FDA WARNING_LETTER - Cyberliquids, LLC - November 09, 2021

The FDA issued a Warning Letter to Anthony Garcia of Cyberliquids, LLC, after reviewing their website, https://www.cyberliquids.com, and determining that the company manufactures and offers e-liquid products, specifically Cyberliquids Vader and Cyberliquids Cereal Vapor, for sale in the U.S. These products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation (21 C.F.R. § 1100.1). The primary violation identified is the marketing of these e-liquid products as "new tobacco products" without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided. The firm's Premarket Tobacco Product Application (PMTA STN PM0003476) received a Refuse to File determination for 31 products and a Marketing Denial Order for 208 products. Cyberliquids is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, as unlawfully marketed products are a high enforcement priority.