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FDA Regulations Struck Down

Today United States District Court Judge Amit Mehta rendered a ruling, as part of the Premium Cigar Association’s litigation against the Food and Drug Administration, striking down the FDA’s decision to regulate premium cigars as arbitrary and capricious.

This is the third major lawsuit with earlier challenges focused on particular regulatory consequences of the FDA’s decision to deem premium cigars involving warning labels and substantial equivalence and premarket review requirements.

Plaintiffs (PCA, CRA, and CAA) were represented by Michael Edney of Steptoe & Johnson LLP.

The Court agreed with the Plaintiffs that “the FDA’s decision not to exempt premium cigars altogether from regulation under the Final Deeming Rule was arbitrary and capricious.” As the Court explained, “In the end, 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 to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.” That statement was not accurate then, and despite litigation counsel’s efforts, it is not accurate now. 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 Court also criticized the agency’s handling of data when the FDA asserted that youth were using premium cigars.

Counsel will brief Judge Mehta on potential remedies for the defects in the agency’s decision to regulate premium cigars. later this month.

“This is another example of membership dollars at work and how important it is for our association to continue to challenge the FDA in the courts. There is still work to be done, but this is welcomed news on the eve of our industry’s gathering,” said PCA President Greg Zimmerman.

“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 Edney. "We are grateful for the Court’s decision and the opportunity for further proceedings in this matter.”

"We'd like to thank our industry partners, especially Cigar Rights of America for the many years of collaboration, support, and advocacy at all levels," added PCA Executive Director Scott Pearce.

The PCA will cover this decision in more detail and provide greater regulatory context during the Friday, July 8 Government Affairs session at the 2022 PCA Annual Convention & Trade Show.


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