Synopsis

A cigar manufacturer challenged the FDA’s deeming rule under the Administrative Procedure Act (APA) as well as the First and Fifth Amendments of the U.S. Constitution. The case was administratively closed due to the delay of the premarket review requirements providing the cigar manufacturers “much of the relief they seek.”

Why it Matter for Public Health

The FDA’s regulatory authority over cigars has been subject to several legal challenges like this one.

Background

On May 5, 2016, the FDA issued the final rule deeming all existing and future tobacco products to be subject to the agency’s jurisdiction, including cigars.

District Court Proceedings

On June 1, 2016, Global Premium Cigars, LLC, a Florida manufacturer of cigars, and its proprietor Enrique Fernando Sanchez Icaza, filed suit in the District Court of the Southern District of Florida. The plaintiffs requested that the court issue a preliminary injunction barring enforcement of the deeming rule during the litigation, and asked the court to permanently strike down the rule.

The lawsuit alleged that:

1. the FDA’s Initial Regulatory Flexibility Analysis did not properly quantify the costs of the rule or identify significantly less costly alternatives to the rule, a violation of the RFA;
2. the enforcement of premarket review against cigar companies will be costly and there is no evidence to support the requirement that cigar boxes carry a warning label covering 30% of the principal display panel, actions that are “arbitrary and capricious,” violations of the APA;
3. the FDA’s cost-benefit analysis for the rule overstates the benefits and understates the costs, an action that is “without observance of procedure required by law,” a violation of the APA;
4. the required warning labels and the enforcement of premarket review with respect to labeling violate the First Amendment’s protection of free speech;
5. the implementation of required warning labels on cigar boxes amounts to a taking, a violation of the Fifth Amendment’s protection from unlawful governmental takings; and
6. the enforcement of premarket review with respect to all products marketed after February 15, 2007, violates the due process clause of the Fifth Amendment.

On July 31, 2017, the court granted a joint motion to stay the proceedings because the FDA’s newly announced regulatory plan for tobacco products “affords Plaintiffs much of the relief they seek.”

Due to the global COVID-19 pandemic, on March 13, 2020 the plaintiffs asked the court to re-open the case requesting emergency relief from the looming deadlines imposed by the AAP v. FDA remedy order. The parties withdrew the motion once it became clear that the remedy imposed by the court in AAP v. FDA was likely to be extended.

Litigation Status

The case has been administratively closed, though the parties may ask to reopen the case if necessary.