SV3, LLC d/b/a Mi-One Brands Warning Letter Details

Summary

SV3, LLC d/b/a Mi-One Brands was cited for manufacturing and distributing electronic nicotine delivery system (ENDS) products through their website without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act before being legally marketed in the United States. The FDA determined that the ENDS products listed on mipod.com were subject to FDA jurisdiction as deemed tobacco products but lacked the necessary premarket approval to remain in commerce.