KommonCentz – FDA Warning Letter
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.
- Company
- KommonCentz
- Product type
- Tobacco
ID · c7ca3ada-2cf6-4c77-90b6-f115d464c52b
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.