FDA's ZYN MRTP Orders Highlight Progress – and Remaining Questions in Tobacco Harm Reduction

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Key Points:

• Regulatory Milestone: On June 30, the FDA granted Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products, marking the first nicotine pouches authorized to carry an FDA-approved reduced-risk claim. 

• FDA-Authorized Claim: Swedish Match may now market ZYN with the statement that using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. 

• Understanding MRTP: Unlike the PMTA pathway, which authorizes products for marketing, the MRTP pathway allows manufacturers to communicate FDA-approved reduced-risk or reduced-exposure information directly to consumers. 

• PMTA vs. MRTP: Products must first receive FDA marketing authorization through the Premarket Tobacco Product Application (PMTA) process by demonstrating they are "appropriate for the protection of public health" before manufacturers can seek separate authorization to make modified-risk claims.

• FDA Recognition of Reduced Risk: During both the PMTA and MRTP reviews, the FDA concluded that authorized ZYN products pose lower risks than combustible cigarettes, reinforcing the agency's recognition of the tobacco harm reduction continuum. 

• Growing MRTP Portfolio: The FDA has now issued MRTP orders for 34 tobacco products, including 20 ZYN nicotine pouches, eight General Snus products, five cigarette-related products, and one additional smokeless tobacco product.

• Limited PMTA Authorizations: Despite millions of PMTA submissions, the FDA has authorized only 95 products from 11 companies, including 45 e-cigarettes, 30 nicotine pouches, 10 heated tobacco products, eight snus products, and two very low nicotine cigarettes.

• Independent Manufacturers Still Limited: Although independent companies helped build the modern U.S. vapor market, only a small number have successfully navigated the FDA's lengthy PMTA process. 

• Adult Demand Continues Growing: In 2024, more than 21.3 million American adults used e-cigarettes, representing approximately one million additional adult vapers compared to 2023.

• Long-Term Adult Trends: Since 2016, adult vaping has increased by 70.2 percent – more than 9.6 million additional users – while adult cigarette smoking declined by 38.6 percent, representing approximately 12.6 million fewer smokers. 

• Prime Adult Demographic: More than half (51.1 percent) of adult e-cigarette users in 2024 were between the ages of 35 and 44, underscoring that smoke-free nicotine products are overwhelmingly used by adults. 

• Youth Tobacco Use at Historic Lows: According to the 2025 National Youth Tobacco Survey, only 7.2 percent of U.S. middle and high school students currently used any tobacco product, including 5.2 percent who used e-cigarettes and 1.7 percent who used nicotine pouches. 

• Youth Vaping Continues to Fall: Youth e-cigarette use has declined by 74 percent since 2019, while nicotine pouch use has remained relatively low and stable. 

• States Increasing Oversight: As of July 2026, 16 states have enacted vapor product directory laws tying legal product sales to FDA authorization or pending PMTA status, further expanding the role of federal regulatory decisions.

• Regulatory Questions Remain: The FDA's authorization of ZYN's reduced-risk claims represents meaningful recognition of tobacco harm reduction while highlighting the complexity and limited throughput of the current PMTA and MRTP framework.

• Public Health Implications: Adult use of smoke-free nicotine products continues to grow alongside historic declines in cigarette smoking and youth tobacco use, raising important questions about whether the current regulatory system adequately reflects evolving scientific evidence and consumer behavior. 

• Bottom Line: The FDA's MRTP orders for ZYN represent a landmark step in formally recognizing the reduced-risk potential of nicotine pouches. However, with only a limited number of products authorized through the PMTA process despite millions of applications and more than 20 million adult consumers, the decision also underscores the need for a more efficient regulatory framework that balances scientific evidence, innovation, adult consumer demand, and public health.

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On June 30, the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products. The decision represents one of the agency's most significant tobacco harm reduction actions in recent years, authorizing the first nicotine pouches to be marketed with an FDA-approved reduced-risk claim. It also highlights the increasingly complex federal regulatory framework governing smoke-free nicotine products, including the relationship between the FDA's Premarket Tobacco Product Application (PMTA) and MRTP pathways.

Under the MRTP order, ZYN may now be marketed with the following FDA-authorized risk modification claim:

"Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

The MRTP process was established under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009, which granted the FDA authority to regulate the manufacturing, marketing, and sale of tobacco products.

Notably, the TCA requires manufacturers to submit applications to the FDA before marketing their products and establishes different regulatory pathways depending on the type of product.

Traditional tobacco products, including cigars, combustible cigarettes, and smokeless tobacco that were commercially marketed before February 15, 2007, may utilize the substantially equivalent (SE) pathway. Newer nicotine products – including e-cigarettes, heated tobacco products, and nicotine pouches – must instead undergo the more comprehensive Premarket Tobacco Product Application (PMTA) process before they can be legally marketed.

Importantly, neither the TCA nor the PMTA process explicitly requires a product to be less harmful than combustible cigarettes. Instead, manufacturers must demonstrate that marketing a product is "appropriate for the protection of public health" (APPH). This standard considers both the likelihood that current smokers will switch to the new product and the likelihood that nonusers, particularly youth, will initiate use.

Even so, FDA's PMTA reviews have repeatedly acknowledged the reduced-risk profile of certain smoke-free products. In granting ZYN's PMTA marketing orders in 2025, the agency concluded that the authorized products "pose lower risk of cancer and other serious health conditions" than cigarettes. Similarly, in authorizing Philip Morris Products S.A.'s IQOS heated tobacco products, FDA determined that the products produce fewer or lower levels of certain harmful constituents than combustible cigarettes.

The MRTP pathway allows manufacturers to communicate FDA-authorized reduced-risk information directly to consumers. Without an MRTP order, companies may not market products using modified-risk claims, even when the FDA has acknowledged reduced toxicant exposure or lower health risks during the PMTA review process.

According to the FDA, a total of 34 tobacco products (excluding devices) have received MRTP granted orders. These include 20 ZYN nicotine pouch products, nine smokeless tobacco products – including eight Swedish Match General Snus products – and five cigarette-related products, including heated tobacco products and very low nicotine cigarettes.

• 22nd Century Group – 2 (Very Low Nicotine Cigarettes)

• Philip Morris Products S.A. – 3 (Heated Tobacco Products)

• Swedish Match USA, Inc. – 20 (Nicotine Pouches)

• Swedish Match North America, Inc. – 8 (General Snus)

• U.S. Smokeless Tobacco Company – 1 (Smokeless Tobacco)

While the MRTP orders for ZYN represent an important regulatory milestone, they also underscore broader questions surrounding the federal regulatory framework for smoke-free nicotine products.

To date, the FDA has issued PMTA marketing granted orders to only 11 companies covering 95 products. These include two cigarettes, 45 e-cigarettes, 10 heated tobacco products, 30 nicotine pouches, and eight snus products.

• 22nd Century Group – 2 (Very Low Nicotine Cigarettes)

• GLAS Inc. – 6 (E-Cigarettes)

• JUUL Labs Inc. – 5 (E-Cigarettes)

• Logic Technology – 8 (E-Cigarettes)

• NJOY LLC – 10 (E-Cigarettes)

• R.J. Reynolds Vapor Company – 16 (E-Cigarettes)

• Philip Morris Products S.A. – 10 (Heated Tobacco Products)

• Helix Innovations LLC – 6 (Nicotine Pouches)

• Swedish Match USA, Inc. – 20 (Nicotine Pouches)

• U.S. Smokeless Tobacco Company – 4 (Nicotine Pouches)

• Swedish Match North America, Inc. – 8 (General Snus)

Since e-cigarettes entered the U.S. marketplace in 2007, smoke-free nicotine products have significantly reshaped the American tobacco landscape. Despite growing adult adoption and continued declines in cigarette smoking, the regulatory process has resulted in marketing authorizations for a relatively small number of manufacturers and products compared to the broader marketplace.

According to the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS), more than 21.3 million American adults aged 18 years or older were current e-cigarette users in 2024. This represents a 3.9 percent increase from 2023 and equates to approximately one million additional adult vapers in a single year.

Adult vaping has grown substantially over the past decade. Since 2016, when 4.7 percent of U.S. adults reported using e-cigarettes, adult vaping has increased by 70.2 percent, representing more than 9.6 million additional adult users. More than half (51.1 percent) of adult e-cigarette users in 2024 were between the ages of 35 and 44. During the same period, adult cigarette smoking declined by 38.6 percent, representing approximately 12.6 million fewer smokers.

At the same time, youth use of both combustible tobacco products and newer nicotine products has declined or remained historically low.

According to the 2025 National Youth Tobacco Survey, just 7.2 percent of U.S. middle and high school students reported current use of any tobacco product, defined as use on at least one day during the previous 30 days. This included 5.2 percent who used e-cigarettes, 1.7 percent who used nicotine pouches, 1.4 percent who smoked cigarettes, and 1.1 percent who smoked cigars.

Youth e-cigarette use has declined by 74 percent since 2019, while nicotine pouch use has remained relatively low and stable.

Federal regulation continues to struggle to keep pace with a marketplace now used by more than 20 million adult consumers. In response, several states have adopted product directory laws intended to distinguish between FDA-authorized and unauthorized products.

As of July 2026, 16 states have enacted vaping registry laws requiring manufacturers to regularly certify the FDA status of their products. While the requirements vary, all permit products with FDA marketing authorization, and some also allow products with pending PMTA applications to remain on the market.

Although tobacco harm reduction products are often portrayed as being developed by large tobacco manufacturers, the modern U.S. vaping market originated largely through independent innovation. E-cigarettes entered the U.S. marketplace in 2007, while major tobacco manufacturers did not begin entering the category until later in 2012 when a large tobacco manufacturer, Lorillard, acquired Blu, and Altria and Reynolds did not launch their own vaping products until 2014. When millions of PMTAs were submitted in 2020, many originated from independent manufacturers and small businesses. However, the FDA has ultimately authorized products from only a limited number of companies.

The FDA's decision to grant MRTP orders for ZYN represents an important milestone in recognizing the reduced-risk potential of certain smoke-free nicotine products. At the same time, it highlights the complexity of a regulatory system in which products must first demonstrate that they are appropriate for the protection of public health through the PMTA process before manufacturers may separately seek authorization to communicate reduced-risk information.

As adult use of smoke-free alternatives continues to grow, cigarette smoking continues to decline, and more states adopt product directory laws tied to FDA authorization, policymakers may increasingly face questions about whether the current regulatory framework effectively balances scientific evidence, consumer demand, and public health objectives.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.