Silver Spring, MD – As of Thursday, April 23, five dietary supplement companies received warning letters for their use of an unapproved stimulant in their products. The companies were accused of using BMPEA (R-beta-methylphenethylamine) as a dietary supplement ingredient. The U.S. Food and Drug Administration (FDA) has given the firms 15 business days to make the needed adjustments to the eight total products involved.
The following companies have received warning letters:
* Hi-Tech Pharmaceuticals, Inc. for Fastin-XR (extended release), Fastin-RR (rapid release) and Lipodrene (Ephedra Free)
* Tribravus Enterprises, LLC d/b/a iForce Nutrition for Conquer (Fruit Punch Slam & Raspberry Lemonade flavors)
* Train Naked Labs LLC for Critical FX, Sudden Impact
* Better Body Sports, LLC for Phoenix Extreme
* Human Evolution Supplements, Inc. for Core Burner
Some of the warned companies claim that their BMPEA are extracted from Acacia rigidula. FDA countered in the warning letter to Hi-Tech Pharmaceuticals, saying they are “aware of no evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical.” If BMPEA can only be made in a laboratory, then BMPEA allegedly does not fit into any definition of a dietary ingredient and is being misbranded when a company uses the ingredient in a dietary supplement.
"FDA has clearly communicated its view that this substance is not a dietary ingredient and has used its enforcement authority, as established under current federal law, to act on the basis of this finding," said Michael McGuffin, President of The American Herbal Products Association (AHPA), in a statement.
FDA has also issued a statement to consumers on its Web site about the issues regarding the labeling of BMPEA, informing them about the argument against the ingredient and how long the companies have to take action.
These warnings come only a few weeks after a study was published in Drug Testing and Analysis that found BMPEA in 11 of the 21 Acacia rigidula samples tested. A similar test was conducted by FDA in 2013 and found the same ingredient in nine of the 21 samples tested. No action was taken by FDA until these warnings were issued.
As of April 8, The Vitamin Shoppe has pulled all products containing Acacia rigidula for the fear that the products may have BMPEA in them. The company cited the study from Drug Testing and Analysis as their reasoning.
Updated on 5/4/15: Hi-Tech Pharmaceuticals issued a press release indicating it filed a lawsuit against the four researchers responsible for the information published in an article in Drug Testing and Analysis known as “An amphetamine isomer whole efficacy and safety in humans has never been studied, B-methylphenylethylamine (BMPEA), is found in multiple dietary supplements,” according to a press release issued by PR Newswire.
The researchers, Pieter A. Cohen, Clayton Bloszies, Caleb Yee and Roy Gerona, are being sued for $50 million in compensatory damages and $150 million in punitive damages for libel and slander. Jared Wheat, the president of Hi-Tech Pharmaceuticals, said that the researchers “have published and/or uttered multiple false and malicious statements about the safety of dietary supplements containing Acacia rigidula manufactured by Hi-Tech and others.”
“What most concerns me was that Mr. Cohen stated that Acacia rigidula was released in 2013 when Hi-Tech has sold Acacia-containing weight loss aids since 2003 and VPX since 2007,” Wheat said. “We were the first to launch them into the marketplace right before the banning of ephedrine alkaloids.”
Cohen, who is a Harvard professor and a self-professed weight loss expert, has argued in interviews that “there is not a single weight loss supplement on the market that is legal and that has been shown to lead to weight loss in humans.” Cohen has written several times about his beliefs that supplements are dangerous and that FDA has failed to enforce proper labeling rules, according to the press release. Cohen could not verify that the lawsuit was taking place.
Posted on 4/27/15