Royal Peptides LLC
FDA issued a warning letter to Royal Peptides LLC (Boynton Beach, FL), operated by Rocco Abate and Michael Fraunfelter, after a July 2026 website review found the company selling unapproved new drugs including Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, and BIMORELIN in violation of FD&C Act sections 301(d) and 505(a). The company marketed these injectable peptides with drug-intended-use claims while attempting to shield itself with 'research use only' disclaimers, which FDA rejected given accompanying human-administration resources like a peptide guide and calculator. FDA warned that failure to correct violations may result in seizure and injunction, and required a written response within 15 business days.
Flagged claims (12)
Tirzepatide has become a major focus of metabolic, endocrinology, obesity, and peptide science due to its unique activity at both the GLP-1 (Glucagon-Like Peptide-1) and GIP (Glucose-Dependent Insulinotropic Polypeptide) receptors.
Benefits of Retatrutide: Boosts metabolism by activating glucagon receptors[,] Enhances glucose control and insulin function[,] Leads to faster and more substantial weight loss than Tirzepatide[, and] Once-weekly dosing
PT-141, also called Bremelanotide (generic clinical name), is a heavily modified synthetic derivative of alpha-melanocyte-stimulating hormone. It has been tested in clinical trials as a treatment for hypoactive sexual desire disorder and acute hemorrhage.
Benefits of Tirzepatide: Enhances insulin sensitivity and glucose control[,] Reduces appetite and cravings[,] Promotes sustainable weight loss[, and] Once-weekly injection for convenience
PT-141: a melanocortin agonist for the treatment of sexual dysfunction
Early trials suggest that Retatrutide may result in up to 24.2% body weight reduction in just 48 weeks, making it one of the most effective weight loss peptides currently being studied.
BIMORELIN is a cutting-edge dual peptide blend combining Tesamorelin (10mg) and Ipamorelin (3mg) for advanced research into hormone modulation, body composition, and cellular recovery.
Tesamorelin and Ipamorelin are synthetic peptides frequently utilized in scientific research involving cellular communication, metabolic regulation, recovery pathways, tissue maintenance, and physiological performance studies.
Unlock dual research potential with Royal Peptides' Mix 10-Pack Kit, combining 5 vials of Tirzepatide 10mg and 5 vials of Retatrutide 10mg—two powerhouse GLP-1/GIP receptor agonists studied for their roles in metabolic and weight management research.
SS-31 (Elamipretide) is a breakthrough mitochondria-targeted tetrapeptide researched for its potential in reducing oxidative stress, enhancing cellular energy production, and supporting mitochondrial function.
Advanced Research Use: Mitochondrial repair, anti-aging, neuroprotection
In studies, Tirzepatide has led to up to 22.5% body weight reduction in participants over 72 weeks—comparable to or even better than Semaglutide (Wegovy, Ozempic).
Required actions (2)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "734884" in the subject line of the email.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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