FDA
What the FDA has said, listed or proposed: statements, category lists, notices and warning letters.
FDA is the agency behind most peptide headlines, but it does different things in different documents. It approves medicines, keeps lists that guide compounding, sends warning letters and issues statements. Mixing them up is how rumors start.
Approval means FDA reviewed a company's evidence for stated uses, and the approved label shows those uses. [V] FDA's compounding categories (1, 2 and 3) describe how FDA says it will treat compounders while it evaluates a substance. They are not approvals. [V] The category list we cite was posted May 14, 2026, and FDA's Category 2 page was current as of April 22, 2026. [V] Each post below says which kind of FDA document it covers and when we last checked it.
Evidence labels: [V] verified in a primary document, [S] secondary source. Reviewed October 25, 2026.
Posts in this topic
- FDA
- Advisory committee
- Policy
Where peptide regulation stands right now: a plain-English timeline
A plain-English timeline of peptide regulation as of October 25, 2026: what FDA documents show, what is only reported, and what is still pending.
- Wellness
- Evidence
- FDA
Peptides, in plain English: what they are, and why one word covers so much
What peptides are, how FDA draws the line between a peptide and a protein, and why the same word covers approved medicines and wellness-market products.
- Policy
- FDA
This week in peptide policy: October 19–25, 2026
A quiet week for official peptide and compounding actions, October 19-25, 2026, with the reported HHS interim policy still under White House review.
- Telehealth
- Legal
- FDA
Hims & Hers, the FTC and the FDA: who has actually said what about telehealth and compounded drugs
What the FTC and FDA have each said about telehealth companies and compounded drugs, from public documents, and what each does not cover.
- Wellness
- FDA
- Policy
From insulin to Ozempic: a timeline of how peptide medicines went from niche to mainstream
A dated timeline of how peptide medicines went from insulin to GLP-1 drugs, and how that changed the money, the FDA rules and public interest.
- Safety and quality
- Compounding
- Wellness
The glutathione injection recall: what FDA's October 1 notice says, and what it doesn't
FDA's Oct 1, 2026 notice on a compounded glutathione injection recall for possible endotoxin: what it says, what CDC and FDA add, what's unconfirmed.
- Compounding
- FDA
- Safety and quality
What FDA's "Category 1" and "Category 2" actually mean (and what they don't)
What FDA's Category 1 and Category 2 labels for compounded bulk substances mean, and what they do not mean, using FDA's own documents.
- Wellness
- FDA
- Compounding
"It's a peptide": three very different things hiding behind one word
Approved peptide medicines, compounded drugs and wellness-market peptides side by side: what FDA reviewed, what a label tells you, and what it does not.
Key terms in plain English
- Approval
- FDA's decision, after reviewing evidence, that a drug may be marketed for stated uses. See FDA's Step 4: FDA Drug Review. [V]
- Category 1, 2, 3
- Labels in FDA's interim policy for compounding substances that were nominated but are not on a bulks list. [V]
- Warning letter
- A written notice from FDA to a company about violations FDA says it found.
- Advisory committee
- Outside experts who advise FDA. Their votes are recommendations. See the Advisory Committee hub.
Primary sources behind this page
- FDA, Bulk drug substances used in compounding under section 503A (retrieved Oct. 25, 2026)
- FDA, Compounding categories list (PDF) (posted May 14, 2026)
- FDA, Category 2 page (current as of Apr. 22, 2026)
- FDA, Drug Development Process, Step 4: FDA Drug Review (retrieved Oct. 25, 2026)