T

he 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.

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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.

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  • Ever since DSHEA was passed, we have been awash in dangerous supplements. The FDA needs more power, not less. Orrin Hatch and the other politicians who supported DSHEA have blood on their hands.

  • “Public health priorities” …really? …I can list a slew of FDA approved drugs which didn’t seem to have the public’s interest in mind – so please let’s just knock off the self-righteous brouhaha. …many of the nutrional supplements that proved effective by empiricism have been snatched off the market because of the idiocy of users who have pre-existing conditions yet CHOSE, that’s VOLITION, to take the supplement any way …

  • This is wonderful how the FDA monitors our safety and well being. Many obese users are desperate to find a solution and take the risks associated. Thank you for saving lives.

  • With freedom comes personal responsibility. What I put into my body is my business. Whether it be a big Mac, a scoop of preworkout or a salad, I assume the risk when I put it in my mouth. Stop trying to use fear tactics to scare us out of our rights and site quack doctors it attempt to prove a point. The only person you’re reaching with an article like this is not someone using the product but an individual who has no knowledge on the subject.

    • Yes! Stop trying to regulate everything! If someone wants to take ephedrine BECAUSE IT ACTUALLY WORKS then that should be their business!! Why aren’t cigarettes outlawed?!? Oh, that’s right. Because you make too much money off of them. Similar to why they would rather take products that help weight-loss off the market because they make more money giving pharmaceutical medicine to fat people. Quit pretending that you care and that it’s not all about money for you people. Selfish.

  • Well what do you expect? Since the day of banning ephedrine everyone want something similar, so when a product comes out with similar effects, that gets banned too. Now the industry needs to mix and match rare/unknown ingredients to try to come close. Each time am ingredient gets banned that worked, the next down the line come in. Hey FDA just let people use what they want while knowing the effects/side effects. Maybe just allow the age old used ephedrine back, and call it a day.

    • Sure let those that pay their own medical bills when admitted to hospital
      for an emergency procedure. Mostly those using these products use state sponsored medical benefits and their negligence ends up costing all of us because most get free healthcare or similar care.

    • Y’all say that but tell your crying family that when they try to cash out on it with lawsuits when y die or get sick or y sue

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