The woman was the picture of health.
She was 53 years old with no medical complications. Her weight was normal, and her blood pressure was low. She didn’t smoke or use drugs. She did a vigorous workout routine several times a week without problems.
But recently, she had added another element to the mix: a dietary supplement called Jacked Power that purported to boost athletic performance.
The listed ingredients seemed relatively harmless. The strongest was 300 milligrams of caffeine per dose. That’s about the same amount of caffeine in 2 to 3 cups of coffee. For a person in good heart health, that shouldn’t have been a problem.
Unbeknownst to the female athlete, however, each dose of Jacked Power contained a hidden ingredient: 290 mg of β-methylphenylethylamine (BMPEA). It has never been tested in humans for safety.
After about 45 minutes of exercise, the woman began to experience clumsiness and numbness in her left hand. In the hospital, doctors determined that she’d suffered a hemorrhagic stroke.
“Unfortunately, this is what we had predicted based on the research in cats and dogs that showed that BMPEA had stimulant properties similar to ephedra or amphetamine,” said Dr. Pieter Cohen, assistant professor of medicine at Harvard Medical School and lead investigator of the woman’s case report in the Annals of Internal Medicine, in an interview with Healthline. “We suspected BMPEA would also raise blood pressure in adults and that this could predispose [a patient] to a blood vessel bursting and bleeding into the brain.”
Although the woman recovered after five days in the hospital, her case raised a larger question: Is the Food and Drug Administration (FDA) doing enough to regulate dietary supplements?
Let the Buyer Beware
Jacked Power isn’t the only dietary supplement that contains BMPEA. Cohen analyzed 21 brands of dietary supplements that listed as an ingredient the herb Acacia rigidula, which contains a number of natural stimulants. Of those studied, 11 of the brands also contained BMPEA, which does not occur naturally in A. rigidula.
“Any supplement that is sold as if it will improve your workout, or so-called ‘pre-workout supplements,’ should be avoided,” warned Cohen. “They often claim to have natural stimulants but in fact might have potentially dangerous synthetic stimulants instead.”
BMPEA is gathering increasing attention from regulatory agencies. Jetfuel Superburn, which contained BMPEA and phenylpropylmethylamine, was recalled after Health Canada issued a warning about the product last year. And last month, 19 days after Cohen submitted his advisory to the FDA, the agency issued warning letters to five companies that were distributing products listing BMPEA as a dietary ingredient.
“BMPEA is not lawfully marketed as a dietary ingredient,” said Jennifer Dooren, spokesperson for the FDA, in an interview with Healthline. “Declaring BMPEA as a dietary ingredient in product labeling causes products marketed as dietary supplements to be misbranded in that the labeling is false or misleading.”
She added, “Manufacturers and distributors do not need FDA approval to sell dietary supplements. Dietary supplement manufacturers and distributers are legally responsible for marketing a safe product that is not adulterated […] [with] active pharmaceutical ingredients that cause their products to be unapproved and misbranded new drugs.”
Burden Is on Federal Regulators
This puts the burden of proof on the FDA and on scientists to demonstrate that a product is unsafe for it to be pulled from the market, rather than on dietary supplement companies to prove that their supplement is safe before it can hit the shelves.
“Currently, the regulations governing the production of supplements do not ensure that only safe products are on store shelves,” said Cohen. “Consumers should be particularly wary of any supplement that suggests it will improve your workouts or help you lose weight.”
The FDA regulates both the food we eat and the medications we take. The agency’s job is to ensure these products don’t contain dangerous ingredients, and, in the case of medications, have the health effects they claim to provide.
However, since 1994, dietary supplements have enjoyed a relatively regulation-free market. Manufacturers don’t have to disclose what ingredients they put into their supplements. And even when they do, the FDA isn’t necessarily checking to make sure they’re selling what they claim to sell.
One study described in The New York Times found that only about 20 percent of the herbal supplements examined actually had DNA from the plant they claimed to contain.