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FDA Kept Quiet About Dietary Supplement Dangers, Study Finds

Apr 9, 2015

According to a new study, many popular weight-loss and workout supplements contain a chemical nearly identical to amphetamine, and pose health risks to those who take them.

Two years ago the Food and Drug Administration (FDA) documented that nine supplements contained BMPEA but never made public the names of those products or the manufacturers. The FDA did not recall the products or issue a health alert to consumers. In December, Canadian health authorities pulled supplements containing BMPEA from store shelves, calling the chemical "a serious health risk," the New York Times reports.

The Canadian government issued a consumer alert about BMPEA, which warned, "Amphetamine stimulants can increase blood pressure, heart rate and body temperature; lead to serious cardiovascular complications (including stroke) at high doses; suppress sleep and appetite, and be addictive."

Public health experts say the FDA is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators come from the industry and have conflicts of interest. Daniel Fabricant, who ran the FDA division of dietary supplement programs from 2011 to 2014, was previously a senior executive at the Natural Products Association, a trade group that has spent millions of dollars lobbying to block stricter laws for supplement makers. Fabricant returned to the association last year as its chief executive, the Times reports. Dr. Cara Welch, his successor at the FDA also comes from the trade group.

Under a 1994 law, supplements are not subject to the rigorous oversight applied to prescription drugs and medical devices, and do not undergo federal reviews of safety or effectiveness before they are sold to the public. Tainted supplements are usually pulled from the market only after consumers are harmed, according to the Times.

In an article published last year, FDA scientists said they noticed many popular supplements listed among their ingredients a little-known plant called acacia rigidula, native to Mexico and southern Texas. Dr. Pieter A. Cohen, lead author of the study published Tuesday and an assistant professor at Harvard Medical School, said it is not uncommon for companies to spike weight-loss and exercise supplements with amphetamine-like chemicals, but hide the chemicals on their labels under plant names to create the impression that they are natural botanical extracts. The FDA reported last year in the Journal of Pharmaceutical and Biomedical Analysis that of 21 popular supplements that listed acacia rigidula on their labels, nine tested positive for BMPEA. The FDA did not identify the specific products.

Three supplements Dr. Cohen’s study found to contain BMPEA— JetFuel Superburn, JetFuel T-300 and MX-LS7—were on sale this week at Vitamin Shoppe, the Times reports. BMPEA was not listed on the label. The other supplements the study identified as containing BMPEA were Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.

Bastiaan Venhuis, a scientist in the Netherlands who studies tainted supplements, said that the physiological effects of BMPEA are most likely very similar to those of DMAA, an amphetamine-like stimulant that can cause heart attacks and strokes. The Department of Defense banned supplements containing DMAA from military bases in 2011 after they were implicated in the deaths of two soldiers.

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