KV Liquids LLC – FDA Warning Letter, Apr 27, 2021

The FDA issued a Warning Letter to Sean Roberson regarding e-liquid products manufactured and sold by KV Liquids via their website, https://www.kvliquids.com. The FDA determined these e-liquids are "tobacco products" under the FD&C Act, subject to FDA jurisdiction since August 8, 2016.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, KV Liquids Funky Monkey, KV Liquids Purple Drink, and KV Liquids Tropical Storm e-liquids were identified as new tobacco products, not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to failure to provide required information under section 905(j).

As a registered manufacturer with over 300 listed products, the firm is responsible for ensuring compliance across all products, labeling, and advertising. Failure to correct these violations may result in regulatory actions including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.