Federal Judge Ruling Says the FDA Cannot Enforce Rule To Label Cigarette Packs With Warnings – Environmental Health Trust


A Texas federal judge ruled that the U.S. Food and Drug Administration cannot enforce a rule requiring tobacco companies to add graphic warning labels to cigarette packs saying the rule grates against tobacco companies’ First Amendment rights. Shortly after the FDA published its new graphic warning label rule, R.J. Reynolds Tobacco Company and several other manufacturers, distributers, and retailers filed suit against the FDA in U.S. District Court for the Eastern District of Texas. The ruling was a major win for the companies. The EU has had cell phone warnings for years.

“When I raise the  issue of cell phone radiation and compare it to smoking in the US, I am repeatedly challenged that ‘if if it were true that cell phones were harmful, they would at least label it.”  This ruling reveals the reality of corporate power. If  the US can’t get warnings about tobacco on cigarette packs, how can we expect this country to put warnings about cell phones? ,” stated Theodora Scarato Executive Director of Environmental Health Trust. “All cell phones have fine print warnings stating that they should be held at a specific distance from the body to ensure compliance with FCCs radio-frequency radiation limits, but most people are unaware, because there is no label here in the USA. Efforts to get a label result in a lawsuit, just like cigarettes.”

In the tobacco/FDA  case, the companies allege that: (1) the FDAs graphic warnings violate the First Amendment; (2) the Tobacco Control Act’s requirement that graphic warning labels be issued and occupy 50% of packaging and 20% of advertising violates the First Amendment; and (3) the FDA’s  issuance of the warnings violated the Administrative Procedure Act (APA).    The industry’s  challenge to the  warning label rule alleges that the rule uses “gruesome images” that are “designed to evoke negative emotions, such as fear and shock,” and that “misrepresent or exaggerate the potential effectives of smoking.”


In 2019, the  FDA had proposed new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking.

The Family Smoking Prevention and Tobacco Control Act (TCA) granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products. The TCA also amended Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), directing FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The TCA amends the FCLAA to require each cigarette package and advertisement to bear one of the new required warnings.

In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. The companies then sued.

Learn more

R.J. Reynolds Tobacco Company et al. v. U.S. Food and Drug Administration et al. (2020) | Public Health Law Center

Court Ruling Against FDA’s Graphic Cigarette Warnings is Wrong on the Law and Must Be Appealed | American Heart Association