"Depending on the outcome of our ongoing review of the safety of 'energy drinks,' which includes caffeine alone and in combination with other ingredients, we will take action as needed with respect to the levels of caffeine in these products," Michele Mital, acting associate commissioner for legislation at the FDA, wrote Nov. 21 in response to a request by two senators and released this week, Roll Call reported.
Even though 5-Hour Energy is sold in the Senate coffee shop, Democratic Sens. Richard Durbin of Illinois and Richard Blumenthal of Connecticut have sought tougher regulation of energy drinks amid reports that the product has been linked to 18 deaths and more than 100 health incidents since 2004.
While Red Bull North America and Monster Beverage Corp. have used trade associations to argue their products' safety, 5-Hour Energy does not have a registered lobbyist, nor does it belong to any industry groups, Roll Call said.
"We're just not set up like that here with a government affairs person," 5-Hour Energy spokeswoman Elaine Lutz said.
Durbin and Blumenthal had sent four letters to the agency in 2012. An aide to Durbin told Roll Call the senators followed up because they thought the original response was insufficient.
A 2006 law requires dietary supplement producers to report to the FDA any adverse effects involving their products. 5-Hour Energy has been associated with 13 deaths since December 2009 and Monster drinks have been linked to five deaths, FDA data released earlier this month indicated.
Because its product is regulated as a beverage, Red Bull is not required to report adverse health incidents.
The FDA is developing clarification of the distinction between dietary supplement drinks and caffeinated beverages such as sodas.
Red Bull, PepsiCo Inc., maker of Rockstar and Amp Energy drinks, and Coca-Cola Co., maker of the Full Throttle beverage, voluntarily report the levels of stimulants in their products and discourage use by children under the age of 12 in line with American Beverage Association guidelines, Roll Call said.
While 5-Hour Energy does not disclose product caffeine level, a Mayo Clinic study reported the level to be 207 milligrams for each 60 milliliter shot. A can of Red Bull or Monster contains about 80 milligrams.
Lutz dismissed the senators' concerns about effects of high levels of caffeine consumption among young people, saying the company doesn't market to children.