Dragging Feet

FDA Foot Dragging on Dangerous Supplements

Even knowing the complicated history of dietary supplements for weight loss, current reports of FDA foot dragging on dangerous supplements are nothing short of shocking.

In an academic journal this week, a group of scientists revealed that dietary supplements containing an amphetamine isomer are still on the market — two years after FDA first knew about it. Adding insult to injury, there’s no indication on the labels of the products that the drug has been added.

The drug in these supplements is BMPEA, an isomer of (chemical variation on) amphetamine that was first synthesized in the 1930s. In animals, it acts a lot like amphetamine, raising blood pressure and heart rate, and stimulating the nervous system. It crosses into the brain, as does amphetamine. The full extent of what it does to humans is completely unknown because it’s never been studied in humans. It’s simply a chemical that’s not legal for use in humans as a drug.

And even with the very vague definition of what a dietary supplement is, BMPEA doesn’t qualify. That’s because it doesn’t occur naturally and it was never sold as a dietary supplement, so it doesn’t qualify to be grandfathered into the definition.

FDA discovered two years ago that Acacia rigidula supplements were spiked with BMPEA. In case you’re wondering, BMPEA does not occur naturally in Acacia rigidula, which is a shrub found in Texas and Mexico. Some of these supplements are sold for body building, others are sold for weight loss.

Back in 2013, FDA found BMPEA in 43% of the Acacia rigidula supplements they tested. Now, the scientists, led by Pieter Cohen of Harvard, found it in 54% of them. FDA responded to this situation with the following statement:

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.

Cohen said of FDA’s response, “I was shocked when I saw this.” Even a trade group that represents the dietary supplement industry was shocked. CEO and President Steve Mister of the Council for Responsible Nutrition said:

We urge FDA to take immediate enforcement action against these adulterated products containing BMPEA and the companies illegally spiking these products with this synthetic drug.

 The Obesity Action Coalition urged FDA to act. President and CEO Joe Nadglowski said:

The OAC urges FDA to do its job and protect the American public from these dangerous, mislabeled dietary supplements. We understand that it’s a tough job, but we’re counting on them to do it.

Canadian regulators have removed such products from the market. BMPEA is banned by the World Anti-Doping Agency. FDA’s delay in fixing this problem is indefensible. There’s no need to wait for someone to die.

Click here to read the study, here to read more from the New York Times, and here to read more from the LA Times.

Dragging Feet, photograph © Ed Yourdon / flickr

Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.


2 Responses to “FDA Foot Dragging on Dangerous Supplements”

  1. April 09, 2015 at 10:58 am, Joe Gitchell said:

    FDA could do much to build the public trust by dialing up their response to this. It should not take mortality to prompt action when this much apparent evidence is available.

    I don’t know all of the details, but it sure seems as though things need to change!

    • April 09, 2015 at 7:16 pm, Ted said:

      The reporting in the NY Times and LA Times was exhaustive and eye-opening. I am really shocked at FDA’s non-response.