July 23, 2026

The Modified Risk Classification of ZYN Nicotine Pouches

WASHINGTON, D.C. – On June 30, 2026, the US Food and Drug Administration (FDA) authorized 20 ZYN nicotine pouch products to be marketed with a modified risk claim. ZYN pouches are tobacco-free, nicotine-containing pouches whose stated purpose is to provide a smoke-free, discreet way to consume nicotine. According to the FDA, this modified risk grant order authorizes these ZYN products to be marketed with the following reduced-risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” It is the fact that these products are tobacco-free that makes them a safer alternative when compared to cigarettes. 

Modified risk tobacco products are defined as any product that is sold or distributed to reduce the harm or risk of tobacco-related disease to individual tobacco users and the health of the population as a whole. For people who smoke cigarettes and other tobacco-containing products, ZYN pouches may be seen as a form of harm reduction. Other organizations, such as the American Heart Association (AHA) and American Cancer Society Cancer Action Network (ACS CAN), issued statements shortly after the authorization of ZYN products as modified risk condemning the FDA’s labeling of these products as reduced-risk. The organizations stated that even though ZYN pouches claim to be safer than cigarettes, they can still be highly addictive, and their long-term health outcomes are largely unknown given the relatively recent appearance of ZYN pouches on the market.

Doctors for America supports harm reduction, including the use of tobacco-free products as a safer alternative to cigarettes. However, the health benefits of ZYN pouches as a harm reduction tool only apply if a person completely replaces tobacco-containing products (e.g., cigarettes) with ZYN pouches. This distinction should be made clear in marketing materials. Furthermore, marketers should make it clear that ZYN pouches are not without risks and can be particularly harmful to youth/adolescents and non-smokers. For youth and adolescents, nicotine can harm brain development, which continues until age 25. Given the highly addictive nature of nicotine, ZYN pouches should not be marketed as safe for non-smokers who have not previously used tobacco or nicotine products as these products may lead to nicotine dependence or addiction. While recognizing the possible benefits of a tobacco-free nicotine product, Doctors for America agrees with the AHA and ACS CAN that a balanced approach is needed to ensure that marketing of ZYN pouches reflects the true risks associated with use.

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About Doctors for America:

Doctors for America (DFA) is a national nonprofit that mobilizes over 40,000 physicians and medical trainees to advocate for policies that improve the health of patients and communities. Through advocacy training and action at the state and federal levels, DFA works to expand access to affordable care, strengthen community health and prevention, and advance health justice and equity. We do not accept funding from pharmaceutical, insurance, or for-profit health care entities, ensuring our work remains fiercely independent and patient-centered. DFA puts patients over politics–and over profits. Find out more at doctorsforamerica.org and on X @drsforamerica or Bluesky drsforamerica.bsky.social.

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