LESSON 2 OF 2
Evidence grades and regulation
By the end you can
- Read the A–D evidence grades
- Explain what FDA approval does and doesn't cover
- Recognize compounding and sports rules
The A–D grades in Peptide Academy materials
A: an FDA-approved product containing the molecule is sold in the US. The grade describes the approved branded product only. B: larger controlled human trials (phase 2b or 3), approval by a major regulator outside the US, or a past FDA approval that was later withdrawn for business reasons. C: small, early or uncontrolled human studies. Approvals only in Russia count as C, because the studies behind them are small and major regulators haven't accepted them. D: animal or cell studies only, or single human case reports. Ungraded: no published research on that exact product, or a formula that isn't disclosed.
Blends and bundles are graded on research about the combination itself. When the combination has never been studied, it is graded D, because its ingredients' research doesn't transfer to the mix.
What approval covers
FDA approval applies to a specific manufactured product, for a specific use, at a specific quality. Semaglutide is approved as Ozempic, Wegovy (an injection and a pill) and Rybelsus (a tablet), not as research powder. Never suggest that a research product is "the same as" an approved drug.
Compounding and sport
The FDA keeps lists of bulk substances that pharmacies may or may not use to compound (mix) prescription drugs for patients. In July 2026 an FDA advisory committee voted to recommend allowing BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon, and voted against DSIP. In 2024 it voted against several, including ipamorelin, CJC-1295 and kisspeptin-10.
These votes are advice to the FDA, not final rules. They are about pharmacies making drugs for patients and say nothing about research-grade material. Status keeps changing, so check the latest before quoting it. Many peptides are also banned in competitive sport by the World Anti-Doping Agency (WADA).
Grade A: Approved US drug
An FDA-approved product is sold in the US; the grade covers that product only.
ExamplesSemaglutide, Tesamorelin
Grade B: Large trials or approval abroad
Phase 2b/3 trials, approval by a major regulator abroad, or a withdrawn past US approval.
ExamplesRetatrutide, Thymosin alpha-1
Grade C: Early human data
Small, early or uncontrolled human studies. Russia-only approvals count here.
ExamplesBPC-157, NAD+, Semax
Grade D: Animal or cell only
Or single human case reports.
ExamplesTB-500, MOTS-c, most blends
Ungraded
No published research on that exact product.
ExamplesAdamax, NA-Semax Amidate
Key terms
- Evidence grade
- The Academy's A–D rating of how strong the research on a product is.
- FDA approval
- Permission to market a specific product for a specific use.
- Compounding
- A pharmacy making a prescription drug for a patient from bulk ingredients, regulated by FDA lists.
- Advisory committee
- A panel of outside experts whose votes advise the FDA but don't decide anything.
- WADA
- The World Anti-Doping Agency, which bans many peptides in sport.
Remember
- A = approved US product, B = large trials or approval abroad, C = early human data, D = animal or cell only.
- Approval covers a specific branded product, not research material.
- Regulatory status changes; check before quoting it.