The U.S. Supreme Court on Monday declined to hear an appeal by major tobacco companies, including RJ Reynolds, challenging federal regulations requiring graphic health warnings on cigarette packaging and advertisements. The decision leaves in place a lower court ruling that upheld the U.S. Food and Drug Administration’s (FDA) mandate.

The FDA’s regulation, adopted in 2020, requires graphic warnings to occupy the top 50% of cigarette packs and the top 20% of advertisements. These warnings include images such as a baby with stunted fetal growth, cancerous growths, and amputated limbs, alongside text descriptions of smoking-related health risks. The warnings aim to promote greater public understanding of the dangers of smoking, particularly among teenagers, as text-only warnings have been deemed insufficiently effective.

Although the regulation remains technically in effect, the FDA has largely refrained from enforcing it amid ongoing legal challenges.

RJ Reynolds, ITG Brands, Liggett, and other tobacco companies argued that the warnings violated their First Amendment rights by compelling them to endorse the U.S. government’s anti-smoking message. They claimed that the graphic depictions misrepresented or exaggerated the health risks of smoking, amounting to unconstitutional compelled speech.

In 2022, U.S. District Judge J. Campbell Barker in Tyler, Texas, sided with the tobacco companies, ruling that the warnings infringed on First Amendment protections. However, in March 2023, the New Orleans-based 5th U.S. Circuit Court of Appeals reversed this decision, finding that the warnings were “factual and uncontroversial,” meeting the legal standard for compelled commercial speech under the First Amendment.

The Supreme Court’s decision to decline the appeal effectively upholds the 5th Circuit’s ruling.

The FDA has defended the graphic warnings as a necessary tool to combat smoking-related health issues, which remain a leading cause of preventable death in the United States. According to the Centers for Disease Control and Prevention, smoking causes over 480,000 deaths annually, despite smoking rates dropping from 42.6% of American adults in 1965 to 11.6% in 2022.

The FDA argued that the graphic warnings are particularly important for deterring teenagers from smoking and reducing misinformation about the health consequences of tobacco use.

The Supreme Court’s refusal to hear the case represents a setback for the tobacco industry, which has long fought against increasingly stringent regulations. The decision may signal the court’s unwillingness to revisit established standards governing compelled commercial speech, particularly in cases involving public health.

When the government requires companies to include warnings on products, like graphic labels on cigarette packs, these rules must meet legal standards that balance public health needs with businesses’ free speech rights. These standards come from important court decisions that outline what the government can and cannot force companies to say.

Under the U.S. Constitution, the First Amendment protects free speech, including the speech of businesses. However, the government can require businesses to provide factual information if it serves a public purpose, such as protecting people’s health or preventing deception.

The courts use two main tests to determine if government-required warnings are fair. The first test focuses on clear and helpful information, as outlined in the key case Zauderer v. Office of Disciplinary Counsel. This ruling allows the government to require businesses to provide factual and non-controversial information if it helps people make informed decisions. For instance, warning labels on cigarette packages explain the health risks associated with smoking, enabling consumers to better understand its dangers. These rules are permissible as long as the information provided is accurate and does not place an undue burden on the business.

The second test balances rights and the public good, drawing from the case Central Hudson Gas & Electric Corp. v. Public Service Commission. This stricter test examines whether the speech relates to a lawful activity, whether the government’s goal—such as protecting public health—is substantial, whether the rule directly advances that goal, and whether it is narrowly tailored to avoid being overly restrictive. Courts often apply this test when businesses argue that government mandates go too far or compel them to endorse a particular viewpoint. Together, these tests help ensure that public health warnings strike a balance between protecting consumers and respecting business rights.

For cigarette labels, the government’s goal is clear: to inform people about smoking’s dangers and reduce confusion about health risks. The FDA argued that graphic warnings, like images of health problems caused by smoking, are more effective than text-only warnings, especially for discouraging teens from smoking.

Courts reviewing these warnings have mostly agreed that they meet the requirements under the Zauderer standard. They’re factual, tied to real health risks, and aim to address a significant public health concern: smoking still causes over 480,000 deaths in the U.S. each year, despite declining smoking rates.

Tobacco companies argue that these warnings do more than provide facts—they say the images are meant to shame smokers and advocate against smoking, which they believe violates their rights. This has led to years of legal battles.

For now, the 5th Circuit Court of Appeals has ruled that the warnings are lawful because they are factual and not overly burdensome. When the Supreme Court recently declined to take up the case, it left this decision in place.

The decision confirms the government’s ability to require warnings about health risks, as long as they stick to the facts and help people make informed choices. Whether it’s cigarettes, alcohol, or other products, these legal standards ensure that public health warnings stay focused on protecting consumers while respecting free speech.

RJ Reynolds declined to comment on the court’s decision.

While this case has concluded, the FDA remains embroiled in other legal disputes with the tobacco industry. On December 2, the Supreme Court is set to hear arguments in a separate case concerning the FDA’s denial of applications to sell flavored vape products.