FDA on Thursday took its first step toward lowering nicotine levels in cigarettes, and is asking the public for input on how best to move forward.
The move is part of a comprehensive plan FDA announced in July 2017 to reduce tobacco-related disease and death.
FDA issues advance notice of public rulemaking
FDA Commissioner Scott Gottlieb said the agency has issued an advance notice of proposed rulemaking that provides an overview of current research on how nicotine makes cigarettes addictive and seeks public feedback on nicotine standards. For instance, FDA in the notice cited an FDA-funded analysis that found lowering cigarettes' nicotine levels to 0.4 milligrams per gram of tobacco filler could reduce the current smoking rate of 15% to 1.4% by 2100, leading to eight million fewer tobacco-related deaths through the end of the century. According to the notice, the analysis found that within one year of implementation, the reduction in nicotine levels would result in "approximately 5 million additional smokers" quitting smoking.
FDA in the notice asked for public feedback on:
- The potential maximum nicotine level that would be appropriate to protect public health;
- The unintended consequences—such as the potential for illicit trade of cigarettes with high-nicotine levels—that might occur as a result of reducing cigarettes' nicotine levels; and
- Whether a new nicotine product standard should be implemented immediately or gradually.
FDA will accept public comments on the notice for 90 days. Once the public comment period ends, FDA said officials then will decide whether to move forward with a proposed rule to reduce nicotine levels in cigarettes.
In addition, FDA announced plans to release two additional notices of proposed rulemaking related to tobacco products. Gottlieb said one of the notices will focus on the role flavors, including menthol, play in the initiation, use, and cessation of tobacco products, while the second will seek public comments and data on regulating premium cigars.
Gottlieb said, "This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country." He continued, "We're at a crossroads when it comes to addressing nicotine addiction and smoking in this country—with important new tools to address this devastating public health burden. And although a potential nicotine product standard for cigarettes is the cornerstone of our approach, we also continue to push forward on additional pieces of the FDA's multi-year plan designed to work in concert to better protect kids and significantly reduce tobacco-related disease and death."
Mitch Zeller, director of FDA's Center for Tobacco Products, said several adults attempt to quit smoking annually, but nicotine is an addictive substance. Zeller said lowering nicotine levels would help adults quit and could help deter young people from experimenting with cigarettes.
Several observers, particularly anti-smoking groups, voiced their support for FDA's move.
American Heart Association CEO Nancy Brown called FDA's notice "a commendable move in the right direction." Brown said, "We encourage the agency to not stop here but move forward quickly with a proposed rule on nicotine levels—not just for cigarettes, but for every combustible tobacco product on the market."
Robin Koval, president and CEO of Truth Initiative, also touted FDA's effort, calling it "a serious, strong response." However, Koval said it is important for FDA to take other steps, as well, such as moving forward on rules the agency delayed last summer to regulate electronic cigarettes.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said a proposed rule to lower nicotine levels "would be the most significant public health proposal … from the U.S. government in the last 20 years." Myers said, "While this issue has been discussed conceptually for years, this is first time we have a government agency saying it is achievable, feasible, and can be implemented in a way that doesn't cause serious negative consequences."
James Figlar, EVP of research and development at R.J. Reynolds Tobacco, said he looks forward "to working with FDA on its science-based review of nicotine levels in cigarettes and to build on the opportunity of establishing a regulatory framework that is based on tobacco harm reduction and recognizes the continuum of risk."
A spokesperson for Philip Morris International said it had not finished reviewing FDA's notice, but the company in the past indicated support for FDA's plan to regulate nicotine, "To Your Health" reports.
However, Erika Sward, assistant vice president of national advocacy for the American Lung Association, said FDA likely will encounter challenges from the tobacco industry. Sward said the tobacco industry likely will "put forward illegitimate and faulty studies during the fact-finding process," adding, "An immense amount of political [support] will be needed to get this across the finish line."
According to the Wall Street Journal, Wells Fargo analyst Bonnie Herzog estimated it could take up to five years for FDA to implement potential changes to how it regulates nicotine levels in cigarettes (Chaudhuri, Wall Street Journal, 3/15; McGinley, "To Your Health," Washington Post, 3/15; Karlin-Smith, Politico, 3/15; Boyles, MedPage Today, 3/15; Stein, "Shots," NPR, 3/15).
Mar. 20 webconference: Here are the latest clinical innovations in cancer care
Learn about new and emerging innovations in medical oncology, including targeted therapies, immunotherapy, and next-generation sequencing, and how your program can prepare for these exciting discoveries.