Judge Amit P. Mehta of the U.S. District Court for the District of Columbia has ruled the U.S. Food and Drug Administration (FDA)’s requirements for warning labels are unlawful and has ordered those requirements to be vacated from the agency’s Deeming Rule on premium cigars. It essentially gives the premium cigar industry a major victory.
The decision found the “the FDA’s subjecting of premium cigars to warnings requirements to be arbitrary and capricious in violation of the APA (Administrative Procedure Act), insofar as the agency failed to provide a reasoned explanation for this action. The court thus declares unlawful and vacates that portion of the Deeming Rule that mandates premium cigars display designated public health warnings on packaging and advertisements.”
Details of the Warning Label Plan can be found here:
The court stated in the ruling:
“In summary, the FDA failed to articulate a reasoned basis for requiring warning labels for premium cigars. Despite its professed interest in ‘help[ing] correct current misperceptions about newly deemed products,’ Hr’g Tr. at 61, the agency did not separately consider whether users or prospective users of premium cigars in fact harbor misconceptions about the product or otherwise remain in the dark about the health risks attendant to premium cigar use. Instead, the agency focused only on the general ‘health risks of premium cigars,’ 81 Fed. Reg. at 29,020–27, and assumed that its findings as to the ‘established data on the health effects . . . of traditional large cigars’ are not only ‘applicable to . . . premium cigars, given that they share the same characteristics and are smoked in similar ways,’ 81 Fed. Reg. at 29,020, but also that these health effects are a sufficient basis for requiring warning labels. That approach was inadequate. ‘By failing to analyze’ whether consumers are in fact misinformed or underinformed as to premium cigar health effects, ‘the agency has failed to offer the rational connection between facts and judgment required to pass muster under the arbitrary and capricious standard.’.
While the cigar industry has not had many victories on the legal front, this has to be considered one of the largest as this essentially has thrown out a portion of the Deeming Rule.