Legal history

Because of the relative novelty of the technology and the possible relationship to tobacco laws and medical drug policies, electronic cigarette legislation and public health investigations are currently pending in many countries. As flavored tobacco cigarettes (except menthol) have been banned in the US, and roll-your-own (RYO) products are seeing massive increases in taxes (e.g., Iowa), electronic cigarettes remain a viable alternative to tobacco for many Americans. [edit]European Union The EU Directive 2001/95/EC(6) on general product safety, applies in so far as there are no specific provisions with the same objective in other EU law. This directive provides for restrictive or preventive measures to be taken if the product is found to be dangerous to the health and safety of consumers. Whether electronic cigarettes could be regarded as falling under Directive 93/42/EEC on medical devices depends on the claimed intended use and whether this intended use has a medical purpose. "It is for each national authority to decide, account being taken of all the characteristics of the product, whether it falls within the definition of a medicinal product by its function or presentation."[51] Because of this vague EU position, member countries in the European Economic Area currently have varying rules. [edit]United States Individual states have differing legal treatment of electronic cigarettes. On 22 September 2009, under the authorization of the Family Smoking Prevention and Tobacco Control Act, the FDA banned flavored tobacco (with the notable exception of menthol cigarettes) due to its potential appeal to children.[52] Wagner says that the use of flavorings such as chocolate could encourage childhood use and serve as a gateway to cigarette smoking.[52] The Food and Drug Administration (FDA) classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) prior to importation to and sale in the United States. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, citing that "the devices should be regulated as tobacco products rather than drug or medical products."[53] Judge Leon ordered the FDA to stop blocking the importation of electronic cigarettes from China and indicated that the devices should be regulated as tobacco products rather than drug or medical devices.[54] In March 2010, a US Court of Appeal stayed the injunction pending an appeal, during which the FDA argued the right to regulate electronic cigarettes based on their previous ability to regulate nicotine replacement therapies such as nicotine gum or patches. Further, the agency argued that tobacco legislation enacted the previous year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions."[55] On 7 December 2010, the appeals court ruled against the FDA in a 30 unanimous decision, ruling the FDA can only regulate electronic cigarettes as tobacco products, and thus cannot block their import.[56] The judges ruled that such devices would only be subject to drug legislation if they are marketed for therapeutic use E-cigarette manufacturers had successfully proven that their products were targeted at smokers and not at those seeking to quit. The District of Columbia Circuit appeals court declined to review the decision blocking the products from FDA regulation as medical devices on 24 January 2011.[57] Concerns about public safety have been raised. However, some former smokers say they have been helped by e-cigarettes, and scientists at the University of California, Berkeley said that e-cigarettes had great potential for reducing the morbidity and mortality related to smoking.