Manufacturer of Naked100® E-liquids Files Suit Against the FDA for Unreasonably Delaying Review of Premarket Applications

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HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--Nov 25, 2025--

On November 21, 2025, the manufacturer of Naked100 ® e-liquids, USA Vape Lab, filed a lawsuit in the United States District Court for the District of Columbia against the Food and Drug Administration, the FDA Commissioner, Martin Makary, M.D, the Department of Health and Human Services, and its Secretary, Robert F. Kennedy, Jr.

In its complaint, USA Vape Lab alleges that it submitted extensive premarket applications for its bottled e-liquid products by the September 9, 2020 PMTA submission deadline and that, despite a provision of the Tobacco Control Act that requires the FDA to issue a final decision on those applications “as promptly as possible, but in no event later than 180 days after receipt of the [PMTAs],” USA Vape Lab has now been waiting over five years—that is, over 1,800 days—for a decision on its applications. USA Vape Lab thus requests that the court compel the FDA to make a final determination on USA Vape Lab’s applications.

USA Vape Lab also alleges that its applications contain extensive evidence of the population-level benefits of its flavored e-liquids, including data from a randomized controlled trial showing that, after six months, almost one-third of study participants had achieved complete abstinence from cigarette use—results that are two to three times the quit rates reported for FDA-approved nicotine replacement therapy products. USA Vape Lab also alleges that data from the study show that Naked100 ® bottled e-liquids in flavors such as Really Berry and Strawberry Pom produce a net positive population-level health impact, with benefits for adult smokers that outweigh any potential risk of youth initiation and with population-level magnitudes of benefit for the flavored e-liquids that exceed even those of the tobacco-flavored products. USA Vape Lab is thus also asking the court to compel the FDA to consider this population-level evidence of health benefits when it reviews the applications.

Huy Nguyen, USA Vape Lab’s founder, stated: “We felt that we had no choice but to initiate this lawsuit. 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 is a Huntington Beach, California-based small business that manufactures industry-leading bottled e-liquids under its Naked100 ® brand, including such flavors as American Patriots, Crisp Menthol, and Lava Flow.

To learn more about USA Vape Lab, visit https://usavapelab.com/.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251125657993/en/

Press Contact: Mr. Huy Nguyen atinfo@usavapelab.com.

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: PROFESSIONAL SERVICES WHITE HOUSE/FEDERAL GOVERNMENT PUBLIC POLICY/GOVERNMENT RETAIL LEGAL TOBACCO SPECIALTY

SOURCE: USA Vape Lab

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PUB: 11/25/2025 02:15 PM/DISC: 11/25/2025 02:15 PM

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