United States Considers Peptide Reclassification

A regulatory update announced in February 2026 could impact the advancement of peptide-based therapies in the United States. HHS Secretary Robert F. Kennedy Jr. stated that the U.S. Food and Drug Administration is considering moving 14 peptides currently classified under Category 2 to Category 1 within its regulatory system.

If confirmed, the change would allow these substances to be prescribed by licensed physicians and prepared by compounding pharmacies under specific regulatory guidelines. Until now, the previous classification has limited the production of and access to these compounds.

Which peptides are on the list?

Among the peptides mentioned are BPC-157, Epitalon, CJC-1295, GHRP-2, GHK-Cu, GHRP-6, Ipamorelin, Kisspeptin-10, Melanotan II, PEG-MGF, MOTS-C, Thymosin beta-4, and Selank acetate. Several of these compounds have been under investigation for their potential in processes such as tissue regeneration, cellular recovery, and metabolic regulation.

Tackling the gray market

The initiative also aims to reduce the so-called “gray market,” in which these substances are often sold irregularly online. By allowing them to be compounded within a regulated environment, the proposal seeks to increase control over quality, purity, and dosage.

And what about Brazil?

While the debate moves forward in the United States, the landscape in Brazil remains different. Brazil’s National Health Surveillance Agency (ANVISA) maintains strict regulations, and many of these peptides still lack authorization for human use in the country.

This shift comes amid a broader transformation in modern medicine, as new therapeutic approaches begin to move from scientific research into the center of regulatory and clinical discussion.