Background. The U. S. District of Columbia Circuit Court of Appeals, on December 7, 2010, decided in favor of manufacturers of certain electronic cigarettes (“e-cigarettes”) in the landmark case, Sottera, Inc., Doing Business as NJOY v. FDA (No.10-5032). In this decision, the Court held that the U. S Food and Drug Administration (“the FDA”): 1) cannot regulate e-cigarettes labeled for “smoking pleasure” purposes, as opposed to therapeutic purposes, under the Food Drug and Cosmetic Act’s (FDCA) drug and device provisions; and 2) such products, unless marketed for smoking cessation or other therapeutic purposes, can only be regulated as customarily-marketed products under The Family Smoking Prevention and Tobacco Control Act, a 2009 law allowing state and local governments to regulate the sale or use of tobacco products. This decision means that e-cigarettes marketed for smoking pleasure purposes only may legally be imported into the U. S. without the safety testing required for drug or medical devices. The Sottera decision, which the FDA may decide to appeal, has already resulted in actions such as local governments enacting laws regulating the use of e-cigarettes, and also has paved the way for the legal marketing and sale of e-cigarettes, as governed by applicable state, local, and federal laws pertaining to the marketing and sale of tobacco products.
Although Sottera, Inc. v. FDA applies to the regulation by the U. S. government of e-cigarettes, the issue of the legal sale and use of e-cigarettes poses an issue for international employers and business owners as well. This article will provide general information and advice to employers worldwide who may find it necessary to address the use of e-cigarettes in their workplaces to the extent they have not done so already.
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