Judge Extends Deadlines In FDA Lawsuit By 30 Days

Judge Extends Deadlines In FDA Lawsuit By 30 Days

In light of the U.S. Food and Drug Administration's new comprehensive plan for the regulation of tobacco products, a judge has granted an extension in the cigar industry's lawsuit that challenges the agency's controversial Final Deeming Rule, which places severe limitations on how cigars are made and sold.

Judge Amit Mehta, who sits on the U.S. District Court for the District of Columbia, yesterday granted a joint motion filed by both sides in the case that extends the briefing deadlines by 30 days. Mehta is presiding over the lawsuit that was jointly filed against the FDA last year by the three major premium cigar lobbying groups—the Cigar Rights of America, the International Premium Cigar & Pipe Retailers Association and the Cigar Association of America. The U.S. Department of Justice is representing the U.S. Department of Health and Human Services, the overseer of the FDA and the defendants in the case.

Before Mehta's decision, the DOJ had a deadline of August 1 to file its response to the cigar industry's motion for summary judgment, which was submitted in February. That deadline is now August 31.

According to the motion, the extension was sought "to consider the consequences of the new comprehensive plan on this litigation, to discuss ways to reduce the need to litigate some of the issues presented in this case, and, if necessary, to confer regarding the most efficient path forward for presenting any remaining challenges to the Rules."

In other words, the DOJ needs more time to figure out exactly how FDA Commissioner Dr. Scott Gottlieb's new tobacco regulation plan affects premium cigars. While Gottlieb extended the pre-market application deadline to 2021, which many in the cigar industry saw as a positive, it's unclear how his announcement affects many of the other rules that were outlined in the FDA's Final Deeming Rule.

Still up in the air are the rules pertaining to cigar brand registration and listing, health documents, advertising requirements and Harmful and Potentially Harmful Constituent reports.

This story is expected to develop in the next coming weeks.