Full Disclaimer

Complete terms of use for this site: scope, no medical or legal advice, no approval or efficacy claims, no guarantee of outcomes, and sourcing/verification standard.

1. Educational purpose only

This website is an independent, public-education resource concerning U.S. federal and state regulation of regenerative medicine products, including mesenchymal stem cell (MSC) and MSC-derived exosome products. It is published solely for general informational and educational purposes. It does not provide, and should not be understood to provide, medical advice, legal advice, regulatory advice, or a recommendation for or against any specific product, treatment, provider, or course of action.

2. Not medical advice; no physician-patient relationship

Nothing on this site is intended to diagnose, treat, cure, or prevent any disease or medical condition, and nothing on this site creates a physician-patient relationship between the site's authors and any reader. Any description of published research findings (including the condition-specific literature summaries on this site) describes what has been reported in the scientific literature; it is not a statement that any product or therapy is safe or effective for any individual reader, and it is not a substitute for individualized medical evaluation. Always consult a licensed physician before making any decision about your health or the health of someone in your care. If you believe you are experiencing a medical emergency, call 911 or your local emergency number immediately.

3. Not legal advice; no attorney-client relationship

The individual(s) responsible for preparing this site are not licensed to practice law and are not licensed to practice medicine in any jurisdiction. Content addressing statutes, regulations, or case law (including the state-by-state summary and the federal Right to Try Act summary) is provided for general educational understanding of the regulatory landscape and does not constitute legal advice, does not create an attorney-client relationship, and should not be relied upon as a substitute for consultation with a licensed attorney admitted in the relevant jurisdiction. Laws and regulations described on this site change over time and may have changed since this site was last updated; always confirm current legal requirements with qualified counsel before relying on them.

4. No approval or efficacy claims

No claim is made, express or implied, that any product, therapy, or treatment discussed or referenced anywhere on this site is safe, effective, or approved by the U.S. Food and Drug Administration for any use, unless the specific text says so explicitly and accurately. As of the most recent update to this site: FDA has not approved or licensed any exosome product for any indication; FDA has stated publicly that clinics and product sellers who claim their unapproved stem cell or exosome products fall outside FDA's regulatory authority are incorrect; and FDA-registered tissue-establishment status under 21 CFR Part 1271 is not the same thing as FDA product approval. See the pathway and 361-restriction pages on this site for a full explanation of this distinction.

5. No guarantee of outcomes

This site makes no guarantee, warranty, or representation, express or implied, regarding the outcome of any medical treatment, the accuracy or completeness of any third-party source cited, or the current legal status of any statute or regulation described. Regulatory citations and enforcement examples reflect the state of publicly available information as of the drafting date noted internally in this project and may not reflect subsequent legal, regulatory, or enforcement developments.

6. Sourcing and verification standard

Every factual and regulatory claim on this site is intended to be traceable to a cited primary source (the United States Code, the Code of Federal Regulations, an FDA guidance document, an FDA enforcement letter or public statement, or a state statute) or a clearly labeled reputable secondary source. Where a claim could not be independently verified against a primary source as of this draft, it is explicitly flagged in the body text using a labeled "Unverified" tag or a dedicated flag box, rather than presented as settled fact. This site should be treated as a working draft pending professional legal and regulatory review before any public use.

7. No promotion of any specific company or product

This site does not name, endorse, market, or promote any specific company, clinic, manufacturer, or branded product, and none of the content is intended as advertising for any commercial regenerative-medicine offering.

8. Third-party links

This site links to external sources, including FDA.gov, govinfo.gov, the eCFR, PubMed, and various law firm and news publications, for citation and verification purposes. Linking to a third-party source does not constitute an endorsement of that source's other content, and this site is not responsible for the accuracy or availability of external content.

9. Corrections

Because this is a draft prepared for internal legal and regulatory review, it has not yet been finalized, fact-checked by outside counsel, or approved for publication. Any errors identified during review should be corrected before this site is considered for any public-facing use.