On June 21, 2022, the Biden Administration announced that FDA would be moving forward to develop a product standard limiting nicotine in cigarettes and other combusted tobacco products to nonaddictive levels.
FDA has been formally considering such a rule for a long time. In 2018, FDA solicited public comment on such a rule. At that time, my UCSF colleagues and I submitted a public comment urging that the rule include all nicotine products, not just combusted tobacco products. That recommendation still holds, especially as the e-cigarette epidemic rages among youth.
Any final rule, however, is years away. According to the While House schedule, the Notice of Proposed Rulemaking (NPRM) will not be issued until May 2023. The NPRM, which will present a specific proposed rule for public comment prior to finalizing the rule. They then assess the comments and issue a final rule. Then the tobacco companies will sue.
And if the companies pick the right judge he or she will just sit on it as a Trump Judge in Texas has been doing for the rule requiring warning labels on cigarette packs. Congress required these warning labels in 2009, 13 years ago and they are still years off.
In contrast, FDA can and should act now to prohibit menthol e-cigarettes
In contrast to issuing rules, which takes years, FDA can act now to prohibit menthol e-cigarettes by simply denying premarket tobacco product applications (PMTA) for menthol e-cigs. While FDA has been denying other flavors because of their appeal to youth, FDA has de facto authorized menthol ecigs — another popular flavor with youth — by simply not acting on the tobacco company applications for menthol ecigs and allowing them to remain on the market in the meantime.
FDA has done this despite the fact that the FDA clearly understands that menthol is more than a “flavor”: it biologically interacts with nicotine to make nicotine more addictive. That’s why, while fruit ecigs most popular first flavor, kids who start with menthol/mint more likely to still be vaping as young adults.
In the meantime, the public should continue to press local and state governments to prohibit the sale of all flavored tobacco products including menthol. As of April 22, 2022, 2 states (Massachusetts and California [pending an industry referendum in November 2022]) and at least 150 localities have banned all flavored tobacco products, including menthol.