DALLAS, August 4, 2026 — The American Heart Association, a relentless force changing the future of health for everyone everywhere, issued the following statement in response to the Food and Drug Administration's announcement four flavored on! nicotine pouches from Helix Innovations. The authorization applies to products in Rich Berry, Cappuccino and Autumn Spice flavors.
"The American Heart Association is deeply concerned by the FDA's decision today to authorize four new flavored on! nicotine pouch products manufactured by Helix Innovations. Nicotine pouches are already the second most popular tobacco product among youth, and flavored tobacco products have long appealed to kids.
"Today's authorization of Helix products was made under an ill-defined nicotine pouch 'pilot program' that the FDA announced it was ending earlier this year. The FDA had stated that the program, which was never adequately explained to the public, was intended to increase efficiency and streamline review of nicotine pouch applications. Yet key questions about the program remain unanswered, including how it differed from the existing premarket tobacco application process and whether any changes were made to the standards used to evaluate these products under the pilot program.
"By authorizing these flavored nicotine pouch products while leaving key questions about the review process unanswered, the FDA appears to be ignoring decades of evidence that the tobacco industry has used flavored products and other tactics to attract and addict youth to its harmful products. The tobacco industry cannot be trusted with the health of our nation's children. Rather than allowing dangerous products on the market, the FDA should protect children's health by prohibiting the sale of all flavored tobacco products, including menthol."
Additional resources
- American Heart Association policy statement: Impact of Smokeless Oral Nicotine Products on Cardiovascular Disease: Implications for Policy, Prevention, and Treatment
- American Heart Association presidential advisory: New and Emerging Tobacco Products and the Nicotine Endgame: The Role of Robust Regulation and Comprehensive Tobacco Control and Prevention
- American Heart Association news release: Modified risk claim for 20 ZYN nicotine pouches risks perpetuating nicotine addiction
- American Heart Association news release: Growing scientific evidence links e-cigarette chemicals to heart health risks
- American Heart Association news release: As youth tobacco use declines, flavored e-cigarettes and nicotine pouches are a continued concern
