May 5, 2024

F.D.A. Posts Injury Data For Red Bull

The Food and Drug Administration posted online 21 reports that had been filed with the agency since 2004 that mentioned Red Bull, including ones that involved hospitalizations for heart problems and vomiting. The mention of a product in a report of a fatality or a death does not mean it caused it or contributed to it.

The release of the filings, after similar releases for three other highly caffeinated energy drinks, appears to underscore the crazy-quilt regulatory pattern governing such products. It also highlights the dearth of data that F.D.A. officials are confronting in determining whether to impose additional regulations.

Officials at Red Bull had no immediate comment, and it has said the beverage is safe. This week, in response to an inquiry from The New York Times, Red Bull said it was unaware of any fatality or inquiry filings that mentioned it.

In recent weeks, the F.D.A. has confirmed or disclosed a total of 18 filings involving fatalities and over 150 others involving injuries that mentioned one of four top-selling energy drinks — Red Bull, Monster Energy, Rockstar and 5-Hour Energy. But the volume of such filings stands in stark contrast to a federal report that found that over 13,000 emergency room visits in 2009 cited an energy drink as a possible cause.

Also, while producers of energy drinks that market them as dietary supplements, a group that includes Monster Energy, Rockstar and 5-Hour Energy, must notify the F.D.A. about death and injuries claiming a possible link to their products, companies that market energy drinks as beverages do not. Such companies include Red Bull, Coca-Cola, which sells NOS, and PepsiCo, which sells AMP.

The F.D.A. this week began publicly releasing adverse event reports related to energy drinks after The Times reported that it had received more than 90 filings about 5-Hour Energy, including ones that cited its possible involvement in 13 fatalities. In October, the agency said it had received five fatality reports that cited Monster Energy.

Those companies have also said that their products are safe and that they did not cause any of the problems reported to the F.D.A.

Article source: http://www.nytimes.com/2012/11/17/business/fda-posts-injury-data-for-red-bull.html?partner=rss&emc=rss

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