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27 November 2025

Increased Federal Enforcement Of Illicit Ends Products

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The Continuing Resolution, which was passed by Congress and signed by President Trump on November 12, 2025, contains language which indicates that there...
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The Continuing Resolution, which was passed by Congress and signed by President Trump on November 12, 2025, contains language which indicates that there will be increased enforcement by the by US Food and Drug Administration's Center for Tobacco Products (CTP or Agency). The Agency is mandated to allocate at least $200M of the $712M in user fees annually collected by CTP from the tobacco industry towards enforcing existing regulation on electronic nicotine delivery systems (ENDS).

CTP has been extraordinarily slow and stringent authorizing ENDS products for sale. CTP received approximately 27 million premarket tobacco product applications (PMTAs) from October 2019 to March 2024. Out of the millions of applications, CTP has issued marketing granted orders (MGOs) for less than 40 ENDS products which is less than 0.001 percent of new product applications.

To date, CTP has authorized less than 40 ENDS products after receiving millions of Premarket Tobacco Applications (PMTA) from ENDS manufacturers. ENDS products which are not authorized by CTP are prohibited to sell. However, consumer demand for ENDS products remains, particularly for flavored disposable ENDS products which continue to dominate the US market.

Estimates vary as to how much of the current US market is composed of ENDS products not authorized for sale in the US. CTP has indicated roughly 54% of the US market are illicit. Other groups have published figures indicating illicit ENDS products comprise 86% to 98% of the market for ENDS in the United States. Suffice it to say, the overwhelming majority of ENDS products have not been authorized and can be readily purchased at convenience stores and vape shops.

In an effort to further stem the tide of illicit vapes and e-cigarettes from China, U.S. Senator John Cornyn and Congresswoman Beth Van Duyne introduced the Ensuring the Necessary Destruction of (END) Illicit Chinese Tobacco Act. Senator Martin Heinrich cosponsored the legislation.

While Congress previously granted FDA the authority to destroy certain illicit drugs and medical devices, FDA did not have the same authority for tobacco products. The new legislation, however, authorizes FDA to destroy adulterated, misbranded, or counterfeit imported tobacco products, such as vapes and e-cigarettes, most of which are manufactured in China. Per Senator Heinrich the END Illicit Chinese Tobacco Act now provides FDA with enhanced enforcement capability and can better combat the influx of illicit vapes and e-cigarettes in the United States and address the national security and public health threat posed by China.

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