FDA Cracks Down on Unapproved Peptide Therapies and Compounding Pharmacies

The FDA sent 30 warning letters to telehealth companies for misleading marketing of compounded GLP-1 peptides and issued multiple warning letters to peptide sellers in 2026. The agency is reclassifying peptides as biologics and tightening compounding oversight.

Regulatory changes and reclassification

• ▪FDA 2026 peptide regulations reclassify many peptides as biologics and tighten compounding pharmacy oversight

Debatable claims

• ▪Compounding pharmacies should be allowed to sell peptides without FDA approval when no approved alternative exists
• ▪FDA restrictions on compounded peptides will limit patient access to needed treatments

FDA enforcement actions

• ▪FDA warned 30 telehealth companies for making false or misleading claims about compounded GLP-1 products
• ▪FDA sent warning letters to Gram Peptides and Wholesale Peptide for illegally selling unapproved peptide products
• ▪Compounded drugs are not FDA-approved and do not undergo review for safety, effectiveness, or quality before marketing

Safety risks and bulk substance concerns

• ▪FDA identified certain bulk drug substances for compounding that may present significant safety risks