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FDA's Comprehensive Plan for Tobacco and Nicotine Regulation

FDA's Comprehensive Plan for Tobacco and Nicotine Regulation Timeline

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 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

FDA Issues Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products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:

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:

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.

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

 

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