FDA WARNING_LETTER - Lady Boss Vapor Inc. - December 28, 2021

On December 21, 2021, the FDA issued a Warning Letter to Cynthia Kinch regarding e-liquid products sold on ladybossvapor.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, products like Blue Razzberry Cotton Candy, Strawberry Milkshake, and Cracked Berries & Milk e-liquids were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 220 products listed. A Premarket Tobacco Product Application (PMTA) (STN PM0000963) was submitted on September 3, 2020, but received a Marketing Denial Order on September 8, 2021, covering 50 products.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products, and a plan for maintaining