District Court Rules That FDA Cannot Regulate E-Cigarettes as Drug-Device Combination Products; FDA Detention Decisions Are Reviewable by Courts

January 14, 2010

By Peter M. Jaensch –
On January 14, 2010, the United States District Court for the District of Columbia issued a decision in Smoking Everywhere, Inc. and Sottera, Inc. d/b/a NJOY v. United States Food and Drug Administration, et al., in which the court granted the plaintiffs’ motion for a preliminary injunction, thereby enjoining FDA from regulating electronic cigarettes as drug-device combination products.  E-cigarettes, which are packaged to look and feel like real cigarettes, are intended to replicate smoking by vaporizing a nicotine liquid that the user then inhales – a process users call “vaping.”

The case arises from detentions imposed by FDA on the import of electronic cigarettes, which FDA contends are drug-devices under the FDCA and therefore subject to FDA regulation. The court concluded that treating e-cigarettes as drug-device combination products, rather than tobacco products, was unlawful, absent a showing that the products are intended to assist in treating nicotine addiction or to “affect the structure or function of the body in a way distinguishable from ‘customarily marketed’ tobacco products.” The court believed that doing so would frustrate Congress’ clear intent to distinguish FDA’s regulation of drugs and devices from its regulation of tobacco products.

The court did not opine whether FDA could regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act, which was signed into law after the FDA detention had been imposed.  It would appear that FDA lacks such authority until it issues a regulation bringing e-cigarettes under its jurisdiction as tobacco products.

The decision holds out the potential for a far wider significance with regard to all products regulated by FDA.  In footnote 8, the court analyzes and rejects FDA’s position that its import decisions are unreviewable by courts. The ruling on this point will undoubtedly suggest that other importers of a variety of products regulated by FDA will sue FDA to challenge import decisions or at least use the threat of a suit as leverage to get FDA to allow imported products into the U.S.

Categories: Import/Export |  Tobacco