Seven Thoughts: Explaining FDA’s Plans to Ban Menthol Cigarettes & “Flavored Cigars”

Today, the U.S. Food & Drug Administration (FDA) confirmed that it was moving forward with plans to ban the sale of menthol cigarettes and at least some flavored cigars.

For those of you that haven’t spent much time talking about hypothetical FDA actions or studying how the agency does its business, this is probably confusing. And if you are one of those people that does pay attention to FDA, today was super confusing.

In short, we don’t know much about FDA’s plans and it could be some time—almost certainly next year—before we have the specifics of what the agency intends on doing, although those intentions will then be subject to change. Based on today’s announcement, it will be many years before any actual bans of menthol cigarettes and/or flavored cigars take effect.

Here’s what I’ve been able to piece together.

1. THIS IS A WEIRD WAY FOR FDA TO ANNOUNCE SOMETHING

FDA typically prefers to have all, or at least most, of its ducks in a row. This is not that and it’s being driven by the citizen’s petition.

In short, over a dozen public health and anti-tobacco groups filed a citizen’s petition asking FDA to ban menthol cigarettes in 2013. FDA didn’t reply to the petition, so last year, one of those groups filed a federal lawsuit. Ultimately, the judge ruled against FDA and told the agency it needed to reply by a certain date, eventually April 29.

That created a weird artificial deadline, something that was likely only compounded by a new administration in the White House, and it’s showing by how unclear this process is.

2. HERE’S WHAT FDA SAID TODAY

The heart of the announcement is:

The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars…

You can read it in full here.

Of note, FDA was also considering whether to create new limits about how much nicotine was allowed in cigarettes. The agency said it is still evaluating that issue and didn’t announce any plans—one way or the other—to implement those today.

3. WHAT THIS MEANS FOR ACID, JAVA, TATIANA & OTHERS

From both what I’ve been told privately and what FDA has said publicly, I think it is likely that some flavored cigars will be allowed under the future rules. At the very least, it’s quite clear that FDA doesn’t feel comfortable saying that all flavored cigars will be banned. Throughout FDA’s announcement, there is the peculiar language used to define the cigars FDA wants to ban.

FDA’s announcement today include this line, emphasis mine:

Flavored mass-produced cigars and cigarillos are combusted tobacco products that can closely resemble cigarettes, pose many of the same public health problems, and are disproportionately popular among youth and other populations.

In a press conference, Mitch Zeller, the director of FDA’s Center for Tobacco Products, seemed to correct himself when responding to a question:

The 480,000 deaths, and that’s a conservative estimate, that occur every year in the United States from tobacco use; number one are completely preventable and number two are primarily associated with combusted products. And we know that the majority of smokers are concerned about their health and want to quit and we know what the public health impact of the use of this product standard authority both for menthol cigarettes and flavors in cigars, little cigars and cigarillos, will have.

Conversely, FDA did use language like “ban all characterizing flavors (including menthol) in cigars” where it doesn’t make a differentiation, though those instances take place in headlines and areas where less clarification is used.

I think it’s notable that FDA said “all characterizing flavors in cigars” and not “characterizing flavors in all cigars.”

This is the level of minutia we have to deal with thanks to the oddity of what was announced, but as someone that has read more FDA announcements than I care to admit, today’s raised some eyebrows and certainly confirmed what sources were saying.

I am told that FDA had a conference call with congressional staffers today and was asked specifically about how this would affect premium cigars—thank you to Sen. Marco Rubio’s staff—and from what was told, it didn’t provide an answer of substance.

The obvious questions are: will there be some flavored cigars allowed in the future, and if so, where will the lines be drawn between what’s allowed and what is not? I’ve been told that in regards to the latter, it’s undecided.

4. “WITHIN THE NEXT YEAR” DOES NOT MEAN MENTHOL CIGARETTES WILL BE BANNED IN 2022

FDA repeatedly mentioned that it plans to announce the proposed rule “within one year.” That is a very obvious tell that the proposal is not finalized.

Normally, FDA would make the announcement of what it was going to do, that same day it would go to the federal register and the process would start. There are many reasons for this, chief amongst them, to avoid creating the uncertainty that days like today did.

Zeller was asked why it took the agency so long to get to this point and why it was needing more time to announce the proposed rule, his reply:

There are very important considerations starting with legal considerations about getting this right as we move forward in the rulemaking process. And the fact that we are going on the record, with a target date for when we hope to be able to publish these two product standards as proposed rules, shows as you heard Dr. Woodcock say, how much of a priority this is for FDA and this administration. We intend to meet that target but beyond that, it’s really impossible to predict how long it would take to complete the rulemaking.

The rulemaking process is, as the name implies, a process.

It will start with FDA finalizing the new product standard, but that’s just the beginning. It will then lead to:

• 60-120 day comment period where citizens, advocacy groups and companies can comment about what FDA says it is planning on doing;
• FDA reviews and replies to comments;
• The White House Office of Management & Budget reviews the finalized rule;
• FDA announces finalized rule with an implementation date for the future.

Zeller mentioned the tens of thousands of comments the agency has received regarding issues like this in the past and that the agency is required to evaluate and respond to them.

My guess is that if FDA is announcing the proposed product standard in a year, even with the quickest reasonable timeline possible, menthol cigarettes and flavored cigars are probably still on sale at the beginning of 2024. (This also would assume no lawsuits, see below.) I’ve heard conflicting opinions about when FDA would have a finalized rule and some certainly think it might be earlier, but even then we are talking about mid-2023 versus sometime in 2024 or beyond.

For context, when FDA announced its last major tobacco regulations—the deeming regulations that affect premium cigars—the proposed rule was announced in April 2014, the finalized rule was announced in May 2016, and parts of the rule went into effect in August 2016.

5. THERE WILL BE LAWSUITS

Menthol made up 36 percent of the cigarettes sold in the U.S. in 2018 according to the Centers for Disease Control; perhaps more importantly, menthol’s market share is increasing while the overall number of cigarettes sold in the U.S. is decreasing.

Here are some thoughts from the world’s largest tobacco brands:

• Altria: Science- and evidence-based information does not support restricting or banning menthol cigarettes.
• British American Tobacco: Regulation should be evidence-based and there is no evidence to support banning menthol cigarettes in relation to their relative health risks compared to non-menthol cigarettes.
• ITG Brands (Imperial Brands, plc): We believe the rulemaking process will reveal that there is no clear scientific evidence to support a federal menthol and flavor ban.

These companies and others like them are not happy about today’s announcement. The legal war chest(s) that will inevitably be assembled to fight these future regulations in court will be large, very large.

It’s also worth pointing out, this is the big leagues. This is going to be a combination of the best attorneys, lobbyists, PR firms and other specialists that money can buy. The menthol component makes this a completely different world from the one that I normally write about, and it’s going to be obvious as the fight plays out. Furthermore, it’s not like the cigarette companies were blindsided by this announcement. They’ve known that a day like today was inevitable, now the battle really begins.

That’s nothing to say about the flavored cigar component which will include many of the same players as well as Swisher (parent of Drew Estate) which arguably has more to lose—at least in relation to how much of a singular company’s business could be affected—than anyone else.

6. FDA HAS AN ACTING COMMISSIONER RIGHT NOW

I bring this up because of how many times it’s been brought up to me today. Practically, it’s not that important; but it does illustrate how bizarre this announcement was.

Typically, when FDA makes an announcement or finalization of a landmark policy change—this would qualify—the agency will avoid doing so without a confirmed commissioner. It’s something that extends to many executive agencies, at least in a pre-Trump world, because acting commissioners are temporary and not confirmed by the Senate. Typically, large policy changes are something that most White Houses have been predictably careful about making.

Currently, Dr. Janet Woodcock is serving as the acting commissioner for FDA. She has long been expected to be nominated for the permanent role, but several senators have raised concerns over her alleged role in making opioids more accessible. There are other objections to her nomination and it seems clear that as of now, her nomination would not succeed. This situation isn’t particularly new—at least within the context of the relatively short time that Joe Biden has been president—and still isn’t resolved.

Woodcock’s boss—Xavier Becerra, the secretary of the Department of Health and Human Services—has been confirmed and he was the one that gave the statement on the rule, something that likely would have been made by the FDA commissioner.

I’m guessing that had there not been a court order necessitating a response today—though it seems likely FDA could have delayed this again—that the White House would have waited to make this announcement until after it had a confirmed commissioner for FDA.

7. THIS WILL AFFECT THE “PREMIUM CIGAR” INDUSTRY

I’m not sure how to describe what this means for the premium cigar industry. Some alternative headlines I considered for this header:

• The premium cigar industry is going to be an affected bystander;
• The premium cigar industry might get an unexpected victory;
• The premium cigar industry will get affected;
• The “premium” issue remains unresolved and perhaps more complicated.

I think the latter is the surest thing of those ideas. Currently, the National Academy of Sciences has commissioned a panel to review whether FDA should create a different set of rules for “premium cigars” compared to other cigars. This is the result of an August court ruling, where a federal court instructed FDA to review whether it properly evaluated regulation “premium cigars” differently.

It is of course, not that simple.

For one, FDA opted to farm the review out to another government organization. This panel, interestingly, was told that it didn’t have to use a previously proposed definition of “premium cigars,” one that would not include any flavored cigars. Instead, it’s free to see if the science and/or data suggests a different definition.

Today’s news, particularly the speculation around whether there might be some differentiation between flavored little cigars and flavored large cigars is certainly interesting in this light. At the very least—as unsatisfactory as it is—the only things that remain clear on the issue are: FDA hasn’t decided what to do with “premium cigars” and hasn’t decided what to do with flavored large cigars.