AspireCig LTD – FDA Warning Letter

The FDA issued a Warning Letter to Daniel Griffin, owner of ecigaspire.co.uk, after reviewing the website and determining that e-liquids were offered for sale to U.S. customers. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act and fall under FDA jurisdiction per section 901(b). The primary violation identified was the sale of "Cloud Chasers Clockwork Orange" e-liquid to a person younger than 18 years of age. This action violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. As a direct consequence of this violation, the product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act. The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations, including 21 C.F.R. Part 1140. The firm must immediately correct this and similar violations and submit a written response within 15 working days. This response must detail corrective actions, including dates of discontinuing violative sales, and a plan for future compliance. Failure to comply could result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.