FDA Proposes New Rule to Regulate E-Cigarettes

May 23, 2014
Paul M. da Costa

On April 25, 2014, the Food and Drug Administration (FDA) proposed a new rule to regulate cigars, electronic cigarettes (commonly called e-cigarettes), and other similar products in the same way that it already regulates cigarettes. The proposed rule involves deeming certain products as tobacco products so that they can be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the FDA will have legal authority to regulate them.

     Under the Family Smoking Prevention and Tobacco Control Act, the FDA has authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products the FDA deems subject to the law by regulation. In the proposal, the FDA sets forth two alternative options to extend its power to regulate cigars and other products.

     The FDA points out in its proposal that the FD&C Act defines “tobacco product” to mean “any product ‘made or derived from tobacco’ that is not a ‘drug,’ ‘device,’ or combination product under the FD&C Act,” which, theoretically, could include products like e-cigarettes, that do not necessarily contain tobacco, but contain nicotine derived from tobacco.

     Additionally, the FDA proposes to restrict the sale of “covered tobacco products” to people eighteen years of age or older. This would require tobacco vendors to verify the buyer’s age by checking the buyer’s birth date on his or her photo identification. The FDA also proposes prohibiting tobacco retailers from using vending machines and other electronic means to sell tobacco products, unless it is in a location where nobody under the age of eighteen would enter.

     Further, the proposal requires that health warnings be displayed on e-cigarettes and advertisements, with specific rules governing the size, color, and text of the warnings. The warning must be permanent, not removable from the package.

     The FDA is seeking comments on how e-cigarettes should be regulated in relation to other tobacco products. The comment period for the FDA’s proposal is open until July 9, 2014.

     We will continue to update you on the status of the proposal, so check back to our blog frequently for more information.