WASHINGTON — Federal health advisers kicked off a two-day meeting Thursday to evaluate more than seven peptide compounds, substances that have exploded in popularity in wellness circles even though there is little scientific proof they are safe or work as claimed.
The Food and Drug Administration is hosting the review with the full support of Health Secretary Robert F. Kennedy Jr., who has called himself a strong advocate for peptides and promised to undo industry restrictions that were put in place during the previous administration.
Among those who have championed peptides are podcaster Joe Rogan and wellness influencer Gary Brecka, who supports Kennedy’s “Make America Healthy Again” initiative and sells peptide vials through an online business. Social media is filled with personal testimonials from users who say the substances helped them gain muscle, bounce back from injuries, or achieve a more youthful appearance.
Despite that enthusiasm, the two-day FDA meeting is expected to highlight a sharp divide over these compounds.
The agency’s own career scientists have signaled they do not believe there is sufficient data to justify making peptides more broadly available — particularly through compounding pharmacies, which create customized medications not offered by traditional pharmaceutical manufacturers.
Many medical and scientific professionals who submitted input ahead of the meeting share that cautious view.
“This is really alarming,” said Rita Jew, a pharmacist and president of the Institute for Safe Medication Practices. “There aren’t that many other substances people are injecting into themselves where you see that the clinical evidence is so lacking.”
However, the panel of outside advisers assembled for the meeting includes at least seven doctors or pharmacists who have financial relationships with the peptide industry. Among them are owners of wellness clinics that sell peptides, pharmacies that manufacture the formulas, and online consulting businesses that market them. Other advisory panels formed under Kennedy’s leadership have drawn criticism over similar apparent conflicts of interest.
Earlier this week, the FDA expanded the 20-member panel by adding several more experts, including academics with no financial ties to the peptide industry.
The panel will vote on whether the FDA should allow seven widely used peptides to be added to an approved list of substances that compounding pharmacies may safely use. Those votes are not binding, and the FDA has previously gone against the recommendations of its outside advisers.
Peptides are the basic building blocks of more complex proteins and trigger hormones in the body that regulate growth, metabolism, and healing. Pharmaceutical companies have developed some peptides into approved medications, including widely used treatments for diabetes and weight loss.
Supporters of the seven peptides under review this week have urged the FDA to consider them for treating conditions such as ulcerative colitis, migraines, and opioid addiction.
In recent years, the FDA had cautioned Americans about the risks of injecting peptides like BPC-157 and TB-500 — both of which are on Thursday’s review agenda. These substances are widely marketed online as tools for recovering from injuries and reducing inflammation, and both are classified as doping substances by international sports authorities.
In a scientific review published before the meeting, FDA scientists repeated their longstanding concerns, consistently noting they could find little data supporting the safety or effectiveness of these compounds. They also flagged risks related to contamination, allergic reactions, and quality control. Most of the available data came from animal studies, primarily involving rats, rather than human clinical trials. For all seven peptides reviewed, FDA staff recommended against approving them for compounding use.
The FDA assessment is just one component of more than 18 hours of scheduled discussions and presentations spread across the two days. The public will also have opportunities to speak directly to the FDA and its advisers during the meeting.
Before the meeting began, the FDA received more than 1,900 public comments, including statements from doctors and patients describing the benefits they say they have experienced from peptides.
“For many people, this is about a therapy that is helping them, and whether they can get it safely and legally from a regulated pharmacy instead of taking their chances in the gray market,” wrote the American Academy of Peptide Medicine, a group made up of doctors and wellness clinic operators who advocate for peptides. The group’s website notes that it is “an educational academy, not a licensing or accrediting body.”
Once the meeting concludes, the FDA will consider the panel’s votes, the discussions that took place, and the public comments before deciding whether to ease access to these peptide compounds.
Those who closely follow FDA policy say the most likely near-term outcome could be a temporary measure assuring compounding pharmacies that they will not face enforcement action for producing the peptides under review. Formally adding the substances to the FDA’s approved compounding list would require new regulations, a process that can take months or even years to complete.
“We’re still going through this process, but I think it’s more than likely that the process will end up at the result that Secretary Kennedy wants,” said Nathan Beaver, an attorney who specializes in FDA regulatory matters.
