FDA Details Policy Plans for Regulating Tobacco Products
The Food and Drug Administration (FDA) announced a new plan for tobacco and nicotine regulation to significantly lower tobacco-related disease and death as well as to better protect kids.
The goal of the multi-year plan is to guarantee that the Agency has sufficient scientific and regulatory basis to implement the Family Smoking Prevention and Tobacco Control Act. The FDA is also offering relief on some timelines stated in the May 2016 final rule that extended their authority over additional tobacco products. Moreover, the FDA will seek public input on other critical issues such as the flavor of tobacco products.
Mainly, the FDA is seeking to raise awareness that nicotine is supplied through products that pose continued risk and is most dangerous when delivered via smoke particles in combustible cigarettes. In efforts to lower the nicotine levels in combustible cigarettes to non-addictive levels, the FDA plans to issue an Advance Notice of Proposed Rulemaking (ANPRM) for input on the potential benefits and adverse effects of reduced nicotine in cigarettes. The Agency believes decreasing nicotine levels could reduce the risk that future generations will become addicted to cigarettes in addition to allowing current addicts to quit.
FDA Commissioner Scott Gottlieb, MD, stated, “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."
To best inform healthcare policies and efforts to protect kids and help current smokers quit, the FDA plans to extend the timelines for submitting tobacco product review applications for newly regulated tobacco products marketed as of August 8, 2016. This will allow the Agency to take some time to seek out meaningful ways to make tobacco products less toxic and addictive. Regarding electronic nicotine delivery systems (ENDS), for example, the FDA plans to develop standards to protect against risks of battery issues and exposure to liquid nicotine in children. The extended timeline will also enable manufacturers to develop better quality, more complete applications.
With the modified timelines, all applications for newly-regulated combustible products (eg, cigars, pipe tobacco, hookah tobacco) would be submitted by August 8, 2021. Applications for non-combustible products such as ENDS or e-cigarettes would be submitted by August 8, 2022.
The new enforcement policy will only impact the newly-regulated tobacco products and not any current requirements for cigarettes and smokeless tobacco. Moreover, the new policy will not apply to provisions of the final rule such as mandatory age and photo ID checks. It will also not affect future deadline for other provisions such as required warning statements, ingredients list, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims (eg, 'light', 'low', 'mild').
The FDA will also be open to public input on various topics such as regulating kid-appealing flavors in e-cigarettes and cigars and the role of flavors in helping some smokers switch to a different form of nicotine delivery.
“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," stated Commissioner Gottlieb.
For more information visit FDA.gov.