The Volokh Conspiracy
Mostly law professors | Sometimes contrarian | Often libertarian | Always independent
The Food & Drug Administration Has a Vaping Problem
Something is wrong at the Food & Drug Administration's Center for Tobacco Products, and federal courts are beginning to notice.
In 2016, the Food & Drug Administration (FDA) deemed electronic cigarettes and other vaping products to be "tobacco" products for the purposes of federal law. This move gave the FDA's Center for Tobacco Products legal authority to regulate vaping products like combustible cigarettes. How the FDA has proceeded to regulate such products since, however, has been something of a mess, suggesting either some degree of administrative incompetence, malice against portions of the industry, if not both.
Last October, the U.S. Court of Appeals for the Fifth Circuit eviscerated the FDA for flouting the basic administrative law requirements of "reasoned decisionmaking" when it denied Triton Distribution's premarket tobacco applications (PMTAs) for a range of vaping products. This is a big deal because vaping companies cannot sell their products if their PMTAs are denied.
In November, the U.S. Court of Appeals for the Sixth Circuit also found fault with the FDA's attention to basic administrative law requirements, this time in the agency's review of PMTAs from Breeze Smoke, another vaping product company. While the Sixth Circuit did not grant Breeze Smoke the relief it wanted, it was critical of the FDA's "formulaic" review of the PMTA materials.
Turning Point Brands is another vaping company that challenged the FDA's denial of its PMTAs, but rather than try its hand in court, the FDA rescinded the PMTA denial because it "found relevant information that was not adequately assessed." Oops.
With this background, it should be understandable why many industry observers raised an eyebrow when the FDA denied PMTAs from Juul Labs, one of the larger and better resourced vaping companies. If any company was capable of submitting a vape product PMTA that meets the FDA's standards, one would think it would have been Juul.
Facing the prospect of a regulatory death-sentence, Juul challenged the FDA's decision, filing a petition for review with the U.S. Court of Appeals for the D.C. Circuit and an application for an emergency stay. Among other things, Juul pointed out that some of the FDA's reasons for denying the PMTAs, such as a lack of certain sorts of information, were simply wrong. In other words, the FDA gave Juul's applications the same sort of sloppy and arbitrary treatment it had given to those of Triton, Breeze Smoke, and Turning Point. In Juul's case, some also suspected the FDA was bowing to political pressure to target Juul.
The D.C. Circuit granted Juul's request, putting the effect of the PMTA denial on hold so the court could review Juul's claims. Perhaps recognizing that the D.C. Circuit would find its conduct wanting, the FDA retreated, issuing an administrative stay of the PMTA denial so that it could conduct additional review of Juul's application materials. As the FDA tweeted that "The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review."
On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review. (1/3) https://t.co/DHDsFNVe1l
— FDA Tobacco (@FDATobacco) July 5, 2022
Faced with the prospect of having to defend its conduct in court, the FDA decided it should take the time to conduct the review it was legally required to undertake in the first place.
As the above should make clear, the FDA's shoddy treatment of Juul is not an aberration. The Agency has time and again flouted basic administrative law requirements in denying PMTAs from vaping companies.
Some may claim that the FDA is merely trying to be careful, due to concerns that vaping products pose risks of nicotine addiction and may encourage some to take up smoking. The reality, however, is that vaping products are far-less dangerous than combustible cigarettes, providing consumers with a safer way to consume nicotine and giving smokers a more effective means of quitting (although FDA regulations bar vaping companies from informing consumers of these facts). Moreover, there is growing evidence that restrictions on vaping products can actually increase smoking, particularly among youth. In other words, the FDA's treatment of vaping products is bad for public health.
The FDA's decision to backtrack on Juul under fire is merely the latest example that something is wrong with the way the Center for Tobacco Products is seeking to regulate vaping products. Unless the FDA changes its ways, its legal losses will mount. And in the meantime, public health will suffer.
To get the Volokh Conspiracy Daily e-mail, please sign up here.
Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Comments may only be edited within 5 minutes of posting. Report abuses.
Please
to post comments
The Federals are protecting their Big Tobacco clients.
Good point.
More denial of reality by the lawyer profession running the FDA and the CDC. It is a nicotine delivery system, using water. The harm of smoking comes from the hundreds of plant by products being burned in cigarettes. Nicotine is addictive, but has some benefits. It is being explored as a treatment for dementia.
Fun-nee (not quite as funny as Jerry “The Nad” Nadler farting on stage), yeah, Alzheimer’s “Control Group” along with “Sleepy Joe” (rim shot)
now that’s Funny, also Sad,
Frank “Deranged, not Demented, there’s a difference”
The Federals are protecting their revenue stream from cigarette taxes. Protection of big tobacco companies is purely incidental.
And the tax revenue from cigarettes.
If these alphabet agencies are to continue then Congress must do it’s job and spell out the exact limits on their powers. Otherwise it is time to start dismantling them and build back better.
Letting them run wildcat and independent serves the corruption nature of those in Congress — why do you think they seek power to begin with — so they can take donations and “donations” to pick up the phone and “ask” the agency to back off a little.
Actually most of it doesn’t even get that far. Congressional corruptions would rather stand there, fist raised over someone else bloody, and then sit back as a line forms, waiting for favor supplications, carrying sealed envelops.
And of course those in Congress who go on to become president then get to unilaterally wield all that power they shifted to the executive
They all violate Article I Section 1, giving all law making power to the Congress. Let Congress read the entire Federal Register into the record each year, and approve it to comply with the constitution.
Congress created those agencies because they don’t want to make those decisions and/or they don’t want to take the political heat for making them.
I fully agree with this. Congress can create an agency, then run to their constituents/donors and say, “see how seriously I take these issues? I’ve voted in favor of an entire department dedicated to the problem.”
Then, when those regulators regulate, they can run to those same constituents/donors and say, “This is terrible how this agency is being run. Elect me to Congress so I can stop this madness.” Meanwhile, we get a series of rules that flip-flop based on who is holding the presidential pen.
We’re moving ever closer to a series of 4-year kingships, where the rules are set by the crown’s decree.
I’m thinking that the recent US Supreme Court ruling against the EPA would be valid if it was also applied to the FDA. I understand that a separate ruling would be needed, but, I think the same principal applies.
What principle is that?
That the FDA has over reached it’s authority by claiming their ability to regulate vaping by defining it as “tobacco products”, when several brands don’t get their Nicotine from tobacco. That should be the job of Congress.
Can you point me to the language in West Virginia that you think sets out that principle?
Perhaps he means that the major questions doctrine is flexible enough to wield against the FDA’s efforts to regulate vaping. Or any other regulatory measures SCOTUS doesn’t like.
Really, vaping isn’t a tobacco product because the law doesn’t specifically say so? What next? Cheese and ice cream aren’t actually dairy products because the law doesn’t specifically say so? Killing somebody by shooting a gun isn’t murder because the murder law doesn’t specifically say so? It’s OK for the president to shoot Supreme Court justices on 5th Ave to create vacancies in the Court because the law against murdering Supreme Court justices doesn’t specifically mention that it’s illegal when the President does it?
It’s water and nicotine, no tobacco at all. And neither one causes cancer (you can get Central Pontine Myelinolysis if you correct the hyponatremia from drinking too much water too fast, and a bad headache/nausea from nicotine toxicity if you smoke a Beautiful St. Luis Rey Serie G Stogie too fast (Yes, the Cigar does have tobacco and its concomitant cancer risk)
Moderation, Moderation (Why I always mix my water with Makers Mark/Angostura Bitters/Orange Peel(for the Vitamin C) and smoke the Cigar slow, (don’t inhale)
Frank
The Congress defined “tobacco product” (in the Food, Drug & Cosmetics Act) as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (Emphasis added.)
By statute, a tobacco product doesn’t need to be delivered from a tobacco plant if it contains nicotine.
Well if a “Woman” can have a Cock, I guess a tobacco product doesn’t have to have tobacco in it.
But the harm to public health may be intentional. It may be viewed as a just punishment for engaging in a vice, and vaping is being attacked as a way of engaging in the vice while escaping its natural punishment.
I mean, the health consequences of vaping, assuming you’re not using black market products, are relatively minor. Basically all the opposition to it is based on viewing it as a pernicious vice, not public health.
Bellmore, there is another reason. Many people who practice addictive habits get quietly aggressive first, and then belligerent if they can’t feed their addictions everywhere and anywhere. A lot of them don’t seem to have any choice about it.
Some folks don’t want to be around that kind of behavior. Some folks find it socially burdensome and unwelcome to have to request that an addict stop practicing his addiction in their company. That accounts in another way for what you think of as priggishness. If you want to reply, please try to do it without quiet aggression or belligerence.
Given impositions which addictions inflict on everyone, I am at a loss to understand why business models to create more addicts have to be tolerated. Where is the long-term upside?
Depends on the addictive drug, doesn’t it? If you’re addicted to a depressant, an opiate for instance, your brain up-regulates activity to compensate, and you get hyper if you’re deprived.
But, if you’re addicted to a stimulant, your brain down-regulates in response, and if you’re deprived you instead get sluggish. Like so many people before their morning coffee. The effect of caffeine consumed this way is so delayed, that you hardly associate the withdrawal symptoms, (Sluggishness, headache.) with the drug, at all. You just wonder why you’ve got a headache, and take an Excedrin to cure it. (Contains caffeine in addition to a pain reliever, because most headaches are caffeine withdrawal symptoms!)
Nicotine is a stimulant, it’s largely indistinguishable from caffeine in effect, (Or for that matter, cocaine.) except for the dosing. The reason it’s more addictive than caffeine is that when you smoke, the drug concentration in your blood goes up REALLY fast, allowing for your brain to more efficiently associate the positive effects with the drug in a conditioning sense. The faster the ‘hit’, the more addictive a drug is. If it were typically consumed in a beverage, it wouldn’t be any more addictive than caffeine, adjusted for dosage.
Of course, since at least one vaping company used nicotine derived from egg plant, using the argument that the FDA can control vaping because they use tobacco looks weak.
I’ve wondered about that since the FDA made the decision that vaping is a tobacco product. Is there any reasonable chance that could get thrown out and they FDA would have to ask Congress to pass the legislation?
Define reasonable chance. There is a non-zero chance of that, but I wouldn’t know how to quantify it beyond that.
I’m not sure that helps, then they start regulating the nicotine as a drug and ban it completely.
But wouldn’t that be the significant kind of change that even the FDA could understand requires explicit legislation? Unless current law allows it, though I thought it only mentioned tobacco itself.
The 5th Circuit was an injunction not a final decision (can’t find if there is a final decision).
As you noted, the 6th Circuit refused to stay the FDA’s denial of the vaping product application.
For Turning Point Brands, even though the FDA rescinded the PMTA denial, I don’t see that they’ve completed their review and approved the product(s).
And with the DC Circuit, again, that’s just an injunction and (again apparently), no final decision has been made.
Until there are final decisions I don’t see where there is , “. . . something is wrong with the way the Center for Tobacco Products is seeking to regulate vaping products.”
There most definitely is something wrong with it, it only remains to be seen if the courts will agree.
Yet another example of an agency with no intention of serving the public.
Eliminate the FDA
But, according to the people that were angry at the EPA decision we simply must defer to these agency experts. There’s no way anyone else has the expertise that these experts expertly wield.
If an arguably beneficial industry needs to be expertly destroyed to satisfy someone’s agenda we need to stand aside and let them do their experting. Anything else is fascism.
Instead of strawmanning, why not engage with what Chevron actually said? Or what critics of West Virginia actually wrote.
The Federal Death Administration is just doing its job as it has for the last six decades, killing as many Americans as it can without actually inciting a public rebellion, in order to reduce the costs of Social Security and Medicare.
(No, really, look at the FDA’s behavior and try to come up with a better explanation.)
Incompetence alone suffices. Add in the natural innate desire of bureaucrats to expand their fiefdoms and protect their pensions.
Malice is unnecessary, and implies competence.
“Malice is unnecessary, and implies competence.”
No, malice does not imply competence. Malice and incompetence are in no way mutually exclusive.
Well then — malice and intent require competence to accomplish the intent. Malice without competence is just flailing.
The kind of competence necessary to fulfill malicious intent is often different from, and I would argue typically less than, the kind of competence required for effective administration of government.
I would use the analogy of explosives: It’s easier to blow up a bank vault in a robbery than to perform controlled demolition of a building. As a more direct example, it’s easier to embezzle money (disregarding the prospect of getting caught) than to accurately predict economic trends.
What is it, with the Biden Administration and the APA? The APA has been on the books for a long time.
The Constitution has been on the books for a long time, too.
First you start out following the rules.
Then you get restive, and start looking for clever work-arounds to accomplish ends you’re not supposed to be pursuing.
Then you get sloppy with your work-arounds.
Then you get the Courts to say, “No point in enforcing this rule, since he can accomplish the same thing in another way, mindlessly enforcing it is pointless.”
Then, finally, you arrive at the point where when people remind you there are rules, you get mad and tell them they’re crazy.
The Biden administration is at step 3, working on step 4.
It’s most likely just incompetence. But your story is much more exciting.
You think the Biden admin has had particular trouble with the APA compared to past admins? I’m not sure that’s true.
The Trump administration mostly had “You have to follow the APA to stop this policy of not upholding the law!” problems, the Biden administration had APA “You have to follow the APA to start doing something that’s got nothing to do with upholding the law!” problem.
They ARE both APA problems, though.
One admin breaks the APA for good, but the other for evil.
Do you realize what a parody of an empty partisan that sounds like?
Partisan, yes. Empty, no. The Trump administration got in trouble for violating the APA in the process of changing policies of NOT enforcing laws, to start enforcing them. Biden gets in trouble for violating the APA in the opposite direction.
As the APA is just about process, not substance, both were violating the APA, legitimately. Biden’s problems are more in the nature of violating his “take care” constitutional duty than Trump’s were, but that’s not an APA relevant distinction.
You are repeating your own subjective views of what each admin did a second time. Does not make them more correct.
Suffice to say your views of enforcement and rule of law are not universal, including lots of courts.
We need “Medical Nicotine” Legislation!!!!!
As a parent of a smoker, I encouraged my son to switch to vaping, which he did, now after a couple of years vaping he’s started to taper off that.
The FDA is nuts, or has a completely different agenda than the health of smokers who are trying to quit.
OTOH vaping leads to higher teen nicotine use
https://jabberwocking.com/vaping-leads-to-higher-teen-nicotine-use/
Yeah, so? Nicotine itself is fairly harmless, it even has established beneficial effects. Tobacco, OTOH, is horrible; Even routinely handling the leaves can cause medical problems, it contains potent carcinogens even before it’s burned.
So, of course the FDA is going to force people using nicotine to consume it mixed with tobacco; Why not? It’s not like they’re trying to safe lives or promote health, they just want to discourage vice.
The FDA taking issues with a highly addictive substance whose full health implications are not well understood seems well within their reasonable ambit to me.
Calling it ‘taking issues’ really raises the abstraction level, to avoid addressing my point. Sure, it’s in their ‘ambit’.
And it’s them doing rather decisively the wrong thing, within their ambit.
The FDA could reasonably seek to diminish smoking. It also could reasonably seek to diminish vaping.
Smokers are dumber and more ignorant than vapers, but vaping is not the conduct of a smart, informed person either.
Dumb Smokers? you mean like Bitter Klinger Barry Hussein O??? “The Smartest Man Sleepy Joe knows” Hunter B??(Hunter Smokes, just Crack, not Tobacco)
So how many packs do you get for giving a (redacted) to your “Betters” at https://www.cor.pa.gov/Facilities/StatePrisons/Pages/Greene.aspx
“Reverend”?
Frank “Still Smokin’ (when I can’t get Edibles, hey Man! I have Glaucoma!)
“The FDA is nuts, or has a completely different agenda than the health of smokers who are trying to quit.”
These things are not mutually exclusive.
The FDA is nuts and has a completely different agenda than the health of smokers who are trying to quit.
The notion seems spurious that public health can be advanced by renewed empowerment for addictive product business models.
C’mon Man!!! the Addicts are just gonna get their fix somewhere, just set up free Cigarette dispensing clinics, along with lighters and ashtrays, like they do with the Heroin….
Hi, friend. I think I can give you some advice on how to improve your condition. Since I order weed online regularly and I like it, you should try this product too. There is a very good online store https://westcoastsupply.cc/cheapweed-buy-cheap-weed-online/ they have fast shipping, great prices and high-quality product. This is what I like most about this store.