By Karen L. Kier, Pharmacist
On behalf of the ONU Healthwise Team 

Too Soon was on Nat King Cole’s 10^th Anniversary album released in 1955. The album peaked at number 7 on the album charts. Too Soon is not as recognized as Unforgettable and Frosty, The Snowman.   

Health and Human Services Secretary Robert F. Kennedy, Jr. is making a significant move with a new policy that could bring some of these controversial peptides to the market. On October 28, Kennedy announced a policy that would allow licensed pharmacies and physicians to compound six previously restricted peptides. 

The policy represents a major shift in federal oversight, but it does not mean they are approved by the FDA. The FDA is responsible for evaluating proven safety and effectiveness based on evidence.

Peptides are a hot subject for wellness. Promoted by fitness enthusiasts, anti-aging clinics and social media influencers, these peptides are being touted for faster injury recovery and better sleep to improve energy, weight management and longevity.

Peptides are short chains of amino acids, which are the building blocks for protein synthesis. The body naturally produces thousands of peptides, helping regulate biological functions, including hormones, immune responses, metabolism and tissue repair. Some prescription medications, including insulin and GLP-1s (semaglutide, tirzepatide) are peptide-based drugs with FDA approval based on research evidence.

The six peptides known as the “Kennedy 6” are different from insulin and GLP-1s due to a lack of good evidence. The “Kennedy 6” are BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax. They have attracted attention for their purported abilities to promote healing, reduce inflammation, improve metabolic health, support brain function, and slow aging.

The proposed therapy benefits include BPC-157 for ulcerative colitis and wound healing and epitalon as an anti-aging and insomnia agent.  TB-500 and KPV have been touted to promote wound healing and reduce inflammation. MOTS-c is suggested to treat obesity, bone loss (osteoporosis), muscle health, and support metabolic function. Semax is proposed to help migraines, cerebral blood flow, and chronic facial pain. Most of these peptides are injectables, with few being oral, topical or a nasal spray.

Scientific evidence supporting these claims in humans remains very limited. Much of the enthusiasm comes from animal research, laboratory studies, anecdotal reports and testimonials rather than well-designed human trials. The FDA has historically restricted certain peptides from being used because of concerns about safety, ingredient quality, and insufficient evidence of effectiveness. 

Kennedy's new enforcement-discretion policy directs the government not to pursue certain federal enforcement against licensed pharmacies and physicians that compound the six peptides, provided they follow specified safeguards. These include patient-specific prescriptions, traceable ingredients, ingredients manufactured using Good Manufacturing Practices, quality testing, appropriate labeling and safety reporting. The policy is intended to provide a more controlled alternative to products purchased through unregulated internet sellers, some of which are marketed as research chemicals.

Enforcement discretion is not FDA approval. Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality before they are marketed. The policy does not establish that these six peptides are safe or effective treatments. The FDA staff scientists have strongly opposed the ability to release these peptides, raising concerns about the lack of reliable human data. Potential problems include allergic reactions, contamination, impurities, inaccurate dosing, and unknown long-term effects. The FDA previously identified concerns involving kidney damage and possible tumor growth with certain peptides.

An FDA advisory committee voted in July 2026 to recommend allowing these six substances to be considered for compounding. This recommendation did not amount to FDA approval, and agency scientists had expressed reservations about the available evidence.

This difference between policy and scientific proof is important when products are promoted for injuries, chronic pain, inflammation or age-related conditions. A product being available through a pharmacy or a healthcare professional does not mean it has undergone rigorous testing.

Someone considering peptides should talk to a qualified healthcare professional who can evaluate the potential benefits, risks and better-studied alternatives. Some good questions to ask include: Is there published human clinical research supporting the specific peptide for my condition? What are the known side effects? Where are the ingredients manufactured? Does the pharmacy or healthcare provider conduct appropriate quality testing? How will I be monitored for side effects or benefits? Avoid purchasing injectable peptides from websites or social media sellers advertising products. Such products may have uncertain ingredients, purity, sterility and dosage.

Despite this policy, there are hurdles. Because these peptides are not FDA-approved, insurance most likely will not cover the therapy. Each state board of pharmacy, including Ohio, controls the practice of pharmacy within their state. Ohio already has regulations that pharmacists in Ohio may not compound BPC-157. The Ohio State Board of Pharmacy would consider these unapproved research chemicals or bulk drug substances, which violates Chapter 4729 of the Ohio Administrative Code. In this case, the Federal government cannot override Ohio laws. 

Consumers should approach the promises of rejuvenation, rapid healing and improved longevity with skepticism. A new federal policy may make certain peptides easier to obtain, but the science has not caught up with the marketing. 

It may be too soon!