FDA WARNING_LETTER - Hi Five Ohm Vape Co

The FDA's Center for Tobacco Products issued a Warning Letter to John Foronda regarding the website http://www.hifiveohmvape.com, which sells e-liquid products in the U.S. The FDA determined that "Jack Hammers Birthday Cake e-liquid" is a tobacco product under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of "Jack Hammers Birthday Cake e-liquid" to a person younger than 18 years of age, which misbrands the product under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products and related advertising comply 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 and a compliance plan, is required within 15 working days. The reference number for the response is RW1800887.