Warning letterPosted May 5, 2026
FDA warning letter to Hearthy Foods, Inc.
CGMP/Dietary Supplement/Adulterated/Misbranded
FDA posted a warning letter to Hearthy Foods, Inc. on May 5, 2026; the letter is dated February 10, 2026. Subject: CGMP/Dietary Supplement/Adulterated/Misbranded. Issuing office: Human Foods Program.
On the record
- Company
- Hearthy Foods, Inc.
- Subject
- CGMP/Dietary Supplement/Adulterated/Misbranded
- Issuing office
- Human Foods Program
- Letter dated
- 2026-02-10
- Posted by FDA
- 2026-05-05
- Source
- FDA warning letters ↗
CFR cited
The record cites 22 sections of 21 CFR Parts 101, 111 and 117.
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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