FDA Seeks Public Comment on a Potential Product Standard to Lower Nicotine in Cigarettes to a Minimally or Non-Addictive Level

The U.S. Food and Drug Administration (FDA) issued Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, an advance notice of proposed rulemaking (ANPRM) seeking public comment for consideration in developing a potential nicotine product standard. Lowering nicotine to a minimally or non-addictive level could potentially save millions of lives, both in the near and long-terms.

The ANPRM includes newly published estimates of one possible policy scenario for a nicotine product standard, including that approximately 5 million additional adult smokers could quit smoking within one year of implementation, compared to the baseline scenario. However, an even greater impact could be felt over time: by the year 2100, its estimated more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. This could result in more than 8 million fewer tobacco-caused deaths through the end of the century.

In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced a new comprehensive plan that places nicotine – and the issue of addiction – at the center of the agency’s tobacco regulation efforts. As the cornerstone of the plan, the release of today’s ANPRM is a major step on the path to dramatically changing the future of smoking in the United States and saving millions of lives.

FDA is seeking comments, research and data on many topics related to a potential product standard for nicotine in cigarettes including, but not limited to:

• What potential maximum nicotine level would be appropriate for the protection of public health;
• How a maximum nicotine level should be measured;
• Whether such a product standard should be implemented all at once or with a gradual, stepped approach;
• Whether a nicotine product standard should also cover additional combustible tobacco products; and
• What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by increasing the amount they smoke – might occur as a result of such a standard.

Given their combination of toxicity, addictiveness, prevalence, and effect on non-users, cigarettes are the category of tobacco product that causes the greatest public health burden. Today’s ANPRM raises options and questions related to establishing a potential nicotine product standard for cigarettes. Setting such a standard could result in many positive public health effects, such as currently addicted smokers switching to a potentially less harmful product or quitting tobacco altogether while also making it much less likely that future generations ever get addicted to cigarettes in the first place.

“Almost 90 percent of adult smokers started smoking by the age of 18, and we’ve known for decades cigarettes are highly engineered and designed to get – and keep – users addicted,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “By moving to consider a nicotine product standard, we are imagining a future in which young people are significantly less likely to get hooked into a lifetime of addiction.”

Beginning in March, the ANPRM will be available for public comment through June 14, 2018. FDA will consider all comments, data, research, and other information submitted to the docket to determine what regulatory next steps may be appropriate. However, the FDA is not seeking comment on reductions in the nicotine levels of any non-combustible tobacco product for this ANPRM.

As part of this announcement, FDA is also issuing Illicit Trade in Tobacco Products After Implementation of an FDA Product Standard, a draft concept paper discussing potential illicit trade implications of product standards more generally. A separate docket for that paper will also open tomorrow and be open for public comments through June 14th.

In July, Commissioner Gottlieb unveiled a new plan for the FDA’s tobacco regulation efforts. While today’s announcement marks the first major step in that plan, the agency intends to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products, and one to solicit additional comments and data related to premium cigars. Other actions will follow to ensure the plan is implemented in a comprehensive way.

These efforts also include examining the role that medicinal nicotine products, such as the gum and patch, can play in helping more smokers quit cigarettes. FDA recently held a public hearing on this issue and established a public docket for comment. Together, this package of actions, done in concert, can result in historic gains in the fight against the overwhelming disease and death caused by tobacco use.