Federal Court Strikes Down FDA Regulation of Handcrafted Premium Cigars

Court Found FDA’s Decision to Regulate Premium Cigars to be “Arbitrary and Capricious”

Today, 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 authority to regulate premium cigars. This is a major victory for the premium cigar industry and is the result of 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.

“We will never forget this day,” said Drew Newman, fourth-generation owner and general counsel of J.C. Newman Cigar Co. in Tampa, Florida.  “For the past seven years, we have been living in regulatory purgatory, knowing that scientific evidence does not support regulating premium cigars like cigarettes and complying with FDA regulation could crush America’s historic premium cigar industry, which is largely comprised of small, family-owned businesses like ours.”

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 largely 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 regulation of premium cigars.

“We are not anti-regulation,” said Newman. “The United States has regulated cigars since the 1790s. After today’s decision, premium cigars will still be regulated by ATF, CBP, FTC, TTB, and other federal agencies. Our family’s goal is to hand roll cigars 100 years from now the same way that we do today and that we did 100 years ago. FDA’s attempt to overregulate and treat premium cigars like cigarettes would have made this impossible.”

“Congress told FDA to regulate youth access and addiction in tobacco,” said Newman. “FDA regulation of premium cigars never made sense because, for nearly a decade, we presented evidence to FDA confirming that children do not smoke premium cigars, that adults enjoy premium cigars in moderation, and the health effects of such moderate use are limited.  Last year, the National Academies of Science, Engineering, and Medicine issued a 520-page report on premium cigars and largely agreed with our analysis of the science, concluding that the overall risk of premium cigars is ‘modest.’” 

Although today’s decision is a clear victory for the premium cigar industry, the Court only provided relief for premium cigars that are entirely handmade, including those that J.C. Newman imports from Latin America.  The Court did not include cigars rolled by hand-operated, antique cigar machines from the 1930s in J.C. Newman Cigar Company’s 112-year-old El Reloj cigar factory in Tampa, the last traditional cigar factory still operating in the United States. 

“Although we are thrilled that the Court has provided relief for cigars made entirely by hand, my family and I are disappointed that the Court did not provide relief for our historic Tampa cigar factory as well, particularly given that the science is the same” said Newman.  “Because we want to keep America’s cigar-making tradition alive, we will continue to petition the government to treat the cigars we handcraft in Tampa just like premium cigars imported from overseas.” 

“My family and I are very grateful to our industry’s three trade associations, the Cigar Association of America (CAA), Cigar Rights of America (CRA), and the Premium Cigar Association, for joining together to challenge FDA’s decision to regulate cigars in court five years ago,” said Newman.  “We are especially thankful to CRA, whose 2014 comments Judge Mehta cited as the primary basis for today’s decision and who funded the part of the litigation that led to today’s landmark decision.  We appreciate Michael Edney’s advocacy in litigating this case for the past 6 years, and we remain very grateful to Congresswoman Kathy Castor (D-FL) and Senator Marco Rubio (R-FL) for their unwavering support of Florida’s historic premium cigar industry in Congress.”