LAKEVILLE, Minn. — On Feb. 3, 2020, a United States district court judge overturned a regulation from the U.S. Food and Drug Administration (FDA) that required six new health warning statements to be printed on premium cigar packaging, cigar boxes and premium cigar advertisements. Federal District Court Judge Amit Mehta found “the FDA’s subjecting of premium cigars to warnings requirements to be arbitrary and capricious in violation of the APA [Administrative Procedures Act], insofar as the agency failed to provide a reasoned explanation for this action.”
The FDA’s deeming regulation would have required that all premium cigar product packages must display one of the following six health warnings statements:
- WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
- WARNING: Cigar smoking can cause lung cancer and heart disease.
- WARNING: Cigars are not a safe alternative to cigarettes.
- WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
- WARNING: Cigar use while pregnant can harm you and your baby.
- WARNING: This product contains nicotine. Nicotine is an addictive chemical.
Each of these warning statements would have been required to appear directly on the two “principal display panels of the package,” making up “at least 30% of each of the principal display panels.” For cigars sold individually and not in a product package, the health warning would need to be posted at the retailer’s point-of-sale on an 8.5-by-11-inch “clear, legible and conspicuous” sign. As for print and other advertisements, the warnings statement would need to be located in the “upper portion of the area of the advertisement” and occupy “at least 20% of the area of the advertisement.”
The court held that one of the basic procedural requirements for a new regulation is that an agency provide adequate reasons for proposing the regulation, including a rational connection between the facts and the proposed regulation.
The court found that the FDA “failed to supply a reasoned explanation to substantiate applying health warnings to premium cigar products because the warnings themselves are factually unfounded for such products [and] the agency did not adequately justify the need for health warnings for premium cigars because premium-cigar consumers already appreciate the risks of regular use.”
That is, the FDA did not adequately justify why the health warning statements were appropriate for a distinct category of the cigar market—namely, the premium cigar.
The court not only vacated the premium cigar health warning statement regulation but also sent the matter back to the FDA for further review and proceedings. Although sellers of premium cigars are not required for now to provide these warning statements, further proceedings by the FDA or the courts could change this. It is necessary for retailers to stay on top of new developments as they occur and modify their procedures as needed to comply with the law.
Thomas Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at firstname.lastname@example.org.