Supreme Court Upholds FDA’s Graphic Warning Mandate
The United States Supreme Court has refused to hear an appeal by tobacco companies challenging the Food and Drug Administration’s (FDA) graphic warning requirements on cigarette packs and advertisements. The decision leaves in place a lower court ruling that the mandated health warnings do not violate the First Amendment rights of tobacco companies.
FDA’s Warning Rule
Implemented in 2020, the FDA requires that warnings illustrating the dangers of smoking occupy the top 50% of cigarette packs and 20% of advertisements. These warnings include graphic images such as amputated toes, a baby affected by stunted fetal growth, and a cancerous growth on a woman’s neck, alongside written descriptions of smoking-related health risks.
While the rule technically remains in effect, enforcement has been delayed due to ongoing legal battles. Tobacco companies, including RJ Reynolds, ITG Brands, and Liggett, filed a lawsuit in 2020, arguing that these warnings misrepresented or exaggerated the health risks and compelled the companies to propagate the government’s anti-smoking agenda.
Health Impacts and the FDA’s Stance
The FDA has justified the warnings as necessary to raise awareness about smoking risks and reduce public misconceptions. According to the agency, text-only warnings have proven insufficient, particularly in deterring teenagers from smoking.
Despite a significant decline in smoking rates in the US—from 42.6% of adults in 1965 to 11.6% in 2022—smoking remains a leading cause of preventable deaths, accounting for over 480,000 deaths annually, per the Centers for Disease Control and Prevention (CDC).
Legal Proceedings and Final Decision
In 2022, a federal district judge in Texas blocked the regulation, citing First Amendment protections. However, in March 2023, the 5th US Circuit Court of Appeals ruled that the warnings were factual and uncontroversial, meeting legal standards. The Supreme Court’s refusal to hear the appeal effectively upholds this decision.
Future Implications
While RJ Reynolds has declined to comment on the court’s decision, the ruling marks a win for public health advocacy. Meanwhile, the Supreme Court is set to hear a separate FDA-related case on December 2, addressing the agency’s rejection of flavored vape products.