The ingredients, apparently new, were popping up on the labels of dietary supplements marketed for weight loss and workouts. Sometimes the label said DMHA. Sometimes, Aconitum kusnezoffii. Or other, even harder-to-parse names.
But what were they, really?
Dr. Pieter Cohen, the Harvard internist and noted supplement detective, took the case. He and his collaborators purchased and analyzed six supplements marked as containing one of the mystery ingredients. They expected that, however they were listed, all the ingredients would turn out to be a stimulant known as octodrine, which the Food and Drug Administration approved decades ago, in inhaled form, as a treatment for bronchitis, laryngitis, and other conditions.
Octodrine did indeed show up in one of the products Cohen analyzed. But the others contained three different stimulants, with unknown or potentially risky side effects. They could speed up heart rate and raise blood pressure. And none, including octodrine, has gone through the process required by the FDA to be included as ingredients in dietary supplements.
Cohen called the results “surprising and alarming.”
The finding, published on Wednesday in Clinical Toxicology, is the latest example of potentially dangerous pharmaceutical ingredients turning up in products that consumers can easily order online or pick up from retail shelves. In some cases, the risk seems to be part of the appeal.
One of the products Cohen tested, a powder called “Cannibal Ferox Amped,” is marketed online by a company called Chaos and Pain in packaging reminiscent of a horror movie poster. “You’re looking at serious quantities of stimulants,” the product description says. It goes on to gleefully cite a review that called the supplement “dangerous and irresponsible.”
Chaos and Pain owner Wayne Banks declined to comment. Other manufacturers didn’t return STAT’s request for comment on the study.
The new findings also highlight just how hard it has been for the FDA to keep potentially unsafe supplement ingredients off the market.
For example, regulators warn that the best-known of these stimulants, called DMAA, can cause cardiovascular problems ranging from shortness of breath to a heart attack. In 2012, the FDA began cracking down on DMAA in supplements, ordering manufacturers to take such products off the market and seizing and destroying them when that didn’t happen. Nonetheless, Cohen found DMAA in the two weight-loss products he tested.
The other three stimulants Cohen identified, including octodrine, have similar chemical structures to DMAA, though their safety profile is unknown. Among the additional findings:
- In the weight loss pills sold as “Simply Skinny Pollen,” Cohen found two different stimulants. “These kind of mixtures are of particular concern,” he said, because the odds of harm may be increased.
- In three different products labeled as containing Aconitum kusnezoffii, Cohen found three different stimulants. “I’m just wondering if anyone knows what’s in these,” he said, speaking broadly about his findings.
- In the workout powder sold as “Game Day,” Cohen found a high level of octodrine. In fact, there was twice as much octodrine per serving in the supplement as the highest dose used to treat asthma, low blood pressure, and other conditions when the drug was marketed in Europe as a prescription therapy. “It’s crystal clear that although this is just a snapshot, these are not trace contaminants,” Cohen said. “These are not things that just happen to be on the machine” when the supplement was being manufactured.
Cohen said he and his collaborators in June shared their findings with the FDA.
FDA spokeswoman Theresa Eisenman said that before the agency takes enforcement action against a product, it goes through a series of steps that include tracking the product’s movement and determining the legality of its ingredients. “The FDA takes action within our legal authority, based on public health priorities and available resources,” Eisenman said.
The stimulants may be coming in from overseas, in some cases.
Three Chinese executives were arrested in a sting operation in September at a supplement trade show in Las Vegas. Prosecutors allege that they and several others brought mislabeled stimulants into the U.S., with plans to illegally put them in supplements to be sold to American consumers. The FDA’s criminal investigations arm investigated the case. (The companies caught up in the sting are not the ones that made the supplements Cohen tested.)
It wasn’t immediately clear whether the supplements Cohen tested are widely popular. None is among the top sellers at the industry’s big retailers.
This article is reproduced with permission from STAT. It was first published on Nov. 8, 2017. Find the original story here.