Millions of Americans are turning to peptides to biohack their health, driven partly by the U.S. Department of Health and Human Services relaxed attitude towards nontraditional medicine. Peptides are chains of amino acids linked by peptide bonds that occur naturally in the body. Peptides signal various parts of your body to release hormones or modulate the body in numerous ways. While insulin, and GLP-1 weight loss drugs are common examples of peptides, there are numerous others most people have never heard of.
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 At least one peptide (Sermorelin) was an FDA approved drug that was withdrawn due to being unprofitable. Others have been used for years but have not gone through clinical trials for assorted reasons. Oxytocin is a peptide, as is the dietary supplement, creatine. Some names for peptide therapies includes Semaglutide, Tirzepatide, Retatrutide (the former are weight-loss drugs), 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. The following is from the Wall Street Journal:
Demand for restricted peptides has fueled an online gray market for injections promising youth, beauty and strength. American businesses are racing—and taking risks—to get in on the craze.
These drugs, which advocate a D.I.Y. approach to health and longevity, are largely unapproved by the Food and Drug Association, meaning they can’t be marketed or sold for human consumption in the U.S. But with the support of Health Secretary Robert F. Kennedy Jr., several popular peptides will soon be up for reclassification, paving the way for a multibillion-dollar wellness gold rush.
Many people equate peptides to snake oil, while others are quick to remind that numerous FDA approved drugs are peptides. Glucagon, the active ingredient in GLP-1 drugs occurs naturally in the body but has a short half-life. Scientists figured out a way to make the half-life last roughly one week rather than mere minutes. Telemedicine startups are trying to cash in on the peptide craze, as are many doctors. Much of the information about peptides comes from peptide sellers and longevity doctors on YouTube. More from WSJ:
Some longevity doctors and medical clinics are selling peptides directly to patients, obtaining substances both domestically and from abroad. Alabama’s Board of Medical Examiners released a statement in May underscoring its stance against doctors “recommending, supplying, prescribing or administering these substances.”
The FDA during the Biden Administration added some popular peptides to the “do not compound” list, preventing compounding pharmacies from producing them. The Trump Administration removed most of these from the list. The FDA will meet in July to discuss whether seven popular peptides should be further unregulated with doctors free to dispense despite not being FDA approved.
This is unfamiliar territory for the FDA. The federal agency begrudgingly tolerates herbs and dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) of 1994 is a federal law that bars the FDA from regulating dietary supplements. The laws are something of a paradox. If herbs work, then they meet the definition of a drug, i.e., any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. If herbs and dietary supplements do not work or are dangerous, then they are something consumers should be protected from the FDA’s perspective. Peptides fall into a similar gray area of the health elixir market. Moreover, peptides are fragile and must be injected rather than taken orally. Thus, they don’t even fall within the category of dietary.
The most interesting thing about peptide therapy from a policy perspective is that the FDA is being dragged – kicking and screaming – into an area of unapproved, crowdsourced DIY medicine. Will this set a precedent? We can only hope. As peptides become more mainstream doctors, longevity clinics and telemedicine firms will not only sell but also provide information on dosing and therapies. From my perspective this empowers individuals to take more control of their health away from the FDA. Americans should be free to try health remedies knowing the FDA has not approved them.
Read more at:
WSJ: Businesses Are Taking Risks to Cash In on the Peptide Gold Rush
Goodman Institute Health Blog: Health Secretary Wants to Boost Access to (Alternative) Peptide Therapies
The New Yorker: Why Are People Injecting Themselves with Peptides?
CBS News: What to know about the “wild, wild West” of viral peptide health claims