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Regulating E -Cigarettes / 3 the perception that e -cigarette smokers (also known as "vapers") are actually smoking conventional cigarettes. Omitting e -cigarettes from smoke-free laws could cause conventional smokers to assume that smoking is permitted and nonsmokers might become needlessly concerned at what they see as a violation of a smoke-free law. Policy Elements Regardless of the type of policy effort pursued to regulate e -cigarettes, each policy shares a few common elements, such as: Clear definitions and concise language: To avoid confusion about what constitutes an e -cigarette, make sure your definitions are explicit about what they cover and broad enough to anticipate future product innovations. This eliminates ambiguity if new products are released that are similar to e -cigarettes but do not fall under a narrow definition. Robust enforcement options: Enforcing restrictions on the sale, marketing and use of e -cigarettes can be challenging unless clear procedures are established, including a reasonable penalty and appeal process. Effective enforcement of these policies often includes coordination among different enforcement agencies and consistent procedures throughout a community. Well-planned implementation process: Establish a process for publicizing the policy and educating the community, as well as procedures for receiving, tracking and following up on complaints. Make sure you set a realistic date for the policy to take effect. Policy Challenges One of the most controversial issues affecting the regulation of electronic cigarettes has been debate over their status as either drug delivery (e.g., smoking cessation) devices or tobacco products. The regulatory status of e -cigarettes was at the heart of recent litigation between the FDA and e -cigarette manufacturers, including Sottera Inc. v. Food & Drug Administration.7 Under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA has authority to regulate "any product made or derived from tobacco that is intended for human consumption" The brands of e - cigarettes being marketed most widely today do not contain tobacco, but most often do contain nicotine extracted from tobaccos Between 2008 and 2010, the FDA determined that certain e -cigarettes were unapproved drug/device combination products, comparable to nicotine patches, which the agency has regulated for years under the drug and device provisions of the federal Food Drug and Cosmetic Act (FDCA). In December 2010, the U.S. Court of Appeals for the D.C. Circuit issued a decision in Sottera, stating that e -cigarettes and other products "made or derived from tobacco' are not "drugs," "devices," or combination products, unless they are marketed for therapeutic purposes — and that the FDA can regulate them as tobacco products under the Tobacco Tol3acco Control Legal consorilu n 875 SLJ[na tAVenUe, Saint Paul, tVlq 55105-3076 vnw.tciconllne.org 651.290.7506