Earlier today, the White House announced that it would once again be delaying a much-anticipated upcoming federal ban on menthol cigarettes. While today’s announcement was surprising, it was certainly not shocking. Every day that has gone by has made the delay far more likely, it’s just somewhat surprising it was announced today.
Today’s announcement was a bit different than other delays as it seems like those in favor of a menthol ban realize that this is a definitive step backward in the process. I’d argue things are still where they were as of late 2023, but today is a win for the tobacco and a loss for those against it.
1. What Does This Have to Do With Cigars?
It’s entirely possible that the answer is “nothing,” but that seems more or less unfathomable.
Since April 2021, the U.S. Food & Drug Administration has been formally working on two different proposals:
- a rule that would ban the sale of menthol cigarettes in the U.S.
- a rule that would ban the sale of flavored cigars in the U.S.
Technically, these two rules are separate regulations. That said, they have functioned like twins during the regulatory process: they were introduced alongside one another, the comment periods for one another were announced and took place during the same time, and they were delayed in December.
There has not been a formal announcement that the flavored cigar rule has also been delayed indefinitely, but I would be flabbergasted if the administration decides to do the flavored cigar rule by itself. I suspect at some point in the next week, we will get a formal clarification that the flavored cigar rule is also indefinitely delayed.
2. What’s the most important thing(s) I should know?
- This decision was not made by FDA, it was made by people further up the totem pole.
- This delay is temporary, FDA has seemingly done what it needed to do, once a White House is ready to move forward, it could move forward very quickly.
3. How did we get here?
- June 2009: Obama Signs Tobacco Control Act — After years of failed attempts, the Family Smoking Prevent and Tobacco Control Act was signed into law. Amongst other things—like giving FDA the authority to regulate tobacco products—it banned the sale of flavored cigarettes, except menthol cigarettes. It is widely reported that the bill wouldn’t have been able to pass had it banned menthol cigarettes.
- April 2013: Groups Announce Citizen Petition to Ban Menthol Cigarettes — More than a dozen groups filed a formal citizen petition to ban the sale of menthol cigarettes.
- June 2020: Groups File Lawsuit Over Citizen Petition — After years of inaction, the groups filed a lawsuit arguing that the FDA hadn’t fulfilled its legal requirements to reply to the citizen petition.
- April 2021: FDA Says it Will Unveil Menthol Cigarette & Flavored Cigar Bans Within a Year — The government had told the court that it would formally reply to the citizen petition by late January, a date that was ultimately extended to April 29, 2021. On April 29, 2021, FDA announced that it would unveil proposed rules to ban the sale of menthol cigarettes and flavored “within a year.” This served as the first step in the formal rulemaking process.
- April 2022: FDA Unveils Menthol Cigarette & Flavored Cigar Bans — On April 28, 2022—so “within a year”—the agency unveiled the proposed rules. This should be viewed as a draft—neither a rough draft nor a final draft—as the rules were subject to a number of other steps: formal comment period, legal review and other actions that could meaningfully change them.
- August 2022: Comment Period Ends — After a 30-day extension, the comment period for the two rules came to an end on Aug. 2, 2022. This meant that the agency could begin to push the rule forward until it was finalized.
- March 2023: “Fall 2023” — Brian King, director of FDA’s Center for Tobacco Products, publicly says that the agency is planning to announce the final rules in the fall of 2023. This is one of a number of public statements and private comments throughout 2023 that made it clear FDA planned to have the rules announced in 2023.
- October 2023: Rules Head to OMB — One of the last steps in the process before the rules could become law was a review at the White House Office of Management & Budget (OMB). By mid-October, the rules were sent to OMB, meaning FDA’s final draft was done and the rules were in someone else’s hands.
- December 2023: Rules Delayed Until 2024 — After much speculation, the White House made it clear that the rules were not going to be announced in 2023. The new date was listed as “03/00/24” though that date wasn’t a deadline.
4. What was formally said?
Not much. The following is the full statement from Xavier Becerra, the secretary of Health & Human Services, which oversees FDA:
Secretary Becerra Statement on the Proposed Menthol Cigarette Rule
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. It’s clear that there are still more conversations to have, and that will take significantly more time.
Becerra is a cabinet member. He serves at the pleasure (of the president.) It’s quite likely that Xavier Becerra is pissed off by this delay and against it. But he serves at the pleasure. If his boss decides to do this, it’s not his place to publicly object to it. I’d take this incredibly short statement to confirm that. For what it’s worth, Becerra was the attorney general of California when the state passed its own ban on menthol cigarettes and flavored cigars.
5. Why Now?
There’s an election in November.
Menthol cigarettes are popular amongst Black smokers. Studies routinely show that more than 80 percent of Black smokers smoke menthols, compared to around a third of white smokers. Menthol cigarettes have long been targeted to Black smokers and tobacco companies have lobbied Black leaders to help keep menthol cigarettes legal. Rev. Al Sharpton and others have argued that banning menthol cigarettes would lead to more Black people being arrested. (To be clear, the law would make it illegal to manufacture or sell menthol cigarettes. It wouldn’t criminalize buying, possessing or smoking menthol cigarettes. This logic is hogwash, but the argument has stuck.)
If I were indifferent about banning menthol cigarettes but motivated to get Joe Biden reelected, I wouldn’t be banning menthol cigarettes in an election year. It’s just one more thing that can give someone a reason not to show up to vote for you.
In February, Politico reported that Dr. Robert Califf, the commissioner of FDA, was privately lobbying to get the ban passed. I took this report to mean that Califf—or someone at his direction—leaked this information. Dr. Robert Califf is the head of FDA, why would he not be private lobbying for things FDA is working on?
6. So what happens next?
I don’t fully understand the legal requirements of how quickly the White House could get the finalized rule announced, though I imagine quite quickly. I suspect that the next Unified Regulatory Agenda, a list of potential regulatory changes and some mild guidance on when they might take effect, will list both rules with no dates.
- If Biden Wins — I would put it at 60/40 odds that the rules get announced during his second term.
- If Trump Wins — I would put it at 1/3 that the rules announced during his second term.
Whenever the rules get announced—and I don’t really see a way they don’t inevitably get announced—FDA has said that there will be a one-year delay in implementation. (That could change, especially if the rules aren’t finalized until a significantly later date.) This means that if the rules were announced on March 15, 2025, sales of menthol cigarettes and flavored cigars would remain legal until, at least, March 15, 2026.
There will then be lawsuits from the tobacco side and who knows how those go.
7. So it’s just going to be radio silence until the rules get announced?
Nope.
Earlier this month, three public health groups filed a lawsuit against FDA arguing that the agency hasn’t acted fast enough to ban menthol cigarettes. This lawsuit, which suddenly has become a lot more interesting, will certainly continue. The lawsuit’s discovery phase could lead to some interesting information about why and how this delay came to be.
Furthermore, a judge could force FDA to act quicker. It certainly wouldn’t be the first time that has happened. (I am curious if the FDA/DOJ argues that it has acted quickly, but the rule is out of its hands.)
A friendly reminder: state and local governments are going to try bans of their own
California and Massachusetts have already passed bans on menthol cigarettes and flavored cigars, though both bans have their own unique exemptions. Other states are going to follow, especially in lieu of today’s news.