District Court Strikes Down FDA Warning Labels for All Cigars & Pipes

In a move that could end up being a mixed bag for premium cigar smokers, a federal appeals court has ruled that the U.S. Food & Drug Administration (FDA) cannot require warning labels for any cigar or pipe tobacco product.

In a 3-0 ruling, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the plaintiffs in the case of Cigar Association of America et al. v. United States Food and Drug Administration et al., i.e., the D.C. cigar lawsuit.

At stake was whether the FDA had met its legal obligations to require warning labels for cigar and pipe tobacco products. The court ruled it did not.

For premium cigar smokers, this ruling has no tangible positive benefits. Earlier this year, a U.S. District Court ruled that FDA could not require warning labels on premium cigars. Today’s decision throws out the district court ruling and modifies it to include all cigars and pipe tobacco products.

Judge Gregory Katsas wrote the opinion ruling that FDA failed to produce any evidence that the warning labels would actually reduce the number of smokers.

“The Deeming Rule does not consider the impact of health warnings on smoking cessation and adoption rates. In fact, the rule scrupulously avoids the issue, and the FDA rarely even contenders otherwise. Instead, the FDA candidly acknowledged that ‘[r]eliable evidence on the impacts of warning labels … on users of cigars [and] pipe tobacco … does not, to our knowledge, exist.'”

The Appeals Court specifically singled out a decision by the U.S. District Court to use language from a notice of proposed rulemaking (NPRM) to help navigate through its earlier decision. The appeals court ruled that the Administrative Procedure Act (APA)—a law that regulates executive agencies like FDA—requires a three-step process, something that isn’t satisfied by an NPRM, which is just a non-binding document the agency can release.

For premium cigar smokers, this could have unintended consequences.

The most obvious impact is that FDA is now likely more motivated to put warning labels back on cigars because it likely wants those warning labels on machine-made and flavored cigars. It seems likely that FDA might have left the warning label issue for just premium cigars alone, but now the target is bigger.

Secondly, the judge whose ruling was overturned—U.S. District Court Judge Amit P. Mehta—is hearing more on this case, specifically questions about product approval later this month. Mehta has delivered mixed rulings for the cigar industry, but this could impact his thinking going forward. He has already asked FDA to delay its product approval deadline in wake of the coronavirus COVID-19 pandemic, something the agency declined to do.

Finally, this means that FDA can once again avoid defining what a “premium cigar” is and is not. The agency has never done so, but Metha’s earlier ruling in regards to warning labels would have forced FDA to do so. Now, there’s no need for it and the agency likely will not.

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.