Peptides get their regulatory closeup

Stay up to date with our Up First newsletter, sent every weekday morning.It's a big week for the peptide industry, and the growing number of Americans who've come to embrace the therapies touted for wellness and longevity.The Food and Drug Administration is convening a panel of outside experts for a two-day meeting starting Thursday to make recommendations on whether compounding pharmacies should be allowed to make some of the most popular injectable peptides.The gathering of the Pharmacy Compounding Advisory Committee is slated to begin early Thursday morning and stretch until Friday afternoon.The group will review the evidence for seven compounds, including some of the most sought-after injectables: TB-500, BPC-157 and MOTs-C.None of them have undergone the kind of large-scale trials to establish safety and effectiveness that are required for FDA drug approvals."I see it as very risky," says Paul Knoepfler, a cell and molecular biologist at University of California, Davis who has tracked the upsurge in demand for these peptides, "These are drugs and they haven't been scientifically proven."And yet the therapies have attracted enormous attention in the wellness space, where they're promoted for injury recovery, muscle growth and fat loss, skin health, metabolism and more.Major direct-to-consumer telehealth companies, med spas and high-end longevity medical practices alike are marketing peptides and their potential.
Proponents argue that the current Biden-era restrictions on compounding of the substances – due to safety concerns and a lack of data — have fueled a grey market of overseas suppliers, raising safety concerns as Americans inject themselves with unvetted substances.It's a message that industry groups are pushing heavily ahead of this week's meeting."When peptides were pulled from the regulated compounding pharmacies, demand didn't go away.It went into the underground," Gary Brecka, a popular podcaster and wellness influencer whose company markets pe...