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The distributor of 5-Hour Energy insists the caffeine-loaded “shot” is safe when used as directed following news that the U.S. Food and Drug Administration had received reports from the company that the product may be linked to 13 deaths in recent years.
The FDA confirmed a New York Times report that it is investigating the deaths, which occurred in the last four years. The investigation is similar to one the agency has launched targeting Monster Energy drink and reports of five possible deaths related to that product.
Elaine Lutz, a spokeswoman for Living Essentials, said the distributor is unaware of any deaths proven to have been connected to 5-Hour Energy and the NYT report acknowledges a filing to the FDA does not necessarily mean the energy shot was ultimately responsible for a death or injury.
Living Essentials is required to pass along to the FDA any reports of possible deaths or injuries linked to its product because it is marketed as a dietary supplement. The makers of energy drinks don’t have to submit such reports.
The NYT report said, “Since 2009, 5-Hour Energy has been mentioned in some 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.”
Lutz said 5-Hour Energy is safe if used as directed, no more than two of the 2-ounce shots a day. The two daily shots, each of which contains about as much caffeine as a cup of coffee, should not be consumed back to back, the company said.
Consumer Reports recently studied the levels of caffeine in 27 energy drinks. “The highest amount per serving was 242 milligrams of caffeine in 5-Hour Energy Extra Strength. The lowest was in 5-Hour Energy Decaf, which despite the name carries 6 milligrams of caffeine per serving.”
Living Essentials said 5-Hour Energy, which is also loaded with B vitamins, is for “hardworking adults who need an extra boost of energy,” but it’s “not an energy drink” and isn’t marketed as a beverage, the distributor said.
Monster Beverage, the maker of Monster Energy, also said its drink is safe if consumed as directed. The Substance Abuse and Mental Health Services Administration said more than 13,000 emergency room visits in 2009 were linked to energy drinks.