Synopsis

An e-cigarette manufacturer challenged serval aspects of the FDA’s deeming rule. The case was dismissed without any rulings on the substantive issued raised.

Why It Matters for Public Health

The FDA’s regulatory authority over e-cigarettes, hookah, cigars, and all other tobacco products was unaffected.

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 May 19, 2016, Lost Art Liquids, a California manufacturer of e-cigarette devices and liquid nicotine, filed suit in the District Court of the Central District of California. Lost Art Liquids requested both a preliminary injunction to bar enforcement of the rule while the litigation proceeded, in addition permanent invalidation of the rule.

The lawsuit alleged that:

1. the FDA’s Final 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 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;
3. the rule’s prohibition on using modified risk descriptors and the requirement that products bear warning labels violate the First Amendment’s protection of free speech and the Fifth Amendment’s protection from unlawful governmental takings; and
4. the FDA’s enforcement of premarket review against e-cigarette companies will be costly, an “abuse of discretion,” in violation of the APA.

After several delays to the court’s proposed briefing schedule, on November 13, 2017, the plaintiffs filed a motion seeking to compel the FDA to produce the administrative record without a protective order. On November 20, 2017, the FDA filed a memorandum in opposition to the plaintiffs’ motion and a hearing on that motion was held on December 12, 2017. On February 6, 2018 the court issued a protective order governing the disclosure of the administrative record. On February 21, 2018 the plaintiffs filed an objection to the protective order.

Litigation Status

On February 19, 2019 the case was dismissed after the plaintiffs’ attorney failed to appear at a scheduling conference.