Cigarette Health Warnings Effective Date Postponed

Following a court ruling, the U.S. Food and Drug Administration postponed the effective date for tobacco manufacturing companies to display new health warnings on cigarette packets and in advertisements, by additional 90 days.

The warnings with color images is to promote greater public understanding of the negative health consequences of smoking.

The move to extend the date was necessitated by a ruling by the U.S. District Court for the Eastern District of Texas in the case of R.J. Reynolds Tobacco Co. et al. v. U.S. FDA on December 2, 2020.

The court has now granted a motion by the plaintiffs to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule to January 14, 2022.

When finalized, the proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements on the cover of cigarette packets.

The Tobacco Control Act (TCA) has granted the FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products. FDA had noted that the Surgeon General’s warnings currently displayed in advertisements have been shown to go unnoticed and be “invisible.”

According to the new rule, color images, depicting some of the lesser-known, but serious health risks of cigarette smoking, will have to be printed prominently on each cigarette package and advertisement will have to bear one of the new textual cigarette health warnings. The FDA has proposed 11 new cigarette health warnings.

The new warnings must appear prominently on cigarette packages and in cigarette advertisements, occupying the top 50 percent of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of advertisements.

If implemented, it will be the most significant change to cigarette labels in the United States in more than 35 years.

The agency estimates that the U.S. tobacco industry will incur an additional expense of about $1.6 billion to make changes in the current format and provide the proposed health warning on cigarette packages.

According to FDA, cigarette smoking remains the leading cause of preventable disease and death in the U.S. It estimates that cigarette smoking is responsible for more than 480,000 deaths per year in the country. About 34.3 million U.S. adults and nearly 1.4 million U.S. youth, aged 12-17 years, currently smoke cigarettes.

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