Elaine Lutz, spokeswoman for Living Essentials, LLC, the distributor of 5-hour ENERGY®, responded to the Food and Drug Administration (FDA) investigation into 5 Hour Energy drinks and adverse health effects.
“5 hour ENERGY® is a compact-sized energy shot intended for busy adults; it is not an energy drink, nor marketed as a beverage," said Lutz, in a prepared statement.
Lutz indicated that Living Essentials takes reports of adverse events tied to the product seriously and complies with all reporting requirements. She also noted that submitting a serious adverse event report with the FDA is not construed by the FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported.
“We recommend on product labels and the 5-hour ENERGY® Website that individuals consume no more than two bottles of 5-hour ENERGY® shots per day, spaced several hours apart. We also recommend individuals new to 5-hour ENERGY® try half a bottle to start, wait 10 minutes and consume the rest later. Consumers who have caffeine sensitivities should consult with a physician before taking, and can consider the “decaf” version. Consumers are also instructed to use or discard any remaining product within 72 hours (three days) after opening," Lutz added.
