Durbin and Blumenthal Remain Stalemated by FDA

Sen. Richard Durbin (D-IL)

While Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) continue to push the U.S. Food and Drug Administration (FDA) for greater regulation and oversight of the energy drink category, for now, all they’re getting is bureaucratic consideration. Last Friday, Michele Mital, the FDA’s Acting Associate Commissioner for Legislation, responded to two recent letters from the senators that urged the agency to set caffeine level limits and require greater transparency in the labeling of energy drinks.

Mital acknowledged that the FDA is aware of growing concerns regarding the energy drink category, however, as with previous communications to the senators, she stopped short of promising any imminent action beyond further study of the products.

“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,” Mital wrote in the letter. “In addition, based on our safety review and within the bounds of our authority, FDA will consider taking appropriate action with respect to the labeling of these products, such as requiring disclosure of the amount of caffeine in food products, limitations on intended use, or warnings about possible adverse effects.”

Over the past 18 months, Durbin and Blumenthal have attempted to initiate tighter regulation of the energy drink category, beginning with the Dietary Supplement Labeling Act of 2011. The act, which has not yet been brought for a vote in Congress, would amend the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of dietary supplements to register their products with the FDA. The act would also amend labeling requirements for dietary supplements.

In April, Durbin sent his first letter to the FDA calling for reform of the way energy drinks are marketed and sold. His letter came five months after the death of Anais Fournier – a 14-year-old girl who suffered from cardiac arrest and caffeine toxicity shortly after consuming Monster Energy drinks in December 2011. In the letter, Durbin mentioned Monster Energy, Red Bull, Rockstar, Full Throttle and AMP as torchbearers for the category and appealed to the FDA to introduce new regulations on ingredients and labeling.

“Young people are especially susceptible to suffering adverse effects,” he wrote, “because energy drinks market to youth, their bodies are not accustomed to caffeine, and energy drinks contain high levels of caffeine and stimulating additives that may interact when used in combination.”

In response, the FDA wrote a letter to Durbin in August claiming that energy drinks are comparable to other highly caffeinated beverages, including Starbucks coffee products. The letter also indicated that the FDA had yet to find that 400 milligrams of caffeine consumed in a day can be toxic.

Durbin and Blumenthal followed with letters to the FDA on Sept. 11, 2012, and Oct. 26, 2012, again asking the FDA to tighten the reins on the sale of energy drinks. The letters now fit with a pattern of even more public scrutiny of these products, including recent revelations of a list of “extreme adverse events” — including hospitalization and deaths — cases recorded by the FDA that are in some way associated with energy drink consumption.