Oglesby & Butler – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Nevin Dowling of iolite.com after reviewing their website and determining that e-liquid products were offered for sale or distribution in the United States. The Iolite Peach Perfect E-Joose e-liquid was identified as a tobacco product under section 201(rr) of the FD&C Act and found to be misbranded under section 903(a)(7)(B) because it was sold to a person younger than 18 years of age.

This sale to a minor violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18. The FDA's investigation confirmed a purchase by a minor from iolite.com.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and 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.