Historically, the Food and Drug Administration (FDA) has been defined by a cautious, evidence-first approach to approving new drugs and ingredients. If a company wants approval for a new prescription or over-the-counter ingredient, the process can take decades. It took 25 years for the agency to approve a new UV filter for sunscreen, largely because of the extensive safety, toxicology, and absorption data the agency required before signing off.
The FDA’s reputation for caution is now facing its biggest test yet.
After a two-day hearing last week, an advisory committee narrowly voted to recommend easing regulatory restrictions on six peptides, adding the substances to the 503A bulks list, a list of ingredients approved for certain compounding pharmacies.
This recommendation came despite FDA scientists concluding there was insufficient evidence to support the safety and efficacy of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax in the FDA’s briefing document for the PCAC meeting. The committee did narrowly reject (6-7) Emideltide for lack of evidence.
This recommendation from the Pharmacy Compounding Advisory Committee (PCAC) does not give the peptides FDA approval, nor does it greenlight pharmacy compounders to make gray market peptides that are currently labeled “for research purposes only” and “not for human consumption” (as a legal workaround for pharmaceutical compounders).
Rather, it’s an initial step in the rulemaking process to potentially add these peptides to the 503A Bulk Drug Substances List, which would give compounding pharmacies the approval to make them. The votes are non-binding, and it will be up to the FDA to decide whether to move forward with the six peptides.
If they do, the next step would be a proposed rule published in the Federal Register, opening a public comment period that typically lasts 60 to 90 days. After considering those comments, the agency would decide whether to issue a final rule, explaining any revisions and responding to significant public feedback. The final rule will not go into effect until its effective date.
The process usually takes approximately 12-24 months, although timelines vary considerably.
Still, in this case, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. could invoke special authority to expedite it.
Based on Kennedy’s comments, like a 2024 X post vowing to stop the FDA from the “aggressive suppression” of peptides, it would appear an acceleration of the rulemaking process could be imminent. On Joe Rogan’s podcast in February of this year, the health secretary said he personally had “used them to really good effect on a couple of injuries.”
He also told the podcaster that the FDA acted "illegally" in 2023 when it restricted 19 peptides from being approved for compounding pharmacies. Kennedy erroneously claimed that the FDA is not permitted to look at the efficacy of a drug. “They’re not allowed to say, ‘Well, we don’t believe these are efficacious,’ or whatever. They can only look at safety.”
It is not typical for an HHS Secretary to interfere with an FDA committee roster. But, just three weeks before the PCAC meeting, Kennedy’s administration announced it had appointed eight new temporary voting panelists. On day 1, all eight of the yes votes came from the eight temporary members added to the committee shortly before the meeting. On Day 2, one of the temporary members broke ranks and joined the "no" votes against emideltide.
Gray market or not, peptides are big business. The global peptide therapeutics market size was valued at $140.9 billion in 2025 and is projected to grow to $164 billion in 2026, according to Grand View Research. The largest regional market in 2025 was North America with a 61.9% revenue share, according to the report.
Biohackers like the self-proclaimed “father of biohacking” David Asprey and Gary Brecka, co-chair of the MAHA Action Committee, have helped amplify the use of injectable peptides. Brecka is known to spread anti-sunscreen conspiracy theories, and infamously told Joe Rogan that the FDA’s GRASE (Generally Recognized as Safe and Effective) status is “the way the FDA decides whether you can micro-poison the population.”
The safety debate around last week's PCAC vote isn't theoretical; it’s backed by extensive adverse-event reports from the FDA briefing document. The high volume of reported injuries resulting from injecting unapproved peptides continues to stack up. Last year, two women became critically ill after getting injected with peptides at an anti-aging conference in Las Vegas.
And if you zoom out globally, regulators outside the US have logged their own adverse event data on these compounds for over a decade.
In June, the Victoria, Australia, Department of Health announced it had been notified of six cases of acute liver toxicity resulting from a counterfeit peptide product labeled Retatrutide that was marketed as a wellness peptide.
Australia's Therapeutic Goods Administration (TGA) reported 89 adverse event reports and two melanoma diagnoses within an 18-month window from Melanotan II (MT-II), the experimental peptide known on social media as the “Barbie Drug,” used for darkening pigment without UV exposure.
MT-II has been associated with serious side effects like muscle tissue breakdown (rhabdomyolysis), kidney dysfunction, prolonged, painful erections (priapism), stroke, darkening of existing moles, new atypical moles increasing melanoma risk, and swelling of the brain.
Also dubbed the “vacation peptide,” the TGA reclassified MT-II to Schedule 9 in February of this year, the same classification as heroin, LSD, and GHB (known as the date rape drug).
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) logged adverse reactions to Melanotan II and warned the public of “serious health risks.” The UK agency is also concerned that MT-II is increasingly being marketed to younger consumers with bright colors and branding and has been focused on removing UK-facing sales websites advertising MT-II since 2011.
To give this context, MT-II is being reviewed at the next PCAC meeting for potential inclusion in the 503A bulks list.
Pending the FDA’s decision on whether to recommend these peptides, compounding pharmacies generally may not compound these six peptides from bulk substances unless the FDA ultimately adds them to the 503A list. Will this stop them? Probably not.
The bigger question is whether we will see Kennedy’s interference in future advisory hearings. Based on his X post, Kennedy clearly has aggressive aspirations to overhaul the FDA. How will this affect the beauty industry and MoCRA? Time will tell.
In addition to the seven peptides the panel weighed in on in July, the FDA also announced it will hold another advisory committee meeting to consider five more peptides by the end of February 2027.