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For reporters & the curious

The primary-source document library

The paper trail behind the peptide story, in one place: the FDA's own actions and briefing documents, the federal docket, and peer-reviewed safety research. These are primary sources - please read and cite the originals. We add to this as the record grows.

FDA actions & safety communications

Certain Bulk Drug Substances That May Present Significant Safety Risks ("Category 2")

The FDA's interim-policy list; several nominated peptides sit here with the agency's stated safety concerns (immunogenicity, peptide impurities, limited human safety data).

FDA / CDER · interim policy

Bulk Drug Substances Used in Compounding Under Section 503A

The FDA landing page explaining how the 503A bulks list and its categories work - the framework the July 2026 review sits inside.

FDA / CDER

FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

States that drugs like retatrutide and cagrilintide cannot be lawfully compounded, and reports hundreds of adverse-event reports tied to compounded semaglutide and tirzepatide.

FDA / CDER

FDA Alert: Dosing Errors with Compounded Injectable Semaglutide

Documents hospitalizations from patients self-administering 5-20× the intended dose from multi-dose vials - a concrete example of the safety gap.

FDA / CDER

Warning Letter - GLP-1 Solution (Sept 9, 2025)

Cites an online seller offering retatrutide, semaglutide and tirzepatide as unapproved new and misbranded drugs.

FDA Warning Letter 715883

Warning Letter - USApeptide.com (Feb 26, 2025)

Targets "research use only / not for human consumption" labeling on peptides sold to consumers - the exact grey-market dodge.

FDA Warning Letter 696885

The regulatory process

PCAC Meeting - July 23-24, 2026 (agenda + all FDA briefing documents)

The official meeting page: the seven peptides under review, the uses evaluated, and downloadable FDA scientific briefing documents for each.

FDA Advisory Committees

Federal Register - Notice of Meeting & Public Docket (FDA-2025-N-6895)

The authoritative process document establishing the meeting and the public comment docket.

Federal Register / FDA · 91 FR 20465 · Apr 16, 2026

Regulations.gov Docket FDA-2025-N-6895

The public docket where comments and background documents for the peptide review are posted.

Regulations.gov (eRulemaking)

Peer-reviewed safety evidence

Multifactor Quality & Safety Analysis of Semaglutide Sold Online Without a Prescription

Market-surveillance study of no-prescription online semaglutide; found measured purity far below label claims and quality-control failures.

JMIR, 2024;26:e65440

Purity & Heavy-Metal Analysis of Falsified Peptide Products

Independent testing found purity from roughly 5-75% and arsenic and lead above injectable-drug limits in falsified peptide products.

Janvier et al., Talanta, 2018

Background coverage (journalism - secondary, not primary)

The wellness world is eager for RFK Jr.'s promised move on peptides

Context on the policy push behind the review. Reported news, not a government document.

NPR · Mar 31, 2026

FDA to weigh easing limits on unproven peptides

Overview of the advisory-committee review and the science debate around it.

PBS NewsHour · 2026

Every link above resolves to its issuing organization. Peppies is independent and unaffiliated with the FDA; background-coverage items are clearly labeled as journalism, not primary sources. If a link ever breaks, tell us and we'll fix it.

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