WASHINGTON — The U.S. Food and Drug Administration is considering changes that could speed up the authorization process for vaping products and nicotine pouches, according to The Wall Street Journal.
The FDA said Monday it intends to evaluate changes to its 2021 Premarket Tobacco Product Application framework, which outlines requirements manufacturers must meet to get new tobacco products authorized. The agency said it is considering a new rule based on its experience implementing the current framework, recent court developments and the growth of an illicit, unregulated market.
The move comes as the FDA has recently authorized several new nicotine pouch products. In August, the agency authorized four new “on!” nicotine pouches in Rich Berry, Cappuccino and Autumn Spice flavors, bringing the total number of authorized nicotine pouch products to 30 at the time.
The FDA then authorized 11 additional ZYN ULTRA nicotine pouch products later in August. The agency now lists 43 nicotine pouch products that are authorized for legal sale in the United States.
The FDA also took action in June involving 20 ZYN nicotine pouches, allowing the products to be marketed with a modified risk claim. The agency said adults who switch completely from cigarettes to the authorized ZYN products have a lower risk of several serious diseases, including mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
FDA officials say the decisions are aimed at helping adult smokers transition away from more harmful products, but public health advocates have raised concerns about flavored nicotine products and their appeal to young people.
According to the 2025 Monitoring the Future study, the percentage of high school seniors who reported using nicotine pouches in the past 30 days rose from 1.4% in 2023 to 4.4% in 2025. Lifetime use among 12th graders also increased from 6.8% to 10% over the past year.
The proposed changes would mark a shift from the Trump administration’s first term’s efforts to restrict flavored e-cigarettes as part of an effort to curb youth vaping. The administration previously warned that sweet flavors were helping attract young people to nicotine products.
