FDA WARNING_LETTER - California Vaping Company Inc. - February 26, 2021
The FDA issued a Warning Letter to David Collins and Dakoda Collins of California Vaping Company on February 26, 2021, following a review of their website, https://calivapeco.com. The FDA determined that e-liquid products offered for sale, including California Vaping Company Toucan Slam, Catalina, Berry Crunch Time, and Caramel Milk, are "new tobacco products" under section 201(rr) of the FD&C Act.
These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order or exemption under section 910(c)(1)(A)(i) or 905(j) of the FD&C Act.
The company, a registered manufacturer with over 1,200 listed products, is responsible for ensuring compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective
ID · b596a77a-1715-4856-a332-fd32648b8387
Full citation text and observation details available on the Dashboard.