# FDA WARNING_LETTER - Novoliq, Inc. - July 09, 2019

Source: https://www.keypedia.com/records/warning_letter/novoliq-inc/0c1960f1-05a5-48e7-ba3c-c01f566d67ac

> FDA WARNING_LETTER for Novoliq, Inc. on July 09, 2019. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Novoliq, Inc.
- Inspection Date: 2019-07-09
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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. §

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/novoliq-inc/e0259158-77a9-4729-8eb2-475b62176f7f

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374
