FDA Issues Warnings on Mislabeled Supplements Following Blumenthal and Durbin's Call to Action

Statement

U.S. Senators Richard Blumenthal (D-CT) and Dick Durbin (D-IL) welcomed action taken by the Food and Drug Administration (FDA) yesterday in response to their letter calling for increased scrutiny of dietary supplements containing "acacia rigidula" which is often used on dietary supplement labels to mask the inclusion of BMPEA -- a potentially dangerous synthetic stimulant. Yesterday, the FDA issued warning letters to five companies regarding eight products which list BMPEA as a dietary ingredient, and some of which identify the source of this stimulant as "acacia rigidula." The FDA announcement is available here.

"For far too long, dietary supplement manufacturers have either failed to list BMPEA on their product labels or have deceptively mislabeled the stimulant as a "natural botanical." There is nothing natural about this synthetic stimulant, which researchers describe as an alternative to amphetamine," said Blumenthal and Durbin. "Last week, we told the FDA: do not wait for tragedy to strike before warning consumers and removing this mislabeled product from store shelves. We are pleased to see that the FDA has heeded our call and finally taken action against the manufacturers of these potentially dangerous products."

The Senators' call to action followed the release of a study earlier this month in which researchers found BMPEA in 11 of 21 over-the-counter dietary supplements. The Senators also criticized the FDA for remaining silent on this issue while the percentage of brands of "acacia rigidula" labelled supplements that contain BMPEA have increased from 42.9% in 2012 to 52.4% in 2014.

The European Food Standards Agency and the Danish Veterinary and Food Administration have both cautioned against the consumption of A. rigidula products, while Canadian health authorities have called BMPEA "a serious health risk" and pulled supplements that contain it from store shelves. Furthermore, the chemical is classified as a doping agent by the World Anti-Doping Agency.

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