By: Louis J. Terminello, Esq. and Brad Berkman, Esq.
Here we are, reporting an interesting development in the arena of regulated products announced via court order earlier this month. Though we’re a bit late in reporting the news, industry insiders may find this latest blog article informative.
For quite some time, the Food and Drug Administration (“FDA”) has been attempting to “deem” premium, hand-rolled cigars under the Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”). If the FDA was successful in deeming these products under the TCA, it would have been able to significantly expand its role to regulate the sales, marketing, and availability of said products.
In 2022, a federal court held that the FDA’s attempt at deeming was arbitrary and capricious since the FDA failed to consider available data concerning the use of premium cigars and their concomitant health effects, particularly on those under 21 years of age. As such, the Plaintiff in the case, the Cigar Association of America, asked the court to vacate the FDA’s decision to deem premium cigars. The FDA, to the contrary, “urged the court to remand without vacatur,” thereby leaving the rule intact.
The details of this matter and the rules and procedures are far too detailed for this short blog post. However, in 2014, the FDA proposed a deeming rule applicable to all products meeting the statutory definition of “tobacco products,” one of which included premium cigars. The FDA invited public commentary and commenced a review of the available data on the use of these cigars. According to the court, one of the “central questions in the rulemaking process was whether different kinds of cigars may have the potential for varying effects on public health, if there is a difference on their effects on youth initiation, and the frequency of the use by youth and young adults.” Also, according to the court, a “robust commentary about the merits of deeming premium cigars followed.”
It seems that the FDA either did not fully review, or intentionally ignored or misapplied, the available data to draw its desired conclusion of deeming premium cigars.
Fast forward to earlier this month, a federal judge for the US District Court for the District of Columbia agreed with the Plaintiff’s position and vacated the FDA’s deeming rule as applied to premium cigars, severely limiting the FDA’s ability to regulate them. Premium cigar manufacturers and aficionados alike were relieved by the initial ruling.
Please feel free to reach out to the Hospitality, Alcohol, and Leisure Industry Group at Greenspoon Marder if you would like additional information on this ruling and how it might affect your business.
