Each year, 660,000 people in the United States are diagnosed with cancer related to tobacco use, and 343,000 people die from such cancers, according to CDC.

FDA to Seek Lower Nicotine Levels in Cigarettes

The agency said it will launch a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards, including issuing an Advance Notice of Proposed Rulemaking to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.

FDA announced on July 28 what it called "a 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." Its approach aims to place nicotine and the issue of addiction at the center of the agency's tobacco regulation efforts, in order to ensure FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. "To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products," its announcement said.

It also said a key part 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."

"The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users," FDA Commissioner Dr. Scott Gottlieb said. "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground."

The agency said it will launch a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards, including issuing an Advance Notice of Proposed Rulemaking to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. "Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA's strategy for addressing the devastating addiction crisis that is threatening American families," Gottlieb explained. "Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products. To be successful all of these steps must be done in concert and not in isolation."

FDA also said it intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016, because this action will give the agency "time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive." It intends to develop product standards to protect against "known public health risks" such as e-cigarette battery issues and concerns about children's exposure to liquid nicotine, the announcement said.

FDA plans to issue this guidance describing a new enforcement policy shortly. "Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications," it said.

"This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact," said Mitch Zeller, J.D., director of FDA's Center for Tobacco Products. "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."

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