Surge in Unapproved Peptide Use Raises Health Concerns in US

More Americans are increasingly using unapproved peptides, which are marketed as solutions for muscle building, skin rejuvenation, and longevity. This trend reflects a growing interest in alternative therapies and wellness practices that often evade rigorous scientific scrutiny. The rise in popularity of GLP-1 weight loss medications has fueled this phenomenon, leading to endorsements from influencers, celebrities, and health advocates, including prominent figures like Robert F. Kennedy Jr..

Many of these peptides, such as BPC-157 and TB-500, have not received approval for human use, and their purported benefits often stem from studies conducted on animals rather than human clinical trials. According to Dr. Eric Topol, a leading expert in research methodologies at the Scripps Research Translational Institute, “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.”

The U.S. Food and Drug Administration (FDA) has long sought to regulate the use of these substances, issuing warnings to clinics promoting unapproved products and adding over two dozen peptides to a list of ingredients that should not be compounded by pharmacies. The agency has faced challenges from advocates like Kennedy, who has pledged to end the FDA’s restrictions on alternative treatments embraced by his followers.

Kennedy’s allies, such as self-proclaimed “biohacker” and “longevity expert” Gary Brecka, actively promote these peptides through various channels. Brecka’s website offers peptide injectables and patches priced between $350 and $600. During a recent podcast appearance, Kennedy reiterated his commitment to dismantling what he calls the FDA’s “war” on peptides and other alternative therapies. Brecka, who declined to comment for this article, has attracted attention for his claims regarding the efficacy of these substances.

Understanding Peptides and Their Risks

Peptides serve as the building blocks of proteins, playing essential roles in various bodily functions, including hormone regulation and metabolism. While the FDA has approved certain peptides, such as insulin and human growth hormone for specific medical conditions, many marketed online remain unregulated and technically illegal to promote as drugs. Despite this, influencers like Joe Rogan have publicly endorsed peptides like BPC-157, citing personal success stories. Rogan stated, “I had tendonitis in my elbow. I started using BPC-157 and it was gone in two weeks.”

Critics argue that the proliferation of unregulated peptides is part of a larger trend towards unproven wellness products. Dr. Topol characterized the situation as “the circus of unproven, expensive and possibly dangerous offerings” that are heavily marketed by wellness clinics. For instance, a Texas-based company, Ways 2 Well, offers “peptide consults” for $99, after which customers receive kits containing peptides along with dosing instructions and syringes.

Market Trends and Regulatory Challenges

The appeal of peptides appears to resonate particularly among individuals desiring alternatives to conventional medicine. Andrea Steinbrenner, a consulting executive, noted her interest in peptides as a means of achieving longevity, repair, and energy. She expressed that “there’s a lot of other things in the universe that the earth supplies” in addition to conventional medicine.

Proponents often claim that peptides are safe due to their natural origins. Brecka emphasized this viewpoint on social media, stating, “Unlike synthetic pharmaceuticals, peptides are naturally recognized by your body.” Critics counter this assertion, warning that many peptides sold online are synthetic versions taken at significantly higher doses than naturally occurring peptides, increasing the risk of adverse effects.

Regulatory loopholes have allowed these products to flourish, with many vendors labeling them as “for research use only.” This terminology aims to circumvent FDA oversight, as the agency does not regulate substances not intended for human consumption. Legal experts suggest that this language is a tactic to evade scrutiny, allowing pharmacies to mix unapproved compounds that may not meet safety standards.

The FDA has attempted to restrict the sale of these peptides, particularly during the COVID-19 pandemic, when it issued multiple warnings against businesses promoting immune-boosting claims. In March 2023, the agency added nearly 20 peptides to its list of high-risk substances, subjecting compounding pharmacies to potential fines and legal action. This move has sparked backlash from wellness advocates and compounding pharmacies, resulting in lawsuits asserting that the FDA acted unlawfully.

Despite these challenges, the tide may be shifting. Recently, the FDA has faced increased pressure from alternative medicine advocates to reassess its stance on peptides. Under Kennedy’s influence, the agency has made changes to its advisory panel, potentially allowing for a more lenient approach toward the approval of certain peptides in the future.

As interest in these substances grows, healthcare professionals are noting a rise in patient inquiries regarding peptides. Dr. Anita Gupta from the Johns Hopkins School of Medicine urges caution, advising patients to ask their healthcare providers about the long-term safety of such treatments. “That’s the question I would ask if I was a patient,” she stated.

This evolving landscape of peptide use in the United States raises significant questions about health safety, regulatory oversight, and the implications of alternative therapies in modern medicine. As the conversation continues, both proponents and critics will likely play vital roles in shaping the future of this controversial wellness trend.