More than six months passed since the September 9, 2020 submission deadline for premarket tobacco product applications (PMTAs). That’s six months into the one-year grace period products that had submitted applications had to stay on the US market. However, it seems highly unlikely that the US Food and Drug Administration (FDA) will finish reviewing all the applications in time, and the final rules for PMTAs and SEs (substantial equivalence) FDA announced this January have also been withdrawn. It is unclear when the final rules will be published, or when FDA might complete its review of PMTAs it received, so it seems that all that manufacturers can do now is wait, hope, and wait some more.
First, a brief recap
FDA provides three pathways to legally market and distribute new tobacco products in the US – premarket tobacco applications (PMTAs), substantial equivalence reports (SEs), and exemption from demonstrating substantial equivalence requests (EX REQs).
PMTAs may be submitted when seeking FDA marketing authorization for any new tobacco product, but this doesn’t necessarily mean that all new tobacco products must submit a PMTA. For example, new tobacco products that can demonstrate it has the same characteristics as a predicate tobacco product or has different characteristics than the predicate product but the new product does not raise different questions of public health can submit an SE report. (A predicate product is one that was commercially marketed in the US as of February 15, 2007 or is a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act). Or, if the new tobacco product is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive; or the proposed modification is minor and to a legally marketed product, then an EX REQ would be the more appropriate pathway.
New tobacco products that would need to submit a PMTA include e-cigarettes, hookah products, and certain cigars (FDA is currently not enforcing PMTA requirements for premium cigars following a US District Court for the District of Columbia order).
Overwhelming number of submissions
According to Mitch Zeller, director of FDA’s Center for Tobacco Products (CTP), the organization received thousands of PMTA submissions for millions of tobacco products by the September 9 deadline, as well as SE applications for 6,800 products from 100 companies and EX REQ applications for 350 products from 15 companies. As of mid-January 2021, FDA completed processing all of the SE and EX REQ applications, and completed processing PMTA submissions for more than 4.8 million products from more than 230 companies, with more PMTAs still being processed.
The next step after a submission is processed is the acceptance review process to confirm that the product falls under CTP’s jurisdiction and that basic requirements of an application are met. FDA can refuse to accept the application, and if the product in that application is currently on the market, it must be removed from the market of face FDA enforcement action.
As of mid-January 2021, FDA accepted SE applications for about 5,200 products and refused 1,600 products; accepted EX REQ applications for 250 products and refused 100 products; and accepted PMTA applications for about 84,000 products and refused about 3,100 products.
Accepted applications still have to go through a filing (for PMTAs) or notification review (for SEs and EX REQs) followed by a substantive review, which evaluates the scientific data in the application and is the longest and most thorough step in the entire process. As of mid-January, FDA had already completed this phase and issued over 50 SE and 125 EX REQ marketing orders for tobacco products. For PMTAS, FDA has just started substantive reviews on hundreds of products.
Given the number of PMTA submissions and other contributing factors such as the number of products included in a submission and the variety of submission formats, Zeller says it is highly unlikely that FDA will be able to complete its review of all PMTA submissions by September 9, 2021.
“We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by FDA,” he said. “We will focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies regardless of size, prior to September 9, 2021, at which time they risk FDA enforcement per FDA’s guidance.”
According to Zeller, If the product does not meet standards in the law for marketing, it will not receive a marketing order from FDA and must be removed from the market. If the product does meet standards, it will get a marketing order and may remain on the market subject to conditions in the order.
Final rules withdrawn
On January 19 this year FDA announced it had finalized two key rules for the premarket review of new tobacco products, namely the PMTA final rule and the SE final rule, providing additional information on the minimum requirements for the content, format, and review of applications in both pathways. This was heralded as an important milestone. However, the two final rules were displayed in the Federal Register but did not publish. A day later, the agency received an executive order from the White House to withdraw any rules that did not publish in the Federal Register by noon on that day, and as such the rules were withdrawn.
In announcements on its website, FDA says it is “working with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.” It has not yet been announced when we might expect to see these new rules.
Public list of deemed products released, but full of gaps
On February 16, FDA published its public list of deemed new tobacco product applications, which was meant to share a list of timely-submitted applications in accordance with applicable laws, or, in other words, were on the US market on August 8, 2016; are currently on the US market; and were the subject of a request for marketing authorization submitted to FDA by September 9, 2020. The list includes over 2,000 products, including about 1,100 cigars, over 330 pipe tobacco products, and over 660 waterpipe tobacco products. These were products from the SE and EX REQ pathways.
What’s missing from the list, though, are products that submitted applications through the PMTA pathway, like e-cigarettes and hookah products. Also missing from the list are deemed tobacco products that are grandfathered from the premarket review process and deemed products that have received FDA marketing authorization.. Considering that this is a list of deemed tobacco products that can be legally sold in the US, these omissions have raised concerns among industry stakeholders that the public, as well as distributors and retailers may misunderstand what is legal or not.
And so, with all these delays and gaps, it seems like it’s still going to be a long wait before the future for many e-cigarette and hookah products and their manufacturers become clearer.