Hollings researcher co-leads AACR subcommittee calling for nicotine limits
Medical University of South Carolina
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Benjamin Toll, Ph.D., co-leads the Tobacco Products and Cancer Subcommittee of the American Association for Cancer Research (AACR), which has endorsed a federal policy that would make cigarettes far less addictive by setting a maximum nicotine product standard.
view moreCredit: Medical University of South Carolina
The American Association for Cancer Research (AACR) has endorsed a federal policy that would make cigarettes far less addictive. The proposed policy by the Food and Drug Administration (FDA) sets a maximum nicotine product standard, limiting nicotine levels in combustible cigarettes and related tobacco products to 0.7 milligrams per gram (mg/g) – about 95% less than what is currently allowed. That reduction would make cigarettes minimally or nonaddictive, striking at the chemical that keeps people hooked. The AACR policy statement is published in Clinical Cancer Research.
Leading the policy statement on behalf of the AACR Tobacco Products and Cancer Subcommittee were Benjamin Toll, Ph.D., co-director of the Lung Cancer Screening Program at MUSC Hollings Cancer Center and director of the Tobacco Treatment Program and Oliver S. and Jennie R. Donaldson Endowed Chair in Cancer Research at MUSC Health, and Dorothy Hatsukami, Ph.D., the Forster Family Chair in Cancer Prevention and associate director of Cancer Prevention and Control at the University of Minnesota Masonic Cancer Center. The subcommittee brings together content experts and thought leaders in cancer prevention and tobacco research from across the country.
“It’s a group of key opinion leaders who care deeply about cancer prevention and using science to guide policy,” Toll said.
For decades, cigarettes have been the nation’s leading cause of preventable disease and early death. Despite progress in reducing smoking rates, tobacco use still claims nearly half a million American lives every year. Now, the experts say the country has an unprecedented opportunity to change that trajectory.
Public health impact of the policy
If put into action, this would be one of the most powerful public health steps ever taken.
“There’s no question that if you reduce nicotine down to almost nothing, people smoke less, try to quit more or quit altogether,” Toll said. “We’ve never had this kind of opportunity to change such a key health behavior that drives a huge cancer burden.”
Cigarettes expose smokers to thousands of toxic chemicals and known carcinogens. By making them minimally or nonaddictive, researchers anticipate that millions of people would quit and fewer people would ever start smoking, with tremendous health and economic benefits.
“Smoking causes cancer in at least 18 different organ types,” Toll said. “It’s responsible for heart disease, stroke and a host of other illnesses. If we can take the addictive chemical out of cigarettes, it would be transformative for cancer prevention and for public health.”
Scientific studies, including rigorous clinical trials, show that reducing nicotine content to the proposed level significantly decreases smoking behaviors. When cigarettes contain less nicotine, people smoke less, make more attempts to quit and are far more likely to succeed in quitting long-term.
Experts estimate that 13 million Americans would quit smoking in the first year if the policy passes, and millions of lives would be saved in the decades ahead. Toll noted that the projections are based on population models derived from the clinical trial data.
“Those numbers come from mathematical models based on quit rates in the very-low-nicotine cigarette trials,” he said. “It’s a huge potential impact – millions of people quitting within a single year.”
The benefits also extend beyond health. Reducing nicotine could save the U.S. economy more than $1 trillion annually, according to FDA estimates, by reducing health care costs and boosting productivity.
Increasing success and reducing disparities
AACR stresses that the impact could be especially significant for youth and vulnerable groups who are most at risk of becoming addicted to nicotine. But they also caution that the rollout must be carefully managed to reduce health disparities, emphasizing certain communities, such as people with mental health or opioid disorders and menthol cigarette users, who may not experience the same level of benefit without targeted support.
“In general, this approach works for most people,” Toll said. “But for some groups, nicotine isn’t the only driver – it can also be about social or ritual aspects of smoking. That’s why it’s so important to pair this policy with counseling and cessation support.”
To maximize success, AACR calls for a comprehensive strategy that ensures access to affordable, evidence-based resources to help people to quit smoking, including tobacco control programs and quit-smoking helplines. AACR also urges public health campaigns to educate people about the risks of tobacco and the relative harms of different products and to engage with the community to build trust. Toll emphasized that maintaining these support services is critical, particularly as the Centers for Disease Control and Prevention (CDC)’s Office on Smoking and Health faces cuts.
“If this policy were to go through, we have to make sure appropriate treatments are ready to go,” he said. “We can’t reduce nicotine and call it a day.”
Just as critical will be safeguards to prevent illegal markets from popping up or industry loopholes that allow for manipulating products to maintain addictiveness. While the FDA would set and enforce the nicotine standard, collaboration with the CDC and state health departments would be critical for ensuring access to support services and outreach.
For now, the policy is still in the proposal stage, with the FDA required to review and respond to public comments before finalizing it. The ultimate timeline will depend on both the agency’s regulatory process and any legal challenges that arise. Despite these hurdles, Toll said the effort is worth it – and he is optimistic that the policy will ultimately move forward.
“We’re at a watershed moment in this country. Smoking causes such a high level of mortality and disease burden that if we can remove the truly addictive chemical and help millions quit, it would transform public health in a way we’ve never seen before.”
Journal
Clinical Cancer Research
Method of Research
Literature review
Subject of Research
People
Article Title
An AACR Policy Statement to Support a Federal Limit on Nicotine in Combustible Tobacco and Protect Public Health
Article Publication Date
6-Nov-2025
COI Statement
D.K.H. is a consultant for Eli Lilly and provides advice to Antidote Therapeutics. M.L.G. received a research grant from Pfizer and served on the Scientific Advisory Board of Johnson & Johnson. He has also consulted with the US Food and Drug Administration, World Health Organization, and Campaign for Tobacco-Free Kids on the toxicity of tobacco products and tobacco control policies. S.J.L. consults with two companies, Axsome Therapeutics and Flik Therapeutics, regarding the development of smoking cessation medications. He also serves on the external advisory committee for two FDA/NIH-funded TCORS grants and the Africa Centre for Tobacco Industry Monitoring and Policy Research. N.A.R. has consulted for and received a research grant from Achieve Life Sciences for an investigational smoking cessation medication. B.A.T. testifies on behalf of plaintiffs who have filed litigation against the tobacco industry. All other authors report no conflicts.
