In the back-and-forth legal battle to exempt cigars from the U.S. Food & Drug Administration’s regulation under the Tobacco Control Act, a Washington D.C. Court of Appeals has delivered a blow to the cigar industry. Yesterday morning, a panel of judges rejected an appeal filed in May by the cigar industry’s three major trade organizations.
The appeal was filed by The Cigar Association of America et. al., and challenged a previous decision made by D.C. District Judge Amit Mehta, which legally validates the FDA’s requirements for substantial equivalence and upholds the 2007 predicate date for cigars. A predicate tobacco product is one that was on the market as of February 15, 2007. Substantial equivalence is one of three legal pathways to product approval and is the most expensive.
“While we are obviously disappointed in [yesterday’s] ruling, CAA remains proud of the work and effort that has been made on behalf of the cigar and pipe tobacco industries to continue to fight against unreasonable regulation. We have had a lot of success in court in a number of different jurisdictions, and while [yesterday’s] loss is tough, we will not hesitate to take necessary action in the future to continue to protect the interests of the entire cigar and pipe tobacco industries,” said the Cigar Association of America in a statement.
All three presiding circuit judges were in agreement as they unanimously shot down every aspect of the Cigar Association of America’s appeal. The U.S. Court has ruled:
- The 2007 predicate date still stands (as the FDA cannot amend the terms set by the Tobacco Control Act)
- The FDA did not err in setting compliance dates
- The FDA did not fail to provide instructions for filing premarket review applications for substantial equivalence under the Deeming Rule.
Furthermore, the appellate court also rejected the claim that the FDA made a faulty cost-benefit analysis of the Deeming Rule. While the Cigar Association of America asserted that the FDA failed to properly assess the potential economic consequences of the Deeming Rule, the court disagreed.
The rulings have no immediate effect on current regulatory policies for premium cigars, and the deadline to submit premarket applications for new products is still unspecified.
It’s unclear whether or not The Cigar Association will appeal this decision. However, there’s still another pending case before Judge Mehta challenging the FDA’s decision to reject Option 2 of the Deeming Rule, which would exempt premium cigars from regulation. Drew Newman, fourth-generation owner and legal counsel for J.C. Newman Cigar Co. points out that yesterday’s rulings focused broadly on all cigars, whether made by machine or by hand.
“A key distinction is that this appeal relates to all cigars while the pending case before Judge Mehta concerns just premium cigars,” offers Newman. “Therefore, hopefully we’ll still get relief for premium cigars from Judge Mehta.”