Quick TL;DR

• Only FDA-authorized products can be legally marketed in the U.S. Authorization ≠ “approval,” but it means FDA has issued a marketing order (e.g., PMTA, SE, or EX pathway).
• FDA Import Alerts (“Red List”) enable detention without physical examination (DWPE) of unauthorized tobacco products at the border, including snus and nicotine pouches.
• As of 2025, FDA has authorized 20 ZYN nicotine pouch products; other pouch brands/flavors/strengths are generally unauthorized unless specifically listed as authorized.
• SNUSIO gates U.S. shipments to authorized SKUs only, monitors Import Alerts in real time, and adjusts catalog and checkout logic to keep orders compliant.

Nothing in this article is legal advice. Always consult FDA resources or legal counsel for definitive guidance.

What the FDA “Red List” Is (and Why It Matters)

The FDA uses Import Alerts to stop products that appear to violate U.S. law from entering the country. Items placed on a Red List may be subject to Detention Without Physical Examination (DWPE) at the border. Tobacco products (including snus and nicotine pouches) are covered by several alerts; most relevant is Import Alert 98-06 for new tobacco products (other than ENDS) lacking required marketing authorization.

• 98-06 – New tobacco products (non-ENDS) without required marketing authorization may be detained (covers snus & pouches).
• 98-07 – ENDS (vapes) lacking premarket authorization.
• 98-03 – Smokeless tobacco without required warnings.
• 98-08 – Certain regulated tobacco products lacking labeling required by FD&C Act §903(a)(2).

FDA emphasized in 2025 that unauthorized e-cigarettes may be detained under 98-07 and updated 98-06 to focus on non-ENDS products like snus and nicotine pouches.

What Counts as “Authorized” vs. “Unauthorized” (Quick Guide)

Authorized

• Products with a Marketing Granted Order (MGO) via PMTA/SE/EX pathways. You can search FDA’s database of authorized tobacco products and read the underlying orders.
• Nicotine pouches: In January 2025 the FDA authorized 20 ZYN pouch products (3 mg and 6 mg across specific flavors). Those listed SKUs may be legally marketed in the U.S.
• Snus: Several General Snus products have PMTA authorizations (2015) and were later granted Modified Risk orders (2019), subject to strict order conditions.

Unauthorized

• Any new tobacco product without an FDA marketing order (including most non-ZYN nicotine pouches as of today) is considered unauthorized and may be detained under Import Alert 98-06.
• Products with labeling deficiencies (e.g., missing required smokeless warnings or other §903(a)(2) elements) can be detained under 98-03/98-08.
• Pending PMTA ≠ authorization. A submitted application does not create a legal safe harbor for U.S. distribution.

How This Affects Shoppers and Retailers

If a product is unauthorized or listed for DWPE, it can be held by U.S. Customs and FDA. That can mean delays, seizure, or return—costs and outcomes vary. Retailers may choose to restrict or block shipments to the U.S. (or to certain states/counties) to avoid customer disruption and regulatory risk.

SNUSIO’s Compliance Position (What We Actually Do)

We are transparent about how we handle shipments to the U.S. so customers know what to expect.

How we handle U.S. orders

• We ship to the U.S. We accept orders from U.S. customers, but all U.S. buyers act as the importer of record.
• Customer takes the risk. By ordering, you accept that FDA or U.S. Customs may delay, return, or confiscate shipments. SNUSIO cannot guarantee clearance.
• Labeling & documentation. We label and declare our products accurately to follow compliance and international shipping guidelines as much as possible. This helps reduce—but does not remove—the risk of holds at customs.
• Duties, taxes & fees. Any import duties, excise taxes, or customs fees charged by U.S. authorities are the responsibility of the customer. Refusing to pay may result in the shipment being returned with additional handling costs.
• Returns due to customs. If a package is returned to us because of customs refusal, shipping/handling and any additional fees will be deducted from the refund, as outlined in our Shipping & Returns policy.

What this means for you as a U.S. customer

We do our best to prepare shipments properly and provide accurate documentation. However, once the order leaves our warehouse, clearance decisions rest with U.S. authorities. By purchasing from SNUSIO, you acknowledge and accept these conditions.

For more details, please see our Shipping & Delivery and Returns & Complaints pages.

Brand & Product Examples (2025 snapshot)

Note: Authorization status can change. Always confirm in FDA’s searchable database before shipping/ordering.

Planning a U.S. Order? Read This First

• Confirm the exact SKU is in FDA’s authorized list.
• Expect possible border checks; DWPE reviews can delay or return shipments.
• Customs duties/taxes are the customer’s responsibility; refusal to pay can trigger returns and fees.

Useful Resources

• FDA Import Alerts overview
• Search Import Alerts (by number/date/industry)
• Tobacco Import Alerts (98-03/04/05/06/07/08)
• FDA press release: 20 ZYN products authorized (Jan 2025)
• FDA list: Authorized nicotine pouch products
• FDA MRTP orders: General Snus
• Importing Tobacco Products (what FDA checks at the border)