Peptide therapy claims on TikTok: hype vs. human evidence

What did @dr.shuayto actually say?

The argument here is that FDA-unapproved peptides aren't dangerous or ineffective. They just can't be patented. The claim: "It has nothing to do with whether or not they work, but everything to do with money." He points to a 2013 Supreme Court ruling on natural substances and uses Tesamorelin as the one exception, approved only because it could be tied to a specific disease indication that made it commercially viable.

He also argues that since many peptides occur naturally in the body, no single company can own them, which kills the financial incentive to fund large-scale trials. His conclusion: FDA approval is a proxy for profitability, not safety or efficacy.

Does the science back this up?

Partially. The patent economics argument has real support in drug development literature, but it dramatically oversimplifies the FDA's actual role in evaluating safety. The money problem is real. The framing that approval is irrelevant to safety is not.

It's true that the cost of bringing a drug through FDA trials, often cited at $1-2 billion (DiMasi et al., 2016, Journal of Health Economics), creates a structural disincentive to develop compounds without patent protection. This is well-documented and not controversial. However, the FDA's approval process exists precisely to catch harms that don't show up in small, short-term studies. BPC-157, for example, has promising animal data (Sikiric et al., 2018, Current Pharmaceutical Design), but virtually no randomized controlled trial data in humans. Calling something safe because it's naturally occurring is a logical leap. Cortisol is naturally occurring. So is arsenic.

The 2013 Supreme Court case (Association for Molecular Pathology v. Myriad Genetics) was about isolated DNA sequences, not peptides broadly. Applying it as a blanket ruling on all natural substances oversimplifies the legal and regulatory reality.

What did they get wrong (or right)?

He got the economic incentive problem largely right, and that deserves credit. Researchers like Prasad and Mailankody (2017, JAMA Internal Medicine) have documented how return-on-investment shapes which drugs get developed. That's a real and underreported issue in pharmaceutical policy.

But two things are wrong or at least misleading. First, the Myriad Genetics ruling does not straightforwardly prohibit patenting all peptides. Synthetic and modified peptides can and do receive patents. Several FDA-approved peptides, including semaglutide, are patented and derived from naturally occurring compounds. This undermines the core of his argument.

Second, "not FDA approved" does not mean the same thing as "safe." The absence of large trials means we genuinely don't know the long-term safety profile of many compounded peptides. That's not a conspiracy. That's an evidence gap. Framing it as "sometimes it's not worth spending billions" glosses over what that missing data actually means for patients using these compounds today.

What should you actually know?

The regulatory and economic critique here is worth taking seriously, but it should not be a green light to assume compounded peptides are safe by default. Here is what the evidence actually supports.

• Pharmaceutical economics do influence which compounds reach clinical trials. This is documented, not a fringe claim.
• Several peptides used in compounding, including BPC-157 and TB-500, have promising preclinical data but lack phase II or III human trial evidence.
• The FDA placed several peptides, including BPC-157, on the Category 2 withdrawn list in 2022, citing insufficient evidence of safety, not a patent dispute.
• Natural origin does not confer safety. Dose, delivery route, purity, and individual biology all matter, and compounded peptides vary in quality across suppliers.
• If you are considering peptide therapy, the absence of FDA approval means the burden of informed consent falls heavily on the prescribing clinician, not the platform or the TikTok comment section.