Why medical director oversight is the center of medspa compliance for these products
A medspa offering Wharton's jelly or exosome products operates under a different compliance standard than one offering topical treatments or devices. These are biologic products regulated under federal frameworks, and the physician responsible for the medspa, often serving as its medical director, carries oversight responsibility for how they are ordered, stored, and offered, even when the physician is not performing every procedure personally.
That oversight is not a formality. It covers vendor selection, staff training, the content of marketing materials, and the clinic's documentation trail, in addition to clinical supervision. A medspa that treats the medical director's role as a license to display rather than an active oversight function is exposed on several fronts at once.
Supervision and scope of practice
State requirements for physician supervision at medspas vary, and they intersect with, but are separate from, federal rules governing the products themselves. A medical director should confirm, independent of the vendor relationship, that the clinic's staffing and supervision model meets the requirements of the state in which it operates.
This is a legal and licensing question, not a product question, and it should be answered with counsel familiar with your state's medical practice act, not inferred from vendor marketing materials.
Marketing review: what should be checked before anything publishes
FTC guidance on health-related marketing requires competent and reliable scientific evidence behind any claim about a product's effect, and recent FDA warning letters to distributors in this space have cited website and social media content describing disease benefits as evidence of unapproved intended use. A medical director, or a designated compliance reviewer, should check every page, post, and caption referencing these products before it goes live, not after a complaint arrives.
Review content the practice publishes, commissions or republishes, and ask counsel how affiliate or other third-party claims affect its responsibilities.
- No disease, condition, or symptom named as something the product addresses
- No claims of healing, repair, regeneration, or improved outcomes
- No use of the term stem cell therapy to describe these offerings
- No testimonials presented as representative results
- No research-use-only language used to describe a product being offered for patient use
Vendor and product documentation the medical director should hold on file
A medical director's oversight is only as good as the documentation behind it. That includes lot-specific certificates of analysis, donor eligibility and testing summaries available on request, and, where applicable, the full ingredient or characterization data a supplier discloses to verified accounts.
Holding this documentation is not a one-time intake step. It should be refreshed as new lots are ordered, since release testing and lot identifiers change shipment to shipment. For exosome products specifically, FDA states no exosome product is FDA approved; these products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions rest with the physician and their own regulatory counsel.
State law considerations
Some states have enacted laws specific to non-FDA-approved regenerative therapies; Florida, for example, passed SB 1768, effective mid-2025, which permits physicians to use certain non-FDA-approved stem cell therapies in specific practice areas with informed consent and disclosure requirements. Laws like this address physician authority at the state level and do not change the product's federal regulatory status.
A medical director operating in a state with this kind of statute should still treat federal intended-use and marketing rules as the binding floor, not treat the state law as a substitute for them.
A starting checklist for internal compliance review
Treat this as a living document reviewed on a set schedule, not a one-time setup task.
- Confirm physician supervision model meets state requirements
- Review all product-related marketing copy before publication, including social and affiliate content
- Maintain current lot documentation for every product in inventory
- Confirm staff know not to characterize these products as stem cell therapies or disease treatments
- Revisit the checklist whenever a new product, platform, or marketing channel is added
Frequently asked questions
Can a medspa offer these products without a physician on site at all times?+
That depends on your state's supervision and scope-of-practice requirements for the specific services offered, which is a licensing question separate from the product itself. Confirm the staffing model with counsel familiar with your state's medical practice act.
What should a medical director check before marketing content goes live?+
Confirm it does not name a disease or condition, does not claim healing or improved outcomes, does not call the offering stem cell therapy, and does not include testimonials. This review should extend to social media and affiliate content, not just the clinic's own website.
Does a state law like Florida's SB 1768 override federal rules for these products?+
No. State statutes addressing non-FDA-approved therapies govern physician authority at the state level. They do not change how the product itself is regulated federally, and marketing and intended-use rules still apply.
Where should we go for guidance specific to our state and situation?+
Regulatory counsel familiar with both HCT/P and biologic drug regulation and your state's medical practice act is the right resource. This article is educational and is not legal advice.