ITC Orders NJOY Ace Imports Off U.S. Market

The U.S. International Trade Commission (ITC) has ruled that vape manufacturer NJOY’s pod-based Ace device and its pods infringe Juul Labs patents, and ordered imported Ace devices and pods removed from the U.S. market. 

The decision, handed down Wednesday by the full commission, confirmed an August 2024 preliminary ruling by an ITC administrative law judge. Juul Labs filed the patent complaint with the ITC in July 2023. 

The ruling will force NJOY and its corporate parent Altria Group to stop importing the NJOY Ace and Ace pods within 60 days, unless the ITC decision is overturned by the Trump administration’s Office of the U.S. Trade Representative. The ITC order would not necessarily apply to NJOY Ace products made in the U.S., but currently they're all manufactured in Asia.

The Juul Labs ITC complaint and a companion federal lawsuit were filed just four months after Altria sold its 35 percent share in Juul, and bought NJOY for $2.75 billion.

Soon after Juul Labs filed its ITC complaint, Altria/NJOY retaliated with its own ITC filing (and federal lawsuit), accusing Juul of patent violations. That case is still ongoing, according to Reuters.

“Big Vape” companies fight for FDA authorization, market share

The NJOY Ace was the first pod-based vape to receive FDA marketing authorization (April 2022), and last June menthol refill pods for the Ace became the first “flavored” vaping products authorized by the agency. The FDA has authorized just eight vaping devices that are currently available—all produced by manufacturers now owned by three major tobacco companies.

The Ace device and pods are manufactured for NJOY under contract by Chinese vape pioneer Smoore. Juul’s devices are also made in China, as are virtually all mass-market vaping devices. 

However, unlike the NJOY Ace, Juul Labs’ flagship vape device, the JUUL, has not been granted authorization by the FDA. After issuing a marketing denial order (MDO) in 2022 for the JUUL and its refill pods, the FDA backed down and stayed its own order two weeks later. In 2024—two years later—the FDA rescinded its MDO and placed Juul Labs’ marketing application back into scientific review. Juul's application remains in review.

Juul’s sales have declined in recent years in the convenience store/gas station segment of the U.S. vape product market, where Juul is primarily sold. The Nielson report for the four-week period ending Dec. 30, 2024, showed Juul Labs holding 24.2 percent of market share—down from 74.6 percent in May 2019, according to Tobacco Reporter. NJOY held just 2.6 percent market share during the previous four-week period.

R.J. Reynolds’ Vuse brand captured 42.0 percent of the Nielson-tracked market during the December period, mostly due to sales of the Vuse Alto, which was granted FDA authorization in July 2024. Most of the rest of the market consists of various disposable vapes, none of which have received FDA approval.

The ITC: Big Tobacco’s favorite (anti-)competitive tactic

The ITC isn’t a criminal or civil court. Rather, it is a federal agency that advises the executive and legislative branches on trade issues, and has quasi-judicial power over international trade, ruling on issues like patents, copyright law, and unfair imports. However, its decisions can be overturned by the White House.

Major tobacco companies have used ITC complaints and other patent infringement lawsuits regularly in attempts to short-circuit market competitors and would-be competitors. 

In 2022, a federal jury awarded Altria $95 million in a lawsuit that claimed R.J. Reynolds’ Vuse Alto infringed three Altria patents. 

Reynolds, which is owned by British American Tobacco (BAT), said the lawsuit was retaliation for its own patent complaint against Altria regarding heated tobacco product IQOS, which Altria then intended to sell in the United States under license from manufacturer Philip Morris International (PMI). In that dispute, Altria was ordered by the ITC to stop selling imported IQOS devices.

In October 2023, R.J. Reynolds filed an ITC complaint accusing multiple disposable vape manufacturers, distributors and retailers with unfair import practices. Days later, NJOY/Altria filed a federal lawsuit against many of the same companies (and some others), charging them with illegally selling their flavored products in the state of California, and also violating federal law.

In addition to the case decided this week, Juul Labs has filed multiple ITC complaints and lawsuits, mostly against manufacturers and sellers of JUUL clones and Juul-compatible pods.