The Food and Drug Administration (FDA) finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) for electronic nicotine delivery systems (ENDS).
The guidance, which covers e-cigarettes and vapor products, as well as liquid nicotine and nicotine-containing e-liquids, explains:
- Products to which this guidance applies;
- When a PMTA is required under the statute and regulations;
- General procedures for review of an ENDS PMTA;
- What information the FD&C Act requires you to submit in a PMTA; and
- What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH).
Under FDA regulation of e-cigarettes that began in 2016, ENDS that were already on the market had to apply for FDA approval to remain available after August 2021.
“The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product,” said Acting FDA Commissioner Ned Sharpless in a statement. “There are no authorized e-cigarettes currently on the market.”