FDA WARNING_LETTER - TBD Liquids - August 27, 2019

Record Details

On August 22, 2019, the FDA issued a Warning Letter to John Fitch of TBD Liquids, LLC, following a review of their website, https://www.tbdliquids.com. The FDA determined that TBD Liquids' e-liquid products, specifically Rainbow Sherbet and Raspberry Sorbet, are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** TBD Liquids sold Rainbow Sherbet and Raspberry Sorbet e-liquid products to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** * **Product Packages:** Packages for several e-liquid products, including Rainbow Sherbet and Raspberry Sorbet, lacked the required "WARNING: This product contains nicotine. Nicotine is an addictive chemical." statement, violating 21 C.F.R. § 1143.3(a). This misbrands the products under sections 903(a)(7)(B) and 903(a)(1) of the FD&C Act. * **Website Advertising:** The website advertising for several e

Company: TBD Liquids
Inspection Date: August 27, 2019
Product Type: Tobacco
Office: Center for Tobacco Products
People: Ann Simoneau (Director)
John Fitch

Open in Dashboard

ID · a66a5985-247e-4423-ace7-cdffb70adbbc

Violation Codes10

21 CFR 1100.221 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 CFR 1140.321 CFR 1143.3(a)21 CFR 1140.14(b)21 CFR 1143.3(b)

Full citation text and observation details available on the Dashboard.