MO · 10-Q · 2026Q2 · Full report

FDA Nicotine Product Regulation

ALTRIA GROUP, INC. · 2026-07-30 · Importance 44 · Surprise 60 · In source text

In May 2026, the FDA issued enforcement guidance for e-vapor and oral nicotine pouch products with pending PMTAs, generally indicating that it will not prioritize enforcement while applications undergo scientific review or while certain Supplemental PMTAs have been pending for more than 180 days. Helix has submitted PMTAs for multiple on! and on! PLUS oral nicotine pouch products from May 2020 through June 2026; the FDA issued marketing orders for on! PLUS tobacco, mint and wintergreen products in December 2025, but had not authorized any other on! or on! PLUS products as of July 27, 2026. NJOY ACE and NJOY Daily have FDA marketing orders, although NJOY ACE is subject to U.S. ITC exclusion and cease-and-desist orders and JUUL has asserted patent infringement claims against NJOY Daily. FDA denials, marketing-order withdrawals, enforcement actions or changing requirements could require product removals and materially affect Altria’s innovative nicotine businesses, cash flows or financial position.

Key facts

• The FDA guidance indicates it generally will not prioritize enforcement against e-vapor and oral nicotine pouch products with pending PMTAs that are undergoing scientific review or pending Supplemental PMTAs (other than flavored e-vapor products) that have been accepted and pending for more than 180 days. source
• The FDA guidance states products appealing to youth and products presenting public health or safety concerns greater than those typically presented by e-vapor or oral nicotine pouch products generally will not be eligible for enforcement discretion. source
• In May 2026, the FDA issued guidance concerning how it intends to enforce premarket review requirements for certain e-vapor and oral nicotine pouch products with pending PMTAs. source
• Altria stated that products containing nicotine analogues are not subject to the FDA regulatory framework for tobacco products because the statutory definition does not cover nicotine analogues. source
• The FSPTCA requires the FDA to issue a marketing order with respect to a PMTA no later than 180 days after receipt of the PMTA, and allows expedited judicial review within 30 days for parties that receive a marketing denial order. source
• Cigars, e-vapor products and oral nicotine pouches first regulated in 2016 that were on the market as of August 8, 2016 and not subsequently modified had to file an SE report or PMTA by the filing deadline of September 9, 2020 to remain on the market. source
• Helix submitted PMTAs for on! PLUS oral nicotine pouches in additional flavors in November 2025 and June 2026. source
• In September 2025, the FDA launched a pilot program intended to increase efficiency and streamline the review process for PMTAs for select oral nicotine pouch products. source

Impact estimates