Weeks of December 22 and 29, 2025 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

U.S. Federal & National Developments

• FDA Authorizes on! Plus: The FDA authorized the marketing of six on! Plus nicotine pouch products manufactured by Helix Innovations (Altria). This marks the first authorization under the FDA’s new pilot program designed to expedite the review of non-combustible products. (See analysis below)

• FDA PMTA Workshop: FDA issued a Federal Register notice (FRN) announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on February 10, 2026, 9 am–5 pm ET. The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. (See analysis below)

• Illicit Vape Legislation: The Senate passed the "Ensuring the Necessary Destruction of Illicit Chinese Tobacco Act" as part of a broader government funding package. The bill grants the FDA clear authority to destroy adulterated or misbranded tobacco products intercepted at the border.

• Juul vs. NJOY Patent Dispute: The U.S. International Trade Commission (USITC) officially instituted a Section 337 investigation following Juul Labs' patent infringement complaint against NJOY and Altria. This probe targets vaporizer devices and cartridges alleged to infringe on Juul's patents.

• NJOY Ace Import Ban: Reports confirm that the Trump administration declined to intervene in the USITC’s exclusion order against NJOY Ace products, meaning the ban on importing these products remains in effect.

• Juul Seeks to Bar Altria Use of UCSF Records in Vape-Patent Case: Juul Labs Inc. asked an Arizona federal judge to bar Altria Group Inc. and its NJoy units from using documents Juul says were inadvertently uploaded to a public University of California at San Francisco database that could undermine its nicotine-salt vape patent.

State-Level Updates

• Pennsylvania: The state legislature passed House Bill 1425, establishing a directory of FDA-authorized e-cigarettes allowed for sale. If signed by Governor Shapiro, Pennsylvania will become the 14th state to enact such a registry.

• Virginia: A federal judge granted a partial preliminary injunction blocking enforcement of specific provisions of Virginia's new law banning unapproved vape products. The court dismissed some claims but allowed the preemption argument to proceed.

• Alabama: The Alabama Supreme Court maintained a temporary restraining order on the state's new vape law in a 4-3 decision, halting enforcement while litigation proceeds.

• Arkansas: State legislation targeting illegal vapes has drawn attention for including a unique provision that bans the personal possession of products not listed on the state’s registry.

• Ohio: An Ohio appeals court ruled that the state Attorney General’s lawsuit against vape shops for selling unauthorized products was preempted by the federal Tobacco Control Act, stating that enforcement of FDA authorization status is a federal, not state, responsibility.

• Kentucky: With a January 1, 2026 deadline approaching, state officials and advocates are pushing for strict enforcement of Senate Bill 100, which requires licensure for all tobacco and vape retailers.

• Missouri: The Department of Health and Senior Services launched a new website, "You Can Quit," providing resources for residents attempting to stop using tobacco and nicotine.

Industry & Trade Press

• Market Authorization Speculation: Following the on! Plus news, trade press reports suggest that Glas may be the next e-cigarette brand to receive FDA marketing authorization, although this has not been officially confirmed.

• Altria Market Expansion: The authorization of on! Plus is viewed as a significant competitive victory for Altria in the modern oral nicotine category, allowing them to better compete with Philip Morris International's ZYN.

International Developments

• France: The Council of State suspended a government decree that would have banned nicotine pouches. The court ruled that manufacturers were not given sufficient time to reorganize and noted that commercial sales were already restricted under existing laws.

• United Kingdom: New research indicates a tenfold increase in nicotine pouch use over the last five years, prompting calls from Action on Smoking and Health (ASH) for tighter regulations.

• Jordan: The government announced tax reductions on heated tobacco products and e-cigarettes to encourage the transition from combustible cigarettes.

• Mexico: Critics continue to argue that Mexico's strict ban on vape sales has failed, fueling a black market rather than reducing use.