WASHINGTON — The Food and Drug Administration is investigating 92 patient reports, including 33 hospitalizations and 13 deaths, of people who took products marketed under the label 5-Hour Energy, said Shelly L. Burgess, team leader for food, veterinary and cosmetic products within the F.D.A., on Nov. 15.
“The existence of an adverse event report does not necessarily mean that the product identified in the report actually caused the adverse event,” she said. “F.D.A. assesses the relationship, if any, between a product or ingredient and the reported adverse event. If we find a relationship between consumption of the product and harm, F.D.A. will take appropriate action to reduce or eliminate the risk.”
The F.D.A. will continue to work with the complainants, medical professionals, state and local health authorities, and dietary supplement manufacturers and distributors, Ms. Burgess said.
“F.D.A. cautions consumers that 5-Hour Energy and other products marketed as ‘energy shots’ or ‘energy drinks’ are not alternatives to rest or sleep,” she said. “If someone is thinking about taking one of these products, they should consult with their health care provider to ensure that there are no underlying or undiagnosed medical conditions that could worsen as a result of using them.”
Living Essentials, L.L.C., Farmington Hills, Mich., distributes 5-Hour Energy shots.
“Living Essentials, L.L.C. is unaware of any deaths proven to have been caused by the consumption of 5-Hour Energy,” said Elaine Lutz, a spokesperson for Living Essentials.
She said one shot contains about as much caffeine as a cup of a leading premium coffee. 5-Hour Energy contains an energy blend of citicoline, tyrosine, phenylalanine, taurine, malic acid, glucuronolactone and caffeine, according to Living Essentials.
Living Essentials recommends people consume no more than two bottles of 5-Hour Energy per day and that they not drink it with alcohol, Ms. Lutz said. Women who are pregnant or nursing and children under age 12 should not drink 5-Hour Energy, according to Living Essentials.
Living Essentials complies with the Dietary Supplement Health and Education Act, as regulated by the F.D.A. and the F.D.A.’s Good Manufacturing Practice regulations, Ms. Lutz said.
The F.D.A. also is investigating a possible connection between energy drinks and the deaths of five people (see Page 35 in the Nov. 6, 2012, issue of Food Business News).