January 03, 2020
The Food and Drug Administration (FDA) has issued an enforcement policy on the manufacturing and distribution of unauthorized flavored e-cigarette products that appeal to children.
The Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization comes following the results of several national surveys indicating a significant increase in the use of ENDS products among youth over the last few years, as well as an outbreak of vaping-related lung injuries in 2019.
“FDA will prioritize enforcement of flavored, cartridge-based ENDS products (other than tobacco- and menthol-flavored products), which are produced primarily by large manufacturers. This policy should have minimal impact on small manufacturers (e.g., vape shops) that primarily sell non-cartridge-based ENDS products, unless they market to youth or fail to take adequate measures to prevent youth access.”
Specifically, FDA will prioritize enforcement against flavored, cartridge-based ENDS products (other than tobacco- and menthol-flavored products), all ENDS products for which the manufacturer has failed to take adequate measures to prevent access by minors, and any ENDS product targeting minors or with marketing likely to promote use by minors.
FDA intends to prioritize enforcement beginning 30 days after issuance of this Final Guidance. They will also prioritize enforcement of any ENDS product offered for sale after May 12, 2020.
“FDA believes that there are significant public health benefits of the policy set forth in this guidance, which is aimed at curbing the dramatic rise in youth use of ENDS products and will help address safety issues connected to ENDS products that are not fully understood—e.g., the development of acute or chronic lung injuries associated with use of vaping products as well as battery explosions with ENDS products—particularly given that these products have been marketed without premarket evaluation. These current public health issues affirm the importance of the premarket review process, as contemplated by the Tobacco Control Act, to scientifically evaluate products based on a public health standard.”
Food and Drug Administration. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization [published online January 2, 2020]. https://www.fda.gov/media/133880/download. Accessed January 3, 2020.