Enrique Fernando Sanchez Icaza and Global Premium Cigars, LLC v. U.S. Food and Drug Administration

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No. 1:16-cv-21967 (S.D. Fla. 2016)

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 have requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeds and asked the court to permanently strike down the rule. The FDA filed its answer on October 3, 2016.8

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.” The case may be reopened by a motion by one of the parties.