The proliferation of nicotine pouch ingestions by children has prompted the FDA to call for child-resistant packaging for all products.
RT’s Three Key Takeaways:
- FDA demands child-resistant packaging, citing a sharp rise in nicotine pouch poisonings, with nearly three-quarters of reported cases involving children under age five.
- Nicotine is highly toxic to young children, with as little as 1–4 milligrams causing serious symptoms such as vomiting, confusion, or unconsciousness.
- Parents and caregivers must store products securely, as the FDA urges safe storage, immediate medical attention for accidental ingestion, and quick contact with Poison Control at 1-800-222-1222.
The US FDA is demanding nicotine pouch manufacturers use child-resistant packaging to protect American children from accidental, harmful exposure, according to an agency announcement.
According to the FDA, reported nicotine pouch exposure cases reported to US Poison Centers has steadily increased since from April 2022. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
Read also: Sharp Increase in Nicotine Pouch Ingestions Among Young Children
Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness.
“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary, MD, MPH. “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.”
The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children. Parents and caregivers should safely store all nicotine products, including pouches, in secure locations away from children in original packaging and seek immediate medical attention if accidental ingestion occurs. If a person of any age eats a nicotine pouch, accidental or not, immediately call Poison Control HELP number at 1-800-222-1222.
Child-resistant packaging can serve as an essential safety barrier to prevent children from accidentally ingesting nicotine products and demonstrates a manufacturer’s commitment to protecting public health. Manufacturers with a pending premarket application for a nicotine pouch product who intend to incorporate child-resistant packaging or other measures to mitigate the risk of accidental exposure to children should contact the FDA through their assigned Regulatory Health Project Manager (RHPM) or at [email protected] or 877-CTP-1373.
To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.
