U.S. federal officials have received reports of 13 deaths over the past four years that cited a possible link to 5-Hour Energy, the popular and highly caffeinated shot.
The same product has been mentioned in some 90 filings with the Food and Drug Administration over the past few years, a third of which involved serious or life-threatening injuries like heart attacks and convulsions, according to a summary of the agency's records reviewed by the New York Times. The newspaper said it found one case of a spontaneous abortion.
Energy drinks have been the subject of much review over concerns about their caffeine or sugar content and questions about their herbal ingredients. Health officials and addiction experts have repeatedly sounded the alarm about mixing energy drinks with alcohol.
The product's distributor, Michigan-based Living Essentials LLC, issued a statement saying 5-hour Energy is not an energy drink but rather a "compact-sized energy shot" that is "an effective dietary supplement" when used as directed.
The FDA does classify the product as a dietary supplement rather than a beverage — the two categories are regulated differently.
Health Canada earlier this year reclassified energy drinks from a natural health product to a food so the agency could have greater oversight over its regulation, but 5-hour Energy was not included as it's classified as a "shot," a spokesman for the agency told QMI Agency. It remains a natural health product. But the spokesman said it doesn't mean the regulations are any less stringent. For example, he said the caffeine content must be on the label.
Citing 5-hour Energy in a report doesn't constitute proof it was responsible for an injury or death. And the company maintains it "takes reports of any potential adverse events" tied to its products "very seriously."
"Living Essentials LLC is unaware of any deaths proven to have been caused by the consumption of 5-hour Energy."
The FDA last month disclosed it is investigating five deaths that had a possible link to another energy drink, Monster Energy.
— with files from Reuters