FDA warning letter
Royal Peptides FDA warning letter: what it says
royal-peptides.com · Updated 20 October 2026
On 24 August 2026 the FDA's Center for Drug Evaluation and Research sent a warning letter by email to Royal Peptides LLC, of Boynton Beach, Florida, about its website, royal-peptides.com. The letter says it follows a review of the site in July 2026.
According to the letter, the FDA considers seven of the store's products to be unapproved new drugs: tirzepatide, semaglutide, retatrutide, SS-31 (elamipretide), PT-141, tesamorelin, and a tesamorelin and ipamorelin blend sold as BIMORELIN. It says that introducing them into interstate commerce violates the Federal Food, Drug, and Cosmetic Act.
As evidence the letter quotes the store's product pages and articles, including weight-loss results from studies of tirzepatide and retatrutide, a list of research uses for SS-31 that includes mitochondrial repair, anti-aging and neuroprotection, and a description of PT-141 trials in low sexual desire and erectile dysfunction.
The letter notes that the store labelled its products for research use only and not for human or animal consumption. It says that, despite those labels, the website shows the products are intended as drugs for human use, pointing also to bacteriostatic water sold alongside a peptide guide and a peptide calculator.
The letter asks the company to reply within 15 business days of receiving it, with the steps it has taken to correct the violations it describes, or with any information showing its products are not in violation. It says that failing to address them could lead to regulatory or legal action without further notice, including seizure and injunction.
Timeline
July 2026
The FDA reviews the store's website, according to the letter.[1]
24 August 2026
The FDA sends the warning letter by email. It names seven products as unapproved new drugs and asks for a written reply within 15 business days of receipt.[1]
October 2026
The homepage at royal-peptides.com loads and shows a storefront listing peptides with prices.[3]
What this means for buyers
- A warning letter sets out the FDA's view of what it found. It is not a court ruling, and the FDA says a company that disagrees can send its reasons and supporting information.
- The FDA says this letter came from a review of the store's website. The letter does not report a test of any product.
- The FDA posts its warning letters on fda.gov. It may later send a close-out letter, once it has verified that a company has corrected the problems a letter raised. Check there for anything newer than this page.
- This page is about the store at royal-peptides.com. Check the web address before you pay.
- The prices below come from stores in our index. A price listing is not a test of the product.
Our directory keeps a record of this vendor: Royal Peptides.
Sources
- 1. Warning letter to Royal Peptides LLC (MARCS-CMS 734884). U.S. Food and Drug Administration, published 24 August 2026.Supports: The letter's date and recipient, the July 2026 review of the website, the seven products the FDA calls unapproved new drugs, the claims it quotes, its note on the store's research-use labels, the 15-business-day reply and the warning of further action.
- 2. About Warning and Close-Out Letters. U.S. Food and Drug Administration, published 20 March 2024.Supports: A warning letter sets out what the FDA believes are significant violations, and the recipient can answer it, including with its reasons for disagreeing. A close-out letter may follow once the FDA has verified corrections.
- 3. royal-peptides.com homepage, read by PeptidesFinder. PeptidesFinder, accessed 20 October 2026. Address: royal-peptides.com.Supports: The homepage loaded and showed a storefront listing peptides with prices.
Archived copies are from the Internet Archive. This page reports public records and the companies’ own statements, and claims nothing beyond them. If something here is wrong, tell us.
Current prices for these peptides
The letter names all seven, ipamorelin as part of the tesamorelin blend. Below are the three cheapest retail listings in our index for each, cheapest per milligram first. Out-of-stock listings and prices under review are left out, and so is Royal Peptides.
Tirzepatide
Compare all 429 retail prices- 1. Wholesale Peptides Company$7.91 for 10 mg$0.791/mg
- 2. Amino Annex$52.00 for 60 mg$0.867/mg
- 3. Pure Compounding Labs$52.09 for 60 mg$0.868/mg
Semaglutide
Compare all 317 retail prices- 1. Peptaire Labs$35.00 for 30 mg$1.17/mg
- 2. Maple Labs$13.00 for 10 mg$1.30/mg
- 3. Renova Peptides$40.00 for 30 mg$1.33/mg
Retatrutide
Compare all 463 retail prices- 1. PeptiNova$555 for 500 mg$1.11/mg
- 2. Grey Matters Research$73.00 for 60 mg$1.22/mg
- 3. Carolina Chemical$122 for 100 mg$1.22/mg
- 1. Divine Bougie$39.00 for 50 mg$0.780/mg
- 2. Biohacker Direct$394 for 500 mg$0.788/mg
- 3. Rarevbiolabs$50.00 for 50 mg$1.00/mg
- 1. Biohacker Direct$86.18 for 100 mg$0.862/mg
- 2. MT Meipept$96.00 for 100 mg$0.960/mg
- 3. Wholesale Peptides Company$12.17 for 10 mg$1.22/mg
Tesamorelin
Compare all 658 retail prices- 1. Biohacker Direct$317 for 200 mg$1.59/mg
- 2. The PepLair$40.00 for 20 mg$2.00/mg
- 3. Divine Bougie$40.00 for 20 mg$2.00/mg
Ipamorelin
Compare all 574 retail prices- 1. Wholesale Peptides Company$12.57 for 10 mg$1.26/mg
- 2. Divine Bougie$16.00 for 10 mg$1.60/mg
- 3. Grey Matters Research$18.00 for 10 mg$1.80/mg