FDA Slow to Warn About Dietary Supplement Dangers

FDA Slow to Warn About Dietary Supplement Dangers

FDA Slow to Warn About Dietary Supplement Dangers

A newly published study is critical of the Food and Drug Administration (FDA) for being slow to take action against weight-loss and dietary supplements that contain chemical ingredients that pose health risks to supplement takers.

Though the FDA determined two years ago that nine supplements contained the amphetamine-like chemical BMPEA, the agency did not make public the names of those supplements and did not recall the products or issue a consumer health alert. In December, Canadian health authorities pulled supplements containing BMPEA from store shelves, and issued a consumer alert about BMPEA that 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 supplement industry in part, perhaps, because the current and immediate past heads of the division that oversees supplements come from the supplement industry, according to the Times. Daniel Fabricant, who ran the division of dietary supplement programs from 2011 to 2014, was previously a senior executive at the Natural Products Association, a trade group. He returned to the association last year. His successor, Dr. Cara Welch, also comes from the trade group. The association has lobbied against the Dietary Supplement Labeling Act, which would require supplement labels to carry information about side effects and about ingredients that could be harmful to pregnant women and children.

The FDA does not have the authority to regulate supplements in the same way it regulates prescription drugs and medical devices. Supplements do not undergo testing for safety and effectiveness before they reach the market. Action against tainted or mislabeled supplements usually comes after consumers are harmed, according to the Times.

FDA scientists published an article last year in the Journal of Pharmaceutical and Biomedical Analysis reporting that a number of popular supplements listed the little-known plant acacia rigidula on their labels. According to Dr. Pieter A. Cohen, lead author of the study published on Tuesday and an assistant professor at Harvard Medical School, it is not uncommon for companies to spike weight-loss and exercise supplements with amphetamine-like chemicals, but disguise the chemicals under plant names to create the impression that they are natural botanical extracts. Of 21 supplements that listed acacia rigidula on their labels, nine tested positive for BMPEA, but the agency did not identify specific products.

After unsuccessful attempts to learn which supplements contained BMPEA, Dr. Cohen and other scientists conducted their own tests and identified BMPEA in 11 of 21 products. Three of them—JetFuel Superburn, JetFuel T-300 and MX-LS7—were on sale this week at Vitamin Shoppe, the Times reports. The other supplements 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. DMAA 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. In 2013, the supplement OxyElitePro was linked to 24 cases of acute non-viral hepatitis. Two of the people taken ill required liver transplants and one person died.

Read more at: www.yourlawyer.com/articles/title/fda-kept-quiet-about-dietary-supplement-dangers-study-finds



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