More Americans are injecting themselves with unapproved chemicals that are touted as ways to increase muscle mass, rejuvenate skin and prolong life, the latest example of the country’s fascination with alternative therapies and wellness gimmicks.
Behind this trend is the growing popularity of weight loss drugs GLP-1, a class of so-called peptides approved to help lose weight quickly.
But the peptides touted by influencers, celebrities, and wellness gurus are different: Many have never been approved for human use, and much of their supposed evidence comes from studies in rats and other animals. Several peptides, such as BPC-157 and TB-500, are banned by international sports authorities as doping substances.
“None of them are proven,” said Dr. Eric Topol, a research methods expert and director of the Scripps Translational Research Institute. “None have gone through what would be considered proper clinical trials, but still, a lot of people are taking them. It’s really remarkable.”
Among those who have highlighted the benefits of peptides is Health Secretary Robert F. Kennedy Jr., who has built strong national support among Americans deeply skeptical of health experts, pharmaceutical companies and traditional medicine.
For years, the Food and Drug Administration (FDA) has tried to control this sector, sending warning letters to clinics that promote the products and adding more than two dozen peptides to a list of ingredients that should not be manufactured by specialty pharmacies, which often prepare custom formulas.
This approach may be coming to an end.
Kennedy has pledged to end the “FDA’s war” on peptides and other popular alternative treatments in his “Make America Healthy Again” movement.
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Some of Kennedy’s friends and collaborators are among the biggest supporters, such as Gary Brecka, a self-described “biohacker” and “longevity expert,” who sells peptide injectables, patches and nasal sprays through his website at prices ranging from $350 to $600.
In a May appearance on Brecka’s podcast, Kennedy again vowed to “end the war at the FDA” against peptides, stem cells, psychedelics and other alternative therapies.
“Music to my ears!” Brecka responded.
Brecka declined to be interviewed for this article.
A “circus” of wellness products produced without scientific evidence
Peptides are essentially the building blocks of the most complex proteins. Within the human body, peptides activate hormones necessary for growth, metabolism and healing.
The FDA has approved several peptides as medications, including insulin for diabetics who do not produce it naturally and human growth hormone for children with developmental disorders caused by low levels of this hormone.
However, many other peptides promoted online have never been approved, making their marketing as medications technically illegal. Under current FDA guidelines, these peptides are also not suitable for compounding, as the process of pharmacies creating personalized medications for patients is called.
That hasn’t stopped celebrities and influencers from promoting them.
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Popular host Joe Rogan, for example, has repeatedly praised BPC-157, a peptide derived from acids present in the intestine.
“I had tendonitis in my elbow, I started using BPC-157 and it went away in two weeks,” Rogan told his podcast audience last year.
He is among the celebrity clients featured on the website of Ways 2 Well, a Texas-based company that offers peptides, stem cells, vitamin infusions and other alternative treatments.
This is all part of the “circus of unproven, expensive and possibly dangerous offerings” promoted by wellness and longevity clinics, said Topol, who has written about the industry.
For $99, Ways 2 Well offers a “peptide consultation” with a doctor, after which the company ships the peptide vials along with a “complete kit with dosage, instructions and syringes,” according to its website.
The company’s founder, Brigham Buhler, is a former pharmaceutical sales representative. Buhler did not respond to requests for comment.
A “natural” alternative to modern medicine
Andrea Steinbrenner, a consulting executive, said she was drawn to peptides after hearing about their benefits for “longevity, repair, anti-aging and energy” from an acquaintance who runs a clinic outside San Diego.
Steinbrenner and her husband now receive monthly infusions at the clinic, along with daily supplements.
“I think peptides are popular now because we are the aging generation and we are looking for alternatives to modern medicine,” he said. “I firmly believe in modern Western medicine; it is necessary. But there are many other things in the universe that the Earth provides for us.”
Peptide advocates often claim that their products are safe because they are based on substances present in the body.
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“Unlike synthetic drugs, peptides are naturally recognized by the body,” Brecka told his more than two million followers on Instagram in February.
Critics point out that commercially available peptides are often imperfect synthetics and are taken in doses much higher than those produced by the body, increasing the risk of allergic reactions and other harm.
Brecka sells more than a half-dozen peptides, including ipamorelin and CJC-1295, both flagged by the FDA for serious health risks.
Like other peptides sold on Brecka’s website, vials of ipamorelin are labeled: “for research use only.”
A strategy to avoid control
The expression “for research use only” is common in the peptide space, including in forums where users exchange advice on purchasing, dosing and combining different drugs.
A Facebook group tells its members which words to avoid. “Instead of ‘taking,’ you are ‘investigating’ the peptides,” one post notes.
Lawyers specializing in the issue say this language is an attempt to circumvent FDA regulations. The agency does not oversee chemicals that are not intended for human use.
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It is often unclear whether these peptides are produced in the United States by pharmacies and mislabeled for research, or whether they are purchased from chemical manufacturers, many of them located in China and which are not subject to the FDA’s drug quality standards.
“Research-grade peptides contain impurities,” said Paul Knoepfler, a cell biologist at the University of California, Davis. “They contain chemicals used in the purification process and peptide fragments that you don’t want to receive.”
On platforms like TikTok, companies from China and other countries offer to ship dozens of varieties of peptides to the United States for as little as $5 a vial.
“What do they really contain?” asked Knoepfler. “If someone injects it under their skin, what do they get?”
The FDA has been working to restrict peptides for years
During the COVID-19 pandemic, the FDA issued more than half a dozen warning letters to companies promoting peptides with “immunostimulating powers.”
In 2023, the agency added nearly 20 peptides to a list of substances that should not be used in compounding formulations due to safety risks. Pharmacies that violate the measure risk fines, legal action or the possible revocation of their state licenses.
This provoked opposition and demands from entrepreneurs in the wellness sector and compounding pharmacies.
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One coalition, Save Peptides, warned its supporters that: “The FDA is violating our fundamental human right to access alternative medicine using regenerative peptides.”
A lawsuit filed by a major compounding pharmacy alleged that regulators had skipped legally required steps when adding the peptides to the FDA’s list of high-risk substances. The litigation forced the agency to back down, and late last year the FDA agreed to convene two public meetings with outside advisers to review several peptides flagged for health risks.
In both cases, the experts agreed with the FDA, ruling that the substances were too risky for their formulation.
But, some industry members disagree.
“Doctors should have all the tools they need to treat diseases at their disposal, and because of the FDA’s inaction, they don’t,” said Lee Rosebush, who helped file the lawsuit against the FDA and represents a group of large compounding pharmacies.
Changes may be coming
The FDA, under Kennedy, recently removed several experts from the compounding advisory panel.
This could pave the way for the appointment of more peptide-friendly experts, who could vote to allow some of the drugs the FDA had previously banned. Alternatively, the FDA could simply publish a list of peptides and inform pharmacies and clinics that the agency will not enforce bans against them.
For now, doctors say they’re getting more questions from patients who are excited about peptides and looking for prescriptions.
“Patients should ask their health care professionals: Are these drugs safe long-term?” says Dr. Anita Gupta of the Johns Hopkins School of Medicine, who served on the FDA’s compounding committee until earlier this year.
“That’s the question I would ask if I were a patient,” he said.
