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"Certain supply chain information is confidential between the supplier and retailer" and makes it difficult for FDA to release lists of retailers offering recalled supplements and foods, says Commissioner Scott Gottlieb. But a draft guidance says for some Class I cases, which pose reasonable probability of serious adverse health consequences or death, additional information about retailers selling potentially harmful product may be key to protecting consumers.
Ohio Board of Pharmacy proposes placing into Schedule I kratom constituent ingredients mitragynine and 7-hydroxymitragynine, a change that would prohibit kratom sales in the state. The board's findings "parrot the false propaganda" of FDA in its "crusade to ban kratom," says the American Kratom Association.
Memory Health supplement was developed and is launching in the US after a small European study of Alzheimer’s patients finds improvement in patients taking a carotenoid/omega-3 combination, says marketer Avantius Group. A larger-scale, double blinded clinical study is underway in Europe.
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Warning to contract manufacturer Avalon Packaging points out all but one of the problems that have dogged the kratom industry, including saying the herb's safety for its intended use should be proved to FDA before it is used in supplements and noting GMP problems, an area a kratom industry trade group discusses specifically in the standards program also published Nov. 20. While FDA also notes another problem kratom industry has wrestled with over past year, salmonella contamination, it doesn't allege Avalon's products are opioids.
Health, Beauty And Wellness Product Launches: CBD For Sleep, Menstrual Discomfort, Stemtech In Oral Care
HempMeds offers smaller RSHO options; Orgain emphasizes clean label; G-Cubed with superfoods for cardio health; Sleep gummies from Hemp Bombs; Medterra formulates CBD for menstrual symptoms; and Farlong line on VitaBeauti.
Health, Beauty And Wellness Business News: PepsiCo Incubates In Wellness, Cost-Cutting Spurs Profit At FitLife
Harvest Health in cannabidiol wellness with CBx Enterprises; MusclePharm revenues climb 12%; Celsius beverage sales up on retail expansion; CarnoSyn beta-alanine sales drive Natural Alternatives' growth; FitLife shows profit as cost-cutting continues; and PepsiCo incubates wellness start-ups.
Innovus acquires Boston Topicals' ThermoMax hand warming cream in hot and warm formulations, BreastLife with amino acids to firm and lift women's breasts and HealthiFeet made with Knosis transdermal delivery system in a formulation firm says has been shown in a trial to increase temperature and blood flow in feet of diabetic patients. HealthiFeet will complement a product Innovus already offers and targets for consumers with diabetes, Diabases leg and foot relief topical.
Democrats potentially could target tightening regulatory oversight of some industries after regaining a majority in House, but Trump administration's high priority on reducing regulatory burdens bodes well that legislation to expand FDA's current authorities over the US supplement sector will not emerge before Congress' next session opens in 2021. NJ Democrat Frank Pallone could be member of Congress most commonly mentioned and lobbied by supplement industry during next session as Energy and Commerce chairman.
Audit finds two of three memory supplements tested contain none or lower levels of active supplement than stated on labeling. In a report for current and previous ranking minority members of Senate Special Committee on Aging, GAO points to continuing issues with economic adulteration for gingko biloba.
ThermoLife Tries To Flex Litigation Muscle Against Nitrate Marketers In False Advertising Complaints
ThermoLife International files two false advertising complaints alleging competitors also marketing nitrate-based workout products deceive consumers and disparage its business. The company is seeking damages after setbacks in patent infringement complaints.
Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.
Council for Responsible Nutrition, Consumer Healthcare Products Association and Natural Products Association urge FDA to allow colony forming units on probiotic product labels while nixing current labeling regulation’s allowance of metric weight, as the measurement does not reflect live microbials.
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