Sottera, Inc. v. FDA
Food / Drug / Medical-Device Law | Government Regulation
On December 7, 2010, the U.S. Court of Appeals for the District of Columbia Circuit struck down a Food and Drug Administration (FDA) effort to broaden its own jurisdiction by expansively interpreting what is meant by a "medical device." The court ruled that Congress did not intend to permit FDA to regulate electronic cigarettes (or "e-cigarettes") as medical devices. The decision was a victory for WLF, which filed a brief opposing FDA's regulatory efforts. The court agreed with WLF that FDA's authority to regulate "medical devices" is limited to products promoted for their therapeutic benefits, at least when the products are derived from tobacco. The court held that e-cigarettes are not "medical devices" because they are not promoted for any therapeutic use. If FDA wishes to regulate the sale of e-cigarettes, it may do so only in connection with its authority to regulate tobacco products, the court said.