The US Food and Drug Administration (FDA) has called on nicotine pouch manufacturers to implement child-resistant packaging in response to a concerning rise in accidental nicotine exposures among young children. This announcement, made on March 5, 2024, highlights the potential dangers these products pose, particularly in light of reported cases of nicotine poisoning.
In a statement, FDA Commissioner Dr. Marty Makary expressed his alarm over the increasing number of incidents involving young children. He noted that the “fruity flavors and bright, colorful designs” of many nicotine pouch products could easily be mistaken for candy, making them particularly attractive to children. The FDA’s recommendation aims to mitigate the risks associated with these “accidental” and “harmful” exposures.
FDA’s Findings and Recommendations
The FDA has authorized a total of 20 nicotine pouch products, all of which employ child-resistant packaging. This regulatory action began in January 2024, when the FDA first granted marketing authorization for certain nicotine pouches. Notably, the brand ZYN, owned by Philip Morris International, was recognized as the only nicotine pouch deemed appropriate for public health protection, largely due to its child-resistant packaging that has been in place since its launch over a decade ago.
Despite this progress, many other brands on the market lack FDA authorization and do not feature child-resistant packaging. The FDA has encouraged manufacturers with pending premarket applications for nicotine pouch products to incorporate child-resistant measures to help prevent accidental exposures to children.
Nicotine pouches are small packets containing a mixture of nicotine, flavorings, and other ingredients that users place between their lip and gum, allowing nicotine to be absorbed through the mucous membranes. Between April 2022 and March 2025, reported cases of nicotine pouch exposures to US Poison Centers have steadily increased. Alarmingly, approximately 72% of these cases involved children under the age of 5.
Health Risks and Consumer Safety
The FDA has emphasized that the concentrated nicotine found in these products can be harmful or potentially fatal to young children, even in small amounts. Research indicates that ingestion of doses as low as 1 to 4 milligrams of nicotine can trigger toxic effects in young children. Symptoms of nicotine poisoning can manifest as abdominal cramps, confusion, seizures, loss of consciousness, headache, and vomiting.
In response to these health risks, the FDA has provided guidance for consumers on the safe storage of nicotine pouches to minimize the risk of accidental exposure. The agency advises parents and caregivers to securely store all nicotine products, including pouches, away from children and in their original packaging. If accidental ingestion occurs, individuals are urged to seek immediate medical assistance and to contact Poison Control at 1-800-222-1222.
Kathy Crosby, CEO and President of the Truth Initiative, a nonprofit organization dedicated to preventing youth nicotine addiction, expressed deep concern over the recent surge in accidental exposures. “To help safeguard young people from the preventable harms of these products, it’s critical for manufacturers to prioritize child-resistant packaging,” she stated. She also urged the FDA to consider the risks associated with accidental exposure and packaging safety when reviewing new products.
Nicotine pouches have rapidly gained popularity, becoming the second most-used nicotine product among youth, according to the US Centers for Disease Control and Prevention (CDC). A recent report from the Truth Initiative indicated that the use of oral nicotine pouches 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, with only 0.5% of Americans using nicotine pouches, compared to 9% who smoke cigarettes and 3% who vape or use e-cigarettes, as reported by US Census Bureau data.
The FDA’s call for child-resistant packaging serves as a crucial step towards enhancing consumer safety and reducing the risk of accidental nicotine exposure among children. As nicotine pouch usage continues to rise, the agency’s focus on packaging safety will play an essential role in safeguarding public health.