Audrey Ernst 

Associate Editor 

Loyola University Chicago School of Law, JD 2028 

On September 2nd, 2026, U.S.-based tobacco companies Helix Innovations, LLC and NJOY, LLC (collectively, Altria) filed a lawsuit against the FDA to vacate its 2021 Pre-Market Tobacco Applications (PMTA) rule. Specifically, Altria seeks to block the enforcement of pre-market review requirements for pending tobacco products which primarily affect smokeless tobacco products and electronic nicotine delivery systems (ENDS). Under the Tobacco Consumer Act (TCA), the FDA is mandated to approve or deny applications for tobacco products within 180 days. However, Altria argues that the promulgation of the 2021 PMTA rule coupled with the 2016 “Deeming” Rule has caused extensive regulatory backlogs for the FDA, resulting in their numerous violations of the statutory deadline to review tobacco product applications.  

Altria’s complaint contends that delays have harmed both domestic business and public health by creating a regulatory gridlock. Under the 2021 PMTA rule, tobacco manufacturers are required to submit substantial evidence reports with distinct materials for each product, including risk investigations, marketing plans, environmental and population impacts, and other uniquely relevant documentation. While U.S. manufacturers seeking to comply face excessive red tape stalling scientifically backed products from reaching the market, foreign-sourced tobacco products have flooded the U.S. market with unregulated alternatives that expressly target American youth. By failing to issue timely decisions, the FDA has inadvertently undermined consumer safety and penalized companies attempting to follow the law.   

A well-intentioned regulation erodes the FDA application process 

The TCA requires that any tobacco product developed after 2007 be subject to pre-market review by the FDA. This pre-market review requires that the FDA determine if the product is appropriate for the protection of public health.  In 2016, the FDA created the “Deeming” Rule, subjecting virtually all tobacco products to pre-market provisions and forcing many products off the market until deemed safe by the FDA. This new rule immediately created an extensive backlog of products seeking to re-enter the market and resulted in years’ worth of guidance, extended deadlines, and industry-driven backlash to the rule’s application. 

Then in 2021, the FDA proposed the PMTA rule, opening the door for significant scrutiny by the already affected tobacco industry. The rule sought to create a stronger regulatory review for new tobacco products entering the market, primarily ENDS and other smokeless tobacco products. Further, the FDA interpreted the TCA’s 180-day rule to allow a delay of the clock’s start until the last piece of information necessary to complete the submission was received, which in cases cited by Altria, has taken up to six years. The rule also added new application requirements, increasing the backlogs of applications, which Altria argued, was arbitrary, capricious, and against APA standards.   

Good-faith regulatory efforts fail to ensure public safety 

With the rapid emergence of smokeless tobacco and ENDS products on the market, there has been growing concerns of marketing to adolescents and the emergence of underregulated products. While tobacco manufacturers argue that smokeless tobacco and ENDS products provide a beneficial alternative to standard cigarettes, the FDA’s actions seek to establish higher compliance standards for these products. The FDA claims that the application process allows the agency ample time to investigate risks and benefits to the populations as a whole, determine whether or not these products would encourage individuals to begin using products, and to understand the methods and controls used to manufacture the products.  

To combat the slow application process, the FDA proposed a new rule in 2026 attempting to address the lack of registration among foreign manufacturers. Additionally, in 2025, the FDA announced a pilot program to fast-track review of certain smokeless tobacco products to replace unauthorized competitors in the market. Plaintiffs contend that these efforts will have negligible effects while the 2021 PMTA rule is still in place.  

This pending litigation grew out of the concern that foreign-based companies entering the U.S. markets will not face standard FDA requirements. Altria cites financial losses to domestic companies and profit increases for foreign manufacturers since the PMTA rule’s enactment, negating the purpose of the regulatory framework. Further, the application process and effort put into entering the market has arguably prevented domestic manufacturers from focusing on research and development to improve products.  

While regulatory industries are known to have played a critical role in protecting the health and safety of consumers, especially when it comes to regulating market entry, this complaint displays a gap in the process. The lack of collaboration between industry leaders and agency commissioners has opened the door for under-regulated and potentially unsafe products to replace rule-compliant manufacturer products.  

The tobacco industry has faced years of scrutiny, which led to the development of the TCA to manage the risks, and prevent marketing directed at youth. However, recent regulations appear to upend these safety precautions so arduously fought for. The ability to come to a resolution under a less tedious framework that still provides high standards for safe market entry seems essential to avoid these unregistered illicit products from continuing to enter the US tobacco market.