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FDA Never Publicized Dietary Supplement Risks Highlighted in New Study

Apr 10, 2015

A new study published in the journal Drug Testing and Analysis found that weight-loss and workout supplements across the country have been spiked with an amphetamine-like chemical known as BMPEA. The New York Times reports that although the U.S. Food and Drug Administration (FDA) documented the presence of this chemical in nine supplements two years ago, the public was never made aware of these risks; the agency did not even name the products, issue a recall or a health alert.

Unlike the FDA, Canadian health regulators removed supplements containing BMPEA in December, calling it a "serious health risk" New York Times reports. The FDA stated that a review of supplements with the chemical "does not identify a specific safety concern as this time."

NYT reports that, according to public health regulators, the FDA has been slow to act because top agency officials have strong ties to the supplement industry, which rakes in $33 billion a year. In recent years, two top FDA officials were former leaders of the largest supplement industry trade and lobbying group; one of them is still working for the agency.

The supplement trade group Natural Products Association spent millions of dollars lobbying against laws that would impose stricter safety standards of supplement makers. NYT reports that Daniel Fabricant was a senior executive at that group before running the FDA's division of dietary supplement programs from 2011 to 2014. He returned to the agency last year, and but the person who replaced him comes from the same trade group. Michael F. Jacobson, the executive director of the consumer advocacy group Center for Science in the Public Interest said "To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house," according to NYT.

There have been mounting safety concerns surrounding the supplement industry recently. In February, the office of New York Attorney General Eric Schneiderman accused four major retailers of selling tainted herbal supplements. Schneiderman led 14 state attorneys general last week in asking Congress to give the FDA more authority to regulate supplements.

In 2013, FDA scientists published an article noting that many popular supplements contained an ingredient called acacia rigidula, which turned out to be BMPEA. Last year, the agency reported in The Journal of Pharmaceutical and Biomedical Analysis that the substance was present in nine out of 21 samples of popular supplements. The products containing the BMPEA were not named, however.

Dr. Pieter A. Cohen, an assistant professor at Harvard Medical School and lead author of the new study, conducted his own testing along with researchers at other universities after being unable to get answers from the FDA about which supplements contained BMPEA. Supplements found to contain the substance include Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.

Canada recalled JetFuel Superburn in December after finding that the product contained BMPEA along with another amphetamine-like substance. Regulators warned about the risks of BMPEA: "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."


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