FDA WARNING_LETTER - LDSD Vapor LLC d/b/a AtascaVapes - August 02, 2022

The FDA issued a Warning Letter to LDSD Vapor LLC d/b/a AtascaVapes, identifying that the company manufactures and distributes e-liquid products, specifically "AV MONKEY NUTZ 50MG," which are considered tobacco products under the FD&C Act. The letter states that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order from the FDA.

This absence of marketing authorization renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act under section 301(p). The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and distribution of the non-compliant products, and a plan for maintaining future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.