Warning letters can follow an inspection, a review of marketing materials, or a complaint, and describe specific violations such as disease claims, missing required licensure, or deviations from manufacturing or tissue-handling requirements. They are a public record, not a confidential notice.
In 2026, FDA issued warning letters to several distributors of private-label Wharton's jelly and exosome products, including R3 Medical Companies, Blue Horizon International LLC, and Dynamic Stem Cell Therapy, citing disease-related claims found on company websites and social media. Each letter framed the marketing content itself as evidence that the products were being sold as unapproved drugs.
Clinics evaluating a vendor can read these letters as part of a broader picture of how FDA currently enforces claims in this category. A letter addressed to one company does not describe another company's practices. Registration and licensure documentation for any specific vendor is something a buyer should request and verify directly rather than infer from public enforcement history.
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.
Public warning letters show buyers the kinds of marketing claims FDA is currently enforcing against in this product category.