The man who promised to "end the FDA's war on peptides" is now running the entire Department of Health and Human Services.
Whether you love him, hate him, or have no idea what's happening—this is the single biggest shift in peptide policy we've seen in decades.
Let me break down what's actually going on.
THE PROMISE
In May, Robert F. Kennedy Jr. appeared on Gary Brecka's podcast and made a statement that sent shockwaves through the optimization community:
"FDA's war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, ivermectin, hydroxychloroquine, vitamins, and anything else that advances human health and can't be patented by Pharma."
He specifically named peptides.
The guy who controls the FDA's budget, appoints its leadership, and sets its enforcement priorities has publicly stated that peptide suppression is ending. That's not a rumor. That's the HHS Secretary saying the quiet part out loud on a podcast with two million followers.
And this isn't some politician making empty promises. Kennedy has already started making moves.
Gary Brecka’s Tweet
THE CHESS MOVES
Move #1: New FDA Commissioner
Kennedy installed Dr. Marty Makary as FDA Commissioner. Makary is a Johns Hopkins surgeon who spent the last few years criticizing the FDA publicly. He called the U.S. government "the greatest perpetrator of misinformation" and said Americans are "the most over-medicated, sickest population in the world."
This is not a status-quo guy.
On April 17, 2025, Makary announced a new policy limiting employees of pharmaceutical companies from serving on FDA advisory committees. The panels that decide which drugs get approved, which compounds get banned, which peptides make the list—those panels used to include people who literally work for the companies being regulated.
Makary said: "Public trust in the healthcare-industrial complex is at an all-time low. We need to restore impeccable integrity to the process and avoid potential conflicts of interest."
Why does this matter for peptides?
Because guess who's been showing up to advisory meetings to oppose compounded peptides? Eli Lilly. Literally. At the December 2024 Pharmacy Compounding Advisory Committee meeting, an Eli Lilly representative spoke against AOD-9604—a peptide used for fat loss.
Why? Because compounded peptides are competition for their weight loss drugs.
Move #2: Advisory Committee Shakeup
Kennedy removed experts from the FDA's Pharmacy Compounding Advisory Committee (PCAC)—the group that recommends which peptides can and can't be compounded.
The implication? He's clearing the board to appoint peptide-friendly experts who might actually vote to allow compounds that were previously banned.
Dr. Anita Gupta from Johns Hopkins served on that committee until earlier this year. She's now on the outside looking in.
Move #3: FDA Layoffs
On March 27, 2025, HHS announced that roughly 3,500 FDA employees—nearly 20% of the agency—would be laid off as part of the DOGE restructuring initiative. The terminations went into effect in early April.
Whether you think that's good or bad depends on your perspective, but here's the practical reality: fewer enforcement resources means less capacity to crack down on compounding pharmacies.
RFK Tigher Control
THE BATTLE LINES
Here's the part that should make your brain hurt a little.
On one hand, you have RFK Kennedy promising to free peptides from FDA suppression.
On the other hand, you have the SAFE Drugs Act—introduced by two Indiana congressmen—trying to crush compounding pharmacies with new regulations.
Both things are happening simultaneously.
Kennedy wants to open access. Eli Lilly wants to close it. And they're fighting on different battlefields.
Kennedy controls the executive branch—FDA enforcement, advisory committees, regulatory guidance.
Eli Lilly is playing the legislative game—Congress, lobbying, bills that restrict compounding at the statutory level.
If Kennedy wins, peptides get easier to access. If Eli Lilly wins, compounding gets strangled regardless of what the FDA does.
This is why you need to pay attention. The future of peptide access isn't being decided by science. It's being decided by politics and money.
THREE SCENARIOS TO WATCH
Scenario 1: Enforcement Discretion
The FDA could simply announce that it's exercising "enforcement discretion" on banned peptides. Translation: "We're not going to enforce these rules."
This wouldn't change the law, but it would effectively tell compounding pharmacies, "Go ahead, we're looking the other way." This is the fastest path to expanded access and requires zero Congressional action.
Scenario 2: Advisory Committee Overhaul
Kennedy could stack the Pharmacy Compounding Advisory Committee with peptide-friendly experts. When the committee reviews BPC-157 or Thymosin Alpha-1 again, they could vote to allow compounding.
This takes longer but creates more durable policy change.
Scenario 3: Legislative Battle
Bills like the SAFE Drugs Act could pass and actually tighten restrictions, creating a counterforce to Kennedy's deregulation push. This would be the pharmaceutical industry fighting back through Congress while Kennedy fights for access through the executive branch.
A genuine policy war.
WHAT THIS MEANS FOR YOU
First, understand that we're in a transition period. The old FDA regime is being dismantled, but the new one isn't fully in place yet. That means uncertainty—but uncertainty can cut both ways. Access might expand faster than anyone expects, or enforcement might get chaotic and unpredictable.
Second, quality matters more than ever. If enforcement discretion becomes the norm, more suppliers will enter the market—including sketchy ones. When the gates open wider, you need to be even more careful about where you source. Third-party COAs, established suppliers, verified purity—these things become your protection when the regulatory environment gets murky.
Third, stay informed. This story is moving fast. What's true today might change in three months. The people who navigate this successfully are the ones who understand the landscape and adapt.
🎬 WATCH THE FULL BREAKDOWN (Rumble Video)
I go deeper into all of this in my latest video. If you want the full picture—including the Gary Brecka connection and what's actually legal right now—check it out here:
RFK Jr. Takes Down the FDA as Big Pharma Cashes In on Peptides
This is the most significant regulatory shift we've seen in the peptide space in decades. Whether it opens doors or creates chaos depends on how well you understand what's happening. The video breaks down the timeline, the players, and what you should actually be doing right now to stay ahead of this.
Free 2-day air shipping on orders $250+. All discounts stack with code “LEE” unless noted.
Stay educated. Stay strategic.
Talk soon,
Lee
Peptide Community & Member Perks
FURTHER READING & SOURCES
For those who want to dig deeper into the developments covered in this newsletter:
RFK Jr. & Peptide Policy
CNN: "The trend of unproven peptides is spreading through influencers and RFK Jr. allies" — https://www.cnn.com/2025/11/15/health/peptides-unregulated-influencers
ABC News/AP: "Americans are injecting themselves with unproven peptides sold by influencers and RFK Jr. allies" — https://abcnews.go.com/US/wireStory/americans-injecting-unproven-peptides-sold-influencers-rfk-jr-127514590
FDA Commissioner Makary & Advisory Committee Changes
FDA Official Announcement: "FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees" (April 17, 2025) — https://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-announces-new-policy-individuals-serving-fda-advisory-committees
STAT News: "Makary says FDA will remove pharma representatives from advisory panels" — https://www.statnews.com/2025/04/17/fda-advisory-panels-pharma-industry-employees-patients-caregivers/
FDA Layoffs & Restructuring
STAT News: "HHS cuts to include 3,500 FDA layoffs" (March 27, 2025) — https://www.statnews.com/2025/03/27/hhs-job-cuts-include-3500-fda-layoffs-anxious-workers-await-friday-layoff-notices/
Fierce Biotech: "RFK Jr. cuts 4,700 FDA and NIH jobs as HHS eliminates 'an entire alphabet soup of departments'" — https://www.fiercebiotech.com/biotech/nearly-5000-fda-and-nih-staffers-laid-hhs-eliminates-entire-alphabet-soup-departments
SAFE Drugs Act of 2025
Congress.gov: Full Text of H.R.6509 — https://www.congress.gov/bill/119th-congress/house-bill/6509/text
Rep. Yakym Press Release: "Yakym, Carson Introduce Bill to Protect Patients from Unsafe Compounded Drugs" — https://yakym.house.gov/posts/yakym-carson-introduce-bill-to-protect-patients-from-unsafe-compounded-drugs
Alliance for Pharmacy Compounding Analysis: "Hoosiers introduce anti-compounding bill… and it's a mess" — https://a4pc.org/news/hoosiers-introduce-anti-compounding-bill-and-its-a-mess
Eli Lilly & Compounding Battle
Foley & Lardner: "GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding" — https://www.foley.com/insights/publications/2024/12/glp-1-drugs-brand-companies-push-fda-limit-compounding/
December 2024 FDA PCAC Meeting (AOD-9604, CJC-1295, Thymosin Alpha-1) — https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-4-2024-meeting-pharmacy-compounding-advisory-committee-12042024
Background: Peptide Compounding Legal Landscape
Safe Harbor Group: "FDA's Overreach on Compounded Peptides: Legal Battles and How Clinics Can Push Back" — https://safehg.com/fdas-overreach-on-compounded-peptides-legal-battles-and-how-clinics-can-push-back/