FDA WARNING_LETTER - CIGNOT INC

The FDA Center for Tobacco Products issued a Warning Letter to Victoria Vasconcellos regarding e-liquid products sold on http://www.cignot.com. The FDA determined that Black Cherry e-liquid is a tobacco product under section 201(rr) of the FD&C Act and is misbranded under section 903(a)(7)(B) of the FD&C Act.

The violation stems from the sale and distribution of Black Cherry e-liquid to a person younger than 18 years of age, which violates 21 C.F.R. § 1140.14(b). This regulation prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18. Because the product was sold to a minor, it is deemed misbranded.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance, is required within 15 working days.