FDA Import Alert Red List for Nicotine Pouches

The FDA maintains Import Alert lists (commonly called "Red Lists") of firms and products that may be detained at the US border without physical examination. This is known as Detention Without Physical Examination (DWPE).

For nicotine pouches, two import alerts are relevant:

• Import Alert 98-06 — Tobacco products for which a marketing authorization order has not been issued (no PMTA/SE approval)
• Import Alert 98-08 — Tobacco products lacking labeling requirements specified under section 903(a)(2) of the FD&C Act

When a product or firm appears on these lists, US Customs and Border Protection (CBP) can detain shipments at the port of entry. This directly affects consumers ordering nicotine pouches from international retailers.

If you order nicotine pouches from an international store and the brand or manufacturer is on the FDA Red List, your shipment may be:

• Detained at the US port of entry by CBP
• Held for FDA examination and potential refusal of admission
• Delayed significantly (weeks to months) during the review process
• Destroyed or returned to the sender if refused

To avoid these risks, consider purchasing from US-based stores that ship domestically, or stick to FDA-authorized brands like ZYN and On! that are manufactured in the US.