New warning requirements for tobacco products were ruled to violate the Tobacco Control Act and the Administrative Procedure Act in the DC Circuit Court of Appeals on Tuesday. The three-judge panel said the requirements which were introduced by the Food and Drug Administration (FDA) to communicate the health risks of smoking “failed to consider how the warnings would likely affect the number of smokers.”
The opinion was filed by Judge Katsas. He said the regulations would require extensive health warnings on advertisements or packages for cigars and pipe tobacco. “The warnings inform prospective and current smokers that cigars cause various diseases, create pregnancy risks, are addictive, and are not a safe alternative to cigarettes. The warnings must be printed on at least thirty percent of the two ‘principal display panels’ of each cigar package, with contrasting white-on-black or black-on-white ink,” the opinion stated.
The appeals court reversed the decision made by the District of Columbia District Court in its judgment claiming their interpretation “accords with common sense.” The warnings were required to cover four times the area on packages than under previous laws and would cost at least $100 million. The plaintiffs in the case were cigar associations who argued the warning requirements for cigars and pipe tobacco were “arbitrary and capricious.”
The opinion claimed that the FDA acknowledged there is no reliable evidence that warning labels impact cigar and pipe tobacco users. “Congress required the FDA to consider whether any regulation … 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,” the opinion stated.
Michael Edney of Steptoe & Johnson argued on behalf of the appellants, including the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America. Lindsey Powell with The U.S. Department of Justice represented the FDA.
Tobacco companies including R.J. Reynolds have also filed a lawsuit alleging these requirements are burdensome and asked them to participate in government anti-smoking advocacy.