The FDA (Food and Drug Administration) regulated electronic cigarettes as tobacco products in early 2011. This decision taken by the agency lays to rest a legal battle that has been brewing between since 2009.
Legal grey area
Electronic cigarettes first hit overseas markets back in 2002, but wasn’t until 2006 that thy entered the US market. The absence of scientific evidence about the safety and efficacy of these devices made it challenging to reach a conclusive decision about legalizing them just like traditional tobacco cigarettes. Until the recent ruling, e-cigarettes operated in a legal grey area, where they were not fully considered tobacco products or drug delivery devices. Over the last three years or so, many a court battle about health benefits (as propounded by e-cig manufacturers) and FDA’s insistence on categorizing them as medical devices, have been fought.
E-cigarette manufacturers prove that the devices are marketed for vaping pleasure
FDA gave up its fight in December 2010 when the U.S. Court of Appeals for the District of Columbia Circuit ruled that electronic cigarettes did not meet the definition of ‘medical devices’ as per the Federal Food, Drug and Cosmetic Act (FDCA). The Court deemed that devices would fall under the law only if they are advertised for therapeutic use. E cigarette manufacturers were able to prove in court that the electric devices were intended for vaping pleasure and not as cessation devices. With this, electronic devices are officially ‘tobacco products’, with regulations being less strict but taking more time for implementation.
In September 2009, the FDA prohibited flavored tobacco (exception being menthol cigarettes) owing to its appeal to children, under the Family Smoking Prevention and Tobacco Control Act.
Soon after, it classified electronic cigarettes as drug delivery devices, and subjected them to regulations under the FDCA prior to their importation and sale in the country. This categorization was overruled in January 2010.
March 2010 saw the US Court of Appeal granting a stay of injunction pending an appeal, with the FDA defending its right to regulate electric cigarettes
The Appeals Court ruled against the FDA in December 2010, and District of Columbia Circuit appeals court declined FDA’s appeal to review the decision of regulating electronic cigarettes as tobacco products.
American states have established their own regulations with regard to the marketing of electronic cigarettes. The marketing of electronic cigarettes to minors is banned under law in many states, including California, New Hampshire, Washington and Arizona.
USA Today says that over one million Americans have admitted to using electronic cigarettes to give up smoking since they first became available in the United States in 2006. E-cigarette sales are estimated to be in the region of $100 million. The important question is how FDA will assess and deem electronic cigarettes from different manufacturers. This will be clear only months (or years) after the new regulations are issued and the FDA starts attending to applications from e-cigarette companies.