The Pharmacy Compounding Advisory Committee recommended in July that the FDA allow Americans to have greater access to six peptides despite there being little to no human studies proving they work or are safe.
The six peptides are BPC-157, KPV, TB-500, MOTS-C, Epitalon, and Semax, which are used to treat things like ulcerative colitis, wound healing, inflammation, metabolic and bone health, tissue repair, and more.
What are Peptides?
These synthetic peptides are often modified versions of the peptides found in the body. The human body produces more than 7,000 known types of peptides, which are short chain amino acids. Peptides are often referred to as “mini proteins” because longer chains of amino acids are proteins.
Some injectable peptides are thoroughly tested on humans and are FDA-approved, such as insulin and GLP-1s, which are both approved to treat type-2 diabetes. In fact, GLP stands for glucagon-like peptide.
Others, however, like the six recommended in July for sale at compounding pharmacies, are not FDA-approved. The advisory committee recommended they become available for sale at compounding pharmacies, which are businesses that mix medications using ingredients from FDA-inspected facilities, although the drugs themselves tend not to be FDA-approved. Still, many require a doctor’s prescription.
War on Peptides?
Three years ago, the Biden FDA banned the six peptides and more than a dozen others from being sold at compounding pharmacies citing “significant safety risks” from lack of human testing, outraging some peptide users like the highly influential Joe Rogan, whose number one podcast has an audience of 11 million.
“The war on peptides is going on right now,” he said. “There is no danger that these things are causing, there’s no public health concern. There’s no people dropping dead.”
Another peptide user is current Health and Human Services Secretary Robert F. Kennedy, Jr., who vowed to end the war on peptides.
“I’m a big fan of peptides,” he said. “I’ve used them myself and used them with really good effect on a couple of injuries.”
After the ban on certain peptide sales at compounding pharmacies, instead of slowing down, sales only increased, driving customers to the so-called grey or black market.
“They get a little flyer in their email or something, and they hear from somebody else, ‘I got it from this place.’ They don’t even know,” Rogan said. “And they try it and you’re getting nonsense, bogus peptides.”
Kennedy blamed the Biden administration’s ban. “We created the black market, a very dangerous black market,” he said.
In his role as HHS Secretary in the second Trump administration, Kennedy appointed new members to the Pharmacy Compounding Advisory Committee who voted in July to reverse much of the previous ban and allow six peptides to be sold at compounding pharmacies.
Kennedy said if the FDA approved the recommendation, these peptide purchases at compounding pharmacies will be safer than those purchased on the black market, largely because the ingredients will come from facilities that are inspected by the FDA, many of which are in India and China, he said.
“You know you’re getting a good product,” he said. “You know you’re getting what you bought.”
Doctors’ and Scientists’ Concerns
A number of doctors and scientists have expressed concern over the conflicts of interest associated with the advisory committee’s recommendations, including former cardiac surgeon and nutrition and longevity expert Dr. Steven Gundry.
“Anytime you stack the deck I have worries. Actually, six of the committee members were actually people from the peptide industry that’s supposedly being regulated,” he told CBN News. “So it’s kind of like a fox guarding the henhouse.”
Dr. Gundry and others remain troubled by the lack of clinical data on the six peptides, while at the same time point out the safety and efficacy of other injectable peptides that are well-studied and FDA-approved.
“Insulin is a peptide. GLP-1 is a peptide. Peptides are just pieces of amino acids linked together that tell cells what to do. So there’s nothing inherently wrong with peptides,” Gundry said. “It’s just that when a new peptide comes out, synthetically, and you just don’t have human trials that make it safe or not safe, sometimes we rush into these things.”
Rita Jew, President of Institute for Safe Medication Practices, is another health care expert who expressed concern about the recommendation.
“This is really alarming,” she said. “There aren’t that many other substances where people are injecting into themselves, where you see that the clinical evidence is so lacking and yet the practice is so prevalent.”
She and others are worried about potential unintended consequences.
“An immunological response from the peptides is one of the risks,” she said. “The other risk that people have not talked a lot about, depending on what the peptide is, is because some of these peptides have a growth-promoting effect. And it may sound good upfront, but what it can actually do is to turn on some of the genes in your body that cause cancer.”
Patients will need a doctor’s prescription to purchase any of these peptides from a compounding pharmacy. Not all doctors are willing to write one.
“If it sounds too good to be true, it usually is too good to be true. But everybody’s looking for that golden ticket,” Dr. Gundry said. “I always like to remind my patients, when you talk, and meet with, and study these 105-year-old people who are thriving, none of them were injecting themselves with peptides.”
It’s unclear when the FDA will rule on the committee’s recommendation. While it is non-binding, the FDA often goes along with it.
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