FDA Official to Sen. Durbin: Agency Investigating Safety of Energy Drinks

WASHINGTON The U.S. Food and Drug Administration (FDA) has confirmed it is investigating the safety of energy drinks on the heels of reports linking such beverages to several deaths.

The agency sent a letter to a Democrat in the U.S. Senate who has been pressuring FDA to explore the potential risks associated with energy drinks: Dick Durbin of Illinois. Durbin and Sen. Richard Blumenthal, a Connecticut Democrat, have raised concerns over the caffeine levels and other ingredients like guarana and taurine in energy drinks.

"There is very clearly a lack of understanding about the health effects of energy drinks and their ingredients especially on children and adolescents," said the senators in a statement Tuesday.

Michele Mital, FDA's Acting Associate Commissioner for Legislation, revealed the agency is looking into whether energy drinks may pose significant risks when consumed excessively or by certain individuals such as those with pre-existing cardiac conditions and young people.

FDA also is investigating deaths and other serious adverse health effects that have been linked to energy drinks, Mital noted. Records have revealed reports of 13 deaths connected to 5-hour Energy drinks, and five deaths have been linked to Monster Energy drinks.

FDA has underscored the reports are merely allegations and that it does not draw conclusions until it completes its investigations. But FDA's probe could prove difficult without access to crucial medical records of the deceased.

"In general, FDA does not have the authority to require the production of medical records by families or health care providers," Mital wrote, "but we are requesting that such records be provided on a voluntary basis, even as we remain sensitive to the wishes of families and the constraints under which the health care providers operate in light of state and local laws governing disclosure."

Mital said the review could be aided by engaging specialized expertise outside the agency, most likely through consultation with the Institute of Medicine and possibly through an advisory committee.

The fatality reports have raised questions over whether energy drinks should be subject to more stringent regulations. Among other considerations, based on its review and within the limits of its authority, FDA will consider imposing such regulations as "requiring disclosure of the amount of caffeine in food products, limitations on intended use, or warnings about possible adverse effects," Mital said.