Novoliq, Inc. – FDA Warning Letter, Jul 9, 2019
On March 6, 2019, the FDA issued a Warning Letter to Frankie Wei of NovoLiq, following a review of the website https://www.novoliq.com. The FDA determined that NovoLiq's e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.
The letter identified two primary violations: 1. **Sales to Minors:** NovoLiq sold NovoLiq Nicotine Salts Neoberry e-liquid to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** The website's labeling and/or advertising for e-liquid products, specifically NovoLiq Nicotine Salts Neoberry, NovoLiq Nicotine Salts RootSoda, NovoLiq Nicotine Salts BlueBaco, and NovoLiq Nicotine Salts Chablis, failed to include the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or 21 C.F.R. §
ID · 0c1960f1-05a5-48e7-ba3c-c01f566d67ac
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