Synopsis

An e-cigarette user sued the FDA arguing that the deeming rule violates the Administrative Procedure Act (APA), as well as the First and Tenth Amendments of the U.S. Constitution.

Why It Matters for Public Health

The FDA’s deeming rule was subject to multiple challenges by e-cigarette manufacturers and retailers—this case is one example of a legal challenge filed by an e-cigarette user, reflecting the many different avenues that exist for legal challenge to federal regulations.

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 e-cigarettes and their components and parts.

District Court Proceedings

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 proceeded and asked the court to permanently strike down the rule.

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-cigarettes would drive up the costs for devices and liquids for consumers and push consumers toward combustible 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 of requiring premarket review of e-cigarettes, an action that is “without observance of procedure required by law,” a violation of the APA;
4. the rule would 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 effectively prevented the state of West Virginia from reducing its Medicaid budget by “compelling the state to expend money…on tobacco related healthcare costs,” in violation of the Tenth Amendment’s protection of the state’s rights.

In lieu of answering the complaint, the FDA filed a motion to dismiss the case on October 28, 2016 arguing that Mr. Faircloth lacked standing to challenge the Deeming Rule as a consumer of vaping devices. 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 all claims except for the claim that the deeming rule violated 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.

Litigation Status

Most of the claims were dismissed by the court and the First Amendment claim was voluntarily dismissed by the plaintiff. The case is closed.