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TOP STORY California State Assembly passes bill authorizing retail sales of CBD food supplements Deciding to not wait for the Food and Drug Administration to act, the California State Assembly recently passed a bill that would authorize the retail sale of hemp-derived cannabidiol (CBD)—a move intended to supplant a position adopted by health officials in 2018 that has caused a commotion. The bill now goes to the Senate, where proponents hope and expect to get the same kind of bipartisan support that helped it pass the Assembly. Read more→ UNPA NEWS
GOED, UNPA to host intentional adulteration seminar June 12 In the recent FDA draft guidance on mitigation strategies to protect food against intentional adulteration, which is part of FSMA, FDA defined Key Activity Types that are ‘significantly vulnerable.’ This rule requires a Food Defense Qualified Individual on staff as well as Food Defense Safety Plans. GOED and UNPA are offering a webinar June 12 (free to UNPA Executive Members; $99 for other members) to inform attendees about the rule. which will include a presentation by UNPA's Larisa Pavlick, a former FDA investigator. Need a PCQI? June 26-28 training with a DS, food and botanicals focus UNPA will conduct Preventive Controls Quality Individual (PCQI) training with a focus on dietary supplements, food and hemp-oil products and other botanically derived ingredients, June 26-28, in Westminster/Denver, Colo. Register today! Expert Insights OnDemand: Ten kinds of synthetic biology likely to affect your clean-label product Jim Thomas, co-director of ETC Group, provides a detailed look at 10 new and emerging genetic technologies that may impact the supply chain for food and dietary supplement ingredients. TRADE Trump administration opens exclusion process for List 3 China 301 Tariffs The Trump administration and U.S. Trade Representative have opened an exclusion process for List 3 China 301 tariffs, which encompass many ingredients used in the natural products industry. With the exclusion process, that fight is over, but the natural products industry was just hit with proposed List 4 China 301 tariffs. REGULATORY FDA official highlights noncompliance with dietary ingredients requirement, enforcement challenges Only a small fraction of the ingredient notifications required under DSHEA have been submitted to FDA since the 1990s, according to Office of Dietary Supplement Director Steven Tave. Tave, at the recent public meeting on dietary supplements on May 6, suggested his agency doesn’t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not. HEMP/CBD USDA issues legal opinion on authorities for hemp production In response to questions about hemp's legality, in particular concerning interstate transportation of hemp and who may obtain a license to produce hemp, USDA said that after it publishes regulations implementing the new hemp production provisions, states and Indian tribes may not prohibit the interstate transportation or shipment of hemp lawfully produced. In another notice, the agency clarified avenues for tribal participation under authorities in the 2014 farm bill to grow industrial hemp for research purposes during the 2019 growing season. TSA allows flyers to travel with CBD oil and drug derived from marijuana The Transportation Security Administration (TSA) has changed its cannabis policy to allow passengers to travel with some forms of CBD oil and a drug derived from marijuana that has been approved by FDA. All forms of marijuana were previously prohibited in carry-on bags and checked luggage. Hemp Industries Association launches ‘Hemp is legal ’ campaign in Times Square Hemp Industries Association is launching a national campaign aimed at addressing Facebook’s current advertising policy of prohibiting the marketing and promotion of industrial hemp via Facebook and Instagram. The current Facebook policy still classifies hemp as an illegal, prescription or recreational drug. New mouse study finds level of liver toxicity for CBD A recent study from the University of Arkansas for Medical Sciences has found a level of liver toxicity for CBD, putting up a big caveat to the notion within the hemp/CBD world that its products have nothing in the way of safety concerns. DSHEA AT 25 Will FDA change its definition of dietary ingredient? The current definition of a dietary substance in FDA’s 2016 draft guidance differs greatly from the definition of a dietary ingredient under DSHEA. If FDA stands by its definition in the draft guidance, it could mean that the agency might not give the thumbs-up to ingredients that aren’t regularly consumed in the diet or that aren’t nutritional in purpose. M&A ACTIVITY Solabia Group acquires Algatech Solabia Group announced its acquisition of Algatech Ltd., which specializes in the development, cultivation and commercialization of ingredients delivered from microalgae for supplement, food and cosmetic brands. The acquisition will allow the companies to benefit from an extended network and base of expertise, as well as new marketing channels and an expanded customer base. PARTNERSHIPS BASF and Glycosyn partnership to capitalize on HMO and gut-health interest BASF is to enter an agreement with biotechnology firm Glycosyn to commercialize human milk oligosaccharides (HMO) for use in dietary supplements, functional nutrition and medical food. GLOBAL REGULATORY Solgar Polska under investigation by Polish authorities over supplement price fixing Poland’s Office of Competition and Consumer Protection is to initiate proceedings against Solgar Polska after the authority accused the firm of supplement price-fixing within the country. Foods with Function Claims in Japan: Firms have benefitted most from the regulations FANCL, Nippon Suisan and Ezaki Glico are three of the biggest beneficiaries of Japan's Food with Function Claims. The regulatory category was introduced four years ago and gave firms more opportunities to make health claims without going through the more stringent Food for Specified Health Uses process. EC follows EFSA opinion and lowers vitamin D levels in infant formula The European Commission has amended regulation that dictates vitamin D and erucic acid requirements for infant and follow-on formulas. The update now requires infant formulas to contain a minimum of .48 micrograms per 100 kilojoules and erucic acid shall now exceed 0.4 percent of total fat content. ADULTERATION Adulterant to watch: Higenamine hazards in the sports supplements market In 2018, the World Anti-Doping Agency published findings on a substance called higenamine in unpredictable and potentially harmful quantities in some supplement products. Less than two years later, a peer-reviewed study documented inaccurately labeled and potentially harmful levels of the substance in weight-loss and sports/energy supplements available for purchase via the internet in the United States. BOTANICALS Setting the record straight: Botanical Safety Consortium is not involved in regulatory decisions, says consortium co-chair The main purpose of the Botanical Safety Consortium, a public-private effort bringing together stakeholders in the botanical supplement space, is “advancing the science of botanical safety evaluation [and is] not involved in making regulatory decisions,” said co-chair Cynthia Rider. RETAIL Amazon helps lift traffic for Whole Foods Amazon Prime is bringing more shoppers into Whole Foods Market stores, but traffic metrics from digital marketing firm inMarket show the retailers are still working out the omnichannel equation. SUSTAINABILITY From potatoes to coffee, plant breeders are changing crops to adapt to an uncertain climate future Crop scientists are working overtime to ensure that future populations are fed even as the effects of climate change continue wreaking havoc on once-predictable weather patterns. The hope lies in switching out favored grains, vegetables and fruits for warm-weather adapted varieties with less of a carbon footprint. COMMENTARY Growth of online sales threatens to create new division of industry unconcerned with today’s norms A new force is shaping the dietary supplement market, one that operates largely outside of normal industry channels. The growth of the online sales channel, and brands that operate exclusively in that space, is an increasingly powerful force, according to Nutraingredients-usa.com's Hank Schultz. UNPA MEMBER COMPANY NEWS Sensapure event addressed opportunities for product development In a collaborative effort with UNPA, Sensapure hosted a Salt Lake City event tapping into the world-class expertise of industry leaders to address four significant opportunities for product development in the nutraceutical/ sports nutrition industry. Speakers, such as Shawn Wells, CEO of Halo Research, and Joe Chang, science officer for NuSkin, provided thought-provoking insight on what’s next for the world of nutrition and beyond. Sabinsa Curcumin C3 Reduct self-affirmed GRAS After a comprehensive review of safety and toxicology data by an independent panel of scientists of international repute convened by Soni & Associates Inc., Sabinsa’s patented, color-free Curcumin C3 Reduct tetrahydrocurcuminoids, a metabolite of curcumin, has been found to meet criteria as Generally Recognized As Safe (GRAS) as per FDA’s scientific procedures. INNOVATION Danish researchers extract protein from seaweed: We have proven the principle Researchers from the Technical University of Denmark have discovered a way to extract proteins from three varieties of seaweed. The project, headed by Professor Charlotte Jacobsen, worked with ingredient supplier CP Kelco. MARKETING Expert vs. influencer: Network on a mission to empower the new generation of health experts Two nutrition scientists, who became angry about the number of social media celebs with more influence than health experts, have created a network to empower their colleagues to have a real impact on the future of nutrition. MARKET RESEARCH Dietary supplement sales growth rebounds six percent in 2018 U.S. supplement sales appear to be on a steady growth track, having shown 6 percent sales growth in 2018—a marked improvement over the 5.4 percent growth reported in 2017, according to NBJ data.This is notable for an industry that has now reached $46 billion in annual sales and is poised to surpass $50 billion annually by 2020. Weekend warriors driving sports nutrition market Whether it’s a Tough Mudder, a tri, or Monday-morning spin class, odds are that you or someone you know is sweating over something. The number of consumers thinking deliberately about how to fuel their engines has grown—and makers of sports-nutrition products find themselves facing a whole new set of mouths to feed. Pessimism increases among millennials; anxiety replaces weight as top concern Two new studies highlight the unique struggles of millennial and Gen Z consumers globally and in the U.S. Much of their pain stems from economics, with findings from the Deloitte Global Millennial Study underscoring that a dismal coming-of-age job market makes them keenly aware of how few financial goals they’ve accomplished, while a new report from the Hartman Group finds that stress and anxiety have taken over as these two cohorts’ top health concerns. RESEARCH Resveratrol’s blood pressure-lowering mechanism may explain potency British researchers looking into resveratrol’s blood pressure-lowering abilities believe the mechanism outlined in their study in the journal Circulation may be a common feature to explain the efficacy of 'antioxidant' molecules. ‘Public health significance’: DHA omega-3 linked to better artery health in general population Increased levels of omega-3s may be associated with less aortic calcification among men in the general population, with the effects seemingly driven by DHA (docosahexaenoic acid), according to a new study in Nutrition, Metabolism and Cardiovascular Diseases. Gut bacteria regulation a target for easing anxiety Probiotic and non-probiotic food and supplements that regulate gut microorganisms may ease a number of anxiety symptoms, according to a review from researchers in China. Levagen PEA shows benefits for knee osteoarthritis A new study published in the Inflammopharmacology Journal shows that Levagen, Gencor’s palmitoylethanolamide (PEA) extract, is safe and effective for knee osteoarthritis. Reactivation of PTEN tumor suppressor for cancer treatment through inhibition of an MYC-WWP1 inhibitory pathway PTEN is a critical tumor-suppressive phosphatase that is active in its dimer configuration at the plasma membrane. Researchers from Harvard identified indole-3-carbinol, a compound found in cruciferous vegetables, as a natural and potent WWP1 inhibitor, thus unraveling a potential therapeutic strategy for cancer prevention and treatment through PTEN reactivation. FDA WARNING LETTERS & GUIDANCES Current FDA enforcement actions and guidances Keep up to date on FDA’s current enforcement actions, including general warning letters, recall information and GMP compliance issues, with this link to FDA's website. Search and sign up for a variety of FDA Guidances. 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