As indicated in prior pieces, the oral nicotine pouch market has exploded in popularity in the United States over the past few years. Experts indicate that in the United States, the nicotine pouches market accounted for around $3.95 billion in sales in 2024 and is expected to grow to around $49.54 billion by 2033. Nicotine pouches have become popular with people looking for alternative ways to satisfy their nicotine cravings while minimizing exposure to traditional combustion-related chemicals found in cigarettes. Declining cigarette smoking rates in the U.S. and consumers looking to move away from traditional combustible cigarettes and/or nicotine vapes are fueling the market growth of nicotine pouches.
To date, U.S. Food and Drug Administration (FDA) has only approved 20 nicotine pouch products for sale in the United States. Additionally, noting the surge in purchase and consumption of nicotine pouches, FDA has become increasingly concerned about accidental exposure and ingestion of nicotine by children since approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age. Per FDA, from April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. As a result, FDA has urged all manufacturers of nicotine pouches to utilize child resistant packaging to prevent children from accidentally ingesting nicotine products and to demonstrate the nicotine pouch manufacturers' commitment to protecting public health.
Under pressure from various interest groups and stakeholders, FDA is slated to announce a pilot program whereby FDA intends to fast-track nicotine pouch reviews for 4 large tobacco companies by December 2025. Health and Human Services Secretary Robert F. Kennedy Jr. recently mentioned nicotine pouches are the safest way to consume nicotine, and that "vapes are second." RFK Jr. added that "we are fast-tracking approval" of some vapes. However, no vaping products are included in the pilot authorization program, despite Kennedy's claim and President Donald Trump's 2024 campaign promise to "save vaping."
Typically, the tobacco product approval process takes many years. As reported by Benzinga Capital, FDA has "been under pressure from the White House and other leadership to improve the efficiency of nicotine pouch reviews." This year, tobacco companies have been lobbying for changes, including a faster and clearer FDA authorization process." The recently announced modified authorization process aims to "resolve legal uncertainties for products currently on the market without full FDA authorization, streamline product launches and provide clearer pathways for new product introductions."
Further, Cristine D. Delnevo, director of the Rutgers Institute for Nicotine and Tobacco Studies, set out to assess how widely nicotine pouches are being used among U.S. adults, and to establish a baseline for monitoring future changes in user habits. The findings from Rutgers were recently published in JAMA Network Open, and are believed to be the first estimates of daily nicotine pouch use. The study found most adults who use nicotine pouch products also have a history of tobacco use and may be choosing the nicotine pouch products as a possible step toward reducing or quitting more dangerous forms of nicotine delivery.
Delnevo noted "the highest prevalence of current and daily nicotine pouch use was among adults with a history of tobacco use who had recently quit, suggesting that nicotine pouches may have played a role in their cessation." Delnevo also emphasized "[o]ur results suggest that adults may be using nicotine pouches for harm reduction given that use is highest among those that have recently quit another tobacco product or e-cigarettes."
We will continue to keep you updated as the proposed expedited review process for nicotine pouches by FDA begins to develop. Should you have any questions about the nicotine pouch space market in the United States, please do not hesitate to contact our experienced FDA & Biotechnology Team at Buchanan.
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