FDA WARNING_LETTER - Vape Goddess LLC

The FDA issued a Warning Letter to Megan Elise Strouse, operating Vape Goddess, following a review of http://www.vapegoddess.net. The FDA determined that e-liquid products, specifically "Vape Goddess Guilty Pleasure e-liquid," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified was the sale of "Vape Goddess Guilty Pleasure e-liquid" to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. The product is defined as a "covered tobacco product" under 21 C.F.R. § 1140.3.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales and advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products imported into the U.S. are subject to detention. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required