Formal Request for FDA HPHC Testing Delay Expected This Month

Last week, the two sides of the main lawsuit over the U.S. Food & Drug Administration’s (FDA) cigar regulations gave a status update on where the legal battle is and should proceed in their respective opinions. Most of what was mentioned in a document sent to U.S. District Court Judge Amit P. Mehta was legal maneuvering, or potential legal maneuvering, but we now know that the cigar trade groups plan to file a formal request to delay an upcoming deadline for testing.

In December, attorneys for the three cigar trade groups responsible for the main lawsuit—Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR)—indicated they wanted FDA to delay the deadline for harmful and potentially harmful constituents (HPHC) testing.

Given that FDA has not delayed the Nov. 8, 2019 deadline, the attorneys have now indicated they will either amend the original complaint or file a separate complaint asking the court to delay the deadline. That request is expected within the next two weeks.

This article outlines HPHC testing in more detail.

Elsewhere, the two sides presented different timelines for a different lawsuit originally filed in Texas. That lawsuit was filed by En Fuego, a Dallas area cigar shop, El Cubano Cigars of League City and the Texas Cigar Merchants Association. While some of the complaints in the En Fuego case were similar to the original Cigar Association lawsuit, it raised other questions including how the FDA regulations would affect retailers.

FDA had asked the Texas court to combine the two lawsuits together, which was originally denied and then granted. The judge in the En Fuego case ultimately reversed her original opinion, later finding that the core of the Texas case—whether FDA should treat premium cigars differently—would ultimately be decided in the D.C.-based Cigar Association lawsuit.

Much of the arguments made in the Texas case last summer were centered around a then-upcoming deadline for warning labels to be placed on cigars. A decision in early July in the D.C. case delayed that requirement until an appeal was resolved.

Now—more than six months later—the two sides have proposed various schedules to resolve the merits of the En Fuego case. The cigar trade groups are pushing for an earlier schedule with the briefing stage resolved in April, FDA has proposed two different schedules—depending on whether the court will consolidate some matters—with briefs and replies due by either mid-June or the end of July.

In addition, attorneys for FDA indicated they will wait to see what the trade groups do in regards to three claims as part of the original lawsuit.

This status update was delayed due to the government shutdown.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.