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Federal appeals court overturns FDA tobacco warnings rule
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Federal appeals court overturns FDA tobacco warnings rule

The US Court of Appeals for the DC Circuit overturned a US Food and Drug Administration (FDA) rule on tobacco warnings on Tuesday, holding that the FDA did not adequately consider whether its regulation would have an impact on the number of smokers.

The case, Cigar Associations of America v. United States Food and Drug Administration, rose over the FDA’s promulgation of regulations that require “extensive health warnings on packaging and in advertising for cigars and pipe tobacco.” The FDA issued the rule to communicate health risks associated with smoking, but the DC Court stated that it “failed to consider how the warnings would likely affect the number of smokers.”

Taking into consideration whether a regulation will increase or decrease the number of smokers is a requirement under the Tobacco Control Act. The court drew particular attention to the fact that the FDA stated that “[r]eliable evidence on the impacts of warning labels . . . on the users of cigars [and] pipe tobacco . . . does not, to our knowledge, exist.”

The lower court had granted summary judgment to the FDA, and the DC Court reversed that ruling.