A U.S. Court of Appeals ruling reinstates the FDA's authority -- at least temporarily -- to stop e-cigarettes from entering the country after a lower court ruled that the agency does not have the authority to regulate electronic cigarettes, even though Congress granted the agency the power to regulate tobacco products(www.fda.gov) in 2009.
The FDA filed the appeal after a U.S. District Court judge granted an injunction(ecf.dcd.uscourts.gov) on Jan. 14 that blocked the FDA from stopping electronic cigarettes from entering the country. The appeals court granted a stay of the district court's injunction, pending an appeal. The stay reinstates the FDA's authority.
District Court Judge Richard Leon said in the Jan. 14 ruling(ecf.dcd.uscourts.gov) that the Family Smoking Prevention and Tobacco Control Act passed last year does give the agency the authority to regulate "any product made or derived from tobacco that is intended for human consumption." That could include e-cigarettes, which contain nicotine extracted from tobacco.
FDA officials, however, say they would prefer to regulate e-cigarettes as drug delivery devices rather than as tobacco products because treating e-cigarettes as the former would give the agency far broader control, including the ability to block importation of the devices and their components.
The agency said in its appeal that it has regulated nicotine products, including nicotine patches, for years under the drug and device provisions of the Food, Drug and Cosmetic Act, or FDCA. The agency argued that tobacco legislation enacted last year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions."
An agency spokesperson declined to comment on the case, which is ongoing.
According to court records, the dispute between the FDA and e-cigarette distributors started in September 2008 -- before the tobacco legislation passed -- when the agency put a hold on two shipments of e-cigarettes at Los Angeles International Airport. A month later, FDA officials issued notices of detention on the grounds that shipments belonging to Smoking Everywhere Inc. -- one of the companies that later sued the FDA -- appeared to be "adulterated, misbranded or otherwise in violation" of the FDCA.
In July 2009, the FDA issued a warning about e-cigarettes to consumers and physicians after the Division of Pharmaceutical Analysis in the agency's Center for Drug Evaluation and Research said samples from the products had detectable levels of known carcinogens and toxic chemicals.
Manufacturers have touted the smokeless products, which are battery-operated devices that turn nicotine and other chemicals into a vapor that is inhaled by the user, as safer than conventional cigarettes. However, public health officials have countered(www.fda.gov) that the products have not been adequately tested and should not be marketed to young people.