FDA's Comprehensive Plan for Tobacco and Nicotine Regulation
FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the U.S. in the years to come.
Key Features of the Comprehensive Plan for Tobacco and Nicotine Regulation
- Regulatory Policies on Addiction, Appeal, and Cessation
- Seeking evidence and public comment on potential FDA regulation
- Increasing access to, and use of, medicinal nicotine products to help people quit
- Educating the public and correcting misperceptions about nicotine
- Science-Based Review of Tobacco Products
- Extending certain compliance dates
- Seeking industry feedback on application processes
- Implementing product standards for safety
- Youth Tobacco Prevention Plan
Regulatory Policies on Addiction, Appeal, and Cessation
Seeking evidence and public input on potential FDA regulation:
- Tobacco Product Standard for Nicotine Level of Combustible Cigarettes
- Lowering nicotine in cigarettes to a minimally or non-addictive level through the creation of a potential nicotine product standard could decrease the chances that future generations become addicted to cigarettes, and could make it easier for more currently addicted smokers to quit.
- The advanced notice of proposed rulemaking sought public comment on these topics and offered newly published estimates of one possible policy scenario for a nicotine product standard.
- FDA also issued a draft concept paper, Illicit Trade in Tobacco Products After Implementation of an FDA Product Standard, which discussed potential illicit trade implications of product standards more generally.
- Regulation of Flavors in Tobacco Products
- FDA has issued an advance notice of proposed rulemaking to help determine how best to regulate flavors in tobacco products, including menthol.
- FDA plans to expedite the review and analysis of comments on this notice
- Regulation of Premium Cigars
- An advance notice of proposed rulemaking about regulation of “premium” cigars sought input on the appropriate definition of “premium" cigars, use patterns, and public health considerations.
FDA Issues Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products
The guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products, including flavored e-cigarettes and cigars, and describes how FDA intend to prioritize its enforcement of products that do not have premarket authorization.
Increasing access to, and use of, medicinal nicotine products to help people quit
FDA is examining actions and working with sponsors to increase access to, and use of, FDA-approved medicinal nicotine products intended to help smokers quit. The Nicotine Steering Committee held a public hearing in early 2018, which focused on Evaluating Safety and Efficacy of Nicotine Replacement Therapies (NRTs).
Educating the public and correcting misperceptions about nicotine
In December 2017, FDA launched an adult public education campaign, Every Try Counts, which offers messages of support to smokers trying to quit. The campaign encourages smokers to keep practicing the quit because every quit attempt is a step toward success.
Most people—especially smokers trying to quit—know that cigarettes are addictive, but many do not understand the role of nicotine in cigarette addiction. FDA is embarking on an effort to engage stakeholders and the public in an educational dialogue and correct common misperceptions around nicotine and addiction.
Science-Based Review of Tobacco Products
Extending certain compliance dates
The agency extended timelines to submit tobacco product review applications for deemed regulated products that were on the market as of August 8, 2016. The revised timelines afford the agency time to explore clear and meaningful measures to ensure tobacco products are less toxic, appealing, and addictive. In addition, the additional time will allow companies to develop higher quality, more complete applications informed by further guidance from the agency.
- Applications to market deemed regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, must now be submitted by August 8, 2021.
- Applications to market deemed regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, must now be submitted by August 8, 2022.
Requirements from the deeming rule that occurred prior to these new extended compliance dates must still be met. For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.
Seeking industry feedback on application process
FDA also plans to seek feedback to improve and enhance industry’s ability to comply with federal tobacco regulations through proposing new foundational rules, hearings seeking public comment and feedback, and guidance documents for regulatory compliance related to:
- Premarket tobacco applications (PMTAs),
- Modified risk tobacco product (MRTP) applications, and
- Reports to demonstrate substantial equivalence (SE).
The FDA also plans to finalize guidance on how it intends to review premarket tobacco applications for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information and webinars.
Implementing product standards for safety
Future efforts will also explore additional product standards that could prevent injuries from known tobacco product risks, including:
- A potential product standard to prevent "vape" battery explosions.
- Product standard to address concerns about children’s exposure to liquid nicotine.
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.
Youth Tobacco Prevention Plan
Preventing youth use of, and access to, tobacco products
A focused segment of the Comprehensive Plan, known as the Youth Tobacco Prevention Plan, aims to stop youth use of, and access to, tobacco products—especially e-cigarettes. Significant regulatory and research efforts related to access, marketing, and education are already underway.
- Launching full scale e-cigarette messaging effort under “The Real Cost” campaign brand
- Sent warning letters to companies misleading kids with e-liquids that resemble children’s food products
- Requested critical product information from companies about the youth-appeal of their e-cigarettes
- Unveiled Youth Tobacco Prevention Plan
- Sent warning letters to retailers who illegally sold JUUL to underage youth
- Requested critical information from JUUL Labs on marketing and research related to youth initiation and use
- Provided update on provisional substantial equivalence review process
- Published three advance notices of proposed rulemaking for public comment:
- Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
- Regulation of Flavors in Tobacco Products
- Regulation of Premium Cigars
- Launched “Every Try Counts” public education campaign to encourage adult smokers trying to quit cigarettes
- Launched “This Is Our Watch” program to educate retailers
- Expanded “The Real Cost” campaign to include messaging on e-cigarettes
- Announced FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation
- March 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan
- November 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
- September 2018: FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
- August 2018: FDA In Brief: FDA takes steps to improve efficiency, transparency of tobacco product application review process as part of comprehensive framework to reduce the disease and death related to tobacco products
- August 2018: Advancing Tobacco Regulation to Protect Children and Families- Updates and New Initiatives from the FDA
- June 2018: Flavors in Tobacco Products: What are the Potential Risks and Benefits to Public Health?
- June 2018: Upcoming Tobacco Product Listing Deadline June 30: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
- June 2018: Special Announcement - FDA Extends Comment Periods for ANPRMs and Draft Concept Paper
- June 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
- May 2018: FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products
- May 2018: FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
- May 2018: FDA, FTC take action against companies misleading kids with e-liquids that resemble children's juice boxes, candies and cookies
- April 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes
- March 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors--including menthol--in tobacco products
- March 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels
- November 2017: Guidance--Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised)
- September 2017: A Nicotine-Focused Framework for Public Health, by FDA Commissioner Scott Gottlieb and CTP Director Mitchell Zeller in the New England Journal of Medicine
- July 2017: Press Release--FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
- July 2017: Speech--Protecting American Families: Comprehensive Approach to Nicotine and Tobacco