Today, U.S. District Judge Amit P. Mehta ordered the U.S. Food and Drug Administration (FDA) to exempt premium cigars from tobacco regulations that the Agency put in place in 2016. This ruling, which follows nearly seven years of litigation, is a historic victory for the industry and a significant pushback against arbitrary FDA regulation.
Cigar Rights of America (CRA), which helped to fund the successful challenge along with the Premium Cigar Association, argued that the inclusion of premium cigars in a 2016 “Deeming” rule by FDA was fundamentally misguided and based on unsound science. In its appearance before the court on May 23, 2022, CRA demonstrated that the Agency had failed to demonstrate a public health rationale and improperly rejected a previously considered option to exempt the category.
On July 5th of last year, Judge Mehta agreed, ruling that the inclusion of premium cigars was arbitrary and capricious, in violation of the Administrative Procedures Act. Specifically, Judge Mehta found that FDA ignored scientific evidence on the use of premium cigars that CRA submitted and “instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue.”
“This is a great day for the premium cigar industry. Judge Mehta has handed down a scathing rebuke of the FDA and its rule. This underscores what we have been saying for years: premium cigars are different and should be treated as such.” Says Scott Pearce Executive Director of the Premium Cigar Association
Since that time, the industry has eagerly awaited today’s official announcement by the court that establishes a federal definition for premium cigars, allowing their exemption. The ruling effectively brings much-needed regulatory relief to the entire industry.
The Premium Cigar Association contributed both financially to the decades-long litigation fight and supplied key data and information utilized in this remedy, including state tobacco age of purchase data, and sounded the alarm on the impeding FDA proposal, including Tobacco Product Manufacturing Practices.
Robert Levin, president of CRA, stated upon learning of Mehta’s ruling, “today is a monumental day in the history of the premium cigar industry.” Levin continued, “The court’s ruling is further testament to the years-long effort by the CRA legislative and legal teams to give voice to our long-held belief that premium cigars should never have been regulated by FDA in the first place.”
“This is a day of victory for premium cigar manufacturers, retailers, and consumers. There is no better day to smoke a victory cigar than today”, says Greg Zimmerman, President Emeritus of the Premium Cigar Association.
The Premium Cigar Association will host a Facebook Live on Friday, August 11, 2023 at 2 p.m. to discuss the implications of this remedy and decision. The association will also publish an explanation primer this week for retailers and manufacturers.