08/21/2018 - FDA EXTENTION

FDA's Comprehensive Plan for Tobacco and Nicotine Regulation

asd;lfja;dsFDA'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:

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.

Tobacco Product Application Review - A Public Meeting
October 22-23, 2018
Silver Spring, MD

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.


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