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Reference information only. Therapept does not sell peptides and does not provide medical advice.Research-use notice

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FDA Warning-Letter Patterns in Peptide Marketing

Published FDA warning letters and unapproved-drug communications in this sector cluster on intended-use claims and unapproved products — not on whether a COA percentage was high.

Therapept EditorialUpdated 12 September 20268 min readReviewed by Therapept Editorial

FDA’s published concerns about unapproved GLP-1 products marketed for weight loss are about the product and the claim, not about a research-chemical catalogue’s chromatography. Compounding Category 2 notes for ipamorelin concern characterisation and immunogenicity risk in compounding, which is a different system again.

What to read in a letter

  • The intended use FDA says the firm assigned.
  • Whether an approved product already occupies that use.
  • Whether the letter is about compounding, unapproved new drugs, or labelling.

Sources

  1. FDA — Concerns about unapproved GLP-1 drugs used for weight loss
  2. FDA — Certain bulk drug substances for use in compounding may present significant safety risks

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