Many of the dietary supplements that FDA recalled for containing banned drugs returned to the market containing the same substances within months or years of the recall, according to a study published Wednesday in JAMA.
Under the Dietary Supplement Health and Education Act, manufacturers do not need FDA approval to sell dietary supplements, nor do they need to show proof that their supplements contain the ingredients listed on their labels.
According to the New York Times' "Well" blog, the supplements are "considered safe until proven otherwise" and are usually only recalled after complaints of injury. Overall, about 50% of FDA drug recalls since 2004 have involved supplements containing banned substances.
For the study, researchers examined 27 of the 274 supplements that FDA recalled between 2009 and 2012. They purchased the supplements between eight months and four years after they had been recalled.
The supplements were marketed for:
- Enhanced sports performance;
- Sexual enhancement; and
- Weight loss.
The researchers found that 18 of the 27 supplements still contained a banned pharmaceutical substance, including sibutramine—a weight-loss drug linked to heart attack and stroke—and phenolphthalein, a laxative that has been linked to cancer.
Twenty of the 27 supplements examined were made in the United States, and 13 of those contained banned ingredients. Further, many of the supplements contained the same drug for which they had been recalled.
The researchers recommended that the law be more aggressively enforced or altered to increase FDA's regulatory authority to better protect consumers from the recalled supplements (Doyle, Reuters, 10/21; O'Connor, "Well," New York Times, 10/21).