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A University of North Carolina at Chapel Hill clinical trial found that graphic health warnings on little cigars and cigarillos significantly increase users’ intentions to quit and promote behaviors linked to tobacco cessation. These findings could provide the cigar-specific evidence the FDA previously lacked in efforts to require cigar warnings.

Published in JAMA Network Open, the study, led by Adam O. Goldstein, MD, MPH, and a multidisciplinary team from UNC Family Medicine, UNC Lineberger Comprehensive Cancer Center and collaborating institutions, is the first rigorous trial to test the long-term impact of graphic health warnings on little cigars and cigarillos, a tobacco product often overlooked in public health regulation.

Addressing a Regulatory Blind Spot
While cigarette regulation has advanced over the years, little cigars and cigarillos, which are frequently flavored, inexpensive, and perceived as less harmful, have largely escaped similar scrutiny. These products are disproportionately used by young adults and Black or African American communities, exacerbating health disparities.

“Despite widespread knowledge that cigar smoking causes 9,000 premature deaths a year, little cigars and cigarillos have received little regulatory attention,” said Goldstein, Elizabeth and Oscar Goodwin Distinguished Professor and director of the Tobacco Intervention Program at UNC School of Medicine. “Our findings show that graphic warnings on little cigars and cigarillos can be a powerful tool to ultimately lower and prevent such deaths.”

Study Design and Major Findings
The randomized trial included 1,029 adult little cigars and cigarillos users across the U.S., who were assigned to one of three groups: those exposed to six new graphic health warnings, six current FDA text-only warnings, or no warnings. Over 21 days, participants viewed their assigned warnings once a week and completed daily surveys.

Key results include:

  • Increased Quit Intentions: Participants who saw graphic health warnings reported significantly higher intentions to quit (average score: 2.9 out of 4) than those who saw text-only (2.5) or no warnings (2.6).
  • More Quit Attempts: 40% of the graphic health warnings group reported a quit attempt in the past week, compared to 30% in the other groups.
  • Behavioral Shifts: Those exposed to graphic health warnings were more likely to “butt out” or skip using little cigars and cigarillos—behaviors linked to reduced use and future cessation.
  • Across almost all little cigars and cigarillos use behaviors, the current FDA text-only warnings had similar outcomes to the no warning condition.

“These are the strongest data yet showing that graphic warnings on little cigars and cigarillos can influence real-world quitting behaviors,” said co-author Kristen L. Jarman, MSPH.

Policy Implications
The study arrives at a pivotal time for tobacco regulation. Previous FDA efforts to require warnings on cigars have faced legal hurdles due to a lack of cigar-specific evidence. This trial fills that gap with robust, empirical data.

“Current FDA text-only warnings aren’t enough,” said Goldstein. “Our findings support the need for graphic warnings on little cigars and cigarillos packaging, both in the U.S. and internationally.”

The research aligns with global tobacco control efforts, including the WHO Framework Convention on Tobacco Control, which has led over 120 countries to adopt graphic warnings for cigarettes, but rarely for cigars.

A Public Health Opportunity
Given the disproportionate impact of little cigars and cigarillos use on vulnerable populations such as young adults who use little cigars and cigarillos at much higher rates, graphic warnings could be a vital intervention. “This is about more than regulation, it’s about protecting everyone from preventable harm,” said Chineme Enyioha, MD, MPH, a study co-author.

Looking Ahead
While the study’s three-week duration and controlled setting are limitations, the robust findings support a need for further research into long-term outcomes, real-world implementation, and the effects of larger warning labels. The authors also recommend exploring similar strategies for other cigar types and related behaviors, such as blunts (i.e., marijuana use in little cigars and cigarillos).

Research Team
The study was conducted by a collaborative team from UNC Family Medicine and the UNC Lineberger, including Goldstein, Jarman, Enyioha, Paschal Sheeran, PhD; Sonia A. Clark, MHA; Leah Ranney, PhD; Sarah D. Kowitt, PhD, MPH; and Nadja A. Vielot, PhD; Jennifer Cornacchione Ross, PhD, Department of Health Law, Policy, and Management, Boston University School of Public Health; James F. Thrasher, PhD, MA, MS, University of South Carolina Arnold School of Public Health; and Desmond Jenson, JD, Commercial Tobacco Control Programs, Public Health Law Center.

Funding and Disclosures
The study was supported by funding from the National Cancer Institute and the Food and Drug Administration Center for Tobacco Products. The authors reported no conflicts of interest.

Read the full article here.