FDA WARNING_LETTER - Buku Vapor LLC - January 12, 2022

On January 12, 2022, the FDA issued a Warning Letter to Buku Vapor LLC, identifying that the company manufactures and distributes e-liquid products, specifically "BUKUVAPOR FREEBASE Nicotine Solution Vegetable Glycerin 100mg/ml Volume: 150ml," which are deemed tobacco products under the FD&C Act.

The FDA determined that this e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. The product is being sold without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt from this requirement. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter states that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement. Buku Vapor LLC has over 10,600 products listed with the FDA. The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and a plan for maintaining compliance. Failure