Altria has had to stop US sales of its NJOY Ace, the first pod-based vape to receive FDA marketing authorization and the only menthol-flavored e-cigarette product legally sold in the US.
Altria Group has halted the sale of its NJOY Ace e-cigarette products in the United States, effective March 31, 2025, after the US International Trade Commission (ITC) ruled that the device infringes on four patents held by rival Juul Labs. The ban applies to all imports and sales of the NJOY Ace device and its pods, which are currently manufactured in China and Malaysia.
The ruling, finalized in late January and subject to a 60-day presidential review, marks a major setback for Altria’s e-vapor strategy just two years after acquiring NJOY for US$2.75 billion. Juul had filed its ITC complaint in July 2023, shortly after Altria divested its 35% stake in the company. Altria responded with a countersuit that remains unresolved.
The implications are significant: the NJOY Ace was not only the first pod-based vape to receive FDA marketing authorization (in April 2022), but also, as of June 2024, the only menthol-flavored e-cigarette product legally sold in the US. Its removal leaves a gap in a market that remains saturated by unauthorized disposable vapes, many of which are flavored and imported illicitly.
Altria c.e.o. Billy Gifford criticized the ITC decision in January, saying it “undermines public health, especially in context of a market that is overrun by illicit products.” Industry observers echo this concern, noting that regulatory-approved options for adult smokers are now further limited.
The ban cuts short what had been NJOY’s strongest growth phase to date. In Q4 2024, the brand saw a 15.3% year-over-year increase in shipments and expanded its market share in the US. multi-outlet and convenience channel to 6.4%. Nevertheless, it remained a distant third behind RJ Reynolds’ Vuse (42%) and Juul (24.2%).
Analysts view the ITC ruling as a blow to Altria’s already fragile position in the e-vapor sector. Deutsche Bank recently downgraded the company from “Buy” to “Hold,” citing mounting regulatory headwinds and competitive uncertainty. “The exclusion order puts NJOY on ice just as it was gaining traction,” noted one analyst. “It raises serious questions about Altria’s path forward in non-combustibles.”
Altria has several options: it could appeal the ruling to the US Court of Appeals for the Federal Circuit, though this won’t delay enforcement. Alternatively, it could negotiate a licensing deal with Juul or proceed with a redesign of the NJOY Ace.
In fact, the company has already submitted substantial equivalence (SE) exemption requests to the FDA for a modified version of the Ace that it claims avoids three of the four contested Juul patents. However, regulatory experts warn that any substantial redesign—particularly those affecting the device’s aerosol production or heating mechanism—will likely trigger a new premarket tobacco product application (PMTA) process. This could delay a relaunch by a year or more.
The case highlights how patent litigation has become a defining feature of the US vape industry’s commercial landscape. The ITC, a trade body with quasi-judicial authority which handles intellectual property disputes involving imported goods, has increasingly become a venue of choice for major players looking to block competition. Previous cases involving IQOS, Vuse, and other devices have similarly reshaped the market through exclusion orders rather than public health assessments.
Technically, the Office of the US Trade Representative (USTR), which is part of the Executive Office of the President, has the authority to overturn the ITC ruling on public policy grounds, including public health. However, such interventions are rare. Given Trump’s tariff and trade stance, which seeks to protect US innovation, penalize reliance on Chinese manufacturing, and prioritize IP enforcement, this administration is unlikely to overturn an ITC order that favors a US innovator (Juul) over a product made abroad (NJOY Ace), even if that product is FDA-authorized.