In response to mounting pressure, the FDA issued warnings to five supplement companies last week regarding the risks associated with beta-methylphenethylamine, or BMPEA. BMPEA is widely used in weight loss and energy supplements, but has an ingredient similar to amphetamine.
Supplement makers claimed that BMPEA was allowed in dietary supplements because it occurred naturally in a shrub known as Acacia rigidula. Dr. Pieter Cohen of Harvard University, who has criticized the FDA’s slow action on BMPEA, conducted a study of products listing Acacia rigidula as an ingredient, suspecting it signified the presence of BMPEA.
In its letters to the supplement companies, the FDA stated that it was “aware of no evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical [Acacia rigidula].”
The FDA emphasized that BMPEA is “not a dietary ingredient.” It defines a dietary ingredient as “a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.” With the warning letters, the FDA has made clear that BMPEA falls into none of those categories.
Per the FDA, calling BMPEA a dietary ingredient on supplement labels is therefore false and misleading.
The FDA warned the companies to cease distribution of their supplements, or face enforcement action. The FDA is also requiring the companies, within 15 days of receipt of the letter, to state in writing the steps taken to correct the violations and what they have done with product currently on the shelves.
Dr. Cohen has called on the FDA to require rigorous evidence of efficacy and safety before any supplements promoted as improving health or performance can be sold to the public.