RFK Jr. Moves to Loosen Restrictions on Unapproved Peptide Drugs

Health and Human Services Secretary Robert F. Kennedy Jr. has taken steps to expand public access to several unapproved peptide drugs that are heavily promoted across the wellness industry.

In a draft policy filed in the Federal Register, Kennedy announced that the Department of Health and Human Services (HHS) will exercise "enforcement discretion," opting not to take legal action against licensed compounding pharmacies or physicians that prepare six specific peptides:

• BPC-157 (promoted for tissue repair and ulcerative colitis)
• Epitalon (promoted for sleep, insomnia, and longevity)
• KPV (promoted for wound healing and inflammatory conditions)
• MOTS-c (promoted for metabolic health)
• Semax (promoted for migraines and chronic pain)
• TB-500 (promoted for tissue repair and muscle recovery)

The draft policy originated directly from the health secretary's office rather than from the Food and Drug Administration (FDA).

In July, an FDA advisory panel, which included newly appointed members with ties to the peptide industry, voted to recommend allowing compounding for the six substances. However, that vote went directly against the recommendations of FDA staff and agency scientists, who concluded there is insufficient clinical evidence to prove the substances are safe and effective.

Defending the decision, Kennedy wrote that the policy "advances patient choice and freedom while appropriately protecting patient safety."

The administration argues that permitting regulated compounding pharmacies to prepare these medications will redirect consumers away from an illicit "gray market" of unregulated online sellers offering unproven "research-use-only" compounds.

In a statement supporting the strategy, HHS spokesperson Emily Hilliard noted:

“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides.”

An HHS spokesperson further clarified to reporters:

"The policy does not grant FDA approval or establish clinical safety and effectiveness. It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers."

Under the draft rules, compounding pharmacies must utilize FDA-registered ingredient suppliers, obtain laboratory certificates verifying raw material purity, and mandate serious side-effect reporting.

Health experts and consumer advocacy groups have voiced strong opposition, warning that bypassing standard drug review procedures poses risks to public health. Dr. Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, stated that the FDA was essentially “turning a blind eye”.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, warned that the policy could expose consumers to untested products:

“Imagine what it means for the nation’s top drug regulator to announce they won’t enforce the laws on people making completely untested compounds and distributing them to the public.”

Peptides are short chains of amino acids that the human body naturally produces to regulate hormones, skin health, and immune functions. While several peptide-based drugs such as insulin and mainstream GLP-1 weight-loss medications have full FDA approval, unregulated peptides have surged in popularity online. Influencers and social media trends such as "biohacking" and "looksmaxxing" frequently market unapproved peptide combinations as quick solutions for muscle building, anti-aging, and rapid injury recovery.

Kennedy's draft guidance will remain open for a two-week public comment period through November 13th. The temporary policy will remain in place until the FDA establishes a formal, finalized rule regarding compounded peptides.

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