Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

FDA Statement

• For Immediate Release: October 22, 2018
• Statement From: Scott Gottlieb, M.D.

When we first unveiled our comprehensive plan on tobacco and nicotine regulation, we set out to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the risks associated with lighting tobacco on fire.

As we continue to advance these policies to significantly reduce tobacco-related disease and death, including a particular emphasis on protecting kids from the dangers of nicotine, it’s critical that we have an efficient regulatory process that puts novel products like e-cigarettes through an appropriate series of regulatory gates to fully evaluate their risks and their potential benefits. Such products still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes. And those risks require closer scrutiny. We must also take a closer look at how these products impact youth use of nicotine and tobacco, and how they may promote adult cessation of combustible cigarettes.

As part of this ongoing work, this week we’re holding a two-day public meeting to discuss the policies and processes for tobacco product application review. The discussion on the tobacco product review process is important because the regulatory review of individual products gives the FDA the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users. For e-cigarettes, for example, under the most likely path for marketing authorization, manufacturers of these products must show that marketing the product is appropriate for protecting the public health, taking into account their risks and benefits to the population as a whole. This includes evaluating whether these products get kids addicted to nicotine – a grave concern that we’re addressing through a variety of tools such as cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.

But in order to properly evaluate these and all tobacco products, we’ve committed to developing new guidance and regulations -- including the development of product standards -- that will better spell out the rules of the road for industry and make the regulatory process for products such as electronic nicotine delivery system (ENDS) more efficient. We’ve also focused on ways to improve the efficiency and transparency of tobacco product application review process and taken steps to provide additional information about the FDA’s science-based review decisions to manufacturers. And we’ve updated our processes related to the FDA’s review of a subset of tobacco products. We also plan to announce additional improvements to the product application and review processes that we expect will provide industry more predictability on timelines for the review of certain applications.

This week’s meeting will give us an opportunity to gather information about general scientific principles relevant to substantial equivalence (SE) reports, exemption requests, premarket tobacco product applications (PMTA) and modified risk tobacco product (MRTP) applications. The meeting will seek suggestions for further process improvements. Presentations from FDA staff, expert panels and live question-and-answer sessions are expected to address other topics relevant to the submission of tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered review and environmental assessments. We’re hopeful that by gathering tobacco product manufacturers, importers and retailers, scientific and medical experts, government agencies, as well as academic researchers and public health organizations at this meeting, we can leverage the information shared to ensure that there’s a clear, viable pathway to seek FDA authorization, which can result in the marketing of potentially less harmful products for adult smokers who still seek access to nicotine but don’t want all the risks associated with combustion.

The meeting builds on commitments we made when we first announced our comprehensive plan that aims to ensure the agency has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To allow the FDA to encourage innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes, we provided a compliance policy for industry submission of premarket applications for newly deemed products that were on the market on the market as of Aug. 8, 2016 – the effective date of the final deeming rule that extended the FDA’s authority to additional tobacco products such as e-cigarettes. Under the current compliance policy – which we have said we’re revisiting in light of the growing youth use of e-cigarettes – the FDA expects that manufacturers will develop higher quality and more complete applications, as the agency continues to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. These measures, which will focus on protecting youth, could include an examination of flavors/designs that appeal to children, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine. We’re also exploring the development of product standards or other regulations for known public health risks such as battery safety issues for e-cigarettes to protect public health and make the review process more effective.

As part of that these efforts, we also intend to issue regulations outlining what information is to be included in PMTAs, MRTP applications and SE reports. We’ll also update guidance on PMTAs for ENDS such as e-cigarettes, including how we intend to review such PMTAs. Additionally, we’ll continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

We need a strong application review process that ensures new tobacco products meet the FDA’s regulatory standards, for example, whether the marketing of the product is appropriate for the protection of the health of the overall population. The review process is a critical part of our mission to reduce tobacco-related disease and death. To achieve these goals, we also need a regulatory process to ensure that these same products, including e-cigarette products, are kept out of the hands of youth. No child should be using any tobacco product. We’ll take many additional actions in the coming months to address the youth use of tobacco products and e-cigarettes in particular. We’ll continue to use all the tools at our disposal to ensure our comprehensive plan on tobacco and nicotine regulation meets its public health objectives.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.