January 25, 2011 - The D.C. Circuit on Monday, January 24th rejected the U.S. Food and Drug Administration’s (FDA) bid to reconsider an earlier decision ordering the agency to treat electronic cigarettes as tobacco products rather than medical devices.
The U.S. Court of Appeals for the District of Columbia (D.C.) Circuit unanimously denied the FDA’s request for an en banc (refer to the hearing of a legal case where all judges of a court will hear the case (an entire "bench"), rather than a panel of them) hearing to rule on whether products that contain nicotine but not tobacco fall beyond the agency’s regulatory reach under the Federal Food, Drug and Cosmetic Act.
The appeals court also left in place a preliminary injunction barring the FDA from regulating the so-called e-cigarettes under the FDCA.
The ruling forces the FDA to consider the extent to which it should regulate the products under the Family Smoking Prevention and Tobacco Control Act, while also weighing a possible appeal to the U.S. Supreme Court, according to Gregory Garre, a lawyer for Sotterra Inc., the appellee.
The D.C. Circuit’s decision marks the second blow to the FDA in the case in the past two months. On Dec. 7 a three-judge panel of the appeals court told the agency that it must regulate e-cigarettes as tobacco products under the Tobacco Act, not as drugs or devices under the FDCA. (Federal Court of Appeals - e-cigarettes - rules against the FDA..)
The US Food and Drug Administration (FDA) on Monday, December 20, 2010 filed a petition to ask the entire U.S. Court of Appeals for the District of Columbia (DC) Circuit to hold a new hearing and review the FDA’s appeal, which was rejected December 7, 2010 by a three-judge panel. (U.S. FDA files new appeal in e-cigarette lawsuit..)
The agency has regulated nicotine-replacement products for years and gained authority to regulate the production and marketing of cigarettes and other tobacco products for the first time in 2009. If the government decided to regulate e-cigarettes as tobacco products, manufacturers would still face significant regulations, but it would be easier to bring the devices into the market. (E-Cigarette Industry Wins Federal Court Victory by DAVID KESMODEL, The Wall Street Journal, 1/24/2011)
FDA - mission based on law to ensure new tobacco products do not pose an increased threat to the American public..
The case is Sottera Inc. et al. v. FDA et al., case number 10-5032, in the U.S. District Court for the District of Columbia Circuit.
Reference: DC Circ. Won't Revisit Decision On E-Cigarettes by Derek Hawkins (additional reporting by Leigh Kamping-Carder), Law360.com, 1/24/2011.
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