Prohibited stimulants are found back in supplements

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

According to a study published Tuesday in Clinical toxicology, with its lead author, saying FDA oversight over the supplement industry remains lagging behind.

Pieter Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance of Massachusetts, and their co-authors examined the composition of 17 U.S. over-the-counter, over-the-counter supplements that were labeled to include deterenol. a beta-agonist that has never been approved for use in the U.S. and that the FDA banned supplements in 2004.

In these brands, researchers found nine stimulant compounds that are not allowed in supplements and eight different combinations of stimulants. Less than half contained only deterenol (47%). Four brands included two stimulants, two brands combined three stimulants, and two other brands combined four stimulants.

These stimulants included phenpromethamine (Vonedrine), BMPEA, oxylphrine, octodrine, higenamine, 1,3-DMAA, 1,3-DMBA, and 1,4-DMAA.

Deterenol has been found in several supplements sold in the U.S. in previous studies, with its presence confirmed by FDA chemists, although the agency has banned it. However, the researchers noted, the agency “has not advised manufacturers to remove deterenol from products nor has it warned consumers to avoid supplements labeled as containing deterenol.”

Cohen said MedPage today that’s why the new study was needed: “It’s very unfortunate that it requires new information like how to publish our study to get the FDA to act,” Cohen said, “and they haven’t.”

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

The FDA also noted the presence of fenpromethamine in supplements while Cohen’s team was working on this study, but said, as with deterenol, the agency has refused to ask manufacturers to remove it or alert the public.

“The FDA doesn’t remove the fruit that hangs the most, it doesn’t even warn consumers about its finding,” Cohen said.

The FDA declined to answer specific questions from MedPage todayinstead of emailing a statement, “The FDA is reviewing the findings of this document,” a spokesman wrote. “We appreciate studies like this to raise awareness and draw the necessary attention to these issues. However, in general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding. on a specific topic. “

Cohen’s group noted that his is not the first study to report these findings, some dating back at least seven years.

“It looks like the FDA isn’t active in this space, so companies can do whatever they want,” Cohen said. “Even when the FDA tries to do something … it’s clear they don’t monitor in a way that ensures the removal of stimulants.”

The ban on ephedra in 2004 has sparked the explosion of other questionable stimulants in supplements, Cohen said. Manufacturers have introduced lesser-known and untested stimulants into supplements, which often include them in the bottle. Sometimes “it’s about the FDA reading the label and doing its job,” Cohen said.

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

Steve Tave, JD, who headed the FDA’s Office of Dietary Supplement Programs for 5 years until this month, was in favor of asking manufacturers to be listed in a national database, he said at a conference in September . (A copy of your prepared comments was shared with MedPage today by Cohen.)

“The question of ‘dietary supplements are regulated’ is a red herring. Of course it is and it’s nonsense to suggest otherwise,” Tave said. “I think we can comfortably say, at the very least, that the market for dietary supplements is not perfectly regulated … Although we could know more than 10,000 registered facilities around the world, we don’t know what they produce and we don’t have a way systematic to know when new products are introduced to the market or what ingredients they contain “.

The FDA inspected less than 5% of pre-pandemic registered supplement facility annually, said, adding, “The non-compliance rate when we inspect is very high, probably the highest for any product. regulated by the FDA, with frequent deficiencies in the basic requirements “.

“Why are there so many breaches?” He asked rhetorically. He claimed a “regulatory gap” that prevents the FDA from taking enforcement action in many cases, due to the need to establish evidence, availability of resources, and what he called “peculiarities of the law” that hold hands. of the agency.

And he denied that the agency turned a blind eye to illegal supplements, noting that the agency had issued “at least 57 warning letters” and filed a court order and two seizures during fiscal year 2019.

In the Cohen group study, 35 samples of 17 supplements were analyzed at NSF International and the National Institute of Public Health and the Environment of the Netherlands, which yielded matching results. Most were marketed for both weight loss (eight) and sports / energy improvement (six).

Limitations of the study included a small sample size and focus on deterenol products clearly listed as an ingredient.

Last updated: March 23, 2021