The United States Court of Appeals for the District of Columbia Circuit unanimously ruled in favor of the Premium Cigar industry today, by striking down a former ruling that warning labels are required on cigar products. The court ruled that the FDA warning labels are “arbitrary and capricious.” The complete opinion of the court can be found here.
The panel of three appellate judges noted that FDA’s proposed cigar warnings are four times the size as existing health warnings and would cost the cigar industry $100 million to implement. The FDA rule would have made it unlawful to manufacture or sell any cigar product without one of six rotating warning statements.
The FDA had argued:
“The warning statements required by this final rule will help
consumers better understand and appreciate the risks and
characteristics of tobacco products.”
Circuit Court Judge Gregory G. Katsas noted in today’s ruling:
“The Tobacco Control Act permits the Food and Drug Administration to regulate tobacco products for the public health, but only after considering whether the regulation would likely increase or decrease the number of
smokers. Under this authority, the FDA promulgated regulations requiring extensive health warnings on packaging and in advertising for cigars and pipe tobacco. The FDA concluded that these warnings would help communicate the health risks of smoking, but it failed to consider how the
warnings would likely affect the number of smokers. We hold that this failure violated the Tobacco Control Act and the Administrative Procedure Act.”
In closing, the court ordered:
“Congress required the FDA to consider whether any regulation under section 906(d)(1) would likely affect the number of tobacco users. In promulgating the warning requirements for cigars and pipe tobacco, the FDA failed to satisfy that obligation. We therefore reverse the grant of summary judgment to the FDA and the denial of summary judgment to the plaintiffs. Given our disposition on the merits, we dismiss as moot the plaintiffs’ appeal from the denial of their motion for a preliminary injunction. Finally, we remand to the district court for further proceedings consistent with this opinion.”
This is a significant win for the Premium Cigar industry in the long fight to overturn the FDA regulations on the industry.
On news of the announcement, Drew Newman, general counsel of J.C. Newman Cigar Co., America’s oldest family-owned premium cigar company. stated:
“We have long believed that there is no legal or scientific basis for FDA to regulate premium cigars like cigarettes. Today, the U.S. Court of Appeals for the D.C. Circuit agreed, concluding that FDA ‘acted arbitrarily and capriciously’ in deciding to require massive new warning labels on cigars. Today’s decision also raises serious questions about the legality of health testing, premarket review, and other costly and onerous requirements of FDA regulation.
In light of today’s decision, we hope that the courts and FDA will reconsider the regulation of premium cigars altogether. As an industry of small, family-owned businesses that handcraft natural products in small batches, regulating premium cigars like cigarettes simply does not make sense.”
Javier Estades, head of premium cigar operations for Tabacalera USA and chairman of the Cigar Association of America exclaimed:
“We are very pleased to see that after all our efforts, the D.C. Court of Appeals court has reversed the District Court, holding that the FDA health warnings for cigars violated the Tobacco Control Act and are therefore improper on any type of cigars. This is truly a victory of the industry and proves that working together makes us stronger.”
Cigar Rights of America Executive Directory, Glynn Loope, added:
“This pronouncement by the court ratifies what the courts and members of Congress have been saying for years: A reflexive, unstudied, ‘one-size-fits-all’ approach to regulation simply doesn’t work. For all too long, that has been the approach of the agency, and the courts continuously tell them they’re wrong.
It’s time for court decisions like today, and messages from hundreds of members of Congress from both sides of the aisle to be heard: Exempt premium cigars from the most onerous elements of these regulations, and reform the most economically threatening rules that have already been implemented.”
The next step will be July 22, when the Premium Cigar industry will present its case challenging the FDA regulation in its entirety before Judge Amit P. Mehta of the U.S. District Court for the District of Columbia.