EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar Warning Letter Details

Summary

EVO Brands, LLC and PVG2, LLC (doing business as Puff Bar) were cited for distributing electronic nicotine delivery system (ENDS) products without FDA marketing authorization orders, which is required for all new tobacco products under the Federal Food, Drug, and Cosmetic Act. The company's ENDS products were being received and delivered in the United States in violation of FDA jurisdiction requirements that apply to all products containing nicotine from any source, including those expanded under legislation signed in March 2022. The FDA determined these products were adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act and related regulations.