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Posted: Sat Jun 05, 2010 5:07 am Post subject: Legal status by region |
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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.
In Australia, the sale of electronic cigarettes containing nicotine is illegal
In Brazil, electronic cigarettes sales, importation or advertisement of any kind are forbidden. Anvisa, the Brazilian health and sanitation federal agency, found the current health safety assessments about e-cigarettes not to be yet satisfactory to make the product eligible to be approved for commercialization.
In Canada, as of March 2009, imports, sales, and advertising are banned. In March 2009, Health Canada also advised Canadians not to purchase or use any electronic smoking products. Health Canada cited the Food and Drugs Act, stating that electronic smoking products containing nicotine require market authorization before they can be imported, marketed, or sold. No market authorization has been granted for any electronic smoking product.
In Denmark, the Danish Medicines Agency classifies electronic cigarettes containing nicotine as medicinal products. Thus, authorization is required from the retailer before the product may be marketed and sold. The agency has clarified, however, that electronic cigarettes that do not administer nicotine to the user, and are not otherwise used for the prevention or treatment of disease, are not considered medicinal devices.The use of electronic cigarettes has not been prohibited in Copenhagen Airport, but at least one airline (Scandinavian Airlines) has decided to ban their use onboard flights.
In Netherlands, use and sale of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.
In New Zealand, the Ministry of Health has ruled that the Ruyan e-cigarette falls under the requirements of the Medicines Act, and cannot be sold except as a registered medicine.
In Panama, importation, distribution and sale has been prohibited since June 2009. The Ministry of Health cites the FDA findings as their reason for the ban.
In Singapore, the sale and import of electronic cigarettes, even for personal consumption, is illegal.
In United Kingdom, use and sale of electronic cigarettes is currently unrestricted, although the MHRA has proposed bringing all nicotine products except tobacco within the medicines licensing regime.
European Union
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 EC 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 ecigs 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.“
Electronic cigarettes may fall under the definition of a medicinal product laid down in Directive 2001/83/EC, either if the product is presented as a remedy against nicotine addiction or if it is qualified as restoring, correcting or modifying physiological functions.
United States
The Food and Drug Administration (FDA) has classified electronic cigarettes as drug delivery device and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA). As a result, they require market authorization prior to importation and sale into the country. This classification was overruled by Judge Richard J. Leon citing that “the devices should be regulated as tobacco products rather than drug or medical products” ". Leon continued, saying “This case appears to be yet another example of F.D.A.’s aggressive efforts to regulate recreational tobacco products as drugs or devices”. However, a US Court of Appeal upheld the FDA's original classification in March 2010 allowing them to restrict and ban unauthorized products. 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 last 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."
In addition to this, states have begun to consider either including electronic cigarettes in bans that affect tobacco or banning their sale entirely. California Governor Arnold Schwarzenegger vetoed a bill that would ban the sale of electronic cigarettes within the state on grounds that “if adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so."The fact that California has some of the strictest cigarette laws in the country further complicates the picture. Further, the state of New Jersey has recently sought to include the electronic cigarette under the New Jersey Smoke Free Air Act. One of the main justifications New Jersey Assemblywoman Connie Wagner seeks to use is the flavoring of electric cigarettes. On September 22nd 2009, under the authorization of the Family Smoking Prevention and Tobacco Control Act banned flavored tobacco (with the notable exception of menthol cigarettes) due to its potential appeal to children. Ms. Wagner advocates that the use of flavorings such as chocolate could encourage childhood use and serve as a gateway to cigarette smoking. In addition to New Jersey, New Hampshire, New York and Pennsylvania have begun efforts to restrict electronic cigarette use in various forms.
New Hampshire’s reform campaign fits into its own dynamic and unique category. In New Hampshire a group of students, partnered with a group called “Breathe New Hampshire” petitioned the state government to ban the sale of electronic cigarettes to minors. While sale of electronic cigarettes to minors remains legal, some worry that electronic cigarettes will serve as a gateway to smoking cigarettes. One teen involved in the legal proceedings claims that her peers will see electronic cigarettes as similar to “having a new cell phone. It’s cool. It’s electronic.”
Arizona has a planned ban of selling electronic cigarettes to minors. _________________ “with one heart, hand in hand, are all the healthy people in the world”
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