Draft · pending Kyle + Mackenzie sign-off

Reputable.IRB-governed research
FDA · PCAC Briefing
v.01

What PCAC means for your brand — in 20 minutes.

A free 1:1 readout for peptide and wellness founders, the week after the July 23-24 vote.

  • What PCAC recommended, peptide by peptide
  • Language for investors, retailers, and customers
  • The real vote → rule → market timeline
7
peptides
20 min
1:1
IRB
governed
Reserve a slot

1:1 · 20 min · July 27-31

01 · What is happening

On July 23-24, 2026, the FDA's PCAC reviews seven peptides for possible inclusion on the Section 503A Bulks List and votes advisory recommendations.

Mackenzie: verify votes
July 23BPC-157, KPV, TB-500, MOTS-c
July 24Emideltide (DSIP), Semax, Epitalon
02 · What it does not do

The vote is a recommendation, not a rule. It does not add anything to the 503A list, and it does not make anything legal to compound the next morning.

On July 25, the status of all seven peptides is exactly what it was on July 22.

03 · The actual timeline
  1. 2023

    FDA restricts a group of peptides via its Category 2 list.

    verify
  2. Apr 2026

    Twelve peptides come off Category 2 after nominators withdraw.

  3. Jul 23-24, 2026

    PCAC reviews seven peptides and votes.

  4. By Feb 2027

    Second PCAC meeting expected to review five more.

  5. After that

    FDA rulemaking decides what actually lands on 503A. No date.

04 · Why it matters

Two reasons — neither is the headline one.

01

The signal

The committee's reasoning is the clearest public read yet on how the FDA weighs the human evidence behind each peptide.

02

The noise

Headlines will claim the FDA legalized or banned peptides. Neither is true. Being able to answer that correctly is a competitive advantage.

And underneath both: if the real finish line is rulemaking, the window to build credible human evidence is now, while the process runs, not after the rule lands and everyone needs data at once.

06 · How we run studies

IRB-governed research, plain English.

Every Reputable study runs under independent oversight — the safeguards of a clinical trial, built for real-world wellness.

IRB oversight

Every protocol is reviewed and approved by an independent Institutional Review Board before enrollment. They sign off on design, consent, risk, and data plan.

Participant safeguards

Informed consent

Plain-language consent before enrollment.

Right to withdraw

Leave anytime, no penalty.

Data privacy

De-identified for analysis; PII stored separately and encrypted.

Adverse event reporting

Events logged, reviewed, and reported to the IRB on their timeline.

Methodology

Defined cohort, pre-intervention baseline, fixed duration, each participant compared to their own baseline. Endpoints locked before the study starts. Results reported with sample size, effect size, and limitations.

Real-world evidence — not a placebo-controlled drug trial. We're clear on which is which.

Kyle: confirm IRB name
07 · Common questions

Before you book.

Who is the intended audience?

Founders and operators at peptide, supplement, and wellness companies affected by the July PCAC agenda. Not intended for consumers or clinical guidance.

Which peptides are covered?

All seven under review: BPC-157, KPV, TB-500, MOTS-c, Emideltide (DSIP), Semax, and Epitalon, with context on evidence standards and expected timeline.

How is the session structured?

A 20-minute 1:1 session by video or audio: a focused readout followed by your questions. No slide deck, no sales pitch.

Are there any fees or commitments?

No. The session is complimentary, with no obligation on either side.

08 · Book the readout

1:1 · Complimentary · This week only, July 27–31

The Post-PCAC Executive Readout

What the committee actually recommended — and what it means for your category.

  • PCAC's recommendation and reasoning, peptide by peptide
  • Talking points for investors, retailers, and customers
  • Real timeline from vote → rule → market impact
  • Evidence bar: what data your category actually needs
Agenda≈ 20 min
  1. 0–2 minIntros + your top question
  2. 2–12 minFocused readout on your peptides
  3. 12–18 minYour questions
  4. 18–20 minWhat to watch next
Pending

Calendar link pending

Booking embed drops in here — Calendly, Cal.com, or equivalent iframe. Needs the call owner's scheduling link before this goes live.

Request this week's readout

Limited slots · July 27–31 only

  • No slide deck
  • No obligation
  • Educational only

If it makes sense to talk about research after, we can. Otherwise, you keep the readout.

Reputable.v.01 · Draft
IRB-governed, wearable-powered studies for wellness brandsconfirm with Kyle

Educational only. Not medical, legal, or regulatory advice. No peptide discussed is FDA-approved.

© 2026 Reputable Health

Book the 20-minute call1:1 · Free · July 27–31