Federal health advisers began meeting Thursday to review more than a half-dozen peptides, substances that have become a growing wellness trend despite limited evidence of their safety or effectiveness. The two-day meeting, hosted by the Food and Drug Administration (FDA), has the backing of Health Secretary Robert F. Kennedy Jr., who has described himself as a "big fan" of peptides and vowed to overturn industry restrictions.
Peptide supporters include podcaster Joe Rogan and wellness influencers such as Gary Brecka, who sells peptide vials online and supports Kennedy’s "Make America Healthy Again" agenda. Social media platforms are filled with testimonials from individuals claiming peptides have aided in muscle building, injury recovery, or presented anti-aging effects.
Despite this support, the FDA's meeting is expected to highlight a significant division regarding these compounds. FDA career scientists have expressed that insufficient data exists to support wider availability, particularly from compounding pharmacies, which prepare customized medications not offered by traditional drugmakers. Many medical and scientific experts share this stance.
"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 convened for the meeting includes at least seven doctors or pharmacists with financial ties to the peptide industry. This group includes owners of wellness clinics that sell peptides, pharmacies that produce them, and online consulting businesses that promote them. Some of the expert panels appointed under Kennedy have previously faced criticism for alleged conflicts of interest.
Earlier this week, the FDA added several experts to the 20-member panel, including academics without industry connections.
Regulatory Review
The experts will vote on whether the FDA should permit seven popular peptides to be added to a list of substances deemed safe for compounding by pharmacies. These votes are not binding, and the FDA has, at times, deviated from the recommendations of its outside experts.
Peptides are fundamental components of proteins, stimulating hormones within the body essential for growth, metabolism, and healing. Pharmaceutical companies have successfully brought several peptides to market as medications, including widely used treatments for diabetes and weight loss.
Supporters of the peptides under review are asking the FDA to consider them for various medical conditions, such as ulcerative colitis, migraines, and opioid addiction.
In recent years, the FDA has cautioned the public about the risks associated with injecting peptides like BPC-157 and TB-500, both of which are scheduled for review. These chemicals are marketed online as aids for injury recovery and inflammation reduction. International sports authorities classify both as doping substances.
In a scientific review released ahead of the meeting, FDA scientists reiterated their ongoing concerns. Regulators stated they found minimal data on safety or effectiveness and raised alarms about potential contamination, allergic reactions, and quality control issues. The majority of available data originated from animal studies, primarily in rats, rather than human trials.
For all seven peptides under examination, FDA staff recommended against making them available for compounding.
The FDA's assessment is one component of over 18 hours of scheduled discussions and presentations across the two days. The meeting also provides opportunities for public input, allowing members of the public to address the FDA and its experts.
Ahead of the meeting, the FDA received more than 1,900 public comments, including statements from doctors and patients detailing the benefits they have experienced with 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," stated the American Academy of Peptide Medicine, a group comprising doctors and wellness clinic operators who advocate for peptides. The group's website identifies it as "an educational academy, not a licensing or accrediting body."
Following the meeting, the FDA will consider the votes, discussions, and public comments before deciding whether to ease access to the peptides. Industry observers suggest a likely outcome could be a temporary policy assuring pharmacies that they will not face enforcement actions for compounding the peptides under review. Formally adding the substances to the FDA's list of safe compounds would necessitate new regulations, a process that can take months or years.
"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 specializing in FDA issues.