Pressure from various officials finally got the FDA to step in regarding beta-methylphenethylamine (BMPEA), a substance used in weight loss, energy boosting and pre-workout supplements. The FDA issued stop distribution letters to companies producing BMPEA-containing supplements. This is a move I can support, unlike many other FDA positions on non-Big Pharma products.
Experts in Canada consider BMPEA to be a “serious health risk” due to the fact that this “super-caffeine” can result in rapid and irregular heartbeat. No big surprise there! BMPEA is a close relative to amphetamines.
However, I wouldn’t be me if I didn’t bust the FDA’s chops a little. It seems they were aware of BMPEA since 2013 but it wasn’t considered worthy of attention. Never mind the fact that, as you’ll see in the FDA’s letter, BMPEA does not in fact meet any definition of that which could be called a “dietary supplement.” Never mind the fact that several of the supplement manufacturers were including BMPEA in the products but labeling it as an extract of Acacia rigidula or blackbrush, a rare plant grown only in Texas and Mexico. Never mind that Canada banned sales of the product in December 2014.
It’s no wonder the New York Times took the FDA to task for its “lethargic” response. In fact, a Harvard Medical School study, released two weeks ago, stated that BMPEA wasn’t a true dietary supplement and that 11 of the 21 brands studied that mentioned blackbrush actually contained BMPEA. Add some healthy pressure from Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT) asking the agency to take “swift, appropriate, regulatory action against these mislabeled and deceptive dietary supplements” and suddenly, the FDA is concerned.
On April 22, five warning letters were issued demanding the companies “immediately cease distribution” of the supplements in question. Those companies are:
- Hi-Tech Pharmaceuticals Inc. in Norcross, GA, producer of Fastin-XR, Fastin Rapid Release and Lipodrene Extended Release.
- Better Body Sports LLC in Ventura, CA, producer of Phoenix Extreme.
- Train Naked Labs LLC of Palm Bay, FL, producer of Critical FX and Sudden Impact.
- Human Evolution Supplements Inc. of Hollywood, FL, producer of Core Burner Watermelon Powder.
- Tribravus Enterprises LLC, (dba iForce Nutrition) of Vista, CA, producer of Conquer supplements (Fruit Punch Slam and Raspberry Lemonade flavors).
The letters contained the follow language:
“Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is 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. BMPEA is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, BMPEA is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, BMPEA is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Accordingly, BMPEA is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Declaring BMPEA in your product labeling as a dietary ingredient causes your product marketed as a dietary supplement to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.”
It’s heartening to see the FDA take action, albeit delayed, against supplement manufacturers that are purposely hiding a potentially dangerous ingredient. Obviously, the manufacturers know that BMPEA does not qualify as a “dietary supplement,” otherwise they wouldn’t have hidden it.
It remains to be seen if any actual harm was caused by the supplements containing BMPEA, however, it’s a safe bet that a class action lawsuit isn’t far away.