FDA takes enforcement action against BMPEA.
- In recent weeks, we have seen increased media coverage regarding concerns about beta-methylphenethylamine (BMPEA) in dietary supplements in the United States. Congressmen have urged FDA to take enforcement action and a major supplement trade association has imposed a “no-sale” policy for BMPEA supplements as a condition of membership. Many have questioned the safety and the regulatory status of BMPEA for use as a dietary ingredient in dietary supplements.
- FDA has now taken enforcement action, issuing Warning Letters to five companies marketing products that list BMPEA as a dietary ingredient. FDA’s position is that BMPEA does not meet the statutory definition of a “dietary ingredient” permitted for use in dietary supplements. By law, a dietary supplement is defined as a product intended to supplement the diet that bears or contains one of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a 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. According to FDA, “BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.” Further, two of the Warning Letter recipients identified the botanical Acacia rigidula as the source of the BMPEA, but FDA has conducted research establishing that BMPEA is not a constituent or extract of Acacia rigidula. FDA considered specific products to be misbranded for that reason as well.
- FDA’s enforcement actions in this space indicate that the Agency is taking a closer look at BMPEA and Acacia rigidula in dietary supplements, but several unanswered questions remain. For instance, FDA’s Warning Letters make no mention of whether Acacia rigidula may appropriately be used as a botanical ingredient in dietary supplements. If so, is it a new dietary ingredient requiring notification? What is the full extent of the relationship between dietary supplements that contain Acacia rigidula and the masked presence of BMPEA? The supplement industry and consumers alike are now on notice about the alleged dangers of BMPEA, but some speculate that bad actors simply will find other synthetic stimulants to market under the guise of botanical ingredients in the future. The full ramifications of the BMPEA backlash remain to be seen.