# FDA WARNING_LETTER - Tampa FuM Corp. - June 16, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/tampa-fum-corp/7725bc9c-8d8b-4ecb-87ab-caa246d29cf4

> FDA WARNING_LETTER for Tampa FuM Corp. on June 16, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tampa FuM Corp.
- Inspection Date: 2020-06-16
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Ken Villei, Francis K. II Villei, and Lissette C. Villei after reviewing their website, https://fumvaping.com, and determining that their e-liquid tobacco products are subject to FDA jurisdiction. The primary violation identified is that the advertising for several e-liquid products, including FuM Jolly Melon and FuM Chocolate Bar, fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the e-liquid products misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). The FDA requires immediate correction of this violation and similar deficiencies across all advertising platforms. A written response is required within 15 working days, detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance. Failure to comply could result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Jose S. Ramos](https://www.globalkeysolutions.net/people/jose-s-ramos/37c97275-052f-4d2a-bd2a-ca7858ac23d2)
- [Francis K. II Villei](https://www.globalkeysolutions.net/people/francis-k-ii-villei/6b580fc9-4b12-4a93-a1e1-9477e736d078)
- [Lissette C. Villei](https://www.globalkeysolutions.net/people/lissette-c-villei/26da66d3-dad7-4b53-9d0e-aef15e9e1b54)

Company: https://www.globalkeysolutions.net/companies/tampa-fum-corp/6e98300f-f7a5-4701-8e5a-a6149d0d4884

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