FDA WARNING_LETTER - Lecig Enterprises Inc - February 17, 2022

The FDA issued a Warning Letter to LeCig Enterprises, Inc. on February 17, 2022, following a review of submissions and inspection records. The FDA determined that LeCig manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "LeCig Cinnamon Roll 36mg 30ml" e-liquid without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

LeCig Enterprises, Inc. is a registered manufacturer with over 600 listed products. A Premarket Tobacco Product Application (PMTA), STN PM0003586, submitted on September 9, 2020, received a Marketing Denial Order on September 15, 2021, covering 85 products. The FDA states that all new tobacco products on the market without premarket authorization,