Supplement Manufacturers Often Ignore FDA Warning Letters Madison.com Fitness, Sports Fitness & Fitness

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MONDAY, August 1, 2022 (HealthDay News) — A substantial proportion of the products remain available for purchase after the U.S. Food and Drug Administration issued a warning letter targeting specific supplement products, according to a research published in the July 26 issue. According to the letter. Journal of the American Medical Association,

Peter A., ​​MD, of the Cambridge Health Alliance in Somerville, Massachusetts. Cohen, and his colleagues examined the frequency of drug recalls and the presence of FDA-prohibited drugs in supplements following FDA warning letters. Dietary supplement products that were previously the subject of an FDA warning letter regarding the presence of the amphetamine analog β-methylphenethylamine, the ephedrine analog methylsynephrine, or the dimethylamylamine analog Octodrine were included.

The FDA issued warning letters regarding 31 supplement products. The researchers found that one of these 31 products had been recalled by the manufacturer. Six years after the issue of the warning letters, nine products (29 percent) remained available for purchase online. Of these nine products, four (44 percent) listed the presence of at least one prohibited ingredient on the label: one label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. After chemical analysis, five of the nine products were found to contain at least one FDA-restricted ingredient: four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued a warning letter.

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The authors write, “The FDA should consider ways to ensure that banned drugs are removed from supplements, perhaps by testing products sold after warning letters and recalling whenever products remain adulterated.” mandatory.”

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One author revealed to be the subject of a civil lawsuit brought by Hi-Tech Pharmaceuticals, a supplement company.

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