FDA Responds to Energy Drink Plea; Cites GRAS Standards

In response to a letter co-signed by two U.S. senators lobbying for stronger energy drink regulation, the U.S. Food and Drug Administration says it's examining the nature of energy drinks and any casual risks to health, although it reiterated other caffeine-containing products have a long history of safe use in the U.S.

Michele Mital, acting associate commissioner for legislation speaking on behalf of the FDA, noted in a letter addressed to Senators Richard J. Durbin and Richard Blumenthal that energy drinks containing caffeine and other ingredients are a relatively new class of products and have the potential to raise safety or regulatory issues, but "there is a long history of safe use of other caffeine-containing products in the United States.”

"FDA is aware, however, that new products and patterns of use require us to remain vigilant, and we are working to strengthen our understanding of the nature of energy drinks and any casual risks to health," Mital added. 

Still, for ingredients added to products marketed as beverages, regardless of the technical effect in the food (flavor or otherwise), “the safety standard is a reasonable certainty of no harm,” Mital wrote. As such, any substances used as flavorings have to meet Generally Recognized As Safe (GRAS) standards.

Further, the letter also stated that under the Federal Food, Drug and Cosmetic (FD&C) Act, in evaluating the safety of an ingredient added to food, claims regarding purported benefits of any type are not considered. The safety decision for a food ingredient is not based on an analysis of risk versus benefit, but is based on safety alone, the FDA says. The technical effect of a conventional ingredient comes into play as a regulatory matter when FDA determines that a tolerance for the ingredient is necessary to ensure safety, with tolerances required under the FD&C Act’s food additive provisions to be set at a level that ensures safety and is no higher than needed to achieve an intended technical effect.

With respect to taurine and guarana, the FDA searched its literature, but said it “did not find any information that calls into question the safety of these ingredients as currently used in beverages.” Thus, to date, FDA has made no determination with respect to the intended technical effect of their use in “energy drinks,” which may include both flavoring and stimulant effects.

“But if, in the course of our surveillance, we learn of information raising safety concerns about the use of these substances, we will evaluate it and determine whether enforcement or other regulatory action is needed to protect the public health,” Mital stated.

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