FDA Authorizes ZYN Modified Risk Claim for 20 Products
The U.S. Food and Drug Administration has authorized 20 ZYN nicotine pouch products to be marketed with a modified risk claim. The decision followed FDA’s scientific review of the products and applies only to listed ZYN products in 3 mg and 6 mg strengths.
- FDA issued Modified Risk Tobacco Product (MRTP) orders for 20 specific ZYN nicotine pouch products.
- The authorization applies only to selected ZYN products in 3 mg and 6 mg strengths and does not apply to other ZYN products, strengths, or nicotine pouch brands.
- FDA authorized one specific modified risk claim for those products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
- FDA concluded that the authorized claim is scientifically accurate for these specific products and understandable to consumers.
- The decision does not mean ZYN is safe, risk-free, “FDA-approved,” or approved for smoking cessation.
FDA Authorizes Modified Risk Claim for Certain ZYN Nicotine Pouches
The U.S. Food and Drug Administration (FDA) oversees the authorization and marketing of tobacco and nicotine products. On June 30, 2026, FDA announced that it had issued Modified Risk Tobacco Product orders for 20 ZYN nicotine pouch products manufactured by Swedish Match USA, Inc. The products had previously been authorized for sale in the United States in January 2025, but the MRTP orders separately authorize one modified risk claim for those specific products following additional scientific review.
The authorization applies to 10 ZYN varieties—Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen—each in 3 mg and 6 mg nicotine strengths. It does not apply to other ZYN products, nicotine strengths, or nicotine pouch brands.
What Is a Modified Risk Tobacco Product?
A Modified Risk Tobacco Product (MRTP) is a tobacco product that has received FDA authorization to be marketed with specific risk-related information. This authorization is separate from permission to sell the product and requires its own scientific review.
The MRTP pathway requires reduced-risk claims 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.
To receive an MRTP order, a manufacturer must demonstrate that the proposed claim meets FDA’s legal and scientific standards. In the case of ZYN, FDA reviewed evidence relating to relative health risks, consumer perception and understanding, public comments, and recommendations from the Tobacco Products Scientific Advisory Committee before reaching its decision.
What Claim Did FDA Authorize?
FDA has authorized the following claim for these specific products:
Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
The authorization follows a thorough review of scientific evidence, including information on the products’ health risks, consumer understanding of the claim, potential impacts on youth, and broader population-level considerations. FDA concluded that the claim is scientifically accurate for the authorized products and that consumers understand what the claim means.
Why This Matters for Adults Who Smoke
More than 25 million American adults still smoke cigarettes. For these adults, understanding the differences among tobacco and nicotine products can be challenging, particularly when there is widespread confusion about nicotine and the relative risks of different tobacco products.
FDA stated that its review of modified risk products is intended to help adult consumers access clear, science-based information about the relative harms of tobacco products so they can make informed choices. In this case, FDA concluded that allowing the authorized claim to be marketed for the specific ZYN products would benefit the population as a whole.
For adults who smoke, this type of information may help clarify that not all tobacco and nicotine products carry the same risks.
Following the announcement, Bret Koplow, the Acting Director of the FDA Center for Tobacco Products, had the following to say:
“Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
A Product-Specific Decision
FDA did not authorize a modified risk claim for all nicotine pouches, nor did it authorize the claim for all ZYN products. Instead, FDA reviewed evidence submitted for 20 individual products and concluded that the claim met the required scientific standard for those products alone.
Which ZYN Products Are Included?
FDA listed 10 ZYN varieties, each in 3 mg and 6 mg strengths, for a total of 20 products. Nicokick also sells additional ZYN products and strengths that are not covered by the FDA modified risk orders.
| ZYN product sold on Nicokick | Strength(s) sold | FDA MRTP order coverage |
| Chill | 3mg, 6mg | Covered |
| Cinnamon | 3mg, 6mg | Covered |
| Citrus | 3mg, 6mg | Covered |
| Coffee | 3mg, 6mg | Covered |
| Cool Mint | 3mg, 6mg | Covered |
| Menthol | 3mg, 6mg | Covered |
| Peppermint | 3mg, 6mg | Covered |
| Smooth | 3mg, 6mg | Covered |
| Spearmint | 3mg, 6mg | Covered |
| Wintergreen | 3mg, 6mg | Covered |
| Black Cherry | 3mg, 6mg | Not covered |
| Peach | 3mg, 6mg | Not covered |
| Dragonberry | 3mg, 6mg | Not covered |
| ZYN Ultra: Arctic Mint, Chill Mist, Citrus Zest, Fresh Spearmint, Menthol Ice, Peppermint Frost, Signature Smooth, Wintergreen Blast | 9mg, 11mg | Not covered |
What This Decision Does Not Mean
This decision does not mean ZYN is safe, harmless, or risk-free. It also does not mean that ZYN is “FDA approved,” approved for smoking cessation, or intended to help consumers quit smoking.
It also does not apply to all ZYN products, all nicotine strengths, or any other nicotine pouch brand.
Nicokick's Stance
We are pleased to see FDA recognize the value of clear, evidence-based communication for the millions of U.S. adults who smoke. This product-specific decision represents an important step toward helping adult consumers better understand differences among tobacco and nicotine products.VP Regulatory
FAQs
- FDA issued Modified Risk Tobacco Product orders for 20 specific ZYN nicotine pouch products, allowing them to be marketed with one authorized modified risk claim.
- The authorization applies to 10 ZYN varieties in 3 mg and 6 mg strengths: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.
- FDA authorized 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.”
- No. FDA’s decision applies only to the specific ZYN products covered by the authorization and does not apply to other nicotine pouch brands.
- No. FDA’s authorization does not mean that ZYN is safe, harmless, or risk-free.
- No. The authorization does not mean that ZYN is approved for smoking cessation.
- FDA concluded that the authorized claim is scientifically accurate for the specific products reviewed and understandable to consumers. It is also the first MRTP authorization for nicotine pouch products.
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