Vaping

D.C. Circuit Rejects Challenge to FDA E-Cigarette Regulations

The court was correct to reject most of the arguments, but was too dismissive of the First Amendment concerns.

|The Volokh Conspiracy |

On Tuesday, the U.S. Court of Appeals for the D.C. Circuit turned away a set of challenges to the Food and Drug Administration's regulation of electronic cigarettes and other vaping devices.  Specifically, in Nicopure Labs v. FDA, a unanimous panel held that the FDA's regulation is neither arbitrary and capricious under the Administrative Procedure Act nor unconstitutional under the First Amendment. These conclusions are not particularly surprising, but it would still be premature to conclude the FDA's current regulatory approach does not raise serious constitutional concerns.

The plaintiffs' APA claims never struck me as particularly strong. Before the D.C. Circuit, Nicopure Labs and the Right to Be Smoke Free Coalition did not challenge the FDA's decision to "deem" e-cigarettes and other vaping products to be "tobacco products." Rather, they argued that the FDA acted arbitrarily and unlawfully in not taking the additional step of adopting an easier way for e-cigarettes to obtain pre-market approval form the FDA.

Under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), tobacco products not on the market prior to 2007 will be required to obtain approval from the FDA before they may be sold. Thus, once e-cigarettes were deemed to be tobacco products, they were subject to this statutory requirement. It would perhaps be a good idea for the FDA to facilitate the rapid approval of e-cigarettes, but it's not a violation of the APA for the agency to fail to adopt this course As the court noted, the plaintiffs' "wholesale objection is to Congress' design, not to any arbitrariness on the FDA's part in carrying it out."

The panel also made quick work of the plaintiffs' claim that it is unconstitutional to prohibit e-cigarette manufacturers from promoting their products through the distribution of free samples. Such a limitation, the plaintiffs' tried to claim, violates the First Amendment. As I noted in my comments on the district court's opinion, this argument is a bit of a stretch. A prohibition on free samples is, in effect, a prohibition on the price at which a product may be sold, and is thus best understood as economic regulation, not the regulation of speech, and I would have been shocked if even a single judge on the panel had concluded otherwise.

The plaintiffs' other First Amendment claims, against the prohibition on making "modified risk" claims about e-cigarettes unless and until such products are approved as "modified risk tobacco products" by the FDA, were more serious, and I am not entirely convinced by the courts' dismissal of these claims.

Under the FDA's current interpretation of the Tobacco Act, it is unlawful for an e-cigarette manufacturer to simply inform consumers of things the FDA has itself said about their products, even with a disclaimer. According to the FDA, "the inhalation of nicotine (i.e. nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products," yet an e-cigarette maker could not paste this language on their product package or include it in an ad. Nor could they say that "several studies support the notion that the quantity of toxicants [in e-cig vapor] is significantly less than those in tobacco cigarettes and tobacco smoke and similar to those contained in recognized nicotine-replacement therapies," even thought the FDA has said as much in the Federal Register. And were an e-cigarette maker to say that "there is emerging data that some individual smokers may potentially use ENDS to transition away from combustible tobacco products" (again using the FDA's own words), they would be making a "smoking cessation claim" which, according to the FDA, may only be made once the product in question has been approved as a drug or medical device.

The D.C. Circuit concluded that these prohibitions were fully consistent with the First Amendment. The requirement that e-cigarette makers seek and obtain FDA approval of their products as "modified risk tobacco products" before they can make factually true statements about e-cigarettes and their contents "is reasonably tailored to advance the substantial government interest in protecting the public health and preventing youth addiction." As Judge Pillard explained:

Deliberately selling an e-cigarette as less risky without going through the requisite regulatory review for reduced-risk tobacco products renders the sale-as-labeled unlawful, just as selling saw palmetto extract as a drug without FDA premarket approval was unlawful.

It is true that saw palmetto extract may not be marketed as a drug without prior FDA approval, but prior D.C. Circuit decisions have held that the FDA may not prohibit factual statements about nutritional supplements and the like that fall short of medicinal claims.

In Pearson v. Shalala, for instance (another case concerning the FDA), the court explained that "when government chooses a policy of suppression over disclosure-at least where there is no showing that disclosure would not suffice to cure misleadingness-government disregards a 'far less restrictive' means." This decision is not distinguished in Nicopure Labs. It is not even mentioned.

It's not just D.C. Circuit precedent that is in tension with the Nicopure Labs holding. In Thompson v. Western States Medical Center, the Supreme Court warned that "We have . . . rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information." According to Judge Pillard, however, the Court struck down the limitation on pharmacist speech at issue because the government had failed to identify any basis for its conclusion that warnings or disclaimers would be insufficient to safeguard the government's interest. To me that is an awfully stingy interpretation of that Supreme Court decision.

Congress may have concluded that warning labels or disclaimers are insufficient (though not specifically with regard to e-cigarettes, as they were not on the market at the time the Tobacco Act was adopted. More importantly, is it really the case that a blanket Congressional finding is all it takes to defeat a First Amendment claim?

If restrictions on commercial speech are subject to heightened scrutiny, it would seem that more than a categorical assertion is required to justify the censorship of factually true statements. After all, as the Supreme Court held in Rubin v. Coors Brewing, the government "must demonstrate that harms it recites are real and that its restrictions will alleviate them to a material degree," and no such showing has been made here.  If the FDA had to substantiate the basis for its proposed graphic warning labels for cigarettes, I would think the federal government should have to actually substantiate the claim that indisputably true statements are sufficiently misleading, even when accompanied by warnings or disclaimers, to justify a prior restraint on speech. Apparently not.

The reality is that while the FDA has acknowledged that e-cigarettes are less dangerous than traditional cigarettes, much of the public remains in the dark. And insofar as public perceptions of the relative risks of e-cigarettes affects whether smokers attempt to quit smoking, public misperception as to the relative risk of e-cigarettes cost lives. This does not obligate the FDA to sing the praises of e-cigarettes, or refrain from prudent regulation, but it should counsel against censoring speech that would inform the public – smokers in particular – and potentially save lives.

It is perhaps ironic that this opinion was released the same week as a review essay in Science extolling the potential benefits of e-cigarettes and warning of the dangers of prohibitionist regulatory approaches. In upholding the FDA's actions, Judge Pillard was not content with deferring to the agency's expertise. She instead put the court's imprimatur on specific claims about the relative risks of e-cigarettes that stand in stark contrast to the opinion of some of the nation's foremost health professionals.

From the opening line of the opinion, Nicopure Labs reads like a brief for an e-cigarette prohibitionist group, as if the judges themselves had concluded the e-cigarettes are a threat that must be regulated. To my mind, it would have been better for the court to remain more agnostic on the policy merits of FDA's moves, confining its analysis to the legal merits of the FDA's moves.

I understand the D.C. Circuit's reluctance to invalidate the regulatory scheme for tobacco products Congress created, particularly as such a decision could up-end some aspects of drug regulation as well. But I think it was a mistake to pretend as if public health concerns are indisputably on the side of the FDA's actions and to be so dismissive of the serious First Amendment implications of upholding prior restraints on truthful speech that could save lives.

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  1. “Before the D.C. Circuit, Nicopure Labs and the Right to Be Smoke Free Coalition did not challenge the FDA’s decision to “deem” e-cigarettes and other vaping products to be “tobacco products.” ”

    This whole business of ‘deeming’ that aren’t actually true gives me a headache.

    1. Yeah, when I saw that I couldn’t help wondering about the backstory leading to their decision to not challenge the “deeming”.

      1. It’s because it would be pyrrhic victory. here is no doubt that as soon as the courts struck down the “deeming” then Congress would start drafting its own regulations, and it would probably end up much worse than the current tobacco products law.

        1. That may be why they didn’t challenge it, but the practice of “deeming” true things that are objectively false is still an outrage.

    2. “Deeming”

      “We live in a nation of laws, not men!”

      “But the law says men may just say stuff and it becomes law!”

    3. Think of it like deeming a gun a weapon. In reality, it’s the bullet doing the damage, the gun just acts as the machine that delivers the bullet.

      1. That would be like deeming that rolling papers are tobacco products, or pipes are tobacco products.

        Sure you can use them for other things (almost exclusively federal contraband), but the vast majority – almost the exclusive uses – are for either tobacco or contraband.

        An e-cig nebulizer, on the other hand, is essentially never used for tobacco. If this was narrowed to only general nebulizers that could use tobacco distillates, or to proprietary models that have tobacco distillates produced that might be one thing, but many of these e-cigs use proprietary vials for which there is no tobacco derivative available anywhere.

        So that wouldn’t even be like declaring a box of matches a tobacco distillates, but declaring an oxy-acetylene rig a tobacco product – sure, with a lot of effort you could make it work, but no one does because it’s idiotic.

        1. And in fact, rolling papers are deemed a tobacco product.

          Now, as for e-cig nebulizers, they are used for tobacco products. Specifically, the nicotine that they deliver is derived from tobacco. IE, it’s a highly refined tobacco that goes into it.

          1. But as I’ve pointed out, that’s like declaring plastic soda bottles “coffee products”, just because some of the sodas are caffeinated, and the caffeine derives from coffee.

            At some point we’ve got to reform the legal system, institute a recognition that, whatever else legal fictions might be, they are fictions. They’d probably be more honestly characterized as legal lies.

            1. There’s a key difference here. Caffeine products aren’t regulated like tobacco products.

              But what you’re really calling for here is a reclassification, whereby tobacco products should be called “nicotine and nicotine use” products, rather than just defining tobacco products as nicotine and nicotine use products.

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  3. The truth is a bit more difficult.

    The Tobacco industry has a long, long history of marketing a slight “safety” improvement on their products, then marketing them as safe or safer when the actual additional level of safety imparted is minimal at best. These include filtered cigarettes, “low tar” cigarettes, “light cigarettes” and so on.

    And yes, there was published research promoting the additional “Safety” of these measures, even by major organizations, like the American Cancer Society. And a couple of studies showed very modest gains. But nothing like not actually smoking. They weren’t actually SAFE. They just showed an modest decrease at the time.

    https://www.rstreet.org/2016/08/18/low-tar-cigarettes-had-merit-said-american-cancer-society-so-do-e-cigarettes/

    So, this debate about e-cigarettes is a repeat of the “ultra-light” cigarette, “low-tar” cigarette, and “filtered cigarette” arguments from before, in the FDA’s opinion. And before being willing to let the tobacco/nicotine companies broadly market an item as “safe” or “low risk”, once again….the FDA wants extensive, regulatory-level studies. Not a few isolated studies. And based on past experience with “safer” cigarette/nicotine options, they’re probably right.

    1. This is the point where you have to distinguish the “tobacco” industry from the “nicotine” industry; While tobacco is the primary source of nicotine, in much the same way as coffee is the primary source of caffeine, both are capable of being marketed apart from the source plant material.

      You don’t treat Mountain Dew’s bottler as part of the “coffee industry”. Why should vaping products have to be viewed as part of the tobacco industry?

      This matters a great deal, because in contrast to coffee, which is largely innocuous, tobacco is a really NASTY plant. Even handling the leaves without ingesting it can cause skin cancer.

      But nicotine, isolated from the other compounds in tobacco, is just another stimulant. Depending on dose and administration route, it’s no worse than caffeine.

      From a public health standpoint, the basis for regulating tobacco is obvious. The basis for regulating nicotine? Not so obvious.

      1. Brett, I think there’s a basis for regulating vaping somewhat based on the other chemicals in the vaping devices,which may be dangerous.

        But don’t let that disagreement, which is minor (and which may not even be a disagreement- you may agree with that for all I know) detract from the fact that I think you have made a great point here.

        Nobody actually believes that the federal government should regulate anything that is addictive. Nobody. Nobody believes that limits should be placed on shopping, chocolate, the quantity of sex (I realize that some want the government to regulate sex in other ways, but nobody is calling for a limit on the sheer quantity of sex someone has, i.e. a regulation of sex addiction), church bingo, etc. Not even the biggest big government liberal or the most socially conservative of social conservatives thinks that way.

        The reason we regulated tobacco so heavily is exactly as you say. Because in addition to the nicotine, tobacco contained all sorts of highly dangerous chemicals that were harmful to health. And once that is true, the nicotine, of course, makes the problem worse, because the harmful substance makes it worse.

        So we regulate tobacco. Not nicotine.

        1. Right, strong case for regulating tobacco. Much weaker case for regulating nicotine, which if not for the historical association with tobacco would probably be on the GRAS list in terms of its effects.

          And while there’s a case for regulating vaping devices as a form of consumer safety regulation, there’s no case for regulating vaping devices, as such, as tobacco.

          Because they’re not, any more than a soda bottle is coffee just because many sodas have caffeine in them that originates in coffee plants.

          1. Right, and that regulation would come from the FTC or the Consumer Product Safety Commission, not the FDA.

            Because the risk would be a defective product, not a drug. At most the FDA might have a role in identifying things that cannot be included in the formula – like THC oil (currently illegal for different reasons, obviously).

          2. Nicotine would never be on the GRAS list. Nicotine poisoning is real, especially with growing numbers of concentrates being sold. The lethal dose for a child is considered to be 10 mg. There have been several reported deaths after nicotine ingestion.

            http://www.inchem.org/documents/pims/chemical/nicotine.htm#PartTitle:7.%20TOXICOLOGY

            1. Caffeine poisoning is real, too. It’s the dose and the administration route that make the poison, many of the compounds on the GRAS list will kill you dead if you take too much. Aspirin, for example.

              It’s a question of whether they’re reasonably safe in the proper dose, not whether you can consume it by the pound without harm.

              1. Water poisoning is real too. The real issue here is how easy it is to take too much. And it’s VERY easy to take too much nicotine.

                Asprin, BTW, is not on the GRAS list, for a number of reasons. You’re confusing the GRAS list with the Generally recognized as safe and effective, which is very very different.

                1. That’s bullshit. Nobody’s dying from chewing nicotine gum. Tons of people are dying from smoking.

                  Moral scolds lie about nicotine being more dangerous than it is because they dislike people who gain pleasure from using it.

            2. As a slight aside:
              Nicotine’s lethal dose is complicated – 10mg is about the nicotine content of a single cigarette.

              It’s also tied up with a LOT of bad science (on both the pro- and anti-smoking sides).
              Here’s a short paper from a few years back:
              How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century

                1. Toddlers can die from consuming all sorts of generally safe substances.

      2. “Even handing the leaves without ingesting it”

        You’re perhaps talking about Green Tobacco Sickness? That’s nicotine poisoning. Just absorbed straight through the skin from raw tobacco.

        Fact is, nicotine is much, much worse than caffeine. Now, you may make claims about “depending on dose and administration route it’s no worse than caffeine”….IE, if you have much lower doses of nicotine, it’s about equal to a much higher dose of caffeine. Dose and route of administration are major contributors to how dangerous something is. Fentanyl is so dangerous BECAUSE it’s effective at such a low dose. If you inj

        Moreover, deliberately inhaling particulates and vaporized liquids is almost never a good idea. Which is basically what vaping is. If I said “here’s some antifreeze, we’re going to vaporize it, the you’re going to inhale it”….what would you say?

        Studies put the risk of early death due to E-cigarettes at about that as chewing tobacco. Which is still not good.

        1. Nope, nicotine isn’t worse than caffeine. Where are all the deaths from Nicorette and Nicoderm.

          You just have contempt for people who get pleasure from activities you think are too risky.

  4. It’s not difficult to trace the line from Thompson v. Western States Medical Center’s invalidation of section 503A’s restrictions on advertising and promoting a particular compounded drug to the New England Compounding Center’s meningitis outbreak that killed over 100 people. Although I agree with the premise that keeping people ignorant lest they make unwise choices is an impermissible purpose for a commercial speech regulation, Thompson is hardly the poster child for that conclusion. Justice Breyer’s Thompson dissent looks persuasive, if not prophetic, to those who survived the outbreak, and to the survivors of those who didn’t.

  5. “ From the opening line of the opinion, Nicopure Labs reads like a brief for an e-cigarette prohibitionist group, as if the judges themselves had concluded the e-cigarettes are a threat that must be regulated.”

    Doesn’t that explain it all?

  6. Implicit in the views of many conspirators is a flat-out challenge to the FDA’s power to control labeling and require approvals of specifics claims prior to marketing. If the Consoiracy would have its way, the FDA might be able to approve marketing, but once marketed would either have no say over what advertising claims are made, or would have to prove claims false (rather than the other way around) in order to do any enforcement.

    I think the Conspiracy has taken the view that a regime in which claims are presumed false and unlawful until proven true (and proven true to the FDA’s administrative satisfaction) is inconsistent with the First Amendment. And that’s the fundamental premise of the FDA’s whole scheme of enforcement.

    1. “Implicit in the views of many conspirators is a flat-out challenge to the FDA’s power to control labeling and require approvals of specifics claims prior to marketing. ”

      Yes, let me make that explicit: The statute creating the FDA didn’t repeal the 1st amendment.

      1. No, it didn’t. And let’s make it abundantly clear. The FDA controls a company’s ability to sell something across state lines (which pretty firmly falls within the commerce clause). They say you can, or cannot sell such an item.

        And you can say whatever semi-legal statements you want about an item you’re selling. But the FDA then has the right to deny you the ability to sell it. You can say your meat is free from insects and mouse crap. But the FDA has the right to inspect it (under the interstate commerce clause) and the right to deny you the ability to sell it, for whatever reasons they choose. For examine, perhaps it is full of mouse crap.

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