Peptide and GLP-1 Enforcement Tracker: Every FDA Letter, DOJ Case and Lawsuit, 2025 to 2026
This page is a running, dated record of enforcement and regulatory actions against companies that sell research peptides and GLP-1 drugs in the United States: FDA warning letters, Department of Justice cases, lawsuits brought by drug manufacturers, state attorney general actions, and FDA proposals or advisory votes that change what can be sold or compounded. It covers April 2025 to 25 September 2026 and currently lists 25 entries, newest first. Each row links to the document it rests on.
How entries are sourced. An action is listed only if the Bureau could open a primary source for it: the FDA's warning-letter database or press pages at fda.gov, a justice.gov press release, a state attorney general's release, or the company's own investor release. Where no primary page exists or it does not carry the fact in question (for example, advisory committee tallies), a named major outlet is cited instead. Every source link was fetched live on 25 September 2026. Anything the Bureau could not verify against a source with a date on it is left out, and the omissions are listed at the end of the page. The date in the first column is the date on the document; where the FDA published a letter later, the posting date is given in the row.
Disclosure. Peptide Bureau earns affiliate commission from some research-peptide vendors; the terms are on the disclosures page. Vendors appear in this tracker on the strength of the public record alone, whether or not the Bureau has any relationship with them. As of this update, none of the vendors the Bureau scores appears in the table.
The tracker: 25 actions, newest first
| Date | Who | Action type | What it says | Source |
|---|---|---|---|---|
| 2026-09-18 | Empower Clinic Services, LLC dba Empower Pharmacy (Houston, Texas) | FDA warning letter | The FDA says the 503A pharmacy compounded semaglutide and tirzepatide products that were essentially copies of approved drugs in inordinate amounts, called the claimed differences "pretextual" given the volume, and cited insanitary conditions found at a November 2025 inspection. Posted 22 September. | FDA letter 738238; CBS News, 24 Sept 2026 |
| 2026-08-24 | TXP Innovations LLC dba Tex Peptides (Dallas, Texas) | FDA warning letter | Semaglutide, tirzepatide, retatrutide, SS-31, tesamorelin, PT-141 and bacteriostatic water sold as research products are unapproved new drugs, because the website shows they are intended for human use. Posted 1 September. | FDA letter 735067 |
| 2026-08-24 | Royal Peptides LLC | FDA warning letter | Tirzepatide, semaglutide, retatrutide, SS-31, PT-141, tesamorelin and a product listed as "BIMORELIN" are unapproved new drugs; the letter cites bacteriostatic water sold alongside a "peptide guide" and "peptide calculator" as evidence of intended human use. Posted 1 September. | FDA letter 734884 |
| 2026-08-24 | Peptide Partners LLC (Sarasota, Florida) | FDA warning letter | Coded GLP-1 S, GLP-2 T and GLP-3 Reta (semaglutide, tirzepatide, retatrutide), SS-31, tesamorelin, PT-141 and a reconstitution solution are unapproved new drugs despite research-use-only labels. Posted 1 September. | FDA letter 735063 |
| 2026-08-24 | Peak Performance Peptides | FDA warning letter | Bac water, GLP-3R (retatrutide), semaglutide, SS-31, PT-141 and tesamorelin are unapproved new drugs; selling bacteriostatic water as a solvent is cited as providing the means to prepare an injectable drug. Posted 1 September. | FDA letter 735127 |
| 2026-08-24 | NuScience Peptides LLC | FDA warning letter | Tirzepatide, semaglutide, retatrutide, survodutide, mazdutide, PT-141, tesamorelin, a tesamorelin and ipamorelin blend and BAC water are unapproved new drugs; the letter cites bacteriostatic water sold alongside a "peptide calculator". Posted 1 September. | FDA letter 733652 |
| 2026-08-12 | Eli Lilly and Company v. Aesthetic Envy, Astra Peptides, Legendary Peptides, Striker Pharmacy, Texas Peptides, Lone Star Peptide | Lawsuit (manufacturer) | Lilly filed six federal lawsuits in California and Texas against sellers of retatrutide, an investigational drug not approved anywhere, and said it has referred more than 200 individuals and entities to the FDA, DOJ, state attorneys general and licensing boards. | Lilly news release; CBS News, 12 Aug 2026 |
| 2026-07-30 | Paradigm Peptides: Matthew J. Kawa and Jennifer L. Stechkober (US Attorney, N.D. Indiana) | DOJ case (sentencing) | The owner was sentenced to 70 months and his sister to 16 months after pleading guilty to introducing unapproved new drugs into interstate commerce with intent to defraud and mislead, with a $5 million money judgment against Kawa; CBS reported he admitted forging laboratory certificates. | DOJ press release; CBS News, 30 July 2026 |
| 2026-07-23 to 24 | FDA Pharmacy Compounding Advisory Committee | FDA advisory vote | The committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon for the 503A bulks list while emideltide (DSIP) failed 6 to 7; FDA staff had recommended against each one, and the votes are not binding. | FDA meeting page; STAT, 24 July 2026; Bureau analysis |
| 2026-06-17 | Wholesale Peptide (Brooksville, Florida) | FDA warning letter | Prostamax and gonadorelin sold as "research use only" are unapproved new drugs because the product labeling and website show they are intended for human use. Posted 23 June. | FDA letter 729447 |
| 2026-06-16 | 25 telehealth companies | FDA warning letters (batch) | The FDA posted warning letters to 25 telehealth companies over their marketing of compounded GLP-1 drugs, including semaglutide and tirzepatide products. | RAPS Regulatory Focus, 16 June 2026 |
| 2026-04-30 | FDA | FDA proposal | The FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk substances, with comments due 29 June 2026. | FDA press announcement |
| 2026-04-01 | Justin Bradley Watkins, osteopathic physician (US Attorney, District of Utah) | DOJ case (indictment) | A federal grand jury indicted a Utah physician accused of buying unapproved peptides from China, including tirzepatide, semaglutide, retatrutide and BPC-157, and selling them to more than 200 patients; an indictment is an allegation, not a finding of guilt. | DOJ press release |
| 2026-03-31 | Gram Peptides (Rancho Santa Fe, California) | FDA warning letter | Retatrutide (sold as "GLP-1-R peptide"), tirzepatide and bacteriostatic water for injection are unapproved new drugs despite "Research Use Only" labels. Posted 7 April. | FDA letter 721806 |
| 2026-03-31 | Lovega LLC dba Pink Pony Peptides (Wellington, Florida) | FDA warning letter | "GLP-2 TZ," "GLP-3 RT" and bacteriostatic water are unapproved new drugs intended for human use. Posted 7 April. | FDA letter 721088 |
| 2026-03-31 | PekCura Labs (Pensacola, Florida) | FDA warning letter | "GLP-1-S," "GLP-2-T," "GLP-3-R" and bacteriostatic water are unapproved new drugs intended for human use. Posted 7 April. | FDA letter 721709 |
| 2026-03-31 | Prime Sciences (Scottsdale, Arizona) | FDA warning letter | Cagrilintide, "GLP1-R," "GLP1-S," "GLP1-T," mazdutide and BAC water sold in a reconstitution kit are unapproved new drugs intended for human use. Posted 7 April. | FDA letter 721805 |
| 2026-03-31 | Mile High Compounds LLC (Clifton, Colorado) | FDA warning letter | "GLP-1 SM," "GLP-2 TRZ," "GLP-3 RT" and BAC water are unapproved new drugs; the FDA reviewed both the website and the company's linked community forum. Posted 7 April. | FDA letter 721600 |
| 2026-03-03 | 30 telehealth companies | FDA warning letters (batch) | The FDA announced 30 warning letters to telehealth companies for false or misleading claims about compounded GLP-1 products on their websites. | FDA press announcement |
| 2026-02-06 | FDA and HHS; Hims & Hers | FDA statement and DOJ referral | The FDA said it would restrict GLP-1 active ingredients used in mass-marketed, non-approved compounded drugs, and the HHS general counsel said he had referred Hims & Hers to the Justice Department over its plan to offer a compounded version of a weight-loss pill. | STAT, 6 Feb 2026 |
| 2025-09-09 | Hims & Hers Health, Inc. dba Hims | FDA warning letter | Website claims such as "Same active ingredient as Ozempic and Wegovy" for compounded semaglutide are false or misleading and make the products misbranded. Posted 16 September 2025. | FDA letter 716567 |
| 2025-09-09 | GLP-1 Solution (online seller, Berlin address) | FDA warning letter | Retatrutide sold to US consumers online is an unapproved new drug and misbranded; the site also offered compounded semaglutide and tirzepatide. Posted 16 September 2025. | FDA letter 715883 |
| 2025-08-05 | Connecticut Attorney General; Triggered Brand | State AG settlement | Triggered Brand agreed to stop selling "research grade" GLP-1 drugs, resolving the state's May lawsuit, with a $300,000 judgment suspended after $18,500. | Connecticut AG release |
| 2025-05-21 | Connecticut Attorney General; Triggered Brand; Made In China | State AG lawsuit | The attorney general sued Florida-based Triggered Brand under the Connecticut Unfair Trade Practices Act for selling "research grade" GLP-1 peptides to consumers without prescriptions, and issued a civil investigative demand to the Made In China marketplace. | Connecticut AG release |
| 2025-04-23 | Eli Lilly and Company v. Mochi Health, Willow Health, Fella Health and Delilah, Henry Meds | Lawsuit (manufacturer) | Lilly sued telehealth companies selling compounded tirzepatide, alleging, in Mochi Health's case, that patients were switched to versions with additives such as niacinamide. | NPR, 23 Apr 2025 |
By type: 14 individual FDA warning letters, 2 FDA announcements covering 55 further letters to telehealth companies, 1 FDA proposal, 1 FDA advisory vote, 1 FDA statement with an HHS referral to the DOJ, 2 DOJ criminal cases, 2 rounds of manufacturer lawsuits against 10 defendants, and 2 state attorney general actions.
What the pattern shows
Research-use-only labels have not worked as a defence. All eleven 2026 letters to research-peptide sellers in the table (the five in March, Wholesale Peptide in June and the five in August) use the same construction: despite labels such as "for research use only" or "not for human consumption," the FDA says evidence on the website shows the products are intended to be drugs for human use. Ten of the eleven name bacteriostatic water, either as a product in its own right or as evidence that the seller was supplying the means to prepare an injection. The August letters to Royal Peptides and NuScience go a step further and cite a "peptide calculator" on the seller's site.
The product list widened. The March letters dealt almost entirely with GLP-class compounds sold under coded names (GLP-1 S, GLP-2 T, GLP-3 R). The June letter applied the same template to gonadorelin and Prostamax, and by August the letters also covered SS-31, PT-141, tesamorelin and a tesamorelin and ipamorelin blend.
Letters now arrive every few months. In 2026 the FDA dated batches of letters to peptide or GLP-1 sellers on 31 March, 17 June, 24 August and 18 September, and announced telehealth batches on 3 March and 16 June. Each letter to a named seller carries an FDA posting date four to eight days after the date on the letter.
Enforcement is no longer only letters. 2026 added a criminal sentence of 70 months for a research-peptide vendor, a federal indictment of a physician for selling imported peptides to patients, six lawsuits by Lilly over retatrutide, and an HHS referral of a listed telehealth company to the DOJ. The 2025 Connecticut case shows state attorneys general using consumer-protection law against "research grade" GLP-1 sellers.
Compounding is moving in two directions. For GLP-1 drugs the FDA is closing doors: the April 2026 proposal would keep semaglutide, tirzepatide and liraglutide off the 503B bulks list, and the Empower letter, which CBS News described as the first time the FDA has waded into when customising a medication becomes mass-copying, targets a 503A pharmacy. For a group of older research peptides the advisory committee voted the other way in July, though no rule has followed and FDA staff opposed every one. The Bureau's PCAC vote analysis sets out what that vote does and does not change, and the legal status guide explains the underlying law.
What is not in the table, and why
Peptide Sciences, one of the best-known research-peptide storefronts, posted a notice saying it had voluntarily shut down operations. It is omitted because the Bureau found no primary document or major-outlet report that fixes the date; the notice itself is undated and the widely repeated 6 March 2026 date comes from trade blogs and law-firm posts. Other vendor closures in the same period (Science.bio, Strate Labs, Amino Asylum) are left out because their only sources are the vendors' own notices or trade sites, which fall outside the sourcing rule above. The Bureau's vendor shutdowns page records what those notices say. The tracker also does not list letters the FDA has not posted, private civil suits between competitors, or the 2025 telehealth letter wave beyond the two September 2025 letters whose pages the Bureau opened.
How to cite this page
The table is published under a Creative Commons Attribution 4.0 licence: you may reproduce, chart or adapt it, including commercially, with credit to Peptide Bureau and a link to this page. Suggested citation:
Peptide Bureau, "Peptide and GLP-1 Enforcement Tracker," updated 25 September 2026, https://peptidebureau.com/peptide-enforcement-tracker.html
The permalink above will not change when entries are added. Each row also has its own anchor, formed from its date and name, for example https://peptidebureau.com/peptide-enforcement-tracker.html#2026-09-18-empower-pharmacy. For the underlying facts, cite the primary source linked in each row as well.
Corrections
If a date, name or summary here is wrong, or you know of a verifiable action that is missing, email [email protected] with a link to the source. Corrections are dated on this page.
This page reports public enforcement records. It is not legal or medical advice, and a warning letter or lawsuit is an allegation by the agency or company that issued it, not a court finding, unless the row says otherwise.