Prohibited stimulants again found in supplements

Weight loss and sports supplements were found to contain cocktails of banned and unapproved stimulants, including a dangerous stimulant that the FDA ordered manufacturers to stop using years ago.

This is evident from a study that Tuesday in Clinical Toxicology, with the lead author saying FDA oversight of the supplement industry is lagging.

Pieter Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance in Massachusetts, and co-authors examined the composition of 17 brands of over-the-counter supplements in the US, purchased online and labeled deterenol, a beta version. agonist that was never approved for use in the US and banned from supplements by the FDA in 2004.

With those brands, the researchers found nine stimulants that should not be in supplements, and eight different combinations of stimulants. Less than half contained deterenol alone (47%). Four brands included two stimulants, two brands combined three stimulants, and two other brands combined four stimulants.

These stimulants include fenpromethamine (Vonedrin), BMPEA, oxilofrin, octodrine, higenamine, 1,3-DMAA, 1,3-DMBA, and 1,4-DMAA.

Deterenol has been found in several supplements sold in the US in previous studies, and its presence has been confirmed by FDA chemists – even though the agency has banned it. Still, the researchers noted that the agency “has not advised manufacturers to remove deterenol from products, nor has it warned consumers to avoid supplements labeled as containing deterenol.”

Cohen told MedPage today that’s why the new study was needed: “It’s a real shame that new information, like publishing our study, would be needed for the FDA to act,” Cohen said, “and they didn’t.”

He said he was especially surprised to find that fenpromethamine was the second most commonly detected stimulant. It was used briefly as a nasal inhaler in the 1940s, but has never been approved for oral administration.

FDA also noted the presence of fenpromethamine in supplements while Cohen’s team worked on this study, he said, but as with deterenol, the agency has declined to ask manufacturers to remove it or warn the public.

“The FDA does not remove the lowest hanging fruit or warn consumers of their findings,” Cohen said.

FDA declined to answer specific questions MedPage today, instead emailing a statement: “The FDA is reviewing the findings of this document,” a spokesperson wrote. “We value these types of studies to raise awareness and draw attention to these matters. In general, however, the FDA does not comment on specific studies, but assesses them as part of the body of evidence to support our understanding of a particular topic. to increase. “

Cohen’s group pointed out that their research isn’t the first study to report such findings, some of which go back at least seven years.

“It seems that the FDA is not operating in this space, so that companies can do whatever they want,” Cohen said. “Even if the FDA tries to do something … they are clearly not following up in a way that ensures that stimulants are removed.”

Banning ephedra in 2004 led to the “explosion” of other questionable stimulants in supplements, Cohen said. Manufacturers have included lesser-known untested stimulants in supplements, often listed on the bottle. Sometimes “it’s a matter of the FDA reading the label and doing its job,” Cohen said.

Cohen called on Congress to reform the additional laws and the FDA to enact “robust” enforcement.

Steve Tave, JD, who led the FDA’s Office of Dietary Supplement Programs for five years until this month, was in favor of requiring manufacturers to be listed in a national database, he said at a conference in September. (A copy of his prepared comments was shared with MedPage today by Cohen.)

“The question ‘are dietary supplements regulated’ is a red herring. Of course, and it’s silly to suggest otherwise,” Tave said. “I think we can at least safely say that the nutritional supplement market is not perfectly regulated … While we may know more than 10,000 registered facilities around the world, we don’t know what they produce, and we don’t have a systematic way. to know when new products come onto the market or what ingredients they contain. “

FDA inspected less than 5% of registered supplement facilities annually prior to the pandemic, he said, adding, “The rate of non-compliance when we inspect is very high – probably the highest for all FDA-regulated goods, with frequent shortcomings in basic requirements. “

“Why is there so much non-compliance?” he asked rhetorically. He went on to argue a “regulatory loophole” that in many cases prevents the FDA from taking enforcement action, due to the need to establish evidence, the availability of resources, and what he called “idiosyncrasies in the law” that remain the hand of the service.

And he denied that the agency is turning a blind eye to illegal supplements, noting that the agency had issued “at least 57 warning letters” and filed an injunction and two seizures in fiscal 2019.

In Cohen’s research, 35 samples from 17 supplements were analyzed at NSF International and the National Institute for Public Health and the Environment, with corresponding results. Most were marketed for weight loss (eight) or sports / energy enhancement (six).

Study limitations included small sample size and focus on products with deterenol clearly listed as an ingredient.

Last updated March 23, 2021