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WARNING LETTER
•Ferrum City Liquid•April 5, 2022

Ferrum City Liquid – FDA Warning Letter, Apr 5, 2022

Record Details

The FDA issued a Warning Letter to Daniel Laughery and Ashley Milner of Ferrum City Liquid on November 24, 2021, following a review of their website, ferrumcityliquid.com. The FDA determined that their e-liquid products, specifically "Blooberry" and "Choculate," are tobacco products under the FD&C Act and are being manufactured and sold in the U.S. without required marketing authorization.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company is a registered manufacturer with 69 products listed with the FDA. A Premarket Tobacco Product Application (PMTA), STN PM0001345, submitted on September 8, 2020, was denied on September 7, 2021, covering all 69 products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

Ferrum City Liquid must submit a written response within 15 working days detailing actions taken

Company
Ferrum City Liquid
Inspection date
April 5, 2022
Product type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Ele Ibarra-Pratt (Acting Director)
View Company Profile

ID · ca051af8-3a41-4ce5-8544-c3925f3184a5

Violation Codes10
21 CFR 1100.121 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387j(a)21 U.S.C. 387j(c)(1)(A)(i)21 U.S.C. 387e(j)21 U.S.C. 387e(j)(1)(A)(ii)21 U.S.C. 387e(j)(3)21 U.S.C. 30121 CFR 1141

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Other documents for Ferrum City Liquid
  • WARNING_LETTER - 2022-08-02August 2, 2022

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