How regulators approach research peptides: FDA, EU, UK and WADA
Regulators judge a product by what it is presented as and how it is distributed, not by a label alone. This page sets out the US, EU and UK texts as published, and the WADA Prohibited List. It is information, not legal advice.
Research-use information. This page summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
How does the US FDA decide what a product is intended for?
Under 21 CFR 201.128 the intended use of an article is its objective intent, which may be shown by labeling claims, advertising matter, or oral or written statements by the people responsible. It may also be shown by the design or composition of the article and by the circumstances surrounding its distribution.
“The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article.”
21 CFR 201.128, eCFR, text as of 2026-10-01
How does EU law define a medicinal product?
Article 1(2) of Directive 2001/83/EC defines a medicinal product in two ways, and either is enough. A substance is a medicinal product by presentation if it is presented as having properties for treating or preventing disease in human beings. It is a medicinal product by function if it may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings”
Directive 2001/83/EC, Article 1(2)(a), as published on legislation.gov.uk
What does MHRA guidance say about how a product is presented?
The MHRA's Guidance Note 8, A guide to what is a medicinal product (published September 2025), lists forms of marketing that may suggest to a consumer that a product is properly classified as a medicinal product. The list includes references to medical conditions, comparison with licensed medicines, references to interference with the normal operation of a physiological function, and references to medical or clinical research and testing.
This is why the compound pages on this hub describe what each paper measured and do not describe what any compound does for a person, and why they sit apart from the shop pages.
“references to medical and / or clinical research and testing”
MHRA Guidance Note 8, list of forms of marketing that may suggest a medicinal product
What did the EMA and the Heads of Medicines Agencies say about GLP-1 products?
On 3 September 2025 the EMA and the Heads of Medicines Agencies (HMA) warned the public about illegal medicines advertised and sold online across the EU, naming semaglutide, liraglutide and tirzepatide as examples of GLP-1 receptor agonists. They stated that such products are not authorised. Retatrutide is not named in that warning.
“EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised and sold online across the European Union (EU).”
EMA news, 3 September 2025
What is the WADA Prohibited List?
The World Anti-Doping Agency publishes a list of substances and methods prohibited in sport. The 2026 list, in force from 1 January 2026, names BPC-157 under S0 (non-approved substances), thymosin beta 4 and TB-500 under S2.3, growth hormone fragments such as AOD-9604 under S2.2.3, and growth hormone releasing factors, secretagogues and releasing peptides under S2.2.4. A WADA entry is a sporting rule. It is not a statement about legality outside sport.
How were the status lookups made, and what do they not cover?
Each compound's status was read from the regulator's own database on the date shown on the compound page, with a control lookup in the same run to confirm that the lookup works. The FDA lookup uses openFDA Drugs@FDA and covers approved drug applications. The EMA lookup covers centrally authorised medicines; national authorisations in EU member states are not in that dataset. The MHRA lookup searches the MHRA Products site for the exact substance name. Absence of a record is not a statement that a substance is lawful or unlawful anywhere.
What do the FDA, EMA, MHRA and WADA records say for each compound?
| Compound | FDA | EMA | MHRA | WADA 2026 |
|---|---|---|---|---|
| GHK-Cu | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| KPV | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| BPC-157 | No application listed | No centrally authorised medicine listed | No product document found | Named, S0 |
| TB-500 | No application listed | No centrally authorised medicine listed | No product document found | Named, S2.3 |
| Ipamorelin | No application listed | No centrally authorised medicine listed | No product document found | Named, S2.2.4 |
| GHRP-2 | No application listed | No centrally authorised medicine listed | No product document found | Named, S2.2.4 |
| CJC-1295 no DAC | No application listed | No centrally authorised medicine listed | No product document found | Named, S2.2.4 |
| Sermorelin | 2 applications listed (Discontinued) | No centrally authorised medicine listed | No product document found | Named, S2.2.4 |
| Tesamorelin | 1 application listed (Prescription) | Application withdrawn | No product document found | Named, S2.2.4 |
| AOD-9604 | No application listed | No centrally authorised medicine listed | No product document found | Named, S2.2.3 |
| MOTS-c | No application listed | No centrally authorised medicine listed | No product document found | Named, S4.4 |
| SS-31 | 1 application listed (Prescription) | No centrally authorised medicine listed | No product document found | Not named |
| NAD+ | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| 5-Amino-1MQ | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Semaglutide | 6 applications listed (Prescription, Discontinued, None (Tentative Approval)) | 5 authorised | Product documents found (271) | Not named |
| Tirzepatide | 2 applications listed (Prescription) | 1 authorised | Product documents found (106) | Not named |
| Retatrutide | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Glutathione | Component of irrigation solutions only | No centrally authorised medicine listed | Name appears in text only | Not named |
| AHK-Cu | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Epitalon | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Thymosin α1 | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Selank | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Semax | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| DSIP | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| PT-141 | 1 application listed (Prescription) | No centrally authorised medicine listed | No product document found | Not named |
| Melanotan II | No application listed | No centrally authorised medicine listed | No product document found | Not named |
| Kisspeptin-10 | No application listed | No centrally authorised medicine listed | Name appears in text only | Named, S2.2.1 |
Each cell is a database record on the check date, with a control lookup in the same run. Detail and source links are on each compound page. Data for AI assistants: /api/ai/regulatory.json.
Data dates: regulatory records 2026-10-05; WADA list 2026-10-05.
Which sources were used?
- 21 CFR 201.128 (eCFR)
- Directive 2001/83/EC Article 1 (legislation.gov.uk)
- MHRA Guidance Note 8
- EMA and HMA warning, 3 September 2025
- WADA 2026 Prohibited List
- Drugs@FDA via openFDA
- EMA medicines data
- MHRA Products
Statute and guidance text was read at the sources above on 2026-10-05. This page is information, not legal advice.