Broughton Welcomes FDA Authorization of ZYN Nicotine Pouches

Broughton welcomes the US Food and Drug Administration’s (FDA) decision to authorize ZYN nicotine pouches for sale. This critical milestone underscores the importance of science-based tobacco harm reduction and provides adult smokers with a viable alternative to combustible cigarettes.

Nicotine pouches, a modern oral nicotine product (MONP), eliminate the harmful by-products of combustion, offering smokers a safer path towards quitting traditional cigarettes. However, the industry still faces challenges in ensuring these products are responsibly marketed and rigorously regulated.

CEO, Chris Allen, commented: “This FDA authorization is a significant step forward in tobacco harm reduction, demonstrating the vital role of scientifically validated products in providing consumers with less harmful options. At Broughton, we are committed to supporting the development of innovative nicotine products that can transform public health outcomes.”

Chris further added "Many people have had concerns that FDA would take a similar stance to ENDS and not authorize any non-Tobacco or non-Menthol flavored products. This news does back FDA's narrative that there is not a de facto ban on flavors and authorized on the evidence of low uptake in youth. Overall, this is a huge boost for the oral pouch category, providing confidence in the ability to obtain Marketing Orders"

With smoking-related illnesses claiming over 8 million lives annually, reduced-risk products like nicotine pouches represent a pivotal opportunity to change the global health landscape. Sweden’s success in achieving smoke-free status through a balanced approach to regulation and alternative products demonstrates what is possible when innovation and harm reduction go hand in hand​​.

Broughton partners with nicotine innovators to deliver comprehensive regulatory and scientific consultancy, ensuring reduced-risk products meet the highest standards of safety and efficacy. With expertise spanning toxicological risk assessments, behavioural studies, and regulatory submissions, Broughton is the trusted partner for companies navigating the complex PMTA process.

Through tailored strategies, extensive FDA insight, and a proven track record of PMTA Marketing Order successes, Broughton streamlines the path to compliance, enabling manufacturers to bring innovative oral nicotine products to the US market with confidence.

For any business considering a PMTA submission for oral nicotine products, Broughton offers the expertise, strategic guidance, and regulatory knowledge needed to succeed while contributing to global tobacco harm reduction efforts.

For more information about Broughton’s PMTA services, visit https://www.broughton-group.com/premarket-tobacco-product-application