Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistLBC Products Inc. was warned for selling and distributing e-liquid products containing nicotine without required premarket authorization orders, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations under section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1, which require "new tobacco products" to obtain marketing authorization before being legally sold in the United States. The warning noted that under legislation signed in March 2022, FDA's jurisdiction expanded to include all nicotine-containing products regardless of nicotine source, and LBC Products' e-liquid products fell under this expanded regulatory scope without the required compliance measures in place.