FDA WARNING_LETTER - Krazie Vapes

The FDA's Center for Tobacco Products issued a Warning Letter to Krazievapes.com after reviewing their website and determining that e-liquid products 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.

The primary violation identified was the sale of two e-liquid products, "Bazooka Sour Straws Blue Raspberry e-liquid" and "Twisted Tongue Cinnamon Swirls e-liquid," 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 (21 U.S.C. § 387c(a)(7)(B)) because it violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors.

Krazievapes.com is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance, must be submitted within 15 working days.