Peptide boom hits US as regulators weigh loosening restrictions

The Food and Drug Administration will convene an external advisory panel in July to consider whether to reduce restrictions on more than half a dozen popular peptides.

The FDA’s action comes after Health Secretary Robert F. Kennedy Jr. publicly expressed support, saying on the Joe Rogan podcast that he is a “big fan of peptides” and has personally used them with “really good effect.”

Peptides are short chains of amino acids that help build proteins and regulate key body functions.

Their popularity has surged despite limited human testing. While some peptide-based drugs have FDA approval, many trending versions are untested injectables with little clinical evidence supporting their safety or effectiveness.

In 2023, regulators under the Joe Biden administration removed 14 peptides from the approved list of substances that compounding pharmacies could manufacture, citing risks including toxicity, immune reactions, and contamination.

However, seeing a surge in demand for injectable peptides, especially in the wellness market, many compounders started importing them from China and selling them online for tens to hundreds of dollars.

Marked “for research use only,” these products bypassed federal oversight, and peptide injections, claiming to help lose weight, improve skin, or build muscle, gained instant traction.

However, many claims about the benefits of peptides lack substantial research backing.

The head of the Alliance for Pharmacy Compounding said a sudden regulatory change without pharmaceutical-grade ingredients could create confusion.

The agency will meet with outside advisers to decide whether compounding pharmacies can produce several popular peptides, a decision that could reshape access to this fast-growing but loosely regulated market.