The Food and Drug Administration (“FDA”) oversees the approval and regulation of prescription drugs, over-the-counter drugs, medical devices, many food items, cosmetics and tobacco products. This includes smokeless tobacco products and nicotine pouches. It is illegal to manufacture, sell or distribute nicotine pouches without first obtaining the FDA’s approval.
Recently, the FDA announced a new pilot program designed to streamline the review of nicotine pouch applications. This initiative marks a significant shift in how the agency handles approval for new nicotine products.
What are nicotine pouches?
Nicotine pouches are small, white packets placed between the lip and gum. They are similar to smokeless tobacco pouches. However, they do not contain tobacco leaf. They deliver nicotine absorbed through the mouth lining, offering an alternative to smoking or vaping.
Why the FDA introduced the program
The FDA launched the pilot program in response to the growing popularity of nicotine pouches. The surge in new nicotine pouch product submissions overwhelmed the existing review system. As such, approvals were slowed and regulatory oversight was delayed. According to the FDA, the new program aims to reduce review times, improve consistency, and ensure only products that meet scientific and safety standards reach the market.
Additionally, this move comes amid rising concerns about youth use and misleading marketing claims for oral nicotine products. The agency’s goal is to better protect consumers while allowing legitimate manufacturers to bring responsibly developed products to market more efficiently.
Why nicotine pouches deserve their own review process
Before this pilot program, nicotine pouches were reviewed under the same Premarket Tobacco Product Application (PMTA) process as traditional tobacco products. Examples include cigarettes, cigars, and e-cigarettes.
Because nicotine pouches differ from traditional tobacco products in composition, delivery method, and health impact, they require a specialized review process. The new FDA pilot program allows regulators to focus on the characteristics unique to nicotine patches. These include formulation, absorption, and potential addiction risks of nicotine pouches.
Lastly, the pilot program is designed to streamline the review process for nicotine pouches, indicating a move to provide adult smokers with more options for reduced-risk alternatives.
What comes next?
The FDA will evaluate the program’s success before expanding it to more manufacturers. If the pilot proves effective, it could become a model for other emerging nicotine or drug-delivery products seeking FDA approval.
