Alien Vape LLC

Warning LetterOpen

United StatesIssued Jun 28, 2024Center for Tobacco Products

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

Letter Details

Firm: Alien Vape LLC
Location: United States
FEI Number: N/A
Country: United States
Issue Date: June 28, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Alien Vape LLC was warned that its e-liquid products sold on alienvape.com are tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act because they contain nicotine from any source. The company failed to comply with premarket authorization requirements, which mandate that "new tobacco products" obtain an FDA premarket authorization order before being legally marketed in the United States. The warning referenced the March 2022 legislation that expanded FDA's tobacco product definition to include all nicotine-containing products, regardless of whether the nicotine derives from tobacco or other sources.