OMB Says NPRM on Nicotine Limits Coming in May 2023 (Update)

The Biden administration’s plan to limit the nicotine limits in cigarettes and potentially other tobacco products is scheduled to get announced in May 2023 according to a new filing by the White House Office of Management and Budget (OMB).

Two weeks ago, a report by the Wall Street Journal indicated that the White House would likely announce that it was moving forward with plans to create nicotine limits for cigarettes sold in the U.S. FDA made its first formal announcement regarding such a plan in 2018, which focused on whether enacting nicotine limits for cigarettes would be helpful in reducing the number of cigarette smokers in the U.S. While the 2018 announcement focused mainly on cigarettes, it opened the door to enacting it for other tobacco products as well.

Earlier today, OMB added a new entry to its regulatory agenda, the first of many steps to actually getting the proposal enacted into law. Because of how early in the process today’s action is, there’s not much to be gleaned about what might be announced—let alone what could be enacted—but it does leave open the door to it applying to more products than just cigarettes.

OMB’s website describes the proposal as such:

Tobacco Product Standard for Nicotine Level of Certain Tobacco Products

Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Nearly all these adverse health effects are ultimately the result of addiction to the nicotine in combusted tobacco products, leading to repeated exposure to toxicants from those products. Nicotine is powerfully addictive. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and half of adult smokers become addicted before age 18. This proposed rule is a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain finished tobacco products. Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit. This product standard would also help to prevent experimenters (mainly youth) from initiating regular use, and, therefore, from becoming regular smokers. The proposed product standard is anticipated to benefit the population as a whole while also advancing health equity by addressing disparities associated with cigarette smoking, dependence, and cessation.

Like pretty much every rule FDA will attempt to introduce regarding tobacco regulation, the next steps are likely to be lengthy and highly contested.

Whenever FDA issues a notice of proposed rulemaking (NPRM)—which OMB says is scheduled for next May—it will give a more formalized proposal of what the agency intends to do. Like what is currently happening regarding separate proposed rules regarding flavored cigars and menthol cigarettes, the public and industry would then be given time to comment on the proposal.

Update — FDA has issued its own statement on the matter, including a clarification that the May 2023 dates are “not intended to be a precise estimate” regarding when an announcement may come.

After that, FDA is required to reply to the commenting process—though not every comment made—before it announces a final rule, which would be the last step the agency needs to do before actually enacting a new law.

That process only describes what FDA would need to do and does not take into account what would be inevitable, well-funded legal challenges against the nicotine standards law.