Peptides find their way to the Public

The FDA’s Pharmacy Compounding Advisory Committee met on Thursday and Friday, July 23-24, 2026, convening to consider whether seven peptides should be made available more widely.1 Six of the seven received a green light, so to speak.

This committee is subject to the Federal Advisory Committee Act (FACA) which requires the composition of the Committee to be non-federal employees, and to be open to the press and subject to the Freedom of Information Act for all documents.2 It is a standard way of conducting business for the federal government where outside professional and expert opinions are needed, but they are advisory, only.

The Pure Food and Drug Act of 1906, was enacted to meet the outrage from food tampering and hidden ingredients in drugs, like opium and alcohol,3 but perhaps mostly driven by the outrage from Upton Sinclair’s book, The Jungle. This book was supposed to expose poor working conditions of immigrants, but instead, its depiction of the shocking practices of food processing and canning in Chicago, led to outrage about food safety.4 The Food, Drug and Cosmetic Act was enacted in 1938, to protect the public from adulterated or misbranded foods, drugs, devices and cosmetics, triggered by a poisoning event of an antibiotic that killed 100 people.5

We are already acquainted with the famous GLP-1 drugs for obesity and insulin,6 which are peptides.

A peptide looks like a chain of beads with each bead being an amino acid and the chain a peptide bond between each one. A peptide is a relatively short chain of 2-50 amino acids. A protein is much longer, complex and folded. The chain of beads has a nitrogen group at one end and a carbon group at the other.7

Peptides are promising as we have seen with GLP-1 for obesity. Others claim to help with “enhancing muscle strength, boosting the immune system, reducing inflammation, and helping the body heal from injury.”8 They are promising, but yet there is no science showing their efficacy, a requirement for drug approval by the FDA. Neither is there any science or evidence showing they are dangerous or have side effects that would warrant concern. More research is needed.

But in the meantime, The Secretary of Health and Human Services, Sec. Kennedy, has argued they should be made available to the public without unnecessary hurdles.9

Peptides are not illegal, but not available for human consumption. Peptides can be purchased for “research use” in a kind of gray market, that likely knows these peptides are being purchased for consumption. Sec. Kennedy has argued that making peptides available through FDA processes would eliminate the risk these mail order “research purposes” peptides pose.10

Compounding pharmacies exist to compound drugs that are needed but not FDA approved, or approved in the amount of the dose, for example. Compounding pharmacies have to follow best practices and ensure that the process and product is sanitary. The materials that are available to compound are approved on the bulk drug list, Sec. 503A of the Food, Drug and Cosmetic Act.11

Here are the seven peptides and their claims considered by the Committee:

• BPC-157: Recommended for inclusion; proposed to treat ulcerative colitis.

• KPV: Recommended for inclusion; proposed for wound healing and reducing inflammation.

• TB-500: Recommended for inclusion; proposed to promote wound healing.

• MOTS-c: Recommended for inclusion; proposed for insulin resistance, obesity, and osteoporosis.

• Epitalon: Recommended for inclusion (7-4 vote); marketed for insomnia and longevity.

• Semax: Recommended for inclusion (8-5 vote); promoted for migraines and neurological conditions.

• Emideltide: Rejected (6-7 vote); had been under review for opioid withdrawal and chronic insomnia.

The seventh peptide, “emideltide” was rejected, citing "potentially dangerous downstream consequences," according to one Committee member. It has the potential to be addictive and that was enough to tip the vote against it.12 The FDA staff were reported to have been opposed to all of them on the list for lack of scientific evidence.

The Committee is expected to review five more by the end of February 2027.13

New Regulations for Peptides

As mentioned earlier, GLP-1 is a kind of glucagon peptide, but one that has been FDA approved as a drug. This process begins with testing for safety on laboratory mammals, or in simulated computer models (planned exclusively in the future) to see if it is safe. An LD50 might be established, that is, how much of the drug can cause 50% of the test population to die, as a way to standardize safety against all other drugs using the same measure. If the drug passes the safety testing, it is then tested in the laboratory for efficacy — does it really do what it claims for obesity? If it passes this level of testing then it can be tested on humans for safety and then efficacy. There are often setbacks along this regulatory pathway, and many drugs never make it to the end.

The development of GLP-1 as a very commercially successful drug and the recent consideration of these seven peptides being approved for the first time for the Bulk Drug list, indicates there will likely be more drug applications in the future. So today, the FDA published new protocols for testing peptides in the drug approval process.14

There is an interesting dynamic here that has peptides available with a prescription from a compounding pharmacist which could dampen the gray market or perhaps later, a black market for peptides; making it safer for everyone.

It is unfortunate that adverse events are not reported for bulk drugs. In FDA approved drugs, it has always been an incredibly useful way to monitor new drugs that are released after years of testing.

Finally, the Committee makes a recommendation and it is still up to FDA to publish it as a proposed rule and then take comments before it becomes law.

Share

Photo credit: https://www.evotec.com/solutions/drug-discovery-preclinical-development/modalities/peptides