October 22, 2014 — JAMA has published a study suggesting that many dietary supplements the FDA recalls because they contain dangerous ingredients return to store shelves within months, and often with the same ingredients — or additional banned ingredients.
The author of the study, Dr. Pieter A. Cohen, is an assistant professor at Harvard Medical School who has published several studies exposing dangerous ingredients in supplements — most recently DMBA, a stimulant he found in 12 supplements that is nearly identical to DMAA, which the FDA banned in 2012.
Between January 2009 and December 2012, the FDA recalled 274 dietary supplements. Many of these supplements were re-introduced to the market with identical packaging or only slight changes to their brand-name, label, and/or ingredients.
Dr. Cohen and colleagues purchased 27 products that were apparently identical and still available about one year after they were recalled. Researchers used the same analytical methods that the FDA’s field laboratories use to look for illegal ingredients:
“We found that 66.7% of recalled supplements still available for purchase at least 6 months after FDA recalls remained adulterated with banned ingredients.”
About 85% of supplements for sports-enhancement remained adulterated with banned ingredients one year later.
Shockingly, 6 out of 27 (22.2%) of the recalled supplements were re-introduced with 1 or more additional banned ingredients that were not identified by the FDA. Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.
The researchers warned that action by the FDA has not been effective at eliminating potentially dangerous supplements. More aggressive enforcement of the law, changes to increase the FDA’s enforcement powers, or both may be necessary to prevent sales of these products in the future, the researchers concluded.
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