On June 30, 2026, FDA issued modified risk granted orders to Swedish Match USA, Inc., a wholly owned subsidiary of Philip Morris International Inc., for 20 ZYN nicotine pouch products, authorizing the company to market those products with the 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 orders cover ten ZYN varieties—Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen—each in 3 mg and 6 mg nicotine strengths.

What FDA Authorized

The ZYN orders are modified risk tobacco product, or MRTP, orders. That means FDA has authorized specific marketing claims about the relative risk of the covered ZYN products compared with cigarettes. FDA determined that the products satisfied the statutory standard for a risk modification order, including that, as actually used by consumers, the products will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users and nonusers of tobacco products. 21 U.S.C. § 387k(g)(1).

FDA’s modified risk authorization is subject to important limitations. The order does not mean that FDA has “approved” ZYN, that ZYN is safe, or that ZYN may be marketed as a smoking cessation treatment. FDA’s orders also impose postmarket surveillance and study obligations and state that the authorizations are effective for five years. FDA will continue to monitor whether the authorized claims remain accurate and whether the products’ marketing affects youth, nonusers, dual users, and adult smokers in ways that could undermine the public-health basis for the order.

Background: The MRTP Pathway

Congress created the MRTP pathway in Section 911 of the Federal Food, Drug, and Cosmetic Act as part of the 2009 Tobacco Control Act. Under Section 911, a tobacco product may not be marketed with modified risk claims unless FDA first issues an MRTP order. A “modified risk” claim includes express or implied claims that a tobacco product presents a lower risk of tobacco-related disease, is less harmful than another tobacco product, contains a reduced level of a substance, presents reduced exposure to a substance, or is free of a substance. The statute also captures descriptors such as “light,” “mild,” or “low,” as well as other consumer-directed actions reasonably expected to lead consumers to believe the product presents lower risk or reduced exposure. 21 U.S.C. § 387k(a)–(b).

FDA’s MRTP review framework is informed by its March 2012 draft guidance, Modified Risk Tobacco Product Applications, which remains FDA’s operative guidance on the content and organization of MRTP applications and calls for a broad scientific showing addressing, among other things, product characterization, nonclinical and clinical evidence, consumer perception and understanding, actual-use behavior, population-level modeling, proposed labeling and advertising, and postmarket surveillance.

Consistent with that guidance and the statutory review standard, the MRTP process is deliberately demanding. FDA’s review is not limited to whether a proposed modified risk claim is scientifically accurate in isolation, but also considers whether consumers will understand the claim appropriately and whether marketing the product with that claim is expected to benefit the health of the population as a whole. In doing so, FDA evaluates both individual and population-level effects, including relative health risks, the likelihood that current tobacco users who would otherwise continue using more harmful products will switch, the likelihood that nonusers will start using the product, the risks and benefits compared with FDA-approved cessation products, public comments, and other available scientific evidence. FDA also makes MRTP applications available for public comment, subject to confidentiality protections, and refers applications to the Tobacco Products Scientific Advisory Committee. For ZYN, FDA opened a public comment docket in June 2025, the comment period closed in March 2026, and TPSAC held a public meeting on the applications in January 2026. 21 U.S.C. § 387k(g), (g)(4).

Reduced Risk Claims vs. Reduced Exposure Claims

The MRTP pathway recognizes two principal types of modified risk claims: reduced risk claims and reduced exposure claims.

A reduced-risk claim communicates that using the product reduces harm or the risk of tobacco-related disease compared with another tobacco product. For this type of order, FDA must find that the product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users and nonusers. 21 U.S.C. § 387k(g)(1).

A reduced-exposure claim is different. It communicates that the product, or its smoke or aerosol, contains a reduced level of a substance, presents reduced exposure to a substance, or does not contain a substance. Congress created a special rule for exposure modification orders, allowing FDA to authorize such claims where long-term epidemiological evidence may not yet be available, but the available evidence supports that the product is reasonably likely to reduce morbidity or mortality, substantially reduce exposure to harmful substances, and not mislead consumers into believing that the product has been shown to reduce disease risk unless that has been demonstrated. 21 U.S.C. § 387k(g)(2). Exposure modification claims can help communicate meaningful reductions in toxicant exposure, but they do not necessarily authorize a disease-risk claim.

FDA’s MRTP authorization for ZYN is particularly notable because it is a risk modification authorization: FDA authorized a claim identifying lower risk of specific smoking-related diseases when ZYN is used instead of cigarettes.

MRTP Authorization Is Different from PMTA Authorization

The ZYN MRTP orders should not be confused with FDA’s earlier PMTA marketing authorizations. In January 2025, FDA authorized 20 ZYN nicotine pouch products through the premarket tobacco product application, or PMTA, pathway. That PMTA authorization allowed the specific products to be legally marketed in the United States because FDA found that marketing the products would be “appropriate for the protection of the public health,” or APPH.  21 U.S.C. § 387j(c)(2)(A).

A PMTA marketing granted order is not permission to make reduced-risk or reduced-exposure claims. The PMTA pathway asks whether a new tobacco product may be marketed at all, considering the risks and benefits to the population as a whole, including users and nonusers, as well as product chemistry, toxicology, manufacturing, behavioral evidence, and youth-risk considerations. By contrast, as noted above, the MRTP pathway asks whether a manufacturer may communicate specific modified risk or exposure information to consumers. In other words, PMTA authorization gets the product onto the market; MRTP authorization governs what the company may say about comparative risk or exposure.

Other Products with Authorized MRTP Claims

FDA’s MRTP program has historically moved slowly and has produced only a limited number of authorizations. Before the ZYN orders, FDA had authorized MRTP claims for several other product types, including Swedish Match General snus products, Philip Morris’s IQOS heated tobacco system, 22nd Century Group’s VLN reduced-nicotine cigarettes, and U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff.

• In 2019, FDA issued the first MRTP authorizations for Swedish Match General snus products, a smokeless tobacco category. Those orders authorized risk modification claims and have since been renewed. FDA’s granted orders list reflects renewed General snus orders issued in November 2024.

• Starting in 2020, FDA has also authorized exposure modification claims for IQOS heated tobacco products, permitting claims that IQOS heats tobacco but does not burn it, significantly reduces the production of harmful and potentially harmful chemicals, and that switching completely from conventional cigarettes to IQOS significantly reduces the body’s exposure to harmful or potentially harmful chemicals. In April 2026, FDA renewed those MRTP orders for certain IQOS products marketed by Philip Morris Products S.A.

• In 2021, FDA authorized exposure modification claims for VLN King and VLN Menthol King combusted cigarettes. Those claims concerned reduced nicotine exposure—not reduced disease risk—and FDA required prominent contextual language explaining that less nicotine does not mean safer and that all cigarettes can cause disease and death.

• In 2023, FDA authorized a risk modification claim for Copenhagen Classic Snuff, allowing the company to state that smokers who switch completely from cigarettes to that product reduce their risk of lung cancer. FDA emphasized that the authorization was product-specific, time-limited, and subject to postmarket requirements.

See Modified Risk Granted Orders | FDA.

Against that background, the ZYN authorization represents the first MRTP authorization for nicotine pouches. It extends FDA’s MRTP precedent to a fast-growing category of oral nicotine products that do not involve combustion and do not contain cut, ground, powdered, or leaf tobacco.

The Challenge of Communicating Relative Risk

For years, tobacco policy has struggled with a central communications problem: the public-health goal is to eliminate combustible cigarette use, but many consumers continue to misunderstand the relative risks of different nicotine products. FDA has noted that many tobacco users hold misperceptions about the varying risks of tobacco products and that adults who fully switch from cigarettes to lower-risk alternatives can generally reduce their health risks and exposure to harmful and potentially harmful constituents.

That is why the ZYN MRTP authorization is so important. FDA is not merely allowing a nicotine pouch product to remain on the market. It is authorizing a clear, consumer-facing disease-risk claim that expressly compares the product with cigarettes. If communicated responsibly, that type of claim can help adult smokers understand that the greatest danger comes from continued cigarette smoking and that complete switching to a lower-risk, non-combusted alternative may reduce their risk of serious disease.

Conclusion

FDA’s ZYN MRTP authorization is a landmark development in tobacco regulation and should be viewed as a harm-reduction milestone. Although FDA makes clear that nicotine pouches are not risk-free, no tobacco product is safe, and that the orders do not authorize smoking cessation claims, the authorization confirms that, with the right evidentiary showing and appropriate postmarket controls, FDA is willing to authorize direct, disease-specific comparative-risk claims for non-combusted nicotine products. FDA’s order also preserves the agency’s ability to monitor real-world effects and withdraw the authorization if the statutory requirements are no longer met.

Most importantly, the ZYN MRTP orders reinforce a principle that should be central to modern tobacco policy – while complete cessation remains the best outcome, not all tobacco products present the same risk. For adult smokers who are unwilling or unable to quit, accurate information about the continuum of risk can matter, and FDA’s authorization of the ZYN claim may help more smokers understand the risks of continued cigarette use and encourage complete switching to lower-risk alternatives, provided that the benefit is not offset by youth or nonuser uptake.