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Dietary supplement scandal sparks call for Congress to act against agencies' 'revolving door'

Dexaprine XR
dexaprine.org
The products that Dr. Pieter Cohen and his colleagues identified as containing BMPEA include Dexaprine XR.

On Monday, the New York Times editorial board called for Congress to enact a law that would permanently require federal employees above a certain grade level to recuse themselves from any official action involving a former employer or client, “including trade associations and their members.”

The call for such a law comes after the publication last week of a study that identified 11 popular weight-loss and workout herbal supplements as containing beta-methylphenethylamine (BMPEA), a chemical very similar to the powerful stimulant amphetamine. 

The study, led by Dr. Pieter Cohen, an assistant professor at Harvard Medical School, was published in the journal Drug Testing and Analysis.

As Cohen and his co-authors note in their study’s introduction, the FDA has known for two years that these products contained BMPEA. In fact, the agency announced as much in a study it published last year. But the FDA did not take those supplements off the market. Nor did the agency warn the public about them — or release the names of the supplements.

It wouldn’t even release the names to scientists like Cohen, which is why he and his colleagues felt compelled to conduct their own study.

Compare the FDA’s action (or inaction) with what happened when Canadian health officials learned last fall through their own tests that certain dietary supplements contained BMPEA: They yanked the products off the shelves and warned Canadian citizens that the supplements “pose serious health risks.”

As the Canadian officials pointed out in their warning, amphetamine stimulants can suppress appetite, but they can also increase blood pressure and heart rate, and at high doses can lead to serious cardiovascular problems, including stroke. Such drugs can also become addictive.

By contrast, FDA officials told reporters last week that the agency does not have “a specific safety concern at this time” about the supplements.

Never tested on humans

As Cohen and his study co-authors point out, although BMPEA has been around since the 1930s, when it was developed as a possible replacement for amphetamine, no one knows for sure what the chemical’s effects are in the human body because it has never been tested on people. Animal studies have shown, however, that BMPEA raises blood pressure and heart rate — just like amphetamine.

Cohen and his colleagues also point out that consumers can’t know for sure which supplements have BMPEA, as the chemical seldom appears on the labels. Most of these products do, however, list acacia rigidula (blackbrush), a little-known shrub native to Mexico and southern Texas as an ingredient — even though BMPEA has never been extracted from that plant. The supplement makers finagle their labels in this manner, Cohen told the New York Times reporter Anahad O’Connor, to disguise amphetamine-like chemicals under the names of obscure plants, a tactic that also makes the ingredients seem “natural.” 

Serious conflicts of interest

As I’ve noted in Second Opinion before, the FDA is severely hampered in protecting the public from fraudulent and unsafe dietary and other supplements because the $33-billion-a-year supplements industry— aided by powerful congressional friends, particularly Sen. Orrin Hatch, R-Utah — have successfully fought off any meaningful attempts to regulate not only the industry’s health claims, but also the safety of its products.

The FDA can only take significant action against a supplement after it’s on the market and has been shown to be harmful — in other words, after some people have been hospitalized or die. Few consumers realize this fact, however, when they purchase vitamins, minerals, herbal or homeopathic “medicines” and other dietary supplements at their local pharmacy, grocery or “natural health” store.

But the FDA’s lack of regulatory teeth may not be the only factor behind its inexplicable inaction regarding BMPEA. The FDA also has a serious “revolving door” problem: FDA officials often come to their posts from the industries they regulate and then return to those industries after they leave government.

It’s a situation that raises serious conflicts of interest — ones that need to be addressed by Congress — as the Times’ editorial board explains:

Much of the responsibility for the F.D.A.’s sluggish response [to the discovery that BMPEA was being used in supplements] must fall on Dr. Daniel Fabricant, who left a senior position at the Natural Products Association, a trade group for supplement makers and sellers, to head the F.D.A.’s division of dietary supplement programs in early 2011 and who jumped back to the trade association as its chief executive in the spring of 2014. He has been succeeded at the F.D.A. by several acting directors; the current one is Cara Welch, from the same trade group. Both dragged their feet on BMPEA. …

The F.D.A. says it hires people with industry ties because it needs experts from diverse backgrounds in public health, academia, science and industry working collaboratively to produce the best health outcomes. And some experts say that an industry perspective helps the agency understand what impact a regulatory action might have in the business world.

But consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

Additional information

You can read the New York Times editorial — and O’Connor’s earlier article about the FDA’s conflicts of interest — on the newspaper’s website. Cohen’s study can also be read in full on the website of the journal Drug Testing and Analysis.

FYI: The products that Cohen and his colleagues identified as containing BMPEA are JetFuel Superburn, JetFuel T-300, MX-LS7, Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.

Some of these products have already been pulled off the market by their manufacturers, and at least one trade group for the supplements industry, the Council for Responsible Nutrition, has called on the FDA to make sure all are recalled.

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