Why documentation matters more than marketing claims
FDA has sent warning letters to distributors of private-label Wharton's jelly and exosome products over disease claims appearing on websites and social media, and FDA treats distributor and affiliate content as evidence of a product's intended use. Pain management and PM&R practices evaluating a new supplier should weigh what documentation is actually provided over how a product is marketed.
Riverside
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
54- Pain Medicine
- 21
- Physical Medicine & Rehabilitation
- 33
Account verification and ordering
An NPI number verified against NPPES is required before an account can place an order. This applies whether a practice bills under pain medicine, physical medicine and rehabilitation, or both specialties.
- NPI required at setup
- Certificate of analysis, donor eligibility summary, and lot release record available per lot
- Exosome characterization data and full ingredient disclosure available to verified accounts
Receiving shipments across the West
Cryopreserved lots ship overnight on dry ice in validated containers after slow-rate freezing and storage at -80 degrees Celsius. Lyophilized exosome formats ship at ambient temperature and are shelf-stable under normal storage per the supplier. Either way, confirming the shipment and logging the lot number at receipt supports the traceability a practice needs at the patient-record level.
Verifying regulatory posture
Exosome products are not FDA approved and are generally regulated as biologic drugs under section 351; Wharton's jelly products are offered under the supplier's HCT/P framework, and whether a specific use qualifies under 21 CFR 1271.10 is a determination for the practice and its counsel. We recommend Riverside practices confirm their posture with the Medical Board of California before ordering.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
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.
Frequently asked questions
How does Precision Biologics handle the disease-claim scrutiny FDA has applied to this category?+
We do not make disease, condition, or outcome claims about our products, and we recommend practices evaluate any vendor on documentation rather than marketing language, consistent with what FDA has cited in recent warning letters.
Can a combined pain medicine and PM&R group use one account?+
Yes, provided the account is verified against a valid NPI number for the billing entity placing orders.
What should we ask for before our medical director approves a new exosome vendor?+
Request the supplier's characterization data, full ingredient disclosure, and certificate of analysis, and confirm with your own counsel how the product is regulated for your intended use.