Cigarette smoking kills about 480,000 Americans every year, according to 2014 estimates from the Office of the U.S. Surgeon General.
To combat this public health concern, the FDA announced in a March 15 statement(www.fda.gov) that it was issuing an advance notice of proposed rulemaking (ANPRM)(www.federalregister.gov) to explore reducing nicotine in cigarettes to "minimally or nonaddictive levels."
The FDA first announced a comprehensive regulatory plan(www.fda.gov) that included lowering nicotine levels in cigarettes in July 2017.
Pointing to the known dangers of these tobacco products, FDA Commissioner Scott Gottlieb, M.D., noted in the current statement that cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users.
"Given their combination of toxicity, addictiveness, prevalence and effect on nonusers, it's clear that to maximize the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes," he said.
- The FDA announced on March 15 that it was issuing an advance notice of proposed rulemaking to explore reducing nicotine in cigarettes to "minimally or nonaddictive levels."
- The FDA first announced a comprehensive regulatory plan that included lowering nicotine levels in cigarettes in July 2017.
- The agency recently published new estimates on the benefits of reducing nicotine in cigarettes in the New England Journal of Medicine.
The ANPRM offers a review of current scientific evidence on how nicotine contributes to the addictiveness of cigarettes. The FDA is inviting public comments on this research and the data provided.
In particular, said Gottlieb, the FDA is seeking input on questions such as
- What potential maximum nicotine level would be appropriate for the protection of public health?
- Should a nicotine-related product standard be implemented all at once or gradually?
- What unintended consequences -- such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine products levels by smoking more -- might occur as a result of any actions taken?
"As we explore this novel approach to reducing the death and disease from combustible cigarettes, it's critical that our policies reflect the latest science and (are) informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment," Gottlieb added.
AAFP President Michael Munger, M.D., of Overland Park, Kan., said in an Academy statement released March 20 that the AAFP "applauds the FDA's decision to gather information on how to best implement a regulation that would reduce nicotine levels in cigarettes."
"Tobacco use is the leading preventable cause of death and illness in our nation," he said. "Every day, family physicians see the devastating impact that smoking has on our patients. We welcome the FDA's commitment to reducing the number of Americans who smoke, thereby improving their health."
Estimates of Reduced Nicotine Benefits
FDA investigators recently published new estimates on the benefits of reducing nicotine in cigarettes in the New England Journal of Medicine.(www.nejm.org)
Using simulation models to project potential population-level effects of this regulatory action, researchers said if nicotine in cigarettes was reduced, about 5 million more adult smokers might quit smoking within a year of the rule's implementation.
The researchers further estimated that by 2100, more than 33 million people -- mostly youth and young adults -- would avoid becoming regular smokers because of the lower nicotine limits. Overall, smoking rates could fall from the current median baseline estimate of 12.8 percent to as low as 1.4 percent under the policy scenario, the study said.
"All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century -- an undeniable public health benefit," Gottlieb said in the release.
"Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes. And this unprecedented public health opportunity, contrasted against the cost of doing nothing, weighs heavily on me."
Regulating Nicotine Delivery Product Alternatives
Gottlieb said the FDA's multiyear plan to reduce tobacco-related disease and death and protect kids from smoking includes addressing cigarette addiction and helping current adult smokers who still seek nicotine to get it from less harmful sources.
"To that end, the agency's regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms," he said.
Gottlieb said this can be achieved through ongoing regulatory work to develop foundational rules, guidance, product standards and additional regulations.
"At the same time, we plan to take vigorous enforcement steps to make sure that tobacco products aren't being marketed to kids, including e-cigarettes. No youth should use a tobacco product," he said.
Additional FDA Tobacco Actions
The FDA plans 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. A second ANPRM will solicit additional comments and data related to the regulation of premium cigars.
In November 2017, the FDA announced the formation of a Nicotine Steering Committee(blogs.fda.gov) charged with re-evaluating and modernizing the agency's approach to the development and regulation of safe and effective nicotine replacement products such as nicotine gums, patches and lozenges.
Gottlieb noted at the time that the aim was to ensure the agency has the right policies in place to enable development of product innovations that are better able to help smokers quit combustible cigarettes and maintain abstinence.
"This could include changes to the labeling and indications for existing products or a new product that might deliver nicotine at different rates, or through different delivery mechanisms entirely," he said.
The agency also plans to take new steps to ensure its policies and processes are efficient, predictable and consistent with the mandate of the Family Smoking Prevention and Tobacco Control Act, Gottlieb stated.
"We're committed to making sure that we have transparent regulatory policies and best practices in place to maximize our public health impact," he said. Achieving that goal may require issuing foundational rules and guidance documents to delineate key requirements of the regulatory process, such as demonstrating substantial equivalence and submitting applications for new tobacco products.
The FDA also will release a framework for how it will address provisional substantial equivalence applications for products that entered the market during a grace period set up in the law. These provisional products may remain on the market unless the FDA finds them not substantially equivalent.
"As we move forward with these efforts, we have an opportunity to more formally solicit feedback, and we'll continue to foster a public dialogue to reshape our country's relationship with nicotine and seek public input on policies that will guide us toward a healthier future," Gottlieb said.
Public comments on the ANPRM on reducing nicotine levels(www.federalregister.gov) may be provided to the FDA through June 14 at 11:59 p.m. EDT. The AAFP plans to submit its own comments during this period.
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