February 3, 2020 - US District Court Judge Ahmet Mehta today ruled against FDA and vacated the requirement for health warnings on premium cigar packages and advertisements. The court concluded that FDA failed to provide a “reasoned explanation” for requiring such warnings on premium cigars and that, based on “usage patterns and user demographics,” the FDA health warnings were not justified. As a result, the court vacated the health warnings provision, as to premium cigars.
The decision was in a case filed in Texas by Texas manufacturers and retailers, and transferred to Washington DC, where it was consolidated with the industry action pending there. Judge Mehta, who has had that case since it was filed in July 2016, previously upheld the health warning requirements as to all cigars, and the appeal of that decision is still pending in the DC Circuit Court. Notably, while the health warnings requirement has been vacated as to premium cigars, there is still no FDA definition for “premium” cigar. Accordingly, that definition remains unclear.
For context, premium cigar packaging panels (lid and front side) and conventional advertising (magazines and web content) would have been impacted because blatant warning messages would have been required to cover 20-30% of advertising in all media. Additionally, any contact beyond direct consumer engagement–social media posts, catalogs, email content, and most other avenues of communication would have been affected. The required warning statement regulation was set to take effect in August 2018 (see New FDA Webinar for Cigar Manufacturers: Required Warning Statements). Also see the the FDA's Cigar Labeling and Warning Statement Requirements effective August 13, 2018.
Drew Newman, General Counsel and Great-Grandson of the Founder of JC Newman Cigar Co., stated:
"Today is an important and historic day for the American premium cigar industry, and we should celebrate it. However, our victory is not complete. Premium cigars are still regulated by FDA, and we are 99 days away from the May 12, 2020 premarket review deadline. In three months, we will be required to file substantial equivalency reports for all new cigars first sold after 2007. This is a monumental and exorbitantly expensive requirement that no one has been able to meet, and we urgently need relief from it."
Going forward, non-premium cigars will be required to exhibit warning labels.