The Food and Drug Administration sent letters to the makers of eight dietary supplements Thursday, warning the companies that their products contain BMPEA, a synthetic stimulant that medical experts say is potentially dangerous.
BMPEA is listed as a dietary ingredient on the product labels, but the substance does not meet the legal definition of a dietary ingredient, the FDA states. Two of the companies further identified the source of this stimulant as the botanical Acacia rigidula. The FDA informed the supplement makers that BMPEA was neither an appropriate dietary ingredient nor an extract of acacia rigidula.
In December, the Canadian government, which called BMPEA “a serious health risk,” pulled supplements that contain it from store shelves.
The U.S. agency’s warning letters came after pressure from at least three U.S. senators and a team of researchers led by an expert at Harvard Medical School. They all have urged the FDA to take steps to remove the stimulant from the market.
The FDA first tested 21 workout and weight loss supplements in 2013 that listed the 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 at the time.
Two weeks ago, researchers 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.
BMPEA Could Affect Blood Pressure
BMPEA has not been tested in humans, but has been found to increase blood pressure in cats and dogs.
“These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,” Cohen told CBS News earlier this month.
The FDA gives the following warning to the supplement makers: “We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace.”
The FDA’s warning letters:
- Hi-Tech Pharmaceuticals, Inc. (Products: Fastin-XR (extended release), Fastin-RR (rapid release), Lipodrene (Ephedra Free))
- Tribravus Enterprises, LLC d/b/a iForce Nutrition (Products: Conquer (Fruit Punch Slam & Raspberry Lemonade flavors))
- Train Naked Labs LLC (Products: Critical FX, Sudden Impact)
- Better Body Sports, LLC (Product: Phoenix Extreme)
- Human Evolution Supplements, Inc. (Product: Core Burner)