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FDA Authorizes Marketing of Zyn Nicotine Pouches

Amy Ralph Mudge Co-Chairs, Moderates Session at 8th Annual Legal, Regulatory and Compliance Forum on Advertising Claims Substantiation

The U.S. Food and Drug Administration (FDA) recently approved the marketing of 20 Zyn nicotine pouches, marking the first time nicotine pouches have received such authorization. This decision came through the premarket tobacco product application (PMTA) pathway following a rigorous scientific evaluation. It also highlights the growing popularity of nicotine pouches as an alternative to traditional tobacco products. Produced by Swedish Match, a subsidiary of Philip Morris International, Zyn offers a variety of flavors and nicotine strengths, appealing to adult users seeking alternatives to cigarettes and smokeless tobacco.

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To grant marketing authorization, the FDA requires comprehensive evidence that a product provides more benefits than risks to public health. In the case of Zyn, regulators determined that the pouches carry significantly lower health risks compared with cigarettes and smokeless tobacco. Unlike traditional smokeless tobacco, Zyn products deliver nicotine in powdered form that dissolves in the user’s mouth.

Under Section 910 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, the FDA must determine that a product meets the “appropriate for the protection of the public health” (APPH) standard. This determination involves evaluating risks and benefits for the entire population, including both users and nonusers of tobacco products. The FDA balances potential negative impacts, such as youth initiation, against positive outcomes, such as helping adult smokers switch to less harmful products. A product can only be authorized if the overall benefits outweigh the risks.

Key Findings Supporting Zyn’s Authorization

The FDA’s decision to authorize Zyn was informed by data on user behavior, product perception and consumer intentions. Zyn’s PMTA included a 10-week study tracking product usage, which revealed that nearly 25 percent of participants transitioned entirely from other tobacco products to exclusive Zyn use. Additional surveys showed a decline in cigarette and moist snuff usage among participants who adopted Zyn. Notably, these patterns were consistent across different flavors, demonstrating that flavor variety did not disproportionately influence usage.

Consumer perception data also played a vital role in the FDA’s analysis. Research indicated that adults over the age of 24 who smoked cigarettes and intended to quit were the most likely to use and purchase Zyn products. Many former and non-tobacco users found the products unappealing, reducing concerns about unintended uptake among these groups.

While the FDA recognized Zyn’s potential to benefit adult smokers, the agency remained cautious about the possibility of youth usage. To mitigate these risks, the FDA imposed strict marketing restrictions on Zyn, requiring the company to ensure its advertisements and promotions are targeted exclusively to adults. The agency has also committed to closely monitoring the product’s impact and will take enforcement action if youth usage rises or if compliance issues emerge. Such measures are intended to strike a balance between providing harm-reduction tools for adults and preventing unintended consequences among younger populations.

The FDA’s authorization demonstrates that companies can meet the APPH standard without comparing flavored products directly to tobacco-flavored alternatives. Despite ongoing legal debates about whether such comparative studies are required, the FDA determined that sufficient evidence existed without this additional analysis. This approach may have implications for future applications from other nicotine pouch manufacturers.

The authorization of Zyn represents a significant milestone in tobacco harm-reduction efforts and highlights a shift in the industry toward alternative products. With cigarette sales continuing to decline, companies are focusing on new nicotine delivery methods to meet consumer demand. While rising in popularity, Zyn has faced criticism from lawmakers and public health advocates over concerns about youth appeal and marketing practices, but Philip Morris has stated that it will not engage in influencer marketing or strategies targeting younger users. Instead, the company emphasizes that Zyn is designed for adults seeking to transition away from more harmful tobacco products.

By authorizing Zyn, the agency has acknowledged the role nicotine pouches can play in reducing harm for adult smokers. The FDA’s approach to regulating this category will likely set important precedents for future applications as the nicotine pouch market continues to grow. For now, Zyn’s authorization signals a new chapter in the evolving landscape of tobacco harm reduction.

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