Warning letterPosted June 3, 2025
FDA warning letter to Mother Earth Minerals, Inc.
Unapproved New Drugs/Misbranded
FDA posted a warning letter to Mother Earth Minerals, Inc. on June 3, 2025; the letter is dated March 28, 2025. Subject: Unapproved New Drugs/Misbranded. Issuing office: Human Foods Program.
On the record
- Company
- Mother Earth Minerals, Inc.
- Subject
- Unapproved New Drugs/Misbranded
- Issuing office
- Human Foods Program
- Letter dated
- 2025-03-28
- Posted by FDA
- 2025-06-03
- Source
- FDA warning letters ↗
CFR cited
The record cites 9 sections of 21 CFR Parts 111 and 201.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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