FDA Files
FDA Files
Posted FDA letters and notices, with the actual document linked. Primary records only.
Documented records
DOCUMENTED. FDA posted warning letters on Sept. 1, 2026 (dated Aug. 24) to five peptide sellers, stating that products sold as “research use only” are unapproved new drugs. The letters are FDA’s allegations; each firm was told to respond within 15 business days.
REPORTED. FDA’s page confirms a July 23-24, 2026 advisory committee meeting on seven peptides; outlets report the panel supported six of them (including BPC-157) for the 503A bulks list and rejected one. The votes are nonbinding and a formal rule would be needed before pharmacies could compound them.
DOCUMENTED. FDA posted warning letters on Apr. 7, 2026 (dated Mar. 31) to five peptide sellers, citing unapproved new drug violations; all five letters also name bacteriostatic water sold alongside the peptides. The letters are FDA’s allegations; each firm had 15 working days to respond.
DOCUMENTED. FDA posted warning letters on Dec. 17, 2024 (dated Dec. 10) to four online sellers of research peptides, saying their semaglutide, retatrutide and related products are unapproved new drugs. The letters are FDA’s allegations; each firm had 15 working days to respond.
Mentioned in the wire
Status note: This item includes industry discussion, public posts, or submitted tips. It is not an allegation of wrongdoing and should not be treated as verified fact unless specifically marked Documented or Confirmed.