Last week the New York Times editorialized about conflicts of interest with the FDA that cast an ominous light on the discovery earlier this month of an amphetaminelike substance in diet pills and sports supplements.
The compound, called BMPEA, according to a story in the Los Angeles Times, has not been tested in humans, and is found in a variety of products you can buy over the counter. The ingredient is labeled Acacia rigidula, a shrub that grows in Texas. Industry observers know that that listing an ingredient like this often signals that the manufacturer is trying to disguise a chemical additive as a natural plant substance.
But, according to the journal Drug Testing and Analysis, BMPEA can be produced only synthetically, which is not the form listed on the labels, and whose health risks are unknown.
The journal’s authors said the FDA discovered the presence of BMPEA in dietary supplements in 2013 but did not inform consumers or require it to be removed from the products. “The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements,” they wrote. “Physicians should remain vigilant for patients presenting with toxicity from sports and weight-loss supplements as they might contain undisclosed stimulants, such as BMPEA.”
The FDA began researching supplements with Acacia rigidula in 2012, and a year later wrote about the presence of a “non-natural” amphetaminelike substance in nine of 21 supplements tested.
The recent journal study analyzed 21 brands of Acacia rigidula supplements; BMPEA was found in more than half, including Jet Fuel Superburn, Jet Fuel T-300, Fastin-XR.
A spokeswoman for the FDA told the L.A. Times, “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.”
One of the study’s authors, Dr. Pieter Cohen from Harvard Medical School, called the FDA’s response to a potentially dangerous substance “completely inexcusable.”
Some manufacturers seem to be more concerned about patient safety than the government. Vitacost, a division of the grocery chain Kroger, makes a supplement with the so-called “fat-burning” compound, and its representative told the Los Angeles Times that it removed all products from its website that contain BMPEA, including Aro Black Series Burn, the one mentioned in the study, until it could conduct further studies.
As the L.A. Times story made clear, the 1994 Dietary Supplement Health and Education Act of 1994 excused supplements from FDA testing prior to marketing. Studies such as the one in Drug Testing and Analysis fuel the ongoing battle among supplement makers, regulators and researchers over their safety and efficacy. (See Patrick’s newsletter, “Eat. Drink and Be Wary: The Truth About Diet Supplements and Sports Drinks.”)
Unlike scrutiny of prescription drugs, whose trials are reviewed by the FDA and whose permission must be granted before the medicine may be sold to consumers, supplements aren’t subject to this oversight. The FDA is allowed to intervene only after a problem with a product is discovered. As the L.A. Times summarized, the “result has been a cat-and-mouse game in which researchers discover problems, regulators act and supplement makers adjust their products and practices, only to start the process all over again.”
In March, supplement retailer GNC Holdings Inc. settled a case about product ingredients that were not listed on their labels with New York’s Attorney General. It agreed to use DNA-based testing to authenticate the ingredients in certain herbal supplements.
After that case, 13 other attorneys general asked Congress to give the FDA more authority over the supplements industry.
The New York Times editorial pulled no punches, calling the FDA “lethargic” about regulating dietary supplements. The BMPEA incident, it said, “is a classic example of what happens when industry representatives infiltrate the agency that is supposed to regulate them.”
The N.Y. Times lays much of the responsibility for such lethargy at the feet of Dr. Daniel Fabricant. He was a senior executive at the Natural Products Association (NPA), a trade group for supplement makers and sellers, who became head of the FDA’s division of dietary supplement programs in 2011. Last spring, he went back to the trade association, as chief executive. His successive acting directors at the FDA have included the current one, Cara Welch, also from the NPA. “Both dragged their feet on BMPEA,” the paper opined.
The FDA justifies it hiring practices by claiming to need experts from a variety of experience in public health, academia, science and industry to produce the best health outcomes.
That’s not unreasonable on its face: Industry perspective is valuable in helping a regulatory agency understand the effect of its actions on commerce.
But, as the editorial concluded, “[C]onsumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the FDA 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.”