According to the National Association of Tobacco Outlets (NATO), on Dec. 7, 2022, the U.S. District Court for the Eastern District of Texas issued a decision vacating the Federal 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 criminal and civil penalties would have been administrated if the regulations were violated by either a manufacturer or a retailer, said NATO.
The decision issued on Dec. 7 involved a lawsuit filed in April 2020 by R.J. Reynolds Tobacco Co. and other plaintiffs regarding a second set of cigarette health warnings. 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, NATO elaborated.
With the FDA’s graphic cigarette health warnings being vacated, the regulations have been revoked and cannot be enforced against manufacturers or retailers.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 which 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. NATO will update its members of any further legal actions regarding this litigation.