Howard Sklamberg, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was recently interviewed on NPR's "Morning Edition," discussing FDA regulation of synthetic peptides as they gain popularity among wellness influencers.
Howard noted that compounding pharmacies – where lots of patients obtain peptides, some of which aren't FDA-approved – are regulated differently than typical drug manufacturers. He highlighted that this increases consumer risk, particularly when products are produced in large quantities.
"That's been a longstanding challenge for FDA for many years," Howard noted. "You then have to have systems in place that guarantee that the product doesn't have contaminants [and that] the right procedures are being used."
Howard added that the marketing of some peptides as supplements classifies them as a sort of unregulated drugs, with the volume of products available becoming a "Wild West" for FDA regulators.