FDA Extends Deadlines for Regulating E-Cigarettes and Other New Tobacco Products

Agency also seeks to lower nicotine levels in cigarettes

Written By:Elizabeth Mendes

The US Food and Drug Administration (FDA) announced last week that they are extending the date for manufacturers to submit applications to get approval to market new types of tobacco products including e-cigarettes. The FDA moved back the deadline by several years.

Last year, the FDA for the first time said it would start regulating all tobacco products, including e-cigarettes, hookahs, cigars, and other products in the same way it does cigarettes. The new regulation gives the FDA the authority to review the ingredients and health risks of all tobacco products and enforce other key rules. 

Companies submitting for approval to market e-cigarettes and other non-combustible tobacco products now have until 2022. The application deadline for new combustible products such as cigars and hookah tobacco is in 2021. Manufacturers will be able to continue to market their products while the FDA reviews applications. 

FDA also wants to explore lowering nicotine levels in cigarettes to combat tobacco problem

The FDA included the application deadline changes as part of its “new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.” As part of this plan, the agency also announced that it would focus more efforts on the issue of nicotine, the highly addictive substance in cigarettes and other tobacco products. The FDA said it will “begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.” This will include soliciting comments from the public. 

The American Cancer Society’s advocacy affiliate Cancer Action Network (ACS CAN) commented on the FDA’s new plan in a statement. ACS CAN said that the agency’s “vision of potentially reducing nicotine in cigarettes to below addictive levels could begin to create a critical public health strategy to address the leading cause of cancer and preventable death due to the use of cigarettes.” But in reaction to the announcement, ACS CAN said: “The actions to extend the compliance date for manufacturers to submit marketing applications for newly deemed products will allow many cigars, e-cigarettes, and other tobacco products to stay on the market for years before a crucial first-step review by the FDA to determine their public health risk.”  

What we know now – and what we don’t

While the FDA and other organizations continue to study e-cigarettes as well as the idea of trying to lower nicotine levels in tobacco products, it is important to remember there are still many unknowns. What we do know is that smoking causes cancer. It also can damage nearly every organ in the body, including the lungs, heart, blood vessels, reproductive organs, mouth, skin, eyes, and bones. Other forms of tobacco such as spit and smokeless tobacco are also major health risks, including causing cancer.  

If you use tobacco and want to quit or know someone who does, call the American Cancer Society at 1-800-227-2345 or read our information on How to Quit Smoking or Smokeless Tobacco. Research shows that getting help increases your chances of success.

The American Cancer Society medical and editorial content team

Our team is made up of doctors and oncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing.

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