The Food and Drug Administration’s (“FDA”) proposed deeming regulations raise concerns for cigar manufacturers with product labels that include descriptors such as “light,” “mild,” “medium” or “low.” In 2009, the Tobacco Control Act banned these descriptors for cigarettes. The stated rationale for the ban was the assertion that many consumers believed that descriptors such as “light” or “mild” meant that certain cigarettes were less harmful than other cigarettes.
In the preamble to the Proposed Rule, the FDA states that “[o]nce finalized, products deemed under this rule will be subject to the same FD&C Act provisions that cigarettes . . . are subject to, with respect to the . . . prohibition against use of modified risk descriptors (e.g., ‘light,’ ‘low,’ and ‘mild’ descriptors) and claims unless FDA issues an order permitting their use.” In its comments submitted in response to the Proposed Rule, Altria, owner of one of the nation’s top-selling cigar brands, Black & Mild, expressed concerns with a categorical ban of particular descriptors.
Altria acknowledges that Congress concluded that certain words represent a modified risk claim for cigarettes, but argues that Congress did not make that determination for all tobacco-derived nicotine products. To extend to other tobacco products the per se ban of descriptors tied to cigarettes would exceed the FDA’s regulatory authority and would violate the First Amendment, according to Altria.
In its comments, Altria states that the statutory text and history of the Tobacco Control Act do not support a categorical ban of words such as “mild” for all tobacco-derived nicotine products. Altria argues that the Tobacco Control Act does not allow the prohibition of terms such as “mild” when the terms are not used to convey a message about risk. Rather, Altria argues that the Tobacco Control Act only prohibits the use of such terms when used as a “descriptor” of “modified risk.” Relying on a company-sponsored survey of over 300 cigar smokers, Altria takes the position that the word “mild” in its Black & Mild brand is not used to claim that the brand is less harmful than other cigar brands. Because “mild” is not used as a “descriptor” of “modified risk,” Altria argues that the FDA lacks the regulatory authority under the Tobacco Control Act to impose such a ban.
Additionally, Altria takes the position that the ban of a well-established trademark like Black & Mild violates the U.S. Constitution. The First Amendment protects commercial speech. When the government seeks to place restrictions on commercial speech, such as the ability of a cigar manufacturer to use the term “mild,” the government, or in this case, the FDA, has the burden of proving the ban would serve a substantial governmental interest and that there are no less restrictive means of serving that interest. “To impose a per se prohibition on particular terms without a scientific basis for doing so would fail this test,” according to Altria.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders tobacco practice partner, at 804.697.1420 or by email.