FDA Authorizes Additional Nicotine Pouch Products for Legal Marketing in the U.S.
Company-controlled informational and advertising content published by Nicokick.
The Food and Drug Administration (FDA) authorized 17 additional nicotine pouch products in August 2026, adding them to the agency’s list of products authorized for legal marketing in the United States. The decisions covered 4 on! products announced on August 4, 2 additional on! products recorded by the FDA on August 19, and 11 ZYN Ultra products on August 21. The information below is intended for current nicotine users over the age of 21.
These decisions followed FDA review through the Premarket Tobacco Product Application (PMTA) pathway and came after the agency launched a nicotine pouch pilot program in 2025 to increase efficiency and streamline PMTA review.
The additional FDA-authorized products are reflected on the agency’s authorized nicotine pouch product list, including products with different flavors, nicotine strengths, and formats.
- The FDA recently authorized 17 additional nicotine pouch products, including new on! and ZYN Ultra varieties.
- The latest decisions add products with different flavors, nicotine strengths, and formats to FDA’s authorized-product list for adult (21+) current nicotine users.
- FDA authorization allows a product to be marketed, while modified risk claims require a separate MRTP order.
What Products Were Authorized?
On August 4, 2026, the FDA authorized 4 new nicotine pouch products from the on! brand:
- on! Rich Berry 2mg
- on! Cappuccino 2mg
- on! Cappuccino 4mg
- on! Autumn Spice 2mg
The FDA granted marketing authorization for 2 additional on! products on August 19, 2026:
- on! Rich Berry 4mg
- on! Autumn Spice 4mg
According to FDA, these products were reviewed as part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline nicotine pouch review through the PMTA pathway.
On August 21, 2026, the FDA authorized 11 ZYN Ultra products made by Swedish Match USA, Inc.:
- ZYN Ultra Chill 9mg
- ZYN Ultra Citrus 9mg
- ZYN Ultra Cool Mint 9mg
- ZYN Ultra Deep Freeze 9mg
- ZYN Ultra Menthol 9mg
- ZYN Ultra Peppermint 9mg
- ZYN Ultra Smooth 9mg
- ZYN Ultra Spearmint 9mg
- ZYN Ultra Wintergreen 9mg
- ZYN Ultra Wintergreen Chill 9mg
- ZYN Ultra Smooth 11mg
Together, these decisions add 17 authorized SKUs to the FDA’s nicotine pouch product list. Please note that descriptors may have since been added to certain product names and not all products are currently stocked on Nicokick.
Authorized Product Attributes
One aspect of the recent FDA decisions is the set of product attributes reflected in the authorization announcements.
The FDA announcements identify products with:
- Mint, fruit, coffee, and spice flavors
- Product-specific formulations and moisture characteristics evaluated as part of FDA’s review
- Multiple nicotine strengths ranging from 2mg to 11mg per pouch
Additional flavor categories and nicotine strengths are reflected in the FDA-authorized product list. These descriptions identify product attributes and do not imply a sensory, performance, safety, or risk benefit.
What Does FDA Authorization Actually Mean?
One area that continues to cause confusion is the difference between FDA authorization to market a product and FDA authorization to make health-related claims. These are different regulatory concepts.
A company seeking to market a new nicotine pouch product typically submits Premarket Tobacco Product Application (PMTA) to the FDA. If the agency determines that marketing the product is appropriate under the statutory public health standard, it may issue a Marketing Granted Order (MGO). An MGO authorizes the product to be legally marketed in the United States.
However, an MGO does not mean that a manufacturer can market the product as lower risk, safer, healthier, or otherwise superior to another tobacco or nicotine product. Those types of claims require a separate authorization.
FDA’s May 2026 guidance on enforcement priorities describes the agency’s current enforcement policies for certain unauthorized electronic nicotine delivery systems and oral nicotine pouch products. The guidance states that it does not establish legally enforceable responsibilities. It also describes circumstances in which FDA does not intend to prioritize enforcement, including certain products with pending applications that have been accepted and filed. Products covered by the policy remain unauthorized unless and until FDA grants marketing authorization.
How is MRTP Different?
A Modified Risk Tobacco Product (MRTP) order is a separate FDA pathway that allows specific reduced-risk or reduced-exposure claims if they are supported by evidence and authorized by the agency.
During an MRTP review, the FDA evaluates additional evidence, including consumer understanding, population-level impacts, and whether any proposed claims could mislead consumers.
On June 30, 2026, FDA issued modified risk granted orders for 20 specific ZYN nicotine pouch products in 3 mg and 6 mg strengths. Those orders apply only to the products and claim covered by FDA’s decision; they do not apply to ZYN ULTRA products or to the nicotine pouch category generally. Twenty products received the first MRTP orders in June 2026.
| FDA Term | What It Means |
| PMTA | The application a company submits to the FDA before marketing a new tobacco or nicotine product |
| MGO | A Marketing Granted Order means the FDA has authorized a specific product to be legally marketed in the United States |
| MRGO |
A separate FDA order that allows specific modified risk or exposure claims when those claims are authorized by the agency |
Regulatory Developments Since 2025
The August 2026 authorizations followed FDA regulatory activity concerning nicotine pouch applications that began in 2025.
In 2025, the FDA launched a nicotine pouch pilot program aimed at improving review efficiency and reducing application backlogs.
The recent authorizations suggest that the agency continues to work through applications.
What Comes Next?
FDA review of nicotine pouch applications remains ongoing, and additional decisions may be announced in the future. Newly authorized products are added to the FDA’s public list of authorized nicotine pouches.
For adult 21+ current nicotine users, the latest decisions mean that additional products with specified flavors, nicotine strengths, and formats now appear on FDA’s authorized-product list.
Our Stance
Nicokick reviews products for FDA marketing authorization or qualifying pending PMTA status before listing, consistent with its internal product-selection process. Product status is subject to review and does not mean that an unauthorized product is FDA approved or authorized.
- It means 17 additional nicotine pouch products completed FDA review and received authorization for legal marketing in the United States. Adult 21+ current nicotine users can review the agency’s authorized-product list for the specific products covered.
- FDA’s May 2026 enforcement guidance describes limited circumstances in which the agency does not intend to prioritize enforcement for certain unauthorized nicotine pouch products with pending applications that have been accepted and filed. Coverage under that policy is not FDA authorization, approval, or an indication that authorization will be granted. Nicokick reviews FDA authorization or qualifying pending PMTA status before listing products.
- FDA authorization means a product can be legally marketed, but it does not mean the product is FDA-approved, risk-free, or suitable for everyone. Nicotine is addictive, and nicotine pouches are intended only for adults 21+ who already use nicotine products.
FAQs
Important Disclaimer: This article is provided for informational and advertising purposes only. It does not make any claim that nicotine pouches are safe, safer than cigarettes or other tobacco products, or effective for smoking cessation. Any reduced-risk or modified-risk claim would require separate authorization from the U.S. Food and Drug Administration for the specific product. Nicotine is addictive and intended only for adults age 21 and over who currently use tobacco or nicotine. Adults considering changes to their tobacco or nicotine use should consult a qualified healthcare professional.
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