Supplement Manufacturers Often Ignore FDA Warning Letters | Health, Medicine and Fitness
Physician Information Staff
MONDAY, Aug. 1, 2022 (HealthDay News) — Considerable proportion of products remain available for purchase after U.S. Food and Drug Administration issued warning letters targeting specific supplements, research letter says published in the July 26 issue of Journal of the American Medical Association.
Pieter A. Cohen, MD, of Cambridge Health Alliance in Somerville, Massachusetts, and colleagues looked at the frequency of drug recalls and the presence of FDA-banned drugs in supplements after FDA warning letters. Dietary supplements that have previously been the subject of an FDA warning letter regarding the presence of the amphetamine analog β-methylphenethylamine, the ephedrine analog methylsynephrine, or octodrine, an analogue of dimethylamylamine, were included.
The FDA has issued warning letters regarding 31 supplement products. Researchers found that one of these 31 products had been recalled by the manufacturer. On average six years after the warning letters were issued, nine of the products (29%) remained available for purchase online. Four of these nine products (44%) indicated the presence of at least one prohibited ingredient on the label: one label declared the prohibited ingredient included in the warning letter from the FDA and three listed other ingredients prohibited by the FDA. Five of the nine products contained at least one ingredient prohibited by the FDA after chemical analysis: four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.
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“The FDA should consider ways to ensure that banned drugs are removed from supplements, perhaps by testing products sold after warning letters and imposing recalls whenever products remain adulterated,” the authors write. authors.
One author revealed that they were the subject of a civil lawsuit filed by Hi-Tech Pharmaceuticals, a supplement company.