Judge Amit P. Mehta of the U.S. District Court of Columbia has ruled the U.S. Food and Drug Administration’s decision to not exempt premium cigars from regulation on the Final Deeming Rule was arbitrary and capricious. While Mehta’s decision does not throw out the Deeming Rule, he is asking the cigar industry and FDA to prepare briefings before July 26, 2002, before deciding on a remedy.
In a concurrent ruling, Mehta decreed against the cigar industry when it said that the FDA failed to consider the costs and benefits of subjecting small businesses within the premium cigar industry to regulation, as required by the Regulatory Flexibility Act.
Judge Mehta ruled: “there 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.” 81 Fed. Reg. at 29,020 (emphasis added). In other words, the agency did not evaluate the data on premium cigar usage patterns and “reasonably explain” why those patterns did not reduce public health risks.”
The second decision involved misleading data by the FDA in a study done by Christine Delnevo. The study found 3.8% of 12 to 17 years olds claimed to smoke a cigar over a 30-day period, but 3.3% of them smoked a premium cigar. When looking at 3.3% of a 3.8% percent of a population of 12 to 17-year-olds estimated a 25,000,000 – it comes out to 0.1% or 31,350. The judge said this essentially flies in the face FDA’s exertion that: “Although youth and young adults tend to smoke mass market cigar brands, they are also using premium cigars” and ruled the FDA acted arbitrarily and capriciously.
The next steps are still a little unclear. While today’s ruling doesn’t nullify the Deeming Rule, it could lead to that.
Even so, the cigar industry is claiming victory:
“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 in a statement.
“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 Michael Edney, legal counsel for the cigar industry. “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.