FDA WARNING_LETTER - Cloudchasor LLC - March 12, 2021

The FDA Center for Tobacco Products reviewed cloudchasor.com and determined that e-liquid products, specifically Cloudchasor Crumblincookie 60ml and Cloudchasor Habanabanana 60ml, are manufactured and offered for sale or distribution in the U.S. These products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The identified e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed 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 firm, a registered manufacturer with over 3,300 products listed with FDA, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative activities