FDA regulation on handcrafted premium cigars vacated

FDA regulation on handcrafted premium cigars vacated

FDA regulation on handcrafted premium cigars vacated 800 449 Michel Arlia

The U.S. District Court for the District of Columbia vacated the U.S. Food and Drug Administration’s (FDA) regulation of handcrafted premium cigars. As a result, FDA no longer has the authority to regulate premium cigars in the U.S. This is a significant victory for the premium cigar industry and resulted from seven years of litigation. FDA could appeal this decision or restart the complex, multi-year process of trying to re-regulate premium cigars, but both seem unlikely.

In 2016, FDA decided to treat handcrafted premium cigars like cigarettes and other mass-market tobacco products and subject them to a massive regulatory regime. Unlike mass-produced products like cigarettes, premium cigars are boutique products, handcrafted in small batches mainly by small, family businesses. The cost to comply with FDA’s countless requirements for reporting, testing, and labeling threatened to destroy the premium cigar industry. On July 5, 2022, Judge Amit P. Mehta held that FDA’s decision to regulate premium cigars was “arbitrary and capricious” because the agency failed to consider evidence showing that premium cigars are used in moderation and have limited health effects. Today, Judge Mehta announced that the appropriate remedy is striking down the regulation of premium cigars.

Although the decision is a clear victory for the premium cigar industry in the U.S., the Court only provided relief for premium cigars that are entirely handmade. The Court did not include machine-made cigars rolled.