FDA warned three peptide sellers over tirzepatide and retatrutide products
The letters show how FDA is targeting online sellers of tirzepatide and retatrutide labeled for research use, not for people.
The Food and Drug Administration sent warning letters dated March 31, 2026 to three companies that sell peptide products online, telling each that the products it offers are unapproved new drugs under the federal Food, Drug, and Cosmetic Act [1]. The letters name Lovega LLC, doing business as Pink Pony Peptides, of Wellington, Florida; Gram Peptides, of Rancho Santa Fe, California; and Mile High Compounds LLC, of Clifton, Colorado [1]. The nonprofit Partnership for Safe Medicines collected the letters into a compilation dated April 7, 2026 [1].
The Pink Pony Peptides letter, identified as MARCS-CMS 721088, says FDA reviewed the company's website in December 2025 and found it offering "GLP-2 TZ," "GLP-3 RT" and "Bacteriostatic Water" for sale in the United States [1]. The letter states that the page for "GLP-2 TZ" described tirzepatide as a dual GIP and GLP-1 receptor agonist that helps "reduce appetite and increase satiety," "enhance insulin sensitivity and glucose control" and "support fat loss over time with clinical precision" [1]. The page for "GLP-3 RT" described retatrutide as an agonist at the GIP, GLP-1 and glucagon receptors that helps the body "torch fat, suppress appetite, regulate blood sugar, and even improve metabolic function" [1]. Those product names are the seller's own labels, not drug names recognized by FDA.
The Gram Peptides letter, MARCS-CMS 721806, says FDA reviewed that company's website from January to March 2026 and found it selling "Retatrutide" (also called "GLP-1-R peptide"), "Tirzepatide" (also called "GLP-2 peptide") and "Bacteriostatic Water for Injection" [1]. Quoted site text says the retatrutide product "influences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models," and that the tirzepatide product is "associated with significant decreases in body weight in both animal and human studies" [1].
Both letters say the companies labeled the products for laboratory research only or said they were not for human consumption, but that other statements on the same websites showed the products were intended for human use, making them drugs [1]. FDA also said that selling bacteriostatic water alongside peptides that require reconstitution before injection shows the water is meant to be used with them, so it is a drug too [1]. The agency said none of the products has an approved application, and that injectable products are of special concern because they go directly into the body and bypass some of the body's defenses against toxins and microorganisms, which can lead to serious and life-threatening conditions [1]. The Mile High Compounds letter, MARCS-CMS 721600, carries the same date and lists the company and its Colorado address; the products it covers are not identified in the entry for that firm [1].
Why it matters for patients
People deciding between a prescription GLP-1 medication and a cheaper peptide bought online may see labels such as "research use only" and assume the products have been checked. These letters show FDA's position that those labels do not change how the products are being marketed or sold, and that no approved applications are in effect for them [1]. FDA's stated concern is not about tirzepatide or retatrutide as molecules, but about specific products sold by specific sellers without agency review of their identity, strength, purity or sterility [1]. A warning letter is not a recall or a court order, and the letters do not say whether any of the companies stopped selling the products.
What happens next
Each letter gives the company 15 working days from receipt to write back to FDA's Center for Drug Evaluation and Research describing the steps taken to correct the violations and prevent repeats, or explaining why the company believes it is not in violation [1]. FDA said failure to address the matter may lead to regulatory or legal action, including seizure and injunction [1]. The letters are signed by Tina Smith, M.S., a captain in the U.S. Public Health Service and director of the Office of Unapproved Drugs and Labeling Compliance [1]. Whether any of the three companies has responded has not been disclosed [1].
Sources
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