A Food and Drug Administration advisory panel last week recommended loosening compounding restrictions for six out of seven peptides it reviewed, despite safety and efficacy concerns expressed by agency scientists. The panel, several of whom are sellers of experimental peptides, dismissed the views of the agency’s staff, voting in favor of allowing compounding production of comparatively unregulated peptide treatments. Specifically, the six peptide products could be added to an approved list of ingredients that specialty pharmacies can use to make custom medications. But such compounded peptides are not FDA-approved and therefore not subject to the same safety and efficacy standards as medicines that go through the standard regulatory review process.
Though the FDA generally follows advisory panel’s recommendations, it’s unclear how the agency will act, particularly given that staff scientists have expressed their opposition to easing access to any of the peptides in question. Historically, the FDA has strongly warned against the use of peptides not approved for marketing due to a lack of data from clinical human trials, the risks of allergic reactions and unknown manufacturing impurities, particularly when compounded. Furthermore, MedPage Today reported last month that at the annual meeting of the American Medical Association delegates urged the FDA to improve their handling of peptides. The group recommends that unapproved synthetic peptide products, currently being obtained from mostly unregulated sources, undergo rigorous regulatory evaluations before licensing.
STAT News reports that under normal circumstances the final decision would be made by FDA scientists, but it’s possible that Trump administration officials could intervene and overrule them. Health and Human Services Secretary Robert F. Kennedy Jr. is a self-avowed “big fan” of these unapproved compounds. And the FDA convened the advisory panel meeting at the behest of Kennedy, a number of lawmakers and the peptide industry itself.
Kennedy and others want to make peptides available to Americans, but through FDA-inspected facilities rather than what the Secretary says are “very, very substandard” gray- and black-market options.
However, Partnership for Safe Medicines Executive Director Shabbir Imber Safdar stated that “these votes are a serious setback for patient safety,” adding that “the Pharmaceutical Compounding Advisory Committee voted to advance substances that FDA’s own scientists flagged as lacking adequate evidence of safety, efficacy, or quality. The Committee’s recommendation will inevitably be interpreted by many as an endorsement of broader clinical use. It is not.”
Among the six agents evaluated by the panel that got a yes vote was a chemical called BPC-157, which is one of the most popular peptides among longevity and wellness influencers. It’s used for inflammatory conditions as well as tissue repair, tendon and ligament healing.
BPC-157 is a synthetic peptide derived from gastric juice. It’s touted by influencers for its potential to accelerate tissue healing and gut repair. But human data is currently limited to several small studies. And there are concerns regarding possible negative effects of angiogenesis associated with this peptide. This is the process through which new blood vessels form from pre-existing ones and is essential for normal cellular growth and wound healing. However, it also plays a potential role in cancer where it supplies tumors with the oxygen and nutrients needed to grow and spread.
Journalist Sara Talpos wrote an excellent exposé on peptides in Undark, revealing intriguing facets of peptide-based therapies such as BPC-157, including their history and applications. In it, she describes how peptides are short and simple chains of amino acids that are the building blocks of proteins. In the human body, they often serve as an inter-cellular communication system. Some peptides are approved for marketing by regulatory authorities like the FDA and taken regularly as medicines by tens of millions of people annually. Examples include insulin for diabetics, as well as glucagon-like peptide-1 agonists such as semaglutide-based Ozempic and Wegovy that can be used for weight loss. Others, such as BPC-157, have been embraced by wellness influencers and popular podcasters like Joe Rogan as a treatment for patients seeking relief from health conditions that may not be well-managed with conventional medical treatment.
While BPC-157 and some other peptides show promise, thus far they lack robust human clinical evidence for the conditions they’re marketed to treat.
Surging Demand for Peptides
There’s what one could call a peptide craze in America at the moment. Millions of Americans are already injecting unapproved chemicals like peptides promoted by a hodgepodge of wellness influencers and celebrity podcasters. Americans are self-administering products like BPC-157 based on what they see on forums such as Reddit, and generally not from what the advice of their physicians.
Alex Wade Ginsberg, writing in his blog, Drugstore Cowboy, laments the advisory panel’s line of reasoning in which high commercial demand for peptides is evidently replacing the need for science and proper forms of regulatory review of the safety and efficacy of the products.
“Influencers, wellness clinics, telehealth companies, and podcast personalities spent years promoting peptides as shortcuts to faster recovery, better sleep, weight loss, improved cognition, lower inflammation, and slower aging. Consumers began buying them. Businesses formed to serve those consumers. The businesses then pointed to the size of the market as evidence that regulators needed to accommodate it.”
What’s especially problematic, according to Ginsberg, is that now that compounding may move ahead, few lay consumers will understand the legal difference between an FDA-approved drug and a substance permitted for compounding. And should the FDA go along with the advisory panel’s recommendations, the numbers of users of a variety of peptides will surely grow.
Believed by some to help with healing, recovery and reduction of inflammation, advocates go so far as to suggest peptides can increase longevity. More than 84% of patients cite social media, podcasts, influencers, or online forums as key sources of their information, sometimes in lieu of their doctors’ advice.
A recent Sermo survey of hundreds of United States-based physicians indicate that almost half of the responding doctors reported that patients disclosed use of unapproved peptides in the past year. Two-thirds of physicians said they are “very” or “moderately” concerned about patients accessing investigational peptides outside supervised clinical pathways, with more than four out of five asserting that FDA licensing is “essential” or “very important” to how they would counsel patients on peptide use.
Worldwide, the wellness industry is lucrative, as it’s worth trillions of dollars and is expanding substantially. But the risks of taking the wrong substance, dose or combination of products are real.
Furthermore, it’s conspicuous that a Pew Research Center analysis of thousands of large wellness accounts found that only around 40% have a formal medical professional background. The majority are business owners and so-called life coaches. Relying on these sources for health advice and products may not be in the interests of consumers’ well-being.