UNITED STATES
FDA posts list of PMTA submissions

The US Food and Drug Administration (FDA) has released a list of deemed new tobacco submitted via the Premarket Tobacco Product Application (PMTA) pathway by the 9 September 2020 deadline, reports CStore Decisions.

The FDA had already posted the list for tobacco products whose applications had been submitted via the Substantial Equivalence (SE) and Exemption from SE Request (EX REQ) pathways back in February. Due to the large amount of applications submitted via the PMTA pathway, the list, which includes over 6 million products, has only just been completed now.
Another reason for the delay was that the FDA needed to contact each individual applicant requesting the dates of initial marketing and current marketing status of each product that had been applied for, reports CStore Decisions.
As it continues to review tobacco product applications, the FDA will be updating the lists on a regular basis. According to CStore Decisions, since there are constant changes happening as the applications move through the review process, the data that is posted may be correct at that time but is subject to being corrected at a later point in time.
Although the lists are available to the public, it is advised that retailers discuss the status of certain tobacco products’ application and marketing authorization directly with their suppliers.

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