Altria Group’s vape arm, NJOY, has filed a federal lawsuit claiming the Food and Drug Administration (FDA) has unlawfully dragged its feet on reviewing vape applications—effectively blocking the company’s flavored products without issuing a final decision.
Filed Aug. 21 in the U.S. District Court for Western Louisiana, the suit accuses the FDA of letting NJOY’s appeal of a marketing denial order (MDO) sit unresolved for nearly three years. The original denial, issued in 2022, covered NJOY DAILY products in Blue + Black Berry, Watermelon, and Tropical Twist flavors. NJOY insists it addressed the FDA’s concerns with new data, yet the agency still hasn’t ruled.
Adding fuel to the fire, Altria announced the same day that it would release a new line of nicotine pouches without waiting for FDA authorization—a bold move mirrored by rival R.J. Reynolds, which recently began test-marketing flavored disposables under its VUSE ONE brand.
The “Pocket Veto” Problem
The Tobacco Control Act requires the FDA to act on premarket tobacco applications (PMTAs) within 180 days. NJOY argues the FDA’s inaction amounts to an illegal “pocket veto,” keeping companies in regulatory limbo indefinitely. While NJOY DAILY in Rich Tobacco and menthol flavors eventually received authorization, the fruit-flavored options remain unresolved.
According to NJOY, internal FDA documents obtained through a Freedom of Information Act request show that agency scientists actually concluded the company’s flavored products were effective at helping adult smokers fully switch from cigarettes. The same documents indicate FDA communications staff believed NJOY’s youth prevention marketing exceeded safeguards approved for other products.
Despite these findings, NJOY says the FDA has ignored repeated requests for clarity, leaving the company unable to market its flavored vapes while competitors flood shelves with unauthorized disposables. The lawsuit asks the court to force the FDA to issue a decision, warning that ongoing silence inflicts financial harm.
The case was filed in Louisiana, where appeals would be heard by the Fifth Circuit Court of Appeals—a court known to side with vaping industry plaintiffs.
Big Tobacco’s High-Stakes Gamble
What makes this fight more explosive is that Altria and Reynolds are now openly selling products without prior FDA approval, the same behavior they’ve long criticized from overseas manufacturers. Reynolds recently launched five synthetic nicotine VUSE ONE disposables in flavors like Berry Melon and Strawberry Kiwi. The company argues the products are legal since PMTAs were filed before the May 2022 synthetic nicotine deadline.
That claim doesn’t hold up under the law, which allowed only a short grace period ending July 2022. After that, synthetic nicotine products without FDA authorization are illegal. Ironically, Reynolds has previously demanded strict FDA enforcement against exactly this type of flavored disposable.
Altria is taking a similar approach with its Helix Innovations subsidiary, which just introduced on! PLUS nicotine pouches. The company filed PMTAs for the products in June 2024 but says delays in FDA review entitle it to move forward anyway.
“While the FDA’s review timelines have extended far beyond the 180-day statutory requirement,” Altria stated, “Helix has complied with all regulations.”
The Bottom Line
With NJOY suing, Reynolds test-marketing unauthorized vapes, and Altria pushing out new nicotine pouches, Big Tobacco is daring the FDA to respond. What happens next could reshape not only the future of NJOY but also the broader enforcement of America’s tobacco laws.
