The Latest Ruling

On August 29th, Judge Lisa G. Wood of the U.S. District Court for the Southern District of Georgia struck down the U.S. Food & Drug Administration’s (FDA) graphic warning rule for cigarette labeling and advertisements, delivering the second setback this year for the agency’s long-running effort to require prominent health warnings. This setback continues a series of losses for the FDA regarding the Tobacco Control Act (TCA). Most recently, the U.S. Court of Appeals for the DC Circuit affirmed a U.S. District Court ruling that rebuked the FDA’s handling of premium cigars. In that ruling, Judge Amit Mehta of the U.S. District Court for the District of Columbia found that the FDA had acted arbitrarily and capriciously when it came to the agency ignoring evidence during the regulatory process that was presented by Cigar Rights of America that contradicted FDA assertions on the risk profile. This stunning victory for the premium cigar industry, represents the most significant rollback in tobacco regulatory policy in history and resulted in premium cigars being vacated from the FDA’s regulatory purview.

Regarding the graphic warning labels, in her opinion Judge Wood granted summary judgment to Philip Morris USA Inc. and other plaintiffs, finding that the FDA failed to disclose the raw data from the studies it relied on during the rulemaking process. This omission, she ruled, prejudiced the plaintiffs’ ability to meaningfully participate in the notice-and-comment process that is an important part of the Administrative Procedures Act (APA).

While Judge Wood concluded that the rule was not arbitrary or capricious and did not violate the TCA, the lack of transparency around the agency’s underlying data was enough to invalidate the rule.

January’s Ruling in Texas

Judge Wood’s ruling follows a January decision from Judge J. Campbell Barker in Texas, who temporarily barred enforcement of the graphic warning rule after finding that the FDA likely violated the APA. That ruling has since been appealed to the Fifth Circuit.

The overall dispute stems from the 2009 Family Smoking Prevention and Tobacco Control Act, which requires cigarette packages and advertisements to carry one of nine textual warnings specified in the statute and directs the FDA to create corresponding graphic warnings.

The FDA’s first attempt at implementing these rules in 2011 was struck down by the D.C. Circuit as a violation of the First Amendment. In 2020, the agency issued a revised final rule with 11 graphic warnings intended to promote greater public understanding of smoking’s health risks. Tobacco companies, including Philip Morris, challenged the rule, arguing that it exceeded the agency’s statutory authority and violated the APA.

What’s Next

With Judge Wood’s and Judge Barker’s ruling, the FDA’s 2020 graphic warning rule is again on hold. The decision underscores how FDA continues to struggle to craft graphic warnings that can withstand judicial scrutiny, whether on constitutional or procedural grounds.

The government is expected to appeal, meaning the case will likely remain tied up in litigation for the foreseeable future. These ongoing failures by the FDA not only represent a significant rebuke of the agency’s handling of the tobacco industry writ large, particularly in relation to the TCA, but also continue to result in a significant waste of taxpayer dollars to which the FDA should be held accountable.

For now, the statutory requirement remains in place that cigarette packaging carry one of the nine textual warnings outlined in the TCA, without the graphic depictions FDA has sought to mandate.

Broader Implications

Although the case directly concerns cigarette packaging, it has broader relevance for how courts assess the FDA’s regulatory authority and adherence to statutory boundaries. For the premium cigar industry, which has long argued that FDA’s regulatory approach fails to account for product distinctions, the litigation serves as another reminder of the importance of limiting agency overreach.

CRA will continue to monitor developments in this case and provide updates on what they may signal for the future of FDA tobacco regulation.

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