FDA Issues Grants ZYN modified Risk Orders 

The U.S. Food and Drug Administration has issued modified risk orders for 20 ZYN nicotine pouch products.  This marks a notable moment for evidence-based communication about nicotine pouch products in the U.S.

Key Takeaways
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  • FDA issued Modified Risk Tobacco Product (MRTP) orders for 20 specific ZYN nicotine pouch products in 3mg and 6 mg strengths.
  • The orders allow those products to be marketed with one authorized modified risk claim.
  • FDA said its review is intended to support clear, science-based information for adult users about the relative harms of tobacco products.
  • The decision is narrow: it applies to specific ZYN products, not all ZYN products, not other strengths, and not the nicotine pouch category as a whole.
  • The authorization does not mean ZYN is safe, risk-free, “FDA approved,” or approved for smoking cessation.

A New Milestone for ZYN

The U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products. The decision, announced on June 30, 2026, followed FDA's scientific review of the company’s MRTP applications and applies only to the products covered by the orders.


The authorized products include ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen, each in 3 mg and 6 mg nicotine strengths. These products had already been authorized for sale in the U.S. through the PMTA pathway in January 2025; the MRTP orders are a separate decision about what may be communicated about these products.

The FDA-Authorized Claim

FDA has authorized the following modified risk claim for the specific products covered by the orders:

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

Why the Decision Matters

The MRTP pathway requires reduced-risk claims about tobacco products to be supported by scientific evidence and reviewed by FDA before they are used in marketing. It is intended to prevent broad or misleading health claims and to limit any authorization to the specific products and wording supported by the evidence.


In its announcement, FDA said it reviewed information including the products’ relative health risks, consumer understanding and perception of the claim, youth risk data, and the potential population-level impact. FDA concluded that Swedish Match demonstrated that the specific claim is scientifically accurate for these ZYN products, that consumers understand the claim, and that marketing the products with the claim would benefit the population as a whole.


For the millions of U.S. adults who still smoke cigarettes, accurate information about differences among tobacco and nicotine products can matter. The opportunity here is not to overstate the decision, but to report it clearly: FDA authorized one modified risk claim for a defined set of products after scientific review.

FDA on Clear, Science-Based Information 

FDA’s Acting Director of the Center for Tobacco Products, Bret Koplow, described the purpose of modified risk review in the agency’s announcement:

FDA’s review of modified risk 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.
Bret Koplow
Acting Director of the Center for Tobacco Products, FDA

What MRTP Does and Doesn't Mean

An MRTP order allows specific risk-related information to be communicated for specific products when FDA determines that the relevant legal and scientific standards are met. It is not the same thing as a general approval of a product, a brand, or an entire product category.


For ZYN, the orders apply to the 20 listed products only. The authorization does not extend to other ZYN products, other strengths, or other nicotine pouch brands. It also does not mean the products are safe, harmless, risk-free, or approved for smoking cessation.

An Important Signal 

The significance of the FDA decision is its precision. Rather than making broad statements about nicotine pouches generally, FDA’s MRTP pathway evaluates specific evidence for specific products and specific claims.


That distinction matters for adult consumers, retailers, and regulators alike. Clear communication can help reduce confusion, but only when the limits of the authorization are kept just as clear as the claim itself.

Northerner Perspective 

This is a major moment for science-based communication. The 25 million Americans who smoke deserve accurate information about the real differences between cigarettes and other tobacco and
nicotine products.
Laura Leigh Oyler 
Vice President of Regulatory

Products Not Covered by the FDA Orders 

The following ZYN products sold through Northerner are not included in FDA’s MRTP authorization.

Products sold on Northerner Strength(s) listed Reasons not covered
ZYN Peach 3 mg, 6 mg  Not included in the MRTP applications covered by FDA’s orders.
ZYN Dragonberry 3 mg, 6 mg Not included in the MRTP applications covered by FDA’s orders.
ZYN Black Cherry 3 mg, 6 mg Not included in the MRTP applications covered by FDA’s orders.
ZYN Ultra (all flavors) 9 mg, 11 mg ZYN Ultra products and strengths were not included in the MRTP
applications covered by FDA’s orders.

FAQ

  • FDA issued MRTP orders for 20 specific ZYN nicotine pouch products, allowing those products to be marketed
    with one authorized modified risk claim.
  • No. The authorization should not be described as “FDA approved.” FDA issued product-specific MRTP orders
    authorizing a specific claim.
  • The orders apply to ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint,
    and Wintergreen in 3 mg and 6 mg strengths.
  • No. FDA’s decision applies only to the listed products and strengths. It does not apply to other ZYN products or
    other nicotine pouch brands.