Naked 100 Manufacturer Sues FDA Over PMTA Delays and Vaping Product Enforcement

The manufacturer of the popular Naked 100 e-liquid brand has filed a federal lawsuit against the U.S. Food and Drug Administration (FDA), alleging unlawful delays in reviewing its Premarket Tobacco Product Applications (PMTAs). The lawsuit was brought by Schwartz E Liquid, doing business as USA Vape Lab, a Southern California–based independent vape manufacturer.

The complaint was filed on November 21 in the U.S. District Court for the District of Columbia and names the FDA, FDA Commissioner Martin Makary, the U.S. Department of Health and Human Services (HHS), and HHS Secretary Robert F. Kennedy, Jr. as defendants. The case centers on the FDA’s handling of PMTA reviews for vaping products and the agency’s growing enforcement actions against products still awaiting marketing authorization.

FDA PMTA Delays and the 180-Day Legal Requirement

Under the Family Smoking Prevention and Tobacco Control Act, the FDA is required to make PMTA marketing decisions “as promptly as possible,” and no later than 180 days after receiving an application. USA Vape Lab states that it submitted numerous PMTAs before the September 2020 submission deadline for e-liquids and vaping products.

Despite the clear legal timeline, the company claims it has waited more than five years for decisions on its applications, far exceeding the statutory 180-day window. The lawsuit argues that these FDA PMTA delays violate federal law and have created uncertainty for U.S.-based vape manufacturers that have attempted to comply with the regulatory process.

Vape Product Seizures and Increased FDA Enforcement

For several years following the PMTA deadline, the FDA largely exercised enforcement discretion, allowing vape products with pending PMTAs to remain on the market. This informal policy gave manufacturers confidence that they could continue selling their products while awaiting regulatory review.

According to the lawsuit, that approach changed in 2025, when federal authorities began targeting companies with pending applications. USA Vape Lab alleges that some of its products were seized during coordinated enforcement actions and raids that took place around September 10 at vape distributors and retail stores.

USA Vape Lab founder Huy Nguyen stated that the company had no choice but to file a lawsuit after years of inaction followed by sudden enforcement actions. The company argues that the FDA cannot legally ignore PMTA marketing applications for years and then penalize manufacturers for lacking marketing granted orders.

Lawsuit Seeks Court Order For FDA Action on PMTAs

The lawsuit asks the federal court to compel the FDA to complete its PMTA review process and issue marketing decisions within 90 days. This request is based on the Administrative Procedure Act, which allows courts to force agencies to act when they unlawfully delay required duties.

The case also challenges how the FDA evaluates flavored vaping products, particularly non-tobacco e-liquids. USA Vape Lab argues that the FDA should consider population-level public health benefits when weighing the risks and benefits of flavored e-liquids compared to tobacco-flavored products.

The company claims that adult smokers are more likely to successfully switch away from combustible cigarettes when they have access to flavored vaping products. In its PMTA submissions, USA Vape Lab states it provided extensive scientific data, including randomized controlled trials showing that approximately one-third of study participants using its flavored e-liquids were able to completely quit smoking cigarettes.

PMTA Lawsuits Grow as Vape Industry Challenges FDA Process

If the FDA ultimately rejects the PMTAs and issues Marketing Denial Orders (MDOs), USA Vape Lab has the legal right to appeal those decisions in a federal circuit court. Dozens of vaping manufacturers have already filed PMTA appeals, challenging how the FDA applies its standards.

This lawsuit is the second major case in recent months to challenge FDA PMTA decision delays. Earlier this year, NJOY, a vaping subsidiary of Altria Group, filed a similar lawsuit alleging that the FDA violated the Tobacco Control Act by failing to issue timely PMTA decisions.

As FDA enforcement against unauthorized vaping products continues to increase, lawsuits like this highlight ongoing legal and regulatory uncertainty across the U.S. vaping industry.