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Judge Rules Against FDA in Regulation Lawsuit


The U.S. Food and Drug Administration must provide solid reasoning as to why it should regulate premium cigars, a federal judge said this week in a ruling in a six-year-old lawsuit from industry groups.

U.S. District Judge Amit Mehta in Washington, D.C in a 19-page decision said the FDA has failed in some cases to recognize studies that find premium cigar smoking does not represent a substantial health risk to the small number of adults that smoke them.

“The agency ignores or overlooks” evidence backing the claims of Cigar Rights of America and other trade groups challenging a 2016 decision by the FDA to regulate premium cigars. 

The plaintiffs, which also include the Premium Cigar Association and the Cigar Association of America, provided two studies as part of their argument as to why the FDA should not regulate premium cigars as it does other tobacco products, including convenience store cigars.

Both showed negligible effects of premium cigars on users and that young smokers rarely used them.

The FDA, though, ignored the data provided and instead alleged there was no data available for it to consider, the judge wrote. 

“…Instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue: “[T]here were no data provided…”, Mehta, an Obama appointee, wrote in his decision. 

Parties will now present briefs to the court on whether the FDA’s decision to regulate premiums should be vacated or if the question of regulation should be sent back to the agency for its reconsideration.

“The family-owned manufacturers and retailers that make and sell premium cigars have long believed the FDA mishandled its decision to regulate premium cigars,” Michael Edney of Steptoe & Johnson, the lead attorney handling the case, said in a press release. “We are grateful for the Court’s decision and the opportunity for further proceedings in this matter.”

In a press release, Drew Newman, general counsel of J.C. Newman Cigar Co., said the ruling “is a vindication of the premium cigar industry’s long and relentless campaign to show that there is not a scientific basis for regulating premium cigars like cigarettes.”

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