More than half of US adults take a dietary supplement. The FDA has warned consumers about the risks they pose before, but new research shows just how much of a problem over-the-counter dietary supplements with unapproved ingredients are.
In a new Journal of the American Medical Association study, researchers looked at supplements the FDA issued warnings about from 2007 to 2016. They identified potentially harmful or undeclared drugs in more than 700 (776) supplements.
Most of the supplements claimed to have sexual benefits, help weight loss, or build muscle. One out of every five products contained multiple ingredients the FDA had never signed off on. Experts also found manufacturers sometimes replaced ingredients listed on labels with cheaper alternatives. Researchers even discovered two stimulants that never had FDA approval for people to take orally.
The study also highlights flaws in the FDA's regulation process. The agency classifies them as food rather than drugs, and typically issues voluntary recalls when tests show a supplement had unapproved ingredients. Researchers found the FDA recalled less than half (360 of 746) of the supplements it had found to be adulterated.
Those supplements left on the shelves can lead to serious consequences. One 2015 study found more than 23 thousand (23,005) emergency room visits each year were for a bad reaction to dietary supplements.
To date, the FDA has not taken any regulatory action to remove those two stimulants. Researchers hope their findings might give Congress a reason to amend supplement laws, as the current ones are 24 years old. Their suggestion — require firms to register supplements with the FDA before they go on sale.