On November 10, FDA solicited comments on proposed amended regulations addressing the use of tobacco brand names that are also nontobacco brand names.

The Tobacco Control Act required FDA to issue regulations restricting the use of brand names that are also nontobacco brand names.  As set forth in the original regulation, a manufacturer could not use a brand name that was the same as a nontobacco product brand name, unless both the tobacco product and the nontobacco product were sold in the United States on January 1, 1995.  The goal of the brand name restriction was to insure that tobacco manufacturers could not use popular nontobacco products for their tobacco brand names, which purportedly would make the tobacco products more attractive to minors.

The brand name restriction generated a storm of controversy and litigation against FDA.  If enforced literally, it would have required market removal of numerous tobacco brands that happened to share names with nontobacco products.  Even worse, it would have allowed nontobacco product manufacturers to interfere with tobacco brand names by introducing new products that shared the tobacco product’s name.  After a lawsuit was filed challenging the brand name restriction, FDA implemented a temporary solution to the problem.

FDA has now proposed final regulations that address, in part, the problems presented by the original brand name restriction.  Comments, which may be submitted on regulations.gov, are due by January 31, 2012.

Under the proposed regulation, a tobacco manufacturer cannot use a brand name for cigarettes or smokeless tobacco if that brand name was first registered with the U.S. Patent and Trademark Office for a nontobacco product, unless:

(1) the cigarette or smokeless tobacco product was sold on or before June 22, 2009 (the enactment date of the Tobacco Control Act), or

(2) for products introduced after June 22, 2009, the manufacturer obtains an exemption from FDA by demonstrating that the tobacco brand name “does not, based on its use for the nontobacco product, have a substantial appeal to children or adolescents.”

Although the proposed regulation addresses many of the problems with the original brand name restriction, the FDA exemption procedure would appear to present First Amendment concerns by implementing a prior restraint on commercial speech.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.