FDA has what it needs to prohibit “non-menthol” cigarettes

On April 19, 2023, Politico published “RJR uses California as test market for skirting upcoming national menthol cigarette ban” describing how RJR has been promoting its “non-menthol” cigarettes as a way to get around California’s prohibition on the sale of all tobacco products. According to the article California AG Rob Bonta is “investigating” what his options are, even though it is clear that these “non-menthol” cigarettes violate California law.

At the same time, the FDA is finalizing its proposed rule prohibiting the sale of menthol cigarettes. According to Politico, an FDA spokesperson “said that at the federal level, the final rule banning menthol cigarettes will be comprehensive. ‘The final rule will take into consideration all of the public comments, including comments on compliance and enforcement of the rule, such as how [the tobacco industry] may attempt to evade the requirements of the rule’.”

While the proposed FDA rule is limited to menthol as a “characterizing flavor,” as the FDA spokesperson said, the final rule will take into account public comments. This is an important point, because the final rule has to be based on the public record submitted through the formal notice and comment process.

Fortunately, the public comment (record) includes at least one public comment calling on the FDA to move beyond simply prohibiting menthol as a characterizing flavor but also menthol analogs that have the same effects.

In particular, the public comment “FDA should prohibit all menthol flavor additives, compounds, constituents, and ingredients in cigarettes, and should not limit the proposed standard to prohibiting menthol as a ‘characterizing flavor’” we submitted on August 1, 2022 makes exactly that recommendation. Among other things, it says:

“FDA correctly pointed out that the effects of menthol are not limited to providing a pleasing taste, reducing the harshness of nicotine, and making it easier to initiate and continue smoking. Rather, menthol interacts with nicotine at the level of receptors in the brain which makes the nicotine even more addictive, particularly to the developing brains of adolescents and young adults. Therefore, FDA should not limit the proposed standard to prohibiting menthol merely as a “characterizing flavor,” but should instead extend the proposed standard to prohibiting all menthol flavor additives, compounds, constituents, and ingredients in cigarettes to ensure that the proposed standard protects the public health, especially the health of young people. [citations omitted]”

The comment anticipates the strategy the companies are using in California and includes a whole section explaining why “FDA should ensure that the tobacco industry does not evade the menthol prohibition by prohibiting menthol and menthol analogs as ingredients.

(The Regulations.gov tracking number for this comment is l6b-ew3y-c1ye. The comment is available in the official government record at https://www.regulations.gov/comment/FDA-2021-N-1349-175335.)

In addition, in a paper he published in American Journal of Public Health, Brian King, the director of the FDA Center for Tobacco Products, noted that “policies based on characterizing flavor might not cover constituents added by the manufacturer that provide a cooling sensory experience (e.g., similar to menthol) that can increase appeal, but are not the characterizing flavor.”

The proposed rule also appropriately defines flavor as “the multisensory experience ( i.e., taste, aroma and cooling or burning sensations in the mouth and throat) of a flavor during use of a tobacco product” which clearly includes the new “non-menthol” cigarettes as flavored. (Even the tobacco companies accept this definition as scientifically valid and use it to design their products.)

While making sure to block menthol analogs in the final product standard, FDA could and should order “non-menthol” cigarettes off the market right now

The Family Smoking Prevention and Tobacco Control Act already prohibits the sale of all cigarettes with characterizing flavors other than menthol. Indeed, by giving these cigarettes that have a cooling agent it a name — “non-menthol” — non-menthol is a characterizing flavor. Thus, if they are not menthol, cigarettes with the non-menthol characterizing flavor are currently illegal under federal law. As a result, FDA should pull them off the market now, regardless of what it does on the menthol cigarette product standard.

Of course, RJR could argue that FDA authorized the sale of “non-menthol” cigarettes on the grounds that they are “substantially equivalent” to RJR menthol cigarettes.  As Politico explained, substantial equivalence is “a pathway for tobacco companies to bring a new product to market that has either the same traits as existing products or is a similar product with minor changes.” Since a menthol cigarette was used as predicate product, then this means “non-menthol” cigarettes are substantially the same as menthol. Thus, if RJR uses this substantial equivalence determination to argue that “non-menthol” cigarettes are actually menthol cigarettes (and so legal to sell nationally at this time), that would clearly make them illegal to sell in California.

In any event, the ambiguity caused by the FDA substantial equivalence decision for this and other similar products needs to be addressed in the final menthol product standard in addition to prohibiting menthol analogs.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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