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REGULATORY Winckler: FDA to maintain enforcement under Trump, although state AGs ready if needed Nutraingredients-usa.com At least in the short term, the pace of FDA enforcement is not likely to change with the Trump Administration, according to former FDA Chief of Staff Susan Winckler, who is now chief risk management officer at Leavitt Partners. Winckler, who spoke at UNPA's recent NDI conference in Salt Lake City, noted that regardless of who Trump appoints to lead the FDA, most of its institutional DNA remains and that if FDA has difficulty addressing any issues, other authorities, such as state AGs, are ready to step in. Read more→ UNPA NEWS
Regulatory Update #3: FDA Inspections, Part IIThis second part of a primer on FDA inspections by UNPA's Larisa Pavlick addresses frequency of inspections, how the agency determines risk, how companies can best anticipate inspector expectations and a list of resources. Requires UNPA member log in to view. Read more→ Next Thursday! UNPA's members' meeting at Expo WestUnited Natural Products Alliance RSVP today for UNPA's annual members' meeting at Natural Products Expo West, to be heldThursday, March 9, from8-8:50 a.m., in Room 201D of the Anaheim Convention Center.The meeting isopen to UNPA members and invited guests, and there is no charge to attend. NOTE: You'll need your show badge and ID to gain access to the convention centerThursdaymorning. Learn more andRSVP→ Register for ICSB, CHPA Dietary Supplements SeminarRegistration is open for the following conferences, both of which are sponsored, in part, by UNPA. UNPA's Larisa Pavlick is speaking at ICSB. International Conference on the Science of Botanicals, April 3-6, Oxford, Miss. CHPA Dietary Supplement Seminar, May 10, NorthBethesda, Md. (UNPA member discount available) Recently posted at unpa.com: FDA Inspections 101 by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance (requires log in) The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295 Border Tax Memo by Patricia Knight and Peter Reinecke, UNPA Senior Political Advisors (log in) U.S. Dept. of Commerce international buyer services program at Expo West (log in) FDA meeting with Cara Welch & Steven Tave, summary by Larisa Pavlick (log in) Tablet & Encapsulation Equipment and DEA, report and regulatory resources by Larisa Pavlick (log in) "Three Myths About Dietary Supplements … and How Knowing the Right Answers Is Good for Your Integrative Medicine Practice," article by Loren Israelsen and Frank Lampe Plus, updated industry events calendar,Member Memos(log in) and UNPA educational archives (log in).LEGAL FTC, Maine AG target marketers of joint, memory supplements; GMOs and 'natural' labeling case may headto Supreme CourtNaturalProductsINSIDER, Foodnavigator.com FTC and the Maine AG have announced a lawsuit against nine defendants accused of using false and misleading advertisingto market supplements for back and joint pain and memory improvements. So far, five companies have agreed to injunctions against making unfounded claims and agreed to cite competent and reliable science for future claims. POM vs. Coke was heard by the Supreme Court, but now the industry may see another high profile case reach the high court: Briseno vs. ConAgra -- this time over GMOs and "100-percent natural" labels. Read coverage: FTC, Maine AG target marketers of memory improvement→ Will the ConAgra 100 percent natural case end up in the Supreme Court?→FEDERAL POLICY Industry awaits fallout from tax and tariff changes, ponders impact to ingredient sourcingNutraingredients-usa.com, Nutritional Outlook Questions about border walls, new tariffs and the volatile nature of the Trump Administration has companies in the dietary supplement industry anxiously reading the tea leaves of tax policy as tax reform gains new momentum. Among other things the new plan could overhaul how taxes are assessed on products that cross the border. The consensus: the global sourcing of ingredients is one area where the president’s policies could directly impact the industry. Read coverage: Industry awaits fallout of potentially big tax and tariff changes under GOP leadership→ How will Donald Trump affect global ingredient sourcing→REGULATORY FDA carefully weighing vinpocetine commentsNutraingredients-usa.com FDA has received more than 800 comments about vinpocetine as the agency continues to assess its regulatory status. Despite five positive NDI notifications back in the '90s, the agency continues to suggest it is not a dietary ingredient.Read more→REGULATORY FDA calls meeting to discuss use of the term ‘healthy’FDALawBlog FDA has announced it will hold a public meeting to give interested persons the chance to discuss use of the term “healthy” on products. The meeting may help inform FDA on future rulemaking, but it remains to be seen whether any activity could move forward given the Trump Administration’s application of its recent Executive Order on rulemaking.Read more→ORGANIC Organic industry prioritizes research, consumer education for 2018 Farm BillFoodnavigator-usa.com Increased funding for research to improve production tops the organic industry’s wish list of policy actions that it wants legislators and regulators to consider as they begin in earnest the long process of reauthorizing the 2018 Farm Bill.Other top priorities are funding for consumer education, access to land programs, consistent application of organic standards and transparency into benefits for farmers.Read more→PRODUCT TESTING Analytical labs say the more information the better in working with clients; ConsumerLab.com finds B vitamin products inconsistentNutraingredients-usa.com, Nutraceuticals World “Don’t be shy. Tell me everything.” As part of this series on how supplement companies can work with contractors, this article provides insight from analytical labs such as UNPA members Alkemist Labs, Covance Laboratories and Flora Research Laboratories as well as ChromaDex. Based on the results of a recent test by ConsumerLab.com of 49 B vitamin and B-complex products, the labels may be misleading. The company found discrepancies between label information and what is actually in the supplement for three products. Read coverage: More information is always better in working with analytical labs, service providers say→ ConsumerLab.com evaluates B vitamin supplements→PRODUCT CLAIMS Experts offer pitfalls in marketing claims for products addressing blood sugar managementNutraingredients-usa.com Marketing the benefits for supplements in the blood-sugar-management category is a matter of carefully crafting claims to make sure there’s substantiating science and that claims comply with FDA and FTC standards, according to speakers at last week’s Blood Sugar Management Forum. Ivan Wasserman of UNPA member Amin Talati Upadhye LLC noted common pitfalls and questions of marketing and claims substantiation.Read more→FINANCIALS Herbalife announces joint venture with TCM products and Tasly Group in wake of flat 2016Nutraingredients-asia.com In reporting flat FY2016 sales, Herbalife announced its agreement in principle to form a joint venture with Traditional Chinese Medicine products and services firm Tasly Holding Group that will commercialize high-quality consumer health products based on Tasly’s portfolio of patents, proprietary formulations, know-hows and clinical studies.Read more→ GLOBAL REGULATORY Botanical backlog prompts industry to ponder motives of EU regulationNutraingredients.com Belgium released its third update to the BELFRIT (Belgium, France, Italy) list of approved botanicals, while a list of more than 2,000 health claims are still awaiting approval by the European Commission. The backlog for some botanicals has stretched out for as long as seven years and is leading industry to wonder if the Nutrition and Health claims regulation is meant to discourage innovation.Read more→UNPA MEMBER NEWS CRB appoints Ryan Schroeder as president in succession plan;NBJ publishes second annual 'Dark' issueCRB, NewHopeNetwork Engineering-solutions company CRB has announce that Ryan Schroeder has been elevated to the role of president to oversee worldwide operations and the performance of all CRB business units. Schroeder began as a young engineer with CRB in 1988 and has moved up through the ranks to leadership positions. CEO and Chairman Jeffrey Biskup will remain in his position to work closely with and help guide the direction of the company until his eventual retirement.Read more→ Read this preview ofNutrition Business Journal'sDark Issue 2, which will illuminate some of the shadier corners of the supplements industry, including sloppy science and peer review, and questions about nanotechnology and kratom. Also learn how to participate in the future.Read more→MOU PARTNERS NEWS ABC’s Blumenthal wins international ethnopharmacology awardNutraingredients-usa.com ABC’s founder and director, Mark Blumenthal, has added to his list of accolades with recognition from the Society of Ethnopharmacology in India, which awarded him the International Ethnopharmacologist of the Year title at the society’s recent scientific conference in Surat, Gujerat, India. Ethnopharmacology is a branch of ethnobotany and pharmacology focused on traditional knowledge and customs, concerning medicinal substances, especially those of plant origin.Read more→MARKET RESEARCH Trump presidency may spur new focus on staying healthy; vitamin D remains top supplement; store brands outpace national brands in key retailersNaturalProductsINSIDER, Nutraceuticals World NMI analyst Steve French provides details from a recent study of how Americans have been impacted by the results of the recent elections and how they say it is affecting their health and wellness attitudes. French noted that the current uncertainty about healthcare is prompting more consumers to look for ways to stay healthy. Probiotics have replaced multivitamins as the fourth most popular supplements behindvitamin D, fish oil and CoQ10in a recent survey from ConsumerLab of more than 9,500 supplement users. Other supplements rounding out the top 10 include B vitamins, magnesium, curcumin/turmeric, vitamin C and calcium.Store brands are gaining market share against the big national brands in America’s fastest growing mass merchandiser retail channels, according to the latest sales statistics from Nielsen. Read coverage: Trump presidency’s effect on health and wellness→ Vitamin D maintains popularity among supplement users→ Store brands gaining share in US retail channels→RESEARCH Omega-3s for asthma; chickpea potential; lychee aids cognition; white mulberry for diabetes; omegas decrease mortality; gut bacteria and inflammationNewHopeNetwork, Nutraingredients.com, Nutraceuticals World Omega-3s reduce the production of allergy and asthma-producing antibodies—but don’t work well if used with steroids, according to new research from the University of Rochester Medical Center. Ciceritol extracted from chickpeas has prebiotic potential, with a new study from China showing it can boost the microflora of the colon and promote the production of short-chain fatty acids (SCFA).Saponins extracted from lychee seeds helped improve cognitive function and prevented neuronal injury in rats induced with Alzheimer’s disease, according to a new study from Southwest Medical University in Sichuan, China. Two fractions of polysaccharides extracted from white mulberry have been found to relieve symptoms of diabetes in a study on rats from China. Women with a high omega-3 status are up to 20 percent less likely to die from any cause, compared to those with low levels of DHA and EPA, according to a new study published in the Journal of Clinical Lipidology. Gut inflammation correlates with a change in the nutrients available to bacteria, according to a study led by UT Southwestern Medical Center. The findings may lead to development of new prevention and treatment strategies for IBD. Read coverage: Scientists discover more about omega’s asthma fighting potential→ Chickpea extract a potential prebiotic: China study shows microflora and short chain fatty acid benefits→ Lychee and Alzheimer’s: Saponins boost rats' cognitive function almost as effectively as drug→ White mulberry extracts clearly relieve diabetes symptoms in rat model: Study→ Omega-3 could decrease mortality rate in post menopausal women, study suggests→ Researchers identify mechanisms behind changes in gut bacteria during inflammation→ Comments are closed.
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