Americans Turn to Unapproved Peptides Amid Wellness Craze

More Americans are increasingly injecting themselves with unapproved peptides, substances marketed for muscle building, skin rejuvenation, and even life extension. This trend reflects a growing fascination with alternative therapies and wellness strategies, particularly fueled by the recent popularity of GLP-1 weight loss medications. These medications are a class of peptides approved for rapid weight loss, but many of the peptides being promoted online by influencers, celebrities, and wellness advocates have never received approval for human use.

Many of these unapproved peptides, such as BPC-157 and TB-500, are even banned by international sports authorities due to their classification as doping substances. Dr. Eric Topol, a prominent research methods expert and director of the Scripps Research Translational Institute, stated, “None of them are proven. None of them have gone through what would be considered adequate clinical trials, but nonetheless many people are taking these. It’s actually quite extraordinary.”

Among those endorsing the benefits of these peptides is Robert F. Kennedy Jr., who has garnered a significant following among individuals skeptical of traditional medicine and health experts. The Food and Drug Administration (FDA) has been attempting to regulate this area, sending warning letters to clinics promoting these substances and adding over two dozen peptides to a list of ingredients deemed unsuitable for compounding by specialty pharmacies.

Kennedy has expressed intentions to end the FDA’s regulatory measures against peptides and alternative treatments as part of his “Make America Healthy Again” movement. Supporters of this initiative include self-described “biohacker” and “longevity expert” Gary Brecka, who markets peptide injectables, patches, and nasal sprays for prices ranging from $350 to $600 each through his website. In a May podcast appearance, Kennedy reiterated his commitment to “end the war at FDA” on peptides, stem cells, and psychedelics, to which Brecka responded positively.

Peptides function as building blocks for more complex proteins and play pivotal roles within the human body, influencing growth, metabolism, and healing. While the FDA has approved certain peptides, such as insulin for diabetics and human growth hormone for children with growth disorders, many of those marketed online remain unapproved, thereby technically illegal to promote as drugs. The FDA has also classified these peptides as ineligible for compounding, a process through which pharmacies create custom medications for patients.

Despite this, the endorsement of these substances by celebrities and influencers continues unabated. For instance, Joe Rogan has frequently praised BPC-157, claiming it alleviated his tendonitis within two weeks. He is among the celebrity clients listed on the website of Ways 2 Well, a Texas-based company offering peptides alongside other alternative treatments. Critics, including Dr. Topol, label this trend as part of “the circus of unproven, expensive and possibly dangerous” offerings promoted by wellness clinics.

Consumers can pay $99 for a “peptide consult” through Ways 2 Well, after which the company provides peptide vials along with comprehensive dosing instructions and syringes. The founder of the company, Brigham Buhler, a former pharmaceutical sales representative, did not respond to requests for comment.

Individuals like Andrea Steinbrenner, a consulting executive, have sought out peptides after hearing claims about their benefits regarding longevity and anti-aging. Steinbrenner and her husband now receive monthly infusions at a clinic outside of San Diego, in addition to daily supplements. She noted, “I absolutely believe in modern-day, western medicine—it’s necessary. But there’s a lot of other things in the universe that the earth supplies.”

Proponents often claim that peptides are safe due to their natural occurrence in the body. Brecka, addressing his two million Instagram followers, stated, “Unlike synthetic pharmaceuticals, peptides are naturally recognized by your body.” Critics, however, argue that the peptides available for sale are often synthetic versions taken at doses much higher than those naturally present, which increases the risk of adverse reactions.

Many of the peptides sold on Brecka’s website, including ipamorelin and CJC-1295, have been flagged by the FDA for serious safety concerns. Notably, the ipamorelin vials carry the label “research use only,” a designation frequently used throughout the peptide market. This “research use” terminology is often regarded as a method to circumvent FDA regulations, as the agency does not regulate substances not intended for human use.

Concerns have grown about the quality and safety of peptides purchased online, particularly from international sources. Experts point out that many of these products are manufactured in countries with less stringent regulations, such as China. Dr. Paul Knoepfler, a cellular biologist at the University of California Davis, cautioned, “Research-grade peptides are going to have junk in them. They’re going to have chemicals used in the purification process and fragments of peptides that you don’t want.”

During the COVID-19 pandemic, the FDA issued several warning letters to businesses marketing peptides with claims of immune-boosting properties. In 2023, the agency added nearly twenty peptides to its list of substances that should not be compounded due to significant safety risks. Pharmacies that do not comply face potential fines, legal action, or loss of state licenses. This regulatory approach has spurred backlash from wellness advocates and compounding pharmacies, including a lawsuit arguing that the FDA did not follow required legal procedures when adding the peptides to its list.

The litigation prompted the FDA to reverse course, agreeing to organize public meetings with outside advisors to review the safety of several flagged peptides. Despite expert consensus that these substances pose too great a risk to be compounded, advocates argue that healthcare providers should have access to all possible treatments. Lee Rosebush, who helped initiate the lawsuit against the FDA, stated, “Physicians should have every available arrow in the quiver to treat illness.”

Under Kennedy’s influence, the FDA has removed certain experts from its compounding advisory panel, which may lead to the appointment of more peptide-friendly advisors. This could potentially result in the agency relaxing its stance on some previously banned peptides. For the time being, healthcare professionals report an increase in inquiries from patients interested in obtaining prescriptions for these substances.

Dr. Anita Gupta of the Johns Hopkins School of Medicine remarked, “Patients should be really asking their healthcare professionals: Are these medications safe long term? That’s the question I would ask if I was a patient.”

The ongoing debate surrounding the use of unapproved peptides reflects a broader conversation about alternative therapies and the future of healthcare in the United States.