Electronic nicotine delivery systems (ENDS) fall under the definition of tobacco products. A premarket review of new ENDS is required and involves the assessment of several components and parts of the products, such as vape pens, e‑pens, e‑hookahs, e-cigars, e-pipes, e-liquids and flavours. The FDA has recently released guidance for industry on the submission of premarket tobacco product applications (PMTA) for ENDS, to assist with product applications submitted under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). The guidance provides information on when a PMTA is required, what the FD&C submission requirements are, and what should be submitted in an ENDS PMTA to show that a new tobacco product is “appropriate for the protection of public health”. This includes the toxicological assessment of e-liquid ingredients and the emitted aerosols reflecting realistic operating conditions and use patterns.

US Food and Drug Administration (2019). US Department of Health and Human Services Center for Tobacco Products. Guidance for Industry. Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. https://www.fda.gov/media/127853/download


The above items were taken from the July 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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