Informed consent documentation when a product is not FDA approved

Why informed consent matters more for non-FDA-approved biologics

Informed consent carries extra weight when a product has no FDA approval, clearance or license for any disease or condition. FDA has stated that no exosome product is FDA approved; exosome products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions belong to the physician with their own regulatory counsel. Wharton's jelly products are offered under the supplier's HCT/P framework; whether a specific intended use qualifies under 21 CFR 1271.10 is a determination for the clinic and its counsel. Operating in this regulatory environment does not mean a product cannot be purchased or offered; it means the clinic, not the supplier, carries the burden of deciding how the product is used and documenting that decision.

Consent documentation is where that responsibility becomes visible. Consent records document what was disclosed. Have counsel establish the applicable requirements; documentation does not establish legal protection. A clinic's own regulatory counsel should review and approve consent language before it is used, since none of this is legal advice.

What the consent record should establish

Have counsel review the product's status and applicable consent requirements. Consent does not authorize a use prohibited under federal law. The record should avoid implying that the product cures, treats, mitigates or prevents any named condition, and it should not promise a result.

It should also record that supporting documentation, such as a certificate of analysis, donor eligibility summary or lot release record, exists and is available on request, without listing its contents as proof of safety or effectiveness. The patient's acknowledgment that they understand the non-approved status, in their own words or through a signed statement, belongs in the same record.

• Statement of non-approved, non-cleared, non-licensed status
• Statement that use is a physician decision, not a supplier recommendation
• No disease, condition or outcome language
• Reference to documentation available on request
• Patient acknowledgment and signature with date

Keeping consent language consistent with marketing language

FDA's 2026 warning letters to biologics distributors made a consistent point: the agency reads a company's website, social media and affiliate content as evidence of how a product is intended to be used, regardless of what a label or disclaimer says elsewhere. The same logic applies inside a clinic. Review inconsistencies between marketing and consent with counsel; FDA considers promotional claims evidence of intended use.

Clinics that keep patient-facing materials, website copy and consent forms aligned around the same careful language reduce one source of inconsistency counsel may need to address. Internal consistency review, not just a signature on a form, is the practical goal.

State law considerations: the Florida example

State law can expand what a physician is permitted to do without changing what FDA permits for the product itself. Florida's SB 1768, codified at section 459.0127 of the Florida Statutes and effective July 1, 2025, allows MD and DO physicians to use certain non-FDA-approved stem cell therapies in specific practice areas with informed consent and disclosures. It is a state permission structure, not a substitute for federal product rules.

A clinic operating in a state with this kind of statute should treat it as one more layer that consent documentation needs to reflect, alongside the federal regulatory status of the product, not as a reason to loosen the language about approval status. Clinics outside Florida should ask counsel whether a comparable state framework exists where they practice, since these laws vary and some states have none.

Recordkeeping, retention and review cadence

Signed consent forms should be retained with the same discipline a clinic already applies to lot numbers for traceability purposes, since both become relevant together if a patient or regulator later asks which product, lot and consent applied to a specific visit. If your clinic's recordkeeping allows it, consider filing the consent alongside the chart entry that records the lot identifier, rather than in a separate consent-only archive.

Because FDA's enforcement posture toward this category has shifted multiple times in recent years, and new warning letters continue to be issued, consent templates benefit from scheduled review rather than a one-time drafting exercise. A practical cadence is to revisit the template whenever a new warning letter in this product category becomes public or whenever a relevant state statute changes.

Common gaps that undermine a consent record

One gap to check for is a consent form that was written once, early on, and never updated as marketing claims, state law or FDA guidance changed elsewhere in the business. Another gap to check for is language borrowed directly from a supplier's marketing sheet, which may contain the same disease or outcome claims FDA has flagged in recent warning letters.

A third gap to check for is treating consent as purely a legal formality disconnected from clinical practice, so that what the physician verbally tells the patient in the room differs from what the signed form says. Aligning the verbal conversation, the written form and the clinic's own marketing around the same non-approved, non-disease-specific language addresses this inconsistency.

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.