Route 66 Vapor

Warning LetterOpen

Randy Padilla Owner Route 66 Vapor 2663 Louisiana Boulevard Northeast Albuquerque , NM 87110 United States sales@route66vapor.comIssued Aug 31, 2023Center for Tobacco Products

View Letter

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

Letter Details

Firm: Route 66 Vapor
Location: Randy Padilla Owner Route 66 Vapor 2663 Louisiana Boulevard Northeast Albuquerque , NM 87110 United States sales@route66vapor.com
FEI Number: N/A
Country: United States
Issue Date: August 31, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Route 66 Vapor manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products qualified as tobacco products under FDA jurisdiction because they contained nicotine from any source, a definition expanded by legislation signed in March 2022. The products were deemed adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act for being marketed without the legally required premarket authorization for new tobacco products.