FDA Issues Update on Premarket Review process

Earlier this month, the FDA issued a perspective piece from Mitch Zeller, Director of the FDA Center for Tobacco Products, outlining where the agency is in the premarket tobaco product application (PMTA) review process and their plans for the coming year. In it, he notes that they have processed applications for 4.8 million products from 230 companies. The FDA also published a page on Tobacco Product Applications: Metrics & Reporting detailing the breakdown of product applications they have received and processed so far.

All new products that were not on the market prior to the 2016 “deeming rule” were required to submit an application for FDA marketing authorization by September 9, 2020. After that point, the FDA has a year to review their applications, during which time the products can remain on the market unless the FDA determines otherwise. However, after September 9, 2021, any products without an affirmative marketing order from the FDA will no longer be allowed to stay on the market. The FDA has taken steps already to remove some products that did not submit an application for premarket review, warning some e-liquid manufacturers to remove their unauthorized products and seizing other unauthorized e-cigarette products.

Under the pre-market review process, in order for the FDA to approve a tobacco product to be marketed in the US, that product must be “appropriate for the protection of public health.” How this standard is interpreted, and in particular whether it includes the impacts of the product on health equity, remains to be seen. Some public health groups, including the Campaign for Tobacco Free Kids have argued that no flavored products should be approved through the premarket review given their clear role in youth initiation.The FDA will be updating their Tobacco Product Applications page as they move through the review process – check back to see their progress, and keep an eye out for the list of all products than have submitted PMTAs.

Learn more about the premarket review timeline and how it has changed over the years from the Public Health Law Center in their resource, “Extension & An Epidemic: FDA’s Gatekeeping Authority for E-Cigarettes.”