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FDA has drawn criticism for failing to act despite being aware of the adulteration.
More than a year after FDA discovered stimulant adulteration in Acacia rigidula supplements marketed for weight loss and sports performance, a new study1 suggests that the synthetic stimulant is still present in many of the same or comparable products.
Led by Pieter A. Cohen, M.D., a team of researchers found that more that 52.4% of the Acacia rigidula supplement brands tested contained beta-methlyphenylethylamine (BMPEA), an amphetamine-like stimulant that has never been studied for efficacy or safety in humans. Although BMPEA has been marketed as an extract of Acacia rigidula, there is no evidence that the stimulant can be produced by any method other than chemical synthesis, said the researchers.
“The dosages of BMPEA in supplements strongly suggest that the amphetamine isomer is synthetically produced and placed in the supplement to lead to physiologic effects,” the researchers wrote. The study included 21 brands of Acacia rigidula supplements, 11 of which contained BMPEA in individual serving amounts ranging from 0.97 mg to 32.23 mg. The supplements were analyzed with liquid chromatography-quadrupole time-of-flight/mass spectrometry.
16 of the brands analyzed were marketed for weight loss benefits, three were marketed to improve athletic performance, and one was marketed to enhance cognitive function.
FDA Knew About Adulteration
What makes these results even more troubling is that FDA has known about this issue for over a year. In January of 2014, FDA scientists released a study2 which analyzed 21 Acacia rigidula supplements purchased in 2012, finding that 9 of the 21 products contained BMPEA.
But aside from publishing the study in the Journal of Pharmaceutical and Biomedical Analysis, FDA “has yet to inform the public or take enforcement action to remove BMPEA from dietary supplements,” the researchers wrote.
They also noted that the European Food Standards Agency has not approved Acacia rigidula for sale until “additional evidence of safety” is brought forward, and BMPEA is banned by the World Anti-Doping Agency.
Five of the supplements tested by Cohen and his team were also analyzed by the FDA investigators in their study, but FDA has not disclosed which five are the same.
Cohen, who is an assistant professor at the Harvard School of Medicine, told Nutritional Outlook that the FDA’s lack of action is “completely inexplicable,” adding that the agency is neglecting its responsibilities to enforce the Dietary Supplement Health and Education Act (DSHEA) and protect the public health.
“The FDA should clarify that Acacia rigidula is not a legitimate supplement ingredient, and, therefore, all supplements with Acacia rigidula on the label must be mislabeled and withdrawn from the market,” said Cohen. “Furthermore, any supplement that contains BMPEA is clearly adulterated and should be withdrawn.”
Cohen also predicted that if FDA does not act on BMPEA adulteration, it could add fuel to the fire in the ongoing investigation into allegedly adulterated supplements led by New York State Attorney General Eric T. Schneiderman and a coalition of state attorneys general (AGs).
“If the FDA does not act, this will further encourage the AGs to become even more involved in the regulation of supplements, creating a state-by-state patchwork of deals and regulations,” said Cohen. “As we are now sharing word of this stimulant with thousands of physicians across America, not to mention lawyers, I suspect that sooner rather than later we will receive the first reports of serious adverse effects-if they haven’t occurred already.”
CRN Calls for Action
The Council for Responsible Nutrition (CRN; Washington, DC), a leading dietary supplement industry trade association, announced that it shares Cohen’s concerns and also called on FDA to act.
“Given FDA’s earlier findings combined with this new study by Dr. Cohen, we urge FDA to take immediate enforcement action against these adulterated products containing BMPEA and the companies illegally spiking these products with this synthetic drug,” said Steve Mister, president and CEO, CRN.
Mister suggested a number of possible actions FDA could take under the DSHEA, including demanding a product recall, declaring the products misbranded, or proclaiming the products are adulterated because BMPEA has no pre-market notification.
“Although Acacia rigidula supplements represent a very small portion of the dietary supplement industry-so small that we are not aware of specific sales data-FDA has the tools it needs under the law to take action before there are serious health consequences, and CRN is asking the agency to do just that,” said Mister.
1. Cohen PA et al. “An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylmaine (BMPEA), is found in multiple dietary supplements.” Drug Testing and Analysis. Published online April 7, 2015.
2. Pawar RS et al. “Determination of selected biogenic amines in Acacia rigidula plant materials and dietary supplements using LC-MS/MS methods.” Journal of Pharmaceutical and Biomedical Analysis, vol. 88 (January 2014): 457-456.
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