According to The New York Times, U.S. Food and Drug Administration (FDA) records and interviews reveal reports of 13 deaths over the last four years citing the possible involvement of 5-Hour Energy, a highly caffeinated energy shot. The disclosure of the reports is the second time in recent weeks that FDA filings citing energy drinks and deaths have emerged. In October, the FDA acknowledged 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 like heart attacks, convulsions, and, in one case, a spontaneous abortion. 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.
Living Essentials, maker of 5-Hour Energy, released a statement saying that the product is safe when used as directed and that it is “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.”
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 FDA to increase its regulation of the products. 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. 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 New York Times article
5-Hour Energy statement (pdf)