The FDA’s troubled Premarket Tobacco Product Application (PMTA) process is facing another major legal challenge — this time from some of the largest tobacco companies in the country. 

Altria and several related plaintiffs filed a lawsuit against the U.S. Food and Drug Administration on September 2, challenging the agency’s system for reviewing new tobacco products and arguing that years-long delays have turned the PMTA pathway into a regulatory roadblock rather than the review process Congress intended. 

Now, Reynolds American companies want in on the fight. 

On September 8, R.J. Reynolds Vapor Company, Modoral Brands Inc. and American Snuff Company LLC filed their own complaint seeking to join the litigation challenging FDA’s 2021 PMTA rule. 

At the center of both challenges is an issue the vapor industry has been raising for years: FDA is supposed to make decisions on PMTAs within 180 days, yet applications routinely remain pending for years. 

 

Altria Says the PMTA System Is Broken 

Under the Tobacco Control Act, manufacturers of new tobacco products generally must obtain FDA marketing authorization before those products can legally enter the U.S. market. 

The law also establishes a 180-day period for FDA to act on applications. 

According to Altria’s lawsuit, however, FDA has never met that deadline across applicants. Some applications have remained under review for more than six years. 

Altria argues that this has created a system in which manufacturers that invest significant time and money attempting to comply with FDA requirements can remain stuck waiting indefinitely while unauthorized products continue to capture market share. 

The company specifically pointed to its on! nicotine pouch products, some of which remain under FDA review. 

Altria and the other plaintiffs are asking the federal court in Texas to set aside the existing PMTA framework and require FDA to develop a review system that complies with the law. 

 

R.J. Reynolds Joins the Fight 

Less than a week after Altria filed its lawsuit, Reynolds American announced that several of its companies were seeking to join the litigation. 

R.J. Reynolds Vapor Company, Modoral Brands and American Snuff Company are also challenging FDA’s PMTA rule and its implementation. 

Reynolds argues that FDA has allowed the tobacco product review process to become bogged down by years of delays, uncertainty and what the companies characterize as unlawful agency action. 

Like Altria, Reynolds is focusing heavily on the 180-day deadline. 

Reynolds says the current system has created what it calls a “regulatory purgatory” for companies attempting to follow the rules while unauthorized products have continued entering and competing in the U.S. market. 

The companies are asking the court to vacate the existing PMTA rule and require FDA to adopt a framework that produces decisions within the timeline established by Congress. 

 

Why the 180-Day Deadline Matters 

This may be the most important part of the case for the broader vapor industry. 

The Tobacco Control Act did not give FDA an unlimited amount of time to decide whether a new tobacco product should receive marketing authorization. 

Yet the PMTA process has become synonymous with lengthy delays. 

Manufacturers can spend millions of dollars developing applications, conducting testing and submitting scientific evidence only to remain in regulatory limbo for years without a final decision. 

That uncertainty affects far more than manufacturers. 

Distributors and retailers are increasingly being asked to determine whether products are eligible for sale under state directories and registry laws, many of which rely heavily on a product’s federal regulatory status. 

When FDA does not make timely decisions, that uncertainty travels all the way down the supply chain. 

 

The Bigger Problem: A Market Divided Between Waiting and Unauthorized Products 

There is another major argument running through these lawsuits. 

Companies challenging the system say manufacturers that participate in the regulatory process are being punished by FDA delays while competitors that disregard the process have been able to establish significant positions in the U.S. market. 

Reuters reported that the U.S. tobacco product review system has been plagued by both an enormous application backlog and a growing market for products sold without FDA authorization. 

That creates an obvious regulatory contradiction. 

A company can invest heavily in scientific evidence and regulatory compliance and wait years for FDA to make a decision, while another product may enter the market without authorization and remain available unless and until enforcement catches up. 

Whatever someone thinks about individual companies involved in this litigation, that imbalance raises a legitimate question about whether the PMTA system is functioning the way Congress intended. 

 

This Isn't Just About Big Tobacco 

There is an irony here that will not be lost on independent vapor manufacturers. 

Altria and Reynolds have vastly greater financial and regulatory resources than most independent companies that have struggled with the PMTA process. 

Independent vapor manufacturers have been raising many of these same concerns for years: shifting standards, enormous compliance costs, lengthy delays, uncertainty and an authorization pathway that has produced comparatively few successful outcomes for independent vapor companies. 

Now two of the largest tobacco companies in America are arguing that the system itself is fundamentally broken. 

That matters. 

If this litigation ultimately forces FDA to change how it processes PMTAs or requires the agency to adhere more closely to the statutory timeline, the consequences could extend well beyond Altria and Reynolds. 

 

FDA Has Already Begun Changing Its Approach 

The lawsuit also arrives while the FDA has been making changes to its tobacco review program. 

According to Reuters, FDA has recently introduced initiatives including an expedited pathway for certain nicotine pouch applications and changes to enforcement priorities involving some vapor and nicotine pouch products. 

Altria argues that even those reforms demonstrate the shortcomings of the existing system. Some of its nicotine pouch applications included in an expedited review initiative remained pending beyond FDA’s own target date. 

The fundamental question therefore remains: What good is a regulatory pathway if manufacturers cannot reasonably predict when — or even how — FDA will reach a decision? 

 

 

What Happens Next? 

The litigation is still in its early stages, and there is no guarantee the companies will succeed. 

But the scope of the challenge makes it worth watching closely. 

Altria isn't simply challenging the denial of one product. The plaintiffs are asking a federal court to address the structure and implementation of FDA’s tobacco product review system itself. 

With Reynolds companies now seeking to join that fight, pressure on FDA is growing from another major player in the nicotine market. 

For vapor manufacturers, distributors and retailers, the outcome could have implications far beyond the products owned by Altria or Reynolds. 

The vapor industry has spent years asking FDA for a regulatory pathway that is transparent, predictable, science-based, and capable of producing decisions. 

Now some of the largest tobacco companies in the world are asking a federal court for essentially the same thing. 

And that may make this PMTA lawsuit much harder for FDA to ignore.