Why Did FDA Post Adverse Event Reports for Popular Energy Drinks?

November 20, 2012

FDA records show 166 AERs connected to popular energy drinks in the last 9 years.

Before the end of last week, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published two files detailing adverse event reports for energy drinks, including Red Bull, Monster, 5-Hour Energy, and Rockstar product lines.

Consumption of Red Bull was connected to 21 adverse event reports (AERs) filed between January 1, 2004 and October 23, 2012. During the same time frame, 5-Hour Energy was linked to 92 AERs, Monster to 40 AERs, and Rockstar to 13 AERs. A laundry list of AERs made the published reports, ranging from dizziness to death. AERs cited by multiple users included convulsion, abnormal heart rate, syncope (fainting), and vomiting.

In the reports, Red Bull is characterized as a conventional food, whereas the other three brands are characterized as dietary supplements. Under current law, mandatory reporting of AERs is required for dietary supplements, but not conventional foods.

FDA clearly states that the reports only reflect information provided and do not represent a cause-and-effect experience, but there’s wonder as to why FDA is compiling and publicizing this data right now.