Warning letterPosted September 16, 2025
FDA warning letter to Mane & Steel, LLC. dba Mane & Steel
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
FDA posted a warning letter to Mane & Steel, LLC. dba Mane & Steel on September 16, 2025; the letter is dated September 9, 2025. Subject: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth). Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Mane & Steel, LLC. dba Mane & Steel
- Subject
- Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-09-09
- Posted by FDA
- 2025-09-16
- Source
- FDA warning letters ↗
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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