Introduction

In the case of R.J. Reynolds Tobacco Company et al. v. Food & Drug Administration et al., the United States Court of Appeals for the Fifth Circuit delivered a landmark decision on March 21, 2024. This case challenges the Food & Drug Administration's (FDA) implementation of stringent warning labels on cigarette packaging, mandated under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009. The plaintiffs, comprising major tobacco manufacturers, argue that the FDA's rules violate the First Amendment, the Administrative Procedure Act (APA), and the TCA itself by compelling speech that they deem unconstitutional.

Summary of the Judgment

The Fifth Circuit reversed the district court's previous grant of summary judgment in favor of the plaintiffs regarding the First Amendment challenge. The appellate court held that the FDA's warning labels are both purely factual and uncontroversial, thereby falling under the Zauderer standard—a more deferential scrutiny applied to compelled commercial speech. Consequently, the Fifth Circuit concluded that the FDA's warnings do not violate the First Amendment and remanded the remaining claims, including those under the APA, for further consideration.

Analysis

Precedents Cited

The court extensively referenced several key precedents:

• ZAUDERER v. OFFICE OF DISCIPLINARY COUNSEL of Supreme Court of Ohio (1985): Established the standard for compelled commercial speech, requiring that the speech be factual and uncontroversial.
• Central Hudson Gas & Electric Corp. v. Public Service Commission (1980): Introduced an intermediate scrutiny for regulating commercial speech.
• Discount Tobacco City & Lottery, Inc. v. United States (2012): Upheld similar warning label requirements under the Sixth Circuit.
• NetChoice, L.L.C. v. Paxton (2022): Applied the Zauderer standard to compelled disclosures, finding them factual and uncontroversial.
• NIFLA v. Becerra (2018): Distinguished the application of the Zauderer standard in contexts involving controversial topics like abortion services.

Legal Reasoning

The Fifth Circuit analyzed whether the FDA's warning labels met the criteria set forth in Zauderer. The key points in the court's reasoning were:

• Purely Factual: The warnings convey information derived from the Surgeon General's report, addressing the health consequences of smoking. The inclusion of images does not alter the factual nature of the warnings, as they depict realistic and medically accurate representations of smoking-related conditions.
• Uncontroversial: The warnings are based on scientific consensus regarding the dangers of smoking. While the emotional impact of the images may be strong, the underlying facts they represent are not subject to legitimate debate.
• Legitimate State Interest: The FDA has a substantial interest in promoting public understanding of the health risks associated with smoking, especially given the historical context of misleading tobacco advertising.
• Not Unduly Burdensome: The size and placement of the warnings comply with the TCA's requirements, occupying no more than 50% of the packaging's front and rear panels. Moreover, the warnings do not override the manufacturers' ability to communicate their own messages within the remaining space.

Impact

This judgment reinforces the Zauderer standard as a viable means for the government to compel factual and uncontroversial disclosures in commercial speech without violating the First Amendment. It upholds the FDA's authority to mandate warning labels on tobacco products, potentially paving the way for similar regulations in other areas where the government seeks to compel factual disclosures. Additionally, by overturning the district court's decision, the Fifth Circuit strengthens the legal framework supporting public health initiatives aimed at curbing tobacco use.

Complex Concepts Simplified

Zauderer Standard

The Zauderer standard allows the government to compel individuals or entities to include factual and uncontroversial information in their speech or advertising without violating the First Amendment. For such compelled disclosures to pass constitutional muster, they must be:

• Purely Factual: The information must be verifiable and based on objective reality, not opinion or emotion.
• Uncontroversial: The facts presented must not be subject to legitimate dispute; they should be generally accepted truths.
• Legitimate State Interest: The government must have a significant interest in requiring the disclosure, such as preventing consumer deception.
• Not Unduly Burdensome: The requirement should not impose excessive restrictions on the speaker's ability to communicate their own message.

Compelled Commercial Speech vs. Speech Restrictions

Compelled commercial speech involves the government requiring individuals or businesses to convey specific information, whereas speech restrictions involve limiting or prohibiting certain types of speech. The constitutional analysis differs:

• Compelled Speech: Governed by the Zauderer standard if the speech is factual and uncontroversial.
• Speech Restrictions: Governed by the Central Hudson standard, which requires intermediate scrutiny focusing on the government's interest and the regulation's narrow tailoring.

Conclusion

The Fifth Circuit's decision in R.J. Reynolds Tobacco Company v. FDA solidifies the application of the Zauderer standard in cases of compelled commercial speech. By affirming that the FDA's warning labels are both purely factual and uncontroversial, the court has upheld the agency's authority to mandate health warnings on cigarette packaging. This ruling not only supports public health objectives but also clarifies the boundaries of First Amendment protections in the context of government-imposed disclosures. Future challenges to similar regulations will likely reference this decision, potentially shaping the landscape of compelled commercial speech across various industries.

The remand for APA claims indicates that further judicial scrutiny may address procedural or substantive issues related to the rule-making process. However, the affirmation of the First Amendment compliance sets a robust precedent for the FDA and other regulatory bodies aiming to implement public health measures through mandated disclosures.