FDA Authorizes Four New Flavored Nicotine Pouches Amid Youth Health Concerns

On August 5, 2026, the U.S. Food and Drug Administration (FDA) granted marketing authorization for four flavored nicotine-pouch products—Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg—manufactured by Helix Innovations LLC and sold under the on! brand. The decision came through the agency’s pre-market tobacco product application (PMTA) pathway as part of a pilot program launched in September 2025 to streamline nicotine-pouch reviews. The FDA concluded that the products contain lower levels of most harmful and potentially harmful constituents (HPHCs) than cigarettes and traditional oral or smokeless tobacco, many of which were “too low to be quantified.”

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The authorization brings the total number of FDA-authorized nicotine-pouch products to 30. Earlier approvals included 20 ZYN products (Philip Morris International) in January 2025 and six on! PLUS products (Altria) in December 2025. The pilot program was intended to improve efficiency while maintaining scientific standards, and the agency plans to apply its communication practices to all future nicotine-pouch PMTA reviews.

FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions FDA Authorizes 4 New on! Nicotine Pouches C-StoreDiveKTVT - Dallas - Fort Worth NewsHealioFDA authorizes 4 new nicotine pouches from Altria The Hill

• Authorized products: 30 total (20 ZYN, 10 from Helix Innovations/Altria).

FDA authorizes 4 new nicotine pouches from Altria

• Nicotine strengths for the new on! products: 2 mg or 4 mg.

FDA Authorizes 4 New on! Nicotine Pouches

• CDC Foundation analysis found monthly sales of nicotine pouches rose 250 % between January 2023 and August 2025.

FDA Authorizes 4 New on! Nicotine Pouches

• National Youth Tobacco Survey (2023) reported about 460,000 middle- and high-school students using nicotine pouches, the second-most-common tobacco product among youth after e-cigarettes.

NPR

• FDA’s 2025 youth survey indicated stable current use at < 2 % of teens, while Monitoring the Future showed 12th-grader lifetime use rising from 6.8 % (2024) to 10.0 % (2025) and past-30-day use at 4.4 % (2025).

NPR

The FDA emphasized that the authorization does not imply the products are safe or risk-free. Marketing orders require post-market surveillance and may be withdrawn if youth uptake rises, per the agency’s conditional language.

Medical Daily

Public-health advocates warned that the new flavored products could attract young people and called for the FDA to prioritize protecting children rather than expanding flavored options.

The Hill

Youth-use data present divergent pictures. The National Youth Tobacco Survey suggests relatively low and stable prevalence (about 1.7 % of the school-age population), while Monitoring the Future documents a notable rise in 12th-grader lifetime use. Both sources agree flavored products dominate youth consumption, but the magnitude of the trend remains uncertain.

NPR

• “Every new flavored tobacco product authorized by FDA is another gamble with kids’ health,” — Ranjana Caple, American Lung Association

Healio

• “If at any point the agency determines that, among other things, the continued marketing of the products as MRTPs no longer benefits the health of the population as a whole, such as if there is a significant increase in youth uptake, the agency may withdraw the orders.” — The FDA

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