Larry W. Faircloth v. U.S. Food and Drug Administration

You are here

No. 2:16-cv-5267 (S.D. W.V. 2016)

On June 10, 2016, Larry W. Faircloth, a user of e-cigarette devices and liquid nicotine, filed suit in the District Court of the Southern District of West Virginia. Faircloth has 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. In lieu of answering the complaint, the FDA filed a motion to dismiss the case on October 28, 2016.9 Faircloth filed a response to this motion on November 30, 2016, and the FDA filed a reply to plaintiff’s response on December 12, 2016.

On September 28, 2017, the court granted the motion to dismiss as to all claims but one, the claim that the deeming rule violates the first amendment. After setting a new briefing schedule for proceedings on that claim, on June 14, 2019, the parties agreed that the plaintiff would dismiss the case with prejudice.

The lawsuit alleged that:

  1. the FDA’s interpretation of the term, “tobacco product” is “not in accordance with the law” and “in excess of statutory jurisdiction,” a violation of the APA;
  2. the enforcement of premarket review against e-cigarette will drive up the costs for devices and liquids for consumers and push consumers toward cigarettes, rendering the FDA’s action “arbitrary and capricious,” a violation 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 rule will prevent consumers from receiving truthful and non-misleading statements and other forms of protected expression, such as free samples of products, an action that is “contrary to [the] constitutional right,” of free speech protected by the First Amendment, in violation of the APA; and
  5. by removing many e-cigarettes from the market, the FDA has prevented the state of West Virginia from reducing its Medicaid costs by promoting e-cigarettes over combustible tobacco products to reduce healthcare costs, depriving the state of its sovereignty, in violation of the Tenth Amendment’s protection of federalism.