What’s the Status of the Proposed Ban on Menthol Cigarettes?

Biden administration officials have many regulations they’d like to finalize before the end of the president’s term, but it’s unclear whether a proposed rule banning menthol cigarettes is among them.

The proposed menthol cigarette ban was originally announced in April 2022. At the time, HHS Secretary Xavier Becerra said in a statement that the rule “would help prevent children from becoming the next generation of smokers and help adult smokers quit. Additionally, the proposed [rule represents] an important step to advance health equity by significantly reducing tobacco-related health disparities.” An estimated 80% of Black smokers smoke menthol cigarettes, compared with 30% of white smokers.

However, the Biden administration has delayed the final rule several times recently, saying it would be published in August 2023, then pushing that date back to the end of the year, and then saying it would be published in March. When asked about the delays, an FDA spokesperson said in an email in January that the agency “remains committed to issuing the tobacco product standards for menthol in cigarettes and characterizing flavors in cigars as expeditiously as possible; these rules have been submitted to OMB [the Office of Management and Budget] for review, which is the final step in the rulemaking process. As we’ve made clear, these product standards remain at the top of our priorities.”

“Regulations such as product standards go through an extensive rulemaking process, which includes interagency review,” the spokesperson said. “At this stage in rulemaking, the FDA is limited from further discussions about the rules before they are published.”

HHS delayed the rule again in April. “This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” Becerra said in a very brief statement posted April 26 on the HHS website. “It’s clear that there are still more conversations to have, and that will take significantly more time.”

One possible reason previously suggested by observers for the delay is that the Biden administration might have been afraid that issuing the rule could alienate Black voters before the presidential election. Now that the election is over, is the Biden administration rushing to get the rule out before the Trump administration takes over in January?

It’s hard to say. Asked via email for a comment on the rule’s progress, an FDA spokesperson referred MedPage Today to a video clip of an interview that FDA Commissioner Robert Califf, MD, gave at last week’s Friends of Cancer Research annual meeting. When asked what he wanted to accomplish in his last few months as FDA commissioner, Califf replied, “The big deal for the public health is tobacco and food. There are major things there we’re hoping to get done. It’s publicly known that the menthol rule has been an issue.”

An FDA spokesperson said that beyond the video, the agency “[doesn’t] have any additional updates at this time.”

There are two possibilities for the rule as it stands now, Steven Balla, PhD, co-director of the Regulatory Studies Center at George Washington University in Washington, D.C., said in a phone interview. If the rule is still being finalized when Trump takes the oath of office, the chief of staff at an agency such as the FDA “issues a memo instructing the department to halt work on regulations for a 60-day period, which gives them time to look at work in progress and then decide which rules they’re going to stop working on and which rules they’ll continue working on,” he said. “If it still hasn’t been finalized by January 20, it will be up to the Trump administration to decide whether to push forward.”

The other scenario would be that the Biden administration finalizes the rule prior to Inauguration Day, and in that case, it will be subject to disapproval under the Congressional Review Act, he continued. Under that law, which applies to any rule issued fewer than 60 working days before the end of the previous administration, a resolution of disapproval can be introduced in either the House or Senate and must be passed by both chambers. “It’s essentially a one-sentence law saying that the rule is disapproved, nullified, and eliminated as if it never existed,” he explained. “Then the president would have to sign it into law … and the policy would go back to the pre-rule status quo.”

One wrinkle with rules that are nullified under the Congressional Review Act is a provision that says that when a regulation is disapproved under the law, the agency is not allowed to issue a rule in the future that is “substantially similar” to the disapproved one. “The concern of the drafters [of the law] was, ‘What if the agency goes back to business and issues the rule again?'” he said.

What is the definition of “substantially similar?” Balla said that no one knows. But the provision tends to have a big impact: “If you go back almost 25 years, Congress first nullified [President Clinton’s] Department of Labor rule on ergonomics in the workplace … Since then, the department never issued another related rule on ergonomics. So it’s pretty significant.”

This week, as the status of the rule remains uncertain, the Surgeon General’s office issued a report entitled, “Eliminating Tobacco-Related Disease and Death: Addressing Disparities.” The report noted that “the tobacco industry has designed, engineered, and marketed menthol cigarettes and other tobacco products that deliver multisensory flavor experiences which increase the likelihood of tobacco initiation, addiction, and sustained use. Policies that restrict the availability of menthol cigarettes can reduce smoking initiation and prevalence among adolescents, young adults, Black people, and other population groups that have disproportionately higher use of menthol cigarettes.”

Anti-smoking groups have remained relatively quiet about the rule’s status. “We have a lot of concerns about the menthol rule moving forward,” said Erika Sward, assistant vice president for nationwide advocacy at the American Lung Association, in a phone interview. “We’re trying to figure out our next steps.”