Associated Press — More Americans are injecting themselves with unapproved chemicals that are marketed as ways to build muscle, rejuvenate skin and prolong life, in the latest example of the nation's craze. alternative treatments And wellness hacks.
Behind this trend is the growing popularity Weight loss drugs GLP-1a class of so-called peptides approved to quickly help users. lose pounds.
But the peptides promoted influencerscelebrities and health guru differ: many have never been approved for human use, and much of the purported evidence comes from studies in rats and other animals. Some peptides, such as BPC-157 and TB-500, are banned by international sports authorities because doping substances.
“None of them have been proven,” said Dr. Eric Topol, a research methods expert and director of the Scripps Research Translational Institute. “None of them have gone through what would be considered adequate clinical trials, but still a lot of people take them. It's actually quite unusual.”
Those who have highlighted the benefits of peptides include: Secretary of Health Robert F. Kennedy Jr.who built national followers among Americans who are deeply skeptical of health experts, pharmaceutical companies and traditional medicine.
For many years Food and Drug Administration tried to deal with space by sending warning letters to clinics that promote the products and add more than two dozen peptides to the list of ingredients that should not be made in specialty pharmacies, which often custom-mix formulations.
This approach may be coming to an end.
Kennedy vowed to end FDA's “war” on peptides and others alternative treatments which are accepted by many in his Make America Healthy Again movement.
Some of Kennedy's friends and partners are among its biggest supporters, including self-described “biohacker” and “longevity expert” Gary Breck, who sells peptide injections, patches and nasal sprays through his website for $350 to $600 apiece.
In May, speaking on Brackey's podcast, Kennedy again promised to “end the FDA's war” on peptides. stem cells, psychedelics and other complementary treatments.
“Music to my ears,” Breka replied.
Breca declined to be interviewed for this article.
Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger the production of hormones necessary for growth, metabolism and healing.
The FDA has approved a number of peptides as drugs, including insulin for diabetics who do not produce it naturally, and human growth hormone for children with developmental disorders caused by low levels of the hormone.
But many other peptides advertised online have never been approved, making their sale as drugs technically illegal. According to current FDA guidance, these peptides are also not subject to interest calculation – The process by which pharmacies prepare customized medications for patients.
That hasn't stopped celebrities and influencers from promoting them.
Joe Roganfor example, has repeatedly praised BPC-157, a peptide derived from acids found in the intestines.
“I had elbow tendinitis, 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 listed on the website of Ways 2 Well, a Texas company that offers peptides. stem cells, vitamin infusions and other alternative treatments.
It's all part of the “circus of untested, expensive and possibly dangerous” proposals promoted by health and longevity clinicssaid Topol, who has written about the industry.
For $99, Ways 2 Well offers a “peptide consultation” with a physician, after which the company ships vials of peptides along with “a complete kit with dosage, instructions, and syringes,” according to its website.
Company founder Brigham Buehler is a former pharmaceutical sales representative. He did not respond to requests for comment.
Andrea Steinbrenner, an executive with a consulting company, said she was intrigued by peptides after hearing about their benefits for “longevity, recovery, 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 in addition to their daily supplements.
“I think peptides are popular now because we are an aging generation and are looking for an alternative to modern medicine,” she said. “I absolutely believe in modern Western medicine – it is necessary. But there are many other things in the universe that the earth provides.”
Proponents of peptides often assume that their products are safe because they are based on substances found in the body.
“Unlike synthetic pharmaceuticals, peptides are naturally recognized by your body,” Breca told his more than 2 million Instagram followers in February.
Critics point out that marketed peptides are often imperfect synthetics and taken in doses far greater than any peptides in the body, increasing the risk of allergic reactions and other harmful effects.
Breca sells more than a half-dozen peptides, including ipamorelin and CJC-1295—both of which FDA noted for serious security risks.
Like other peptides sold on Brekey's website, bottles of ipamorelin are labeled “for research use only.”
The language of “research use” is common in the peptide space, even on forums where users exchange advice on purchasing, dosing, and “stacking” various drug combinations.
One Facebook group instructs members on what words to avoid: “instead of 'taking,' you 'research' peptides.”
Lawyers in the field say the language is an attempt to circumvent FDA regulations. The agency does not control chemicals not intended for human use.
It is often unclear whether such peptides are manufactured in US pharmacies and mislabeled for research, or whether they are purchased from chemical manufacturers, many of which are located in China and are not subject to FDA drug quality standards.
“Research-grade peptides will contain junk,” said Paul Knopfler, a cell biologist at the University of California, Davis. “The purification process will use chemicals and peptide fragments that you don’t want.”
On platforms like TikTok, companies in China and other countries are offering to ship dozens of varieties of peptides to the U.S. for as little as $5 a bottle.
– What's really there? Knopfler said. “If someone injects it under their skin, what will they get?”
During COVID-19 pandemicThe FDA has released more than half a dozen warning letters companies promoting peptides with “immune-boosting abilities.”
Then in 2023, the agency added about 20 peptides to the list of substances that should not be mixed due to safety risks. Pharmacies that violate this measure risk fines, lawsuits or the potential loss of their state licenses.
This has prompted resistance from healthcare and compounding pharmacies, including lawsuits.
One coalition, Save Peptides, warned its followers: “The FDA is denying us basic human rights to access alternative health care using regenerative peptides.”
The lawsuit, brought by a large compounding pharmacy, alleged that regulators skipped legally required steps in adding peptides to the FDA's list of high-risk substances. The lawsuit forced the agency to back down, and late last year the FDA agreed to convene two public meetings of outside consultants to review several peptides flagged as safety concerns.
In each case, the experts agreed with the FDA, voting that the substances were too dangerous to mix.
Some in the industry disagree.
“Doctors should have every arrow at their disposal to treat diseases, but because of the FDA's inaction, they are not doing so,” said Lee Rosebush, who helped file the lawsuit against the FDA and represents a group of large compounding pharmacies.
Kennedy's FDA recently removed a number of experts from its formulation advisory panel.
This could pave the way for the appointment of more peptide-friendly experts who could vote on the approval of some drugs that were previously banned by the FDA. Alternatively, the FDA could simply publish a list of peptides and tell pharmacies and clinics that the agency will not impose bans on them.
So far, doctors say they are fielding more questions from patients who are interested in peptides and looking for prescriptions.
“Patients should really ask their healthcare providers: Are these medications safe in the long term?” says Dr. Anita Gupta of Johns Hopkins School of Medicine, who until earlier this year served on the FDA's formulation committee. “That's the question I would ask if I were a patient.”
___
AP video journalist Javier Archiga contributed to this story from San Diego.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
