Sottera Inc. v. U.S. Food and Drug Administration

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627 F.3d 891 (D.C. Cir. 2011)

The FDA can only regulate e-cigarettes as a tobacco product, unless they are being marketed as a cessation device.

Background

On April 15, 2009, the FDA denied the import into the U.S. of electronic cigarettes and accessories made by Smoking Everywhere and NJOY. According to the FDA, these products appeared to be unapproved drug-device combination products that were intended to help treat the withdrawal symptoms of nicotine addiction.

Smoking Everywhere filed suit in the United States District Court for the District of Columbia, stating that electronic cigarettes are not intended to help treat withdrawal symptoms of nicotine addiction but, rather, that they are for smoking enjoyment, similar to conventional cigarettes. The court allowed NJOY to join the case with Smoking Everywhere. Both companies sought a preliminary injunction, which would prohibit the FDA from blocking their imports until the case has been decided.

The District Court’s Decision

On January 14, 2010, the court granted the motion for preliminary injunction, and entered judgment in favor of Smoking Everywhere and NJOY. Judge Richard Leon ruled that Congress did not intend tobacco products to be drugs merely because they deliver nicotine—if this were true, traditional cigarettes would also be a drug-device combination product.1 The court also found that the intended use of an electronic cigarette is to encourage nicotine use, rather than prevent or mitigate it.

The Court of Appeals’ Decision

Senior Circuit Judge Stephen Williams affirmed the District Court’s ruling that electronic cigarettes can be regulated solely as tobacco products, and not as drug-device combination products unless they are being marketed with a therapeutic purpose (cessation).2

Litigation Status

The FDA decided not to appeal the decision to the Supreme Court and instead issued a statement of its intent to regulate e-cigarettes as a tobacco product.3


Smoking Everywhere, Inc. v. U.S. Food and Drug Admin., No. 09-771 (D.D.C. Jan. 14, 2010).
Sottera, Inc. v. U.S. Food and Drug Admin., 627 F.3d 891 (D.C. Cir. 2011).
U.S. Food and Drug Admin., Stakeholder Letter: Regulation of E-Cigarettes and Other Tobacco Products (April 25, 2011), http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.