FDA WARNING_LETTER - Cloud House Vape - December 08, 2022

On December 8, 2022, the FDA issued a Warning Letter to Cloud House Vape, identifying that their e-liquid products, specifically "Blue Monster e-liquid products," are being manufactured and distributed without the required premarket authorization. These products are deemed "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i).

This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The failure to provide such a report is a prohibited act under section 301(p). Cloud House Vape's Premarket Tobacco Product Application (PMTA), STN PM0003153, submitted on September 10, 2020, received a Refuse To Accept determination on October 19, 2021, covering 812 products.

The FDA requires Cloud House Vape to submit a written response within 15 working days, detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a