RFK Jr. May Reverse a Peptide Ban He Calls “Illegal.” Former FDA Officials Say He Mischaracterized Their Work.

Health and Human Services Secretary Robert F. Kennedy Jr. is poised to reverse the FDA's 2023 decision to ban 19 peptides from compounding pharmacies, arguing the agency acted illegally by assessing efficacy rather than just safety. Three former FDA officials dispute Kennedy's characterization, stating the 2023 ban was supported by documented safety concerns—including risks of immune reactions ranging from rashes to anaphylactic shock—and that FDA regulations require assessing both safety and effectiveness before approving substances for compounding. Kennedy has described himself as a "big fan" of peptides and has used them personally, but there have been few clinical studies supporting their safety or effectiveness. The demand for these unapproved peptides has exploded via social media and wellness spas, with a notable incident in Las Vegas last year in which two women became critically ill after receiving FDA-banned peptides, though investigators couldn't determine the exact cause. Kennedy has not yet specified which peptides he intends to make available or how the FDA will proceed, but former FDA acting commissioner Janet Woodcock noted the HHS secretary has broad authority to declare the ingredients legal unilaterally.