SZ Vape LLC, d/b/a Vype Vapor Warning Letter Details

Summary

SZ Vape LLC, operating as Vype Vapor, sold electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to receive premarket approval before legal marketing in the United States. The warning was issued following the FDA's review of inspection records determining that the company distributed these nicotine-containing products to U.S. customers without the necessary premarket authorization order in effect.