It Takes Senators and Harvard Physician Experts to Spur FDA to Take Action Against Stimulant-Laced Supplements | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration sent letters to the makers of eight dietary supplements on Thursday warning them that their products contain a synthetic, amphetaminelike stimulant that medical experts say is potentially dangerous. The agency’s actions came after weeks of pressure from at least three United States senators and a team of researchers led by an expert at Harvard Medical School, all of whom urged the F.D.A. to take steps to remove the stimulant — known as BMPEA — from the market (see http://sco.lt/60UzAH and http://sco.lt/8WslFJ).


The F.D.A. discovered the chemical in products in 2013, when it tested 21 workout and weight loss supplements that listed among their ingredients an obscure plant called acacia rigidula. The agency found that nine of these products contained BMPEA, but it did not release the names of the supplements or warn consumers about the risk.


Two weeks ago, a group led by Pieter Cohen, an assistant professor at Harvard Medical School, published a study identifying BMPEA in 11 of 21 supplements that mentioned acacia rigidula as one of their ingredients. Dr. Cohen said that companies were spiking their products with the stimulant and then hiding it under the name of a rare plant to create the appearance that the chemical was a natural botanical extract.


Dr. Cohen and other experts said that BMPEA was not a legitimate dietary ingredient, and they urged the F.D.A. to follow the Canadian government, which called BMPEA “a serious health risk” in December and pulled supplements that contain it from store shelves.


The F.D.A. said at the time that it did not consider BMPEA “a safety concern.” But days later, Senator Charles E. Schumer, Democrat of New York, demanded that the agency ban the chemical “and make sure the companies involved are held accountable.”


Last week, two more Democratic senators, Richard J. Durbin of Illinois and Richard Blumenthal of Connecticut, urged the agency to take “swift, appropriate, regulatory action against these mislabeled and deceptive dietary supplements.”


On Thursday, the agency said it sent warning letters to five companies whose supplements contain BMPEA, notifying them that the chemical was neither an appropriate dietary ingredient nor an extract of acacia rigidula. The companies it notified included Hi-Tech Pharmaceuticals, Human Evolution Supplements, Train Naked Labs, Better Body Sports, and Tribravus Enterprises.