FDA WARNING_LETTER - Adore eLiquid - February 26, 2021

On February 26, 2021, the FDA issued a Warning Letter to Dawn Carrillo regarding e-liquid products manufactured and sold via https://www.adoreeliquid.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, "Adore eLiquid Strawberry Submission" and "Adore eLiquid Blueberry Something" were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 160 listed products, to ensure compliance across all advertising and sales channels. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance.