FDA Releases Guidance on Tobacco Product Warning Labels and Ads

Regulations by 2FIRSTS.ai
Sep.13.2024
FDA Releases Guidance on Tobacco Product Warning Labels and Ads
FDA issues new guidance on tobacco warning labels, following court challenges, with plans for enforcement in 2025.

On September 12th, the U.S. Food and Drug Administration (FDA) website announced that they are providing guidance on the final rule regarding "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements." The rule aims to promote greater public understanding of the negative health effects of smoking by adding new health warnings to cigarette packaging and advertisements.


The final rule was published in March 2020 and faced a challenge in the Eastern District Court of Texas. In December 2022, the district court overturned the rule. However, the government appealed this decision, and in May 2024, the United States Fifth Circuit Court of Appeals overturned the district court's ruling, reinstating the final rule, which is now officially in effect. The plaintiffs are now waiting for review by the Supreme Court.


In the newly released guidance document, the FDA plans to exercise enforcement discretion for 15 months or until December 12, 2025, generally not enforcing the requirements of final rules. For products manufactured before December 12, 2025, the FDA will also provide an additional 30-day grace period, or until January 12, 2026. The FDA has chosen a 15-month orderly transition period, consistent with the initially envisioned 15-month compliance period of the Family Smoking Prevention and Tobacco Control Act, but impacted by litigation proceedings.


The final rule also requires the industry to submit plans and obtain FDA approval to ensure that warning labels on cigarette packaging are displayed and distributed randomly and evenly, while rotating warning labels on cigarette advertisements quarterly. Therefore, entities with cigarette health warning plans that have not yet been approved are advised to submit such plans as soon as possible, but must do so within five months or by February 10, 2025. Entities that had previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.


Notice

1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.

2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.

3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.

Copyright

This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com

AI Assistance Disclaimer

This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.

This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.