According to the Food and Drug Administration, in the last four years, 13 deaths have been reported associated with 5-Hour Energy drinks.
Last month, the FDA received five fatality filings related to another popular energy drink, Monster Energy.
A summary of FDA records reviewed by The New York Times showed that since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion.
NYTimes writer Barry Meier notes the number of reports filed with the FDA that mention 5-Hour Energy appears particularly striking.
“In 2010, for example, the F.D.A. received a total of 17 fatality reports that mentioned a dietary supplement or a weight loss product, two broad categories that cover more than 50,000 products.”
Meier adds that another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone.
Meier claims the rapidly growing energy drink industry is facing increasing scrutiny over issues like labeling disclosures and possible health risks, and the New York State attorney general is investigating the practices of several producers.
Unlike Red Bull, Monster Energy and some other energy drinks, 5-Hour Energy is sold in a two-ounce bottle referred to as a shot.
The company does not disclose the amount of caffeine in each bottle, but Meier cites a recent article published by Consumer Reports that placed that level at about 215 milligrams, compared to 100 to 150 milligrams of caffeine from an eight-ounce cup of coffee.
The FDA’s explanation for doing nothing but sitting on its hands is that they do not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products — thirteen reported deaths, and 13,000 emergency room visits does not apparently qualify as evidence.
“The issue of how to do so is complicated by the fact that some high-caffeine drinks, like Red Bull, are sold under agency rules governing beverages, while others, like 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing ingredient rules and reporting requirements.”
The Times notes the FDA does not publicly disclose adverse event filings about dietary supplements like 5-Hour Energy.
Companies that market energy drinks as beverages are not required to make such reports to the agency, although they can do so voluntarily.