FDA’s New Approach to Nicotine Regulation – What’s In and What’s Out

On Friday, July 28th, FDA Commissioner Dr. Scott Gottlieb announced the agency’s new vision for tobacco regulations. As stated, the central driving force behind the proposed shift in policy is the commitment to reduce the harms caused by combustible tobacco use. The most immediately significant part of Commissioner Gottlieb’s announcement is a proposal to extend the deadline for pre-market tobacco approval applications (PMTA) for newly-deemed tobacco products to August 8th, 2022. FDA will issue guidance on the matter soon.

  • Proposed new deadline for submission of PMTA applications is August 8, 2022
  • Compliance deadlines that have already passed are not affected.
  • Future compliance deadlines (here) for warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituents (HPHC) reports, and the removal of modified risk claims are not affected.

Although Friday’s announcement is a clear signal that the FDA is granting the vapor industry a four-year stay of execution, it bears repeating that this is simply a delay. Commissioner Gottlieb included several pressing issues that concern the vaping community, future vapor consumers, and tobacco harm reduction (THR) advocates, all of which will need to be addressed in short order so that 2022 isn’t just another cliff edge.

Proposed regulation of nicotine content in cigarettes

The proposed policy shift for the FDA centers around refocusing the agency’s regulatory efforts to address the “astonishingly addictive” nature of nicotine. Specifically, the FDA is targeting nicotine delivered via smoking and will be considering a rule that would mandate lower nicotine levels in cigarettes. By forcing manufacturers to produce cigarettes that are, in theory, less or non-addictive, FDA speculates that young people who are at risk for initiating smoking will quickly lose interest or, if they go on to become regular smokers, will have an easier time of quitting.

Very low nicotine content (VLNC) cigarettes are not a new idea and this raises questions that stakeholders and public health advocates will need to tackle. Probably the most immediate concern is how consumers will react to lower nicotine levels: Does such a mandate create an underground market for full-strength cigarettes and will smokers just end up smoking more? Appropriately, these questions will be addressed during the rulemaking process.

As the discussion on vapor products moves toward standards-based regulation and given FDA’s notice of intent to seriously consider limiting the nicotine content in combusted cigarettes, it is worth raising the concern now that we will be having a conversation about nicotine limits for e-liquid and possibly smokeless tobacco. Regulations in the EU have already set the precedent which has spilled into policy being debated in Australia. There is little reason to believe that this won’t be part of the discussion in the US going forward.

Proposed regulation of flavored cigars and noncombustible nicotine products

Unsurprisingly, the FDA will be taking a hard look at flavored tobacco and nicotine products, menthol cigarettes, and using the rulemaking process to issue product standards. While much of the discussion around flavors still revolves around the effect on young people, Commissioner Gottlieb has already started to shift this conversation. Most notably, his comments during his Senate confirmation hearing signaled a potentially more enlightened view of the role flavors play in helping smokers transition to low-risk nicotine products. Going forward, it is vital that the agency’s investigation into flavors is framed around what will benefit smokers and vapers the most.

Many, including CASAA, believe the conversation about flavored nicotine products is more appropriately framed as a discussion about marketing. There are nuances when we talk about marketing, most importantly, establishing the boundaries of the first amendment. It should suffice to say that any regulation regarding marketing standards can not be reduced to “I know marketing-to-children when I see it.” However, the standards should not be so strict that consumers are less interested in the products or left largely in the dark about their pleasurable elements.

Consumer engagement on flavor/marketing standards is paramount and cannot be left to agenda-driven researchers. Although there is cause for celebration over the announcement of FDA’s new vision for tobacco and nicotine regulation, policy change is slow, especially when the walls of long-held beliefs are high. Challenging the decades-old narrative that flavors in tobacco (and nicotine) products exist solely to entice children to become addicted is still necessary–now more than ever.

Clear guidance regarding PMTA, MRTP, and SE applications

Since 2009, the pathway to premarket approval for tobacco products has been fraught with uncertainty. This lack of clarity in the FDA’s expectations regarding the information required to successfully bring a product to market or advertise it as lower risk is presenting financial and paperwork hurdles that very few can overcome. Revising the FDA’s guidance regarding the approvals process is a necessary step in creating a regulatory environment where innovation can occur and low-risk products can more easily be sold.

While a PMTA deadline delay is important to keeping low-risk vapor products on the market for the next four years, the temporary reprieve will be all-for-naught if only a few products will be available after August of 2022.

What’s missing from FDA’s announcement

Grandfather Date

Significantly, FDA did not address modernizing the predicate date for newly-deemed products. Although there was mention of revisiting the agency’s backlog of substantial equivalence (SE) applications and the SE pathway, there is no indication, at this time, that Commissioner Gottlieb will be using FDA’s discretion to enforce a modern predicate date. The February 2007 grandfather date is still a massive barrier to innovation and keeping most vapor products on the market after 2022.

CASAA is asking our members to continue contacting their representatives and urging them to support HR 1136. This bipartisan bill is playing a vital role in keeping the conversation about predicate products and the need to modernize the grandfather date alive. Please visit www.august8th.org to take action.

Updated Language

Even though the FDA is signaling that it will be taking an enlightened approach to regulating reduced- and low-risk tobacco and nicotine products, some of the language used to communicate this policy shift is reminiscent of the old tobacco control playbook. Phrases like “for those who need [nicotine]” and “astonishingly addictive” ignore an evolving understanding of how and why people use nicotine. It also ignores the complexities of substance use and perpetuates the misunderstanding that chemical dependency = addiction = harm.

CASAA has long been a proponent of communicating the benefits of harm reduction without using the language of our opponents. Sometimes, appropriating phrases can be useful in lampooning absurd policies, but in a serious discussion about public health strategy, using the language of our opponents has the unfortunate tendency to validate their fact-free claims about harm. If we are truly going to reframe the conversation around nicotine, we need to be thoughtful and vigilant about how we communicate risk. The idea that low-risk alternatives to combusted tobacco exist solely as a means to achieving complete nicotine or smoking cessation is old thinking. Although this idea has its place in discussions about harm reduction, it cannot be the basis of the overall strategy.

Mandating very low nicotine content in cigarettes

The proposal to limit the nicotine content in cigarettes is being presented as a necessary first step in transitioning smokers to low-risk products. In reality, the real first step was taken when the electronic cigarette was invented (of course, prior to the rise in popularity of vaping, smokeless tobacco should have been promoted as a low-risk alternative to smoking). Steps two through three happened when consumers, backyard innovators, and independent manufacturers modified and improved the products that were on the market. All of that to say that the availability of effective and enjoyable low-risk nicotine products has been and currently is the cornerstone of any strategy to reduce the harm of smoking.

What the FDA is proposing, however, is that vapor products need a heavy assist from the government so that smokers will make the decision to use a lower-risk nicotine product. In no uncertain terms, this is just more coercion and flirts dangerously close to prohibition.

As mentioned above, there are new questions of public health to contend with. We are also mindful that states that are dependent on cigarette tax revenue will be looking to replace those dollars as the smoking rate continues to fall. We should be very concerned that the easiest target will be the rest of the tobacco and nicotine category–which is already happening in several states and municipalities.

What does all of this mean for consumers

In theory, the FDA’s recent decision to delay the PMTA deadlines means consumers will continue to have access to the diverse vapor market for several more years. While the extended timeline for compliance means that vapor manufacturers are likely to stick around, the current compliance deadlines will likely translate to slightly increased costs and, as mentioned above, the 2007 grandfather date remains unchanged. Another reality we will face is heightened opposition from groups who would rather see tobacco and nicotine banned completely.

The narrative from the usual tobacco control groups for the past several years is that the lack of federal regulation of vapor products means 1) we can’t be sure how risky the products are and 2) therefore, state and local governments must take action to impose their own strict regulations. Although Friday’s announcement from the FDA is a clear declaration that the agency is moving forward with regulations, anti-tobacco activists continue to spin the news as if the FDA is giving up their authority.

In addition to the predictable press releases in response to the FDA’s announcement, the disinformation coming from tobacco control was on full display during Dr. Jerome Adams’ confirmation hearing to become the next US Surgeon General. When Senator Maggie Hassan (D-NH) asked Dr. Adams about protecting young people from tobacco and nicotine, she introduced the question by stating that the deeming rule had been delayed. While it is true that one aspect of the rule (PMTA compliance) has been extended, the rest of the rule remains unchanged. In fact, as discussed above, the FDA announced that it will be promulgating even more rules in the near future regarding product standards for e-liquid and batteries.

Senator Hassan’s mischaracterization of the FDA’s announcement is very likely to be repeated and exaggerated at the state and local level. Therefore, it is important to remind lawmakers that the deeming rule took effect and the timeline for compliance began on August 8, 2016. That date has not changed. The national minimum legal purchase age for all tobacco and nicotine products is still 18-years-old. Moreover, compliance deadlines for product registration, ingredient listing, toxicology, and warning labels remain unchanged.

While vapor businesses and their consumers have been given a lifeline, there are still sharks in the water. Now, more than ever, it is vital that lawmakers hear from voters about the benefits of vaping and other low-risk tobacco products.

CASAA is urging our members to continue contacting their representatives and urging them to co-sponsor HR 1136 by visiting www.august8th.org.

Your senators also need to hear your stories about how vaping and other smoke-free tobacco products have affected your life. You can find contact information for all of your lawmakers by visiting www.thrvoter.org.

CASAA relies on contributions from our members to provide timely and accurate information about legislative engagement and the benefits of low-risk tobacco and nicotine products. Please donate today! Any amount will go a long way to helping us keep consumers informed and provide opportunities to engage with lawmakers. Thank You!


Additional Coverage:

FDA News Release – https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm

Dr. Scott Gottlieb’s full remarks – https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm

Brad Rodu – https://rodutobaccotruth.blogspot.com/2017/07/fdas-new-vision-for-tobacco-harm.html

Clive Bates – https://www.clivebates.com/huge-fda-announcement-on-future-tobacco-and-nicotine-strategy/

Jacob Sullum (Reason), “A Cap on Nicotine in Cigarettes Would Be Hazardous to Health” – http://reason.com/blog/2017/08/02/a-cap-on-nicotine-in-cigarettes-would-be

VTA – http://vaportechnology.org/wp-content/uploads/2017/08/FROM-THE-TRENCHES-VTA-UPDATE-AUGUST-1-2017.pdf

SFATA – http://mailchi.mp/sfata.org/sfata-weekly-federal-update-view-from-the-front-lines-c1at2kjhdg-899977?e=2b21cf6c70

This article was originally published at CASAA
Author: Alex Clark

This entry was posted in deeming regulations, e cigarettes, e-cigarette, FDA, FDA deeming, HR 1136, News, nicotine, PMTA, Scott Gottlieb. Bookmark the permalink.