D.C. Judge Rules For FDA On Cigar Lawsuit; Appeal Possible

D.C. Judge Rules For FDA On Cigar Lawsuit; Appeal Possible
In ruling, judge calls FDA action “grossly unfair” to premium cigar industry

A ruling just in from Washington, D.C. upholds much of the U.S. Food and Drug Administration’s stance against the American premium cigar industry, striking down most of the arguments made by the three main lobbying groups in their fight against FDA regulation. At the same time, the ruling judge expressed his displeasure with the FDA’s warning label plan, saying that it “smacks of basic unfairness.”

This morning, Judge Amit P. Mehta of the United States District Court for the District of Columbia ruled in favor of the Final Deeming Rule’s health warning requirements on cigar boxes and advertisements—finding they are not a violation of the First Amendment—as well as cigar industry user fees.

Several in the cigar industry who are close to the lawsuit said an appeal was possible.

Despite his ruling, Judge Mehta called out the FDA for its “grossly unfair” actions against the premium cigar industry. 

“The cigar industry has expended millions of dollars in designing and creating new, conforming packaging, a fact that the FDA does not contest,” Mehta wrote, in spite of the FDA being in a period where it is seeking comments from the public as pertains to premium cigars—comments that could result in a change to those requirements. “Why is the agency insisting that the premium cigar industry expend millions of dollars to conform to regulatory mandates that might be rescinded only months after their effective date? The FDA provides no satisfactory response to either question. Whatever the answers, one thing is certain: Requiring the premium cigar industry to incur substantial compliance costs while the agency comprehensively reassesses the wisdom of regulation, before the warnings requirements go into effect, smacks of basic unfairness. In the court’s view, the prudent course would be for FDA to stay the warnings requirement as to premium cigars.”

Mehta added: “The court’s displeasure with the FDA’s handling of the status of premium cigars, no doubt, provides little consolation to the industry.”

“From an initial reading of the judge’s cause of action, the judge felt that the industry has been faced with unfair burdens and costs from the FDA,” said cigarmaker Rocky Patel, of Rocky Patel Premium Cigars. “He felt that he could not rule against the warning stickers based on the applicable law as alleged in the plaintiff’s present complaint, but it seems he provided a pathway under a different set of applicable causes of legal action under which plaintiffs could possibly seek relief.” Patel said he hadn’t had time to completely digest the ruling.

“We are evaluating the opinion and our attorneys are evaluating all options to protect the industry from the rule,” said Glynn Loope, executive director of the Cigar Rights of America.

Today’s ruling is a result of legal motions filed in October by the three major cigar lobbying groups—The Cigar Association of America, International Premium Cigar & Pipe Retailers Association and the Cigar Rights of America—against the FDA. The groups had sought preliminary relief from such impending FDA rules as larger cigar box warning labels and costly user fees, and argued its case in court in December. The motions sought, among other things, the FDA to vacate costly user fees and set aside the warning label requirements scheduled to go into effect on August 10, 2018.

The lone bit of relief was in pipe tobacco, where the judge ruled against treating retailers who blend pipe tobacco in their stores as manufacturers.

This lawsuit was not the only one fighting FDA regulation. A group of Texas cigar retailers, and a cigar manufacturer based in that state, sued the FDA in January in the U.S. District Court for the Eastern District of Texas. The fate of that lawsuit is still pending.

This is a breaking situation, which Cigar Aficionado will update.