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Tag: FDA peptide regulation

Thymosin Alpha-1, Thymulin, and Thymalin: Three Thymic Substances, Three Different Things

    Quick answer: These three names get used interchangeably across the peptide market, and they should not be. Thymosin alpha-1 is a 28-amino-acid synthetic peptide. Thymulin is a 9-amino-acid synthetic peptide requiring zinc for activity. Thymalin is not a single peptide at all - it is a polypeptide complex extracted from calf thymus. Two […]

Epitalon and Semax: The Two Quietest Names on the FDA’s Peptide List

Quick answer: Both were recommended by the FDA’s advisory committee in July 2026, and both received a fraction of the coverage that BPC-157 and TB-500 did. They also share something more interesting than a vote: nearly their entire published record comes from a single national research tradition, which is exactly the criticism FDA staff raised […]

Research Use Only: What the Label Means, and Why It Didn’t Go Away in 2026

Quick answer: “Research use only” is a statement of intended use, not a disclaimer that protects a seller. Under federal law, what a product legally is depends on what the people selling it intend it for - and intent is judged by everything they say and do, not by the sentence at the bottom of […]

What’s Next for Peptide Regulation: The Compounds FDA Reviews Before February

Quick answer: In July 2026, an FDA advisory committee recommended six peptides - BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon - for the 503A Bulks List. Those votes were advisory, not binding, and nothing is authorized today. The more consequential news is what comes next: FDA has signaled it will review a second group, including […]

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