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The FDA is being challenged in the courts about their arbitrary rules against the premium cigar industry.

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Cigar Industry Asks Court To Drop Cigar Warning Labels, User Fees

Cigar Industry Asks Court To Drop Cigar Warning Labels, User Fees

In light of the U.S. Food and Drug Administration’s recent announcement that it would be reexamining its premium cigar regulations, the cigar industry has double downed on its FDA lawsuit by asking a judge in Washington D.C. to eliminate the agency’s costly user fees and warning label requirements.

The warning label requirements include larger health warning labels on boxes, more stringent placement of said warnings, plus the submission of a “warning plan” by manufacturers to the FDA to ensure random distribution of the new warnings. The requirements are scheduled to go into effect on August 10, 2018.

On March 23, the FDA issued an advance notice of proposed rule making seeking comments and scientific data related to the patterns of use and the health impact of premium cigars, which will be used to inform the agency’s new regulatory policies. According to a response filed by the cigar industry last week in its ongoing lawsuit against the FDA, called Cigar Association of America, et al. v. United States Food and Drug Administration, the FDA’s issuance “confirms that the agency is actively reconsidering the application of warning requirements to premium cigars.”

When the cigar industry argued its side of the FDA lawsuit in front of Judge Amit Mehta of the U.S. District Court for the District of Columbia last December, Mehta was concerned that the FDA’s Deeming Rule concerning premium cigars could potentially be restructured by the FDA itself.

In its response filed last week, the cigar industry highlighted part of Judge Mehta’s back-and-forth with Eric Beckenhauer, the trial attorney for Department of Justice, which is representing the FDA in the lawsuit:

THE COURT: So is it a possibility, in your mind, that the premium cigar industry is going to spend millions of dollars updating these boxes and putting labels on them, only to be told later on, didn’t have to do it?

MR. BECKENHAUER: Your Honor, again, I want to be cautious not to get ahead of the agency if the agency decides to take a different course. But what I would emphasize is —

THE COURT: I guess I just have a real problem, it seems to me, with a government agency telling an entire industry, spend millions of dollars to satisfy a regulation that we’re not sure is going to be on the books a year from now or two years from now.

In other words, Judge Mehta, who has yet to file his opinion in the case, has demonstrated that he is wary of getting ahead of the FDA, which has shown that it didn’t necessarily have all the evidence needed when it published its Final Deeming Rule. The cigar industry believes that the advanced notice of public rule making validates the judges concerns.

The FDA’s advanced notice of public rule making “highlights what we along with our industry partners and now even the court itself have recognized,” said Daniel Trope, senior director of federal government affairs for the International Premium Cigar and Pipe Retailers association. “Costly requirements under this rule were applied to the premium cigar retailers and manufacturers without sufficient evidence to back it up. The filing from our expert legal team was simply reinforcing that critical point.”

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