In 2015 the FDA created the Office of Dietary Supplement Programs. As part of that action, the agency reaffirmed its commitment to remove from the market products that contain undeclared, potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely marketed as dietary supplements.
The FDA also promised better enforcement of good manufacturing practices (GMP) regulation and increased actions against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating diseases) or economic fraud.
This follows the FDA’s crackdown on a variety of dangerous supplements in recent years. Between 2007 and 2016, the agency ordered recalls of 776 products because they contained unapproved, unlabeled drug ingredients that are potentially dangerous. This was reported in a study in JAMA Network Open in 2018, which found that the biggest culprits were supplements marketed for sexual enhancement, weight loss, and muscle building. The most common adulterants were sildenafil (Viagra) for sexual enhancement and sibutramine (a discontinued prescription diet drug) for weight loss.
FDA crackdowns continued in 2017 and 2018, with an emphasis on companies making anti-aging, anti-cancer, erection-improving, performance-enhancing, or immunity-boosting claims for their supplements. In its latest salvo, in February 2019, the FDA warned more than a dozen companies to stop marketing products that purport to improve cognition or prevent, treat, or cure Alzheimer’s disease and other serious diseases, which effectively makes them unapproved new drugs requiring FDA approval.
It’s not clear whether the rise in recalls and warnings has been due primarily to an increase in the number of adulterated or otherwise illegal supplements or to improved FDA enforcement. In any case, these FDA actions almost certainly represent just a small fraction of illegal products.
This article first appeared in the UC Berkeley Wellness Letter.