5-Hour Energy drinks have been cited in the deaths of 13 people in the past four years, according to reports received by the Food and Drug Administration.
The energy shot, distributed by closely held Living Essentials LLC, has been associated with 92 adverse event reports in that time, including 32 hospitalizations, Shelly Burgess, an FDA spokeswoman, said yesterday in a telephone interview. The death reports are open cases being investigated by the FDA, she said.
5-Hour Energy, Monster Beverage Corp. energy drinks and competing products are being targeted by lawmakers, including U.S. Senator Dick Durbin, an Illinois Democrat who wants caffeine limits on the beverages after emergency room visits involving such drinks jumped 10-fold from 2005 through 2009. Regulators last month said drinks from Corona, California-based Monster have been cited in the deaths of five people in the past year according to reports filed voluntarily by doctors and companies with the FDA. 5-Hour Energy is classified as a dietary supplement that boosts energy and isn’t marketed as a beverage, Living Essentials said yesterday in a statement.
The company “is unaware of any deaths proven to have been caused by the consumption of 5-Hour Energy,” Farmington Hills, Michigan-based Living Essentials said. “It is important to note that submitting a serious adverse event report to the FDA, according the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported.”
5-Hour Energy said on its website that its energy shot contains the same amount of caffeine as 12 ounces of a cup of premium coffee. The company said it recommends individuals consume no more than two bottles of the energy shot per day “spaced several hours apart.”
Living Essentials “takes reports of any potential adverse event tied to our products very seriously. We fully comply with all of our reporting requirements,” the company said in its statement.
Caffeine in energy drinks often ranges from 160 milligrams to 500 milligrams a serving, the FDA said in an August letter responding to Durbin’s call for greater industry regulation.