By Timothy S. Donahue

Top Takeaways:

• Overhaul confirmed: FDA says it intends to pursue new rulemaking that could replace the current PMTA framework.
• Signals become policy: The announcement follows months of FDA moves toward faster, more flexible and product-specific tobacco reviews.
• Reviews continue: FDA will keep processing PMTAs under existing requirements while developing potential changes.

The FDA has been signaling a PMTA overhaul. Now it has put it in writing.

On Monday, the agency said it intends to evaluate changes to the premarket tobacco product application (PMTA) regulatory framework, including initiating new rulemaking to replace the framework established by its 2021 PMTA rule.

The announcement provides the first official confirmation yet of a shift that FDA officials have been signaling for months, which Nicotine Insider reported last week could include simplified scientific requirements and faster reviews for vaping products, nicotine pouches and other products.

FDA said its experience administering the 2021 rule, the growth of a widespread illicit and unregulated market, the rapid pace of new product introductions, and recent litigation have convinced the agency that the existing system needs another look.

“FDA believes a modern framework that reflects current market realities and provides greater clarity and predictability is critical to maximizing the protection of public health,” the agency said.

The announcement does not specify what a replacement framework will look like or which existing requirements the FDA might change.

CTP Director Bret Koplow said at the Global Tobacco & Nicotine Forum earlier this month that FDA was moving away from treating every tobacco product and every regulatory submission the same way. “We’re very much mindful that we should not be taking a one-size-fits-all approach,” Koplow said.

Koplow also said the agency has been developing a supplemental PMTA pathway intended to allow manufacturers to make certain changes to already-authorized products without effectively restarting the review process.

Koplow said the supplemental pathway could rely on manufacturing and other information FDA has already reviewed rather than requiring companies to repeatedly submit the same material. “I’m excited about it because I think it will facilitate getting more products authorized faster,” he said.

Monday’s announcement goes considerably further. Rather than modifying how the FDA administers the existing PMTA system, the agency is now formally considering replacing the regulatory framework that underlies it.

The move was becoming increasingly apparent before FDA’s announcement.

In its announcement, the agency cited a federal lawsuit filed this month in the U.S. District Court for the Northern District of Texas that challenges the current PMTA framework. The Sept. 2 lawsuit was brought by Altria subsidiaries Helix Innovations, which markets on! nicotine pouches, and NJOY, along with the Texas Food & Fuel Association and two retailers.

The plaintiffs are challenging FDA’s 2021 PMTA rule and its implementation, including the agency’s review structure and the time applications can remain pending.

FDA did not say the lawsuit caused its decision to reconsider the framework. Instead, the agency listed the litigation alongside its experience implementing the rule, the illicit market, and the pace of product innovation as factors in the review.

The larger question is what the FDA puts in its place.

Keller and Heckman’s Azim Chowdhury told Nicotine Insider in a recent Q&A that the agency has an opportunity to reconsider a regulatory structure developed under market and public-health conditions that have changed substantially.

Smoking rates are historically low, youth cigarette use has fallen dramatically, and youth vaping has declined from its 2019 peak, yet a large market for unauthorized flavored vapor products continues to operate outside the FDA’s authorization system.

Chowdhury cautioned against assuming those trends prove causation between flavored vaping and declining smoking. But he argued that the current environment gives the FDA an opportunity to develop a regulatory system that better reflects differences among products and the continuum of risk.

A major part of that equation is whether companies other than the largest tobacco manufacturers can realistically navigate the PMTA process.

Laura Leigh Oyler, head of regulatory affairs in the USA for Haypp Group, the parent company of Nicokick.com and Northerner.com, has similarly argued that more product-specific review, greater use of existing scientific evidence, and regulatory pathways tailored to individual categories could make the system more workable without eliminating the FDA’s public health standard.

Those questions now move from discussion to rulemaking.