Deeming News: FDA Responds to the Vaping Legal Challenge

A busy week in court also sees three new amicus briefs filed

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Court

Several documents were filed in the Nicopure Labs/Right to be Smoke-Free Coalition lawsuit in the US District Court in Washington last week. Most importantly, the FDA responded to the challenges with its own motion for summary judgement, an answer to their motions. The plaintiffs will now have until August 26 to respond to the FDA motion.

Three additional amicus briefs were also filed, one from Clive Bates and 15 other supporters of vaping as a reduced-risk option for smokers, another from the Vape A Vet Project supporting the plaintiffs, and one from the Campaign for Tobacco-Free Kids and seven other groups in support of the FDA.

The FDA responds: motion for summary judgement

FDA

"Significant risks to the public health"

The FDA’s arguments are summarized in the motion’s introduction, which addresses the challenges in the Nicopure and R2B complaints and explains why FDA has chosen to regulate e-cigarettes.

The FDA dismisses the existence of millions of ex-smoking vapers as “scant evidence,” while recognizing Stanton Glantz’s widely disputed conclusion that e-cigarettes “inhibit cessation” as “some evidence.” It refers to the purported addictiveness of nicotine repeatedly throughout this document, conveniently ignoring its own conclusion that tobacco-derived nicotine in Nicotine Reduction Therapy products like gum and patches doesn’t “appear to have significant potential for abuse or dependence.” The assertion that nicotine “impairs brain development in youth” is debatable too. That idea is based only on a rodent study.

The Court should reject Plaintiffs’ suggestion that e-cigarettes are somehow so unique among tobacco products that they should escape regulation of these known risks.

They raise the issue of explosions, a “problem” that is only known from scattered anecdotal reports, and which would not be remedied by anything proposed in the deeming regs, except for the outright ban that they know will be the ultimate outcome of the rule. And they make the claim that candy-flavored liquids “appeal to youth” — a piece of tobacco control orthodoxy that regulators feel free to state without evidence whenever the urge strikes.

The FDA states that the plaintiffs don’t acknowledge health risks. However, neither complaint (the original suits by Nicopure Labs and the Right to be Smoke-Free Coalition were combined, but attorneys for both plaintiffs are arguing their complaints separately) makes health claims, or challenges the FDA’s dubious health justifications in the deeming rule. It’s disingenuous of the agency to imply that risks aren’t acknowledged when the challenges aren’t based on health benefits. But because health benefit claims aren’t part of the Nicopure and R2B suits, the FDA’s health risk claims may not be challenged in court, at least in this court proceeding.

"The Court need not sift through this evidence"

The Tobacco Control Act makes deeming a necessary precondition to any regulation under the Tobacco Control Act. The FDA could, of course, choose to create a new class of product and regulate e-cigarettes by themselves. However, the FDA doesn’t want to do that.

The Court need not sift through this evidence, however, because Congress entrusted the decision whether to supervise tobacco products, including e-cigarettes, to the expert judgment of the FDA. There can be no doubt that “the FDA has authority under the Tobacco [Control] Act to regulate e-cigarettes,” as the D.C. Circuit held in Sottera, Inc. v. FDA, 627 F.3d 891, 897 (D.C. Cir. 2010), and Plaintiffs cannot escape that conclusion simply because their “open-system” e-cigarettes are refillable. It is equally clear that the FDA’s exercise of the deeming authority is committed to agency discretion, given that Congress authorized it to subject “any” tobacco product (except certain raw tobacco leaf) to the Tobacco Control Act as it “deems” fit. 21 U.S.C. § 387a(b). In any event, the FDA rationally explained why it deemed e-cigarettes subject to the Tobacco Control Act, given their many known risks, as well as why it rejected the regulatory alternatives that Plaintiffs prefer. While Plaintiffs fault the FDA for adopting a “one-size-fits-all” approach, the Tobacco Control Act makes deeming a necessary precondition to any regulation of e-cigarettes—including the age restrictions that Plaintiffs profess to support, Stamler Decl. ¶ 41—and Plaintiffs offer no statutory support for their alternative, à-la-carte approach.

There is likewise no basis to review the FDA’s cost-benefit analysis, as the Tobacco Control Act requires no such analysis, and the Executive Orders under which the agency acted expressly preclude judicial review of its conclusions. Regardless, the FDA reasonably found that the costs of the deeming rule—an estimated $2 per beneficiary per year—were justified by its benefits, including more accurate labels, effective health warnings, and improved product consistency. Similarly misplaced are Plaintiffs’ criticisms of the FDA’s regulatory flexibility analysis, as the agency fully complied with the purely procedural requirements of the Regulatory Flexibility Act.

- FDA Motion for Summary Judgement

The FDA seems to be saying that the court has no standing to review the cost-benefit analysis because the FDA wasn’t required to do one at all, and also the court is forbidden to review any analysis anyway. That may be true. But why would they bother doing a cost-benefit analysis if they knew it wasn’t required?

"The Court should reject Plaintiffs’ suggestion"

Absent the deeming rule, the FDA cannot require e-cigarettes and e-liquids to have accurate labels. It cannot require warnings about their addictive potential. It cannot require that toxic and carcinogenic chemicals be reduced or eliminated. It cannot require that these products be made in accordance with good manufacturing practices. It cannot verify that purportedly “modified risk” products do, in fact, reduce risk. And it can do nothing to prevent risky products from falling into the hands of youth. The Court should reject Plaintiffs’ suggestion that e-cigarettes are somehow so unique among tobacco products that they should escape regulation of these known risks.

Can’t the FDA require accurate labels, demand dangerous constituents be eliminated, and mandate good manufacturing practices without forcing existing products to prove that they are a net benefit to public health — a standard that may not even be possible to meet? Why can’t they regulate ingredients and create lab standards for liquids, outline electronics safety guidelines, and prohibit sales to minors without demanding each product go through a byzantine maze of bureaucratic processes to be approved?

They claim repeatedly that the Tobacco Control Act forces them to regulate e-cigarettes within the same framework as actual tobacco products. If the court agrees with that, we will have to convince Congress to amend the Act, which will be a long, onerous process.

The European Union’s Tobacco Products Directive (TPD) is an awful piece of regulation, with its pointless limits on nicotine strength and bottle size. But it’s a walk in the park compared to the bizarre and intentionally discouraging (and perhaps impossible) set of standards that the FDA has created. At least the EU recognizes that this is an adult consumer product that needs basic safety and purity standards. The FDA instead has created a million-dollar lottery for approval no one is certain will ever be granted.

The Campaign for Tobacco-Free Kids amicus brief

Same Old

The Campaign for Tobacco-Free Kids (CTFK) amicus brief is supported by a who’s who of organizations that have declared a misguided war on vaping, including the American Academy of Pediatrics, the American Cancer Society Cancer Action Network (ACS’ lobbying arm), the American Lung Association, and the American Heart Association.

The brief regurgitates all of the FDA’s supposed reasons for strictly controlling the vaping industry. No surprises there. However, CTFK raises an interesting point.

The legal issue before this Court is not whether e-cigarettes, if properly regulated and used by smokers who otherwise cannot or would not quit smoking, might or might not reduce their risk of disease. Rather, the issue is whether the Deeming Rule is a rational regulation based on the current state of scientific knowledge about the individual and population-wide risks from e-cigarettes.

- FDA Motion for Summary Judgement

Is that the issue? Because, if it is, the scientific knowledge the FDA used as its basis for regulating was relatively slim. Their argument still boils down to “we just don’t know enough.” CTFK acknowledges as much.

Nor does the scientific uncertainty about the scope and severity of the public health impact of e-cigarettes undermine the Deeming Rule. It is precisely the uncertainty that exists today that makes FDA‘s assertion of jurisdiction over e-cigarettes, including the requirement for premarket review, reasonable and appropriate under the APA and consistent with Congress‘s decision to make protection of the public health the TCA‘s central objective. In short, the presence of nicotine in e-cigarettes, the potential presence of other harmful or potentially harmful substances in e-cigarettes, and the growth of the e-cigarette market demand meaningful regulatory oversight. The Deeming Rule more than meets the test of rational agency decision making under the APA.

Is not knowing a reasonable justification for destroying an industry and sending perhaps millions of vapers back to smoking cigarettes?

CTFK relies heavily on survey data showing the recent spikes in vaping by teenagers. But they conveniently gloss over the evidence that most of the kids in those surveys who report previous-30-day use may not have used it more than once in the last 30 days. And they skip the Monitoring the Future survey that showed only 20 percent of high school vapers reported using nicotine.

The Clive Bates amicus brief

The Clive Bates amicus brief was signed by 16 respected supporters of tobacco harm reduction from eight countries. The amici include experts in law, policy, science and medicine — united in the belief that reducing the health risks in nicotine use would be a benefit to public health.

The argument they make is that e-cigarettes could be a dramatic boon to public health if smokers use them as a substitute for cigarettes. However, the FDA’s deeming rule will have unintended consequences that will prevent uptake by smokers and continued use by vapers, actually hurting public health. They argue that the FDA’s cost-benefit analysis completely ignores the unintended consequences, and doesn’t attempt to quantify the damage done by discouraging smokers from switching to vaping.

Bates attacks the five claims made by the FDA to justify the deeming rule, dismissing them one by one with impressive and elegant arguments.

Claim 5: “other institutional changes, such as FDA monitoring of product developments and changes and required ingredient listings, which will enable FDA to propose more informed regulations appropriate for the protection of the public health.”

Response 5: FDA’s burdensome and time consuming PMTA is required for every significant new innovation. In this way, from 8 August 2016, the Deeming Rule creates a de facto block on new innovations that would benefit health. Such innovations may come in two forms: (1) improvements to the safety of the device itself such as temperature control, changes to coil design, new liquid formulation, better refilling mechanisms or other safety features; and (2) improvements that make the product more attractive to smokers and thereby promote switching from high-risk to low-risk nicotine use. Such innovations may relate to ease-of-use (especially important for novices) or convenience (for example small forms based on new batteries).

- Clive Bates amicus brief

Clive Bates is a longtime proponent of reduced-risk nicotine products, and has been one of the most influential fighters for vaping. His resume is almost too long to summarize, but he is the former head of the UK’s Action on Smoking and Health (ASH), and now runs Counterfactual, a public interest consulting firm. He may be the most eloquent defender of e-cigarettes anywhere.

The Vape A Vet Project amicus brief

The amicus filing from the Vape A Vet Project is focused on how the deeming regulations will hurt members of the military by restricting access to vapor products. Specifically, the brief takes aim at the free sampling ban, which they say will interfere with the Project’s mission to provide starter kits and e-liquid to active duty military member and veterans at no cost.

The Vape A Vet Project is a registered 501c3 charity. The organization’s primary goal is to provide active and former service members with the equipment and knowledge necessary to switch from smoking to a vaping at no cost to them.

Who will the court listen to?

Hearing

I’m not a lawyer, and I can’t pretend to understand how Judge Amy Berman Jackson will interpret the evidence. Reading the FDA motion was discouraging. The FDA attorneys seem to have answers to each challenge brought by Nicopure Labs and the R2B Smoke-Free Coalition, and the detail in their motion is impressive.

However, if the FDA is correct that Congress gave them the power to regulate “tobacco products” regardless of proven health risks, why have they bothered detailing the feared health consequences? If the Tobacco Control Act requires no cost-benefit analysis, why did they do one? The Campaign for Tobacco-Free Kids brief seems to agree with the anti-deeming briefs that this will be a contest partly based on the current scientific evidence.

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Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Samuel Ciraulo

    There should be next to no regulations for any vaporizers be it the tank, atomizers, clearomizers, batteries, drip sets, electronic interfaces, software or any E liqs.
    These regulations are criminal in nature for they are literally going to choke the vaping industry out of business and close down thousands of stores across the country.
    These ridiculous regulations will also shut down new vaping innovations and the advancements in vaping technology.
    This is insanity and the FDA is obviously being paid off by Big Tobacco and Big Pharma because they are both going to lose major income when fewer and fewer people are buying Tobacco products and thus fewer and fewer people are getting COPD, cancer and other issues caused by Tobacco.

    This is a disgusting display of false preconceptions. This is horrendous.