USFDA warns 5 companies against sale of BMPEA containing supplements
25 Apr 2015
The US Food and Drug Administration has warned five companies against the sale of dietary supplements containing an unapproved stimulant known as beta-methylphenylethylamine, or BMPEA.
BMPEA, an amphetamine-like substance, has been shown to increase blood pressure and heart rate in animals and has been classified as a doping agent by the World Anti-Doping Agency.
According to an FDA investigation, nine out of 21 supplements containing Acacia rigidula also contained BMPEA even though the plant itself did not contain the substance. The findings of the agency were published in 2013.
The journal Drug Testing and Analysis, earlier this month, published a study that showed BMPEA-containing products continued to be on the market over a year after the publication of the FDA's findings. The agency said it had not identified a safety problem, when asked for the reason.
Citing product misbranding in its warning letters, the FDA said BMPEA did not meet the definition of a dietary ingredient and Acacia rigidula did not contain BMPEA.
Pieter Cohen, an assistant professor at Harvard Medical School and lead author on the Drug Testing and Analysis study, said he was "delighted" the FDA had confirmed that BMPEA did not belong in dietary supplements but added, that he wondered what took them so long.
According to a spokeswoman for the agency, Jennifer Corbett Dooren, the FDA prioritised its enforcement actions based on available resources and the level of safety concern.
The agency faced the challenge of having limited resources to monitor the marketplace for potentially harmful dietary supplements, she added.
The agency's review of the substance did not identify a basis to conclude the substance was generally recognised as safe (GRAS) for use in food. A
ccording to the FDA, declaring BMPEA on product labeling as a dietary ingredient caused the product to be misbranded with a false or misleading label if marketed as a dietary supplement. BMPEA, an unapproved amphetamine-like ,substance was shown to increase blood pressure and heart rates in dogs and cats.