U.S. officials have received reports of 13 deaths over the past
four years that cited the possible involvement of 5-Hour Energy,
according to Food and Drug Administration records.
U.S. officials have received reports of 13 deaths over the past four years that cited the possible involvement of 5-Hour Energy, a highly caffeinated energy drink, according to Food and Drug Administration records and an interview with an agency official.
The disclosure of the reports is the second linking in recent weeks of energy drinks and deaths in F.D.A. filings. Last month, the agency acknowledged it had received five fatality filings mentioning another popular energy drink, Monster Energy.
Since 2009, 5-Hour Energy has been mentioned in about 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of F.D.A. records reviewed by The New York Times showed.
The filing of an incident report with the F.D.A. 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, Michigan, did not respond to written questions about the filings, and its top executive declined to be interviewed. Living Essentials is a unit of Innovation Ventures.
But in a statement, Living Essentials said that 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, California, has repeatedly said that its products are safe, adding that they were not the cause of any of the health problems reported to the F.D.A.
Shares of Monster Beverage, which traded above $80 earlier this year, closed Wednesday at $44.74.
The fast-growing energy drink industry is facing increasing scrutiny over issues like labeling disclosures and possible health risks. Some lawmakers are calling on the F.D.A. 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 bottle that holds two ounces, or about 6 centiliters, and is referred to as a shot. The company does not disclose the amount of caffeine in each bottle, but a recent article published by Consumer Reports magazine placed that level at about 215 milligrams.
An eight-ounce cup of coffee, depending on how it is made, can contain 100 to 150 milligrams of caffeine.
The F.D.A. has stated that it does not have sufficient scientific evidence to justify changing the way it regulates caffeine or other ingredients in energy products. 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.
During an interview Wednesday, Daniel Fabricant, the director of
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