FDA WARNING_LETTER - E-Liquid Circle LLC

The FDA Center for Tobacco Products issued a Warning Letter to Joseph Jarbou and Jonathan Jarbou regarding their website, http://www.inlinevape.com, which sells electronic nicotine delivery system (ENDS) products. The FDA determined that the JUUL Starter Kit, containing four JUUL pods, is a tobacco product subject to FDA jurisdiction.

The primary violation identified was the sale of a JUUL Starter Kit to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and violates 21 C.F.R. § 1140.14(b). This regulation prohibits retailers from selling covered tobacco products, including ENDS, to minors.

The FDA 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 across all sales channels. 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.