LAKEVILLE, Minn. — On June 11, the U.S. Food and Drug Administration's (FDA) Office of Science held a live webinar titled “Deemed Product Review: A Conversation with the Center for Tobacco Products Office of Science.” The purpose of the webinar was to provide an update on, and information about, the agency’s scientific review of market authorization applications for deemed products, which include cigars, pipe tobacco, hookah tobacco and electronic cigarette/nicotine vapor products. The focus of the webinar was on the premarket tobacco product application (PMTA) intake process, application review progress and allocation of agency review resources.
Here are some highlights of what was covered:
- Premium Cigars and Grandfathered Products: The Office of Science staff stated that, because of a court decision, the FDA will not enforce a market authorization requirement on premium cigars. Also, a market authorization application is not required for grandfathered products, which are those tobacco products that were on the market as of Feb. 15, 2007.
- Pre-Market Application Pathways: The Office of Science staff explained the kinds of applications manufacturers can file to seek marketing authorization from the FDA. One application pathway, a substantial equivalency (SE) application, is for those deemed products on the market as of Aug. 8, 2016, and very similar or almost identical to another tobacco product on the market as of Feb. 15, 2007. Most SE applications have been for cigarettes, cigars, pipe tobacco and roll-your-own tobacco products. The other application pathway is a PMTA for those products which are not like any product already on the market as of Feb. 15, 2007. As of Sept. 9, filing deadline the FDA received SE applications for 6,800 products from 100 companies and PMTA applications for 6.5 million products from 500 companies. One reason for the high number of PMTA products is the flavor variations for e-vapor nicotine liquids.
- Application Review Progress: The Office of Science staff stated that the agency will not be able to substantively review all the PMTA applications by the Sept. 9, 2021, deadline imposed by the court due to the large number of applications, the uniqueness of the products and the scientific issues to be considered. Consequently, the FDA’s resources for reviewing SE and PMTA application have been prioritized to focus on those applications for electronic cigarette/nicotine vapor products that will have the greatest health impact and have the largest market share.
- List of Deemed New Products with Timely Applications: The FDA has published several lists on its website of those products for which applications were timely filed by Sept. 9. The Office of Science staff explained that the published lists do not constitute a comprehensive list of all marketable tobacco products because the lists do not include grandfathered products, products with a positive marketing order issued by the FDA as of April l5, 2021, and products for which the manufacturers did not authorize the FDA to publish.
- Possible Extension of Review Period on a Case-By-Case Basis: With the FDA required by a court order to finalize the review of all PMTAs by Sept. 9, 2021, and given the significant number of applications filed, the Office of Science stated that it is “striving to review as many applications as possible during this one year period described in the court order that set the Sept. 9, [2020] application deadline” and that the FDA has the “discretion to defer enforcement action against particular products on a case-by-case basis.” The staff also said that “the likelihood of FDA reviewing all of the applications received by Sept. 9, [2021] is extremely low.” This means that if the application review process has not been concluded by Sept. 9, 2021, the FDA may utilize its discretion and extend the time to review PMTA applications on a case-by-case basis by deciding not to take enforcement action against manufacturers who timely filed PMTAs.
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.
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