Notice & Comment

The FDA’s Big (?) Announcement on Nicotine Regulation

On Friday, the FDA made an unexpected announcement that it was unveiling a “comprehensive regulatory plan” to reduce tobacco-related disease and death. The announcement was surprising in part because the Trump Administration had recently unveiled its Unified Regulatory Agenda, which emphasized deregulation and did not identify any significant planned tobacco-related action.

So what does this plan entail? Announced by Dr. Scott Gottlieb, the new FDA Commissioner, and Mitch Zeller, Director of the FDA Center for Tobacco Products, the FDA’s new approach to tobacco regulation contains three elements, which I’ll address in turn:

  1. Moving towards lowering nicotine levels in cigarettes.
  1. Delaying compliance deadlines for e-cigarettes and other “newly deemed” products.
  1. Inviting comment on additional issues, including menthol and premium cigars.

Nicotine Reduction in Cigarettes

The headline-grabber was that the FDA is considering lowering nicotine levels in cigarettes to “minimally-addictive or non-addictive levels.” As Commissioner Gottlieb emphasized, nicotine makes cigarettes addictive, but it is the byproducts of combustion that make them deadly. Accordingly, making cigarettes less addictive—and encouraging current smokers to obtain nicotine from less harmful sources (or to quit entirely)—has long been recognized as holding tremendous public health promise. And the 2014 Surgeon General’s Report noted that “[t]he technical, social, medical, and regulatory feasibility of this concept continues to grow quickly.”

But it’s important not to get ahead of things. What Commissioner Gottlieb announced was not a proposed rule. Nor was it even a detailed plan (or even the outline of a plan) for moving towards nicotine reduction. In the Commissioner’s own words, he was simply “directing [the] Center for Tobacco Products to develop a comprehensive nicotine regulatory plan.” This is obviously a very, very preliminary step towards an hypothetical future rule, and there were no target dates provided.

Furthering the conversation on nicotine reduction is welcome—and the FDA should be credited for bringing attention to the issue—but some of the breathless headlines go way too far. The wheels of the FDA’s rulemaking process turn slowly even under ideal circumstances. And there is no question that a rule to make cigarettes non-addictive (or minimally-addictive) is one that the tobacco companies will put their whole weight (and financial might) behind defeating. From their own documents, we know the tobacco industry has long been aware that “the primary motivation for smoking is to obtain the pharmacological effect of nicotine.” Cigarettes remain the core of their business, and—despite words to the contrary—all of their actions suggest they will not cede the cigarette market without a drawn out fight (that will end up, ultimately, in the courts). Indeed, at the moment, the industry is mobilizing to fight restrictions on the sale of menthol cigarettes—another public health policy it (correctly) views as a threat to its cigarette-driven profits.

In short, the FDA’s announcement is welcome, but no one should be lulled into expecting that action will come quickly or easily.

(One additional note on this point: Troublingly, some of the language in Commissioner’s speech suggests that the tobacco industry will have a prominent seat at the table as nicotine reduction is discussed. This is a bad idea, for reasons clearly outlined by the World Health Organization, and it will further delay any potential progress towards a nicotine reduction rule.)

Delayed Compliance Dates

Part two of the FDA’s announcement was that the FDA has delayed deadlines to submit product review applications for “newly deemed” products until 2022 (for electronic cigarettes) or 2021 (for newly regulated combustible products including cigars, pipe tobacco, and hookah).

The regulatory background here is messy (more detail in my article here). The short version is that last year, the FDA issued a “deeming rule” extending its regulatory authority to any product meeting the statutory definition of a “tobacco product.” (Previously, it regulated only cigarettes, smokeless tobacco, and roll-your-own tobacco.) Under the terms of the 2009 Tobacco Control Act, any “newly deemed” product must demonstrate that it is a “substantially equivalent” to a product that was commercially marketed in 2007 (which will be difficult for e-cigarettes), or it must prove that allowing its sale would be “appropriate for the protection of the public health.” If it cannot make such a showing, then the FDA, under the statute, should not authorize its sale.

In the final deeming rule, such product applications would have been due in 2018, with products permitted to remain on the market for up to a year while the FDA reviewed the applications. Now, the deadlines have been pushed back by four years for e-cigarettes, and Commissioner Gottlieb suggested that those products would be allowed to stay on the market until the FDA ruled on their applications – which could be many years longer.

This delay was likely calculated to stave off congressional action and lawsuits that could have limited the FDA’s authority, but is nonetheless deeply problematic.

To back up, if you are going to limit nicotine levels in cigarettes, having less harmful nicotine-containing products that appeal to current smokers is a necessity – and e-cigarettes have been proposed as likely candidates. But as noted above, nicotine reduction is not coming anytime soon. So the question is how e-cigarettes should appropriately be regulated in the meantime.

While e-cigarettes are certainly less harmful than cigarettes (likely—though not certainly—far less harmful) on a product-to-product basis, there is plenty of reason to be concerned that they are creating additional public health harms. This is because is seems to be the case that (a) the majority of people using e-cigarettes are also smoking, not using e-cigarettes instead of smoking; and (b) youth are experimenting with e-cigarettes and then progressing to more harmful combustible cigarettes. E-cigarette advocates contest both of these assertions, but the point of regulation is to sort out the conflicting evidence. If manufacturers believe that their products are not causing these harms, then they should be required to demonstrate that to the FDA.

Oddly, the FDA frames this delay as a way to “encourage innovation.” But that is nonsensical. The delay only applies to products that were on the market as of August 8, 2016. After that date, any new product cannot be sold until in undergoes premarket review by the FDA. As press reports have noted, the FDA’s announcement provides a “reprieve” to e-cigarette companies that were worried they would be unable to comply with the FDA’s requirements – but it does nothing to encourage innovation. (Even more so, the delay for the review of combustible products–cigars, cigarillos, hookah, etc. — lacks any plausible public health justification.)

So what is really going on here? As I have written (along with colleagues from the Public Health Law Center), the FDA’s premarket review process has been, to put it generously, a mess. Director Gottlieb, in his remarks, called for a “transparent, predictable, and sustainable” premarket review process, and I could not agree more. But is inexcusable that the FDA has yet to stand up such a process; it could and should have prepared to review product applications during the five years it was working on the deeming rule. I suspect that the FDA was nearly as eager for a delay as the industry, because it was not ready to handle the onslaught of product applications that would have come later in the year. Now the can has been kicked down the road a bit further.

It is also worth noting the problematic role of Commissioner Gottlieb. Before coming to the FDA, he served on the board of an e-cigarette retail chain, and he still held a financial interest in the company at the time he was nominated (and may still). Despite being urged to recuse himself from decisions relating to e-cigarettes, he has declined to do so. While the Commissioner’s belief in the public health promise of e-cigarettes is no doubt sincere, recusal would have been the more appropriate course of action. Instead, he is the face of an FDA announcement that financially benefits e-cigarette companies in a very clear and immediate way, while suggesting the possibility of more aggressive regulation of cigarettes at some undetermined point in the future. This may or may not be a trade-off worth making, but it is unseemly for Commissioner Gottlieb to be the decision-maker.

Inviting Public Comments

The FDA also indicated that it would issue Advanced Notices of Proposed Rulemaking (ANPRMs) to invite comments on (a) the role of flavors—including menthol—in tobacco products, (b) the regulation of premium cigars, and (c) increasing access to medicinal nicotine. There is a lot more to say about all of those topics, but the short version is that the FDA already has all the information it needs on these topics in order to take action. These are not at all new issues. The FDA has already studied the issue of menthol over and over and over again.  It sent the issue to its advisory committee, then issued an ANPRM, then conducted its own review of the science, etc., etc..  Clearly, the FDA has been in no rush to take action.  Likewise, the FDA has already studied (and reported to Congress on) how to ease access to medicinal nicotine.

Re-raising the issue of “premium” cigars in particularly troubling. In the proposed deeming rule, the FDA invited comments on whether and how to regulate premium cigars. In response to extensive comments on the issue, it chose to regulate them like all other tobacco products. There is no reason to reopen that issue – but again, it may be an attempt to stave off congressional interference. Notably, before becoming Commissioner, Dr. Gottlieb—in an article that did not mention any of the health effects of cigars—characterized the FDA’s interest in regulating premium cigars as unjustified regulatory overreach.


In the Trump era—when practically nothing in the way of regulation is expected—it seems almost petty to criticize a government agency that is at least trying to set forth a long-term vision that would benefit public health.

But it is too easy to get distracted by the long-term goal and ignore what the FDA is doing here and now. Reducing nicotine in cigarettes is a worthy vision, but it will require a massive battle with the tobacco industry – and there is no indication that the Administration will ultimately want to go down that road (and good evidence to the contrary). Likewise, rationalizing the product review process will require issuing new regulations – and the Administration has been active in constraining the FDA’s ability to issue new rules.

So what we’re left with is a delay of the regulation of newly deemed products; a delay built on top of the five years it took the FDA to issue the rule. Dr. Joshua Sharfstein, a former FDA Deputy Commissioner, tweeted: “As a package, if @US_FDA can deliver, this is [a] leap forward for public health, but if only reprieve for ecigs advances, could be [a] step back.” That is exactly my fear.

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