FDA Panel Backs Untested Peptides Despite No Human Trials
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- An FDA advisory committee recommended adding six experimental peptides (BPC-157, KPV, TB-500, MOTs-C, Semax and epitalon) to the agency's compounding list, rejecting only emideltide, with all votes passing by slim majorities.
- The six recommended peptides have never been tested in scientifically rigorous human clinical trials, according to Alexander Weber of the University of Southern California, whose research is largely limited to animal studies.
- HHS, which oversees the FDA, nominated eight new advisory committee members the week before the meeting, six of whom had ties to the peptide industry; HHS said all members underwent standard ethics review.
- The FDA's own staff briefs compiled for the committee concluded there is insufficient evidence to support adding the seven peptides to the compounding list, putting the agency's reviewers at odds with the panel's recommendation.
- A New Yorker investigation in April found that peptides purchased through one online retailer contained lead, signs of bacterial contamination, or doses significantly smaller than advertised.
- The unregulated peptide market is estimated at $100 million to $3 billion, with compounds now sold through wellness spas, chiropractor offices and online retailers in the US, UK, Canada and the EU.
- TB-500, one of the recommended peptides, may spur cancer growth through its tissue-regeneration properties, according to Weber—a risk that has yet to be evaluated even in animals.
Why it matters: If the FDA follows its committee, compounding pharmacies can begin manufacturing six peptides that have never passed human clinical trials, lending them an air of proven safety while potentially exposing patients to contamination risks and unknown side effects like TB-500's possible cancer-promoting activity.
