ZIN's success reflects the synergy of three key elements: the credibility of scientific data, the promotion of alternative behaviors by flavor design among adult smokers, and the effective control of adolescent attractiveness. This article will provide an in-depth analysis of how ZYN meets the FDA's "Compliance with Public Health" (APPH) criteria, and provides a practical reference sample for new tobacco companies looking to enter the U.S. market.

 This article was written by Austin Tyner, a documentation specialist at Accorto Regulatory Solutions, a U.S.-based compliance firm focused on PMTA filings. Accorto has extensive professional experience in this field. 2Firsts is a media and think tank focusing on the field of global harm reduction products, tracking the development of new tobacco regulations for a long time, and providing enterprises with information support and professional reference on the path to compliance. As a partner of 2Firsts, Accorto works with us in regulatory interpretation, industry education, and in-depth interviews with major policy milestones to share the latest trends and practical experience of FDA and other regulatory agencies with the industry.

On January 16, 2025, the U.S. Food and Drug Administration (FDA) approved the ZYN nicotine pouch, marking a pivotal moment in the future of nicotine pouch use and the broader regulatory landscape for alternative tobacco products in the United States. As the first nicotine pouch to receive marketing authorization from the FDA, the approval of ZYN has established an important precedent, which means that there will be challenges and opportunities for nicotine pouch products to apply for FDA approval in the future.

ZYN's PMTA specifically approved 20 nicotine pouch products, including 10 flavors, each with two nicotine concentrations to choose from: 3 mg and 6 mg. Approved products include:

· ZYN Chill

· ZYN Cinnamon

· ZYN Citrus

· ZYN Coffee

· ZYN Cool Mint

· ZYN Menthol

· ZYN Peppermint

· ZYN Smooth

· ZYN Spearmint

· ZYN Wintergreen

This approval sets an important precedent for the use of nicotine pouches, as ZYN became the first brand to receive FDA marketing authorization and has not been approved for flavors other than mint and tobacco flavors in any previous PMTA application. It establishes the likelihood that flavored nicotine pouches can be successfully approved through the pre-sale tobacco product application (PMTA) pathway, subject to FDA public health standards. This decision sets important benchmarks for other nicotine pouch manufacturers to warrant authorization for sale in the U.S. if the product provides sufficient scientific evidence to demonstrate that it is less harmful than cigarettes and other smokeless tobacco products, and is marketed responsibly and with evidence-based claims in the app.

The process of obtaining product approval is complex. The process of submitting a PMTA is rigorous and requires an application that provides strong scientific evidence, extensive testing, and a comprehensive presentation and interpretation of this evidence. The FDA requires all nicotine sachet products to meet a series of strict standards to ensure that the net health benefits of each product outweigh its risks. This criterion is known as "Fitness to Protect Public Health" (APPH). It is the onus of the PMTA applicant to provide sufficient evidence that the product meets the APPH criteria. This includes documenting all aspects of product manufacturing, testing, and marketing. Any deficiencies prevent the FDA from issuing a Marketing Authorization Order (MGO). These factors underscore the high standards set by the FDA for new nicotine products and the level of detail required in the application.