The U.S. Food and Drug Administration has urged nicotine pouch manufacturers to use child-resistant packaging following a rise in accidental exposures. From April 1, 2022, to March 31, 2025, U.S. Poison Centers reported a steady increase in cases, with 72% involving children under five years old.
Reported Incidents
Nicotine pouches contain concentrated nicotine, which can be harmful or potentially fatal even in small doses. Toxic effects in young children have been observed at doses as low as 1 to 4 milligrams. Symptoms may include confusion, vomiting, and loss of consciousness.
Statement from FDA Commissioner
“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary. He highlighted that fruity flavors and colorful packaging may resemble candy, making them appealing to children.
Guidance for Families
The FDA advises parents and caregivers to store nicotine products in secure locations and in their original packaging. Immediate medical attention should be sought if accidental ingestion occurs. In the U.S., Poison Control can be reached at 1-800-222-1222.
Manufacturer Responsibilities
Child-resistant packaging is a key measure to protect public health. Manufacturers with pending applications are encouraged to contact the FDA to incorporate safety measures that reduce accidental exposure to children.
Authorized Products
To date, the FDA has approved 20 nicotine pouch products, all using child-resistant packaging. A full list is available on the FDA website.
Glossary
- Nicotine pouches: oral products containing concentrated nicotine, often flavored, placed between the gum and lip.
- FDA (Food and Drug Administration): U.S. federal agency regulating food, drugs, medical devices, and tobacco products.
- Nicotine poisoning: a toxic reaction to nicotine, with symptoms including nausea, vomiting, confusion, and loss of consciousness.
