FDA WARNING_LETTER - KommonCentz

The FDA's Center for Tobacco Products issued a Warning Letter to KommonCentz after reviewing their website, http://www.kommoncentz.com, which offers e-liquid products for sale in the U.S. 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 a "Grape Jolly Rancher" e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18.

KommonCentz is required to immediately correct this violation and any similar ones, 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 of violative sales and a plan for maintaining compliance, must be submitted within 15 working days. The reference number for this case is RW1600562.