General Tech

Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

Health Secretary Robert F. Kennedy has unilaterally granted access to six unproven peptides, popular among members of his Make America Health Again movement, by issuing an 'Enforcement Discretion Policy' that allows specialty pharmacies to sell them despite FDA scientists' concerns about their safety and efficacy. The peptides in question are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. The FDA had removed them from a list of approved compounds in 2023 due to safety concerns. The rule does not change the regulatory status of the peptides, but rather signals that the Department of Health and Human Services will not take enforcement action against compounding pharmacies that produce and sell them. The rule was made available on the Federal Register on October 30, with a more detailed explanation of the policy posted by HHS, citing the FDA advisory panel's July vote to add the peptides back to the list of approved compounds. However, the panel's vote was preceded by Kennedy's stacking of the committee with members favorable to his views.

Read the full article at arstechnica.com →