Update on FDA’s Application Review: PMTA List Posted, Progress Metrics Updated
May 20, 2021
Deemed New Tobacco Product Applications Lists
On May 20, 2021, FDA posted the list of deemed new tobacco products for which a premarket application was submitted to FDA via the Premarket Tobacco Product Application (PMTA) pathway by Sept. 9, 2020. The list includes over 6 million products.
In February, FDA posted the list of deemed new tobacco products with timely applications submitted to FDA via the Substantial Equivalence (SE) and Exemption from SE Request (EX REQ) pathways. At the time, the PMTA list was still being compiled due to the large number of applications, size of applications, and other factors. FDA also had to ensure that the development and posting of the list was done in accordance with applicable laws; for example, FDA needed to contact each individual applicant to request the dates of initial marketing and current marketing status of each product for which an application was submitted by the Sept. 9, 2020 deadline. Please note that FDA used this information to determine if the existence of the pending application could be disclosed to the public and FDA has not independently verified the information provided by applicants about the current marketing status of their products.
The process is now complete for the deemed new tobacco products with timely applications submitted through the PMTA pathway, and updates to the SE and EX REQ lists have been made to reflect final actions taken since their initial posting. Now, all lists of deemed new tobacco products with timely submitted applications are available. The agency will be updating these lists regularly as positive or negative actions are issued on these products.
Per a court order, for deemed new tobacco products on the market as of Aug. 8, 2016, applications for premarket review were required to be submitted to FDA by Sept. 9, 2020. The court order also stated that FDA may defer enforcement of premarket requirements for certain deemed new tobacco products. Generally, FDA intends to prioritize enforcement of those tobacco products described in Agency guidance. However, for up to one year – or until Sept. 9, 2021 – FDA generally intends to defer enforcement of products that were on the market as of Aug. 8, 2016 and for which applications were submitted by the Sept. 9, 2020 deadline. If a negative action is taken by the FDA on an application during that year, the product(s) must be removed from the market or risk FDA enforcement.
FDA is making the lists available to the public to be transparent and increase stakeholder knowledge of these products. However, the lists are only one source of information. Retailers should discuss with their suppliers the current status of any particular tobacco product’s application and marketing authorization.
It is important to note that these are not comprehensive lists intended to cover all currently marketed deemed new tobacco products that a firm generally might manufacture, distribute, or sell without risking FDA enforcement. For example, the lists do not include products from companies that did not provide their information in time to be included, products that are subject to a positive marketing order from FDA before April 5, 2021, or products that were commercially marketed in the United States as of Feb. 15, 2007 and have not been modified. The lists also do not include products that are subject to negative actions from FDA before April 5, 2021 or products with a pending submission that was not submitted by the Sept. 9, 2020 deadline.
Furthermore, as manufacturers are not required to submit more than one application for products that have different names and/or labels if the products are physically identical, some products on the list may also be marketed under a different name and/or label. Lastly, certain products on these lists may also be the subject of a Warning Letter notifying a manufacturer of alleged violations of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, and its applicable regulations. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may risk FDA enforcement actions against such products. To determine if a product has been the subject of a warning letter alleging a failure to comply with applicable statutory and regulatory requirements, visit the warning letters webpage.
Progress on Tobacco Product Application Review
The Agency continues to review tobacco product applications received by the Sept. 9, 2020 deadline through all three pathways and provide updates on its progress through the Tobacco Product Applications: Metrics And Reporting webpage. Today, FDA is also posting the latest metrics charts related to the review of all tobacco products applications. The charts now include data as of April 1, 2021 for the applications submitted through the SE, EX REQ, and PMTA pathways. However, there are a number of important factors and context that need to be considered when reviewing this data.
Due to the extremely large volume of the applications received by the Sept. 9 deadline, and real-time changes to status taking place as applications move through the review process, we are seeing constant changes in the month-to-month data over time. Although the data may be accurate at the point in time when it’s exported from the data tracking systems, there are corrections and adjustments that often need to be made retroactively. For example, an action taken on an application toward the end of a reporting period may not be captured in the systems until the next month; as the data for the next reporting period is being collected, this could require us to go back and update the data from the previous period. Given that many submissions include applications for large bundles of products, this does have the potential to create significant changes over time.
Given these types of changes, and to reduce the number of retroactive corrections to the reported metrics, FDA will now be reporting cumulative fiscal year-to-date information every other month. This data will typically be posted about a month after the close of each reporting period. Although the data is generally accurate to within 10 percent, it should be emphasized that each metric truly represents a snapshot in time and that the data often changes on a daily basis as we work expeditiously to review applications.
Despite the inherent challenges involved with such large sets of ever-changing data, FDA is providing this information on an ongoing basis to deliver a general overview of the progress being made in the application review process. The Agency constantly strives to maintain the commitment to transparency, while balancing the need for accuracy and timeliness.