U.S. FDA authorizes 20 ZYN nicotine pouches to be marketed with a specific modified-risk claim

FDA authorization of a modified-risk claim for nicotine pouches

The orders authorize the 20 ZYN products to be marketed in the U.S. with the following claim:

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

This MRTP order allows a manufacturer to market a tobacco product with a specific claim about reduced risk or reduced exposure compared with cigarette smoking, provided the FDA concludes that the claim is supported by scientific evidence and that authorizing the claim would benefit the health of the population as a whole.

The authorization applies only to the specific products included in the FDA's orders. It does not apply to all nicotine pouches or smokeless tobacco products.

Importantly, an MRTP order does not mean a product is safe or risk free. Nicotine pouches contain nicotine, which is addictive, and the FDA emphasizes that people who do not use tobacco and nicotine products should not start. For adults who currently smoke, completely quitting tobacco and nicotine use remains the best option.

Why did the FDA authorize the claim?

In its MRTP orders, the FDA concluded that the specific modified-risk claim is scientifically accurate with respect to the authorized ZYN products. The agency noted that the products, “as actually used by consumers, would 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 of tobacco products and persons who do not currently use tobacco products.”

The MRTP applications for these nicotine pouch products were submitted in April 2024. As part of its review, the FDA evaluated multiple categories of evidence, including:

• The relative health risks of the products compared with cigarettes
• How consumers understand and interpret the modified-risk claim
• The potential impact of the claim on adults who smoke
• Risks related to youth uptake and use
• The likely effects on population health overall

The agency also considered recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC), public comments, information submitted during the review process, and scientific evidence from other sources.

This authorization builds on the FDA’s January 2025 decision to authorize nicotine pouch products through the Premarket Tobacco Product Application (PMTA) pathway. At that time, the FDA stated that the authorized products contained substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus. As a result, the FDA said these products posed lower risk of cancer and other serious health conditions than such products.

Beyond individual risk: the population-health standard

A key feature of the FDA's MRTP framework is its focus on population-level impact.

The FDA's assessment extends beyond whether a product may present lower risk than cigarettes for an individual user. The agency must also consider potential effects across the broader population, including among adults who smoke, people who do not currently use tobacco products, and youth.

In its decision, the FDA concluded that the authorized ZYN products, when considered alongside the approved claim, would benefit population health as a whole while taking into account both current tobacco users and nonusers.

This population-health standard, in addition to the individual risk assessment, distinguishes the MRTP review process from evaluations that focus solely on risks to individual users.

Continuing oversight and regulatory safeguards

MRTP authorizations are subject to ongoing regulatory oversight.

The FDA's orders include postmarket requirements designed to monitor how consumers understand the claim and how the products are used over time. These requirements include surveillance and studies related to consumer behavior and perceptions of risk.

The agency can revisit its conclusions if new evidence emerges. Continued authorization depends on the products meeting the conditions of the orders and on the evolving scientific evidence.

Public health considerations

The authorization comes amid ongoing public health discussions about nicotine products, including concerns related to youth uptake and the potential appeal of flavored products.

As the FDA stated, its review of modified-risk tobacco products is intended to ensure that adult users have “clear, science-based information about the relative harms of tobacco products, so they can make informed choices.” The FDA also stated that these considerations formed part of its review and population-level assessment, including evidence regarding youth risk alongside evidence related to adults who smoke and may otherwise continue smoking cigarettes.

As with other tobacco and nicotine products, the FDA maintains that people who do not use tobacco products should not initiate use.

A notable regulatory milestone

With this latest decision, PMI holds MRTP authorizations for 20 ZYN products, versions of IQOS devices and consumables, and eight General snus products. The authorization adds to the evidence-based discussion on science-based regulation for smoke-free products and the role that rigorous scientific review can play in helping adults who smoke access accurate information about alternatives to continued smoking.

More information is available in the FDA’s announcement on the modified-risk claim, the FDA’s Modified Risk Granted Orders page, and PMI’s official announcement.