The FDA says it plans to reconsider the rules governing premarket tobacco product applications (PMTAs), including initiating new rulemaking to consider replacing the agency’s current 2021 framework.
In a Sept. 28 announcement, the FDA said its review is being driven by experience implementing the rule, recent judicial developments, the growth of what the agency calls an “illicit and unregulated market,” and the pace of new product introductions. The agency did not identify specific changes it intends to propose or provide a timetable for issuing a replacement rule.
The current PMTA rule took effect on Nov. 4, 2021. It established detailed requirements for the content and format of applications, codified FDA review procedures, and created postmarket reporting requirements for products that receive marketing authorization. The rule also requires applicants to provide information FDA uses to decide whether a new tobacco product meets the statutory standard for marketing.
When the rule was adopted, the FDA said it was intended to improve the efficiency of PMTA submission and review. Five years later, the agency is now saying that market conditions and its experience with the system have prompted it to consider a replacement framework.
The announcement follows a Sept. 2 lawsuit filed by Helix Innovations LLC, NJOY, LLC, the Texas Food & Fuel Association, and two Texas retailers. The plaintiffs are challenging the 2021 PMTA rule in the U.S. District Court for the Northern District of Texas and are asking the court to vacate it. Helix makes nicotine pouches, and NJOY makes nicotine vaping products.
Federal law governing PMTA review says the agency must act “as promptly as possible,” and no later than 180 days after receiving an application under the statute. The plaintiffs argue that FDA’s current framework unlawfully delays the start of that 180-day clock through its acceptance and filing reviews, and that decisions on their applications have taken substantially longer than the statutory period.
The law also requires the FDA to determine whether authorizing a new tobacco product would be “appropriate for the protection of the public health.” That determination must consider risks and benefits to the population as a whole, including both tobacco users and nonusers, as well as the likelihood that existing users will stop and nonusers will start.
For now, the FDA says nothing changes in the review process. The agency will continue processing PMTAs and issuing decisions under existing law while it evaluates a new framework. FDA also says any future changes will follow applicable law and include opportunities for public input.
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