HHS eases restrictions on certain unapproved peptides

Health and Human Services is advancing a policy advancing licensed pharmacies and physicians to compound some unapproved peptides as regulators determine whether to allow their use in compounded medicines. 

HHS Secretary Robert F. Kennedy has advocated for wider access to peptides and has hinted at the possibility of the Food and Drug Administration lifting restrictions on them.

HHS policy on unapproved peptides

Dig deeper:

Reuters reported that the federal agency’s policy allows compounding of six peptides, like BPC-157 and TB-500 — often taken together in a combination known as the "Wolverine stack" without concern of backlash from the Food and Drug Administration. 

The other peptides are epitalon for insomnia, KPV for ​wound healing and inflammatory conditions, MOTS-c for obesity and osteoporosis, and Semax for migraines and persistent pain.

RELATED: What are peptides? FDA may ease restrictions on unproven health fad

Referencing the Health and Human Services policy, Reuters noted that the federal agency would not take enforcement action against compounders that manufacture some peptides if they meet standards on ingredient quality, manufacturing requirements, safety reporting, labeling and patient-specific prescriptions.

Peptides have gained popularity in the past year, in part with support from wellness influencers based on uses including anti-aging to muscle recovery and tissue repair.

What they're saying:

According to Reuters, HHS officials said the policy ​will deter the rampant use ​of certain research-use-only peptides supplied ⁠by foreign manufacturers that pose a safety risk to patients in the United States and improve patient access.

The agency added that "There is significant interest in the use of these peptides in compounding given the lack of approved products," describing it as an interim policy.

What are peptides? 

Big picture view:

Peptides are short chains of amino acids in the body that perform essential functions. Dr. Melinda Ring, director of the Osher Center for Integrative Health at Northwestern University Feinberg School of Medicine, said the body naturally produces thousands of peptides, regulating "everything from hormone signaling to immune response and tissue repair."

 

HealthU.S.