On August 24, 2026, the FDA sent a warning letter to Royal Peptides LLC (reference 734884, posted September 1, 2026). The FDA says it came from “a review of your website royal-peptides.com in July 2026.”
What the FDA quoted
The letter names seven products, including tirzepatide, retatrutide and PT-141, and calls them “unapproved new drugs.” Its evidence is the shop’s own pages, including comparison articles, not only product pages. One line it quoted:
“In studies, Tirzepatide has led to up to 22.5% body weight reduction in participants over 72 weeks…”
The FDA also listed lines written in careful research language.
What it said about the disclaimer
The FDA addressed the site’s research-use labels in a footnote: “Despite statements on your product labeling marketing your products ‘for research use only’ and ‘not for human or animal consumption,’ evidence obtained from your website establishes that your products are intended to be drugs for human use.”
It also counted what the shop sold together: “you market bacteriostatic water alongside a ‘peptide guide’ and ‘peptide calculator,’ resources that collectively provide the means to prepare an injectable drug for human administration.”
What the letter asked for
The FDA asked for a written response within fifteen business days. The letter does not say what happened next.
Alexios reviews a shop’s website for the kinds of wording and product pairings described in this letter, before the shop applies to take card payments. A review does not guarantee any outcome with the FDA or with a payment company.
This article describes public FDA letters. It is not legal advice.
Sources
- FDA warning letter, Royal Peptides LLC, reference 734884, dated August 24, 2026, posted September 1, 2026: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026
- FDA warning letters index: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters