Will the FDA Adopt an Arbitrary and Capricious Ban on Menthol Cigarettes?

The research the FDA relies upon to claim banning menthol cigarettes would improve public health is not aligned with the agency's approach to tobacco regulation.

The U.S. Food & Drug Administration is considering whether to ban menthol-flavored cigarettes. The agency first proposed a ban in 2022, but it has yet to finalize the proposal, prompting some activist groups to sue. (Query whether these groups have standing.)

The FDA and those groups calling for a ban on menthol cigarettes claim that this will benefit public health, but it's not clear the relevant medical research supports this claim, as it is not clear that such a ban will do much to reduce smoking rates or smoking initiation. This is particularly true as some relevant research assumes that users of menthol cigarettes would be able to switch to menthol (or other) flavored e-cigarettes. This is a problem as the FDA has refused to approve any non-tobacco-flavored e-cigarettes to date.

Over at Slate, Jacob Grier looks at the politics of a potential menthol ban, but also discusses the legal peril of the FDA relying upon such research to support a ban on menthol cigarettes.

The FDA's proposed menthol rule relies heavily on a study published in 2021 projecting that a federal ban would avert about 650,000 premature deaths by the year 2060, demonstrating a substantial benefit to public health. However, the modeling in that study assumes that many smokers of menthol cigarettes would switch to e-cigarettes rather than to regular, unflavored cigarettes, and that this switch is most likely to occur if e-cigarettes are available in menthol flavors. The catch? So far, the FDA hasn't authorized a single e-cigarette for sale in menthol or any other nontobacco flavor. . . .

Cliff Douglas, an adjunct professor at the University of Michigan and the president of the Foundation for a Smoke-Free World, is one of the co-authors of the 2021 study mentioned above. "Our modeling on which the FDA depends found that the menthol cigarette ban will be significantly less effective if the agency hasn't provided for a legal, authorized market for alternative products to which smokers of menthol cigarettes can turn," says Douglas. Authorized e-cigarettes are currently a "minuscule percentage of the marketplace," limited to just a handful of products, he notes. Since Biden's 2022 appointment of Brian King as director of the FDA's Center for Tobacco Products, the agency hasn't authorized any e-cigarettes at all.

That doesn't merely make a federal menthol ban less effective; it also opens it up to legal challenge. "If the FDA relies on science, including what we generated, they can't cherry-pick it and just give it partial credence and ignore the rest," says Douglas. "That creates a target for legal challenge for being arbitrary and capricious." This is a reasonable concern given the FDA's recent track record in other tobacco cases: The agency's regulation of premium cigars was struck down last year for being arbitrary and capricious, and e-cigarette makers have prevailed on challenges to its regulatory processes in the U.S. Court of Appeals for the 5th Circuit, producing a circuit split that may reach the Supreme Court.

I've noted before that the FDA has a vaping problem, but it seems the agency's difficulties may extend to combustible tobacco products as well.

Comments

[Abdul Abulbul Amir]

Arbitrary and Capricious!

Also racist.

[F.D. Wolf]

In 2009, the FDA banned flavored cigarettes, but made an exception for menthol. Everyone knows why that exception was made, and it certainly wasn't about health or science. It was 100% about race. (Our totally apolitical regulatory experts in action).

I was a pack-a-day smoker for about 25 years. My brand of choice was Marlboro. I went from Reds to Mediums to Lights. Of the hundreds, if not thousands, of smokers I interacted with in that time, I only ran across two white people who smoked menthols, and both were women. I found menthols quite dreadful and would choose to go without rather than smoke a menthol. Surveys indicate about 80% of black smokers smoke menthols.

The FDA first proposed the menthol ban in 2022, but the Biden administration has delayed it twice, again, for rather obvious reasons. It will almost certainly adopt the ban after the election, regardless of the results.

[Daddyhill]

It seems that federal courts have become adept at cherry-picking certain components of a case or law for approval while rejecting the others. So why shouldn't the FDA be granted similar latitude in their consideration of conflicting evidence? Come to think of it, are there any federal, state, or local agencies that don't pick and choose the data or opinions they find most agreeable? Or private agencies and entities? It's usually called confirmation bias--we pay more attention and give more credence that which tends to confirms our prior beliefs and opinions. We all do it.

In this case, FDA cherry-picking would run counter to common sense. If there are menthol smokers who'd rather fight than switch, it's a certainty that Phillip Morris will figure out how to add some other ingredient that approximates the menthol kick when smoked. Or there will arise a new illicit traffic in menthol smokes imported from somewhere else (central Mexico would be my first guess, but it could be anywhere). Then there are the switchers, who will definitely learn that there are other brands out there that can deliver a nicotine hit that feels just as good as their menthols.

All of that will happen if the FDA bans menthol + nicotine cigarettes but doesn't ban tobacco + nicotine cigarettes. In either case, of course, the FDA/DEA killjoys will have to level up their enforcement skills, a lot. Smokers who can cope with the astronomical price of cigarettes (they were 25 cents a pack in 1968) will continue to do what they've always done, which is to titrate their nicotine dosage from drag-to-drag and from day-to-day.

It's simply true that the US cannot reduce tobacco-associated morbidity and mortality faster than we've been doing it unless we grow a pair and take tobacco out of the equation altogether. It's really not the tobacco companies' fault that lots of people still like smoking cigarettes even 60+ years after we all learned that smoking cigarettes could and would make us sick or kill us with an ever-increasing variety of unpleasant diseases. Smoking cigarettes feels good (eventually or never), and there may be some smokers out there who still idealize Cigarette America icons like WW2 GI's, cowboys, and presidents. So cigarette smoking will continues to have a (foreseeable) future in the US. Smoke 'em if you got 'em.

[Brett Bellmore]

"even 60+ years after we all learned that smoking cigarettes could and would make us sick or kill us with an ever-increasing variety of unpleasant diseases."

Oh, that knowledge goes back a lot further than 60 years. They weren't calling them "coffin nails" for nothing.

I think the problem is that tobacco settlement the tort lawyers cooked up has caused perverse incentives. The tobacco companies have to pay up for selling anything with tobacco in it, but the vape companies that omit tobacco? They're off the hook.

So the gravy train grinds to a halt if vaping displaces tobacco, and never mind that being a great development in terms of public health.

Sure, there's a certain Puritan conviction that pleasures SHOULD ruin your health, but that's the main issue: Government gets a big cut of the profits, and doesn't want to lose the cash.

[NoVaNick]

There are plenty of less toxic alternatives to cigarettes now that didn’t exist 30, or even 10 years ago, yet the anti groups want to ban all of them because they are against anyone experiencing pleasure, or some may say they want to destroy big tobacco for their past sins, not thinking that they wills simply find another product to sell (hello 420!). The more they do this, the longer the cigarette, and all the health hazards that go with it, will endure.

[Dan Schiavetta]

Ever smoke a (banned years ago) Clove cigarette? Wow! It was 1986 and I still remember it.

[F.D. Wolf]

Yes, I have. As the name suggests, they were a mixture of tobacco and ground cloves (and sometimes other spices). (As you can still get tobacco in a bag and roll your own cigarettes, I suppose you could add cloves or anything else yourself). They were effectively banned by the same 2009 FDA rule that banned all flavor additives to cigarettes (with the exception of menthol).

[NoVaNick]

You can still find clove cigarettes-they just call them cigarillos, which aren’t regulated the same way

[Frank Drackman]

C'mon Man, Knee-Grows should try something healthier, like Malt Liquor.

[M L]

The FDA is unconstitutional.

On another topic. A relative with a PhD in biomedical engineering and all sorts of publications on lung imaging told me vapes aren't any safer than cigarettes. I was a little surprised, maybe was a broad brush comment.

[Brett Bellmore]

Generally speaking, you should avoid inhaling anything besides air. But your relative is full of it, based on the medical evidence. Vapes aren't perfectly safe, but they're incredibly less damaging to your health than cigarettes.

[M L]

That's what I thought, too.

[Frank Drackman]

“Biomedical Engineering” which is a major they made up so Pre-Med majors who couldn’t hack the regular engineering could pretend to be an Engineer. I was realistic, majoring in Poultry Science, KFC, Popeyes, Chick Fil-A doesn’t happen by magic. There’s more to it than Dark/White Meat, Manganese for example, alot of people don’t even know what that is.
OK, maybe Vapes are a little more than just Water Vapor and Nicotine (but not much, a little flavoring, propylene glycol) but last I checked there wasn’t any Benzene, Arsenic, Acrylonitrile, Cyanide, like in the Smokes I still occasionally enjoy (like Barry Hussein’s experience with Tobacco, it’s still a “Work in Progress”)

Frank “Still smokin”

[Brett Bellmore]

" but last I checked there wasn’t any Benzene, Arsenic, Acrylonitrile, Cyanide"

That's in the black market vapes that are thriving only because the FDA won't approve any safe flavored vapes.

Tobacco, the plant, contains, even before burning, more carcinogens than I'd care to have to memorize. The stuff is nasty enough that it can cause skin cancer just from handling it, it's a green leafy biowarfare agent.