WASHINGTON — Unapproved peptide drugs have become the new fashionable hack among health influencersfitness trainers and celebrities, marketed as a way to build muscle, shed pounds and look younger.
Online retailers will offer injection vials for between $300 and $600 each. Longevity And health clinics offer in-office exams and injections, sometimes with membership fees of thousands of dollars a month.
But many of the products have never been studied in detail in humans, raising concerns that they may cause allergic reactions, metabolic problems and other dangerous side effects.
Here's a closer look at the science, hype, and potential risks associated with this trend.
In the human body, peptides are short chains of amino acids that perform important functions.
Insulinfor example, controls blood sugar levels and helps break down food into energy. Similar to popular weight loss drugs. GLP-1 – short for glucagon-like peptides – are based on a hormone found in the intestines that helps regulate blood sugar levels.
Food and Drug Administration approved both substances as medicines. But there are many more peptides that have never been approved by regulators as safe or effective, although some have shown interesting results in studies in rodents and other animals.
The synthesized peptides are not new. Some doctors have been prescribing them off-label or for unapproved use for decades to patients with stomach ulcers, nervous system disorders and other conditions.
In recent years, peptides have become the focus of attention health guru and other public figures with large online followings. This has sparked interest in using little-known peptides for unproven purposes such as treating injuries, improving complexion and even prolonging life. Peptides in this group include an alphabet selection of injectable compounds, including BPC-157, Thymosin Alpha, GHK-Copper and many others. Some of them are prohibited by sports regulators because doping substances.
Experts who have studied this area are particularly concerned that some people are combining multiple peptides.
“These influencers often advocate taking a set of peptides every month, so it could be two, three, four different peptides,” said Dr. Eric Topol of the Scripps Research Translational Institute. “That's really what I think is dangerous.”
Celebrities are increasing interest in the trend.
Joe Rogan has repeatedly spoken about the use of BPC-157 for recovery from injuries. Jennifer Aniston talked about taking weekly peptide injections to improve her skin and is currently working as a paid spokesperson for a company that sells peptide-enriched supplements.
“If some celebrity uses a peptide and they say it worked for me, then of course it will become more popular and people will look into it,” said Kay Robins, a clinical nurse practitioner and operator of Pure Alchemy Wellness, a clinic outside San Diego that sells peptide infusions and injections.
Robins says it no longer offers BPC-157 and other peptides targeted by the FDA.
Most unproven peptides advertised online are technically sold illegally.
Any substance that is injected to improve health or prevent disease is classified as a drug that cannot be marketed without FDA approval.
The agency believes that many peptides biological drugsthe most complex and potentially dangerous type of drugs, requiring special precautions during their manufacture and storage. In recent years, the agency has added more than two dozen peptides to list of substances which should not be produced in pharmacies due to safety risks.
Some companies market their peptides as dietary supplements, especially those sold as tablets, gummies, or powders.
Although dietary supplements are less heavily regulated than drugs, the FDA still requires them to contain only ingredients on its list of approved substances. Most peptides are not included on this list and therefore cannot be sold as supplements.
Experts generally agree that taking peptides orally likely has little or no effect because they dissolve in the intestines.
Most injectable peptides sold in the US are manufactured prescription pharmacieswho individually mix medications that drug manufacturers do not stock. Pharmacies are regulated at the state level and generally are not subject to the same scrutiny as companies regulated by the FDA.
In recent years, compounding pharmacies have entered the blockbuster market for GLP-1 drugs. Under FDA regulations, compounding drug pharmacies can make their own versions of prescription drugs if there is a shortage.
Earlier this year, the FDA found that GLP-1 deficiency is overThis meant that compounders had to stop production. But many continued creating custom versions drugs – adding additional ingredients such as vitamin B, which they say benefits patients.
“Previously, there has never been a monetary incentive to go beyond what the law allows for compounding,” said Nathaniel Luckman, a lawyer who specializes in FDA matters. “There were no dollars there.”
Some of the industry's new production capacity has been devoted to the production of unapproved peptides such as BPC-157.
This trend recently caught the attention of the FDA, which added more than two dozen peptides to its temporary list of substances that should not be mixed due to safety concerns.
Secretary of Health Robert F. Kennedy Jr. is among those touting the potential benefits of peptides. He has repeatedly promised to end the “FDA war” on peptides, which have become popular among many followers his Make America Healthy Again Movement.
Some of Kennedy's friends and partners are also well-known peptide marketers, including self-proclaimed “biohacker” Gary Breck and functional medicine physician and author Dr. Mark Hyman.
Some in the peptide field expect Kennedy to lift the FDA's restrictions on the industry, which could include publishing a list of peptides that the agency will no longer try to keep from the market.
___
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 Science Education Media Group and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
