Premarket and Substantial Equivalence for Premium Cigars Clarified by Court

New court documents filed in the case of Cigar Association of America et al. v. United States Food and Drug Administration addresses the issue of premarket review requirements for premium cigars.

The Cigar Association of America and other trade associations asked for clarification of the Aug. 19, 2020 court order that delayed the premarket review requirement for premium cigars [read more here]. The court stated that it declined to vacate the final deeming rule as it applies to premium cigars mainly due to the fact that the U.S. Food and Drug Administration (FDA) doesn’t have the authority to exempt “deemed” product categories from the substantial equivalence process, while it does have some say in how that process is carried out.

In this latest filing, the court states:
“The reason the court did not include vacate as a remedy in its August 19, 2020 Order is rooted in the source of the substantial…

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