The label is defined by function, not by what a seller calls the product. If marketing, labeling, or sales conversations suggest a product is meant to address a disease or condition, FDA can treat it as a drug subject to approval requirements, regardless of how it is otherwise classified as a tissue or cellular product.
This is the issue behind a set of 2026 FDA warning letters sent to distributors of private-label Wharton's jelly and exosome products. The letters cited disease-related claims found on company websites and social media as evidence that the products were being marketed as unapproved new drugs, independent of how the underlying tissue was recovered or processed.
Vendor advertising language carries real regulatory weight. Reviewing how a vendor describes its own products, separate from reviewing the lot documentation itself, is a reasonable part of vetting a supplier. Clinics should keep their own clinical judgment, and any claims they make, distinct from vendor marketing copy.
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.
A vendor's own advertising claims, not just its manufacturing practices, can determine whether a product is being marketed in a way FDA considers an unapproved drug.