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DC Circ. Stay Allows FDA To Stop E-Cigarette Sales
By Ben James
Law360, New York (February 02, 2010) -- A federal appeals court temporarily stayed a district court order on Tuesday that barred the U.S. Food and Drug Administration from stopping electronic cigarettes from coming into the U.S., after the FDA brought an interlocutory appeal challenging the trial judge's decision.
The U.S. Court of Appeals for the District of Columbia Circuit temporarily stayed the Jan. 14 preliminary injunction in order to give the court more time to mull the FDA's emergency motion for a more permanent stay pending appeal.
At issue is U.S. District Judge Richard J. Leon's decision to grant bids for a preliminary injunction from plaintiff Smoking Everywhere Inc. and intervenor-plaintiff Soterra Inc., which does business as NJOY.
The plaintiffs claim the FDA lacks the authority to regulate electronic cigarettes as a banned product under the Federal Food, Drug and Cosmetic Act.
While the Family Smoking Prevention and Tobacco Control Act gives the FDA the authority to regulate tobacco products, it cannot regulate those products as it would a drug or device under the FDCA, Judge Leon said.
Judge Leon pointed to the U.S. Supreme Court's 2000 decision in FDA v. Brown & Williamson Tobacco Corp., in which the high court decided that regulating cigarettes and smokeless tobacco as drugs or devices would essentially lead to those products being banned, which was not what Congress intended.
But the Supreme Court did not intend for its ruling in the Brown & Williamson case to preclude regulation of any and all products that provided users with nicotine, the FDA argued in the emergency motion filed Monday.
The FDA said the injunction was "premised on legal error" and noted that the FDA has for years regulated products like nicotine patches and nicotine lollipops under the FDCA's drug and device provisions.
The FDA added that the injury stemming from the importation and distribution of electronic cigarettes was irreparable, and said that "the court was quite wrong to believe that no injury would result from the use of these harmful and addictive products."
On Tuesday, an FDA representative declined to comment, referring Law360 to the agency's court filings. Attorneys for both NJOY and Smoke Everywhere did not immediately respond to calls seeking comment.
Smoking Everywhere sued the FDA in April 2009 after the agency detained and scheduled for destruction a shipment of electronic cigarettes and notified the distributor that the product violated the FDCA as an unapproved drug-device combination because, among other things, it is intended to treat withdrawal symptoms. NJOY joined the case after a shipment of its own electronic cigarettes was similarly impounded.
Electronic cigarettes allow a user to vaporize and inhale a liquid nicotine mixture derived from tobacco plants, mimicking the act of smoking traditional cigarettes while purportedly avoiding the cancer-causing byproducts.
Smoking Everywhere is represented in this matter by Thompson Hine LLP.
Sottera is represented by Latham & Watkins LLP.
The case is Smoking Everywhere Inc. et al. v. U.S. Food and Drug Administration et al., case number 10-5032, in the U.S. Court of Appeals for the District of Columbia Circuit.
--Additional reporting by Nick Malinowski
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