Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (Guidance for Industry)

Policy Details

Policy Details

Last Action
Guidance Issued
Date of Last Action
Jun 11 2019
Date Introduced
Jun 11 2019
Publication Date
Jun 11 2019

SciPol Summary

On June 11, 2019, the US Food and Drug Administration (FDA) issued a guidance titled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” FDA guidances are not legally binding, but instead convey to relevant stakeholders the FDA’s current thinking on a particular subject. This guidance communicates to manufacturers of electronic nicotine delivery systems (ENDS; e-cigarettes) the FDA’s recommendations for the approval process – referred to as the premarket tobacco product application (PMTA) – of such products. Specifically, the guidance informs on which nicotine products apply to this guidance, when a PMTA is required, the broad review procedures of a PMTA, the information required for a PMTA submission, and recommended information to submit with a PMTA. The FDA states that these recommendations are extremely similar to those outlined in a draft guidance issued on May 5, 2016.

A May 2016 FDA final rule – Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements – explicitly included all ENDS products as tobacco products, and therefore under FDA’s regulatory authority. As such, all ENDS are subject to premarket review by the FDA in accordance with the Federal Food, Drug, and Cosmetic Act and the Tobacco Control Act of 2009. Because of the argument that ENDS promoted cessation of traditional tobacco product (i.e., combustible cigarettes) use among nicotine-dependent individuals, and therefore served as a cessation device, the FDA postponed approval of these devices until August 2022, and allowed them to be sold on the market before going through the FDA approval process. Pressure from public health officials and an uptick in teenage use of e-cigarettes has prompted the FDA to reevaluate its stance. A statement from the FDA indicated that all ENDS products would require premarket applications by August 2021 to stay on the market.

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