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Federal Court Overturns FDA Premium Cigar Warning Labels

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their February 5th online bulletin. Reposted with permission.

A United States federal district court judge issued a ruling on February 3, 2020 “vacating” or overturning the FDA’s deeming regulation that required six new health warning statements for premium cigars to be printed on premium cigar packaging/cigar boxes and premium cigar advertisements.  In the decision issued by Federal District Court Judge Amit Mehta, the court found that “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 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 appear directly on the two “principal display panels of the package,” comprising “at least 30 percent of each of the principal display panels.” For cigars that are sold individually and not in a product package, the health warnings statement would need to be posted at the retailer’s point-of-sale on an 8.5 x 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 percent of the area of the advertisement.”

In its ruling, the court states 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 sent the matter back to the FDA for further review and proceedings.