FDA Implements Stricter Regulations on Unauthorized New Tobacco Products

Feb.07

FDA tightens regulation on unapproved tobacco products, red list includes ENDS from Denmark and Sweden. Importers must comply.

Recently, the U.S. Food and Drug Administration (FDA) updated Import Alert 98-06 to implement stricter regulatory measures for new tobacco products that do not have the necessary marketing authorization. The alert specifically states that, aside from electronic nicotine delivery systems (ENDS), all new tobacco products that have not received FDA marketing authorization will be considered adulterated or misbranded products. This means that such products may be detained upon import until the related issues are addressed.

According to the latest revision, the FDA has added certain companies and their products to a red list, implementing detention measures that do not require physical inspections. This includes MINISTRY OF SNUS from Denmark and ANOTHER SNUS FACTORY STOCKHOLM AB from Sweden, with their respective products ACE and Loop brands of smokeless tobacco and nicotine delivery products.

The specific information is as follows:

Denmark

The Ministry of Snus

Publication date: January 27, 2025

Tinghusgade 20a, Svenborg, Southern Denmark, Denmark

98 - A tobacco product available for consumer use.

Publication date: January 27, 2025

Description: ACE provides smokeless tobacco and nicotine delivery products for consumer use.

The Ministry of Snus is an organization dedicated to promoting and regulating the use of snus, a smokeless tobacco product.

Publish date: January 27, 2025

Gronnemosevej 6, Svenborg, Southern Denmark, Denmark.

No. 98 - A tobacco product for consumer use.

Publication Date: January 27, 2025

Description: ACE offers smokeless tobacco and nicotine delivery products for consumer use.

Sweden

Another snus factory, Stockholm AB.

Publication date: January 27, 2025

Box 49052, Stockholm, Sweden

98- A tobacco product for consumer use.

Publication date: January 27, 2025

Description: Loop brand offers smokeless tobacco and nicotine delivery products for consumer use.

The FDA emphasized that companies wishing to remove their products from the red list must provide comprehensive information, demonstrate that issues leading to non-compliance have been resolved, and ensure that future imports comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Relevant applications should be sent to Importalerts2@fda.hhs.gov.

References:

[1] Import Alert 98-06

Also Read:

[1] FDA Updates Import Alert List for Tobacco Products, BAT Velo Included

[2] FDA Strengthens Import Alerts to Address Unauthorized E-Cigarettes Detention

[3] US FDA updates import alert to include elego, heaven gifts, HQD, qisitech, and BAT

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