A recent ruling by the United States Court of Appeals for the District of Columbia Circuit has dismissed a bid by the Cigar Rights of America (CRA) and Premium Cigar Association (PCA) to stop a federal lawsuit challenging the U.S. Food and Drug Administration’s regulation of premium cigars.

A few weeks ago, the CRA and PCA requested that the appeals court modify its January decision in Cigar Association of America et al. v. United States Food and Drug Administration et al. Their motion aimed to reverse the order that sent the case back to Judge Amit P. Mehta for a determination of the definition of “premium cigars.”

A January ruling in the case had upheld Judge Mehta’s August 2023 decision, which found that the FDA failed to adequately consider public comments regarding the distinct usage of premium cigars when drafting the 2016 deeming regulations. As a result, cigars classified as “premium” are currently exempt from these regulations—including requirements for product approval, advertising restrictions, and user fees.

The CRA and PCA, two of the three cigar trade groups that initiated the lawsuit in 2016, advocated for retaining the existing definition of premium cigars. The definition essentially covers nearly all handmade cigars that do not contain added flavorings. The third plaintiff, the Cigar Association of America (CAA), opposed the motion, with the primary area of contention revolving around the regulation of flavored cigars.

Michael Edney, lead attorney for CRA and PCA, argued that the FDA’s definition, established in the summer of 2020, was sufficient. He stated, “The government has informed us it does not intend to argue for a different definition before Judge Mehta.”

That ruling found that cigars that are exempt from FDA deeming regulations must meet all the following criteria:

• Wrapped in whole tobacco leaf.
• Utilize a 100% leaf tobacco binder.
• Contain at least 50% long filler tobacco (by weight).
• Be handmade or hand-rolled without extensive machinery use.
• Have no filters, non-tobacco tips, or non-tobacco mouthpieces.
• Lack any flavoring beyond tobacco.Contain only tobacco, water, and vegetable gum.
• Weigh more than 6 pounds per 1,000 units.

Edney contended that because the government did not challenge the 2020 definition during its appeal, there was no basis for the court to alter its previous ruling. The January decision stressed the need for a comprehensive debate on what constitutes a premium cigar—a debate that will now proceed under the oversight of Judge Mehta, who has managed the case since its inception.

The final determination could have lasting implications for regulatory practices and the broader tobacco industry.