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TOP STORY Researchers identify nearly 800 ‘supplements’ in FDA database as tainted As reported earlier this week by UNPA, through an analysis of an FDA database, researchers from California have identified nearly 800 products marketed as "supplements" but adulterated with unapproved pharmaceutical ingredients. The study prompted critics of the industry to once again call for reforms to DSHEA. Commenting on the study and industry response, NBJ's Rick Polito notes that “reading the same headlines and expecting different results is insanity. Reading the same headlines and responding the same way is closer to complicity.” Read coverage: Researchers find nearly 800 ‘supplements’ in FDA database identified as tainted with drug ingredients→ Supplement spiked with drugs: Perennial headlines and predictable responses→ Unapproved pharmaceutical ingredients included in dietary supplements associated with U.S. Food and Drug Administration warnings→ UNPA NEWS
UNPA announces new PCQI training, Dec. 5-7, in Lehi, Utah NEW! UNPA announces a new Preventive Controls for Human Food and Dietary Supplements: PCQI Training, scheduled for Dec. 5-7, in Lehi, Utah. This training is certified by FSPCA in cooperation with FDA and is an integral and necessary requirement of FSMA. UNPA member discount for AHPA Botanical Congress at SSW UNPA has collaborated with the American Herbal Products Association (AHPA) to extend AHPA member pricing to UNPA members for the 7th Annual AHPA Botanical Congress, to be held on Saturday, Nov. 10, at the SupplySide West trade show in Las Vegas. UNPA members register using the code "BotConUNPA" during checkout at the AHPA website. NEW UNPA education and events! See "UNPA Events" in the right column for information and links to a number of new UNPA fall/winter events, including a growing list of OnDemand education and webinars. TRADE Natural products industry eyes exclusions, new sources for China tariff relief The latest round of implemented tariffs includes many dietary ingredients, leaving the industry seeking exclusions and new non-China sources. REGULATORY Registration requirement of dietary supplements in Arizona causes stir The Arizona State Board of Pharmacy has begun interpreting its authority in a way that implies practically every manufacturer and marketer of dietary supplements in the state must register as a nonprescription drug facility, according to the American Herbal Products Association. AHPA expressed alarm over the interpretation and warned it could significantly disrupt dietary supplement business in the state. Ohio pushes kratom ban with disputed claims about deaths, use trends State officials have linked the herbal supplement to six deaths and claim most users are injecting it. A leading kratom scientist disagrees. Probiotics and the impact of FSMA With FSMA, FDA was tasked with modernizing the food safety system for foods intended for consumption in the United States. In addition to all foods, the new regulations include all dietary supplements and ingredients, including probiotic products. Learn more in this excerpt from “The Food Safety Modernization Act’s impact on probiotics, ” featuring UNPA’s Larisa Pavlick. LEGAL The rising prevalence of dietary supplement class-action lawsuits There has been a rise of another type of claim in the dietary supplement industry, one that is often more damaging and expensive than a personal injury claim—the class-action lawsuit based on a false advertising or a misbranding theory. Judge moves to grant Monsanto a retrial A San Francisco judge has moved to grant Monsanto a new trial after the August verdict finding that the glyphosate in its RoundUp product had caused Dewayne Johnson’s non-Hodgkin lymphoma. The judge cited “insufficiency of the evidence to justify the award for punitive damages,” according to The Guardian, but is waiting to hear additional arguments before making a final decision. ORGANIC USDA unveils new technology for organic exports USDA has launched a new organic module in its Electronic Trade Document Exchange System to submit and approve organic export certificates online and send them to four foreign trading partners. The technology will help facilitate international trade for U.S. farms and businesses wanting to export organic products. What are you really getting for organic apples? Safe working conditions for farmers, says Organic Center In this response to the AgDaily OpEd entitled, “What are you really getting from organic apples?,” the Organic Center says it is extremely misleading and mischaracterizes pesticide use on organic and conventional farms. The author conflates brand name products with generic chemicals and shows a basic lack of understanding of organic farming practices, the group says. ANALYSIS Vitamin D and bone health: The flawed logic of RCTs for vitamins It was supposed to be the final word on vitamin D for bone health, but a new meta-analysis does more to illustrate the flaws in applying a drug model to essential nutrients than it does to dismiss the potential bone health benefits of the sunshine vitamin. GLOBAL REGULATORY EC to award first health claim for combined effects of nutrients for lowering cholesterol The European Commission intends to authorize for the first time a health claim arising from the combined effects of a number of substances, in a decision that affects firms backing the synergistic effect of nutrients in their products. Italian authorities fine Life120 over €500,000 for illicit supplement promotion Italy’s Competition and Market Authority has fined lifestyle firm Life120 more than €500,000 after the company was found guilty of making false claims and employing non-transparent methods in promoting its food supplement range. RETAIL Amazon launches second line of supplements but something’s missing—transparency Earlier this year, Amazon launched a second line of supplements as part of its Solimo brand. The Solimo line contains none of the transparency initiatives of the Amazon Elements supplements line launched a year prior. HEMP/CANNABIS/CBD CBD product sales to reach $646 million by 2022, says Hemp Business Journal According to hemp-advocacy group Vote Hemp, the CBD product category has grown an enormous 404 percent since the Farm Bill passed in 2014—a bill which included a section called “Legitimacy of Industrial Hemp Research” and allowed agricultural pilot programs for the growth of hemp by institutions of higher education and state departments of agriculture. What is the regulatory status of CBD in food and beverage products? If you ask FDA or DEA if CBD is permitted in foods, beverages and supplements, the answer is a pretty unequivocal "no." If you ask the scores of companies currently selling it in everything from CBD-infused soda to smoothie kits, the answer is "yes." So what’s going on? Over half of consumers interested in cannabis-enhanced food products, research shows As the laws legalizing the use of cannabis shift in North America, consumer interest and readiness to try cannabis-infused products is also evolving, according to recent research by A.T. Kearney. PRODUCT CLAIMS Getting substantiation right for claims especially important in healthy aging market Making claims on products in the healthy aging sector is fraught with peril, as older adults, along with children, are seen as the most vulnerable populations, an says Katie Bond, an attorney with UNPA member Amin Talati Updahye. PERSONAL CARE Use of green beauty brands on the rise Clean beauty options have never been more plentiful, and big brands are taking notice. So while the definition of “clean” beauty varies from person to person, the evident movement toward greater transparency and safer alternatives is something everyone can stand behind. INNOVATION Effective vitamin delivery via gum is an issue worth chewing over, suggests study Chewing gum remains an effective vitamin delivery system for manufacturers such as Get More, Vitamize and U.S.-based Vitaball. The companies’ sponsored a study looking into gum’s potential to address vitamin deficiency. Adaptogens, antioxidants: Latest trends in healthy-aging innovation Botanicals taken from the Ayurvedic tradition hold great promise in the healthy aging category, a product development expert says. New enzyme improves protein solubility in low pH levels Enzyme supplier Amano Enzyme has introduced a new enzyme that it says improves the solubility of protein ingredients at low-pH levels. This is important because proteins typically do not perform well in low-pH environments, the company says. MARKETING Bad buzzwords: Cut ‘cutting-edge’ out of marketing materials How often do you tout your company’s “bleeding-edge” technology—which, you proudly add, is “disruptive” of your product category? Using such buzzwords is likely to turn off prospective clients, according to a study of more than 1,000 B2B U.S. “decision makers” by San Francisco-based PR firm Bospar, conducted by Propeller Insights. Millennial marketing: Life before the ‘fidget spinner’ The way a product is marketed is extremely important to a millennial, but being transparent is even more important when it comes to realizing the buying power of a millennial. Who me? Using the person’s name in the subject line Here’s a surefire way to break through inbox clutter: Put the person’s name in the subject line. That tactic will boost clicks even when the content is “not particularly informative,” according to research conducted by a team of academics, as summarized by the Chicago Booth Review. MARKET RESEARCH U.S. herbal supplement sales are breaking records: Here’s why In the annals of “What’s Old Is New Again,” you would be hard-pressed to find a better case study than herbal and botanical ingredients. For despite the fact that these plant parts and preparations thereof have been rooted in traditional medical systems for millennia, the convergence of contemporary science and a passion for all things “natural” has shot herbal and botanical dietary supplements onto center stage. RESEARCH Whey helps older subjects recover from muscle loss, but collagen does not A new study has found that whey protein supports the recovery from muscle loss among elderly subjects better than do collagen peptides. But neither protein helped prevent the muscle loss in the first place. Pine bark extract may help post-thrombotic syndrome and recurrent thrombosis Pine bark extract (Pycnogenol by Horphag Research) may reduce the incidence of post-thrombotic syndrome following deep vein thrombosis, and recurrent deep vein thrombosis, according to a recently published study. Prebiotic research going beyond the gut Studies are further highlighting several beneficial clinical outcomes associated with prebiotic intake, not only for digestive health but for other purposes, including supporting metabolic, brain and heart health. Some of the latest research is reviewed here. Nitrate-rich fruit and vegetable extract show blood pressure benefits for healthy men Supplements containing nitrate-rich extracts from beetroot, celery stem and leaf and red spinach leaf may help reduce blood pressure, according to a new study published in the Journal of Nutrition and Metabolism. Could probiotic strain help stop fatal 'super-bug' infections? A bacterial strain found in many probiotic products could help fight bacteria linked to potentially fatal MRSA infections, say researchers from the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases. 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. Comments are closed.
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