It came as no surprise that, on Friday November 16, the FDA made clear to the public its plan to get “in front” of the current controversy over the discontinuity in the regulation of so-called “Energy Drinks”. FDA Commissioner Margaret Hamburg had two unpleasant days of “grilling” on the 14th and 15th before House and Senate Committees over FDA’s perceived “passivity” in allowing a regulatory discrepancy in the supervision of compounding pharmacies to permit NECC to produce contaminate drugs which, thus far, have sickened 428 and caused 32 deaths across the US.

Please see our post of  October 30 on the “Compounding Pharmacy Debacle”.

We also post below Commissioner Hamburg’s November 15, 2012 testimony before the Senate Committee on Health, Education, Labor and Pensions.

We feel that it is no accident that, in the same week, FDA has clearly articulated its policy with respect to Adverse Event Reports regarding Energy Drinks. With the announcement on November 16, FDA has chosen to openly discuss the regulatory discontinuity between the treatment of Energy Drinks when sold as “conventional food” as opposed to when sold as “dietary supplements”. After all, as we say in Italian, “Una volta morso, due volte timido”. But, in this case, perhaps, FDA will demonstrate determination to do its duty, as opposed to timidity, the second time around.

Please see the November 16 FDA Policy Statement on Adverse Event Reporting for Energy Drinks below. We believe that significant changes in labeling of Energy Drinks will be forthcoming.