A new study has revealed that an experimental stimulant drug, phenpromethamine, which was never approved for oral use, is part of weight loss and sports supplements being sold today. The stimulant, also called Vonedrine, dates back to World War II, when it was sold as a nasal inhaler. It was later withdrawn from the market.
According to a March 2021 report in Science Alert, a study in the journal Clinical Toxicology is the first “to confirm the presence of phenpromethamine in supplements.” The study revealed eight other banned stimulants, mixed in various “cocktails” in various weight loss and sports supplements. The banned stimulants haven’t been tested in humans. One supplement had for different stimulants contained within it.
The study’s lead doctor, a general internist at the Cambridge Health Alliance and an associate professor of medicine at Harvard Medical School, said that the findings are very surprising. The author believe that the Food and Drug Administration (FDA) should warn consumers that weight loss and sports supplements have experimental stimulants, and that the agency should take immediate steps to remove these stimulants (and supplements) from the market.
The results of the study
The scientists began their study looking for deterenol, a different stimulant, because European studies had found deterenol in other supplements. Deterenol has been linked with “nausea, vomiting, chest pain, cardiac arrest, and even sudden death.” The FDA ruled that dietary supplements could not contain deterenol.
The researchers analyzed 17 US supplement products “that were labeled as containing deterenol or a synonym for the drug.” Researchers found deterenol in 13 of the 17 supplements. They found phenpromethamine in four of the 17 brands.
The FDA has not yet issued any warning about phenpromethamine. The FDA has yet to issue any warnings about deterenol, either, even though the supplement is prohibited by the FDA. “There’s no question that the FDA should have acted as soon as they determined [deterenol] was present,” the internist said.
Is phenpromethamine dangerous?
That’s the issue: no one really knows. In the 1940s and 1950s, phenpromethamine was taken as a nasal inhaler before it was withdrawn. The dangers of taking the drug orally, through supplements, are completely unknown.
Other WWII stimulants have shown up in dietary supplements
According to Science Alert, “In 2004, after the FDA banned the stimulant ephedra from dietary supplements, manufacturers started adding other experimental stimulants, including [one called] 1,3-DMAA.” The FDA has banned 1,3-DMAA from supplements and issued a warning to consumers about the risk of heart disorders if they consume 1,3-DMAA.
Why the FDA is more limited in what it can do for consumers
While the FDA does have general warnings about the dangers of weight loss supplements, saying that may contain “hidden and potentially harmful active ingredients,” it is a bit limited when it comes to protecting consumers from dietary supplements. This is because the FDA does not usually get involved in regulation until after the supplement has made it to market, per the FDA: “In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency’s first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.” If a product causes injury, however, the manufacturer is required by law to report that to the FDA.
Furthermore, while the FDA is in charge of “taking action against any adulterated or misbranded dietary supplement product after it reaches the market,” there are no FDA regulations regarding:
- Proof of product safety
- Proof of accuracy in labeling (though the FDA may review labels as “resources permit”)
- Approval by the agency before selling the product
The study’s lead author recommends that consumers stay away from two types of dietary supplements: anything with a label that says they’ll help you lose weight, and “those labeled as pre-workout or muscle-building supplements. (The latter category excludes protein powders, which generally contain amino acids and are not something to worry about, [the internist] said.)”
In a statement provided to Live Science, the FDA said it is reviewing the new study.
For more than 40 years, Barry J. Nace has worked to protect the rights of victims of medical malpractice and other personal injuries. Throughout his career, he has proven that multimillion-dollar awards are not a matter of luck, but the result of experience, hard work, outstanding trial skills, and an unquestioned dedication to justice. To date, Mr. Nace has produced dozens of verdicts and settlements in excess of $1 million with three in excess of $30 million. Read more about Barry J. Nace.