U.S. Vapes

Warning LetterOpen

Ryan Layman Owner Owner U.S. Vapes 3210 Midwestern Parkway, Suite 200 Wichita Falls , TX 76308 United States ryanlayman22@yahoo.comIssued Sep 13, 2022Center for Tobacco Products

View Letter

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

Letter Details

Firm: U.S. Vapes
Location: Ryan Layman Owner Owner U.S. Vapes 3210 Midwestern Parkway, Suite 200 Wichita Falls , TX 76308 United States ryanlayman22@yahoo.com
FEI Number: N/A
Country: United States
Issue Date: September 13, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

U.S. Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, which have been subject to FDA jurisdiction since August 8, 2016, and require marketing authorization orders before commercial distribution. The e-liquid products were found to be adulterated and/or misbranded under the Federal Food, Drug, and Cosmetic Act because they lacked the necessary premarket approval as "new tobacco products."