FDA said it has received reports of 13 deaths since 2008 possibly related to the use of 5-hour Energy shots, a disclosure that could heighten scrutiny of drinks and dietary supplements that promise to deliver an energy..
5-hour Energy, sold in 1.93-ounce plastic bottles, increasingly has become a fixture at check-out counters of convenience stores and drug stores. Its label promises to deliver a boost of energy "in minutes."
In a statement Wednesday, Living Essentials said 5-hour is intended for "busy adults" and that its product is an effective dietary supplement, containing about as much caffeine as a cup of coffee.
It recommends on product labels that consumers don't drink more than two bottles a day, spaced several hours apart, and that consumers sensitive to caffeine should consult with a physician.
"It is important to note that submitting a serious adverse event report to the FDA, according to 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, or that any person included in the report caused or contributed to the event," the company added in its statement Wednesday.
Living Essentials had about $600 million in sales last year.