The Food and Drug Administration recently announced sweeping regulations for hookah, little cigars, dissolveables, and electronic cigarettes, in addition to the federal agency’s existing power over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The 500-page final rules will significantly impact the burgeoning electronic cigarette industry, and hints at future possible actions by the agency concerning flavored cigars.
In 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority over cigarettes, cigarette tobacco, pipe tobacco, roll-your-own tobacco, and smokeless tobacco. The Act also gave the agency the power to include other products made or derived from tobacco under the same regulatory umbrella through an extensive “deeming” process. The agency did not release their proposed deeming regulations for hookah, cigars, dissolveables, electronic cigarettes, and other novel tobacco products until April 2014. This proposal gathered nearly 120,000 comments from public health professionals, academia, researchers, consumers, and the tobacco and electronic cigarette industries.
The new rules, which may go into effect as soon as August 8, will introduce badly-needed regulation to novel tobacco products, particularly electronic cigarettes. Among the numerous new rules outlined in the expansive 499-page document are a prohibition on selling to minors, registration of manufacturers, a ban on free samples, reporting hazardous or potentially hazardous ingredients, mandating health warnings, and expanding an existing prohibition on products that claim to be lower-risk through descriptors such as “light” and “mild.”
One of the major points of contention for the electronic cigarette industry is a requirement that all newly-deemed products marketed after February 15, 2007 undergo an extensive premarket review process. This process ensures that new products conform to the same manufacturing and product standards as other tobacco products, and that it is not marketed in a false or misleading way. Since most electronic cigarettes came on the market after the February 15, 2007, nearly all manufacturers and retailers of electronic cigarettes must go through the process. The agency is giving the industry two years to comply, and an additional year for review applications before potentially pulling any products from the market.
Though federal oversight will go a long way to taming the “wild west” regualatory environment for these new products, there are still some gaps and areas for local and state regulation. Advertising, flavor restrictions, self-service prohibitions, and sponsorship regulations placed on cigarettes are not expanded to these new products. However, the agency did take the opportunity to announce forthcoming restrictions on characterizing flavors in cigars.
For the time being, the impact of these new rules remain to be seen. An electronic cigarette company has already filed a lawsuit against the FDA, and there is a bill in congress to change the premarket review date.