RFK Jr. takes shortcut to make some unapproved peptides available for use

The Department of Health and Human Services is giving compounding pharmacies a temporary green light to make six peptides while the agency continues to work on a formal rule change.

In a notice filed Wednesday, the agency said it would exercise “enforcement discretion,” meaning it will not take legal action against compounding pharmacies that make the six unapproved peptides. In practice, that means these pharmacies can start offering them now, even though the peptides aren’t yet on the Food and Drug Administration’s list of ingredients compounding pharmacies are allowed to make.

The six peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500.

They’ve been promoted online as treatments for everything from faster healing to younger-looking skin and a longer lifespan. None are approved by the FDA, and the agency’s own scientists concluded there is insufficient data to prove they are safe and effective.

The FDA said compounding pharmacies must certify the identity and purity of the compounds. They must also now report side effects, which was not previously mandated.

The move comes as a growing “gray market” has sprung up around peptides, where retailers sell them labeled “for research use only,” a legal workaround that lets them claim they aren’t…

Original source: https://www.nbcnews.com/health