A significant number of dietary supplement products remain available for purchase even after receiving warning letters from the U.S. Food and Drug Administration (FDA), according to a research letter published in the Journal of the American Medical Association.
The study was led by Dr. Pieter A. Cohen from Cambridge Health Alliance in Somerville, Massachusetts.
The research team investigated the frequency of drug recalls and the presence of FDA-prohibited drugs in supplements after the FDA issued warning letters.
The analysis focused on supplements that had been the subject of an FDA warning due to the presence of prohibited substances like the amphetamine analog β-methylphenethylamine, the ephedrine analog methylsynephrine, or the dimethylamylamine analog octodrine.
The FDA issued warning letters for 31 supplement products in total. Astonishingly, only one of these 31 products was recalled by the manufacturer.
On average, six years after the warning letters were issued, nine of the products (29 percent) were still available for purchase online.
Of these nine, four (44 percent) still listed at least one prohibited ingredient on the label. After conducting chemical analyses, five of the nine products were found to contain at least one FDA-prohibited ingredient.
Two products even contained the exact ingredient for which the FDA had issued the warning letter.
The researchers recommend that the FDA should consider more proactive measures to ensure that banned drugs are removed from supplements.
This could include testing products sold after warning letters have been issued and mandating recalls whenever products remain adulterated.
However, this study has also revealed a potential conflict of interest. One of the authors disclosed being the subject of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company.
This research raises serious concerns about the FDA’s ability to effectively regulate the dietary supplement industry and protect consumers from potentially dangerous substances.
Given that a considerable proportion of products remain available even after warning letters have been issued, there is a clear need for more stringent oversight and regulation of this industry.
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The study was published in JAMA Network Open.
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