An amphetamine-like compound that has never been tested in humans is present in a range of popular diet pills and sports supplements, a study in a pharmacological journal has found.
The substance, known as BMPEA, is found in products advertised as containing Acacia rigidula, a shrub native to Texas. In fact, the study said, BMPEA can only be produced synthetically, is not listed on labels, and its health risks are unknown.
The study, published Tuesday in the journal Drug Testing and Analysis, said the Food and Drug Administration discovered the presence of BMPEA in dietary supplements in 2013 but failed to warn consumers or order its removal.
"The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements," the study said. "Physicians should remain vigilant for patients presenting with toxicity from sports and weight-loss supplements as they might contain undisclosed stimulants, such as BMPEA."
In an interview, Pieter Cohen, an assistant professor of medicine at Harvard Medical School, said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA's failure to act is "completely inexcusable."
FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.
"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," she said.
After a Los Angeles Times reporter called about the study, the manufacturer of Arco Black Series Burn said Monday it was pulling all products containing BMPEA from its website.
"The health and safety of our customers is our highest priority," said Kathleen Reed, director of financial planning and analysis for Vitacost, a Boca Raton, Fla., unit of Cincinnati-based grocery giant Kroger Co. "While the FDA has not declared the fat-burning ingredient BMPEA to be harmful, we take safety concerns very seriously for all of the 45,000+ products sold on Vitacost.com."
The study is another round in a long-running battle between supplement makers, regulators, and researchers over the safety and efficacy of dietary supplements, which, under the 1994 Dietary Supplement Health and Education Act of 1994, are not subject to FDA testing before being brought to market.
With the FDA empowered to act only after problems are discovered, the result has been a cat-and-mouse game in which researchers discover problems, regulators act, and supplement makers adjust their products and practices, only to start the process all over again.
Just last month, nutritional supplements retailing giant GNC Holdings Inc. signed a settlement with New York Atty. Gen. Eric T. Schneiderman requiring it to begin using DNA-based testing to authenticate the ingredients in a series of herbal supplements.
The agreement followed a study by the New York prosecutor that alleged many products contained ingredients that were not listed on their labels. Earlier this month, Schneiderman and 13 other attorneys general followed up with a letter asking Congress to give the FDA more authority over the supplements industry.
The latest study -- by Cohen, his Harvard Medical School colleague Clayton Bloszies, Caleb Yee of Haverford College, and Roy Gerona of UC San Francisco -- stems from research the FDA itself began in 2012 on supplements featuring the Acacia rigidula plant. In a 2013 paper, the agency revealed the presence of a "non-natural" amphetamine-like substance in nine of 21 supplements tested.
The recent study tested 21 brands of Acacia rigidula supplements and found BMPEA in more than half of them. Among them were Jet Fuel Superburn, Jet Fuel T-300, Fastin-XR, and other supplements made by Hi-Tech Pharmaceuticals Inc., based in Norcross, Ga. The company did not immediately comment.
The study said research on dogs and cats from the 1930s and 1940s showed BMPEA was associated with increased blood pressure and heart rate. It is among the compounds banned by the World Anti-Doping Assn.
Mark O'Brian, interim chairman of the Department of Biochemistry in the University of Buffalo's School of Medicine and Biomedical Sciences, said the study's finding that BMPEA was present in supplements was troubling. "It's something no one should be taking at all, and certainly not unknowingly," said O'Brian, who read the study in advance of publication but was not involved in it.
Twitter: @deanstarkman
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