The deadline for e-cigarette manufacturers to submit their premarket tobacco applications (PMTA) to the U.S. Food and Drug Administration (FDA) will be coming sooner rather than later. The FDA announced that the deadline for PMTA applications would move up to 2020, up two years from the previous deadline of 2022.
The earlier deadline comes as a response to the recent ruling by U.S. District Court Judge Paul W. Grimm who ruled that the FDA neglected its authority when it pushed back deadlines set by the 2016 Deeming Rule. While the Deeming Rule came out in May 2016, the FDA had delayed the requirement that manufacturers had to submit applications for products that were on the market as of Aug. 8, 2016, for review. Applications for combustible tobacco products, such as pipe tobacco, hookah and premium cigars, were expected by Aug. 8, 2021. Non-combustible covered products such as ENDS and e-cigarettes were set at Aug. 8, 2022. Now the FDA is proposing a 10-month deadline for e-cigarette and vapor companies to submit their PMTA applications, should the court order it.
Due to the many requirements associated with filing a PMTA applications, as well as the huge financial costs, it is believed that by moving the deadline forward, many smaller manufacturers would be unable to meet all of the requirements needed to successfully file a PMTA with the FDA. Larger manufacturers, such as Altria and JUUL, would have a better chance of meeting the earlier deadline. Should the PMTA deadline for the e-cigarette and ENDS manufacturers happen sooner than expected, it could push many out of business and change the ENDS and e-cigarette industry landscape. Failure to get approval from the FDA for their products could cause them to be pulled off the market.
You can view the FDA’s final guidance document for premarket tobacco applications for electronic nicotine delivery systems (ENDS) by clicking here.