Regulation of Electronic Cigarettes by the FDA
By Mitch Zeller
Thank you for your petition on electronic cigarettes.
First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them.
Some background, which you may already know: The Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products — cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco — under the Federal Food, Drug, & Cosmetic Act. And while it didn’t apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation.
We’ve issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of “tobacco product” and so they’d be subject to the FD&C Act when the proposed rule is finalized.
If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 — but this doesn’t mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products.
There will be two primary ways for tobacco products to obtain that authorization: either an application for “substantial equivalence,” or an application for premarket approval.
“Substantial equivalence” would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent — though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be “appropriate for the protection of public health” to allow the product to be marketed.
We know that those applications may require time and resources to develop. That’s why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application — so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review.
So why are we seeking to regulate these products in the first place? As we discuss in the proposed rule, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. There’s still a lot we don’t know about these products, and this rule will expand the amount of information available to the FDA and the public — that’s good for everyone.
Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don’t know enough to make that call. This rule would help us to continue to analyze the potential benefits and risks of e-cigarettes, including their impact on nonusers and on the population as a whole.
It’s important to remember that this rule isn’t final yet, though. We’re seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes.
The opportunity to comment on FDA’s proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments.
Mitch Zeller is the Director of the Food and Drug Administration’s Center for Tobacco Products.