Company-controlled informational and advertising content published by Northerner. This article is intended for adults aged 21+ who currently use tobacco or nicotine products. 

The U.S. Food and Drug Administration (FDA) authorized 17 nicotine pouch products in August 2026, adding more products to the agency’s list of nicotine pouches authorized for legal marketing in the United States. 

The August decisions included:

• • 4 on! products announced August 4;
  • 2 additional on! products authorized August 19;
  • 11 ZYN Ultra products announced August 21.

The authorizations followed FDA review through the Premarket Tobacco Product Application (PMTA) pathway. They also follow the launch of the FDA’s nicotine pouch pilot program in September 2025, which was designed to make the PMTA review process for nicotine pouch applications more efficient. 

The FDA’s current authorized nicotine pouch product list consists of 43 products. 

On August 4, 2026, FDA announced marketing authorization for 4 on! nicotine pouch products: 

• • on! Rich Berry 2mg 
  • on! Cappuccino 2mg 
  • on! Cappuccino 4mg 
  • on! Autumn Spice 2mg 

The FDA stated these products were reviewed as part of its nicotine pouch pilot program. 

The FDA subsequently recorded marketing authorization for 2 additional on! products on August 19: 

• • on! Rich Berry 4mg 
  • on! Autumn Spice 4mg 

All 6 products now appear on the FDA’s authorized nicotine pouch product list. 

On August 21, 2026, FDA authorized 11 ZYN Ultra nicotine pouch products made by Swedish Match USA, Inc. These include: 

• • 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 Smooth 11mg 
  • ZYN Ultra Spearmint 9mg 
  • ZYN Ultra Wintergreen 9mg 
  • ZYN Ultra Wintergreen Chill 9mg

It should be noted that some product names may have changed since these applications were filed, but the composition of authorized pouches remains the same. Not all products are currently stocked on Northerner either.

The FDA's August authorizations cover products with different: 

• • Flavor designations;
  • Nicotine strengths;
  • Product-specific formulations.

Nicotine strengths among these authorized products range from 2mg to 11mg per pouch. 

These details describe product attributes only. They do not indicate any safety, health, performance, or suitability benefit. 

Additional products and specifications can be found on the FDA’s authorized nicotine pouch product list. 

FDA marketing authorization and authorization to make a modified risk claim are separate regulatory matters. 

A company seeking to market a new nicotine pouch product generally submits a Premarket Tobacco Product Application (PMTA) to the FDA. 

If the FDA determines that the applicable legal standard has been met, the agency may issue a Marketing Granted Order (MGO). An MGO allows that specific product to be legally marketed in the United States. 

An MGO should not be described as “FDA approval.” It also does not, on its own, permit a company or retailer to make modified risk claims about the product. 

The FDA’s enforcement guidance from May, 2026 addresses certain electronic nicotine delivery systems and oral nicotine pouch products marketed without premarket authorization. 

The guidance describes limited circumstances in which FDA generally does not intend to prioritize enforcement of the premarket authorization requirement for certain products with pending applications that have been accepted and filed. 

However, the guidance is non-binding. A product covered by the enforcement policy remains unauthorized unless FDA issues marketing authorization. Inclusion under the policy also does not indicate whether FDA will ultimately authorize the product. 

A Modified Risk Tobacco Product, or MRTP, is part of a separate FDA regulatory pathway involving specific modified-risk marketing claims. 

Receiving an MGO through the PMTA pathway does not automatically permit modified-risk claims. Those claims require separate FDA authorization through the MRTP pathway. A product must first be found “appropriate for the protection of public health” before a company can seek permission to communicate reduced-risk information to consumers. 

On June 30, 2026, the FDA issued Modified Risk Granted Orders (MRGOs) for 20 ZYN nicotine pouch products in 3mg and 6mg strengths. 

Note: These orders apply only to the specific products and claim(s) covered by the FDA’s decision. They do not apply to ZYN Ultra products or to the nicotine pouch category as a whole. 

The FDA launched its nicotine pouch pilot program in September, 2025 to increase efficiency in its review of PMTAs for nicotine pouch products. Since then, the FDA has continued to issue marketing decisions for individual nicotine pouch applications. 

The FDA continues to review nicotine pouch applications, so further marketing decisions are likely to follow.

Newly authorized products are added to the agency’s public list of authorized nicotine pouches. 

For adults aged 21+ who already use nicotine products, the important distinction is product-specific: appearing on FDA’s authorized list means that the particular product has received marketing authorization. It does not mean every product from the same brand or within the wider nicotine pouch category has the same regulatory status. 

We review product regulatory status before listing products, in line with an internal product-selection process. 

Product status should not be interpreted as FDA approval or authorization for claims beyond those specifically permitted by the FDA.

These products are intended only for adult (21+) current nicotine users and are not for non-users. Sales to persons under 21 are prohibited.