Weight loss supplements and other dietary pills have long been a point of contention in the fields of pharmacy technology and public health. For policymakers, scientists, health officials and the common consumer, navigating the long list of untested or questionable ingredients included in such supplements makes it challenging to weigh the long-term pros and cons.
This particularly came to light in a recent study published in the journal Drug Testing and Analysis, in which a group of researchers identified the stimulant beta-methylphenylethylamine (BMPEA) in a wide range of dietary supplements currently on the market.1
BMPEA is similar to amphetamine and is often contained in supplements labeled as Acacia rigidula. Researchers set out to investigate what stimulants were found in these drugs, specifically noting that amphetamines and related stimulants can only be produced by chemical synthesis, despite the fact that many supplement companies label them as botanical extracts.1
BMPEA has only been used in research since it was first synthesized in the 1930s and has never been approved for pharmaceutical use. According to the study, the Food and Drug Administration found BMPEA being mislabeled as Acacia rigidula in many dietary supplements in early 2013, but did not take any measures to warn the public.1
The team conducted their own tests on dietary supplements and found BMPEA in 11 of 21 products including Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES, Yellow Scorpion, JetFuel Superburn, JetFuel T-300 and MX-LS7.
The team concluded, “We recommend that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.”1
One challenge facing the FDA and other regulatory organizations is that supplements do not undergo the same rigorous standards of approval as other drugs. Many supplement suppliers tout Acacia rigidula as a necessary component of their offerings. Canadian health regulators have already recalled several supplements for containing BMPEA, but it seems the FDA is not as quick to react.
The FDA released a brief statement, saying, “While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers.”
Dr. Pieter Cohen, one of the study’s lead authors, expressed his dissatisfaction with measures taken by the FDA. On CBS This Morning, Cohen stated, “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.”2
While BMPEA hasn’t been tested on humans, it has been shown to raise blood pressure in animal testing. Cohen continued, “These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death.”2
The Council for Responsible Nutrition called on the FDA to remove these items from the market in response to the published research. In a press release, the organization stated “We share the concerns of Dr. Pieter Cohen and his study co-authors regarding BMPEA, an amphetamine isomer stimulant that should not be used in dietary supplement products because it is a synthetic drug-like substance, not a dietary ingredient.”3
1 “An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements,” by Pieter A. Cohen, Clayton Bloszies, Caleb Yee and Roy Gerona, Drug Testing and Analysis, April 7, 2015. http://onlinelibrary.wiley.com/doi/10.1002/dta.1793/full
2 “CRN Asks FDA to Enforce the Law,” Council for Responsible Nutrition, April 7, 2015. http://www.crnusa.org/CRNPR15-AsksFDAtoEnforcetheLaw040715.html
3 “Supplement expert: FDA “completely dropped the ball” by Jason Kashdan, CBS News, April 7, 2015. http://www.cbsnews.com/news/new-study-warns-against-dietary-supplements-containing-bmpea-calls-fda-action/