U.S. Pictorial Health Warnings Postponed Again

The new effective date for the FDA’s final rule on health warnings is Jan. 9, 2023, after the U.S. District Court for the Eastern District of Texas ruled to extend the date in R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al.

Deadlines tied to the effective date have also shifted. For instance, while the FDA strongly encourages entities to submit cigarette plans as soon as possible, the deadline for submission is now March 12, 2022.

The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 directed the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements.

In March 2020, the FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings consisting of textual warning statements accompanied by color graphics, in the form of photorealistic images, depicting the negative health consequences of cigarette smoking.

The new graphic warnings, which depict some of the lesser known health risks of smoking, such as diabetes, must cover at least the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.

In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were ultimately thrown out in court.

The industry won several postponements of the new health warnings’ effective date in court.

This is the FDA’s second attempt to enact graphic health warnings under the TCA. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.