Nearly $33.8 Million Worth Of Unauthorized E-Cigarettes Seized By FDA And U.S. Customs

May 22, 2025 – Chicago, IL – In a significant enforcement operation, the U.S. Food and Drug Administration (FDA) in coordination with U.S. Customs and Border Protection (CBP) announced the seizure of nearly 2 million units of unauthorized vape and E-cigarette products at the Chicago port of entry, with a total estimated retail value of $33.8 million. This unprecedented crackdown underscores federal authorities’ intensifying efforts to block the importation and distribution of illicit vapor products, most of which are fruit flavored vapes originating from China.

This seizure is part of a larger, federally coordinated campaign aimed at curbing the rising influx of unregulated vape products in the U.S. market, particularly those that pose a significant health risk to American youth. According to the FDA’s official statement source, the seized items violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) and lacked the mandatory Premarket Tobacco Product Application (PMTA) authorization—making their sale and distribution within the U.S. illegal.

A Breakdown of the Operation

The enforcement action began in February 2025, as a collaborative initiative between the FDA’s Center for Tobacco Products (CTP) and CBP. The investigation led to the interception of multiple shipments of unauthorized electronic nicotine delivery systems (ENDS).

“We continue to uncover large volumes of e-cigarette products attempting to evade federal inspection through mislabeling, price manipulation, and packaging camouflage,” said Bret Koplow, acting director of the FDA’s CTP. “Even when these products attempt to hide their true identity, our agents are equipped to detect and stop them from entering the U.S. supply chain.”

These illegally imported vapor devices and fruit flavored e-cigarettes were mostly mislabeled in an effort to bypass both tariff assessments and federal safety reviews. The items were falsely declared with vague product descriptions and undervalued invoices, a tactic often used to obscure the true nature and worth of the cargo.

The China Connection: Dominant Source of Unauthorized Vape Imports

According to the FDA, the vast majority of seized shipments originated in China, reaffirming the country’s prominent role as a manufacturing hub for fruit flavored vapes, nicotine pods, and disposable E-cigarettes. Although many of these products are legally sold in other markets, they are not authorized for sale in the U.S. without FDA approval.

“FDA and its federal partners will continue taking aggressive steps to prevent illegal vape products from entering and spreading within the U.S.,” stated Dr. Marty Makary, the newly appointed FDA Commissioner. “Blocking the flow of unauthorized E-cigarettes protects our youth from exposure to addictive nicotine and unlawful marketing tactics.”

Key Legal Violations

The seized products were found to be in violation of multiple federal statutes, including:

FD&C Act – for lacking PMTA authorization;
Intellectual Property Violations – some units used copyrighted trademarks without permission;
False Customs Declarations – many importers submitted misleading or fraudulent documents.

In response, the FDA issued Import Alert notifications to 24 importing firms and customs brokers associated with these shipments, outlining their potential violations of federal criminal statutes related to import declarations. These notices require importers to provide a written explanation of how they will comply with U.S. tobacco laws within 30 days.

FDA’s Expanding Enforcement Footprint

This is not the first time the FDA and CBP have taken decisive action against illegal vapor products. Previous major seizures include:

Los Angeles International Airport (2023) – $18 million in unauthorized vapes seized;
Miami Warehouse (2023) – $7 million worth of illegal vapor products confiscated;
Chicago (June and October 2024) – combined $77 million in illegal E-cigarette seizures.

In total, the FDA has issued:

Over 750 warning letters to manufacturers and distributors;
More than 800 warnings to retail stores;
Fines and civil suits against 87 manufacturers and over 175 retailers.

This aligns with the U.S. government’s comprehensive strategy to enforce the Tobacco Control Act, which includes regulatory control over ENDS, nicotine vapes, and flavored vape products. Photos-of-some-of-the-seized-products-displayed-by-the-FDA

Youth Use and the Battle Against Fruit Flavored Vape Products

One of the central concerns driving this enforcement is the surge in youth usage of fruit flavored E-cigarettes. According to the CDC source, over 2.1 million U.S. middle and high school students reported current use of e-cigarettes in 2024, with flavors such as mango, blueberry ice, and cotton candy among the most popular.

“Flavored vape products are especially dangerous for adolescents,” said Dr. Brian King, Director of the FDA’s Office of Tobacco Products. “They act as a gateway to lifelong nicotine addiction, and these enforcement actions are an essential line of defense.”

This crackdown, therefore, targets not only import compliance but also the public health crisis fueled by widespread youth access to unauthorized flavored vape products.

What This Means for the Vape Industry and E-Commerce Sellers

For vape wholesalers, e-commerce platforms, and independent exporters—especially those operating outside the U.S.—this is a critical reminder of the regulatory risks involved in attempting to enter the American vape market.

If you’re an independent foreign trade seller or private label vape brand, consider these actionable steps to stay compliant:

Apply for FDA’s PMTA Authorization
Without PMTA clearance, your product is considered illegal in the U.S. Learn more about the process here.
Avoid Deceptive Labeling and Invoicing
U.S. Customs and FDA are now cross-verifying cargo documentation more rigorously than ever.
Be Transparent with Customs Declarations
Attempting to underreport values or mislabel cargo can trigger federal criminal investigations.
Consult U.S.-based Regulatory Experts
Consider hiring compliance consultants to vet your product and submission process.
Monitor FDA Import Alerts and Warning Letters
Visit FDA’s Import Alert Database to stay informed on restricted importers and flagged products.

Conclusion: Compliance or Consequences

The FDA’s latest $33.8 million seizure serves as a sobering reminder that the U.S. vape industry is under intense regulatory scrutiny. For companies looking to succeed in this lucrative but high-risk market, compliance is no longer optional—it’s a necessity. From proper licensing to full documentation and ethical marketing practices, only those who respect the rules will survive and thrive in the American vapor marketplace.

Whether you’re a vape brand, e-cigarette wholesaler, or dropshipper, the message is clear: Get compliant or get caught.