New FDA Guidance Declaring Bulk Caffeine Products Illegal Is an Unqualified Victory for Public Safety
Statement of CSPI Policy Director Laura MacCleery
The Food and Drug Administration today issued an important final guidance declaring that highly concentrated bulk caffeine products—powders and liquids—are illegal. The FDA declared that these supplements are too dangerous to be sold, and that the agency is prepared to take enforcement action against anyone marketing them.
This action will save lives and remove a serious hazard for consumers. The policy follows the tragic deaths in 2014 of two young men—Logan Stiner and James Wade Sweatt—who died in separate incidents one month apart following unintentional overdoses of highly concentrated caffeine products. Working with CSPI, the courageous families of these two men pressed their case at the FDA, in the news, and on Capitol Hill, speaking out to highlight the risks. In December 2014, CSPI petitioned to ban the very products that are the subject of the FDA’s announcement today.
Members of Congress—including Senators Sherrod Brown, Richard Blumenthal, Robert Casey, Richard Durbin, Ed Markey, and Chuck Schumer—had also called for a ban on these supplements.
Anyone selling these supplements online should now be on notice that the products are illegal if they are highly concentrated. We offer high praise and gratitude for this unequivocal win for public health and safety, and for the compassionate leadership of Steven Tave, director of the FDA’s Office of Dietary Supplement Programs.