January 22, 2026
I am Dr. Akashleena Mallick. I am a physician and public health researcher with the nonprofit National Center for Health Research.
A modified-risk authorization requires a clear benefit to public health. That standard is not met here. I will explain why.
I want to begin by supporting the concerns previously raised by UCSF and Tobacco Free Kids about the use of nicotine pouches by about half a million U.S. middle and high school students. I will now focus on the medical, pediatric, and public health harms of ZYN.
A modified-risk order requires proof of less disease. The FDA found no data on the health impact of ZYN. Relying on General snus data is inappropriate because these products differ in use, toxicology, and marketing. We agree with the FDA that data on Swedish adults do not apply to U.S. teenagers. That’s why FDA’s General Snus MRTP is not a valid precedent for ZYN.
Claims of reduced risk for cancer, heart disease, and stroke would require decades of follow-up to make them comparable to the risks of cigarettes. No such data exists. Short-term biomarkers and toxicant comparisons cannot prove disease reduction. Nicotine itself harms the heart and blood vessels, as concluded by the American Heart Association and the European Society of Cardiology. Nicotine raises blood pressure and heart rate and worsens vascular function- key pathways for heart attack and stroke. Without long-term data showing fewer cancers, heart attacks, or strokes, any claim of reduced risk is misleading and probably incorrect.
US poison center data show nicotine pouch exposures rose dramatically, from 181 cases in 2022 to over 900 cases by early 2025. Nearly three-quarters of these cases involved children under age five, mostly from accidental ingestion. A peer-reviewed national study found that nicotine pouch ingestions in young children rose more than 760 percent in just three years and were more likely than other nicotine products to cause serious harm or hospital admission. These injuries are happening now.
ZYN has a record of aggressive marketing with a rewards program that encourages more frequent use, including in children and adolescents. If the goal of ZYN was to give a safer alternative to smoking, why is ZYN successfully focusing its marketing on children and teens, most of whom don’t smoke?
Independent research shows that modified-risk claims are often misunderstood as “safe.” Leading to dual use, delayed quitting, and use by non-smokers who then become addicted. Some states apply lower taxes to MRTP products, and companies push for those cuts. Lower prices increase use among both smokers and non-smokers.
The FDA said e-cigarettes would help adults quit. Instead, they helped fuel a youth nicotine epidemic. Nicotine pouch sales have already risen more than 10-fold, from 126 million units in 5 months in 2019 to over 800 million units in 3 months in early 2022.
There is no long-term evidence that ZYN reduces mouth cancer, lung cancer, heart disease, or stroke. But there is clear evidence of pediatric poisonings, likely cardiovascular harm, problematic marketing, and increasing risks to public health.
For these reasons, ZYN nicotine pouches do not meet the legal standard for modified-risk authorization.
Thank you.
Click here to read our written comment to the FDA on the Modified Risk Tobacco Product applications for ZYN nicotine pouch products.