Modified risk claim for 20 ZYN nicotine pouches risks perpetuating nicotine addiction

WASHINGTON, D.C., July 1, 2026 - The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN flavored nicotine pouch products. The American Heart Association, a relentless force changing the future of health for everyone everywhere, issued the following statement:

"The American Heart Association is deeply concerned by the FDA's decision to allow ZYN flavored nicotine pouches to be marketed with a modified risk claim. This decision empowers the tobacco industry to aggressively market these products in its efforts to perpetuate nicotine addiction by hooking children and adults on a range of harmful products. Tobacco companies spend millions trying to mislead the public into thinking nicotine pouches are safe, but the industry's real goal is to addict a new generation to nicotine.

"Flavored tobacco products have been repeatedly shown to appeal to youth. The tobacco industry's marketing tactics have led to an increase in youth use and contributed to the increased popularity of nicotine pouches, which are now the second most commonly used tobacco product among middle and high school students. Allowing these flavored products to be marketed as 'lower risk' than cigarettes gives the tobacco industry opportunity to capture more market share and addict kids and adults for a lifetime, which runs counter to the requirement that modified risk products benefit the health of the population as a whole.

"Tobacco and nicotine products are not safe. Allowing reduced-risk claims without clear evidence that people will completely switch away from combustible cigarettes could result in dual and poly use and prolonged addiction, rather than ending it. The FDA must consider not just how a product compares to combustible products, but how it is marketed and real-world uses, including how it impacts initiation.

"The FDA must closely monitor how these products are marketed and used, and it must be prepared to act quickly if this decision leads to increased youth use, dual or poly use or continued nicotine addiction. The American Heart Association remains committed to advancing policies that prevent initiation, ensuring all products are appropriately reviewed for their impact on health before they are allowed to be sold and supporting proven cessation tools that help people permanently quit."

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About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives. Dedicated to ensuring equitable health in all communities, the organization has been a leading source of health information for more than one hundred years. Supported by more than 35 million volunteers globally, we fund groundbreaking research, advocate for the public's health, and provide critical resources to save and improve lives affected by cardiovascular disease and stroke. By driving breakthroughs and implementing proven solutions in science, policy, and care, we work tirelessly to advance health and transform lives every day. Connect with us on heart.org, Facebook, X or by calling 1-800-AHA-USA1.   

For Media Inquiries: Arielle Beer: [email protected]

For Public Inquiries: 1-800-AHA-USA1 (242-8721)
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