The U.S. Food and Drug Administration (FDA) is calling on manufacturers of nicotine pouches to implement child-resistant packaging in response to an alarming increase in accidental exposures among young children. This announcement was made on March 12, 2024, after reports indicated a rise in cases leading to nicotine poisoning, particularly in children under the age of five.
In a statement, FDA Commissioner Dr. Marty Makary expressed concern over the rising incidents. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion,” he said.
The FDA has already authorized 20 nicotine pouch products, all of which feature child-resistant packaging. Notably, ZYN is the only nicotine pouch that the FDA has deemed appropriate for public health, according to its manufacturer, Philip Morris International. The company emphasized that ZYN’s child-resistant packaging has been in place since its launch over a decade ago.
Despite the FDA’s regulatory measures, many brands remain unverified and do not utilize child-resistant packaging. The agency is encouraging manufacturers with pending premarket applications for nicotine pouch products to incorporate such safety measures to mitigate risks associated with accidental exposure to children.
Nicotine pouches are small, moist packets filled with a powder containing nicotine, flavorings, and other ingredients. Users place them between their lip and gum, allowing nicotine to be absorbed through the mucous membranes. Data from the FDA indicates that from April 2022 until March 2025, the number of reported nicotine pouch exposures to U.S. Poison Centers rose significantly, with approximately 72% of cases involving children younger than five years old.
The concentrated nicotine in these products poses serious health risks to young children, even in small amounts. Ingesting doses as low as 1 to 4 milligrams has been linked to toxic effects, including symptoms such as abdominal cramps, confusion, seizures, loss of consciousness, headache, and vomiting. The FDA has provided guidelines for consumers on how to store nicotine pouches safely to prevent accidental exposure, advising parents and caregivers to keep all nicotine products secured away from children and in their original packaging.
In a statement, Kathy Crosby, CEO and President of the Truth Initiative, a nonprofit organization working to prevent youth nicotine addiction, highlighted the urgency of addressing this issue. “The recent rise in accidental exposure to nicotine pouches is deeply troubling, especially when it involves our youngest and most at risk,” she said. She further urged manufacturers to prioritize child-resistant packaging and for the FDA to consider the risks of accidental exposure when reviewing new products.
Nicotine pouches have gained popularity as the second most-used nicotine product among youth, according to the U.S. Centers for Disease Control and Prevention (CDC). A report released by the Truth Initiative noted that use among high school students nearly doubled, rising from 1.3% in 2023 to 2.4% in 2024.
Despite this increase, the overall user base remains relatively small. Only 0.5% of Americans currently use nicotine pouches, compared to 9% who smoke cigarettes and 3% who use e-cigarettes, based on data from the U.S. Census Bureau.
As the FDA continues to monitor the situation, it emphasizes the importance of child-resistant packaging to protect vulnerable populations from the dangers associated with nicotine products.
