Is FDA going to ban menthol as a “characterizing flavor” or an ingredient? It matters

Today the FDA, with important support from the Biden Administration, announced that it would be moving to ban menthol as a “characterizing flavor” in cigarettes. In so doing, the FDA acted as requested in a Citizen’s Petition submitted by the Public Health Law Center in 2013.

This is an important step forward.

Today’s FDA letter to the Public Health Law Center provides a good summary of the history of the menthol issue, a brief summary of the scientific evidence, responses to public comments submitted to the FDA opposing the Citizen’s Petition, and commits to move forward and “to make this proposed rule one of the Agency’s highest priorities.”

This letter is very thorough and could form the basis for issuing the actual rule, which will hopefully speed up the process.

As I discussed before the FDA acted, however, it is important that FDA ban menthol as an ingredient not just as a characterizing flavor. Just banning menthol as a “characterizing flavor” would allow tobacco companies to continue using menthol in cigarettes and cigars the ingredient as long as they don’t promote the cigarettes and cigars as “menthol.”

While the Citizen’s Petition only asked that menthol be banned as a characterizing flavor, based on current knowledge, the FDA needs to ban menthol (and its analogs) as an ingredient.

Why? Menthol has many effects that go beyond its flavor, including interacting with nicotine in a way that boosts addiction and making smoke (nicotine) easier to inhale.

The fact that HHS Secretary Xavier Becerra’s statement supporting FDA action talks about “banning menthol in cigarettes and cigars” seems to support banning menthol as an ingredient.

There is no question that the tobacco companies will fight the new rule tooth and nail, including going to court. But, the reality is that they will fight it as hard as they can whether menthol is banned as an ingredient or just as a characterizing flavor.

To empower the FDA to do so, it is important that the Public Health Law Center and other public health groups urge the FDA to ban menthol as an ingredient through the coming public comment process so that the tobacco industry cannot claim that the FDA is going beyond what the petitioners asked for.

FDA action does not lessen the need for localities and states to prohibit the sale of flavored tobacco products, including menthol

While the FDA moving forward on menthol is a big step forward, this will be a long process. FDA must issue a draft rule and accept and assess public comment before issuing a final rule. Then the tobacco companies will sue.

So a final enforceable rule is years away.

That’s why, in the meantime, localities and states should continue passing laws to prohibit the sale of all flavored tobacco products (including menthol). Such laws have broader reach than the proposed FDA menthol rule (which just will cover cigarettes and cigars) and how the FDA will handle menthol e-cigarettes and newly deemed products is unknown.

They also take effect quickly.

The FDA did not couple the menthol rule making with reducing nicotine in cigarettes

Contrary to recent press reports suggesting that the FDA would couple action on menthol with action to reduce nicotine levels in cigarettes, the FDA did not announce action on nicotine levels.

This was a good decision. Dealing with menthol is more important than issuing a nicotine regulation, especially given that the FDA is having to deal with a huge number of applications to authorize new tobacco products.