R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration
Several tobacco manufacturers, distributors, and retailers challenged the U.S. Food and Drug Administration's (FDA) March 2020 graphic health warning rule on First Amendment grounds. Under the challenged rule, cigarette packaging and advertisements would be required to display graphic health warnings covering 50% and 20%, respectively. While this challenge was pending, the effective date of the rule was postponed several times.
In this ruling, the judge granted partial summary judgment in favor of the plaintiffs, holding that the rule is invalid under the First Amendment.
R.J. Reynolds Tobacco Company et al. v. U.S. Food and Drug Administration et al., No. 6:2020cv00176 - Document 106 (E.D. Tex. 2022).
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
A violation of the right to expression, free speech or similar right to express oneself without limitation or censorship. The industry may claim that a regulation infringes on their right to communicate with customers and the public. Similarly, they may claim that mandated warnings infringe on their freedom to communicate as they desire.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"Its verbal aspect makes a falsifiable claim—that smoking causes head and neck cancer. But it is unclear how a court would go about determining whether its graphic aspect is “accurate” and “factual” in nature. The image may convey one thing to one person and a different thing to another. One person might view the image as showing a typical representation of the sort of neck cancer caused by smoking before a person could seek medical treatment. Another person might view the image as showing a stylized, exaggerated representation of neck cancer, perhaps in an effort to provoke repulsion. Others might interpret the depicted person’s gaze, in conjunction with the text, as expressing regret at her choice to smoke or the message that smoking is a mistake. All of those interpretations would be at least reasonable. The imagery in the warnings here is provocative. As to each warning, it is not beyond reasonable probability that consumers would take from it a value-laden message that smoking is a mistake.138 For that reason alone, the graphics make all of the warnings here not “purely factual” and “uncontroversial” within the meaning of Zauderer. But that is just one possible interpretation of the graphic warnings. This highlights a broader problem. It is not apparent—and the FDA has not made a record-based showing—that each image and-text pairing conveys only one, unambiguous meaning that is factually correct. . . ."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
Several tobacco manufacturers, distributors, and retailers challenged the U.S. Food and Drug Administration's (FDA) March 2020 graphic health warning rule on First Amendment grounds. Under the challenged rule, cigarette packaging and advertisements would be required to display graphic health warnings covering 50% and 20%, respectively. While this challenge was pending, the effective date of the rule was postponed several times.
In this ruling, the judge granted partial summary judgment in favor of the plaintiffs, holding that the rule is invalid under the First Amendment.