Citing an increase in “accidental, harmful exposure” among children, the FDA is urging firms to use childproof packaging to help reduce the risk of such events. The notice (here) indicates that over the period “[f]rom April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.” These relatively new nicotine products can pose a significant threat of serious adverse events, including death, in adults and children, especially in the more vulnerable pediatric population.
With some authorized pouches containing up to 6 mg of nicotine, the danger is real for children where “[t]oxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams.” The FDA is also warning consumers to ensure that they keep the pouches in a secure location, away from access by children. Consumers should also seek medical attention if a pouch is accidentally ingested. In addition, there may be products illegally marketed without FDA clearance that can contain up to 16.6 mg of nicotine.
The Agency notes that “[t]o date, the FDA has authorized 20 nicotine pouch products [of different strengths and formulations from one company], all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.” The FDA is recommending that manufacturers with a pending premarket application that plan to use child-resistant packaging or other options to prevent accidental ingestion contact their regulatory project manager to discuss this important issue. From the FDA’s tone relative to the increase in accidental nicotine pouch exposures, any manufacturer seeking authorization for a nicotine pouch will most likely need to incorporate some type of child-resistant element into its packaging to secure FDA clearance.
