Study Uncovers Potentially-Dangerous Supplement Products Hidden by the FDA

Dangerous Supplement Products Hidden by the FDA

Dangerous Supplement Products Hidden by the FDA

The U.S. Food and Drug Administration (FDA) has kept quiet about nine products found to contain BMPEA, a chemical similar to amphetamine. The agency would not name the products, issue a recall or a health alert. Researchers who tried unsuccessfully to get answers from the agency conducted their own tests and published the results in the journal Drug Testing and Analysis. In comparison, Canadian health regulators recalled JetFuel Superburn in December after finding that the product contained BMPEA along with another amphetamine-like substance. The government 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.” Regulators called BMPEA a “serious health risk” New York Times reports.

In 2013, FDA scientists published an article finding 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. However, the agency would not identify the products.

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.

The FDA stated that a review of supplements with the chemical shows it “does not identify a specific safety concern as this time.” But NYT reports that there is another reason the agency is so hesitant to act: in recent years, two top FDA officials were former leaders of the largest supplement industry trade and lobbying group. Daniel Fabricant ran the FDA’s division of dietary supplement programs from 2011 to 2014. Prior to this, he was a senior executive at the supplement trade group Natural Products Association. The group spent millions of dollars lobbying against laws that would place stricter laws on supplement makers.

Fabricant left the FDA last year and returned to the group. His replacement also comes from Natural Products Association. 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 safety concerns surrounding the supplement industry recently. The industry largely polices itself and does not need to under more rigorous testing as with drugs. In February, the office of New York Attorney General Eric Schneiderman reported that four major retailers sold herbal supplements tainted with unapproved and potentially dangerous substances. Last week, Schneiderman led 14 state attorneys general last week in asking Congress to give the FDA more power to regulate the supplement industry.

Read more at:

This entry was posted in Legal News and tagged , , , , . Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.