FDA WARNING_LETTER - Bull Smoke

The FDA's Center for Tobacco Products reviewed bullsmoke.com, determining that Bull Smoke Cherry Blast Flavor Cartridges e-liquid products are tobacco products subject to FDA jurisdiction. The investigation revealed a critical violation: the firm sold an e-liquid product to a person younger than 18 years of age. This action directly violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. Consequently, the Bull Smoke Cherry Blast Flavor Cartridges e-liquid is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The FDA mandates immediate correction of this and similar violations, requiring the firm to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales channels. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days. Failure to comply could lead to severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal for misbranded products.