The U.S. District Court of the District of Columbia has vacated FDA’s warning label requirements for cigars and pipe tobacco.
If that sounds familiar, it’s because today’s ruling was more legal minutia than real-world change.
In February, Judge Amit P. Mehta—the same judge behind today’s ruling—ruled that FDA could not require warning labels for “premium cigars,” a term that had not yet been defined. In July, the U.S. Court of Appeals for the District of Columbia Circuit—a different court—ruled 3-0 to overturn Mehta’s ruling and apply it to all cigars and pipe tobacco.
That left the future for a new rule in legal limbo.
Today, Mehta granted vacatur, meaning that the warning label parts of the rule will be vacated in full. The Department of Justice—on behalf of the U.S. Food & Drug Administration—had requested that Mehta remanded the rule.
If the rule had been remanded, it would have created an easier pathway for FDA to introduce rules requiring warning label for cigars and pipe tobacco in the future. In short, FDA would have been able to submit its plans to the court and Mehta could have ruled as to whether FDA had corrected its error, specifically, the contention that the agency didn’t properly evaluate the effectiveness of warning labels against the impacts.
Instead, the plaintiffs in this case asked Mehta to formally vacate the rule, which he agreed to do.
This means that if FDA wants to introduce new rules for warning labels in the future it will have to start the process over from scratch. This would require a formal comment period, responses by FDA and then the introduction of new rules.