FDA Provides Update on PMTA List

Agency posts data on tobacco applications received through EX REQ, SE pathways
FDA update on SE, EX REQ and PMTAs
Graphic courtesy of the FDA

SILVER SPRING, Md. — A long-awaited list that will help convenience-store retailers determine which tobacco products they can legally sell is here, at least in part.

The U.S. Food and Drug Administration (FDA) completed the processing step for all exemption from substantial equivalence requests (EX REQ) and substantial equivalence (SE) reports submitted to the agency by Sept. 9, 2020; however, that step is ongoing for premarket tobacco product applications (PMTAs), or the third pathway for manufacturers to market new tobacco products.

Data on the EX REQ and SE applications, including how many were accepted or rejected and which companies submitted products, is available on a new FDA webpage, Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP) said in a Feb. 16 memo.  

The largest chunk of applications submitted for premarket review, though, came in the form of PMTAs.

The FDA so far has processed PMTAs for more than 4.8 million products from 230 companies. The size, complexity and diversity of the PMTA submissions posed additional challenges to the FDA, Zeller said. One firm, for example, submitted information on more than 4 million tobacco products within a single 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.”

The processing step includes the physical or electronic intake of the submission and determining the type and number of applications contained in the submission, Zeller said. It also entails ensuring the files are safely viewable and uploading the files into internal review systems to prepare them for the next step in the review process including acceptance review, filing review and substantive review.

Before publicly sharing which companies submitted PMTAs, the FDA must verify the dates of initial marketing and current marketing status of products. The FDA has verified this information for about 86,000 products received through the PMTA pathway as of Feb. 16.

Zeller said the agency is continuing to process application packages submitted by the Sept. 9 deadline and aims to share the final PMTA submissions numbers “as soon as possible.”

Through the SE pathway, the FDA received applications for 6,800 products from 100 companies. It received applications for about 350 products from 15 companies for the EX REQ pathway.  

The published list of SE and EX REQ products that applications have been submitted for includes about 1,100 cigars, 330 pipe tobacco products and 660 waterpipe tobacco products. Most electronic nicotine delivery systems (ENDS) products were submitted through the PMTA pathway.

While this list, and the PMTA list that the FDA still intends to publish, is a helpful guidance to retailers, it is not an end-all be-all in determining which products are legal to sell. The list does not include entries for companies that did not verify the marketing status of their products before the time of posting, Zeller said.

Lists will also not contain products with a pending submission that was not submitted by the Sept. 9, 2020, deadline, or products commercially marketed in the United States as of Feb. 15, 2007 (grandfathered products), and have not been modified.

The FDA still recommends retailers discuss with their suppliers the status of any tobacco product application or any product’s marketing status. Retailers can also check the FDA’s metrics and reporting page for updates on tobacco product applications.

The FDA was granted authority over e-cigarettes, cigars and hookah products when the deeming rule took effect on Aug. 8, 2016. Deemed tobacco products became subject to the requirements of the Tobacco Control Act that already applied to cigarettes and smokeless tobacco products.

This included the requirement that a new tobacco product receive premarket authorization from the FDA prior to marketing, according to the agency, which can be done through a PMTA, EX REQ or SE. While PMTAs may be submitted when a firm is seeking marketing authorization for any new tobacco product, SE and EX REQ pathways are for new tobacco products that are similar to a predicate product or that have been modified.

The FDA issued a compliance policy to provide manufacturers of deemed products that met the definition of a new tobacco product and were on the market as of Aug. 8, 2016, time to submit their applications for authorization by Sept. 9

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