US: New health warnings on cigarette packages will not be implemented until end of 2025

The United States Food and Drug Administration (FDA) has released directions regarding the regulation of graphic warnings on cigarettes. The agency said it would not implement the new regulation until December 12, 2025.[1]. 

The Tobacco Products; Required Warnings for Cigarette Packages and Advertisements regulation requires cigarette manufacturers to rotate 11 health warnings on cigarette packages. These are combined text and color visual warnings that describe the negative health consequences of tobacco use. Manufacturers, wholesalers, and retailers must submit a plan to the FDA for rotating these warnings.

Effective implementation not before the end of 2025

The text includes provisions on the terms of application prescribed by the FDA. In particular, it mentions that the agency will exercise its discretionary power in matters of application and that a transition period of 15 months is provided, with entry into force as of December 13, 2025. This 15-month period corresponds to the transition phase initially envisaged in the text of the legislation on the prevention of family smoking and the fight against tobacco. It was renewed, the FDA noting that "the litigation [initiated by the manufacturers] had disrupted this timetable"

Manufacturers, wholesalers and retailers must submit to the FDA a plan for quarterly rotation of required warnings in cigarette ads. The plans must be submitted as soon as possible, “but in any event within five months, or before February 10, 2025,” the agency said.

These warnings must occupy the upper 50 % of the surface area of the front and back of cigarette packets and at least 20 % of authorized advertisements.

While most smokers are generally aware that tobacco use is harmful, they underestimate the severity and magnitude of the health risks. Given the scope and frequency of exposure to messages, many studies[2]-[3] demonstrate that health warnings on tobacco products are particularly appropriate for informing smokers and non-smokers about the risks associated with tobacco use. Finally, warnings contribute to reducing disparities in health knowledge by providing low-income smokers with regular access to health information.

The tobacco industry's constant opposition

The implementation of the new health warnings, which the Food and Drug Administration (FDA) had planned for in 2012, was delayed until 2020, following appeals by the tobacco industry against the measure. The regulation was published in March 2020, but it was challenged in court on several occasions by the tobacco industry. The Eastern District Court of Texas struck down the text in December 2022. The government appealed the decision, and in May 2024, the United States Court of Appeals for the Fifth Circuit in New Orleans reversed the district court's decision and unanimously upheld the legality of the graphic health warnings on cigarette packages. As a result, the reference text now in force is indeed the latest FDA regulation.[4].

A petition by the plaintiffs for Supreme Court review is pending, the FDA said.

Because of these tobacco company lawsuits, the United States currently ranks near the bottom of the world on this provision. It has lagged behind many countries in implementing this cost-effective measure, which is now required by 138 countries and territories worldwide. Indeed, in the United States, the way in which health messages are implemented has remained unchanged since 1984. Their effectiveness is particularly limited by the small size of the warnings, their placement, and the lack of a combined image.

©Tobacco Free Generation

AE

[1] Hannah Hammond, FDA Says It Won't Enforce Graphic Cigarette Health Warning Rule Until December 2025 at Earliest, CSP daily news, published September 12, 2024, accessed September 16, 2024

[2] Fong, Geoffrey T et al. “The impact of pictures on the effectiveness of tobacco warnings.” Bulletin of the World Health Organization flight. 87.8 (2009): 640-3. doi:10.2471/blt.09.069575

[3] Hammond D, Fong GT, Borland R, McNeill A, Cummings KM, Hastings G. Effectiveness of cigarette warning labels in informing smokers about the risks of smoking: findings from the International Tobacco Control (ITC) Four Country Survey. Tob Control. 2006;15(Suppl III):iii19–25. doi: 10.1136/tc.2005.012294

[4] Generation without tobacco, United States: Federal appeals court upholds legality of health warnings on cigarette packages, published on April 6, 2024, consulted on September 16, 2024