Deputy Assistant Attorney General Arun G. Rao delivered testimony at a Senate Judiciary Hearing on June 12, 2024, addressing the urgent need to combat the illegal distribution and sale of unauthorized electronic nicotine delivery systems, commonly known as e-cigarettes.

Rao emphasized the significant public health risk posed by illegal e-cigarettes, particularly to the nation's youth. "Safeguarding the well-being of our nation’s youth is a paramount concern for the department, especially in this area," he stated.

Illegal e-cigarettes have become prevalent across the United States, with many products originating from abroad, particularly China. Manufacturers have been exploiting the premarket authorization process by making minimal alterations to previously denied products and reapplying for FDA approval. Some overseas manufacturers misdeclare shipments at ports of entry to evade import alerts, while retailers manufacture their own products in individual stores.

The Justice Department supports the FDA's efforts to keep illegal e-cigarettes off the market by defending FDA denial orders in court. Rao noted that over 80 legal challenges have been filed by manufacturers against FDA decisions, with the department prevailing in more than a dozen cases across seven courts of appeals.

The department also enforces the Tobacco Control Act alongside the FDA. The FDA has pursued monetary penalties against over 55 manufacturers and 100 retailers and issued warning letters to hundreds more. While unable to impose penalties directly, the Justice Department assists in collection actions to ensure compliance.

Significant enforcement actions include partnering with the FDA for domestic seizures of unauthorized e-cigarettes and bringing civil injunctive actions referred by the FDA. Although these actions do not recover monetary penalties, they serve as important deterrents.

Recognizing the complexity and evolving nature of illegal e-cigarette distribution and sales, Rao announced a multi-agency Task Force created earlier this week. This Task Force includes multiple law enforcement partners such as ATF, U.S. Postal Inspection Service, U.S. Marshals Service, Customs and Border Protection, and FTC. Its purpose is to address this threat through comprehensive enforcement strategies.

Rao concluded his testimony by expressing readiness to work with Congress on legislative efforts addressing this issue: "Congress has an important role to play to ensure that the department and FDA are able to effectively pursue critical enforcement actions."

In closing remarks, Rao conveyed confidence in making further progress against illegal e-cigarette sales: "I am confident that working together we will make additional progress in the fight against illegal sale of unauthorized e-cigarettes and will safeguard the well-being of all Americans, especially our youth."

Thank you.

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