CBER's responsibilities span licensing biologics through the BLA process, overseeing HCT/Ps under 21 CFR Part 1271, and issuing enforcement correspondence, including warning letters, to companies the center believes are out of compliance.
FDA sent 2026 warning letters to distributors citing disease claims on websites and social media. CBER is the FDA center with jurisdiction over Wharton's jelly and exosome products.
Knowing that CBER is the specific FDA center with jurisdiction over this product category is useful context for reading vendor documentation. CBER registration or correspondence with CBER describes a company's standing with the agency; it is not an endorsement of a product's claims or an approval of the product itself.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Understanding which FDA center governs this product category helps a buyer interpret what a vendor's registration or correspondence with FDA actually represents.