VapeHub Incorporated d/b/a VapeHub Warning Letter Details

Summary

VapeHub Incorporated manufactured and distributed e-liquid tobacco products containing nicotine 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 governing tobacco products under section 901(b) of the Federal Food, Drug, and Cosmetic Act, which requires "new tobacco products" to have premarket approval before legal U.S. marketing. This violation applied to nicotine products from any source following the 2022 legislative expansion of FDA's tobacco jurisdiction beyond tobacco-derived nicotine.