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Sunday, December 30, 2012

FDA to commission outside review on energy drinks.


The New York Times (11/28, B7, Meier, Subscription Publication) reports that the Food and Drug Administration released a letter (pdf) Tuesday, saying it would likely "seek advice from outside experts to help determine whether energy drinks posed particular risks to teenagers or people with underlying health problems." Although the agency has previously said it was "investigating possible risks posed by popular products like 5-Hour Energy, Monster Energy and Red Bull," FDA spokesperson Shelly Burgess "said the new letter was the first time that the FDA had said it might turn to outside experts." The letter, which was sent to Democratic Sens. Richard J. Durbin (IL) and Richard Blumenthal (CT), "follows disclosures that the agency received reports of 18 deaths and over 150 injuries that mentioned the possible involvement of energy drinks."
        The AP (11/28) adds that the letter, which was sent on Nov. 21, "said that the FDA was studying energy drinks to see if they posed a risk when consumed by 'vulnerable groups' such as young people, or in excess - but it did not indicate that any immediate action would be taken against the drinks makers." In the letter, the FDA also "said there is no scientific literature that calls into question the safety of taurine and guarana, two ingredients often used in energy drinks." Sens. Durbin and Blumenthal had asked the agency to "look further into the health impact of energy drinks."
        According to CQ (11/28, Lorber, Lesniewski, Subscription Publication), the FDA's letter "took some pressure to elicit." Sens. Durbin and Blumenthal "sent four letters to the agency" regarding energy drinks. A "Durbin aide said the senators found the original response insufficient."
        Senators urge agency to act now. The Wall Street Journal (11/28, Esterl, Subscription Publication) reports Sens. Durbin and Blumenthal responded to the FDA letter in a joint statement released Tuesday. Quoting from the statement, the Journal noted that the senators lauded the FDA for undertaking a review on the potential impact of energy drinks on the health of children and adolescents, but emphasized that "more needs to be done and quickly."
        Bloomberg News (11/27, Edney) adds that in their statement, Durbin and Blumenthal said the FDA "can and should take action now to regulate energy drinks that are marketed as beverages."
        Separately, Bloomberg News (11/27, Stanford, Edney) notes that Goldman Sachs analyst Judy Hong issued a client note Tuesday, noting that the FDA's responses to the senators "questions over the safety" of energy drinks was "encouraging" and predicting that any "regulatory outcome" from the pending review is "likely to be 'benign.'"

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