According to an analysis of Class I drug recalls made over nine years, many of the FDA-approved products that were recalled during that period weren’t actually medications for diseases and other medical conditions. Rather, they were “adulterated dietary supplements,” such as sexual enhancement, body building, and weight loss pills.
Of the 465 recalled drugs examined in the study, 237 were supplements, and the actual number of recalled supplements is likely much higher considering that the study was limited to only one drug class. The findings led researchers to call for “more stringent enforcement” of rules governing the dietary supplement industry, as well as additional regulations for those products that more closely follow the standards used for pharmaceutical drugs. Supplements currently don’t have to undergo the same rigorous safety trials as medication does, leading some public health advocates to worry that unsafe products may be bypassing scrutiny before being released into the market.
The FDA’s comparatively lax regulation of supplements has sparked some recent controversy over energy products like Monster and 5 Hour Energy. Although those drinks have sent Americans to the emergency room by the thousands, the FDA still doesn’t have much oversight over them. Energy products may contain little-known ingredients such as taurine without manufacturers being forced to prove their safety.
This lack of prospective testing leads to a dynamic in which unsafe products often aren’t identified before they’re available for purchase and have already caused consumers medical harm. For example, the FDA finally issued a warning for the common workout supplement ingredient DMAA just this week after concluding that it may lead to an unhealthy rise in blood pressure. That warning — which doesn’t have enforcement power behind it, since it’s just an “advisory” statement and not a formal recall — was issued after the ingredient was legally used in products that are widely available at stores like GNC and the Vitamin Shoppe for over half a decade. During that time, the FDA received at least 86 reports of associated health concerns with products that use DMAA, including at least five deaths.
More stringent safety testing requirements before DMAA’s general use might have revealed potential problems with the chemical at a much earlier stage — and that could very well extend to the rest of the FDA-recalled dietary supplements as well.