August 2, 2018
By: Scott Gottlieb, M.D., and Mitch Zeller, J.D.
FDA Commissioner Scott Gottlieb, MD
This summer marks nine years since the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law, and one year since we announced the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation. This comprehensive plan places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The multi-year roadmap provides a framework for regulating nicotine and tobacco and is designed to reframe the conversation around nicotine and harm reduction.
A principal reason people continue to smoke cigarettes — despite the dangers — is nicotine. Our plan recognizes that nicotine isn’t directly responsible for the morbidity and mortality from tobacco, but creates and sustains addiction to cigarettes. It’s the delivery mechanism for nicotine that’s more directly linked to the product’s dangers. That’s why our plan focuses on minimizing addiction to the most harmful products while encouraging innovation in those products that could provide adult smokers access to nicotine without the harmful consequences of combustion and cigarettes.
Over the past year, we’ve taken important steps toward fully implementing this plan as part of our overarching goal: a world where cigarettes can no longer create or sustain addiction, and where adults who still seek nicotine could get it from potentially less harmful sources. In implementing this comprehensive plan, we’ve already issued three important advance notices of proposed rulemaking (ANPRMs) that have the potential to reframe the tobacco landscape. These ANPRMs focus on:
- The potential development of a product standard to lower nicotine in cigarettes to minimally or non-addictive levels – which could make it harder for future generations to become addicted in the first place and could allow more currently addicted smokers to quit more easily or switch to potentially less harmful products. Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it’s clear that to maximize the possible public health benefits of our regulatory tools granted to us under the Tobacco Control Act, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes. We believe this pivotal public health step has the potential to dramatically reduce smoking rates and save millions of lives;
- The role that flavors – including menthol – play in initiation, use and cessation of tobacco products. Input on these issues will assist in the consideration of the most impactful regulatory options the FDA could pursue to achieve the greatest public health benefit. We’re proceeding in a science-based fashion, building a strong administrative record by securing more information about the potential positives and negatives of flavors in both youth initiation and in getting adult smokers to quit or transition to potentially less harmful products; and,
- The patterns of use and resulting public health impacts from what are often referred to as “premium” cigars to inform the agency’s regulatory policies.
The public comment periods for all three ANPRMs, which were extended by 30 additional days to allow more time for submissions, have now closed. We are beginning the process of reviewing those comments.
Mitchell Zeller, J.D., Director of FDA’s Center for Tobacco Products
At the same time, the FDA is also pursuing additional new policies as part of our comprehensive plan as well as our ongoing commitment to improve the efficiency and effectiveness of our tobacco regulatory programs.
Part of these efforts are aimed at making the pathway for developing nicotine replacement therapy (NRT) products more efficient to promote the development of novel NRT products. The agency’s efforts to re-evaluate and modernize its approach to the development and regulation of NRT products is aimed at opening up new pathways for the development of improved products, regulated as new drugs, that demonstrate that they are safe and effective for the purpose of helping smokers quit.
Many of our new efforts, as part of our comprehensive plan, are aimed at using our existing authorities under the TCA to minimize addiction to the most harmful products, principally cigarettes, while encouraging innovation in new products that may offer adults less harmful forms of nicotine delivery.
A key part of achieving these goals is issuing foundational rules and guidances to help industry better understand what is needed to submit product applications. At the same time, we are pursuing new efforts to improve the transparency and efficiency of the premarket review process.
These important foundational steps are a key element of our efforts to advance the pre-market review of tobacco products. This review is one of the most important responsibilities we have. It’s how we can assess new products and their potential impact on the public health. This is our opportunity to determine how a product may positively or negatively affect both non-users and current users. So, it’s crucial that we continually improve in this area and have a transparent and efficient process.
To address these goals, we’re committing to a number of steps, some new, to respond to stakeholders and to make the regulatory process more efficient, predictable, and transparent for industry, while also advancing the agency’s public health mission. Establishing a rigorous, predictable, science-based framework for the premarket review of tobacco products is a key element of our program.
Among the steps that we are pursuing to better achieve these goals:
- Proposing foundational rules: We all need to be on the same page regarding the basic “rules of the road,” especially when it comes to what’s expected in premarket applications. We’re working to propose new rules to help industry on topics including Substantial Equivalence, Premarket Tobacco Applications, Modified Risk Tobacco Product Applications, and Tobacco Product Manufacturing Practices. We will begin publishing these foundational proposed rules in the coming months. They will lay out a transparent, modern, and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements.
- Holding a public meeting on premarket review: Within the next few months, the FDA will hold a public meeting on the premarket application and review process. The goal of the meeting is to solicit comments on our processes and provide a dedicated venue for specific suggestions on how to further improve them. Potential topics for discussion include: how to achieve greater efficiencies in review, while continuing to protect public health; how to review products that are rendered “new” due to changes made to comply with a product standard; and, how to facilitate greater company consultation with the FDA prior to submitting applications.
- Exploring opportunities for premarket review efficiencies through rulemaking and guidance and new administrative steps to modernize and improve the review process: The FDA is taking additional steps to pursue the shared interest with industry of increased flexibility and efficiencies within the application review process. If carefully developed, rulemaking and guidance efforts in this area could help ensure that our public health standards for premarket review are met while mutually benefiting both the industry and the FDA. For example, an opportunity may exist to allow for faster and cheaper development of products that will benefit public health. In the months ahead, the FDA intends to explore what improvements can be made along these lines within our existing legal authorities. We also plan to advance a comprehensive suite of improvements to the review process, as part of a Regulatory Modernization, to make our program more efficient, transparent, predictable, and efficient. We will unveil these programmatic reforms in advance of our upcoming public meeting.
These programmatic and process improvements are aimed at solidifying the FDA’s regulatory pathways and improving its predictability and transparency. As the FDA advances its regulatory approach to these important public health considerations, it’s critical that we keep in mind a bedrock principle: No kids should be using any tobacco or nicotine-containing products, including e-cigarettes.
Protecting our nation’s youth from the dangers of tobacco products is among the most important responsibilities of the FDA. That is why we recently launched our Youth Tobacco Prevention Plan.
We look at the marketplace for tobacco products today and see increasing concern from parents, educators, and health professionals about the alarming youth use of tobacco products like JUUL and other e-cigarettes. Our mission at the FDA is to protect the public’s health, and we want to assure the public we’re using all of our tools and authorities to quickly tackle this public health threat. We will not allow our efforts to give manufacturers time to file premarket applications with FDA — that are informed by the foundational rules and guidance that we’re now advancing — to become a back door for allowing products with high levels of nicotine to cause a new generation of kids to get addicted to nicotine and hooked on tobacco products.
Our Youth Tobacco Prevention Plan reflects our commitment to address these risks. Congress gave us many powerful authorities, including enforcement, product standards, premarket review, sales and promotion restrictions, and public education. We’ll use every tool available to protect our nation’s kids.
We’ve already announced several vigorous enforcement actions and education efforts aimed at addressing youth use of nicotine, and e-cigarettes in particular. More such actions are imminent. Among the steps we’ve already taken are: sending warning letters to companies for selling e-liquids resembling juice boxes, candies and cookies; sending warning letters to retailers for selling JUUL e-cigarettes to underage youth; working with eBay to remove Internet listings for JUUL, and with other e-cigarette manufacturers to help the FDA better understand the youth appeal of these products; and, creating the first e-cigarette public education ad, with a full-scale advertising campaign to begin this fall.
These are important first steps. But we still need to do more to address use of tobacco products by kids. That’s why we’re working to quickly advance the following three new initiatives:
- Expediting action on flavors: The issue of flavors, including flavored e-cigarettes and e-liquids, is at the forefront of any discussion of youth use. However, some flavored tobacco products may also play a role in helping some adults quit smoking cigarettes. Now that the comment period has closed, we intend to expedite the review and analysis of the comments so that we can leverage the information into policy as quickly as possible, should the science support further action.
- Developing an e-cigarette product standard: The FDA has also begun exploring a product standard for e-cigarettes to help address existing concerns. As part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin, and nicotine in e-liquids. While the process for establishing a product standard takes time, we recognize the urgency in setting some minimum, common sense standards, and will work to address this on an accelerated timeline.
- Exploring ways to accelerate enforcement: We’re also looking at ways that the FDA can act even more efficiently when we become aware of violations affecting youth use of e-cigarettes, such as illegal product marketing to youth. We need to be faster and more agile when we identify new risks. We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review. These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching and we will take swift action wherever appropriate. We are evaluating new ways to strengthen our partnership with sister agencies, including the Federal Trade Commission. We will also announce a robust series of additional enforcement actions in the coming months.
We have made great strides since we first unveiled our Comprehensive Plan for Tobacco and Nicotine Regulation last year. The components of this program we have outlined are intended to work as an integrated package of reform. We will pursue all of these policies simultaneously. Each is interconnected. Each element supports the others. We intend to achieve all of the elements.
We remain on track to meet our ambitious goals. But there is still much work to be done.
The staff at the FDA’s Center for Tobacco Products is working hard to use our available tools to protect Americans from the harms of being addicted to tobacco products. And today, we’re committing to redoubling our efforts. Too many kids are still starting to use tobacco products and getting addicted. And, too many adults are still struggling to quit or to switch to less harmful options. To reduce the disease and death caused by tobacco use, the FDA will do everything within our power to help all ages.
Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
Mitch Zeller, J.D., is Director of the FDA’s Center for Tobacco Products