RFK Jr. to Allow Broad Use of Unapproved Peptide Injections

Health and Human Services Secretary Robert F. Kennedy Jr. said on Wednesday that he would allow widespread patient access to unapproved peptide injections made popular by internet influencers, sparking serious concern among drug safety experts.

The plan would bypass the most standard Food and Drug Administration safeguards for approving drugs, such as tests to see if the compounds work better than a placebo and whether they might cause cancer or birth defects. To do so, Mr. Kennedy announced “enforcement discretion,” meaning he will tacitly allow companies to produce the unproven injections without going through the usual review process.

Mr. Kennedy, who has said publicly that he has benefited from using peptides, propelled the matter forward, declaring on podcasts early this year that the F.D.A. would lift restrictions to widespread use.

But in a highly unusual turn of events, the document released Wednesday suggested that his action was unilateral and couched the decision as Mr. Kennedy’s alone. F.D.A. scientists previously advised against widespread use of the peptides, and none were present in at least one meeting Tuesday finalizing the policy.

“The secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety,” the document posted on the H.H.S. website said.

Emily Hilliard, a spokeswoman for the Department of Health and Human Services, said the new policy requires “patient-specific prescriptions, traceable ingredients, quality testing and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”