In a recent commentary published in JAMA, experts from the Rutgers Institute for Nicotine & Tobacco Studies have urged the U.S. Food and Drug Administration (FDA) to quickly regulate nicotine pouches. The call comes from Cristine Delnevo, director of the institute, and Mary Hrywna, associate professor, who argue that swift action is necessary to prevent nicotine pouches from following the same path as e-cigarettes.
Delnevo describes nicotine pouches as “a noncombustible or smokeless product that contain nicotine, but no tobacco and are intended for oral consumption.” She notes that these products are sold in various strengths and flavors and highlights Zyn as a leading brand. Despite their growing sales, Hrywna points out that “the use of these products among youth and adults in the U.S. remains low.”
The FDA’s current stance on nicotine pouches involves requiring manufacturers to submit premarket tobacco product applications (PMTAs). However, Hrywna states that “the FDA has not made a final decision on any application for a nicotine pouch brand.” Delnevo believes there are lessons to be learned from the FDA’s regulation of e-cigarettes, particularly with Juul’s market dominance.
Both experts emphasize the importance of monitoring youth tobacco use behaviors. Delnevo warns that “nicotine, even in pouches containing no tobacco leaf, is an addictive substance,” while Hrywna suggests that nicotine pouches could reduce harm if users switch from more dangerous tobacco products.
The commentary also addresses why issuing marketing authorizations is crucial. Hrywna explains that the FDA must evaluate scientific evidence regarding risks and benefits before acting on any tobacco product. Delnevo stresses the need for swift regulatory action to prevent uncontrollable market growth.
