EC Supply, Inc. Warning Letter Details

Summary

EC Supply, Inc. was cited for distributing Electronic Nicotine Delivery Systems (ENDS) products without premarket authorization as required under the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA's tobacco product regulations, which require "new tobacco products" to obtain premarket authorization orders before legal marketing in the United States. This violation was particularly significant given the March 2022 legislative expansion of FDA tobacco jurisdiction to include products containing nicotine from any source, not just tobacco-derived nicotine.