FDA warning letters name tirzepatide sold by three online peptide sellers
Three online sellers of peptide vials were told by the FDA their tirzepatide, semaglutide and retatrutide products are unapproved drugs that cannot be shipped across state lines.
The Food and Drug Administration posted warning letters dated Aug. 24, 2026 to three online peptide sellers, telling each that the products it sells are unapproved new drugs. The lists include tirzepatide, the molecule in Mounjaro and Zepbound, and semaglutide, the molecule in Ozempic, Wegovy and Rybelsus [1][2][3].
The recipients are NuScience Peptides LLC of Cornelius, North Carolina [1]; Royal Peptides LLC of Boynton Beach, Florida [2]; and TXP Innovations LLC, doing business as Tex Peptides, of Dallas [3]. All three letters came from the FDA's Center for Drug Evaluation and Research and were signed by Tina Smith, M.S., a captain in the U.S. Public Health Service who directs the agency's Office of Unapproved Drugs and Labeling Compliance [1][2][3].
What the letters list
NuScience Peptides drew citations for nine items: "GLP-2 Tirz Peptide," "GLP-1 Sema Research Peptide," "GLP-3 RT (Retatrutide) Research Peptide," "Survodutide," "Mazdutide," "PT-141 Peptide (Bremelanotide)," "Tesamorelin Research Peptide," "Tesamorelin Ipamorelin Blend" and "Bacteriostatic water for Peptides (BAC Water)" [1].
Royal Peptides drew citations for seven: "Tirzepatide," "Semaglutide," "Retatrutide," "SS-31 (Elamipretide)," "PT-141," "Tesamorelin" and "BIMORELIN" [2]. One quoted page compared tirzepatide and retatrutide for weight loss, attributing "up to 22.5% body weight reduction in participants over 72 weeks" to tirzepatide and "up to 24.2% body weight reduction in just 48 weeks" to retatrutide [2]. The site also sold a kit pairing five vials of tirzepatide 10 mg with five vials of retatrutide 10 mg [2].
Tex Peptides drew citations for seven: "Semaglutide (GLP-1 SEM)," "Tirzepatide (GLP-2 TRZ)," "Retatrutide (GLP-3 RT)," "SS-31 (Elamipretide)," "Tesamorelin," "PT-141 (Bremelanotide)" and "Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)" [3].
Why FDA treats the vials as drugs
Each site carried disclaimers describing its products as intended only for laboratory or research work and not for human or veterinary use. FDA wrote that other content on the same websites showed the products were meant for people. The cited evidence included claims about managing obesity, type 2 diabetes and other conditions, and the sale of bacteriostatic water next to a peptide calculator or peptide guide, which the agency described as providing the means to prepare an injectable drug for human administration [1][2][3].
A product the FDA considers a "new drug" needs an approved application on file before it can be shipped between states. According to the letters, none of the named products has one, and they are not generally recognized as safe and effective for the uses described in their labeling [1][2][3].
FDA said injectable products raise particular concern because they enter the body directly, sometimes into the bloodstream, bypassing some of the body's defenses against toxins and microorganisms [1][2][3]. The letters do not report laboratory testing that found contamination in these products, and they do not describe any patient being harmed. The allegations concern how the products were labeled, marketed and sold.
Why it matters for patients
Buyers sometimes assume a "research use only" label puts a peptide outside drug rules. These letters show FDA reading the whole website, including product claims and the sale of supplies for mixing injections, and treating the vials as human drugs when the surrounding pages point that way [1][2][3].
The tirzepatide and semaglutide named here are not the FDA-approved brand products. The letters do not say whether any of the three companies holds a pharmacy license, who manufactured the vials, or whether the contents matched the labels. None of that has been disclosed.
FDA has not announced a recall of any of these products, and it has not said what customers should do with vials they already have. How much was sold, to how many people, and whether any of it reached patients has not been reported [1][2][3].
What happens next
Each company has 15 business days from receiving its letter to reply by email to FDAAdvisory@fda.hhs.gov, using the reference number in the subject line: 733652 for NuScience Peptides [1], 734884 for Royal Peptides [2] and 735067 for Tex Peptides [3]. The responses are supposed to describe steps taken to fix the violations and prevent repeats, with supporting documents.
FDA said failing to address the violations may bring regulatory or legal action without further notice, including seizure and injunction [1][2][3]. FDA posts warning letters on its website [1]. Whether any of the three companies has answered has not been reported.
Sources
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026
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