Tobacco Firms Urged to Submit Health Warnings

The U.S. Food and Drug Administration (FDA) is encouraging tobacco companies to submit their plans for compliance with the agency’s upcoming graphic health warning requirements as soon as possible, and in any event by March 16, 2021.

Following two postponements, the effective date for graphic health warnings is now Jan. 14, 22.

The FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” establishes new required cigarette health warnings for cigarette packages and advertisements. Each required warning, comprising a textual warning statement and its accompanying color graphic, must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020.”

The FDA says it intends to revise its relevant guidance documents related to the rule with the new effective date.

Tobacco companies may contact CTP with questions about the effective date.

The graphic health warning requirements had originally been scheduled to take effect on June 18, 2021. Due the Covid-19 pandemic, they were postponed to Oct. 16, 2021.

In November, R.J. Reynolds Tobacco Co., Liggett Group and ITG Brands, along with cigarette retailers, asked for further postponement. The companies argued they would suffer irreparable harm if they were forced to spend millions of dollars to comply with a rule that might soon be invalidated.

“These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated,” the companies stated.

On Dec. 2, the U.S. District Court for the Eastern District of Texas granted their request and postponed the effective date by an additional 90 days.