Warning letterPosted September 16, 2025

FDA warning letter to Matthew Stern, CEO MyStart Health LLC.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)

FDA's record ↗

FDA posted a warning letter to Matthew Stern, CEO MyStart Health LLC. 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
Matthew Stern, CEO MyStart Health LLC.
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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