FDA Announces Next Steps on Posting Filed PMTAs
Now that the Sept. 9 deadline has passed, the U.S. Food and Drug Administration (FDA) is reiterating that it intends to be as transparent as possible on the status of PMTA submissions and plans to post a list of the deemed new tobacco products that were on the market in the U.S. as of Aug. 8, 2016, are still on the market now, and for which a premarket submission was made by Sept. 9, 2020.
However, before making such a list available, the FDA needs to ensure that publishing any such information complies with federal disclosure laws and regulations. For example, before the FDA can include a specific product on this public list, the agency may need to verify with companies, on a case-by-case basis, the current marketing status of a product and whether it was on the market as of Aug. 8, 2016. Thus, companies may be contacted by the agency for follow-up questions to verify information about the submissions.