Outrage of the Month: The FDA, Peptides and RFK Jr.
Health Letter, May 2026
By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group
If you’re not outraged, you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
On July 23 and July 24, 2026, the Food and Drug Administration (FDA) will hold a public meeting of the Pharmacy Compounding Advisory Committee to discuss easing restrictions on seven peptides that the agency removed three years ago from a list of bulk drug substances that compounding pharmacies can use. At a later meeting, the committee will consider wider access to an additional five peptides that were also banned in 2023.
Peptides are a favorite of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, who has used them to treat his own injuries. They are also championed by many health and wellness influencers. They are short chains of amino acids, usually administered by injection (under the skin or into a vein). Since pressure to broaden access to peptides comes directly from the HHS secretary, the FDA will have to decide whether to stand up for science or acquiesce to Kennedy’s wishes.
There is no credible reason to believe that peptides deemed unproven or unsafe in 2023 are now miraculously safe and effective. If convincing data on the safety and effectiveness of any of the 12 peptides had emerged in recent years, such findings would already be widely known.
Unapproved peptides are touted for wound healing, inflammation, insomnia and many other uses. Some are approved as drugs based on clinical research, including insulin and glucagon-like peptide-1 (GLP-1) receptor agonists that are frequently used for Type 2 diabetes and weight management. However, the FDA has previously found that the unapproved peptides are either unproven, unsafe or both, and frequently are contaminated with other substances.
When the FDA banned the compounding of many peptides in 2023, it cited risks related to immune reactions (immunogenicity) for certain routes of administration, impurities and a lack of “sufficient information to know whether the drug would cause harm when administered to humans.” For one peptide, KPV, the FDA said it had “not identified any human exposure data on drug products containing KPV administered via any route of administration.”
On July 23, the committee will discuss BPC-157-, KPV-, TB-500- and MOTS-c-related bulk drug substances. The FDA has reviewed these substances for ulcerative colitis (BPC-157), wound healing and inflammatory conditions (KPV), wound healing (TB-500), and obesity and osteoporosis (MOTS-c). TB-500 is a synthetic version of a protein fragment known as thymosin beta-4, and the substances are used interchangeably.
On July 24, the committee will discuss emideltide, semax and epitalon. The FDA has reviewed these drug substances for opioid withdrawal, chronic insomnia and narcolepsy (emideltide); cerebral ischemia, migraine and trigeminal neuralgia (semax); and insomnia (epitalon).
At a later meeting, to be held before the end of February 2027, the committee will discuss cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II and mechano growth factor.
At present, the Pharmacy Compounding Advisory Committee has six vacancies, including the chairperson and a consumer representative. The committee has only three voting members and one industry representative. With new appointees before the July meeting, the committee could be filled with members who would rubber stamp Kennedy’s wishes, as has been the case with vaccine recommendations from the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.
Consistent with FDA and state regulations, compounding pharmacies can use bulk drug substances to make customized versions of medications and to mix drugs when there is a shortage of an approved version. However, compounded drug products are not approved by the FDA and are subject to lower regulatory standards than approved drugs. Public Citizen’s Health Research Group recommends that they not be used except in unusual situations when a patient’s medical needs cannot be met by an available FDA-approved drug.
The forthcoming Pharmacy Compounding Advisory Committee meeting and the subsequent FDA decisions about the 12 peptides under reconsideration are a key test of the agency’s credibility and its commitment to public health, rather than Kennedy’s ill-advised directives. All these peptides, like any new drugs, should go through the FDA’s standard approval process, not a more lenient workaround alternative pathway that defeats the agency’s purpose.