The D.C. Circuit struck down new rules issued by the U.S. Food and Drug Administration that required health warnings on advertising and packaging for cigars and pipe tobacco. The court held that the FDA acted arbitrarily and capriciously in promulgating the rules because it failed to consider whether the new warnings would help increase or decrease the number of smokers.
Under the Tobacco Control Act, the FDA may regulate the sale or distribution of any tobacco product if it determines that the regulation "would be appropriate for the protection of public health." In order to make that determination, the FDA is required to consider the likelihood that the regulation will increase or decrease the number of tobacco users in the overall population.
The FDA issued a rule requiring cigar advertising and packaging to include one of six warning statements, which explain that cigar smoking causes various diseases, creates pregnancy risks, is addictive, and is not a safe alternative to cigarettes. The FDA also required a warning on pipe tobacco that explained that the product contains nicotine, which is an addictive chemical. In promulgating the rule, the FDA said that the "warning statements required by this final rule will help consumers better understand and appreciate the risks and characteristics of tobacco products."
Three cigar and pipe tobacco industry associations challenged the rule, arguing that the new warning requirements violated the Tobacco Control Act because the FDA did not adequately consider how the warnings would impact smoking. The district court agreed, but, on appeal, the D.C. Circuit reversed.
An agency action promulgating a rule is "arbitrary and capricious" if it fails to consider an important aspect of a problem before it, including any factor that is required to consider by law. Because the FDA did not consider whether the new warnings would increase or decrease the number of smokers -- as it was required to do -- the D.C. Circuit held that the FDA violated the Tobacco Control Act and acted arbitrarily and capriciously. The court concluded, "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."
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