Vape Company Takes FDA to Court for Stalling Premarket Decision for Half a Decade

Key Points

• Plaintiff: Schwartz E-Liquid (USA Vape Lab)
• Defendant: U.S. Food and Drug Administration (FDA)
• Court: U.S. District Court for the District of Columbia
• Case Number: 1:25-cv-04093
• Main Allegation: FDA violated federal law by failing to rule on a PMTA within the required 180 days
• Requested Relief: Court order requiring FDA to issue a decision within 90 days
• Counsel: Thompson Hine LLP represents Schwartz

2Firsts, November 26, 2025 — According to Law360,California vape company Schwartz E-Liquid, doing business as USA Vape Lab, has filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia, accusing the agency of unlawfully delaying its decision on flavored e-cigarette products for five years — far beyond the 180-day statutory limit under the Food, Drug, and Cosmetic Act (FDCA).

In the complaint filed Friday, Schwartz said the FDA’s inaction has left the company in “limbo,” unable to plan its business strategy or decide whether to continue investing in its flavored products. The lawsuit argues that the agency’s failure to issue a decision effectively blocks lawful market participation and creates uncertainty for American manufacturers.

Schwartz further alleges that the FDA seized some of its products from a Chicago distributor despite claiming to exercise “enforcement discretion” toward products with pending premarket applications that were already on sale when FDA oversight began. The company contends that competing products remain on store shelves, while its own were unfairly targeted.

The complaint also accuses the FDA of favoring major tobacco firms — including Altria and Reynolds American — by conducting expedited reviews for their applications, even when those were filed long after Schwartz’s submission.

Schwartz is asking the court to compel the FDA to render a final decision within 90 days and to take into account the population-level reach of flavored products when evaluating their public health impact. The company argues that flavored e-cigarettes, while potentially less effective per user in reducing cigarette use, have far greater popularity and reach, resulting in a larger net reduction in smoking overall.

In a statement, Schwartz founder Huy Nguyen said:

“We felt that we had no choice but to initiate this lawsuit. The FDA has ignored its statutory duty for years while threatening American manufacturers with seizures over products that are still awaiting a lawful decision.”

The FDA did not immediately comment on the lawsuit.

Image source: Law360