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Cigar Industry Argues In Court For Relief From The FDA

Dec 15, 2017 | By Andrew Nagy
Cigar Industry Argues In Court For Relief From The FDA

Months after filing legal motions that ask for preliminary relief from such impending FDA rules as larger cigar box warning labels and costly user fees, the cigar industry argued its case yesterday in court. Cigar Aficionado was present at the hearing.

An audience of about 30 people, most affiliated with the cigar industry, packed inside court room 10 to watch Judge Amit Mehta of the U.S. District Court for the District of Columbia hear both sides of the case, called Cigar Association of America, et al. v. United States Food and Drug Administration.

Jointly 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 U.S. Food and Drug Administration, the motions ask for, 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.

Two lawyers, Michael Edney, a partner at Norton Rose Fulbright, and Mark Raffman, a partner at Goodwin Procter, represented the cigar industry. Edney argued all of the contentions outlined in the motions, save for the issue of user fees, which Raffman handled.

Judge Mehta and Edney started off the proceedings with a lengthy back-and-forth argument regarding the FDA’s new warning label requirements. Essentially, the agency wants cigar manufacturers to affix larger warning labels, of which there are six different versions, on their cigar boxes, plus submit a plan to ensure random distribution of the new warnings. Additionally, cigar advertisements would be required to include a larger warning label, too.

Edney artfully summarized the cigar industry’s argument, which boils down to the warning labels violating the First Amendment and are “an unconstitutional restriction on commercial speech.”

“The warning labels crowd out the manufacturers’ communications with customers,” said Edney. “The FDA provided no evidence that larger warning labels will abate cigar use.”

After Edney spoke, the lawyer for the Department of Justice, which represents the FDA, was allowed time for a rebuttal. During the DOJ’s time, Judge Mehta brought up the fact that Dr. Scott Gottlieb, the FDA’s commissioner, announced earlier this year that the agency is reevaluating its regulation of the premium cigar industry.

“If FDA is still studying premium cigars, how can I make a ruling?” Judge Mehta asked. “I have a real problem with a government agency asking [premium cigar] companies to spend millions of dollars to satisfy the Deeming Rule when it may not be on the books a year from now.”

He continued to grill the DOJ lawyer on the matter of retailers also having to submit a warning label plan.

“I find it odd that the agency assumes [retail cigar shop owners] don’t know how to rotate,” Judge Mehta said.

After a short recess, Raffman got up before Judge Mehta to argue why the court should vacate the costly user fees framework included in the Final Deeming Rule. Raffman contested that the new rule is “not a user fee because we are being charged to cover the cost of e-cigarettes,” which aren’t required to pay user fees, yet.

Judge Mehta seemed less than enthusiastic about this argument, saying that he believes the Federal Smoking Prevention and Control Act, which gave the FDA the power to regulate tobacco, clearly shows that user fees can be applied to any newly deemed tobacco products, including cigars.

After three hours of deliberation, the proceedings were over. In his closing remarks, Judge Mehta acknowledged that the case “was unique” and said that he would get a decision to both parties “as soon as I can.”

It’s expected that his ruling won’t come until late January.

“Yesterday was a year in the making and a historic moment for the premium cigar industry,” said Glynn Loope, executive director of the Cigar Rights of America. “The presentation of the arguments by our legal team, and the questions and exchange with the judge, to me, highlighted the flaws in the Deeming Rule and the need for regulatory relief. Judge Mehta was obviously well-versed on the issues and seemed quite fair in the questions he posed to both side.”

FDA

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