Dietary supplements previously banned by The U.S. Food and Drug Administration (FDA) are still available in stores, both online and at fixed locations across the U.S. Manufacturers of these banned substances have taken a new tact in producing supplements that include these dangerous additives, adding them to already approved supplements, in an effort to hide their inclusion.
In a study dated Oct 21, 2014 published in the Journal of the American Medical Association (JAMA), study authors Pieter A, Cohen, M.D., Gregory Maller, BS, Renan DeSouza and James Neal-Kababick, BS, present evidence indicating, among other things, that drugs on the FDA’s list of recalled substances continue to be available on average of 34.3 months after the FDA recalls. The FDA recalled 274 dietary supplements between Jan. 2009 and Dec. 2012, 27 of which were the subject of this study. U.S. drug manufacturers accounted for fully 74 percent of the banned substances.
The study went on to say that 63 percent of the supplements scrutinized contained the same tainted additives, with 22.2 percent incorporated one or more FDA banned substances. Conclusions drawn from the study authors include giving the FDA more enforcement avenues, which may require additional legislation to be passed by Congress. They also indicate that drug manufacturers are ignoring FDA guidelines, because enforcement is lax, and has not been effective in removing these adulterated supplements from retail location providing consumer access.
According to a press release from the FDA final rules for dietary supplements, dated June 2007, the federal government has established rules and regulations concerning good drug manufacturing practices that are meant to be adhered to by all drug manufacturers selling dietary supplements in the United States. The availability of these drugs already banned by the FDA casts doubt on these regulations that were intended to safeguard the general public and confirm lack of contaminant inclusion, quality of manufacturing guidelines as well as definitive labeling practices.
The FDA’s Commissioner of Food and Drugs, Andrew C. von Eschenbach, M.D. indicated that these rules and regulations were adopted to assure that consumers of dietary supplements, “can be confident” that banned substances are not included in the products they purchase, and they contain exactly what is printed on the label. He added that recent amendments would drive the drug manufacturing industry to, “report all serious dietary supplement related adverse events to FDA.”
The main offenders of these rule and regulations are supplements related to sexual enhancement, sports enhancement, and weight loss aids. The conclusions indicated in the JAMA study are surprising, considering drug manufacturers generally abide by the rules and regulations put forth by the FDA.
The aforementioned dietary supplements investigated for using banned substances continued to ignore FDA recalls of the substances. In 11 of 13 (85 percent) sports enhancement supplements studied, these drugs remained contaminated, with 6 of 13 (67 percent) in the category weight loss supplements, as well as 1 of 5 (20 percent) of sexual enhancement drugs.
The FDA’s enforcement arm will need to take a more aggressive stance against these offending dietary supplement manufacturers, in an effort to curb the availability of these banned substances from appearing on American store shelves, whether online or otherwise. Education is key in this area, and the FDA needs to try harder to educate the overall population about the risks of these potentially dangerous substances, while at the same time using the court system to bring a measure of control to bear on these companies.
By Jim Donahue