Industry News
Altria's Two-Front FDA Fight: Texas Lawsuit Paused as Pouch Units Defend Agency in Maryland
Altria's subsidiaries spent early October on both sides of the FDA. On October 8, a federal judge in Texas paused their lawsuit attacking the agency's 2021 premarket review rule, at the request of both the companies and the FDA. Two days earlier, the same subsidiaries asked a federal judge in Maryland to let them join the FDA's defense against public-health groups that want the agency's lenient enforcement policy thrown out.
Both cases decide how long unauthorized nicotine pouches and vapes can stay on shelves while their applications sit in review, which makes them relevant to anyone who buys or sells those products.
The Texas case: on hold while the FDA rewrites the rule
Helix Innovations, which makes Altria's on! pouches, and NJOY, its vape unit, sued the FDA on September 2 in the Northern District of Texas, joined by the Texas Food & Fuel Association and two retailers. They argued that the 2021 Premarket Tobacco Product Application (PMTA) rule lets the agency blow past the 180-day review deadline in the Tobacco Control Act through a multistage acceptance, filing and scientific review process.
The plaintiffs asked the court to vacate the rule and block enforcement against their products with applications pending more than 180 days. However, on September 28, the FDA announced it would reassess the rule and consider new rulemaking to replace it.
The next day the agency and the plaintiffs jointly asked for a stay, and on October 8 Judge James Wesley Hendrix granted it, citing the anticipated rulemaking. The parties must file joint status reports every 45 days. The order does not decide whether the FDA violated the deadline, and the FDA says it will keep processing applications in the meantime.
Three Reynolds American companies—R.J. Reynolds Vapor, Modoral Brands and American Snuff—had moved on September 8 to intervene with their own complaint against the same rule. As of mid-October, the court had not ruled on that request.
The Maryland case: Altria on the FDA's side
The second case is the lawsuit filed July 14 by the Campaign for Tobacco-Free Kids and other health groups, which challenges the FDA's May 8 guidance on enforcement priorities. That guidance says the agency generally will not prioritize enforcement against products whose applications have been accepted and filed and have been pending more than 180 days, with extra conditions for flavored vapes. The FDA Tobacco Center resets playbook strategies frequently, but this specific guidance remains a flashpoint for litigation.
The plaintiffs say it illegally lets unauthorized products, including flavored pouches and e-cigarettes, stay on the market and that the FDA skipped notice-and-comment rulemaking.
On October 6, Helix, NJOY and the trade group American Vapor Manufacturers (AVM) filed motions to intervene in support of the FDA. Their filings describe what they stand to lose if the guidance is vacated: canceled orders, stranded inventory, lost shelf space and wasted application spending.
AVM's filing names member companies whose products rely on the policy, including NicQuid, which said products covered by a now-rescinded denial order account for about 56 percent of its sales, and Charlie's Chalk Dust, which has at least 56 products under scientific review. California's USA Vape Lab asked to join on September 28. The court has not yet ruled on the motions.
The irony is deliberate. In Texas, Altria's companies say the FDA's framework is unlawful because reviews take too long. In Maryland, they defend the FDA's enforcement policy because it shields their pending products from the consequences of those same delays. Their filings acknowledge the tension and argue that the guidance is a stopgap, not a fix.
The other side
The health groups' position is that neither delay nor discretion can substitute for authorization, and that products the FDA has never cleared, especially flavored ones, should not be sold to adults in the meantime. The FDA has authorized only a few dozen nicotine pouch products, including some on! and ZYN variants, and a limited set of vapes. Recently, the FDA authorizes 11 stronger ZYN Ultra pouches, signaling some progress in the review backlog.
Everything else on the market is there because of enforcement discretion. If the Maryland court sides with the plaintiffs, the practical effect could be the largest forced delisting of nicotine products since the 2020 flavored-cartridge policy.
What it means for shoppers and retailers
For adult consumers, the stay in Texas means no quick court-ordered change to how the FDA reviews products. The real action is the FDA's promised rulemaking, which has no published proposal or timeline yet. The Maryland case is the one to watch: if the enforcement guidance falls, products with pending applications, including many of the pouch and vape brands sold in convenience stores and online, could face enforcement before their reviews are finished.
Retailers should expect distributors to start asking harder questions about which products are covered by the guidance. While the industry waits for finality, products like ZYN Peppermint and other authorized brands remain the most stable options for inventory planning. Consumers interested in these products often ask, "Do You Spit With ZYN?" as they transition to these regulated alternatives.
The bottom line
Altria's companies have agreed to wait on the FDA's rewrite of the application rule, while fighting to keep the enforcement policy that currently keeps their unauthorized products on shelves. The stay buys the FDA time; the Maryland intervention shows how much the industry believes rides on the agency's willingness to look the other way until reviews are done. For a broader look at the industry, you can browse our Tobacco Guide: Pipe Tobacco, Wraps, Cigarillos & Pouches — All Articles.