Considering FDA’s Authority on Graphic Warning Labels for Cigarettes: A First Amendment Challenge
In August, a group of tobacco companies filed a petition for certiorari with the U.S. Supreme Court (SCOTUS), seeking a review of a U.S. Court of Appeals for the Fifth Circuit decision that the First Amendment does not bar U.S. Food & Drug Administration (FDA) from requiring graphic warnings on cigarette packaging. Although this request may have escaped the notice of many, if SCOTUS agrees to hear the case, its ruling could significantly impact the premium cigar industry, especially if FDA attempts to regulate our industry again in the future. Currently premium cigars are not subject to regulation as a result of the August 2023 decision by the U.S. District Court to vacate FDA regulation of premium cigars. Prior to that decision, in February 2020, the same court vacated health warning requirements for cigars and pipe tobacco
How We Got Here:
In March of 2020, the U.S. Food & Drug Administration issued a final rule requiring new health warning statements, that would be accompanied by colorful photorealistic images, to cover the top 50% of the front and back panels of cigarette packs and the top 20% of cigarette advertisements.
In April 2020, a group of tobacco industry plaintiffs filed a lawsuit against FDA, claiming that its rule to implement new graphic health warnings on cigarette packages and advertisements violates (i) the First Amendment, (ii) the Administrative Procedure Act, and (iii) the health warning requirements outlined in the Family Smoking Prevention and Tobacco Control Act. In December 2022, the U.S. District Court for the Eastern District of Texas ruled in favor of the industry plaintiffs, granting summary judgment and vacating the FDA’s graphic warning rule.
In March 2024, the U.S. Court of Appeals for the Fifth Circuit reversed the District Court decision by finding that the FDA’s required warnings are permissible under the First Amendment.
Why It Matters:
From a tobacco and nicotine industry perspective, according to Bryan Haynes, Partner at the law firm Troutman Pepper, a Supreme Court ruling on the constitutionality of FDA-mandated graphic warnings would mark a pivotal regulatory development. Such a decision would not only directly affect the immediate issue of graphic warnings on cigarette packaging but also have broader implications for the authority of regulators to compel commercial speech across various industries. The outcome could set a precedent for how much control regulatory agencies, like FDA, have in enforcing speech-related mandates on companies.
This case is particularly important for those in the premium cigar industry. If SCOTUS upholds the lower court’s decision, it could restrict FDA’s ability to impose similar graphic warning requirements on premium cigars in any future FDA regulatory attempts. Since premium cigars are often marketed differently and target a specific demographic, the industry has consistently argued for a more tailored regulatory approach that distinguishes these products from other types of tobacco. A ruling in favor of limiting FDA’s authority could bolster this position, potentially leading to more lenient regulations for premium cigars in the future.
Given the potential impact on regulatory practices, both within the tobacco and nicotine sectors and in the broader consumer-packaged goods industry, members of these sectors should closely monitor the Supreme Court’s consideration of this petition. The decision could redefine the boundaries of regulatory power over commercial speech and set new standards for how products are marketed and labeled.
When Will We Know More:
Currently, the Supreme Court is on a break and will reconvene on the first Monday of October. As of now, the respondent—in this case, the Department of Justice (DOJ)—must file a brief arguing why the Supreme Court should not hear the case. After this, there is an opportunity for the tobacco companies to submit a reply brief if necessary. Once these briefs are submitted, the justices will review the petition, the opposing brief, and any reply brief to decide whether to grant or deny the request for certiorari. A decision from the Court on whether to hear the case will likely be made in late fall to early winter.