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          FDA's Comprehensive Plan for Tobacco and Nicotine RegulationCTP Newsroom FDA's Comprehensive Plan for Tobacco and Nicotine Regulation
  
  	
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Text of milestones graphic

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.

Read statement from FDA Commissioner Dr. Scott Gottlieb

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.
	See also: FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookiesThe 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.

Alt Text for Milestones of FDA's Comprehensive Plan for Tobacco and Nicotine Regulation image

**SEPTEMBER 2018**

Launching full scale e-cigarette messaging effort under “The Real Cost” campaign brand**MAY 2018**

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**APRIL 2018**

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**MARCH 2018**

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**DECEMBER 2017**

Launched “Every Try Counts” public education campaign to encourage adult smokers trying to quit cigarettes**NOVEMBER 2017**

Launched “This Is Our Watch” program to educate retailers**SEPTEMBER 2017**

Expanded “The Real Cost” campaign to include messaging on e-cigarettes**JULY 2017**

Announced FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation

Additional Resources

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: Upcoming Tobacco Product Listing Deadline June 30: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
	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
	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

                                                                                  Content current as of:
      01/06/2022CTP Newsroom

          
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