All substantial equivalence (SE) reports and exemption from substantial equivalence requests (EX REQ) received by the FDA ahead of the 9 September 2020 deadline have now been processed. The data, which shows how many applications of submitted products were accepted and rejected, is now available on a new FDA webpage, according to CSP.
The list will help stores and retailers determine which tobacco products are legal to sell. However, the largest part of the applications submitted came in the form of premarket tobacco products applications (PMTAs) for which the process has not yet been completed. So far, the FDA has processed PMTAs for more than 4.8 million products from 230 companies, reports CSP.
Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), said that the size, complexity and diversity of the PMTA submissions were posing a huge task for the FDA, explaining that one company had filed information on more than 4 million tobacco products in one submission.
“Given the high level of public interest in these submissions, we’d hoped to be able to share a list of products submitted under all three pathways at once,” Zeller said. “However, we have not completed processing all of the applications submitted through the PMTA pathway. Because we want to provide as much of an update as possible, we are therefore sharing the SE and EX REQ list and providing a PMTA update at this time.”