No. 2:16-cv-3468 (C.D. Cal. 2016)
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 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. The FDA answered the complaint on November 14, 2016.7
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.
On February 19, 2019 the plaintiffs’ attorney failed to appear at a scheduling conference at the case was dismissed.
The lawsuit alleged that:
- 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;
- 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;
- 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
- the FDA’s enforcement of premarket review against e-cigarette companies will be costly, an “abuse of discretion,” in violation of the APA.