Tobacco Products

FDA's New Plan for Tobacco and Nicotine Regulation


On July 28, the FDA announced a new comprehensive plan which 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.

A key piece of the approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes. Accordingly, the FDA is announcing several efforts to shift the trajectory of tobacco-related disease and death.

Lowering Nicotine in Cigarettes to Non-Addictive Levels

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 levels in cigarettes to non-addictive levels, we could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

  • FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.
  • FDA intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.

 

 

Public Comment and other Opportunities to Communicate with FDA

The FDA seeks to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes. Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.

  • FDA intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek public comment on the role that flavors in tobacco products—including menthol—play in attracting youth, as well as the role they may play in helping some smokers switch to potentially less harmful forms of nicotine delivery.
  • FDA intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars.
  • FDA plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.
     

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 newly-regulated products that were on the market as of August 8, 2016. Under the revised timelines:

  • Applications to market newly-regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, must be submitted by August 8, 2021.
  • Applications to market newly-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:

  • FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues.
  • FDA intends to develop product standards around concerns about children's exposure to liquid nicotine.

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. www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.pdf. Accessed September 9, 2016

 

Page Last Updated: 08/10/2017
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