Researchers report effectiveness of FDA ban on ephedra.
- In the 1990s and early 2000s, ephedra-based dietary supplements were widely marketed and consumed as stimulants and weight loss aids in the United States. Ephedra consumption was linked to various serious adverse health effects, including heart attack, stroke, seizure, high blood pressure, and cardiac arrhythmia. In certain cases, ephedra consumption was linked to sudden death. FDA responded to the growing controversy over ephedra by investigating the safety of the substance, concluding that it posed an unreasonable risk to consumers, and ultimately issuing a final rule in 2004 to prohibit the sale of dietary supplements containing ephedra altogether.
- Researchers have reviewed 13 years worth of data regarding ephedra-related deaths and poisonings, concluding that FDA’s ban on this substance produced a significant public health benefit. According to the report, which was published in the New England Journal of Medicine, the “number of poisonings resulting in major effects or deaths has decreased by more than 98% since 2002. The 2004 FDA ban has proved to be a very effective means of limiting the availability of ephedra and therefore its potential toxicity in the United States.”
- The ephedra controversy resulted in FDA’s first official ban of a dietary supplement. More recently, FDA took enforcement actions that resulted in an effective ban on the marketing of DMAA — a stimulant linked to high blood pressure, cardiovascular problems, and even heart attacks. In the case of DMAA, however, FDA specifically noted that it had not undertaken the “lengthy scientific and legal steps” required by law for the Agency to formally ban a compound in a dietary supplement. Rather, the Agency relied on Warning Letters and facility visits to stop firms from producing and marketing DMAA. Even more recently, in the wake of increased media coverage citing concerns about beta-methylphenethylamine (BMPEA) in dietary supplements, FDA issued a series of Warning Letters to companies marketing this substance as a dietary ingredient in violation of the law. It remains to be seen whether FDA’s more recent utilization of “effective bans” against dietary supplement products will have the same degree of public health efficacy as a formal prohibition.