HHS Greenlights Six Unapproved Peptides Despite FDA Doubts

HHS authorized compounding pharmacies to produce six peptides, including BPC-157, that FDA scientists say lack sufficient safety and efficacy data.

@sharedot

HHS Greenlights Six Unapproved Peptides Despite FDA Doubts

By @sharedot · · 6 pages

  • Crypto
  • Regulation
  • Peptides

HHS authorized compounding pharmacies to produce six peptides, including BPC-157, that FDA scientists say lack sufficient safety and efficacy data.

A fatal dose and a regulator's warning

Australian actor and martial artist Richard Norton, 75, died on March 30, 2025 after an injection of unapproved peptides CJC1295 and ipamorelin triggered anaphylaxis and cardiac arrest, according to coroner David Ryan's findings dated Oct. 28.

Norton had told his doctor's nurse two days before he died that he had been administering double the prescribed dose. According to USA Today, the report also identified asthma and hypertrophic cardiomyopathy as contributing factors.

The Guardian reports Ryan recommended Australia's Therapeutic Goods Administration consider shifting the peptides from schedule 4 prescription-only drugs to schedule 10, restricting them to clinical trials.

The surprising reversal

Even as the coroner called for tighter restrictions in Australia, the U.S. moved the other way.

According to NBC News, on Wednesday the Department of Health and Human Services gave compounding pharmacies the okay to start producing six much-touted peptides — BPC-157, epitalon, KPV, MOTS-c, semax and TB-500 — even though the FDA's own scientists have concluded there is insufficient data showing those peptides are safe and effective.

USA Today notes the findings come as U.S. Health Secretary Robert F. Kennedy Jr. moves to broaden access to certain unapproved peptides. The regulator's own scientists are being overruled in favor of market access.

A grey market with influencer fuel

Peptides are small proteins promoted by online influencers as treatments for faster healing, younger-looking skin, better sleep, muscle growth, recovery and even a longer life.

According to NBC News, some peptides are used in FDA-approved medications for diabetes and obesity, but a grey market has been flooded with products containing unapproved peptides.

Australia's TGA has separately warned consumers about the risks of importing and using unapproved peptides promoted online, and The Guardian reports the regulator previously warned about a peptide user who tore an oesophagus after using a counterfeit product.

Norton's death appears to be the first confirmed fatality Down Under linked to unapproved peptides, per NBC News citing the ABC.

What comes next

The regulatory paths are diverging.

Coroner Ryan recommended the TGA review the peptides' potential benefits and risks and consider limiting their use to clinical trials or other experimental settings, saying he was not satisfied they should remain prescribable given acknowledged uncertainty about their benefit and risks, The Guardian reports.

In the U.S., NBC News reports the doctor who prescribed Norton's peptides, Dr. Jerzy Muchnicki, has accepted accountability for his errors in judgment and will no longer prescribe peptides, though he has not yet responded to NBC News's request for comment.

With HHS opening compounding production and influencer demand intact, the American grey market is set to grow even as Australia weighs a clampdown.

Sources

  1. nbcnews.com › Richard Norton, actor and martial artist, died after peptides triggered heart attack, coroner says
  2. usatoday.com › 'Mad Max' actor Richard Norton died after peptide injection, coroner finds
  3. theguardian.com › Coroner calls for TGA to review unapproved peptides after death of Australian actor

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