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Next Steps on the Sept. 9 Premarket Submissions

September 21, 2020

The Sept. 9 premarket submission deadline for certain deemed new tobacco products marked a major milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by FDA. 

Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency. As Mitch Zeller, CTP Director, stated in a recent perspective piece, FDA strives to be as transparent as possible with regards to the status of these submissions and plans to provide regular updates to the public over the course of the next year. Accordingly, FDA wants to be sure that the public and, specifically industry—most of whom are experiencing FDA’s premarket review process for the first time—have a general understanding of FDA’s review process and reasons FDA might contact a submitter. For those that made premarket submissions, it is important to respond promptly to correspondence from FDA as failure to do so may have an impact on the status of the products contained in the submission.

Review Process

Generally, the FDA review process will consist of three phases:    


Read more about each of the phases by submission type: Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE) Report, Exemption from SE Request (EX REQ). Note that the PMTA process also includes a fourth phase for post-market reporting.

Contact Points

Verification Communications: FDA 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, FDA needs to ensure that publishing any such information complies with federal disclosure laws and regulations. For example, before 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. In the coming weeks, FDA plans to contact submitters, as appropriate, if the Agency needs to ask follow-up questions to verify such information about the submissions. 

Procedural Communications: FDA may contact the submitter at several other points during the review process, such as at the end of Phase 1 (acceptance) to notify a company whether their submission was accepted. Notifications of these types are the first ones that FDA will be sending out to a submitter. Later in the process, such as at the end of Phase 2 (notification/filing), FDA may contact a submitter to notify them if their submission was filed (for a PMTA), and in Phase 3 (review/action) to notify a company if they have deficiencies or of issuance of an order (positive or negative).

Compliance and Enforcement

Now that the submission deadline has passed, FDA intends to prioritize enforcement against any electronic nicotine delivery system (ENDS) product that continues to be sold and for which the agency has not received a premarket submission as indicated in FDA’s enforcement priorities guidance. Additionally, based on several factors—including the likelihood of youth use or initiation—FDA will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization. New data, such as that from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable ENDS will be an enforcement priority for the agency. However, as the result of a recent court decision, FDA will not enforce the premarket review requirement for “premium” cigars.

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