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Federal Judge Invalidates

FDA Graphic Cigarette Health Warnings

The Food and Drug Administration’s (FDA) graphic cigarette health warnings are found unconstitutional.

Thomas Briant • NATO

On Dec. 7, 2022, the U.S. District Court for the Eastern District of Texas issued a decision vacating the Food and Drug Administration’s (FDA) graphic cigarette health warning regulations because the regulations violate the free speech protections under the First Amendment to the U.S. Constitution. By vacating the regulations, the graphic cigarette health warnings are nullified and devoid of any legal effect.

This is a significant legal decision for both cigarette manufacturers and retailers that sell cigarettes because the FDA graphic cigarette health warnings would have applied to not only cigarette manufacturers, but also to retailers, and there would be criminal and civil penalties if the regulations were violated by either a manufacturer or a retailer.

BACKGROUND

The Family Smoking Prevention and Tobacco Control Act, which is the federal law that authorized the FDA to regulate tobacco products, provides that the agency adopt new cigarette health warnings that have both words and a graphic picture to replace the current Surgeon General warnings that manufacturers print on the side of cigarette packages and on manufacturer-created cigarette advertisements. Note that the Federal Cigarette Labeling and Advertising Act, which is the law that requires the Surgeon General warnings be printed on cigarette packs and cigarette

advertisements, does not require retailers to print a Surgeon General warning on cigarette advertisements that the retailer itself makes or produces.

Eleven years ago, on June 22, 2011, the FDA issued its first rule (i.e., regulation) requiring nine text and graphic picture health warnings on the top half of the main front and back panels of cigarette packages and 20% of the top of cigarette advertisements made or produced by manufacturers or retailers. However, cigarette manufacturers sued the FDA, and the U.S. Circuit Court for the District of Columbia ruled that the graphic cigarette health warnings were unconstitutional because the government would be requiring private companies to advertise the government’s anti-smoking message. This Circuit Court ruling remanded the regulations back to the FDA to allow the agency to change the graphic cigarette health warnings to conform to constitutional standards.

FREE SPEECH UNDER FIRST AMENDMENT

The First Amendment to the U.S. Constitution protects the freedom of speech. This freedom includes the ability to speak and the right to not speak at all. The U.S. Supreme Court has also held that speech includes commercial speech, which is advertising. That is because advertising is how manufacturers and retailers “speak” to customers about the products that they sell. A government regulation requiring private companies to print and display anti-smoking graphic health warnings on product packages and in product advertisements has a direct impact on commercial speech and must meet constitutional standards.

To be constitutional, government mandated statements such as cigarette health warnings need to be accurate, non-controversial and factual. Moreover, the government statements must be narrowly drafted so as not to be more extensive than necessary.

SECOND GRAPHIC CIGARETTE HEALTH WARNINGS

On March 18, 2020, the FDA finalized a second rule with a new set of 11 graphic cigarette health warnings. Then, in April and May of 2020, two lawsuits were filed seeking to overturn this second set of graphic cigarette health warnings. One lawsuit was filed against the FDA by R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., ITG Brands LLC, Liggett Group LLC and several other companies. The second lawsuit was filed by Philip Morris USA Inc. and Sherman Group Holdings LLC.

The decision issued on Dec. 7, 2022, involved the first lawsuit filed by R.J. Reynolds Tobacco Co. and other plaintiffs. In this decision, the court determined that the second set of graphic cigarette health warnings violated the First Amendment’s right to refrain from speaking. That is, the government’s cigarette health warnings would have compelled manufacturers and retailers to speak by displaying cigarette packages on store shelves and advertising cigarettes when, if given the choice, manufacturers and retailers would choose not to do so.

Moreover, the court also found that the graphic cigarette health warnings were not purely factual, but rather open to interpretation by consumers. In addition, the warnings were not narrowly tailored, but rather more extensive than necessary. This means that the government could have pursued other, less burdensome alternatives, such as increasing funding for its own anti-smoking advertisements or expanding education efforts about the health impacts of smoking.

With the FDA’s graphic cigarette health warnings being vacated, the regulations have been revoked and cannot be enforced against manufacturers or retailers. This also means that retailers that create or produce their own cigarette advertisements are not required to file a graphic cigarette health warning rotational plan with the FDA, which describes what warnings would appear on retailer advertisements over a certain period of time.

At this time, it is not known whether the FDA will appeal the court decision vacating the graphic cigarette health warnings.

Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.