FDA Final Rule Outlaws Certain Brand Names

Your brand that you worked to protect may be in jeopardy.  Under the final rule issued by FDA March 19, 2010, manufacturers may not use a brand name of a nontobacco product as the brand name for a cigarette or smokeless tobacco product unless the brand name was being used by both the tobacco product and nontobacco product sold in the United States on January 1, 1995. 21 CFR 1140.16 (a) This means that if a company started manufacturing a cigarette or smokeless brand after January 1, 1995 and that brand name is also used on a nontobacco product, that brand name will no longer be able to be used on the tobacco product effective June 22, 2010.

There is no limitation in the final rule on the timing of the existence of the nontobacco product with the same name. For instance, it does not matter if the nontobacco product of the same brand name as the cigarette or smokeless brand began to be used after the cigarette or smokeless brand. The FDA prohibition will apply to the cigarette or smokeless brand anyway. Therefore, tobacco manufacturers and brand owners will not have control over the continued use of their own brands--third parties have effectively been given this control by FDA.

The continued use of certain trademarks legitimately registered at the US Patent and Trademark Office will be outlawed effective June 22, 2010, in direct conflict with established US trademark law. Additionally, this rule flies in the face of the accepted legal premise that trademark rights are property rights that are acquired through use of a mark in commerce, commonly referred to as common law rights, and instead the final rule suggests that these property rights will terminate automatically on June 22, 2010, and later when third parties decide to name their nontobacco products the same name as an existing cigarette or smokeless brand. This raises a host of legal implications.

Why is this important to you? It is likely that a number of tobacco product manufacturers and brand owners will have products that are adversely affected by this final rule. Although FDA also issued an acknowledgement of concerns about this final rule's provision as expressed to the agency, there is no guarantee that FDA will address the issue prior to its effective date of June 22, 2010, or ever address the issue.

What should you do? It is important that tobacco product manufacturers and brand owners identify all cigarette and smokeless tobacco product brand names used after January 1, 1995 to determine whether any in their portfolio will be affected by this final rule. Database searches can be used to better determine whether a cigarette or smokeless tobacco brand is also used for a nontobacco product, and thus prohibited.