On June 11, the FDA finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco application (PMTA) process for electronic nicotine systems (ENDS), including e-cigarettes, vaping devices and nicotine-containing e-liquids. By way of background, when the FDA issued the Deeming Regulations asserting jurisdiction over ENDS in May 2016, it also issued a draft guidance for ENDS PMTAs. The Agency had been promising to finalize that guidance as it proposes to move forward the deadline for these submissions.
There are very few changes between the 2016 draft guidance and the final guidance. Importantly, the final guidance continues to note that nonclinical studies alone generally would not support marketing authorization but it does acknowledge that long-term clinical studies generally would not be required.
The final guidance provides additional recommendations regarding battery safety, including testing certificates for any voluntary electrical standards. The final guidance also provides new recommendations for testing of harmful and potentially harmful constituents (HPHCs) – some HPHCs were removed from the original draft guidance and some were added – and the Agency also decreased the recommended number of replicates for testing.
Although the ENDS guidance certainly provides valuable information for ENDS companies preparing PMTAs for marketing authorization, it is important to note that the guidance only provides non-binding recommendations. Applicants are encouraged to develop scientific testing programs appropriate for their products in order to meet the statutory standard of whether marketing the products is “appropriate for the protection of public health.”