FDA Tightens Import Controls on Certain Tobacco Products

Key points:

1. The U.S. Food and Drug Administration (FDA) has updated its "98-06 Import Alert" list, tightening regulations on certain tobacco products. It also allows for the automatic detention of listed products without additional inspection.

2. The update affects several European brands, primarily from Poland and Sweden, including smokeless tobacco and nicotine delivery products, including 77 Pouches, Loop, and Lundgrens.

The U.S. Food and Drug Administration (FDA) has recently updated its "98-06 Import Alert" list (also known as the "Red List"), further strengthening import regulation of specific tobacco products. 

Under new guidelines, the FDA can automatically detain tobacco products included in the list without the need for additional physical inspections

The update includes several brands and manufacturers, such as 77 Pouches, Loop, and Lundgrens. The products are mainly distributed in Europe, with a focus on Poland and Sweden, and primarily consist of smokeless tobacco and nicotine delivery products.

The following is a specific list.

1. 77 Pouches (Poland)

• Company address: Al. 29 Listopada 94, Cracow, Malopolskie, Poland.
• Product description: "77" brand of smokeless tobacco and nicotine delivery products.
• Publication Date: March 7, 2025.

2. Luna Corporate (Poland)

• Company address: Ul. Obornicka 174, Suchy Las, Wielkopolskie, Poland.
• Product Description: "77" brand's smokeless tobacco and nicotine delivery products.
• Publication date: March 7, 2025.

3. Another Snus Factory Stockholm AB (Sweden)

• Company address: Stora Nygatan 33, Stockholm, Stockholms Lan, Sweden.
• Product description: Loop brand tobacco products.
• Publication date: March 7, 2025.

4. British American Tobacco (Sweden)

• Company Address: Hyllie Stationsvag 14, 31st Floor, Malmo, Skane Lan SWEDEN.
• Product description: Lundgrens brand of smoke-free tobacco and nicotine delivery products.
• Publication date: March 7, 2025.

The FDA stressed that companies seeking to have their products removed from the red list must provide sufficient information to demonstrate that the issues leading to the violation have been addressed and ensure future imports comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Relevant applications should be sent to Importalerts2@fda.hhs.gov.