US Marketers Exploiting Growing Probiotics Demand Warned About Disease, Anxiety Claims
FDA warnings indicate marketers are looking to take advantage of growing demand for probiotics with disease treatment claims and also pitching herbal remedies to consumers to alleviate anxiety, depression and insomnia. New York firm offers OTC sales of injectable serums for skin toning.
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Kyowa Hakka offers Immuse paraprobiotic to activate the plasmacytoid dendritic cells in small intestine while most other probiotics work in large intestine. GOLO's Go-Digest supplement promotes healthy microflora in gut to support overall health.
Anytime COVID Test marketed home-use test without FDA approval or EUA and promoted it with an FDA logo and a “clinical trial number.” Warning letter says “your presentation conveys the misimpression that the product has been approved, cleared, authorized, endorsed or otherwise evaluated by FDA.”
The Congressional Research Service published a dietary supplements report on 20 September that provides an overview of the industry and current regulatory issues, including ‘limitations’ in the US FDA’s authority over supplements and, in particular, the absence of mandatory product listing.