Route 66 Vapor

Warning LetterOpen

Route 66 Vapor 10200 Corrales Road Albuquerque , NM 87114 United StatesIssued Feb 14, 2025Center for Tobacco Products

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

Letter Details

Firm: Route 66 Vapor
Location: Route 66 Vapor 10200 Corrales Road Albuquerque , NM 87114 United States
FEI Number: N/A
Country: United States
Issue Date: February 14, 2025
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Route 66 Vapor, an electronic nicotine delivery system (ENDS) retailer, was found to be selling tobacco products without required premarket authorization orders as mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction requirements for ENDS products containing nicotine from any source, which became subject to FDA oversight following legislation signed in March 2022 that expanded the definition of "tobacco product" to include all nicotine-containing products regardless of source. The products were deemed adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act due to the absence of required premarket authorization for these "new tobacco products."