FDA Panel Backs Six Peptides With No Human Trials
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- FDA advisory committee voted by slim majorities to recommend the agency add six experimental peptides — BPC-157, KPV, TB-500, MOTs-C, Semax and epitalon — to its compounding list, rejecting only emideltide
- HHS nominated eight new committee members the week before the meeting, six of whom had ties to the peptide industry; HHS said all underwent standard ethics review
- None of the seven peptides has been tested in rigorous human clinical trials, per University of Southern California's Alexander Weber — most research comes from animal studies, including MOTs-C's effects on blood sugar and obesity in mice
- The FDA's own research briefs concluded there isn't sufficient evidence to support adding the seven peptides to the compounding list, though the final decision rests with the agency
- The unregulated peptide market is estimated at $100 million to $3 billion, with peptides sold online and offered at wellness spas, chiropractor offices and rehabilitation clinics in the US, UK and EU
- A New Yorker investigation found some peptides purchased through one online retailer contained lead, signs of bacterial contamination or significantly smaller doses than advertised
- TB-500 appears to accelerate tissue regeneration in animals, but Weber warned this same property may also spur cancer growth — a risk not yet evaluated even in animals
Why it matters: If the FDA accepts the recommendation, compounding pharmacies could manufacture these six peptides — lending them credibility researchers say isn't backed by human trial data. Consumers may assume compounding-list inclusion means safety and efficacy, though the FDA's own briefs found insufficient evidence. Six of eight newly nominated committee members had peptide-industry ties.
