Editor's note: The FDA on April 22, 2015, sent warning letters to five companies which manufacture dietary supplements with BMPEA, asking them to stop distributing the products.
April 7, 2015 -- Researchers are warning consumers to avoid dietary supplements labeled as having the active ingredient Acacia rigidula.
The supplements claim to aid weight loss, boost energy, and sharpen attention. But about half of the 21 “natural” acacia products tested by researchers contained a lab-made stimulant called BMPEA, which stands for beta-methylphenylethylamine.
“Whenever you buy a weight loss product, the best you can hope for is that it doesn’t work. But why I would strongly caution against it is that the risk of getting a drug, and maybe even a drug that’s never been tested in humans, is real,” says Pieter Cohen, MD, an assistant professor of medicine at Harvard University.
The test results are published in the journal Drug Testing and Analysis.
Acacia rigidula is a shrub that grows in parts of Texas and Mexico. And BMPEA, which is related to the stimulant drug ephedrine, is the latest speed-like chemical to taint dietary supplements, researchers say.
In 2012, the agency warned 10 manufacturers to remove the stimulant DMAA from their products after supplements containing the ingredient led to cases of liver failure so severe, some people who took them needed transplants. DMAA has also been linked to at least one death.
But the agency has yet to warn consumers or recall products that have BMPEA in them.
In response to Cohen’s findings, the FDA says its first priority when it comes to dietary supplements is ensuring safety.
“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,” says JuliAnn Putnam, an FDA spokesperson, in an emailed statement.
Researcher Criticizes the FDA
While researching the chemical, Cohen says he found something he calls disturbing: In 2012, the FDA’s own scientists also tested acacia supplements and found BMPEA in about half the products they tested. And they determined -- by testing Acacia rigidula leaves -- that there was no such compound in the plant. Their study was published in 2013 in the Journal of Pharmaceutical and Biomedical Analysis.
Cohen, a leading critic of the dietary supplement industry, calls the FDA’s decision to wait for evidence of harm “grossly irresponsible,” especially since Canadian and European regulators have already taken action to keep Acacia rigidula supplements off store shelves.
“If they wait long enough, I suspect they'll have that level of evidence to remove BMPEA from the market. But what are they going to say to a mother who lost her son taking BMPEA supplements? How are they going to explain two years of inaction?” he asks.
Even worse, by making that statement, Cohen says the FDA is essentially giving “the green light to other companies to experiment with introducing their own designer drugs into supplements.”
In fact, Hi-Tech Pharmaceuticals, the Norcross, GA-based company that makes 10 of the supplements Cohen tested, recently put out a press release claiming that the “proprietary weight loss and energy ingredient” in its Acacia rigidula supplements is more potent than both caffeine and ephedrine.
Cohen says BMPEA was first created in the lab in the 1930s. It was shown to cause spikes in blood pressure in dogs and cats and to cross easily into the brain, but it was never tested in humans.
“It made the animals’ hearts race and blood pressure go up,” Cohen says. “We can’t even guess what it does to people.”
In a study posted online , Patrick Jacobs, PhD, an exercise physiologist in Miami, FL, says he gave the supplement Fastin-XR, which is made by Hi-Tech Pharmaceuticals, to 10 healthy, active men between the ages of 18 and 45. His study found that Fastin boosted some measures of metabolism more than caffeine, acacia extract, or a placebo. But it also raised the men’s blood pressures and led to more confusion and tension. Hi-Tech cites his research in their press release.
Jacobs didn’t respond to requests for comment.
Hi-Tech has been on the FDA’s radar before. In 2013, federal marshals seized dietary supplements worth $2 million, because the company ignored the agency’s warning to stop making pills containing DMAA. In response, the company sued the FDA for its “bullying” tactics.
Last year, a judge ordered company executives jailed because they ignored a court order to recall supplements being sold for weight loss that were not supported by reliable scientific evidence.
On Tuesday, a woman who answered the phone for Hi-Tech said company executives were on vacation and couldn’t be reached for comment.
The Council for Responsible Nutrition (CRN), a trade association representing dietary supplement makers, says the FDA should act to protect consumers.
“We share the concerns of Dr. Pieter Cohen and his study co-authors regarding BMPEA … a synthetic drug-like substance, not a dietary ingredient,” Steve Mister, the association’s president and CEO, says in a statement.
The “FDA has the tools it needs under the law to take action before there are serious health consequences, and CRN is asking the agency to do just that.”