FDA Nicotine Pouch Approvals Delayed Despite Expedited Review Program
Reuters reports that despite the FDA having launched a pilot program for expedited review, several popular nicotine pouch products have yet to receive authorization for sale in the United States. Three sources stated that FDA reviewers remain cautious regarding the risks these products may pose to adolescents and other non-tobacco users, including the potential for adults to develop new nicotine addictions. The report notes that applications for four additional brands are currently still pending review.
Key Points at a Glance
- Reuters reports that several popular nicotine pouch products have not yet received FDA authorization for sale in the U.S.
- Three sources indicated that FDA reviewers remain cautious regarding the risks posed to adolescents and new users.
- The report states that the FDA originally planned to accelerate the approval process through a pilot program and anticipated making decisions by the end of 2025.
- In December 2025, six on! PLUS nicotine pouch products, a brand owned by Altria, received authorization.
Applications for the remaining four brands remain in a pending status.
FDA Pilot Program Yet to Deliver Full Approvals
April 2, 2026. According to Reuters, despite the U.S. Food and Drug Administration (FDA) having launched a pilot program for expedited review, several popular nicotine pouch products have yet to receive authorization for sale in the United States.
Sources Say FDA Remains Cautious on Youth and Non-User Risks
Three sources stated that FDA scientific reviewers have not yet approved these products because they remain cautious regarding the risks associated with them—specifically, their potential impact on children, adolescents, and other non-tobacco users.
U.S. Market Size and Regulatory Requirements for Nicotine Pouches
The report notes that the United States is the world’s largest market for harm-reduction alternative tobacco products, valued at approximately $22 billion. Under current regulations, novel tobacco products including nicotine pouches must obtain FDA authorization before they can be legally sold in the U.S.
FDA Balances Harm Reduction Benefits Against Public Health Risks
During the review process, the FDA is required to weigh whether a given product can help smokers transition to lower-harm methods of nicotine consumption without simultaneously posing excessive risks to non-tobacco users and children.
Only on! PLUS Authorized as Other Applications Remain Pending
According to sources, it was originally anticipated that relevant applications would be expedited under a pilot program before the end of 2025. However, except for six on! PLUS nicotine pouch products owned by Altria, which received authorization in December 2025, applications for the remaining four brands are still pending review.
Tobacco Companies Face Setbacks Amid Approval Delays
The report notes that these delays constitute a setback for tobacco companies such as Philip Morris International and British American Tobacco.
Philip Morris International has submitted pending applications for new versions of its best-selling brand, Zyn, while British American Tobacco has submitted applications for its Velo brand. Turning Point Brands also has applications for two nicotine pouch brands included in this pilot program.
Market Reaction: Tobacco Stocks Decline Following Reuters Report
Reuters reported that, in response to this news. Philip Morris International’s share price fell by over 7.00% at one point on Wednesday; British American Tobacco’s shares dropped 1.50%, and Turning Point Brands saw a decline of over 17.00%.
FDA Still Weighing Benefits of Switching Against Addiction Risks
Two sources indicated that one specific concern among FDA reviewers is the potential risk these products pose to adolescents or other non-users—for instance, by encouraging adults who do not currently smoke to develop a nicotine dependency.
FDA Response: Faster Reviews but No Comment on Risk Concerns
In a response to inquiries from Reuters, the FDA stated that applications included in the pilot program would still receive a decision more quickly than most other applications; however, the agency declined to comment on whether its reviewers were indeed concerned about risks to adolescents or new users.
Nicotine Pouches: Lower Risk Than Cigarettes but Not Risk-Free
The report further noted that the FDA has stated nicotine products are highly addictive and are not without risk, even for adults. Nevertheless, compared to cigarettes, nicotine pouches generally pose lower risks; scientific data suggests that if smokers were to switch exclusively to nicotine pouches, their associated health risks could decrease.
FDA Conducts Comprehensive Risk-Benefit Assessment
Reuters reported that the FDA is currently conducting a comprehensive assessment of each nicotine pouch product, weighing its effectiveness in helping smokers switch against associated risk data—including the FDA’s own annual survey data regarding nicotine pouch usage rates and brand preferences among middle and high school students.
Rising Youth Usage Adds Complexity to Approval Decisions
Although usage rates within these demographic groups remain relatively low, they have shown an upward trend in recent years. One source stated that the remaining applications are more complex than anticipated and are currently “on hold,” amid significant concerns regarding the risks posed to adolescents and children. Another source noted that nicotine pouch usage among young adults has risen markedly, and it remains “not entirely clear” whether the benefits offered by the products under review are sufficient to outweigh the associated risks.
