FDA WARNING_LETTER - Pure Smoke LLC

The FDA's Center for Tobacco Products reviewed puresmokeonline.com and determined that PureSmoke 5 Cartomizers Cool Mint ENDS product, a tobacco product under section 201(rr) of the FD&C Act, was sold to a person younger than 18 years of age. This constitutes a misbranding violation under section 903(a)(7)(B) of the FD&C Act, as it violates 21 C.F.R. § 1140.14(b) which prohibits the sale of covered tobacco products to minors. The FDA's investigation confirmed a purchase by a minor.

The company is required to immediately correct this violation and similar issues across all sales and advertising platforms to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales/advertising and a compliance plan, must be submitted within 15 working days to the FDA Center for Tobacco Products.