FDA WARNING_LETTER - Swirling Wind Vapors LLC

The FDA Center for Tobacco Products issued a Warning Letter to Eric Zurlo and Christopher Powell of Incredible Bulk Juice, following a review of their website, http://www.incrediblebulkjuice.com. The FDA determined that their e-liquid products, specifically "Incredible Bulk Juice Jackie Taffy e-liquid," are tobacco products under the FD&C Act.

The primary violation identified was the sale and distribution of "Incredible Bulk Juice Jackie Taffy e-liquid" to a person younger than 18 years of age, which also included a complimentary "Incredible Bulk Juice The Blueberry Slayer e-liquid." 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.

The letter requires immediate corrective actions, including discontinuing the violative sales and distribution, and a written response within 15 working days detailing these actions and a plan for maintaining compliance. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.