A major independent American vape manufacturer has filed a lawsuit challenging the FDA’s delayed responses to vaping product marketing applications.
The lawsuit was filed by the Schwartz E Liquid, which does business under the name USA Vape Lab—manufacturer of the popular Naked 100 e-liquid brand. The company is based in Southern California.
The suit was filed Nov. 21 in the U.S. District Court for the District of Columbia, and names the FDA, FDA Commissioner Martin Makary, the Department of Health and Human Services (HHS), and HHS Secretary Robert F. Kennedy, Jr., as defendants.
FDA now enforces against applicants with pending PMTAs
USA Vape Lab filed numerous premarket tobacco applications (PMTAs) before the September 2020 PMTA submission deadline. However, despite clear language in the Tobacco Control Act assuring applicants that the FDA would render marketing decisions “as promptly as possible, but in no event later than 180 days after receipt,” the company has waited more than five years—about 10 times the guaranteed 180 days.
Until recently, the FDA tacitly allowed manufacturers to continue selling products with pending PMTAs without fear of enforcement actions. But, according to the lawsuit, some of USA Vape Lab’s products were targeted and seized by federal authorities during the Sept. 10 raids carried out on multiple vape distributors and retailers.
“We felt that we had no choice but to initiate this lawsuit,” said USA Vape Lab founder Huy Nguyen in a statement. “We cannot continue to live in a world where the FDA ignores for years the statutory requirement that it decide premarket applications in 180 days and then threatens American manufacturers with seizures of their products specifically because the products lack a marketing granted order.”
USA Vape Lab asks the court to order the FDA to do its job
The lawsuit asks the court to force the agency to complete its review of USA Vape Lab’s products and render a marketing decision within 90 days. The court is allowed under the Administrative Procedure Act to compel action by the FDA.
The lawsuit also asks the court to order the FDA, when reviewing the applications, to properly consider the “popularity, at the population level of the subject liquid products offered in flavors other than tobacco (i) when weighing the benefits of those products against the benefits of Plaintiff’s tobacco-flavored e-liquids and (ii) when weighing the risks and benefits of the non-tobacco-flavored e-liquids.”
USA Vape Lab says its PMTAs contain “extensive evidence of the population-level benefits of its flavored e-liquids,” including a randomized controlled trial that shows a third of study participants using its products achieved complete abstinence from cigarette use.
If the FDA rejects USA Vape Lab’s PMTAs and issues a marketing denial order (MDO), the company is allowed under the Tobacco Control Act to challenge the decision in a federal circuit court of appeals. Dozens of vape manufacturers havefiled MDO appeals in U.S. circuit courts.
The action by USA Vape Lab is the second recent lawsuit to allege that the FDA's PMTA decision delays violates the Tobacco Control Act. Altria Group vape subsidiary NJOY filed a lawsuit against the FDA in August, making similar allegations about the PMTA review process.
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