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A few months ago, Pinchas Cohen learned of a thriving online trade in MOTS-c — a peptide that, when injected into mice, seems to mimic the effects of exercise.
The dean of the USC Leonard Davis School of Gerontology was very familiar with this particular short chain of amino acids. His lab identified it years ago as one of the thousands of peptides that act as chemical messengers in the human body, one he believed might someday have therapeutic uses for humans.
But Cohen was alarmed to learn that his discovery was now being promoted by legions of longevity seekers, fitness enthusiasts and wellness influencers as “exercise in a bottle.” Though not approved by the U.S. Food and Drug Administration, it was widely available online, often in vials marked “for research use only.”
“Turns out that tens of thousands of people are injecting themselves with MOTS-c [that’s] black market, illegal, from unknown sources, unknown purity, unknown sterility, and I strongly object to that,” Cohen said.
Driven by social media hype and a growing distrust of public health guidance, consumer demand for experimental peptides has exploded over the last decade. Now, the clamor over unregulated peptides is fueling a high-stakes policy battle within the federal government. Health and Human Services Secretary Robert F. Kennedy Jr. has described himself as a “big fan” and user of peptides, and has pledged to end the government’s “aggressive suppression” of them.
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Some peptides, such as insulin, human growth hormone and glucagon-like peptide-1, have delivered transformational therapeutic effects when administered to humans.
But every vial of insulin or GLP-1 medication on a pharmacist’s shelf is the product of decades of clinical trials and safety testing. There are reams of data on what these drugs do, for whom they are most effective and in what dose and form they should be administered.
For MOTS-c and a raft of other peptides widely available online, no comparable evidence exists.
Although proponents say the substances help with weight loss, energy and muscle mass, and often cite research that has been done solely on animals or on a very small number of humans, no one knows for certain how or when it should be used in humans. While many users take multiple peptides together in custom combinations, or “stacks,” there is no data on how different synthetic peptides interact with one another.
To date, most of these popular peptides have been available solely in unregulated online marketplaces. But recently, an FDA committee voted to recommend that compounding pharmacies be allowed to manufacture six different peptides already widely available online: BPC-157, TB-500, KPV, epitalon, Semax and MOTS-c. A seventh, emideltide, was voted down.
Compounding pharmacies, which mix bespoke drugs, are a loophole in the U.S. regulatory system. While the drugs they produce aren’t FDA-approved, the pharmacies still have to follow their state’s safety and quality regulations.
Cohen traveled to Washington, D.C., to speak before the committee, many of whose members work for the kind of telehealth, longevity and wellness companies that stand to benefit financially from the peptides’ regulation.