FDA Updates Nicotine Pouches Import Alert 98-06 for 2025

The U.S. Food and Drug Administration (FDA) has updated Import Alert 98-06 for the year 2025. This update emphasizes that all new tobacco products, particularly snus and nicotine pouches, that have not undergone the required premarket review process may be detained without physical examination upon entry into the United States.

Understanding the FDA’s Tobacco Product Regulations

To grasp the significance of this update, let’s first review the FDA’s regulations on tobacco products. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), most “new tobacco products” – those not commercially marketed in the U.S. as of February 15, 2007, or modified after that date – must undergo premarket review. This process involves one of the following:

Obtaining a marketing authorization order from the FDA
Demonstrating substantial equivalence to a predicate tobacco product
Being exempt from substantial equivalence requirements

Tobacco products that don’t have the necessary FDA marketing authorization are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The updated Import Alert 98-06 reinforces the FDA’s authority to detain such products at the border without physically examining them.

The 2025 Red List: Products Subject to Detention

A key component of the updated Import Alert 98-06 is the “Red List,” which identifies specific tobacco products and brands that are subject to detention without physical examination (DWPE). For 2025, the list includes various snus and nicotine pouch products from Denmark, Poland, and Sweden. Here are the main additions:

Denmark

Ministry A/S: ACE smokeless tobacco and nicotine delivery products for consumer use
Ministry of Snus: ACE smokeless tobacco and nicotine delivery products for consumer use

Poland

77 Pouches: “77” brand smokeless tobacco and nicotine delivery products for consumer use
Luna Corporate: “77” brand smokeless tobacco and nicotine delivery products for consumer use

Sweden

Another Snus Factory Stockholm AB: Loop brand smokeless tobacco and nicotine delivery products for consumer use
Belagom AB: “Lagom” brand smokeless tobacco and nicotine delivery products for consumer use

Brands Already on the Red List

It’s important to note that several snus and nicotine pouch brands were already on the FDA’s Red List prior to the 2025 update. These include:

Snus Brands

Göteborgs Rapé
Knox (Products Listed: “Knox Loose snus”)
Lundgrens (Tobacco products only)
Oden’s Snus
Röda Lacket (mislabeled as “Scruf Roda Lacket”)
Siberia (Presumably snus and nicotine pouches)
Skruf Products (Products Listed: “Scruf White Portion No. 27”, “Scruf Portion No. 24 White XTRA STRONG”, “Scruf Portion No. 2 Mint medium”)

Nicotine Pouch Brands

Klint
Lyft (Product Listed: “Lyft Cool Air”)
NOIS
Skruf Superwhite
Velo (Swedish version)
White Fox
XQS

Importers and consumers should be aware that attempting to bring any of these unauthorized products into the U.S. may result in their detention and refusal of admission.

The FDA’s Commitment to Public Health

The FDA’s decision to update Import Alert 98-06 for 2025 reflects its ongoing commitment to protecting public health by enforcing regulations on tobacco products. By preventing the entry of unauthorized snus and nicotine pouch products into the U.S. market, the agency aims to ensure that only products that have undergone proper premarket review and have been deemed appropriate for marketing are available to consumers.

This update also highlights the FDA’s efforts to keep pace with the rapidly evolving tobacco product landscape. While electronic nicotine delivery systems (ENDS) were previously listed in the Red List of Import Alert 98-06, they are now subject to a separate Import Alert (98-07). However, the agency remains vigilant in monitoring and regulating all forms of tobacco products that may pose risks to public health.

Navigating the Regulatory Landscape

As the FDA continues to enforce its regulations on tobacco products, manufacturers, importers, and consumers must stay informed about the latest developments and requirements. Companies seeking to market new tobacco products, including snus and nicotine pouches, in the U.S. should familiarize themselves with the premarket review process and ensure compliance with all applicable regulations to avoid potential enforcement actions.

Consumers, on the other hand, should exercise caution when purchasing tobacco products, especially from online or international sources. Products that have not undergone the necessary FDA review could potentially be harmful to their health.

By working together and adhering to the FDA’s regulations, stakeholders can contribute to the agency’s mission of protecting public health and reducing the burden of tobacco-related diseases in the United States. The updated Import Alert 98-06 for 2025 serves as a reminder of the FDA’s unwavering commitment to this goal and its determination to keep unauthorized tobacco products off the market.

Author
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Matthew Ma

Marketing at Ecigator

With over a decade of experience in the e-cigarette industry, Matthew Ma is a seasoned expert in both the manufacturing and usage aspects of vaping products. His extensive background has provided him with a deep understanding of the intricacies and evolving dynamics of e-cigarettes.

FDA Updates Import Alert 98-06 for 2025: Reinforcing Restrictions on Unauthorized Tobacco Products

Understanding the FDA’s Tobacco Product Regulations