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An analysis of the US FDA’s final rule on health warnings for cigarettes

Published: 12th March 2024 | No. pages: 10
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Description

In March 2020, the US Food and Drug Administration (FDA) issued a final rule titled “Required Warnings for Cigarette Packages and Advertisements”, which stipulates new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic colour images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to foetal growth, cardiac disease, diabetes and more.

The FDA believes that pictorial cigarette health warnings promote greater public understanding about the negative health consequences of smoking as “they increase the noticeability of the warning’s message, increase knowledge and learning of the negative health consequences of smoking, and benefit diverse populations that have disparities in knowledge about the negative health consequences of smoking”.

This report examines the FDA’s final rule, provides analysis of the various arguments against it, and looks at its regulatory impact.

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  • A clear and detailed understanding of current regulatory requirements affecting this sector in a specific jurisdiction, enabling you to be confident your business and your products are compliant.
  • The ability to plan ahead for specific regulatory changes.
  • Strategic understanding of the policy climate within the jurisdiction, enabling you to forecast how it might affect business development.
  • Sources of further information, for example links to full texts of legislation and contact details for relevant government offices.

Table of contents

  1. Background
  2. What are the new textual warning label statements?
  3. Are heated tobacco products subject to the final rule?
  4. Legal challenge to the final rule by tobacco companies
  5. Timeline of delayed implementation of the final rule
  6. Amicus Curiae participation
  7. What do manufacturers need to comply with while the final rule is not enforced?
  8. The FDA’s regulatory impact analysis

Methodology

Our research is completely independent and original. It is conducted by TobaccoIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.

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Description

In March 2020, the US Food and Drug Administration (FDA) issued a final rule titled “Required Warnings for Cigarette Packages and Advertisements”, which stipulates new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic colour images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to foetal growth, cardiac disease, diabetes and more.

The FDA believes that pictorial cigarette health warnings promote greater public understanding about the negative health consequences of smoking as “they increase the noticeability of the warning’s message, increase knowledge and learning of the negative health consequences of smoking, and benefit diverse populations that have disparities in knowledge about the negative health consequences of smoking”.

This report examines the FDA’s final rule, provides analysis of the various arguments against it, and looks at its regulatory impact.

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    “ An analysis of the US FDA’s final rule on health warnings for cigarettes ”