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).

  • United States
  • Dec 7, 2022
  • U.S. District Court, Eastern District of Texas

Parties

Plaintiff

  • R.J. Reynolds Tobacco Co.
  • ITG Brands LLC
  • Liggett Group LLC
  • Santa Fe Natural Tobacco Company, Inc.
  • Necom, Inc.
  • Rangila Enterprises Inc.
  • Rangila LLC
  • Sahil Ismail, Inc.
  • Is Like You Inc.

Defendant

  • U.S. Food and Drug Administration
  • U.S. Department of Health and Human Services
  • Robert Califf
  • Xavier Becerra

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

None

"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. . . ."