Kennedy says he will allow unapproved peptide injections

HHS policy directs FDA not to act against pharmacies selling the peptides

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday that he will allow access to unapproved peptide injections promoted by internet influencers, bypassing most Food and Drug Administration safeguards. A Health and Human Services Department policy posted Wednesday directs the FDA not to take action against pharmacies selling the covered peptides.

The HHS document said, “The secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.” Kennedy said the policy uses “enforcement discretion” to allow production without the usual approval process.

The New York Times reported that the plan bypasses FDA tests that determine whether drugs work better than placebos or cause cancer or birth defects. The Times also reported that the document suggested Kennedy’s move was unilateral and made without agreement from FDA scientists, some of whom had previously advised against the use of unapproved peptides.

Kennedy has said that he has benefited from using peptides, which are short chains of amino acids that give the body instructions. Some of the biggest figures in his Make America Healthy Again movement sell peptide injections and supplements.

FDA-approved and tested peptide compounds include insulin and diabetes treatments. The compounds covered by Wednesday’s document include products marketed to promote longevity and muscle repair.

The policy tells the FDA not to take action against pharmacies selling the peptides, which otherwise would be considered illegal drugs. The instruction applies enforcement discretion to those sales rather than the usual FDA approval process.

An HHS spokesperson said the policy confronts “the risks of black-market peptides” by giving people “a more controlled alternative.” The official statement said the regulatory change responds to safety concerns while the policy document separately cites patient choice and freedom.

Former FDA official Dr. Peter Lurie, now with the nonprofit Center for Science in the Public Interest, said FDA-approved and tested medications already exist for conditions the peptides are purported to help, NBC News reported.

“As people ‘are diverted from those drugs toward this stuff, there will be more unnecessary pain and suffering,’ Lurie said.”