More than half of the Class I drug recalls between 2004 and 2013 involved vitamins and supplements. A Class I recall is the U.S. Food and Drug Administration’s (FDA) most serious designation, signaling that the recalled product contains ingredients associated with a reasonable probability of causing what the agency describes as “serious adverse health consequences or death.
The study, conducted by the St. Michael’s Hospital research team, revealed that 465 drugs were subject to a Class I recall, 237—51 percent—were dietary supplements said Forbes. Most of the recalls were implemented after 2008 for unknown reasons, said the researchers. The three supplement categories involved with the most recalls were marketed for sexual enhancement, bodybuilding and weight loss, respectively. Sexual enhancements supplements accounted for 40 percent of all Class I recalls; a list of those flagged by the FDA as tainted may be accessed here. The study was published in the online edition of JAMA Internal Medicine.
As we’ve explained, while medications undergo safety and efficacy testing in order to receive approval by the FDA for release to market, dietary supplements do not. In the case of supplements, manufacturers must ensure safety, efficacy, and proper labeling. Also, supplements made from products available on the U.S. market prior to 1994 can be sold with no agency review, including a wide variety currently available. Sellers of products containing substances unavailable prior to 1994, need only advise the FDA and do not require approval to be sold.
About two-thirds of all Americans take some sort of dietary supplement and earlier last year, the FDA announced it was seeking clarification on safety rules in effect for dietary supplements, and was issuing draft guidelines meant to assist with firms’ compliance with the 1994 regulation of new dietary ingredients in tablets, powders, liquids, and other supplements, and mandates makers file a safety notification with the agency prior to marketing any dietary ingredient that was not on the market in 1994. Since the law’s passage, the agency said it only received about 700 such notifications.
We previously wrote that Consumer Reports discussed its concern with the 1994 Dietary Supplement Health and Education Act (DSHEA), which it said is industry friendly and does not enable the FDA to regulate supplements as prescription medications. Of note, the Federal Trade Commission (FCC) is the agency that regulates herbal supplement marketing, which includes a ban on claims of medical condition treatment.
The FDA defines a dietary supplement as a product ingested orally and that contains a “dietary ingredient,” which includes vitamins, minerals, herbs, botanicals, or amino acids said Forbes, noting that some 65,000 dietary supplements are on the market and consumed by more than 150 million Americans.
Of concern is that, because of the way in which the regulations are written, supplements may be manufactured oversees before being sold on the U.S. market, noted Forbes. Sometimes, products are created under unsafe conditions and/or made with ingredients deemed Class I drugs by the FDA. This means, explains Forbes, that these products are adulterated with possibly dangerous ingredients such as steroids, Forbes explained.
Also, the huge network of supplement makers globally tends to always be just ahead of detection and can easily change company names and manufacturing locations and can also easily make minor adjustments to product formulas, which sidelines agency investigations, said Forbes.