JAMA study criticizes FDA regulation of supplements for failure to remove banned substances from market
CHICAGO — A JAMA study noted that about two-thirds of dietary supplements recalled by the Food and Drug Administration still contained banned ingredients at least six months after being recalled, according to a study in the journal's October 22/29 issue.
"Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace," said Pieter Cohen of Harvard Medical School, who conducted the study. "More aggressive enforcement of the law, changes to the law to increase the FDA's enforcement powers, or both will be required if sales of these products are to be prevented in the future."
“Any time adulterated health products get to consumers or remain on the market after the FDA has determined they are potentially unsafe illustrates a weakness in the enforcement of the nation’s food and drug laws," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. "Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients. We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk."
The Natural Products Association also announced its support of FDA’s efforts to crack down on any manufacturer selling adulterated dietary supplements. "Studies like this should remind consumers that it is very important to be wary of promises that sound too good to be true and products which primarily are offered online," observed NPA CEO and executive director Daniel Fabricant. "Unfortunately, there are scam artists whose only motivation is money, not consumer safety, and these are the ones continuing to put consumers at risk.”
According to the study, the FDA recalled 274 dietary supplements between January 2009 and December 2012. Twenty-seven of the 274 recalled supplements (9.9%) met inclusion criteria for the study and were analyzed using the same methods at the FDA's laboratories (e.g., gas chromatography/mass spectrometry). Supplements were purchased an average of 34.3 months (range 8-52 months) after the FDA recall. As many as 74% of supplements were produced by U.S. manufacturers.
The researchers found that one or more pharmaceutical adulterant was identified in 66.7% (18 out of 27) of recalled supplements still available for purchase. Supplements remained adulterated in 85% (11/13) of those for sports enhancement, 67% (6/9) for weight loss and 20% (1/5) for sexual enhancement. Of the subset of supplements produced by U.S. manufacturers, 65% (13/20) remained adulterated with banned ingredients.
Turning the research on its head, CRN noted that nine in 10 banned supplements are no longer available for purchase, suggesting that the FDA action is largely successful. "Of the 27 remaining, 18 of the products were identified as containing APIs after being recalled; the other nine had been reformulated. In other words, the FDA’s recall efforts had a more than 93% success rate (256 out of 274)."
"We note also, that once these products were identified by FDA as containing undisclosed APIs, they were recalled under FDA’s ample authority for regulating adulterated drugs — because they are just that, adulterated drugs, regardless of how they were marketed," Mister said. "Increased resources to enforce the nation’s drug laws would more directly address the problem and help reduce the number of unrepentant products to zero. Yet the researchers jump to the recommendation that changes in the law to increase FDA’s powers over dietary supplements are needed, illustrating their call to action is a ‘solution in search of a problem.’"
Banned substances identified in recalled supplements included sibutramine, sibutramine analogs, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor, and various anabolic steroids.
The FDA initiates class I drug recalls when products have the reasonable possibility of causing serious adverse health consequences or death. Recently, the FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. According to Cohen, prior research has found that even after FDA recalls, dietary supplements remain available on store shelves.