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FDA Seeks Expert Advice on Energy Drink Regulations

November 29, 2012 — In a letter sent to Senators Richard J. Durbin of Illinois, the U.S. Food and Drug Administration (FDA) has responded to growing concerns about the safety of energy drinks by indicating that they will seek outside expert advice. The letter has calmed investors, and industry analysts now predict that any future regulatory action will be “benign.”

In the last few weeks, the FDA has confirmed reports of dozens of injuries and deaths linked to energy drinks. This has raised concerns about the level of caffeine and other ingredients in the drinks, especially for young people, pregnant women, and people with pre-existing health problems.

Senator Durbin cited information from the American Association of Pediatrics, which recommends that caffeine should be limited in children. The FDA estimates that the average teenager between 14 and 21 years old consumes about 100-mg of caffeine per day. The FDA wrote,

“FDA agrees that it may be advisable for certain subpopulations, including children and pregnant women, to limit their caffeine consumption and will discuss this with relevant health professional groups.”

The FDA indicated that they will likely seek guidance from experts at the Institute of Medicine. They may also hold public hearings or form an Advisory Committee to investigate whether they should take regulatory action.

Senator Durbin specifically asked the FDA to investigate whether ingredients in energy drinks, such as guarana and taurine might have toxic interactions with caffeine. The FDA said that they were unaware of any scientific information about these drug interactions, but if they become aware of any studies regarding the risk, the agency “might consider” taking regulatory action.

Many people falsely believe that “energy drinks” are “drinks” and therefore classified as a “food or beverage” subject to regulation by the FDA. In reality, energy drinks are regulated as “dietary supplements,” and therefore exempt from strict labeling requirements imposed on foods and drugs in the United States.

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