FDA WARNING_LETTER - Fullest Closet - May 19, 2020

On May 11, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to the operator of https://www.fullestcloset.com after determining that the website offered electronic nicotine delivery system (ENDS) products for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified was the sale of "new tobacco products" without the required premarket authorization, as mandated by section 910(a) of the FD&C Act. The specific ENDS products cited include various "UPDATE Suitable JUUL Device 20PcsLot Vape Pen Pods" in flavors such as Apple, Blueberry, Grape, Mango, Mint, Mixed Fruit, Pink Apple, Pink Lemonade, Strawberry, and Watermelon. These products were deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lacked FDA marketing authorization orders or exemptions. Consequently, these products are considered adulterated under section 902(6)(A) of the FD&C Act.

The FDA requires the company to promptly correct these violations and submit a written response within 15 working days detailing corrective actions, including the discontinuation of violative sales and a plan for future compliance. Failure to comply may result in enforcement