If the FDA finds that a dietary supplement is adulterated with a drug or any potentially harmful contaminant it can issue what is known as a class I recall to protect consumers from such products. So that should make us feel safe as we browse through the websites of our favorite supplement sources, right? Well, not so fast. According to a recent research letter in JAMA, such products don t necessarily disappear immediately.
Dr. Pieter A. Cohen of the Harvard Medical School and colleagues investigated the possibility that such prohibited products are still available to consumers, even after the FDA s recall is in effect. They examined the availability of supplements that were recalled due to adulteration between January 2009 and December 2012; the products had to be available for purchase in July or August 2013 from the websites of manufacturers or retailers; the supplements were the same as those listed in the FDA s recall.
During the period scrutinized, the FDA recalled 274 dietary supplements; of these the researchers found 27 that met all their criteria. Two-thirds of these supplements were still adulterated eight to 52 months after the FDA had recalled them. In particular, 85 percent of those for sports enhancement, 67 percent of those for weight loss and 20 percent of those for sexual enhancement were still adulterated with banned ingredients. Further, most of these supplements contained the same ingredient that had led to the recall.
The authors commented, Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the US marketplace.
You can say that again, ACSH s Dr. Ruth Kava emphasized. And in fact, Dr. Cohen has railed against this ill-advised license to print money while harming customers on several previous occasions. This study should alarm anyone who wants to enhance their health with such supplements. The authors acknowledged that it wasn t clear when the supplements they purchased had been produced before or after the FDA recall. That suggests that the retailers may be keeping older, adulterated products for sale to clear their shelves . We have commented many times, she continued, that the 1994 law known as DSHEA (or the Hatch act), by making it more difficult for the FDA to regulate dietary supplements, has made consumers more vulnerable to potentially dangerous products. It has, however, made supplement manufacturers rich.
ACSH friend, Dr. David Seres, head of nutritional medicine at New York Presbyterian Hospital, has written frequently about dietary supplements. His recent op-ed on CNN Opinion, leaves little doubt about his feelings on this matter: Just because a product is brought to market and labeled as a dietary supplements, guarantees neither efficacy nor, more importantly, safety. On this anniversary of the Dietary Supplement Health and Education Act, with lawmakers now willing to challenge this powerful industry, it is time to reassess the regulation of dietary supplements.