FDA WARNING_LETTER - Bombay Vapor LLC - January 29, 2021

The FDA issued a Warning Letter to Charles Mady of Bombay Vapor on January 29, 2021, following a review of their website, https://bombayvapor.com. The FDA determined that e-liquid products offered for sale, specifically "Date Night" and "Pineapple Express," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 300 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions including civil money penalties, seizure, and/or injunction. Bombay Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations,