Tobacco Products

FDA's Plan for Tobacco and Nicotine Regulation

On July 28, 2017, the FDA announced a new comprehensive plan that places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death in the U.S.

A key piece of the approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products with different levels of risk. The plan focuses on the one product – the cigarette – that is responsible for nearly all tobacco-related disease and death given its combination of toxicity, addictiveness, prevalence, use patterns, and effect on non-users.

Lowering Nicotine in Cigarettes to a Minimally or Non-Addictive Level

Almost 90% of adult smokers started smoking before the age of 181 and nearly 2,500 youth smoke their first cigarette every day in the U.S.2 By lowering nicotine in cigarettes to a minimally or non-addictive level, we could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit. The FDA has begun a public dialogue on this topic and how an achievable nicotine product standard could benefit public health.

Public Comment and other Opportunities to Communicate with FDA

See all FDA opportunities to submit public comments on tobacco products and regulations.

The FDA seeks to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that could reduce the public health harms caused by cigarette smoking. Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms cause by tobacco use. Related comment opportunities include:

Extending Timelines to Encourage Innovations

In order to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes—the agency extended timelines to submit tobacco product review applications for deemed regulated products that were on the market as of August 8, 2016. Under the revised timelines:

  • Applications to market deemed regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, must 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 be submitted by August 8, 2022.

All other compliance deadlines for manufacturers will remain the same. Importantly, the new enforcement policy does not affect any current requirements from the deeming rule that have already passed. For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.

These revised timelines will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive, such as:

Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in 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 PMTAs for ENDS.

The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars, and guidance documents.

1. U.S. Department of Health and Human Services (USDHHS). The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.

2. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral Health Statistics and Quality; 2016. Accessed September 9, 2016

Page Last Updated: 07/16/2018
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