Matthew Stern, CEO MyStart Health LLC.
FDA issued a warning letter to Matthew Stern, CEO of MyStart Health LLC, in September 2025 after reviewing the company's website and finding that it marketed compounded semaglutide using claims that falsely implied equivalence to FDA-approved products such as Ozempic. The specific claims 'Generic Ozempic' and 'Save with generics that offer the same active ingredients and results' were found to be false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
Generic Ozempic
Save with generics that offer the same active ingredients and results.
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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