FDA WARNING_LETTER - Crafty E-Liquids Limited - August 25, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Josef Nolan regarding e-liquid tobacco products advertised on craftyeliquids.com. The FDA determined that several e-liquid products, including Crafty E-Liquids Salts, are tobacco products subject to FDA jurisdiction under sections 201(rr) and 901(b) of the FD&C Act. The primary violation identified is the failure to include the required nicotine warning statement in the advertising for these e-liquid products, as mandated by 21 C.F.R. § 1143.3(b). Specifically, the warning "WARNING: This product contains nicotine. Nicotine is an addictive chemical." was absent. This omission renders the e-liquid products misbranded under two sections of the FD&C Act: 903(a)(7)(B) for violating regulations prescribed under section 906(d), and 903(a)(7)(A) because the advertising is considered misleading by failing to reveal material facts under section 201(n). The letter emphasizes the firm's responsibility to ensure compliance across all advertising and sales platforms. Josef Nolan must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative advertising/sales, and a plan for maintaining compliance. Failure to address these violations may lead to further FDA regulatory action, including detention and refusal of admission for imported products.