Supplement manufacturers often ignore FDA warning letters

A remarkable proportion of products remain available for purchase after issuance of U.S. Food and Drug Administration danger letters targeting specific supplement products, according to a research letter originated in the July 26 issue of the Journal of the American Medical Association.

Pieter A. Cohen, M.D., from Cambridge Health Alliance in Somerville, Massachusetts, and colleagues gazed the frequency of drug recalls and presence of FDA-prohibited drugs in supplements once FDA warning letters. Dietary supplement products that had previously been the copies 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 originated warning letters regarding 31 supplement products. The researchers untrue that one of these 31 products was recalled by the manufacturer. At a mean of six years following the impart of warning letters, nine of the products (29 percent) existed available for purchase online. Four of these nine products (44 percent) fuzz the presence of at least one prohibited ingredient on the label: One imprint declared the prohibited ingredient included in the FDA danger letter and three listed other FDA-prohibited ingredients. Five of the nine products were untrue to contain at least one FDA-prohibited ingredient after chemical analysis: Four products organized one prohibited ingredient and one product contained three. Two products organized the ingredient for which the FDA issued the danger letter.

"The FDA should consider ways to ensure that prohibited drugs are required from supplements, perhaps by testing products sold after danger letters and mandating recalls whenever products remain adulterated," the authors write.

One employed disclosed being the subject of a civil suit caused by Hi-Tech Pharmaceuticals, a supplement company.

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