Tombak LLC

Warning LetterOpen

Tombak LLC 10 South Havana Street, Suite 119R Aurora , CO 80012 United StatesIssued Jan 22, 2026Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Tombak LLC
Location: Tombak LLC 10 South Havana Street, Suite 119R Aurora , CO 80012 United States
FEI Number: N/A
Country: United States
Issue Date: January 22, 2026
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Tombak LLC was warned for manufacturing and selling smokeless tobacco products, specifically Tombak Loose Leaf Chewing Tobacco (unflavored), without required premarket marketing authorization. The FDA determined that these products qualified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act and therefore were adulterated and misbranded for lacking the required marketing authorization order or substantial equivalence determination. The company had failed to submit either a premarket approval application under section 910(c) of the FD&C Act or a substantial equivalence report under section 905(j) before offering these products for sale in the United States.