U.S. Health Warnings Date Pushed Back Again

Image: FDA

A U.S. court has postponed the effective date of the Food and Drug Administration’s graphic cigarette health warning regulation from Oct. 6, 2023, to Nov. 6, 2023, reports Convenience Store News. The ruling represents at least the 10th judge-ordered delay.

Issued on Nov. 7, the court order also pushes back the preferred filing deadline for manufacturers and retailers to submit cigarette health warning rotational plans to the FDA by 31 days, according to the National Association of Tobacco Outlets (NATO).

Each manufacturer and retailer that creates its own cigarette advertisements is required to file a plan with the FDA that sets forth the schedule for rotating the eleven graphic cigarette health warnings on cigarette advertisements. The preferred filing deadline for cigarette health warning rotational plans should now be Jan. 6, 2023, NATO said.

The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings must cover 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 addition, the warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette 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 to be thrown out in court.

In March 2021, the Texas District Court granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. The move was followed by additional postponements.