One February 24, 2022, the FDA submitted two proposed rules on menthol to the White House Office of Management and Budget for review before public release: “Tobacco Product Standard for Menthol in Cigarettes” and “Tobacco Product Standard for Characterizing Flavors in Cigars.” The OMB can approve the proposed rules as submitted, deny them, or approve with changes.
The last time OMB dealt with flavored tobacco products was under President Obama when it dropped menthol and other flavor restrictions from the “deeming rule” under which FDA took jurisdiction over e-cigarettes, cigars, and other non-cigarette tobacco products. Had the Obama OMB allowed FDA to move forward then, much of the damage that flavored tobacco products have done would have been avoided.
Given that President Biden has pledged to follow the science, hopefully OMB will not repeat its past behavior. Here is what he said:
An important detail to watch is whether FDA bans menthol (and menthol analogs) as “characterizing flavors” or “ingredients.” It is important that menthol be banned as an ingredient.
If OMB approves the proposed rules, FDA will put them out for public comment, the next step toward issuing final rules, a process likely to take a year or more.
Once the final rules are issued, the tobacco companies will almost certainly sue, which will further delay implementation, as they done successfully with the FDA’s well-conceived rule requiring graphic warning labels.
That’s why, in the meantime, states and localities should continue to press forward with laws ending the sale of all flavored tobacco products, including menthol.