WASHINGTON — When U.S. health officials meet next month to reconsider a list of controversial peptide drugs, they will hear from a new set of voices: doctors and pharmacists with deep financial ties to the burgeoning industry of unproven chemicals.
The Food and Drug Administration on Monday released its list of participants for an upcoming meeting to reconsider the safety and effectiveness of several popular peptide injections, including some that have been praised by Health Secretary Robert F. Kennedy Jr.
Previous FDA panels on the topic have been composed of academics and researchers. The agency's new group mainly includes health professionals who prescribe, produce or promote peptides, which have become a wellness trend among athletes, influencers and celebrities.
The two-day meeting is the latest example of how Kennedy and his deputies are trying to reshape U.S. health policy in the mold of the Make America Healthy Again movement. Some of the biggest supporters of the movement sell peptide formulas, though many pharmaceutical industry experts consider them illegal, unapproved drugs.
The substances are sold online and promoted by wellness clinics as a means to build muscle, heal injuries and look younger, though there’s little evidence behind those claims. Peptide sellers often skirt U.S. regulations by labeling their products as "for research use only,” since the FDA doesn’t regulate research chemicals.
FDA has raised safety concerns about peptides
Many of the injectable peptides sold in the U.S. are produced by compounding pharmacies, which mix custom medications that aren't available from traditional drug manufacturers.
For several years, the FDA has warned Americans about the risks of injecting chemicals with names like BPC-157 and TB-500, which have not been extensively studied in humans. Both drugs are considered doping substances by international sports authorities. They are among seven peptides set for review in July.
Previous versions of the FDA’s panel on drug compounding — the group that will meet next month — have voted against a string of peptide ingredients brought forward by compounding pharmacies, declaring all of them too risky to be offered to patients. Those panels were mostly composed of experts from universities including Duke, Harvard and Johns Hopkins.
New FDA panel includes peptide proponents
The FDA's new group includes more than a half-dozen panelists who run clinics, online businesses or pharmacies specializing in peptides, which are often given alongside other unapproved therapies, including vitamin infusions.
For example, panel member Dr. Haleem Mohammed runs clinics in Florida that sell injections of peptides, vitamins, testosterone and weight loss medications. The business is part of a national chain of clinics dubbed Gameday Men's Health. The company's website states, "compounded medications offered through our services are not FDA-approved, and the FDA does not verify their safety."
Another panelist, Dr. Gabriel Alizaidy, charges $500 for “peptide and hormone” consultations, including advice on “where to safely get each peptide or compound.” Alizaidy promotes BPC-157, GHK-Cu and other peptides to thousands of followers through his accounts on Instagram and TikTok.
His website contains the disclaimer that each consultation “is educational in nature and does not constitute medical care, diagnosis, or treatment.”
Another member is Bobby Harshbarger, a Tennessee state senator who has multiple connections to the industry. Harshbarger is a pharmacist at his family's business, Premiere Pharmacy, which sells compounded medications for weight loss, longevity, pain and other conditions.
His mother, Rep. Diana Harshbarger, is also a pharmacist and a Republican member of U.S. Congress from Tennessee. Last year she sent a letter to Kennedy calling on him to relax FDA restrictions on a half-dozen peptides.
President Donald Trump has repeatedly praised Harshbarger's support of his "Make America Great Again" agenda. Last year, the president pardoned her husband, Robert Harshbarger Jr., who pleaded guilty more than a decade ago to substituting an unapproved drug from China for one used by patients on kidney dialysis. He was stripped of his pharmacy license and sentenced to four years in prison, which he served.
Mohammed and Alizaidy did not immediately respond to messages from The Associated Press Monday afternoon. A spokesperson for Harshbarger could not immediately provide comment when reached by phone.
Kennedy and his allies previously criticized government panels
The FDA has more than 30 panels of experts who advise the agency on various drugs, vaccines, food ingredients and other products.
Advisory meetings are subject to strict government transparency rules in terms of panel composition and financial disclosures. Experts who have a financial stake in a company or industry are permitted to serve on the panels, but the relationship must be disclosed and regulators are supposed to explain why the person's expertise outweighs their potential conflict of interest.
Kennedy and his allies have been highly critical of federal expert panels, often alleging that they are riven with conflicts of interest, despite federal data showing otherwise.
Last year, Kennedy fired the Centers for Disease Control and Prevention's entire 17-member vaccine panel and replaced it with a group that includes several anti-vaccine voices. A federal judge later said that action likely violated federal rules.
Kennedy told podcast host Joe Rogan earlier this year that he is “a big fan of peptides,” and described using them to recover from injuries.
Former FDA Commissioner Marty Makary — who resigned in May — was also highly critical of FDA advisory panels, complaining that they were expensive, time-consuming and subject to too many financial conflicts.
The number of such meetings plummeted during Makary's tenure. Instead, the FDA held a number of ad hoc meetings with handpicked experts on topics favored by Kennedy, including the risks of talc powder and antidepressants.
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