LAKEVILLE, Minn. — On Feb. 16, Mitch Zeller, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products, published a note updating the agency’s progress on sorting through premarket tobacco product applications (PMTAs).
The agency directed manufacturers of certain deemed tobacco products that were on the market as of Aug. 8, 2016, to submit applications by Sept. 9, 2020, which allows the product to remain on the market during the FDA’s review for up to a year.
Three kinds of applications are included:
- Substantial Equivalency (SE) applications for products that have the same characteristics as a grandfathered product (on the market as of Feb. 15, 2007) or have different characteristics not raising public health questions.
- Exemption from Substantial Equivalence Requests (EX REQ), which concern minor modifications to products currently on the market; and, the largest category.
- PMTAs, for products not on the market Feb. 15, 2007 (such as electronic cigarettes, nicotine vapor products, alternative nicotine products, and some hookah and pipe tobacco), for which SE or EX REQ applications would not apply.
The FDA first determines the category for an application and how many products are included. The application is reviewed to confirm the product is within FDA jurisdiction and the application is generally complete. If so, the application is reviewed more thoroughly to ensure it contains all required information and documentation and, if it does, the FDA considers engineering, chemistry, toxicology, pharmacology, microbiology, individual health impact and the health impact on the overall population. After this, the FDA decides whether to allow the product to continue to be marketed.
Applications covering approximately 5,200 product SE applications were accepted as were EX REQ applications for 250 products. The FDA lists these accepted applications on its website and intends to update this list monthly.
Additionally, 15,020 PMTAs were submitted for some 4.8 million products. Through mid-January, the FDA had accepted PMTAs for approximately 84,000 products. The FDA has not published a list of filed PMTAs due to the number of applications, but plans to publish information about PMTAs as processing continues and verification of initial marketing dates and current marketing status of products proceeds. The FDA has stated it is unlikely to review all applications by the one-year review deadline of Sept. 9, 2021.
The list of accepted applications does not mean these products have received final approval, and for several reasons the lists are not and cannot be complete and comprehensive.
The FDA also maintains a list of grandfathered products not requiring authorization to be legally marketed in the United States; however this list is not comprehensive, either. Further, under a court ruling premarket review is not being enforced against manufacturers of certain “premium cigars.” The FDA recommends that retailers “discuss with their suppliers about the status of any tobacco product application or any product’s marketing status” as an additional way of determining whether the products they are selling are legal.
For more details, the update posted by Zeller, called “Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline,” can be found on the FDA’s website.
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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