Court Clarifies Premarket and Substantial Equivalence for Premium Cigars

0
528
Hands Rolling Cigar

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 equivalence requirement. The FDA, through its Final Deeming Rule, deemed cigars (including premium cigars), pipe tobacco, and e-cigarettes to be subject to the Tobacco Control Act (TCA). The act of “deeming” these products made them subject to a host of automatic statutory requirements under the TCA, including the requirement that newly deemed products obtain premarket authorization before being introduced into commerce (otherwise known as “premarket review”). One form of premarket review, known as “substantial equivalence,” allows manufacturers to receive premarket authorization by demonstrating that a product is “substantially equivalent” to an existing product. The TCA accords the FDA no discretion to exempt “deemed” categories of products from the substantial equivalence process, but it does grant the FDA “broad discretion to ‘prescribe’ the ‘form and manner’ that the substantial equivalence reports must take.

“In view of this legal framework, the court did not “deem” vacated of the Final Deeming Rule insofar as it imposes premarket review requirements on premium cigars a legally viable remedy. Vacatur was not an option because the Final Deeming Rule does not itself impose the premarket review requirements on premium cigars–that is an automatic statutory consequence once a report is deemed subject to the TCA.”