Outrage of the Month: New Research Reveals FDA Fails to Protect Consumers from Dangerous Dietary Supplements

Health Letter, September 2022

By Michael Carome, M.D.

outrage

If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

FDA
Image: JHVEPhoto/Shutterstock.com

For years, the Food and Drug Administration (FDA) has repeatedly warned the public about dietary supplements that have been spiked illegally with drugs that are often dangerous. Among the drugs commonly found in such adulterated supplements are stimulant drugs that have not been approved by the FDA. These supplements often are marketed online for weight loss and to improve exercise performance.

When the FDA becomes aware of such illegal dietary supplements, the agency’s Center for Food Safety and Applied Nutrition typically issues warning letters to the offending companies and asks them to take prompt action to correct the violations and to notify the agency within 15 days of the specific corrective actions taken. These warning letters routinely advise the companies that failure to immediately cease distribution of the illegal products “could result in enforcement action by FDA without further notice” (for example, see here and here).

However, a study published in the Journal of the American Medical Association (JAMA) on July 26, 2022, revealed that the FDA too often fails to take appropriate enforcement action against companies that continue to market illegal dietary supplements after receiving an agency warning letter.

For the JAMA study, researchers at Cambridge Health Alliance and the University of Mississippi assessed the frequency of product recalls and the presence of FDA-prohibited drugs in supplements after FDA warning letters had been issued. Specifically, they examined dietary-supplement products that had been the subject of an FDA warning letter and that contained one of the following illegal stimulants:

  • the amphetamine analogue (compound with similar chemical structure) beta-methylphenethylamine (BMPEA);
  • the ephedrine analogue methylsynephrine; or
  • the dimethylamylamine analogue octodrine.

The FDA issued warning letters for dietary supplements containing these stimulants in 2015, 2016 and 2019, respectively. The FDA warning letters were issued to 18 companies and targeted 31 products. Importantly, these illegal stimulants have been linked to increased risks of stroke and sudden death.

The researchers found that only one of the 31 products was recalled by the manufacturer. Nine (29%) of the supplements remained available for sale online for an average of six years after the FDA issued its warning letters. The labels of four (44%) of these nine available products listed at least one illegal ingredient. Most disturbingly, the researchers chemically analyzed samples of these nine supplements and found that five (56%) contained at least one illegal stimulant, with two containing the same illegal ingredient cited in the FDA’s warning letter.

The findings from the JAMA study demonstrate that the FDA too often fails to appropriately follow up after it issues warning letters to companies that market illegal and dangerous dietary supplements. To better protect consumers, the FDA must ensure that dietary-supplement makers who receive FDA warning letters promptly and permanently cease marketing illegal supplements that endanger consumers’ health.