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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 10

Clearing the market of illegal ENDS products begins at the US ports

ORTEGA L.; BURD K.; BURD B.
Chemular Inc., Hudson, MI, USA

The FDA’s compliance and surveillance efforts are in place to ensure that regulated industry and regulated tobacco products are following the laws designed to protect the public’s health and to prevent tobacco use by minors. However, millions of illegal ENDS products are on the U.S. market today and being sold at retail establishment to underage purchasers daily. According to 2022 National Youth Tobacco Survey (NYTS) in 2022, about 1 in 10 or more than 2.5 million U.S. middle and high school students currently used e-cigarettes. The most used devices among the current users were disposables (55.3%), followed by prefilled/refillable pods or cartridges (25.2%) and nearly 85% used flavored e-cigarettes. The agency has not authorized any flavored ENDS products to date. Many of the illegal ENDS products such as flavored disposables or prefilled/refillable pods have not complied with the premarket requirements prior to importing and/or selling in the US. Most ENDS products are manufactured outside of the US and outside of the agency’s inspection surveillance activities. Importers are required to ensure the tobacco products imported or offered for import comply with all the applicable requirements under the FD&C Act. According to the U.S Department of Commerce’s Census Bureau consumption imports of vapor product devices (ENDS) rose from 2016’s $204.1 million to over $513.1 million in 2022 and the estimated forecast for 2023 is over $620 million. Strengthening the surveillance activities such as conducting physical examinations, requiring proof of compliance with Tobacco Control Act upon entry and increase the number of random screenings at the ports of entry and International Mail Facilities will reduce the number of illegal products and protect public health by making only authorized products available.