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TOP STORY Report suggests octodrine may be the next DMAA-like ingredient in supplements Nutraingredients-usa.com, Clinical Toxicology A research report published in Clinical Toxicology and led by prominent supplement industry critic, Pieter Cohen, M.D., has found DMAA and three similar stimulant-like compounds in dietary supplement-like products purchased on the open market. After analysis, the products were found to contain the following ingredients: 2-amino 6 methylheptain (also called octodrine), 1.4-DMAA, 1,3- DMAA and 1,3 DMBA. Both DMAA and DMBA have been in FDA's crosshairs for a long while. The authors said they have been on the lookout for an ingredient that might be used used to replace DMAA in the market and suggest this may be it. Read coverage: Study finds 'next DMAA' in tainted sports, weight loss products Direct link to theClinical Toxicologyresearch article UNPA NEWS
UNPA's Larisa Pavlick to conduct FSMA workshop at 2018 GOED Exchange UNPA’s Larisa Pavlick will present a pre-conference workshop entitled “The Food Safety Modernization Act and What It Means to You," at the 2018 GOED Exchange. The workshop, which is free for GOED Exchange attendees, will cover two of the key rules affecting the industry, including the Preventive Controls for Human Food rule and the Foreign Supplier Verification Program. See "UNPA MEMBER DISCOUNTS" to the right for discounted registration information. Recently posted at unpa.com: Multi-trade association SARMs press release in support of FDA action against marketers of bodybuilding products containing these illegal ingredients and being sold as dietary supplements. ITC dismisses Amarin omega-3 complaint (Member log in required) FDA proposes dropping ‘authorized’ health claim for soy protein and reduced risk of heart disease (log in) FTC Update:President nominates two for FTC; third nomination likely soon (log in) About naturopathic medicine and link to frequently asked questions Larisa Pavlick's PPT presentation at the 2017 Rocky Mountain Dietary Supplement Forum, Oct. 10,in Boulder, Colo.: "FDA Top 10 Citations & Potential Solutions" (Log in) Loren Israelsen's PPT for his presentation at the FDA ODI meeting, Oct. 3, in College Park, Md. (Log in) The PPT for the UNPA Members' Meeting at the 2017 SupplySide West (log in) Updated PCQI FAQ Plus, updated industry events calendar, Member Memos (log in) and UNPA educational archives (log in). REGULATORY Trump order gives chance to reform regs; USDA seeks science-based approach to biotech regulations Natural Products INSIDER, USDA.gov The Trump administration is granting American businesses—including the supplement industry—an opportunity to seek elimination of, and changes to, regulations. FDA’s various centers have published notices requesting public comment on potential changes to its regulations to reduce regulatory burdens, while continuing to meet its obligations to protect public health. ODSP Director Steven Tave said the agency will be examining cGMPs and other regulations impacting the industry. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service announced it is withdrawing a proposed rule to revise the biotechnology regulations and will re-engage with stakeholders to determine the most effective, science-based approach for regulating products of modern biotechnology, while protecting plant health. Read coverage: Supplement industry has rare opportunity to seek regulatory reform→ USDA to re-engage stakeholders on revisions to biotechnology regulations→ REGULATORY FDA warns consumers about kratom FDA.gov, NPR.org In a statement from FDA Commissioner Scott Gottlieb, the agency has issued a public health advisory related to the FDA’s mounting concerns regarding risks associated with the use of kratom, emphasizing increasing concern given the critical point in the opioid epidemic. FDA raised safety issues such as seizures and liver damage, noting that there isn’t enough evidence that it’s an effective treatment for opioid addiction. UNPA has a no-sale policy for kratom among its members. Read coverage: Statement from FDA Commissioner, Scott Gottlieb, M.D., on FDA advisory about deadly risk associated with kratom→ FDA warns about dangers of natural opioid kratom→ M&A ACTIVITY Naturex improves position with Swedish Oat Fiber deal; Frutarom buys AB-Fortis business; RPI invests in ProTec Nutraingredients.com, Rosewood Private Investments Natural ingredients giant Naturex has confirmed the acquisition of specialized, oat-based extracts manufacturer Swedish Oat Fiber, as the company looks to accelerate the development of its specialty product portfolio. Frutarom Industries has agreed to buy the iron micro-encapsulation technology AB-Fortis from Spanish biotech company AB-Biotics. Senior executives for both parties suggest that the deal is a good fit given that Frutarom has held the license for the AB-Fortis product since 2012. Rosewood Private Investments has announced a majority equity investment in ProTec Laboratory, a leading provider of contract manufacturing services to consumer brands in the dietary supplements, sports nutrition, functional foods and pet care products industries. Read coverage: Naturex strengthens "natural nutrition" position with Swedish Oat Fiber deal→ Frutarom acquires iron microencapsulation patent from AB-Biotics→ Rosewood Private Investments announces majority investment in ProTec Laboratory→ FINANCIALS Nature’s Sunshine reports growth of 4.5 percent for Q3; Vitamin Shoppe takes writedown on losses in earnings release NASDAQ.com, Nutraingredients-usa.com Nature's Sunshine Products reported its financial results for the 3Q, including net sales of $89.3 million, an increase of 4.5 percent year-over-year, and net income of $2.4 million attributable to common shareholders. Increased competition in the sports nutrition space caused dietary supplement retailer Vitamin Shoppe to report its biggest loss since going public in 2009 and sent its share price reeling. The New Jersey-based retailer reported a $106 million goodwill writedown in its latest earnings release. Read coverage: Nature’s Sunshine Products reports third quarter 2017 financial results→ Vitamin Shoppe takes $106 million writedown, reports massive loss→ OBITUARY Industry mourns loss of Terry Dalton, Miami retail pioneerNew Hope Network Natural products retail pioneer Terry Dalton, founder of the Unicorn Village in Miami, a seminal natural foods business in the 1980s and 1990s, passed away last week from head injuries suffered in a bicycling accident. With the Unicorn Village Natural Marketplace and Restaurant, and later Sublime Vegan Restaurant, Dalton brought sophisticated hipness, financial savvy and customers in droves to his full-service natural foods supermarket and restaurant. Read more→ LEGAL USPLabs entangled in case between GNC and Oregon AGNatural Products INSIDER USPlabs LLC, the dietary supplement company facing criminal charges in Texas, has found itself in the crosshairs of a lawsuit brought against one of its former retail customers by Oregon Attorney General Ellen Rosenblum. In response to the lawsuit, alleging that GNC sold products with several controversial ingredients, the retailer has laid the blame on third parties—including USPlabs. Read more→ PRODUCT TESTING USP test showed only one in four Reishi products as genuine Nutraingredients.comOnly five out of 19 supplement products labeled as Reishi mushroom purchased in the U.S. could be verified as genuine Reishi mushroom, according to a new study from the USP and the University of Macau, China. The study was designed to highlight quality issues in the category. Read more→ REGULATORY Surveillance of adverse events for dietary supplementsRegulatory Affairs Professional Society This article, by Rick Kingston of UNPA member Safety Call,discusses past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. It also focuses on the value of post-market surveillance to protect consumers and defines and clarifies the regulatory professional's role in communicating product safety as technology continues to expand data access. Read more→ SELF-REGULATORY STANDARDS GRMA nears completion of national supplier audit standardsNutraceuticals World The Global Retailer and Manufacturer Alliance, a member-based organization with broad industry support from more than 30 major retailers in the grocery, drug, mass merchandiser, club store channels and manufacturers, is in the final stages of completing a comprehensive set of consensus-based standards for the auditing and inspection of suppliers and manufacturers. Thestandards will cover dietary supplements, over-the-counter pharmaceuticals, cosmeticsand medical devices. Read more→ GLOBAL REGULATORY New recommendations to help companies in submitting claims to EUNutraingredients.com A set of recommendations developed by researchers may assist companies in the task of submitting new health claims to the European Union. The guidelines aim to clarify the European Commission legislative framework on functional food health claims and are the outcome of a recent study published in Trends in Food Science and Technology. Read more→ BOTANICALS The disappearing art of wildcrafting; forest farming may be sustainable alternative to wildcraftingNew Hope Network, Nutraingredients-usa,com This article provides a look into the vulnerable supply chain of wild-harvested botanicals and theart of wildcrafting. Beyond the threat of extinction from the human and cultural component, ecosystems are also threatened. This profile includes comments from noted experts in the herbal world, including Roy Upton of AHP, and Trish Flaster of UNPA member Botanical Liaisons. An innovative program administered through a Virginia university is fostering a model for increasing supply chain quality and transparency of wild botanicals via the cultivation of forest botanicals in situ. The concept is called forest farming and is aimed at understory botanicals. Read coverage: The wild world of wildcrafting→ Forest farming seen as sustainable alternative to wildcrafting→ ORGANICS Increasing organic acreage signals maturing U.S. market; NOP issues interim instructions for organic importsFoodnavigator-usa.com, FDALawBlog Double-digit increases in acreage for organic grainsand in soy and corn, in particular, signal the industry is maturing and the U.S. could soon be able to rely on domestic production to meet growing demand for organic products, according to a new report from Mercaris. The integrity of imported organic products has been questioned as international supply chains become increasingly complex and frequently involve a number of businesses, which may be certified under different programs. To address the confusion, the USDA AMS National Organic Program announced the availability of new interim instructions regarding import of organic products. They are intended to clarify and strengthen compliance with existing regulations applicable to imports. Read coverage: High increases in organic production signals a maturing of the American market→ NOP issues interim instruction regarding organic imports→ MEDIA WATCH Could melatonin prove too good to be true?MotherJones An estimated 50 to 70 million Americans have a sleep disorder, and more and more are turning to melatonin for relief. Though it has gained a reputation as a safe, natural remedy, especially compared with habit-forming drugs, the story trots out the old warhorsethat melatonin is not regulated like a drug, and has not been tested to make sure it’s safe for long-term use. The article concludes that when it comes to questions about how much of the hormone to take, consumers are still largely in the dark. Read more→ UNPA MEMBER NEWS PLT receives non-GMO verification for algal DHA lineNutraceuticals World PLT Health Solutions has received non-GMO verification from the Non-GMO Project for its élantria Algal DHA line of ingredients. The verification covered raw materials, manufacturing processes and logistics. It is the first commercially available algal DHA to have verified non-GMO status in the U.S., according to information from the Non-GMO Project. Introduced in the U.S. market by PLT in June of 2016, élantria Algal DHA has been shown to be up to four times more stable than conventionally stabilized algal DHA. Read more→NOW’s Nevada plant has a health-conscious missionNorthern Nevada Business Weekly In a 170,000-square-foot facility in Sparks, Nev., some 300 workers lend a hand to production, packaging and distributionof NOW vitamins, supplements and natural food products. And then there’s the $40 million worth of analytical equipment for testing and quality assurance. The new plant supports NOW’s health mission as well as helping to meet demand for the company, which has seen double-digit growth for the past three years, according to CEO Jim Emme. Read more→ MegaFood becomes first licensee of Tespo dispenser, pod systemNutritional Outlook Within a year of launching its patent-pending dispenser-and-pod system—designed to make dietary supplementation easier for all—Plymouth, Mich.-based health and wellness technology company Tespo announced both the launch of its Tespo Licensing Program and its agreement with MegaFood to become the first licensee of the system. MegaFood will commence selling four of its current supplements using Tespo’s latest dispenser beginning next year. Read more→ RETAIL Will local brands take a hit as Whole Foods streamlines sourcing?Adweek Streamlining processes and improving efficiency are likely goals for Whole Foods Market under Amazon, but where does local sourcing fit into that? A spokeswoman for the company said that the goal is to use local suppliers in the categories where they “will be successful and positioned for growth.” Meanwhile, national and regional chains, such as Kroger and Wegmans, are upping their local game. Read more→ MARKETING Lessons learned from the Keurig rebuke of Fox's Hannity showMediaPost If there is any lesson to be gleaned from the controversy that overtook Keurig last week, when it dropped ads from Fox News after Sean Hannity’s interview with Alabama senatorial candidate Roy Moore, it’s that a potential backlash might be waiting around any corner. And in today’s politically charged climate, it’s likely to move swiftly. Suggests that in these politically divisive times, "business as usual" is a new paradigm, in which power has shifted to the consumer. Read more→ MARKET RESEARCH Innova report notes mindful consumer choices will drive food trends in 2018Nutraceuticals World The increasingly thoughtful and mindful consumer will continue to catalyze changes in the way that companies produce, packageand label their products, according to a 2018 trends forecast from Innova Market Insights. More conscious than ever about making responsible food choices, four in 10 U.S. and U.K. consumers increased their consumption of “healthy foods,” seven in 10 want to know and understand the ingredient list, and one in five in the U.S. are most influenced by “real” ingredients. Read more→ RESEARCH K2 improves artery health; omega-3, 6 may fight ADHA; beta-alanine combats fatigue; aloe has prebiotic potentialNew Hope Network, Nutraingredients.com, Nutraingredients-usa.com A new human clinical study published in the Journal of the American Society of Hypertension reaffirmed vitamin K2’s ability to improve arterial stiffness. Those arteries are hardened by calcium, and the menaquinone-7 form of vitamin K2 works by controlling calcium to activate the body’s K2-dependent proteins to shuttle calcium to the proper areas—out of the blood vessels and into bones. A combination of omega 3 and 6 fatty acids may have a supporting role alongside other therapies for ADHD, according to a review article from the Journal of Lipids. Researchers from the University of Central Florida have found the anti-fatigue effects of beta-alanine, the rate limiting precursor of carnosine, apply to both men and womenirrespective of baseline carnosine levels. Polysaccharides fromAloe vera may boost the growth of beneficial gut bacteria such as Bifidobacterium spp and Lactobacillus spp, says a new study from Chile that supports the prebiotic potential of the compounds. Read coverage: K2 ascends the mountain of letter vitamins→ Omega fatty acid blend shows promise in tackling ADHD→ Study supports beta-alanine supplementation for less fatigue→ Study supports prebiotics potential of aloe vera polysaccharides→ FDA WARNING LETTERS & GUIDANCES Current FDA enforcement actions and guidancesKeep 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. Read more→ Comments are closed.
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