Federal officials have received reports of 13 deaths over the last four years that cited possible involvement of 5-Hour Energy, a highly caffeinated energy shot, according to Food and Drug Administration records and an interview with an FDA official.
The disclosure of the reports is the second time in recent weeks that FDA filings citing energy drinks and deaths have emerged. Last month, the agency acknowledged that it had received five fatality filings mentioning another popular energy drink, Monster Energy.
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 such as heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of FDA records reviewed by The New York Times showed.
The filing of an incident report with the FDA does not mean that a product was responsible for a death or an injury, or contributed in any way to it. Such reports can be fragmentary in nature and difficult to investigate.
The distributor of 5-Hour Energy, Living Essentials of Farmington Hills, Mich., did not respond to written questions about the filings, and its top executive declined to be interviewed. Living Essentials is a unit of the product's producer, Innovation Ventures. But in a statement, Living Essentials said the product was safe when used as directed, and that it was "unaware of any deaths proven to be caused by the consumption of 5-Hour Energy."
Since the public disclosure of reports about Monster Energy, its producer, Monster Beverage of Corona, Calif., has repeatedly said its products are safe, adding that they were not the cause of any of the health problems reported to the FDA.
The fast-growing energy drink industry is facing increasing scrutiny over issues such as labeling disclosures and possible health risks. Some lawmakers are calling upon the FDA to increase its regulation of the products, and the New York state attorney general is investigating the practices of several producers.
Unlike Red Bull, Monster Energy and some other energy drinks that look like beverages, 5-Hour Energy is sold in a 2-ounce bottle referred to as a shot. The company does not disclose the amount of caffeine per bottle, but a recent article published by Consumer Reports placed that level at about 215 milligrams. An 8-ounce cup of coffee, depending on how it is made, can contain from 100 to 150 milligrams of caffeine.
The FDA has stated that it does not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products. How to do so is complicated by the fact that some high-caffeine drinks, such as Red Bull, are sold under agency rules governing beverages, while others, such as 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing ingredient rules and reporting requirements.
In an interview Wednesday, Daniel Fabricant, director of the agency's division of dietary supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy. He said that while medical information in such reports could rule out a link with the product, other reports could contain insufficient information to determine what role, if any, a supplement might have played.
Mr. Fabricant said the 13 fatality reports that mentioned 5-Hour Energy had all been submitted to the FDA by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the FDA when they become aware of a death or serious injury that may be related to their product.
Currently, the agency does not publicly disclose adverse event filings about dietary supplements such as 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, Mr. Fabricant said.
Along with caffeine, 5-Hour Energy contains other ingredients, such as very high levels of certain B vitamins and an amino acid called taurine.
Reached by phone, Living Essentials chief executive Manoj Bhargava declined to discuss the filings.