Tobacco Groups Win Court Challenge to FDA Warnings

WASHINGTON (CN) — U.S. regulators bungled a mandate for cigar and pipe tobacco packaging and advertising to include warnings similar to those used with cigarettes, the D.C. Circuit ruled Tuesday. 

The Food and Drug Administration adopted the regulation in 2016, making it unlawful to sell any cigar products without one of six rotating warnings that included information on various diseases and pregnancy risks.

While cigar packaging had to warn consumers about the product being addictive and not a safe alternative to cigarettes, pipe tobacco packaging had to include warnings that the product contains nicotine.

The regulations were meticulous, targeting everything from the size and color of the warnings to the centering of the font. 

Three cigar groups, including the Cigar Association of America, challenged the requirements in federal court, saying the FDA did not adequately consider how the warnings would affect their industry. 

A federal judge had sided with the government at summary judgment, but the D.C. Circuit reversed Tuesday, finding the government failed to follow all the rulemaking steps and take into account how the new warnings would affect the number of smokers — a requirement of the Tobacco Control Act. 

“In fact, the rule scrupulously avoids that issue, and the FDA barely even contends otherwise,” U.S. Circuit Judge Gregory G. Katsas wrote for a three-judge panel.

The Trump appointee also noted that by the FDA’s own estimate, the warnings would cost the industry over $100 million.

Attorneys for the FDA had called the new warnings “an effective means to help consumers understand and appreciate the risks of using tobacco products.” 

But the D.C. Circuit faulted the government for not considering whether the new information would increase or decrease the likelihood of consumers opting to pick up a cigar or pipe.

“By its terms, section 906(d)(1) required the FDA to ‘tak[e] into account’ whether the warning requirements would affect the number of smokers,” the opinion states. “Because the FDA declined even to consider that question, it violated section 906(d)(1) and acted arbitrarily and capriciously.’

Katsas said the rule had other shortfalls.

“For starters, the passage quoted by the district court failed to disentangle the effects of health warnings from those of age minimums and identification requirements, which involve not simply speech but outright prohibition of certain sales of tobacco products,” he wrote. 

“Moreover,” the judge continued, “the quoted passage does little more than parrot the governing statutory language, rather than set forth evidence or a reasonable explanation of the likelihood that the proposed warnings would cause smokers to quit and prevent others from starting.”

The Food and Drug Administration declined to comment on Tuesday’s ruling, citing a policy for pending litigation. 

On remand, the lower court must tackle constitutional arguments from the cigar groups that the warnings violated their First Amendment rights. 

Katsas was joined on the panel by U.S. Circuit Judge Merrick Garland, a Clinton appointee, and Senior U.S. Circuit Judge A. Raymond Randolph, a George H.W. Bush appointee.

The Cigar Association of America did not respond to requests for comment on Tuesday’s ruling.

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit