Robert F. Kennedy Jr. wants to give patients more access to nonstandard therapies that the U.S. Food and Drug Administration (FDA) has not yet approved. I’m speaking about peptide therapy to be exact. The following is from the Wall Street Journal:
Injectable peptides are used for everything from weight loss to muscle recovery.
The substances, manufactured in China, come in tiny glass bottles with names like “Glow Stack” and “Wolverine Stack.” They promise youthful skin and speedy muscle recovery, delivered in injectable form. Influencers, celebrities and everyday people are raving about peptides, unapproved drugs driving a gray-market craze.
Peptides are short chains of amino acids held together by peptide bonds. In addition to being the building blocks of proteins, peptides also function as signaling molecules. In many cases, they signal to your body to release a naturally occurring hormone. Popular weight-loss drugs are all peptides, which occur naturally in the body. More from WSJ:
But today “peptide” has become shorthand for an injectable drug that hasn’t undergone FDA approval. Sold primarily through an online gray market, where they are labeled “for research use only,” the vials can run from tens to hundreds of dollars apiece.
Some doctors say they talk to their patients about peptides, discussing the pros and cons of different molecules. They cannot, however, prescribe peptides except for those that are FDA approved. When discussing peptide therapies on YouTube, doctors usually make a disclaimer, “I’m a doctor, but I’m not your doctor. Always discuss this with your own doctor.”
The FDA is cracking down on unapproved peptide therapies, and compounding that is taking place outside the regulatory framework. Weight loss peptides are an example. When GLP-1 drugs were in a shortage, compounding pharmacies were free to produce copies. Once the FDA declared the shortage over, pharmacies and prescribers who were used to getting drugs for, say, $200 a month were loath to return to $1,200 per month. The FDA has taken a tougher stance on compounding peptides, but it is not about patent infringement. The FDA under Biden moved to ban 17 peptide therapies, many popular with bodybuilders and the antiaging crowd. More from WSJ:
Kennedy has called himself a “big fan” of these alternative therapies and promised to end the “war on peptides.”
“Middle Americans, all of a sudden, they are going to start learning more about peptides,” he said. “It’s going to legitimize peptides.”
In a recent interview on Joe Rogan’s podcast, Kennedy unveiled plans to lift restrictions on more than a dozen peptides that he claimed were illegally recategorized under the Biden administration. Kennedy appeared to be referring to roughly 17 peptides the FDA reclassified in 2023, citing “potential significant safety risks,” barring compounding pharmacies from making them.
Before the 2023 restrictions, pharmacies were able to compound peptides that had been prescribed by a physician. Since the FDA moved many of them to its “do not formulate” list, online sellers have cashed in on selling unregulated peptides, most of them from Chinese suppliers, in a gray market at steep discounts.
Some names for peptide therapies includes Semaglutide, Tirzepatide, Retatrutide, BPC-157 (body protection compound), Bremelanotide (PT-141; FDA approved for libido and sexual arousal), CJC-1295 (a growth-type hormone), GHK-Cu (Copper Peptide that stimulate collagen production), Ipamorelin (growth hormone and antiaging), MOTS-c (enhances mitochondrial function) and dozens more. A few peptides are FDA approved drugs still under patent protection, while some are in the approval process. At least one peptide (Sermorelin) was an FDA approved drug that were withdrawn due to being unprofitable. Others have been used for years but have not gone through clinical trials for assorted reasons. Insulin is a peptide, as is the dietary supplement, creatine.
Many (if not most) of the gray market peptide sellers offer certificates of purity from third-party labs. A few test their products for endotoxins and sterility with certificates available to download. Virtually all can be obtained quietly without a doctor’s prescription.
It is not clear how Kennedy expects the FDA to allow compounding of drugs that have not gone through clinical trials and why a company would conduct expensive clinical trials. One risk of Kennedy’s push to legitimize peptide compounding at regulated compounding pharmacies is that the products would likely then be pushed out of reach of the biohackers who currently buy them on the gray market.
Wall Street Journal: Peptides Are Everywhere. RFK Jr. Wants to Make Them Even Easier to Buy
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My worry about what Secretary Kennedy is proposing is that the only physicians who will prescribe such therapy will be the uber expensive boutique, longevity practices like what Mr. Kenndy can afford. The compounding clinics will also be specialized and charge high prices. The only ones who will be able to afford gray market peptides will be the CEOs, Wall Street Executives, Silicon Valley biohackers, attorneys and physicians. Everyone else will be priced out of the market. Currently, anybody who puts some effort into learning about peptides can try the therapy. Perhaps we should leave it the way it is in the gray market.