Banned stimulants rediscovered with supplements

Weight loss and sports supplements have been found to contain a banned, unapproved stimulant cocktail, including one dangerous stimulant that the FDA ordered manufacturers to stop using a few years ago. ..

according to it Study published on Tuesday Clinical toxicology, Its lead author states that the FDA’s oversight of the supplement industry continues to lag.

Pieter Cohen, MD and co-authors of Harvard Medical School in Massachusetts and the Cambridge Health Alliance examined the composition of 17 brands of online US commercial supplements labeled as containing beta versions of Deterenol. An agonist that has never been approved for use in the United States and was banned by the FDA in 2004.

Throughout those brands, researchers have discovered nine stimulant compounds and eight different stimulant combinations that are not allowed in supplements. Less than half contained only deterenol (47%). The four brands contained two stimulants, two brands combined three stimulants, and the other two brands combined four stimulants.

These stimulants included phenpromethamine (bonedrin), BMPEA, oxilofrine, 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 a previous study, Its presence Confirmed by FDA chemists -Even though the agency prohibits it. Still, researchers say authorities “do not advise manufacturers to remove deterenol from their products and warn consumers to avoid supplements labeled as containing deterenol.” It was.

Cohen said Today’s MedPage Therefore, a new investigation was needed. “It’s a real shame that we need new information, such as publishing a survey, to get the FDA to take action,” Cohen said.

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

While Cohen’s team was working on this study, the FDA also noticed the presence of phenpromethamine in the supplement, he said, yet, like Deterenol, the FDA would remove it from the manufacturer or generally I declined to ask you to warn me.

“The FDA hasn’t removed the most hanging fruits and hasn’t even warned consumers about their findings,” Cohen said.

The FDA refused to answer certain questions from Today’s MedPageInstead, email the statement. “The FDA is reviewing the findings of this treatise,” a spokeswoman wrote. “We appreciate such research to raise awareness and raise the necessary attention to these issues. However, in general, the FDA does not comment on specific research, but on specific issues. Evaluate them as part of the evidence for better understanding. “”

Cohen’s group pointed out that their study was not the first to report such a finding, but a study that dates back at least seven years.

“The FDA doesn’t seem to be working in this area, and companies can do what they want,” Cohen said. “It’s clear that if the FDA tries to do something … it won’t follow up in a way that ensures that stimulants are removed.”

Ban Ephedra According to Cohen, there was an “explosion” of other suspicious stimulants in the supplement in 2004. Manufacturers put lesser-known, untested stimulants in supplements and often list them in bottles. “It can be problematic for the FDA to read the label and do the job,” Cohen said.

Cohen called on Congress to reform its supplementary legislation and enact a “strong” enforcement for the FDA.

Steve Tave, JD, who oversaw the FDA’s Dietary Supplements Program Department for five years Until this monthIn support of requiring manufacturers to be listed in national databases, said at a meeting in September. (A copy of his prepared remarks was shared with Today’s MedPage By Cohen. )

The question “Is dietary supplements regulated?” Is red herring. Of course it is. It’s ridiculous to suggest that this is not the case, “says Tave. “At least it’s no exaggeration to say that the dietary supplement market isn’t fully regulated ….. you may know about more than 10,000 registered facilities around the world, but what are they? I don’t know if it’s in production. There’s no way to systematically know when a new product was introduced to the market and what ingredients it contains. “

The FDA inspected less than 5% of supplement facilities registered each year before the pandemic, he added. Deficiencies in basic requirements. “

“Why are there so many non-compliance?” He asked rhetorically. He further argues for a “regulatory gap” that prevents the FDA from taking enforcement action in many cases because it needs to establish evidence, resource availability, and “legal habits” that stay in the hands of the FDA. Did.

He denied that the authorities turned a blind eye to illegal supplements and pointed out that the authorities issued “at least 57 warning letters” and submitted one injunction and two foreclosures in 2019. did.

In a study by Cohen’s group, 35 samples of 17 supplements were analyzed in NSF International The National Institute for Public Health and Environment has produced consensus results. Most were sold for either weight loss (8) or sports / energy enhancement (6).

The limits of the study included the small sample size and the focus on products containing deterenol, which is clearly listed as an ingredient.

Last updated: March 23, 2021