Abstract: The Food and Drug Administration’s (FDA) compliance and surveillance efforts are in place to ensure that regulated industry, specifically regulated tobacco products are compliant with the laws designed to protect the public’s health and to prevent tobacco use by minors. However, millions of illegal Electronic Nicotine Delivery Systems (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 (defined as use on ≥1 day during the past 30 days) are ENDS disposables (55.3%) and nearly 85% used flavored e-cigarettes. The agency has not authorized any flavored ENDS products to date. Most ENDS products are manufactured outside of the US and outside of the agency’s inspection biennial 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 rose from 2016’s $204.1 million to over $513.1 million in 2022 and the estimated forecast for 2023 is over $620 million. By strengthening the Customs and Border Protection Agency’s (CBP) and FDA’s surveillance efforts, which include physical inspections, mandating proof of the Tobacco Control Act compliance at entry points and amplifying random screenings at ports of entry and International Mail Facilities, can significantly impact the influx of illegal ENDS products which will aid in preventing these products from making it to store shelves, thereby safeguarding public health.

Lillian Ortega, Kevin Burd, Bryan Burd

Affiliations: Chemular, Inc, Hudson, MI, USA