Fifth Circuit Grants En Banc Rehearing to Challenge to FDA Rejection of Vaping Products

Another potential legal setback for the FDA's attempt to regulate electronic cigarettes as tobacco products.

Today the U.S. Court of Appeals granted rehearing en banc in Wages and White Lion Investments v. Food & Drug Administration, in which a vaping company (Triton Distribution) is challenging the FDA's rejection of its product applications. This could indicate the Fifth Circuit is poised to deliver a substantial legal setback to the FDA.

This case has some history. In October 2021, the Fifth Circuit granted Triton's application for a stay of enforcement after the FDA initially refused to approve its vaping products. In a forceful opinion, the panel majority accused the FDA of a regulatory "switcheroo" because the agency changed its standards for how it would evaluate vaping product applications in the midst of the process. How the FDA handles and assesses such application is important because vaping products that contain nicotine cannot be sold in the U.S. without FDA approval (because the FDA has "deemed" such products to be "tobacco products" under federal law).

A subsequent panel of the Fifth Circuit upheld the FDA's rejection of Triton's applications on the merits, over a forceful dissent from Judge Edith Jones. Not only was this decision in tension with the prior panel decision granting Triton a stay, it was also at odds with that of the U.S. Court of Appeals for the Eleventh Circuit, which found fault in the FDA's approach in a parallel case. That the Fifth Circuit wants to rehear this case en banc suggests more than a few judges on the court are concerned with the how the FDA has been handling vaping product applications, and there is good reason for that.

In addition to the issues raised in this litigation, there is increasing evidence that the FDA's approach to vaping and other tobacco products is ad hoc and more political than scientific. A recent external evaluation of the FDA's tobacco regulatory program (which the FDA itself commissioned) was highly critical of the program's dysfunction.

A firm rebuke from the en banc Fifth Circuit would be an additional wake-up call to the FDA that it needs to reorient its approach to non-combustible nicotine products. The FDA acknowledges that non-combustible products (like electronic cigarettes) pose less risk than combustible cigarettes, and yet since the FDA began regulating vaping products, public understanding of the these relative risks has actually gotten worse. Insofar as the FDA regulation of such products is supposed to advance public health, it is failing.

The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. Food & Drug Administration in May.

Comments

[Longtobefree]

Nice case to have going on when the House of Representatives is looking to cut federal expanses.

[Longtobefree]

OK, cut federal expenses.
But the Freudian slip was to good to just edit - - - - - - -

[I Callahan]

IANAL, but what does cutting federal expenses have to do with the subject?

[Kazinski]

"substnatial legal setback"

I don't know what that is but it sounds bad.

[AmosArch]

I've given up trying to figure out why some of the same authorities and people who are chomping at the bit to loosen every restriction on weed; persecute tobacco and nicotine with equal vigor.

[Á àß äẞç ãþÇđ âÞ¢Đæ ǎB€Ðëf ảhf]

I don't really (want to) believe it, but keeping the tobacco companies healthy to keep paying those sweet taxes and legal settlements seems like the most obvious answer. Nothing else even comes close. It sure isn't prudery.

[Krayt]

Some years back, Juul, a vaping company 50% owned by a tobacco company (I haven't checked lately) ran ads about being socially responsible, removing its product from tens of thousands of "normal" stores, put up posters in other stores, and so on.

This was an attempt, not to fend off regulatory burden, but stir the pot to increase it, by increasing background noise and "common knowledge" of vaping dangers.

At the exact same time, a Republican senator from a tobacco state introduced legislation to restrict vaping. I hypothesized the company was actually deliberately pulling regulatory burden onto itself...and others...rather than trying to fend it off by seeming to appear responsible.

Tobacco paid its dues, everything else from here on out is gravy.

[Brett Bellmore]

They spent a fortune on that "attack us" advertising campaign, too. A streaming service I was getting free anime from would have several long anti-Juul adverts in just a half hour segment, and they were incredibly annoying to anyone who had the slightest actual understanding of the topic.

[Stephen Lathrop]

The FDA acknowledges that non-combustible products (like electronic cigarettes) pose less risk than combustible cigarettes,

Nonsense. Combustible cigarettes which are on the way out will, long term, prove far less risky than a policy to establish a new, burgeoning industry based on addiction-based marketing. Leaving health concerns completely out of it, economic harms suffered by addicted customers will prove harmful enough to warrant banning new non-combustible addictive products.

A society struggling with impacts of existing addictions is trouble enough. Even classically libertarian arguments become paradoxical when the subject turns to creating addiction for profit. Established addicts cease to feel free to make personal choices to give up their addictions, which many say they would do if they could.

[Á àß äẞç ãþÇđ âÞ¢Đæ ǎB€Ðëf ảhf]

Prohibition has never been tried before, so that sounds like a plan.

[Stephen Lathrop]

The Prohibition analogy would apply if the proposal was to ban combustible cigarettes. It does not apply to regulations which might still be used to prevent growth of a new addiction-based marketing scheme.

[Á àß äẞç ãþÇđ âÞ¢Đæ ǎB€Ðëf ảhf]

I think someone has a different concept of how to prohibit things. Hint: the $200 ATF fee on odd guns was not a tax scheme.

[Michael D]

Stephen, it is not your business nor that of any other busybodies to decide what I or anyone else choose to ingest. My body is mine and if you think you have some form of control over it, just admit you accept the premise upon which slavery is justified: namely that self ownership does not exist.

[VinniUSMC]

Nonsense.

The only thing SL is capable of.

[Currentsitguy]

For those of us who used to to kick the real deal vaping has been a godsend. The 90%+ reduction in harm I got from kicking a 28 year 4 pack a day habit can in no way be construed as a bad thing.

I honestly think we should be taking the UK approach by prescribing these things to those who struggle with quitting, and more importantly end the stigma of their public use. They pose zero harm to those around them.

[Dilan Esper]

Nonsense. Combustible cigarettes which are on the way out will, long term, prove far less risky than a policy to establish a new, burgeoning industry based on addiction-based marketing. Leaving health concerns completely out of it, economic harms suffered by addicted customers will prove harmful enough to warrant banning new non-combustible addictive products.

A society struggling with impacts of existing addictions is trouble enough. Even classically libertarian arguments become paradoxical when the subject turns to creating addiction for profit. Established addicts cease to feel free to make personal choices to give up their addictions, which many say they would do if they could.

Stephen, you could not be more wrong.

First, there’s no doubt that vaping is safer than tobacco. No doubt. The major cause of cancer and lung disease is all the “tar”- the various chemicals contained in tobacco smoke. The whole point of vaping is it doesn’t contain all that stuff.

Second, the fact that people enjoy vaping is A GOOD THING. Seriously, it’s VERY IMPORTANT that society designs safe ways to enjoy things that people want to enjoy. Vaping is an enormous breakthrough, allowing people who draw pleasure from nicotine to do so. Pleasure is a good thing. Your position is similar to the Puritans- you are upset that someone, somewhere, might be having fun.

Vaping is the equivalent of better safety devices on bunjee jumping, or safer roller coasters, or better motorcycle helmets. It allows people to do something they enjoy doing with less risk. That is always a good thing.

3. EVERYTHING is sold for profit. Sugary and fatty foods are sold for profit. So is gambling. So is alcohol. So is marijuana.

I am sure that you enjoy several “vices” sold for profit. You aren’t Jesus Christ, without sin. And you are probably glad there is someone out there willing to sell you those things.

4. “Addiction” is meaningless unless the thing is unsafe. There’s, indeed, nothing wrong with addiction. I know people addicted to exercise. They go to the gym impulsively, compulsively. But because the addiction isn’t harmful, it doesn’t matter.

THE ENTIRE POINT of electronic cigarettes is to make the addiction less harmful. Again, that’s a GOOD thing. Indeed, opposing making addictions less harmful is immoral– it’s literally homicidal. You are an evil person if you really believe it is better if only the homicidal versions of addictive substances should be available. You are dangerous and you need to reexamine the premises you live your life by.

[Stephen Lathrop]

Vaping is the equivalent of better safety devices on bunjee jumping, or safer roller coasters, or better motorcycle helmets. It allows people to do something they enjoy doing with less risk. That is always a good thing.

No equivalence at all. None of those is a product based on addiction, paid for by the dose. What is your position on the plight of the children of addicts, whose families lack disposable income because the parents' addictions consume the available funds?

[Absaroka]

And here I thought you didn't like analogies!

But since we're making them, what is your position on the plight of the children of drunks, whose families lack disposable income because the parents’ drinking consume the available funds? Is that a good justification for banning alcohol?

Ditto for expensive cars, gambling, old fashioned cigarettes, junk food, etc, etc, etc.

Short of mandated family budgets, how are we going to avoid parents doing financially irresponsible things?

[Stephen Lathrop]

Absaroka, in this instance I rejected the analogy. My following points did not depend on any analogy. Then you replied with a demand for response to a list of lame analogies. No thanks.

[Dilan Esper]

As I said, "addiction" isn't a get out of jail free card for an evil and sociopathic position that essentially involves deliberately requiring that products be more deadly in an attempt to deter addicts.

My position is that we should try to make addictions as safe as possible, because there are always going to be people addicted to stuff. That reduces the harm and keeps more families together. Whereas you would force nicotine addicts to smoke cigarettes so you can murder them as punishment for their pursuit of a pleasure you reject.

[Stephen Lathrop]

Esper, you argue absurdly on both sides of the point. On the one hand, addicts should freely make their own choices. On the other hand, nicotine addicts are utterly trapped and unable to escape their addictions. Your second assertion is demonstrably contrary to fact. There may be exceptions. If so, the focus of public policy cannot reasonably be to cater to the exceptions at the expense of far larger numbers who will suffer harm.

My response is simple. Use public policy to avoid creating a gigantic new industry which will foreseeably promote massive addiction.

[Dilan Esper]

1. A lot of people like nicotine. You thinking they are trapped is both arrogant and clueless. It’s reminiscent of religious right types who think that people who have a lot of sex must be unhappy and lack self esteem.

People don’t need you to rescue them from pleasure. They need you to go away and stay out of their lives.

2. Even if you were right that it was some terrible thing to create a new industry, you are still making an argument that it’s basically OK to murder thousands of people by denying them a safe product because you are personally offended that someone is making a profit.

You are a broken man, Stephen. Take some time off and take stock. Your ideas are dangerous and homicidal, especially when delivered with so much sanctimony.

[Stephen Lathrop]

Esper, you are full of beans. You argue for leaving people free to make their own choices, while insisting they are so shackled to addictions that not to cater to them is murder.

You insist on that despite the fact that massive numbers of cigarette smokers have quite permanently. Where there is cultural support for quitting, it is not uncommon to see entire extended families who all quit, or employee groups in workplaces who all quit.

Are you one of the addicted, desperately insisting that a decision to quit is beyond your capacity? If so, you are committing suicide. And no one is murdering cigarette smokers except tobacco companies.

However much I might care about the fate of addicted smokers, I recognize I am powerless to help them if they refuse to help themselves. And I do not want to help whiny addicts who insist that to make it easier for them, millions of others ought to suffer a costly addiction which almost all of them will eventually regret.

[Absaroka]

It's incredibly ironic that you say you have spent thousands of hours wearing motorcycle helmets, which unless you have some odd kink probably means you spent thousands of hours riding motorcycles, and yet you are objecting to people vaping.

Once you get on your 'I can ban people from doing risky things they like because I know better' high horse, motorcycles ought to be right at the top of the list of things to be banned.

And FWIW, I don't smoke or vape, but do have thousands of hours riding motorcycles. Which is precisely why I don't want people like you making risk/reward decisions on my behalf.

[Michael D]

Now, get rid of the FDA.

Alternatives to regulation can be hard to envision. But the role of the state, if it has one at all, is to protect rights and guard against fraud, not to prevent people from making risky choices. There are many nonstate mechanisms to ensure a safe and effective drug supply. The courts have a role to play here, one that was stunted when the FDA usurped their function in determining where harm or fraud has occurred. Technology to review consumer products is more robust and easier to use than ever, and there are plenty of other industries where private institutions verify and communicate with the public effectively about quality and safety. Without government-granted monopolies and barriers to entry, drugs would proliferate and prices would almost certainly fall, resolving many issues of access.

In short, the FDA is wrong to withhold drugs from the market and wrong to put the government’s imprimatur on them.

[Brett Bellmore]

I've seen studies of the FDA vs similar agencies in the rest of the world. The FDA is much more restrictive, with no advantage, which means they're actually costing us lives with delayed drug approvals.

I guess they dragged their feet on Thalidomide, and they've been milking that one accidental victory for all this time.

We COULD just get rid of them, and pass a law that any drug approved by at least two countries in the EU was automatically approved here. Or something like that.

The only complexity is that a huge amount of new drug development happens here in the US, because we're about the only country that lets drug companies recoup development costs. And the EU might try to leverage such a law for other advantages, of course.

[Currentsitguy]

Most of the claims made by the FDA are laughable, particularly those that purport sweet flavors are designed to attract children. Have you looked in people's grocery carts recently? Have you looked at the size of people? Have you looked at other people's tables at a restaurant lately?

[Stephen Lathrop]

Your comment seems to elide answering the question whether sweet flavors are more effective at recruiting underage nicotine addicts. You show no awareness of the tactics used for decades by the nicotine addiction industry to recruit children during adolescence, when they can be reached by exploiting poor judgment and social insecurity which will not be as common later.