Upper Limits

Warning LetterOpen

Upper Limits 1205 South 2nd Street Springfield , IL 62704 United StatesIssued Dec 11, 2025Center for Tobacco Products

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

Letter Details

Firm: Upper Limits
Location: Upper Limits 1205 South 2nd Street Springfield , IL 62704 United States
FEI Number: N/A
Country: United States
Issue Date: December 11, 2025
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Upper Limits was warned for selling electronic nicotine delivery system (ENDS) products without required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA requirements applicable to tobacco products containing nicotine from any source, which have been under FDA jurisdiction since the March 2022 legislation expanding the definition of regulated tobacco products. As a "new tobacco product" not commercially marketed in the United States before February 15, 2007, the products required a marketing authorization order under section 910 of the FD&C Act before being legally sold.