FDA regulation of premium cigars 'arbitrary and capricious,' judge finds

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REUTERS/Amira Karaoud

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  • Judge finds agency ignored evidence in deeming premium cigars subject to same law as cigarettes
  • Cigar groups, FDA will submit briefs on remedy

(Reuters) - The U.S. Food and Drug Administration's decision to regulate premium cigars under the same federal law as other tobacco products like cigarettes was arbitrary and capricious, a federal judge ruled Tuesday.

U.S. District Judge Amit Mehta in Washington, D.C., said the agency had ignored relevant data about the health risks of premium cigar use. He asked the FDA and the industry groups challenging the regulations — the Premium Cigar Association and Cigar Rights of America — to submit briefs on whether he should vacate the FDA's decision or simply remand the matter back to the agency.

"The family-owned manufacturers and retailers that make and sell premium cigars have long believed the FDA mishandled its decision to regulate premium cigars," said Michael Edney of Steptoe & Johnson, a lawyer for the plaintiffs. "We are grateful for the court's decision and the opportunity for further proceedings in this matter."

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The FDA could not immediately be reached for comment.

The litigation focuses on the so-called Deeming Rule adopted by the agency in 2016, in which it identified a wide range of tobacco products, including premium cigars, to be subject to its regulatory authority along with cigarettes under the Family Smoking Prevention and Tobacco Control Act.

The plaintiffs said that the agency considered, and rejected, a carve-out for premium cigars, both before adopting the final rule and again in 2017 and 2018 when it solicited additional comments.

They said FDA rules requiring cigar makers to register their products annually and provide ingredient lists for each product, and requiring all products be submitted for laboratory testing, were impractical for hand-made, "artisan" premium cigars.

The industry groups said that, unlike cigarettes and e-cigarettes, premium cigars do not appeal to young people and are not associated with addiction. They cited studies showing that young people are unlikely to use premium cigars, that users of premium cigars are unlikely to smoke them frequently and that infrequent cigar use is not associated with increased mortality.

Mehta on Monday agreed that the FDA had not adequately considered the studies cited by the plaintiffs, instead asserting that there was "no evidence" that premium cigars were less harmful without directly addressing them.

"Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it," the judge wrote.

The case is Cigar Association of America v. U.S. Food and Drug Administration, U.S. District Court, District of Columbia, No. 16-cv-01460.

For Premium Cigar Association and Cigar Rights of America: Michael Edney of Steptoe & Johnson

For FDA: Garrett Coyle of the U.S. Department of Justice

Read more:

Premium tobacco cos tell judge FDA rules don't apply to artisan products

Medical associations back FDA in lawsuit over premium cigar rules

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Reporting By Brendan Pierson in New York

Our Standards: The Thomson Reuters Trust Principles.

Thomson Reuters

Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.