Half Empty, LLC d/b/a Vape Street Warning Letter Details

Summary

Half Empty, LLC d/b/a Vape Street was warned for offering electronic nicotine delivery system (ENDS) products for sale without obtaining required premarket authorization from the FDA. The company's ENDS products, which contain nicotine from any source, are classified as new tobacco products under FDA jurisdiction and must comply with the Federal Food, Drug, and Cosmetic Act before being legally marketed in the United States. The FDA determined these products were being distributed through the company's website (vape-street.com) without the necessary marketing authorization, rendering them unapproved and in violation of FDA tobacco product regulations.