WASHINGTON, DC | September 18, 2025
Today, the U.S. Food and Drug Administration (FDA) announced a new program where they will accelerate premarket tobacco applications for nicotine pouch products. Harold Wimmer, President and CEO of the American Lung Association, issued the following statement in response to the announcement:
“The American Lung Association is extremely concerned about FDA’s new program to fast-track reviews on nicotine pouch products.”
“Nicotine pouches are so new that the short- and long-term health impacts are not known yet. A 2022 study of 44 nicotine pouch products found that 26 of the samples contained cancer-causing chemicals and several other chemicals, including ammonia, chromium, formaldehyde, nickel, pH adjusters and nicotine salt. This lack of independent, long-term research underscores the need for FDA to maintain the most rigorous scientific review process – not to create shortcuts that could put public health at risk.”
“We are already seeing disturbing signs of history repeating itself. Youth use of nicotine pouches is rising, fueled by influencer and celebrity promotions that echo the early playbook of Juul during the youth vaping epidemic. One study found there has been a 641% increase in sales of the products between 2019 and 2022, but just 2.9% of U.S. adults had ever used a nicotine pouch – suggesting significant uptake among people under 21. Even more alarming, a July Pediatrics study found a 763.1% increase in the rate of nicotine pouch ingestions among children younger than six between 2020 to 2023.”
“No amount of nicotine is safe. Nicotine is highly addictive and especially harmful to young people and pregnant women in any form. Instead of rushing the review process, FDA must stop this pilot program, continue applying rigorous scientific standards, and not authorize any additional flavored nicotine pouch products that would attract children.”
“The safest forms of nicotine are FDA-approved nicotine replacement therapies (NRT) – like nicotine gum or patches – proven to help people quit smoking. The pathway to getting products approved as a cessation therapy has long existed and remains open to manufacturers of nicotine pouches, e-cigarettes or other tobacco products that believe they can help people quit smoking or tobacco use completely.”
###
The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy and research. The work of the American Lung Association is focused on four strategic imperatives: to defeat lung cancer; to champion clean air for all; to improve the quality of life for those with lung disease and their families; and to create a tobacco-free future. For more information about the American Lung Association, which has a 4-star rating from Charity Navigator and is a Platinum-Level GuideStar Member, call 1-800-LUNGUSA (1-800-586-4872) or visit: Lung.org. To support the work of the American Lung Association, find a local event at Lung.org/events.
For more information, contact:
Jill Dale
312-940-7001
Jill.Dale@Lung.org
Your Gift Goes 2X Further Today
Give now and double your impact! Every gift is matched dollar-for-dollar up to $100,000 thanks to ProTeam.
