FDA Takes Steps to Protect Consumers From Dietary Supplements with High Levels of Caffeine

April 16, 2018

The U.S. Food and Drug Administration (FDA) wants to better protect consumers from potentially dangerous dietary supplements containing highly concentrated and pure levels of caffeine, according to an April 13 press release.

The FDA is concerned that consumers can use these products excessively and at potentially dangerous doses. And the products sold in bulk packages have been linked to at least two deaths in otherwise healthy individuals.

As an important health concern, the FDA issued a new guidance that goes into effect immediately. The guidance clarifies that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers.

“Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container. We know these products are sometimes being used in potentially dangerous ways,” FDA Commissioner Scott Gottlieb, M.D., said in the press release.

View the press release.