The Food and Drug Administration (FDA) is under a court order to review and either authorize or decline to authorize — by Sept. 9, 2021 — the marketing of new tobacco products for which manufacturers submitted Pre-Market Tobacco Applications (PMTAs). But with numerous applications waiting for review, FDA is unlikely to meet the deadline.
The federal law known as the Tobacco Control Act requires that before a tobacco product may be introduced into the U.S. market, the new product must undergo pre-market review by the FDA and receive marketing authorization from the agency.
If a product was already on the market as of Feb. 15, 2007, the product is grandfathered and does not need a pre-market application nor is FDA authorization required.
For every tobacco product that entered the market after Feb. 15, 2007, one of two applications will be required.
Either a Substantial Equivalence (SE) application that compares a new tobacco product to a similar one that is grandfathered or already has an SE approval order from the FDA, or a PMTA application is required for a new tobacco product that is not similar to a grandfathered product and was introduced into the market after Feb. 15, 2007. The deadline for filing these applications with the FDA was Sept. 9, 2020. Once a manufacturer files a SE or PMTA with the FDA, the agency follows a four-step review process.
First, the FDA conducts a preliminary review of an application to see if everything is complete. Next, the agency files the application if all the scientific studies, evidence and other data accompany the application. Third, the FDA undertakes its substantive review of the application, which can take up to one year or through the deadline of Sept. 9, 2021. Fourth, the FDA issues an order authorizing or not authorizing the application. To authorize an application, the FDA needs to determine that the product “is appropriate for the protection of the public health.”
On June 11, the FDA’s 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 pre-market tobacco applications for “deemed products,” which include cigars, pipe tobacco, hookah tobacco and electronic cigarette/nicotine vapor products. The main focus of the webinar was on the application intake process, application review progress and allocation of agency review resources.
With the FDA required 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” date, and that the FDA has the “discretion to defer enforcement action against particular products on a case-by-case basis.”
According to the FDA website, there were 269 PMTAs filed between October 2019 and July 2020. Then, in August of 2020, one month before the Sept. 9, 2020, filing deadline, some 10,184 PMTAs were filed. During the first nine days of September last year, another 4,567 PMTAs were filed. This means that almost 15,000 PMTAs have been filed and are pending with the agency.
The FDA has now published a list of filed and accepted PMTAs so that industry members know which products have had applications filed.
The complete set of PMTA metrics is available here: https://www.fda.gov/media/150179/download.
The FDA 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 use 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.
The following graphic is from the FDA website, which reports that for the “acceptance” stage in the four-step application review process, applications covering the listed number of products by category have been “accepted” by the agency:
In addition, the FDA reported on its website that it has issued “Refuse to Accept” letters to manufacturers for applications covering 59,229 electronic nicotine delivery system (ENDS) products (i.e., electronic cigarette/vapor products), five cigar products and 25 other kinds of tobacco products. Moreover, the FDA website shows that the agency issued “Refuse to File” letters to manufacturers for applications covering 3,628 ENDS products because necessary information was not included with the applications.
Finally, “Filing” letters have been sent to manufacturers for applications covering 138,377 ENDS products, informing the manufacturers that their applications will be entering the third or “substantive review” stage of the review process. If a SE or PMTA application was not filed for a product and an application needed to be filed by Sept. 9, 2020, then the product is illegally on the market and must be removed from the market.
The FDA continues to work through the large number of submitted applications; however, the agency will unlikely review all of the 15,000-plus applications by the Sept. 9, 2021, deadline. The agency may, however, at its discretion, extend the review time on a case-by-case basis and opt not to take any enforcement action.
Industry members should regularly check the FDA website for additional information on the status of PMTA applications.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.