- As highlighted recently on this blog, FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act). During a provisional period established by the Tobacco Control Act, companies were permitted to continue marketing tobacco products that are “substantially equivalent” to valid predicate products (i.e., products that were commercially marketed as of the February 15, 2007 Grandfather Date). Companies were required to submit “Provisional” Substantial Equivalence (SE) Reports to FDA by March 22, 2011 to justify continued marketing of products that were already on the market, but not grandfathered. Tobacco products subject to Provisional SE Reports are allowed to remain on the market pending FDA’s review and unless the Agency issues a not substantially equivalent (NSE) order.
- On September 15, 2015, FDA issued orders to stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products. FDA evaluated the company’s SE applications and found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol, and Vantage Tech 13 cigarettes were NSE to their respective predicate products. The Agency concluded that the products have “different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them.”
- When FDA issues an NSE order, the tobacco product subject to the order becomes adulterated and misbranded; thus, further marketing or distribution is prohibited. FDA has stated that it will not take enforcement action against retailers for 30 days to give them sufficient time to dispose of current inventory. FDA’s NSE orders mark the first time that the Agency has ordered a company to pull a major brand off the market and serves as a reminder to the tobacco industry of FDA’s significant authorities under the Tobacco Control Act.
Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be hosting a pre-conference seminar on these topics in conjunction with our upcoming Food Packaging Law Seminar. For more information and to RSVP to these events, click here.
For more information about our tobacco & e-vapor regulatory practice in general, click here.