoprotein membrane fluidity enhance mitochondrial function improve micro vessel elasticity reduce homocysteine levels support brain chemical and neurohormones improve synaptic functioning support brain nutrition optimize the relationship of microbiome and brain health as well as support and replenish the endocannabinoid system (ECS). According to Junggren cognitive products on the market can largely be divided into either a stimulant or nonstimulant. The different aspects of cognitive functioning these products provide include increased energy levels improved mental acuity and focus and heightened executive functioning. Many energy-stimulating ingredients such as caffeine bitter orange and guarana have been shown to increase heart rate blood pressure insomnia nervousness and restlessness she commented. As a result many consumers are beginning to seek non-stimulant options that can naturally boost energy and focus for an extended period without the caffeine jitters or crash. Ruminating Ingredients nootropics with promises around mental focus resistance to stress creativity and motivation are becoming more sought after. Millennials students business executives and working mothers are interested in supplements and performance beverages bars that will help them cope with busy and stressful lifestyles within which is an emerging trend in dietary supplements designed for egamers who are looking for concentration and mental stamina she described. In agreement is Inger Larsen director of North America sales Oxford U.K.based Sibelius Natural Products who noted Young adults are more likely to need to multi-task and perform at a more constant level than previous generations. Performance enhancement for jobs and activities are a key area of interest for young adults. In addition When deciding to formulate new generation brain cognitive support products there are many safe and effective ingredients that are available. Cerebelle from Diana Foods is a proprietary blend of extracts made from two potent polyphenol-rich fruits and according to Prestesacque it has been clinically shown to prevent age-related cognitive decline in healthy older adults. The extracts of grape and wild blueberry have also been thoroughly studied to exert positive impact on cognition. The double-blind randomized placebo-controlled study recently published in the Journals of Gerontology by researchers from the Canada-based Institute of Nutrition and Functional Foods (INAF) and the University of Bordeaux France showed that Cerebelle improved the memory of healthy older adults she reported. Specifically in the study 215 healthy older adults from 60 to 70 years of age received either a placebo or 600 mg of Cerebelle daily for 24 weeks. Individuals in both groups performed a series of cognitive tests designed to assess www.niemagazine.com April 2019 Go to www.niemagazine.com gcinutrients for info about this advertiser Pondering Cognitive Support visuospatial learning and episodic memory (Paired Associate Learning PAL) verbal episodic and recognition memory (VRM) and working memory (SSP). Supplementation with Cerebelle according to the researchers improved VRM free recall across the whole cohort. It was further noted that within a subgroup with mild cognitive impairment at baseline six-month supplementation with Cerebelle showed improvements in both PAL and VRM. These results infer that Cerebelle improves verbal memory in healthy elderly people. The study also demonstrated that it improves visuospatial memory or the ability to recall previous events emotions and places in healthy senior people with a lower level of memory performance at baseline summarized Prestesacque. Sibelius sage is a botanical supplement that said Larsen acts on multiple aspects of cognitive function including specific aspects of memory attention anxiolytic and general aspects of inflammation and anti-oxidant. While Salvia officinalis has been used for more than two millennia for general cognitive support we have proven (biochemical in vitro and in vivo trials) that the phytochemical profile and activity of Sibelius sage is unique when compared to other Salvia officinalis varietals she said. Futureceuticals NeuroFactor derived from the whole coffee fruit is clinically shown to significantly increase levels of a key neuroprotein (BDNF) vital to learning memory and higher thinking Wheeler described. NeuroFactor contains a unique profile of polyphenols that have been shown in clinical study to stimulate the production of BDNF (brain-derived neurotrophic factor) a key neuroprotein involved in overall brain health. BDNF has been widely reported to play a critical role in neuronal development maintenance repair and protection against neuro-degeneration. Futureceuticals will be coming out with some exciting functional news in this regard this year that s the gold standard functional outcomes in human subjects he revealed. This cognitive space has lacked that up until this point 30 Nutrition Industry Executive so this is an exciting time for science geeks like us. It s great to see the mouse complete a maze but to document human cognitive improvement is where it s really at he emphasized. Kemin Foods Neumentix is a waterextracted naturally-sourced nootropic that is derived from a patented line of spearmint bred for high polyphenols specifically rosmarinic acid which has demonstrated brain benefits according to Colletti. The nootropic benefits from a recent Neumentix clinical study were sustained over a long period of time improved attention and reactive agility were observed at 30 days and were still present at 90 days she reported. PQQ (pyrroloquinoline quinone) is an ingredient gaining interest as a dietary supplement and nutra-food ingredient geared toward cognitive support. Neumentix has three intervention studies as well as preclinical mechanism of action safety and plant characterization studies supporting its positioning as a cognitive performance ingredient. Colletti noted that the research supports cognitive performance claims such as improves working memory improves short term memory supports sustained attention and focus as well as supports physical agility and choice reaction performance with continued use when taken as recommended. In a recent randomized placebo-controlled double-blind study with 142 young healthy and active women and men Colletti described Neumentix supplementation was shown to improve sustained attention in young healthy adults. These statistically significant effects compared to placebo were observed as early as 30 days following daily supplementation with 900 mg of Neumentix and these significant improvements were still present after 90 days of supplementation. Therefore Neumentix is great solution for consumers looking for an ingredient that works more naturally and over time to support working memory sustained attention and focus without disrupting sleep she commented. Kemin Foods FloraGlo Lutein has been more widely known for its visionsupport capabilities for the better part of two decades but its cognitive support-promoting abilities has emerged according to Ceci Snyder MS RD global vision product manager. Specifically she reported FloraGLO Lutein now has four randomized double-blind placebocontrolled trials to support its use in brain supplements with three new studies just in the last year. For formulators looking for strong support of brain ingredients the new studies show how FloraGLO Lutein and R R -zeaxanthin support blood flow to specific brain regions enhance neural activation support complex attention and cognitive flexibility improve visual memory and (with increased macular pigment optical density) reasoning ability she described. When looking at the observational data on lutein she added some of the more compelling new research reveals the relationship between macular pigment optical density (MPOD) which is a measure of lutein zeaxanthin status in the eye and outcomes in children. Associations have been seen between MPOD and cognitive performance memory and academic achievement in children. In Hassevoort et al. children with higher MPOD made fewer errors while reconstructing previously studied spatial layouts indicating that MPOD was related to greater relational memory performance. PQQ (pyrroloquinoline quinone) is an ingredient gaining interest as a dietary supplement and nutra-food ingredient geared toward cognitive support. And according to Kozlenko while only discovered about 50 years ago researchers have been exploring its benefits in brain health. PQQ (and GCI Nutrients PQQSure) has recently been found to increase the formation of new nerve cells. In addition researchers have found that PQQ can promote growth of new mitochondria This is an important longevity strategy that can help prevent www.niemagazine.com April 2019 Go to www.niemagazine.com kyowa for info about this advertiser Pondering Cognitive Support the diseases of aging. During the life span the brain suffers from multiple sources of damage he explained. As these effects accumulate the development of neurodegenerative disorders can result as well as the risk of stroke from progressive injury to brain blood vessels. Brain trauma is yet another way that the delicate microstructure of brain cells is disrupted leading to loss of cognition and function. PQQ has been found to help guard the brain against these major insults he said. Researchers are uncovering how PQQ functions as a neuroprotective agent that can help protect memory and cognition. Mitsubishi Gas Chemical s BioPQQ is a natural source of pyrroloquinoline quinone created using a patented fermentation process according to Matsukawa who explained that BioPQQ supports cognitive health by promoting nerve growth factor in the brain as well as the creation of mitochondria the energy furnace in cells. BioPQQ also has robust antioxidant effects that potentially protect neurons susceptible to lethal damage from oxidative stress. Matsukawa described one human clinical study which found that taking BioPQQ for eight weeks may reduce confusion anxiety and depression and improve vigor. Other studies suggest that taking BioPQQ for 24 weeks may increase memory recall reverse the decline in cognitive function and improve other higher brain functions like spatial awareness it also has the potential to improve working memory such as learning reasoning and comprehension. BioPQQ he added has been successfully filed as a new dietary ingredient (NDI) with the FDA (U.S. Food and Drug Adminsitration) is GRAS (generally recognized as safe) and has earned Informed-Choice and Informed-Sport certification. Additionally it is newly listed on the European Union s list of Novel Food Ingredients and marketed under its European sister-brand name MGCPQQ. Nutrition 21 LLC s Nitrosigine complex bonds arginine and silicon and is 32 Nutrition Industry Executive stabilized by inositol and has been shown in a study to significantly increase nitric oxide production over arginine AKG agmatine sulfate citrulline malate L-arginine and citrulline according to James Komorowski chief science officer. High levels of nitric oxide lead to better blood flow which accelerates transport of nutrients and glucose to the brain this increase in nitric oxide levels is the proposed mechanism of action for how Nitrosigine significantly boosts cognitive function he asserted. Recent clinical data on Nitrosigine has shown it can enhance mental flexibility processing speed executive functioning mental focus and acuity before and after workouts. Komorowski reported that results from a randomized doubleblind placebo-controlled crossover clin- ical trial demonstrated that Nitrosigine prevents the decline in cognitive function that can be seen following strenuous exercise. This clinical study utilized the Trail Making Test (TMT) which is a widely used instrument designed to assess cognitive processing speed and executive functioning. In the study participants took either Nitrosigine or placebo and the TMT was used to measure cognitive function prior to dosing and immediately after intense exercise at increasing workloads until exhaustion. According to Komorowski results showed that Nitrosigine significantly improved cognitive function parameters of mental acuity focus and processing speed after exercise when compared to placebo. Specifically results showed that Nitrosigine prevented the exerciseinduced cognitive function decline of 51 percent seen in the placebo group. A post-hoc analysis of a separate clinical study which also utilized a TMT showed that after taking just a single dose of Nitrosigine subjects demonstrated significantly improved cognitive flexibility measured by the TMT B-A score he elaborated. Further additional new clinical study results show that Nitrosigine inhibits the metabolic pathway that catabolizes arginine thereby enhancing arginine bioavailability Komorowski added. The study also shows that Nitrosigine decreases levels of arginase an enzyme that impedes nitric oxide production by limiting arginine availability. This is especially noteworthy because arginine as an ingredient itself or when converted from citrulline is highly susceptible to being broken down by arginase while Nitrosigine is not he clarified. Kyowa Hakko s Cognizin Citicoline Lovett described is a potent brain health nutrient found naturally in the body. Cognizin is made by a innovative fermentation process to yield high quality and purity and is backed by research studies to support focus attention and mental energy. Cognizin is GRAS nonGMO (genetically modified organism) stable and soluble so really great for any delivery form. Of course there are other ingredients shown to be beneficial for cognitive support such as vinpocetine and ginkgo. But the opportunities to be successful with brain-support products for younger adults continue to be vast. Life is busier than ever and the demands placed upon adults today require more cognitive acuity and output for a longer duration. NIE Extra Extra Visit www.niemagazine.com to read a study about how mushrooms may benefit cognitive function. FORMOREINFORMATION Diana Food www.diana-food.com cerebelle Futureceuticals www.futureceuticals.com GCI Nutrients www.gcinutrients.com Kemin Foods www.kemin.com health Kyowa Hakko www.kyowa-usa.com Mitsubishi Gas Chemical USA www.biopqq.com Nutrition 21 www.nutrition21.com Sibelius Natural Products www.sibeliusnaturalproducts.com www.niemagazine.com April 2019 A Well-oiled BMJ Machine Bone muscle and joint (BMJ) issues look to disrupt the body but the latest ingredient innovations look to do otherwise. By Nicholas Saraceno Y ou may have heard it many times before but the human body is a well-oiled machine. Of course that is what it should be. From a general perspective proper body maintenance is easier said than done. It is no secret that the organs must work in unison for ideal living even exteriorly the body has to deal with the combination of constant wear-and-tear and long-term effects of damage to one s bones muscles and joints. One particular condition that comes to mind regarding the joints is arthritis. According to the Arthritis Foundation it is the leading cause of disability among U.S. adults the foundation estimates that approximately 54 million adults have arthritis that has been diagnosed by a doctor. More so by the year 2040 this amount is expected to jump to 78.4 million making it more than 25 percent of all adults in the country. There is no doubt that tackling bone muscle and joint health sits high atop ingredients suppliers and manufacturers priority list innovation and research has helped this field continue to strengthen April 2019 www.niemagazine.com over the years. Trending Ingredients The bone-muscle-joint category has a variety of usual players starting with collagen. According to Vincent Hackel CEO of California-based Guzen Development which offers SCP-II (salmon collagen proteoglycan complex) undenatured proteoglycan is beginning to catch fire. It is already being used in Japan and is anticipated to emerge in the U.S. alongside side undenatured type II collagen. Collagen is considered one of the most versatile and important ingredients in modern health & nutrition markets including in functional foods said Heather Arment marketing coordinator (North America) GELITA who has a local location in Iowa. So while collagen has been successfully used for years in topical beauty and personal care products such as body lotions face cream and more recent scientific evidence confirms that the highest efficacy can be achieved when collagen is ingested orally. And GELITA s Collagen Peptides are highly versatile. With their special nutritional and technological properties these pure proteins are enjoying increasing popularity throughout the beverage food and health and nutrition industries not only because they can be easily incorporated into various types of applications but too because they are non-allergenic and free from additives carbohydrates cholesterol fat gluten and sugar and they are neutral in odor and taste. In their natural form they do not react with other ingredients therefore they can enhance and optimize the most diverse applications from liquids to solids. Calcium has also been a popular choice but additional vitamins and minerals play essential roles especially for sports nutrition. Calcium has long been the mainstay for bone health supplements noted Nena Dockery technical services manager with Missouri-based Stratum Nutrition but these supplements rarely contain just calcium. These supplements usually also contain vitamin D3 and magnesium but more supplements now additionally contain other beneficial nutrients such as vitamin C vitamin K2 manganese and even boron. Supplements for muscle health usually center around muscle recovery following Nutrition Industry Executive 33 A Well-oiled BMJ Machine exercise or supplements to improve endurance. Protein-based shakes and other beverage formats are common in this category. Sometimes these contain additional amounts of certain amino acids such as Larginine or glutamine as well as other nutrients like CoQ10 or an immune systemsupporting vitamin mineral blend. Dockery added that Stratum s NEM (branded eggshell membrane) can significantly reduce pain and stiffness within seven to 10 days for people who suffer from daily discomfort and stiffness or even those individuals who need that extra joint support when enduring a new workout helping to reduce biomarkers of cartilage breakdown. She was also in agreement with Arment in regard to collagen but stressed the importance of other options that can help combat inflammation as well. Within the last decade the predominant ingredients in joint health products have changed Dockery said. This category used to be dominated by glucosamine sulfate and hydrochloride and chondroitin sulfate. Their popularity has driven them into the commodity realm of ingredients and quality has suffered as a result. Arising out of this market flux has been an increase in the popularity of several other ingredients including those that are part of the joint structure such as collagen and ingredients that have been studied for general health benefits including those studied for their benefits in supporting a healthy inflammatory response such as curcumin and Boswellia serrata. California-based AIDP offers its patented collagen KoAct. AIDP s KoAct is a patented combination of collagen and calcium that is clinically proven superior to traditional bone health ingredients in improving bone mineral density explained Samantha Ford the company s business development director. K2 is also a strong bone health alternative as it aids calcium in reaching the bone mass and incorporating calcium then into the bone where it is needed for bone building and strengthening. Furthermore it ensures calcium is not deposited in the arteries where it can build up and cause serious cardiovascular risk. Ford also added that as alternative delivery applications continue to grow in popu34 Nutrition Industry Executive larity AIDP is working with manufacturers to help develop solutions including flavor masking and instantizing. While these well-known supplements ingredients have gained stardom throughout the years some manufacturers may not be aware of the fact that sales may have struggled slightly for some of the ingredients in the bone muscle and joint category. Calcium multivitamins vitamin D and magnesium are the most popular bone and joint supplements according to data from NBJ 2018. Other than vitamin D sales for these single ingredient supplements have been stagnant or dropped since 2007 Bruce Brown MPH MA president of New Jersey-based Natreon pointed out. K2 is also a strong bone health alternative as it aids calcium in reaching the bone mass and incorporating calcium then into the bone where it is needed for bone building and strengthening. Samantha Ford AIDP Historically consumers have relied on single ingredient supplements such as calcium but recent clinical studies have turned their attention to more innovative ingredients. Scientific data has proven to be the driving force in consumer sales as well as evolving demand for natural and botanical supplements. The challenge lies in being able to reach a much more general audience as Brown added that manufacturers are seeking ways to communicate novel benefits to a broad demographic profile. Thus they seek ingredient combinations that deliver on the evolving need of the consumer. In many cases the new focus is on Non-GMO (genetically modified organism) Project Verified organic and most importantly clinically proven. Natreon s ingredients deliver on these attributes. In fact David O Leary commercial manager for Marigot Ltd. in Ireland producer of Aquamin (marine multi-minerals) broke down the major manufacturer concerns into five succinct categories 1. Safety Are the products or bioactive compounds being considered seen as safe and is there sufficient evidence to prove this 2. How have the products in question been considered for the end consumer Have they been shown to be efficacious for bone and or joint health (osteoporosis osteopaenia osteoarthritis) 3. Science What level of supporting research is there Has it been published and is this evidence-based research safe and reliable 4. Origin Is it natural Cleanly obtained Non-solvent vs. Water-based 5. Sustainable Is it responsible to the source and environment Additionally manufacturers face the tall task of addressing these concerns while also remaining innovatively relevant in 2019. Innovation As previously noted collagen is beneficial in more ways that one making it a supplement that has been on the rise in fact Natreon s branded form of shilajit has shown its share of potential especially since it can go hand-in-hand with collagen. The bone muscle and joint category has seen an impressive growth in innovation from delivery forms to personal tracking apps to novel ingredients based on clinical studies Brown observed. One of these ingredients has redefined the category and driven growth collagen. Collagen improves bone mineral density muscle growth and joint health making it the new most popular supplement for BMJ health. Supplementing with collagen peptides has proven effective but they aren t vegetarian. Recently we have seen innovation in ingredient offerings that provide non-animal options for consumers seeking improved BMJ health. One such ingredient is PrimaVie shilajit which in recent studies conducted at University of NebraskaLincoln and Ohio State University found PrimaVie supports the body s natural collagen synthesis by upregulating the genes responsible for collagen synthesis. Furthermore this novel ingredient for BMJ health was found to reduce hydroxyproline a biomarker of collagen breakdown. PrimaVie is a vegan option for those seeking non-animal sources to support bone muscle and joint health or for those looking to enhance the health benefits of collagen supplementation. This is an exciting ingredient addition to a category as consumers seek advances in innovation in the bone www.niemagazine.com April 2019 Go to www.niemagazine.com biova for info about this advertiser A Well-oiled BMJ Machine muscle and joint category. Arment seconded Brown s collagen sentiments the ingredient is multi-faceted in the sense that it can be used in a plethora of delivery systems. Collagen-based beverages foods and supplements continually innovate she noted. Recently there have been launches of collagen-based gummies and chews. These convenient portable supplements offer all the benefits of collagen in a fun and indulgent delivery system. Beverages are a convenient delivery system for important nutrients and supplements especially collagen whether ready-to-drink or powders beverage applications are innovating by offering unique flavor profiles and exciting texture sensations. And as collagen is a food in of itself its use in food is expected. In the nutritional bar category collagen lends itself well. Again in this category we are seeing bars offering exciting and worldly flavors along with the benefits of collagen protein. It is important to keep in mind that the idea of innovation is not always as straightforward as it may seem. One must be knowledgeable of where market trends stand at a particular point in time along with being prepared to make adjustments if necessary. Curcumin for instance has helped to lead by example. Companies that are interested in keeping up with the pace of changes within the supplement industry use innovation to keep their ingredients and formulations fresh and new said Dockery. Innovation doesn t simply mean adding in small amounts of the current fad ingredient but looking at changes in market trends regarding dosing formats or ways to show sustainability of the ingredient or perhaps going through the process of making the ingredient non-GMO or organic. In recent years there has been a substantial amount of research devoted to developing innovative ways to improve the absorption of beneficial ingredients such as curcumin. The clinical efficacy of these ingredients is often limited by poor intestinal absorption and or rapid metabolism that can reduce their benefits in the body. This innovation has resulted in the introduction of proprietary ingredient forms with improved clinical benefits and lower doses. 36 Nutrition Industry Executive BMJ Market Status While it is unfortunate that bone and joint pain tends to worsen as a person ages this fact seems to be be a positive detail for this category s market. As our population ages and our lifespans increase the need for bone and joint support products should continue to grow especially as with the desire to stay active later in life said Patrick Stano senior brand manager with California-based Stauber Performance Ingredients the exclusive distributor for Marigot in both the U.S. and Canada. Ford was in agreement also noting that the growth of the bone market will be propelled by the popularity of bone both products and functional foods. in people age 65 and older. These trends coupled with our growing aging population and lack of therapeutic options in mainstream medicine suggest a tremendous market potential for alternatives such as dietary supplements. Wellknown ingredients with strong science backgrounds including collagen vitamins K and D and more recently tocotrienols are bound to do well in this category. These ingredients have shown remarkable benefits without the downsides that are often experienced with traditional medicine. For those suffering from osteoporosis for example available drugs that slow bone loss can have serious side effects such as bisphosphonate-related osteonecrosis of the jaw. Moreover treatment options for osteoarthritis are limited to pain relief use of supportive devices weight loss and steroids. None of these standard protocols remedy the condition. Interest in Research She is even interested to see how collagen products will continue to develop saying they have grown substantially in recent years. Full-spectrum collagens are the next big thing those that provide collagens type I through X. Interestingly enough hip fractures are more prevalent than many may believe which further demonstrates how much of an impact BMJ health plays. Ailments affecting the bone muscles and joints are widespread and their occurrence increases as people age explained Anne Trias MS product director with Massachusettsbased American River Nutrition. For osteoporosis for example the worldwide incidence of hip fracture is projected to increase by 310 percent in men and 240 percent in women by 2050 as reported by the International Osteoporosis Foundation. Arthritis is thought to increase as the population grows and ages with 50 percent of cases occurring Marigot s research focus begins with proof of transparency clean label is vital followed by ingredient effectiveness which Aquamin has demonstrated via human studies. [We are looking for] evidence of efficacy highlighting benefits of products in the chosen categories osteopaenia avoidance maintaining healthy bone density especially in female categories post menopause. Improved bioactivity and bioavailability are also key as more and more consumers become educated for their own health issues O Leary explained. Natural origin science-based ingredients that are clean label and proven are also very much ontrend. Our products [at] Aquamin come with a significant amount of science-based research across bone and joint health he continued. Comparative human studies involving our material tested against other calcium salt forms have been carried out and shown unique efficacy over other mineral forms. In the joint health sector we have looked at comparative studies against widely used joint health products such as glucosamine sulfate. Again our human study evidence suggests that our all-natural unique multi-mineral matrix is more effective at relieving symptoms associated with osteoarthritis and positively influencing pain stiffness and improving mobility. Natreon is continuously seeking results as they relate to the various branded ingredients that the company offers including Sensoril PrimaVie and more. Natreon continues to focus on clinically proven health benefits with our portfolio of www.niemagazine.com April 2019 Go to www.niemagazine.com stauber for info about this advertiser A Well-oiled BMJ Machine ingredients Brown said. The BMJ category is seeking innovation as consumers move away from standard synthetic products that have dominated the industry to natural products that have proven science. Primarily adaptogens along with collagen have driven growth in the category and have appealed to consumers. Natreon has completed or has in progress over 10 clinical studies with outcomes measures in the BMJ category. Our adaptogens Sensoril ashwagandha and PrimaVie shilajit have recently concluded U.S. studies that show positive results. These two adaptogens coupled with our AyuFlex ingredient are our lead ingredient candidates in the category. Besides aging American River Nutrition considers other details including weight and metabolic syndrome among others. It has various studies utilizing its DeltaGold ingredient its branded form of tocotrienol. A variety of factors have been linked with bone and joint health including aging obesity and metabolic syndrome oxidative stress and inflammation Trias mentioned. These are some of the primary endpoints we are now looking at when designing clinical trials. With our DeltaGold tocotrienol ingredient for example we looked at a population of post-menopausal women with osteopenia and although we mainly focused on bone turnover biomarkers we also examined the level of oxidative stress.1 Not surprisingly the annatto-derived vitamin E tocotrienol a potent antioxidant significantly reduced urine 8-hydroxy-2 deoxyguanosine (8-OHdG) a stable and reliable oxidative stress biomarker of DNA breakdown product by 49 percent. It may be in part due to tocotrienol s antioxidant mechanism that we saw the significant improvements in bone remodeling ( 100 percent) along with decreased bone resorption (13-24 percent) after 12 weeks of supplementing daily tocotrienol doses of 300 mg and 600 mg. When possible as it was in this case we strive to design our studies to the gold standard which is randomized double-blind placebo-controlled clinical trials. Our collaborators at Texas Tech University who conducted the study also published an excellent report concerning the safety of consuming higher doses of tocotrienols for an extended time peri38 Nutrition Industry Executive od No adverse events were reported by study participants giving tocotrienol an FDA (U.S. Food and Drug Administration) GRAS (generally recognized as safe) ingredient a stellar safety assessment.2 Considering that obesity and metabolic syndrome have been strongly linked with bone loss and because of our prior clinical success with tocotrienols in bone health the same researchers have designed a second trial in obese post-menopausal women which will run for 24 weeks. DeltaGold tocotrienols will be used at 300 mg day. As more educational materials become accessible consumers are seeking more substantiation to support product claims which is where research comes into play. This holds true even in the professional arena. With today s consumers being better educated on the correlation between health and nutrition Arment explained they are also becoming more interested in understanding how these products work in collaboration with one another. This means consumers will favor products with the greatest amount of scientific research and substantiation to support them. Scientific proof is paramount for active ingredients within the BMJ space. Here successful ingredient companies will offer a collection of high-level peer reviewed clinical studies that illustrate an ingredient s efficacy. Gone are the days of relying on anecdotal evidence. Fact-based clinical research is the basis for structure-function claims and consumer confidence. Even the International Olympic Committee (IOC) is recognizing that collagen supplementation might be beneficial for the athletes. In their recently published consensus statement they concluded that Collagen may support athletes to train harder and perform better. And their findings are based on research primarily conducted with GELITA Bioactive Collagen Peptides. A point to consider is research in healthy subjects achieving results in this environment is a challenge on its own. Within the supplement industry there is greater emphasis now in conducting research in healthy populations Dockery explained. This has always been the requirement from the FDA in order to distinguish supplement ingredient research from that for pharmaceuticals. However achieving meaningful results in subjects who are already healthy is difficult how do you improve on a health status that is already good This is made even more difficult because the FDA also stipulates that except for a select few qualified health claims and claims for deficiency disease prevention through supplementation of specific vitamins or minerals prevention claims are disallowed. Therefore some researchers use exercise as a means of stressing the body and then determine the beneficial effects of dietary supplement ingredients on the rate or degree of recovery from exercise-induced joint pain and or swelling. The joint health ingredient NEM brand eggshell membrane has already been the focus of one published healthy person trial 3 and a second study has just concluded. These trials used exercise as a means of stressing the joints in the hips knees and ankles. These healthy person trials also employed the use of an objective measurement tool in addition to more subjective tools such as questionnaires for assessing pain and stiffness. Reduction in the levels of the cartilage degradation biomarker CTX-II (C-terminal cross-linked telopeptide of type-II collagen) was used to demonstrate the cartilage protection capability of NEM. NIE References 1 Shen CL Yang S Tomison MD Romero AW Felton CK Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018. Epub 2018 01 14. 2 Shen CL Wang S Yang S Tomison MD Abbasi M Hao L et al. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women safety quality of life body composition physical activity and nutrient intake. BMC Complementary and Alternative Medicine. 2018 18(1) 198. Epub 2018 06 30. 3 Clin Interv Aging (2018) 13 285-295. Extra Extra Visit www.niemagazine.com to read how obesity in childhood and adulthood has shown to increase the risk of knee and hip osteoarthritis. FORMOREINFORMATION AIDP www.aidp.com American River Nutrition www.americanrivernutrition.com GELITA www.gelita.com Guzen Development www.guzendevelopment.com Marigot Ltd. www.aquamin.com Natreon Inc. www.natreoninc.com Stauber Performance Ingredients www.stauberusa.com Stratum Nutrition www.stratumnutrition.com www.niemagazine.com April 2019 By James J. Gormley The Participants Are Mariko Hill Product Development Executive Hong Kong www.gencorpacific.com Andrew Shao PhD Interim Senior Vice President Scientific & Regulatory Affairs CRN Washington D.C. www.crnusa.org Dan Lifton President Maypro Ventures Purchase NY www.maypro.com Gary Swanson Senior Vice President Quality Assurance and Control Herbalife Nutrition Torrance CA www.herbalife.com Roberto Pace Vice Corporate Quality Director Indena Milan Italy www.indena.com Ed Wyszumiala Director of Customer Engagement Dietary Supplements U.S. Pharmacopeia (USP) Rockville MD www.usp.org April 2019 www.niemagazine.com N utrition Industry Executive s (NIE) panel of industry experts tackles a range of issues that the industry is dealing with including economic adulteration traceability cGMP (current good manufacturing practice) compliance good agriculture collection practices and even mediocrity. Initiatives such as the The Supplement OWL (Online Wellness Library) and the NHP Research Alliance are discussed. Plus our experts weigh in on the pros and cons of genetic ID testing of plant materials. NIE What is the biggest quality obstacle right now for the natural products industry Economic adulteration or something else and why Lifton Mediocrity is one of the biggest obstacles. Just formulating with the minimum or fairy dust levels of ingredients just to be able to list them. Just sourcing with low-quality ingredients. Just manufacturing to the minimum acceptable standards. Not worrying about whether the products and ingredients have human Nutrition Industry Executive 39 clinical data behind them. Just skirting by with marginally acceptable claims and compliance. These are the most widespread problems and the hardest to change for many companies unfortunately. Shao The mainstream responsible natural products industry develops manufactures and markets safe high-quality products for consumers. However as with any regulated industry there are outliers looking to game the system for economic gain at the expense of consumer trust and well-being. Even for well-meaning companies quality challenges remain. Consumer demand for natural products is at an all-time high and the industry is scrambling to meet that demand at even lower cost and with better convenience. Economically motivated adulteration (EMA) is not itself a root cause of quality challenges for the natural products industry it is an unfortunate consequence resulting from a confluence between market forces (demand) lack of transparency in business practices commoditization of the sector (price pressure) and lack of accountability (enforcement). One might add lack of minimum quality standards to that mix however for example some of the most commonly adulterated botanical products are not lacking standards (analytical methods reference materials limits on contaminants etc ) and EMA often occurs in spite of wellestablished standards. These factors can conspire to create a culture where key questions are not asked price is the number one priority and unscrupulous adulterators can hide their practices. Such a culture can be a powerful supporter of EMA. Pace I agree. Economic motivated adulteration is one of the main issues today. In the last few years adulteration has become very sophisticated and difficult to be discovered with conventional analytical methods. And so the main problem is product safety. Wyszumiala The largest quality obstacles facing most companies right now are related setting proper specifications and utilizing properly qualified reference standards for determining the correct identity of incoming dietary supplements ingredients. In many cases manufacturers are set40 Nutrition Industry Executive ting specifications in a manner that does not fully verify the quality for the incoming dietary supplements ingredients and are not utilizing the proper test methods to fully verify that the incoming materials meet appropriate specifications. In too many cases only infrared spectrometry (IR) is still being used and while IR methods can be useful they are not necessarily the best methods for all ingredients. The problem with not utilizing a proper reference standard for identity is an ongoing issue. If the identity of an ingredient is not properly qualified to a reference standard then there is no way to fully verify its identity. Testing against a supplier s If the identity of an ingredient is not properly qualified to a reference standard then there is no way to fully verify its identity. Ed Wyszumiala U.S. Pharmacopeia sample is not enough to verify the ingredient s identity. If the identity of the ingredient cannot be confirmed it can lead to a misbranded adulterated mislabeled product and GMP compliance cannot be achieved. Swanson Many manufacturers and raw material suppliers use the moniker of quality when describing or marketing their products and ingredients but what does that really mean How many are committed and invested in following good manufacturing practices Many manufacturers either don t have the resources to invest in developing quality control systems including the verification of quality of their ingredients. Some fly under the radar and don t know how to comply with the Food Safety Modernization Act and the other regulations. Others operate in isolation and seldom receive independent technical evalu- ation to measure their compliance and performance which jeopardize the implementation of quality standards in operations and the supply chain. As an industry we are obligated to set the highest standards and we have to do a better job of regulating our own industry. As a member of the food and nutraceutical industry there is a need to collaborate to develop the appropriate methods to mitigate the risk of adulteration. Analytical methods need to be specific in order to ensure that the correct species and parts are identified. NIE What is the biggest compliance (regulatory or legal) issue in the natural products industry right now Shao The greatest regulatory compliance challenge for the natural products industry continues to be with the cGMPs. Certain categories of products (such as botanicals) are complex and can be challenging to manufacture consistently due to natural variation and availability of raw material supply. For some a lack of minimum quality standards complicates things further. However overall responsible industry has made great strides in cGMP compliance since the regulation was finalized more than 10 years ago. On the legal front the greatest issue continues to be products tainted with illegal drugs a form of EMA. This action by a few outliers undermines the confidence of many stakeholders (not just consumers) in the industry. This remains an area of priority for CRN and its members. Wyszumiala I agree. The biggest regulatory compliance issue facing the industry at this point is still the lack of full compliance with GMP regulations. While the progress in GMP compliance over the last decade has been very positive there are still significant gaps that need to be addressed. Testing of dietary supplement products to show that they properly meet label claims is an ongoing concern. In many cases companies are testing only a small portion of the product for verification against the product specification. This allows for products that potentially don t meet label claims to be released. Swanson The natural products industry needs better guidelines in defining the identity potency and purity of botanical ingredients. The botanicals need to be verified to be the right species concentration and without non-declared addition or substitution. Hill Currently CBD is gaining enormous traction in the natural products www.niemagazine.com April 2019 Go to www.niemagazine.com herbalifenutrition for info about this advertiser into the course. Separately we continue to make investments in the latest analytical technologies laboratory instrumentation and scientific training to improve analytical efficiency and accuracy on the production line. industry for its anti-inflammatory and anxiolytic properties however this hemponly derived substance is not approved as a dietary supplement by the U.S. FDA (Food and Drug Administration). Even without solid clinical evidence for its efficacy on non-diseased human population there are still numerous products out in the market using this ingredient without claims. The industry therefore needs to prepare alternatives for when regulatory boards start clamping down on these issues. Levagen by Gencor provides a great alternative to CBD having similar mechanism of actions to CBD by having influence on the endocannabinoid pathway. Levagen is fully traceable approved by the U.S. FDA and has GRAS (generally recognized as safe) status. NIE The Food Safety Preventive Controls Alliance (FSPCA) developed a Preventive Controls Qualified Individual (PCQI) course that is recognized by the FDA. Will getting staff qualified under this be one important step Wyszumiala Yes very much so. Designating the proper staff and having them go through PCQI training will help ensure that quality teams have the correct training and understanding of current Food Safety and Modernization Act (FSMA) requirements. This model also makes a company designate the individual(s) responsible for their food and dietary supplements safety plans implementation and continued compliance. Shao FSMA is a massive and complex law. Reviewing FDA s website there are nearly 20 documents on proposed or final regulations and nearly 60 documents on draft or final guidances. That s a tremendous amount of information to digest and implement. These types of offerings could play a pivotal role in educating regulators and manufacturers and placing them in better positions to enforce and comply with all the requirements. Swanson Professional certification such as that created by the FSPCA is really a testament to how important the work is that we do to in our field to ensure safe manufacturing practices in order to protect consumers. The nationwide certification is something we would encourage our staff who are not yet certified to look 42 Nutrition Industry Executive NIE Briefly where are we on genetic ID testing and verification of plant materials and ingredients Shao Despite the hype created by the NY Attorney General a few years back DNA-based assays for botanical ingredient identification are not a panacea. Analytical methods experts tend to agree that while such methods can be useful in identification of plants (including adulterating species) there are limitations particularly with respect to highly processed or extracted plant material. Often these ingredients don t contain any intact DNA and thus these methods would not be fitfor-purpose. The message from the experts is Don t rely solely on DNA testing to identify ingredients that have been processed. That said great progress continues to be made towards refining and validating the methodology. Wyszumiala Since the New York Attorney General findings in 2015 the industry has been working in various ways to implement DNA ID testing as part of the qualification of botanical ingredients. DNA testing may help in the proper identification of certain botanical ingredients but should not be the only tool used. Additional testing maybe needed to fully confirm the identity of a botanical ingredient especially when qualifying and utilizing formulations that do not include the whole plant such as botanical extracts. Lifton The technology behind this has grown by leaps and bounds in the last few years. As long as natural botanical variability is sufficiently well allowed for in the methods of analysis and identification then it will make it better for manufacturers who are doing their due diligence and for suppliers to ensure that what botanical materials they are buying is what they are getting. Ultimately consumers will be able to have greater confidence that what they see is what they get. Pace Important improvements have been made on genomic ID of plants. Recently our company succeeded in [developing tests] with specific diagnostic kits for each specific species. This technology is under evaluation of USP and FDA and hopefully very soon we will have compendial methods. Nevertheless the genomic ID test is just one piece of the puzzle of the ID tests of botanicals Botanical ID and chemical ID tests remain of paramount relevance for the correct identification of botanicals and the main weapons to fight adulteration. NIE On this topic there is a lot more interest today in genetic ID verification for probiotics why is this important Shao Probiotics like botanicals pose unique technical and analytical challenges due to their complexity. Science indicates that safety and efficacy is strain-specific. The CRN-IPA Best Practices Guidelines for Probiotics recommends probiotic-containing products indicate the genus species and strain on the label. Also FDA expects to see strain-specific information provided in new dietary ingredient notifications involving probiotics. Virtually the only way to decipher live probiotic strains is via genetic testing. So in this case this method is a critical component of assuring the quality and authenticity of this important category of natural products. Wyszumiala Probiotics have similar challenges in determining the identification of specific strains. Many of the larger suppliers are actively working on building their genetic ID testing for the ingredients they are selling in the marketplace. This helps them differentiate their source materials from counterfeit materials in the market. As with any newer testing methodology there is still work to be done in this area but it is a positive step and suppliers are working to implement it as part of their toolkit to help verify their materials where appropriate. Lifton I do see that this is especially important for probiotics because with the wrong strain you can go from effective to worthless in an instant. NIE Also briefly what are the top one to two advances in substantiating fruit-andwww.niemagazine.com April 2019 vegetable serving claims for whole-food powders Shao The advances in this area are based on manufacturers commitment to providing the proper contextual information and qualifying language for claims. Care should be taken when considering fruit and vegetable equivalency claims such that they are truthful and not misleading. This can be accomplished for example by highlighting a specific nutrient or collection of nutrients in the fruit powder (e.g. vitamin C and fiber) relative to a given serving of fruits and vegetables. However simply stating that wholefood powders are equivalent to fresh fruits and vegetables would be misleading as the powders have undergone significant processing that may remove a number of key nutrients some of which science has not even identified. Swanson Supplier verification of ingredients and new technology development such as NMR and Q-Bit genetic sequencing techniques have moved the needle for natural products identification and quality. toylethanolamide) and Hydrocurc (curcumin) both use this technology helping them have enhanced bioavailability functionality (into various formats i.e. powders effervescents RTD shots) as well as having high loading (90 percent) with only 10 perent excipient. This leads to better compliance of the product by endusers. NIE What one advance in ingredient delivery or enhanced bioavailability are you most excited about Lifton Well you asked about probiotics before. And at Maypro we re pretty excited about our ProDURA proprietary branded ingredient. ProDURA Bacillus coagulans is a unique strain of spore-forming bacteria. In their spore form the bacteria are dormant and encased in an outer shell allowing them to withstand the harshest environments. When they encounter the perfect conditions of temperature pH and moisture in the large intestine they then revert to their active form. The result is a highly resilient and bioavailable probiotic that s able to handle extreme conditions like including high temperatures processing stomach acid and bile and is room temperaturestable for up to three years. Pace Phytosome is Indena s completely natural biomimetic strategy to optimize the solubility and bioabsoption of selected botanical-origin ingredients reducing their self-aggregation. Hill The development of LipiSperse delivery technology by Pharmako Biotechnologies has taken enhanced bioavailability and functionality to another level. With numerous pharmacokinetic studies displaying its ability to increase bioavailability of lipophilic substances LipiSperse is currently the most innovative and effective delivery technology for lipidbased substances developed to date. Gencor s Levagen (palmi- such as NMR and Q-Bit April 2019 www.niemagazine.com NIE In 2018 did the industry do a better job overall with purity and using analytical labs to test for heavy metals toxins and other contaminants. If yes how so If not why Wyszumiala Industry has been diligently working apply purity standards for dietary supplements ingredients and products. I have noticed companies are implementing more rigorous and routine testing for heavy metals pesticides and residual solvents. Supplier verification of ingredients and new technology development genetic sequencing techniques have moved the needle for natural products identification and quality. Gary Swanson Herbalife Nutrition Swanson I don t entirely agree. The natural products industry still reacts to regulation changes in order to make changes in the quality of ingredients. We have not seen a dramatic improvement in quality or purity of natural products in the last three years as we expected. The industry needs to step up and set standards for manufacturing and using botanical ingredients. The responsibility remains with the marketers to ensure that the standards for purity contamination and composition are being properly managed. The responsibility is on their shoulders because of specific regulations or laws already in place. Lifton I do think the industry has gotten a bit better with this and the technologies both for purification and methods of analysis have improved. But quality starts in the soil in the water or in the fermentation medium. If you start with the very best inputs you are more likely to have the best outputs. NIE Are advances in automation systems and technology enhancing quality or compliance If so briefly how Shao Most definitely technological advances are helping to improve quality and compliance. For example electronic batch records now instituted in many supplement manufacturers help to streamline documentation and reduce errors during the manufacturing process. Customer relationship management (CRM) software help companies to collect manage and respond to consumer complaints and adverse event reports. Product development databases assist companies in managing their product development pipeline source and approve raw ingredients and manage production by contract manufacturers. All these advancements have led to more efficient quality management systems fewer mistakes and better compliance overall. Swanson Advances in automation systems enhance both quality and compliance for the manufacturing process by reducing potential data entry errors and corrections minimizing reworks and deviations and reducing quality assurance review times. At Herbalife Nutrition we are using technology to create our own automation system (Electronic Batch Record) in order to have a more reliable consistent accurate repeatable and predictable manufacturing process. NIE Do you have any additional comments Lifton Without compliance you cannot have the best quality because regulatory compliance is linked to sets of minimum standards not optimal standards. And quality is not accidental it s intentional. Something you should strive for and ensure well before ingredient or finished product ever hits your warehouse. And it should follow your products every step of the way until it is in the consumer s trusting hands and sits on their supplement shelf. Because that s what it s all about at the end of the day. Fulfilling a promise to every consumer that they have purchased a quality supplement one that is safe one that is shelf-stable and one that is effective. NIE Extra Extra Visit www.niemagazine.com to learn more about genetic ID testing and verification of plant materials and ingredients. Nutrition Industry Executive 43 ThePitch Super MD Choosing A Spokesperson Who Bests Suits Your Supplement By Amy Summers President Pitch Publicity ometimes I describe my job as a high-level matchmaker in the natural products industry. Companies approach me to help them get more exposure for their products to increase awareness and health experts request my services to promote their book practice or visibility with the public. Matching the expertise of a health professional with a quality company and product can produce mutually beneficial results for everyone involved. The product gets a credible third-party voice to explain why it s needed and how to use it while the health expert gains a publicist and a purpose to his or her media campaign. Without each other the product and the expert may not have a sustainable publicity program. For the company they can only get so much exposure on a new product or study. Once it s been reported then what For the experts they can only get so much exposure for themselves or a new book then what However when S 44 Nutrition Industry Executive a company and expert come together you combine both purpose and passion through ongoing storytelling that a good publicist can provide. Once you ve decided to engage a health expert for a publicity campaign how do you choose the right one Do you pick based on title alone Selecting a medical spokesperson for a publicity campaign is not the same as selecting a physician for your next physical. In fact some qualities that make a person a great doctor make them a horrible spokesperson and vice versa. What television producers and reporters are looking for in a health expert is surprisingly not the logical attributes a company may even consider when choosing a representative for their product. I would definitely choose a cardiologist to be my doctor if I had a heart attack but once I was working with a primo cardiologist on a vitamin K2 publicity campaign scored him a spot on the Today show and then he told me he was very sorry but he couldn t make it to the interview. You can only imagine what my client s response was to this news. Here are five top attributes to look for when choosing a medical spokesperson to represent your supplement or ingredient for multimedia broadcast interviews Availability Television interviews can be demanding on your schedule because you literally have to show up somewhere at an inconvenient time hair- makeupand wardrobe-ready often with visuals and all for a three- to five-minute interview. Is it worth it Yes because no one can underestimate the value of connecting an audience with a real person who is sharing the spotlight with your product. But here s the catch That incredibly brilliant doctor who you call your spokesperson needs to be willing to leave his or her busy practice and patients. See the issue Is that doctor willing to leave a www.niemagazine.com April 2019 lucrative practice or busy hospital to go rushing off to CNN with less than 24-hour notice A good doctor will always put patients before media interviews. Therefore the most ideal spokesperson is the retired doctor who has dedicated his or her career to writing speaking consulting and being a go-to media expert on all things health. The second-best spokesperson is the physician who sees patients part-time and sets aside ample availability to devote to media engagements. Both of these options trump any superstar doctor who is loaded up with patient appointments. From a publicist s perspective getting at least 50 percent of an expert s schedule to use for media opportunities is necessary or there will be a minimal level of return on investment from the client s perspective. Attractiveness If you are going to talk about being healthy you better look the part. Think about it if you have a prestigious doctor discussing weight-loss tips but he has a beer belly who is going to believe what s coming out of his mouth Most people are only going to be thinking about what s going into his mouth and then your message is lost. Beyond looking healthy appearance in general is important and spending the money to look good before a TV interview should be in everyone s budget. Your spokesperson is going to be on set under bright lights and projected on highdefinition TV with some of the most beautiful people in journalism anchors. Male or female these news anchors spend time every day in a stylist chair for makeup hair and wardrobe. Unless you are scheduled for a national TV appearance these services will not be available to your spokesperson which is why you will often hear producers say to come camera ready. That means do your own hair makeup wardrobe and oh by the way look fabulous. The do-ityourself approach to hair and makeup does not compare to what a professional can do to get you ready for the spotlight. So whenever possible allow for this expense and encourage April 2019 www.niemagazine.com your spokesperson to purchase the right clothes and schedule grooming before an on-camera appearance. Because most audiences are attracted to good-looking people producers are looking for someone who will catch the viewer s eye. I once worked on a project for an organic food company with a celebrity chef. She had a book a popular restaurant in Los Angeles CA and an A-list clientele including Pierce Brosnan and Billy Bob Thornton. You would think that would be enough material to get her on a local FOX TV affiliate in Los Angeles but no the producer asked me what the chef looked like and to send her pictures before committing to the interview. Luckily the chef passed the test thanks to quality imagery which is why investing in professional headshots is also critical to getting your spokesperson on air. Entertaining Whenever I m coaching an expert for media interviews I tell them they have to do three things in three minutes and in this order entertain educate and pitch. A bad interview is one that starts out with a pitch. You should never do this or you will not be asked back. A boring interview is one that starts out with a ton of facts and information. Producers always fear this which is why especially when I m pitching a physician scientist PhD or other health professional they always ask for clips of other interviews that person has conducted. They are not checking to see how brilliant the person is they could see that on paper. Rather they are checking to see if the expert is lively fun engaging quick down-to-earth relatable and knows how to answer questions not just give lectures. I ve had national television producers ready to book medical experts based on topic and expertise but then see a clip they don t like and it doesn t go through. Producers have told me that certain doctors or other health experts are too flat low energy or stuffy. A lot of this comes down to individual personality so it can be really challenging to coach someone to be more entertaining especially if the doctor has little interest with being in the spotlight in the first place. How do you find an entertaining doctor At the next conference cocktail party you attend notice which doctors attract people to them and keep an audience captivated while laughing and smiling. Most doctors can put on a show during a conference lecture and appear Go to www.niemagazine.com somalabs for info about this advertiser Nutrition Industry Executive 45 ThePitch to be entertaining. You want the doctor who is naturally charismatic and stands out in crowded room. Confidence A common personality trait that every great spokesperson has is confidence and love of the spotlight. I for one do not share this same love and would much rather be situated behind the scenes off camera sharing my expertise in an article audio flash briefing or pitching someone else to be on camera. When I first started out in my career I was the weekly health and fitness correspondent for a local ABC TV affiliate as part of my public relations director role at an international fitness center chain. It was great promotion for the club but I did not enjoy doing it and would never watch any of my own segments as I m too hypercritical of myself especially on camera. You don t want your spokesperson to be nervous or self-conscious on camera. You want your spokesperson to watch his or her own segments to continually improve and most importantly you want a spokesperson who is self-confident and thrives in the spotlight as this makes him or her more entertaining and a better promoter for your product. Smarts I talk about availability attractiveness entertaining and confidence before credibility because usually people think the reverse is true when securing the right spokesperson for a publicity campaign. Credibility is important but there s no need to go overboard for broadcast media. You don t need to engage with the top internist cardiologist cancer specialist or immunologist to speak on behalf of your product when it comes to most broadcast interviews. I always recommend saving these experts for print interviews where being on-camera is not required and there may be more flexibility with time. Journalists who write health stories tend to go deep into research and then break down the information for their readers. They need intelligent experts who are able to go beyond the surface of the health issue and give them something new that they may 46 Nutrition Industry Executive not find in an Internet search. TV producers on the other hand just need the spokesperson to be smart because they are more concerned about the expert speaking in basic sound bites and layman s terms on a subject matter in three to five minutes. They are looking for credentials but not necessarily a medical doctor. In fact many national outlets hire their own physicians to serve exclusively as their medical correspondents to cover health news so it can be more difficult to get a medical doctor on air because you are competing with the station s own staff of physicians. If your expert is someone they don t have like a pharmacist who can discuss drug interactions with supplements for example it is a major plus. There are other titles producers are intrigued with these days holistic naturopathic nutritionist metabolic natural health and fitness experts. Yes on paper a medical doctor may seem to bring your brand heightened credibility but on camera if that physician is not available attractive entertaining smart in a sound bite or lacks confidence on camera it doesn t matter how brilliant he or she is you may never get your publicity campaign front and center in the spotlight. NIE Amy Summers launched Pitch Publicity in 2003 in the face of a rapidly changing climate for communication and media relations. She has 20 years of experience working with major clients in the natural products industry to increase visibility and exposure to targeted audiences through national publicity exposure across all mass media outlets high-level fundraising campaigns and developing key strategic communication strategies. She serves on the board of directors of the University of Florida Alumni Association and the University of Florida College of Journalism and Communications Public Relations Advisory Council. Pitch Publicity is based in New York NY. Receive free daily pitch tips from The Pitch with Amy Summers flash briefing on Amazon s Alexa Google Play iTunes and Podbean www.PitchPublicityNYC.com ThePitch. For more information visit www.pitchpublicitynyc.com. www.niemagazine.com April 2019 IngredientTechnology The Clean Label Conundrum How Can Supplement Makers Comply By Barri Sigvertsen Marketing Manager Lonza Consumer Health & Nutrition or decades physicians and pharmaceuticals were the go-to for health management and the primary focus was efficacy. But a changing consumer goal triggered and has since underpinned the expansion of the supplements industry. Supplements have enabled people to take responsibility for their own health and to prioritize maintaining long-term health. Transparency demands that originally began in the food industry made their way into supplements too via the Dietary Supplement Health and Education Act of 1994 (DSHEA). With a shift in consumer expectations in recent years consumers are paying more attention to transparency and ingredient lists. Clean label is perhaps the biggest. What began as a spontaneous reaction to food safety concerns in the U.K. s meat industry has become a global megatrend whose effects are driving both new product development and reformulation throughout the nutrition F April 2019 www.niemagazine.com sector and beyond. In fact research commissioned by Lonza Consumer Health & Nutrition and conducted by the Natural Marketing Institute (NMI) has shown that 80 percent of U.S. consumers want to know the sources of the ingredients in the products they use. Fifty-four percent also recently said they would prefer to buy dietary supplements derived from natural sources an increase of nearly 60 percent compared to 2013. Conflicting Requirements There is however a dichotomy between the consistent growth of the supplements market and the broadening demand for clean label. Is it possible to strike a balance between authenticity and transparency on the one hand and increasing volumes speed-to-market and complexity on the other How can manufacturers ensure their ingredients processes and end-products match the needs of their customers while complying with the requirements of shareholders regulators and legislators Leading suppliers to the nutrition industry have committed extensive resources to helping their customers overcome these issues. Solutions are now available that enable manufacturers and brand owners to ensure clean label compliance throughout their business. These allow an integrated and reliable approach to clean label in both new product development and reformulation from raw materials and ingredients across production all the way through to delivery forms. A Moving Feast The clean label phenomenon began around 25 years ago and is now a firmly established element of the food and personal care sectors as well as nutritional supplements. At the outset the need was clear-cut consumers were becoming more aware of and concerned about what they were putting into their bodies where it came from Nutrition Industry Executive 47 IngredientTechnology and how it was sourced. This meant formulators sought to reduce the number of ingredients within the product to shorten and clarify its label while operators sought processes to manufacture the product that ensured it adhered to clean label requirements. While this initially might sound simple going clean label is anything but. Not only has no single definition of the term been created or accepted by consumers or the industry but the clean label market is in a constant state of flux. What was often little more than a conversation is now a purposeful movement a concept of many dimensions. What started as taking out mysterious artificial ingredients now includes vegetarianism veganism non-GMO (genetically modified organism) and organic and many more characteristics that simply were not priorities in the early years. So for those supplement makers wishing to service the ever-expanding clean label segment how can these diverse and evolving requirements be met in order to safeguard compliance Seeing and Believing Better visibility and control are without doubt central to a clean label strategy maintaining transparency and quality throughout the supply chain are prerequisites. This means sourcing ingredients of the highest quality from reputable suppliers with rigorous quality and testing standards of their own. Close collaboration with these suppliers about processes and methodologies and risk management means that expectations and standards are aligned and provide reassurance to manufacturers brand owners retailers and consumers alike. A commitment to quality and constant improvements are fundamental. Ensuring best practice and adherence not only to the numerous and evolving quality regulations but also to current food good manufacturing practices (GMP) may appear a daunting challenge. But seeing this challenge as an opportunity rather than an obstacle enables supplement makers to raise the bar and stay ahead of competitors and regulators. Detailed forward planning regular testing and reviews as well as a proactive mindset help to safeguard quality standards and minimize risk. As well as the composition of the products themselves a detailed knowledge of how they are used is essential for compliance. Consumer habits and preferences vary dramatically between 48 Nutrition Industry Executive markets geographies even across different ages and usage levels. Although Millennials are the dominant force behind much of the market s development sustainable and eco-friendly ingredients are important to all age groups as they are seen as a reflection of the consumer s broader values and ethics. The Only Constant is Change With the proliferation of nutritional ingredients and both sourcing and sales becoming increasingly globalized for many businesses compliance undoubtedly becomes more complex. This is an opportunity for proactive and qualitydriven supplement manufacturers. With a firm hand on their own quality stan- Better visibility and control are without doubt central to a clean label strategy maintaining transparency and quality throughout the supply chain are prerequisites. dards a detailed understanding of the regulatory environment and insight into the broad health concerns of consumers worldwide personalization is a chance to develop highly tailored nutritional solutions that deliver precisely the benefits sought in each market. The regulatory landscape is understandably a primary concern for manufacturers and suppliers alike and rightly so. Regulations evolve over time either in response to industry practices or processes or as technology and consumer demands and expectations change. Acting on behalf of consumers regulations drive a safer environment for all and as vendors and suppliers an open discussion on shaping these changes is essential. Despite there being no set industry or regulatory definition as yet moving to cleaner labels requires a new perspective on processes ingredients and labelling to ensure all parts of the process and supply chain comply with industry and consumer expectations. Clean Label Cues With more demands than ever being placed on supplement makers collaboration and partnership are important. Working together with like-minded organizations not only enables each one to comply with the current standards and expectations of its markets but also provides a solid foundation for future growth and development. Clean label compliance can be greatly facilitated by a range of approaches that is now available to supplement manufacturers within the U.S. and beyond including Raw material supplier selection In the excitement of a burgeoning industry feeding increased demand supplier qualification is important. In 2019 supplement manufacturers can secure the clean label status of their products by working with reliable suppliers that offer high quality ingredients from known and natural sources to support new product development and reformulation. Upskilling improving in-house awareness and knowledge of both regulations and quality standards and implementing measures to ensure complete compliance with them including timely responses to changes Collaboration seeking opportunities to work with complementary organizations and associations to help meet evolving demands. The creation last year of the Clean Label Alliance is a prime example of a partnership that brings benefits to the dietary supplement industry as a whole by providing access to knowledgeable resources. Technical advancement recent progression in ingredients equipment and processes mean more clean label production is possible than ever before. This includes vegetarian and vegan ingredients and delivery solutions (such as capsules and tablets) which cater to the growing number of consumers looking to reduce their consumption of animal-derived products as well as a wider choice of clean label excipients. Coming Clean In a rapidly evolving market with many different dimensions it can be difficult to keep abreast of changing consumer www.niemagazine.com April 2019 requirements tightening regulations and novel technology developments. Every year it becomes more and more evident that one size does not fit all which explains the ongoing fragmentation of the dietary supplement market. But certain standards and attitudes prevail across the whole sector the need for safety the requirement for scientific proof of efficacy and the assurance of quality and transparency. While clean label status has been demanded from ingredients suppliers for some time delivery methods are now under equal scrutiny. Sometimes clean label ingredients are more difficult to work with excipients are a good example and therefore have an impact on manufacturing methods speed efficiency and ultimately profitability. As a result clean label formulation or refor- mulation needs a holistic approach to every component of the supplement including the delivery format. This is where the expertise of experienced suppliers becomes invaluable. Where many have worked in nutritional supplements for decades only a small number of these suppliers have the wide-reaching capabilities to adopt the multifaceted procedures necessary for clean label compliance today. As a supplier of integrated science-backed ingredients dosage forms and delivery systems Lonza has both the breadth and depth of knowledge to support dietary supplement manufacturers and brand owners in their development of clean label offerings from concept through processing to the final product. For example since productivity and yield can vary when transitioning to clean label Lonza has practices and processes in place to not only measure productivity but also to help maintain yields throughout the transition. With the help of associated industry partners like the Clean Label Alliance to bring additional know-how and practical assistance Lonza is ideally positioned to assist supplement makers in their clean label developments. To find out more visit www.lonza.com. NIE Barri Sigvertsen Marketing Manager Lonza Consumer Health & Nutrition ConditionSpecific kets in the past concluded B rub . Health indications like blood glucose blood lipids liver health and heart health can all be seen as falling into the broader category of metabolic health. NIE (Continued from page 8) reduction in systemic inflammation. This study was published recently in Phytotherapy Research and is available to product manufacturers interested in metabolic health products. In 2004 Dr. Charles Brenner first discovered nicotinamide riboside (NR) a form of vitamin B3. Brenner found that NR acts as a precursor to NAD (nicotine adenine dinucleotide) an essential coenzyme utilized by the body s cells to generate the energy required for daily activities such as eating drinking sleeping and breathing. According to Frank Jaksch Jr. executive chairman of the board and cofounder of the California-based ChromaDex Corporation NAD levels can also become depleted by metabolic stresses such as overeating and drinking and physical inactivity. When NAD levels are low our cells don t function at their best. We know thanks to credible research that NR increases NAD to support many of the metabolic processes involved in cellular health and have seen fascinating preclinical studies in the areas of cardiovascular health Alzheimer s and Parkinson s he explained. While further research is needed to see if benefits translate to humans we understand mechanistically why NAD and NR may prove to be benApril 2019 www.niemagazine.com References eficial in these areas. Niagen the key ingredient in our flagship product TRU NIAGEN is shown to significantly increase NAD levels by supporting healthy aging and promoting mitochondrial health and cellular energy production which can be an important tool for health optimization during aging he added. While it is an unfortunate fact that a number of Americans have to deal with their metabolic health issues the good news is that many are taking proactive steps to so something about it. In recent years as the consumer trend suggests there is an increase in proactive health solutions Appell noted. We expect this trend to continue strong with more consumers becoming aware of metabolic issues and taking charge of their health. Therefore the future of the metabolic health category looks promising. I believe the market for metabolic health supplements is a relatively new one as it was scattered into distinct mar- 1 Maria Aguilar MD1 Taft Bhuket MD2 Sharon Torres PA2 et al JAMA. 2015 313(19) 1973-1974. doi 10.1001 jama.2015.4260 https media.jamanetwork.com news-item study-finds-high-prevalence-ofmetabolic-syndrome-in-u-s . 2 Avena N. Rada P. & Hoebel B. (2008). Neuroscience Behavior Review 52(1) 20-39. Retrieved from www.ncbi.nlm.nih.gov pubmed 17617461. 3 Shapiro A. Mu W. Roncal C. Cheng K.-Y. Johnson R.J. & Scarpace P.J. (2008). American Journal of Physiology. Regulatory Integrative and Comparative Physiology 295(5) R1370 1375. doi 10.1152 ajpregu.00195.2008). 4 Jeykodi S Deshpande J Juturu V. Salacia Extract Improves Postprandial Glucose and Insulin Response A Randomized Double-Blind Placebo Controlled Crossover Study in Healthy Volunteers. J Diabetes Res. 2016 Oct 10 2016. (BIG Study). 5 Hao L et al. Appetite and Gut Hormones Response to a Putative -Glucosidase Inhibitor Salacia Chinensis in Overweight Obese Adults A Double Blind Randomized Controlled Trial Nutrients. 2017 Aug 12 9(8). pii E869. doi 10.3390 nu9080869 (CARBS Study). FORMOREINFORMATION ChromaDex Corporation www.chromadex.com HP Ingredients http hpingredients.com InnoVactiv www.innovactiv.com OmniActive Health Technologies http omniactives.com Nutrition Industry Executive 49 Conventions&Meetings Vitafoods Europe 2019 to Address Key Challenges in Sustainable Sourcing A s environmental awareness reaches new heights and the world s population continues to rise the issue of providing sustainable foods which also offer a high nutritional value is set to grow in both importance and complexity over the next decade. It is with these considerations in mind that Vitafoods Europe 2019 has developed its agenda. The three-day event (May 7-9 2019 Palexpo Geneva) will focus on bringing the industry together to discuss key challenges such as sustainable sourcing and wider trends including free-from plant-based ingredients and hemp extracts and CBD. This year s show is expected to attract 22 000 visitors and will host more than 1 200 global suppliers active in ingredients and raw materials dietary supplements contract manufacturing and private label and services and equipment exhibiting thousands of ingredients and products. The event has also added to its portfolio and introduced a range of new features including a new Sustainability Square which will showcase the latest consumer and market insights from across the industry allowing visitors to make informed and future-focused buying decisions. To clear up any confusion around updated or newly introduced E.U. and global regulations and allow manufacturers to speed up the process to market Vitafoods has invited experts from the European Federation of Associations of Health Products Manufacturers (EHPM) who will be offering one-to-one consultations as part of a new Regulatory Clinic. While a new Clinical Trials Zone will offer a step-by-step guide to the clinical trial process a Diversity & Inclusion Roundtable will open the discussion on the importance of establishing diversity in the workforce to create an inclusive environment and the benefits this will bring. Additionally the Vitafoods Education Program will return this year with a new flexible structure giving delegates the chance to attend specific sessions individual days or the full three-day agenda. Running throughout the event the program will have 11 summits and more than 50 industry and business experts to discuss and debate breakout trends and the industry s latest studies. Supplementary events are also taking place across the three days including the Community Breakfast Diversity & Inclusion Roundtable Nutrition Capital Network s Sixth Annual European Investor Meeting Good Manufacturing Practices (GMP) Training by EAS Consulting Group NutraIngredients Awards 5K Run and Yoga Wellness sessions. For more information visit www.vitafoods.eu.com. Don t miss a single issue of NIE in 2019 go online to renew your free subscription today NIEmagazine.com April19 50 Nutrition Industry Executive www.niemagazine.com April 2019 Advertiser Index AIDP 27 (866) 262-6699 www.niemagazine.com aidp Balchem 5 (845) 326-5600 www.niemagazine.com balchem Bergstrom Nutrition 3 (360) 693-1883 www.niemagazine.com bergstrom Biova LLC 35 (877) 682-2673 www.niemagazine.com biova Certified Nutraceuticals 1 (951) 600-3899 www.niemagazine.com certifiednutraceuticals GCI Nutrients 29 (650) 697-4700 www.niemagazine.com gcinutrients Herbalife Nutrition 41 (310) 410-9600 www.niemagazine.com herbalifenutrition Kyowa Hakko USA 31 (212) 319-5353 www.niemagazine.com kyowa Nutrition 21 LLC 7 (914) 701-4500 www.niemagazine.com nutrition21 Olcott Plastics C4 (630) 584-0555 www.niemagazine.com olcott Pinnacle Labs Int l. 19 (800) 600-4634 www.niemagazine.com pinnaclelabs PLT Health Solutions C3 (973) 984-0900 www.niemagazine.com plt Sabinsa Corporation C2 (732) 777-1111 www.niemagazine.com sabinsa Soma Labs Inc. 45 (732) 271-3444 www.niemagazine.com somalabs Stauber 37 (714) 441-3900 www.niemagazine.com stauber Industry Events April 9-10 SupplySide East Meadowlands Exposition Center Secaucus NJ east.supplysideshow.com May 7-9 Vitafoods Europe 2019 Palexpo Geneva Switzerland www.vitafoods.eu.com June 26-27 Personalized Nutrition Innovation Summit Hotel Kabuki San Francisco CA https personalizednutrition-usa.com events personalized-nutrition-2019 June 26-28 China (Guangzhou) International Health Industry Expo China Import and Export Fair Complex Guangzhou China www.djkz.org en October 15-19 SupplySide West Mandalay Bay Convention Center Las Vegas NV west.supplysideshow.com THE NUTRITION INDUSTRY S NEWS & INFORMATION RESOURCE NIE s Upcoming Issue Highlights June 5 16 19 ad closing July August 6 27 19 ad closing 2019 NIE Supplier Sourcebook Company Profiles Washington & the Natural Industry Sept. Oct. 8 9 19 ad closing Nov. 9 20 19 ad closing Immune Health SupplySide West Show Issue NIE Awards Sports Nutrition Our 2019 Media Planner Is Available At NIEmagazine.com 2019-Media-Planner Contact One of Our Ad Specialists Today Russ Fields at (732) 432-9600 ext. 102 or e-Mail RussF VRMmedia.com Barry Young at (732) 432-9600 ext. 103 or e-Mail Barry VRMmedia.com April 2019 www.niemagazine.com Nutrition Industry Executive 51 SupplieroftheMonth Nuherbs 14722 Wicks Blvd. San Leandro CA 94577 Phone (800) 233-4307 Wilson Lau Nuherbs founded in 1979 and the largest TCM (tradition Chinese medicine) supplier in North America supplies pharmacopeia-grade geoNuherbs authentic conventional and organic Chinese herbs. Herbal identity of every ingredient is confirmed macroscopically and chemically when there is a method provided in the Chinese Pharmacopeia. Each lot of every herb is tested for pesticide residues heavy metals micro bacteria and other quality indices. The company s emphasis on quality begins at the farms from which it sources extends to comprehensive testing and proper processing of each herb and careful storage of the botanicals in Nuherbs California warehouse. The company also offers ultra-custom Nuherbs Bespoke Extracts. Nuherbs comprehensive array of practitioner supplies includes the Superior Trading line. Wilson Lau is the third generation of his family to lead Nuherbs. He has a BA in economics and geography from Macalester College and a law degree from Santa Clara University School of Law. He is a member of the American Herbal Products Association (AHPA) Board of Trustees and has held various leadership roles within that organization. Lau also participates in botanical sustainability initiatives in China. Vice President NIE Nuherbs is a third generation future generations. family business. How is the company carrying on the vision of its founder Dr. Bing Yon Lee NIE What is the Ai Cao Yao system and how does Nuherbs implement it Lau I am the third generation of my family in this business. In 1935 my grandmother Dr. Bing Yin Lee became one of the first female graduates from the Chinese Medical Institute of Shanghai. Dr. Lee brought her decades of clinical experience to the United States in 1974 and opened a practice in San Francisco s Chinatown. She became one of the first licensed acupuncturists in California in 1984 after completing her PhD at the San Francisco College of Acupuncture. To assure a steady supply of quality Chinese herbs for Dr. Lee s practice her daughter and son-in-law my parents Pat Kwan and Henry Lau opened an herbal pharmacy in Oakland s Chinatown in 1979 which quickly became known for the reliability quality and traceability of the products they supplied. My family s small pharmacy grew to be Nuherbs the leading supplier of TCM herbal ingredients to manufacturers as well as impeccable finished products relied upon by TCM and acupuncture practitioners as well as retailers. Although we have grown quite large in this our 40th anniversary year we are still true to our roots. By viewing what we do as healers first and business people second we maintain the trust of our customers. We ve also made commitment to sustainability of herbs part of our mission so they will be available to 52 Nutrition Industry Executive Lau The phrase Ai Cao Yao which means love herbal remedies describes what is at the heart of our sourcing practices for herbs. It s responsible stewardship honoring the gifts of nature and using them responsibly. Our practices prevent over-harvesting and ensures quality. Specifically each herb is assessed to confirm it can be harvested sustainably and we support and are involved in organizations that do this. We identify the right region in which it should be grown for the activity we seek. We make sure it is collected at the proper time using the right techniques for the health of the plant and the herb s activity. We use processing methods that ensure the final product is safe and of high quality. Our rigorous safety and quality systems ensure we will have consistent results and storage practices ensure our products stay that way. Finally we choose partners that share these values many of which we have worked with since China was opened to outside trade. NIE Why did Nuherbs decide to have a scholarship program and how does one qualify Lau Nuherbs decided to launch a scholarship program because we wanted to support the future of TCM. We want to make sure that there will be a pipeline of qualified practitioners to share the wonders of TCM through their success. Based on our experience as practitioners we know that once people see the results that they themselves their friends and family have with TCM they become believers and advocates of TCM. When we launched the scholarship program we realized there was a dearth of scholarships for TCM students and we felt like it was something that we could commit to longterm. We believe that we have to support students practitioners and the profession so the ecosystem could thrive in the U.S. We can t be the future of TCM by ourselves it takes a whole community. It s also a way we can give back and share our success. NIE What is geo-authenticity and how does the company provide traceability Lau Geo-authenticity which in TCM is sometimes called Di Dao (authentic source) is the principle that herbs wildcrafted or cultivated where they naturally grow will have better potency and authenticity compared to those cultivated in non-native locations. The temperature soil terrain micro-climate and humidity all influence potency of the plant. Because of our longevity in the business we have established lasting relationships with growers are wildcrafters in these specific regions to ensure our supply. Because we get our herbs directly from our long-term partners we know exactly where they were grown. By sourcing herbs from us our customers participate to ensuring the future of these plants. www.niemagazine.com April 2019 Go to www.niemagazine.com plt for info about this advertiser Go to www.niemagazine.com olcott for info about this advertiser