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Judge Deems FDA “Unfair” in its Refusal to Postpone Cigar Warning Rule

Sep 11, 2019 | By Gregory Mottola
Judge Deems FDA “Unfair” in its Refusal to Postpone Cigar Warning Rule

Although the Food & Drug Administration wants to require premium cigar companies to put larger health warning labels on its packaging, the agency has yet to finalize the details of its own policy—and a D.C. federal judge says that the delay is unfair to the cigar industry.

According to a report by legal news service Law360.com, U.S. District Judge Amit P. Mehta said in a court hearing yesterday that there’s “something ‘unfair’ about the refusal to push off the effective date of the rule while it mulls new evidence, making ‘an industry expend millions of dollars to hurry up and rush to comply’ while the agency could still change its mind.”

The FDA was given authority to regulate the cigar industry in 2016, and one of its major mandates is a requirement for cigar companies to place large health warning labels that cover at least 30 percent of the cigar box. At this point, there is no set deadline for those warnings to appear, and the FDA remains undecided on many of the particulars for the warnings as it reevaluates its own policy and reconsiders details such as how broad the rule should be and whether there is any evidence that premium cigars pose less of a health risk than other tobacco products.

The cigar industry sued to block these warnings, in the case Cigar Association of America et al. v. U.S. Food and Drug Administration et al. This is part of two different legal cases against the FDA that the cigar industry is involved in, both of which are before Judge Mehta of the U.S. District Court for the District of Columbia.

Yesterday’s hearing wouldn’t be the first time that Judge Mehta criticized the FDA for its dubious policy pertaining to warning label requirements. Last year, the judge declared the FDA’s warning plan to “smack of basic unfairness,” even after ruling in favor of the FDA, saying that the health warning requirements are not in violation of the first amendment. The cigar industry appealed.

The delay has left cigar companies unsure of when these regulations will exactly go into effect. “Because of this ongoing litigation, there is no exact deadline for cigar warning labels,” said Drew Newman, general counsel for J.C. Newman Cigar Co. “It all depends on when the appeals will be exhausted. Generally speaking, we expect that to happen next year. I think that it would be safe to say that as of now warning labels will take effect next year unless a court throws them out.”

Yesterday’s court hearing was not a final judgment, and the cigar industry still awaits Mehta’s final decision from the bench on whether or not it will get an extended deadline to meet the FDA’s warning label requirements or if there is legal basis for the warning labels in the first place.

FDA

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