Prohibited stimulants can be found again in supplements

Weight loss and sports supplements have been found to contain cocktails of banned and unapproved incentives, including a dangerous stimulant the FDA ordered manufacturers to discontinue use years ago.

According to a study published Tuesday in Clinical toxicology, its lead author stating that FDA oversight of the supplement industry continues to lag behind.

Pieter Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance of Massachusetts, and co-authors reviewed the makeup of 17 U.S. over-the-counter brands purchased online that were labeled to include deterenol, a beta- agonist that was never approved for use in the US and that the FDA banned supplements in 2004.

Throughout 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 incentives, two brands combined three incentives and two other brands combined four incentives.

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

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

Cohen said MedPage Today that’s why the new study was needed: “It’s really unfortunate that it would require any new information, such as the publication of our study, for the FDA to act,” Cohen said, “and they didn’t.”

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

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

“The FDA does not eliminate fruits with the lowest level of hanging, it does not even warn consumers about their discovery,” Cohen said.

The FDA declined to answer specific questions from MedPage Today, instead of emailing a statement: “The FDA is reviewing the results of this work,” a spokesman wrote. “We appreciate such studies to raise awareness and bring 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 better understand a particular issue. “

Cohen’s group pointed out that theirs is not the first study to report such findings, some going back at least 7 years.

“It looks like the FDA is not active in this space, so companies can do what they want,” Cohen said. Even when the FDA is trying to do something … they clearly are not looking in a way to ensure the elimination of incentives.

The ban on ephedra in 2004 led to the “explosion” of other questionable stimulants in supplements, Cohen said. Manufacturers have slipped in lesser-known stimulants, untested in supplements, often listing them 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 for the FDA to adopt “robust” enforcement.

Steve Tave, JD, who led the FDA’s Bureau of Food Supplement Programs for 5 years until this month, favored the requirement that manufacturers be included in a national database, he told a conference in September. (A copy of his prepared remarks was shared with MedPage Today of Cohen.)

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

The FDA inspected less than 5 percent of pre-pandemic registered supplement facilities annually, he said, adding: “The non-compliance rate when inspecting is very high – probably the highest for any FDA-regulated product with frequent deficiencies. in the basic requirements. “

“Why are there so many nonconformities?” he asked rhetorically. He went on to claim a “regulatory gap” that prevents the FDA from taking enforcement action in many cases because of the need to establish evidence, the availability of resources, and what he called the “oddities in the law” in the agency’s hands.

He also denied that the agency was turning a blind eye to illegal supplements, stressing that the agency had issued “at least 57 warning letters” and filed an injunction and two seizures in fiscal year 2019.

In the Cohen group study, 35 samples of 17 supplements were analyzed at NSF International and the National Institute for Public Health and the Environment in the Netherlands, obtaining appropriate results. Most were marketed either for weight loss (eight) or for sports / energy boosting (six).

The limitations of the study included a small sample size and emphasis on deterenol products clearly listed as an ingredient.

Last updated March 23, 2021