PMTA Guidance Finalised for ENDS by FDA…

Long awaited, but finally it’s here.

After a long wait, the FDA finalised its guidance on PMTA applications for ENDS and released this to the industry on 11 June 2019.

The guidance sets out a number of non-binding recommendations and states that, ultimately, when the FDA comes to review a PMTA application, decisions will be based on obligations that stem from the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j).

Take a look at the guidance below:

Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)

Applications for Premarket Review of New Tobacco Products

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

For further information, please contact us.

Arcus.

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