Nov. 19, 2010

FDA Continues Fight to Regulate Electronic Cigarettes

The Food and Drug Administration has authority to regulate so-called "electronic cigarettes" that vaporize nicotine but do not contain tobacco, a Justice Department lawyer argued today in the U.S. Court of Appeals for the D.C. Circuit.

Last year, a federal judge in Washington ruled the government improperly blocked an inbound shipment of e-cigarettes into the United States, saying that the FDA doesn’t have authority to regulate the product because it is not marketed for therapeutic uses such as to treat smoking addiction.

DOJ’s Alisa Klein of the Civil Division today tried to convince a three-judge appeals court panel to reverse the trial judge’s issuance of an injunction against the FDA. The appeals court stayed enforcement of the injunction pending resolution of the dispute.

Garre_gregory_kagan_#3056D6Latham & Watkins partner Gregory Garre (at left), who chairs the firm’s Supreme Court and appellate practice group, represented Scottsdale, Az.-based Sottera, which sells e-cigarettes under the brand “NJOY.”

E-cigarettes are battery-powered devices that resemble real cigarettes. The FDA blocked the importation of e-cigarettes on the ground that they are unapproved drug devices under the federal Food, Drug and Cosmetic Act. Tobacco products are generally exempt from the drug and device provisions of the FDCA.

The Tobacco Control Act of 2009 gives the FDA authority to regulate “tobacco products,” a term that was closely scrutinized today by the appeals court panel consisting of Judges Merrick Garland and Brett Kavanaugh and Senior Judge Stephen Williams.

Klein of the Justice Department said the FDA has long regulated nicotine products that include smokeless cigarettes, nicotine lollipops and nicotine inhalers. In 2008, the FDA refused to allow the importation of “Nicogel,” a hand gel made of liquefied tobacco. The FDA said the gel was an unapproved drug.

“If electronic cigarettes are a safe method of nicotine maintenance, that could be approved if the science supports it,” Klein said in court.

Garland questioned what he called the “unique” procedural element of the case. The government’s position in the litigation is established in a blocking order—stopping the shipment of electronic cigarettes—and not in a detailed administrative record. Kavanaugh and Williams examined the extent to which Congress can step in to fill a regulatory void to clarify the scope of FDA regulatory authority.

Garre, arguing for NJOY, said the product is not marketed as a smoking cessation device. He said if the FDA could show that the e-cigarettes are marketed for therapeutic reasons, the injunction against the FDA would not apply.