Comment from Hunt Dan

PCAC Public Comment — Docket FDA-2025-N-6895 Submitted by: Dan Hunt, Founder — Field Vitality (Maui, HI) Chairman and Members of the Pharmacy Compounding Advisory Committee, I submit this comment as a healthcare entrepreneur who has spent the past year building a physician-led telehealth platform on Maui, Hawaii. I have witnessed firsthand the profound demand for peptide therapeutics and the consequences of restricting access to them. Peptides are not experimental novelties. They are biologically fundamental signaling molecules that our bodies naturally produce. BPC-157 accelerates tissue repair in ways no conventional pharmaceutical matches. MOTS-C regulates mitochondrial function and metabolic health. TB-500 supports connective tissue recovery. These compounds have been used safely by thousands of patients under physician supervision for years. The current regulatory gray zone — where peptides are neither fully restricted nor affirmatively authorized for compounding — does not protect patients. It drives them to unregulated sources. Every week in my community, I meet people who have turned to gray market peptide suppliers because they cannot access these therapies through legal channels. They buy unverified products from unregulated sources because the legitimate path is blocked. Removing these peptides from Category 2 and placing them on the 503A Bulks List would: - Bring patients back into regulated, physician-supervised care - Enable licensed compounding pharmacies to produce quality-controlled products - Reduce the gray market that currently thrives on regulatory uncertainty - Allow telehealth platforms like ours to provide safe, monitored access The evidence is clear. The demand is real. The patients are waiting. I urge the committee to recommend removal of BPC-157, TB-500, MOTS-C, and the remaining peptides from Category 2 restrictions and affirm their place on the 503A Bulks List for compounding. Respectfully, Dan Hunt Founder — Field Vitality Maui, HI