Jurisdictions

{ "jurisdictions": [ { "id": "jp", "name": "Japan", "region": "Asia", "verdict": "grey", "classification": { "product_status": "Not cells, so outside the Act on the Safety of Regenerative Medicine. Sold with therapeutic claims it becomes a regenerative medicine product or drug under the PMD Act.", "clinical_status": "Administered as free private medical practice at physician discretion. No committee review, no provision plan, no mandatory adverse-event reporting.", "cosmetic_status": "Culture supernatant permitted as cosmetic raw material under the Standards for Biological Raw Materials. Human placenta extract prohibited." }, "legal_basis": [ { "instrument": "Act on the Safety of Regenerative Medicine", "citation": "Amended act in force 31 May 2025", "date": "2025-05-31", "summary": "Added in vivo gene therapy. Extracellular vesicles and oligonucleotides explicitly left out of scope." }, { "instrument": "PMD Act", "citation": "Act No. 145 of 1960 as amended", "date": "", "summary": "Governs products. Therapeutic claims require approval." }, { "instrument": "Standards for Biological Raw Materials", "citation": "MHLW Notification No. 210 of 2003, revised 2026", "date": "2026", "summary": "Governs human-derived cosmetic raw materials. Placenta extract prohibited." } ], "permitted": [ "Administering exosomes as free private medical practice", "Culture supernatant as a cosmetic raw material", "Cell therapies under a Class I-III provision plan", "Conditional and time-limited approval or Sakigake designation" ], "grey": [ "The entire private exosome clinic sector, lawful because nothing addresses it", "Physician personal import used to stock clinic inventory", "Marketing an unapproved imported product to clinics", "'Exosome therapy' used interchangeably with unfractionated supernatant" ], "prohibited": [ "Human placenta extract as a biological raw material", "Disease-treatment claims on an unapproved product", "Advertising an unapproved therapy as established" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "restricted", "dental_pulp": "allowed", "ipsc": "allowed", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "low", "recent_actions": [ { "date": "2023-10", "body": "JSRM", "target": "Policy proposal", "note": "Proposed bringing EVs into ASRM scope. Not adopted in the 2025 amendment." }, { "date": "2024-04", "body": "JSRM", "target": "Providers", "note": "Guidance issued to institutions offering supernatant and exosome therapy." } ] }, "route_in": "Fast: supply physicians in the private market, accepting the position rests on a regulatory gap. Durable: an ASRM provision plan or a PMD Act filing with conditional approval.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [ "Whether the next amendment cycle brings EVs into scope", "Whether personal import at inventory scale draws enforcement" ], "priority": 2 }, { "id": "kr", "name": "South Korea", "region": "Asia", "verdict": "grey", "classification": { "product_status": "Permitted as a cosmetic ingredient with safety standards. No injectable approval exists.", "clinical_status": "Cell therapies permitted via designated institutions under the 2025 ARBA treatment category. Injecting a cosmetic-grade vial is off-label use of a non-injectable.", "cosmetic_status": "Permitted with safety standards. The word 'exosome' is banned in advertising unless plant or animal derived." }, "legal_basis": [ { "instrument": "Advanced Regenerative Bio Act", "citation": "Amendment in force 21 February 2025", "date": "2025-02-21", "summary": "Created the advanced regenerative medicine treatment category. Designated institutions may treat outside trials and charge patients on five-year approvals. Around 112 institutions designated." }, { "instrument": "Cosmetics Act", "citation": "Article 8, Appendix 3", "date": "", "summary": "Safety standards for human cell and tissue culture fluid." }, { "instrument": "MFDS advertising rules", "citation": "Effective 21 January 2025", "date": "2025-01-21", "summary": "Prohibits 'exosome' in cosmetic advertising unless plant or animal derived. Bans hospital-exclusive framing and quantitative anti-ageing claims." } ], "permitted": [ "Manufacturing exosome cosmetics to MFDS standards", "Export of cosmetic-grade product", "Cell therapy under the ARBA treatment category", "Clinical trials under MFDS" ], "grey": [ "Cosmetic-grade vials used intradermally after laser or microneedling", "Whether ARBA reaches acellular EVs at all", "Products exported as cosmetics and injected in the destination market" ], "prohibited": [ "The word 'exosome' in consumer cosmetic advertising for human-derived product", "Medical or drug-like claims on a cosmetic", "Intravenous administration of a cosmetic product" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "allowed", "dental_pulp": "allowed", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "moderate", "recent_actions": [ { "date": "2025-05-26", "body": "MFDS", "target": "Online cosmetic advertising", "note": "237 violations identified, roughly half readable as drug or medical claims." } ] }, "route_in": "A supply market before a sales market. The realistic play is sourcing or co-manufacturing, not selling into it.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [ "Whether acellular EVs fall within ARBA scope. Genuinely unresolved." ], "priority": 4 }, { "id": "cn", "name": "China", "region": "Asia", "verdict": "restrictive", "classification": { "product_status": "Inside the ATMP framework since June 2025. Exosome-membrane dressings are Class III device combination products since December 2025.", "clinical_status": "Only within an approved trial or a filed hospital clinical-research study, which cannot charge patients.", "cosmetic_status": "Prohibited. Human cells, tissues and human-derived products banned as cosmetic ingredients. 'Exosome' not in the approved catalogue." }, "legal_basis": [ { "instrument": "NMPA/CDE technical guidance", "citation": "June 2025", "date": "2025-06", "summary": "Brought extracellular vesicles including exosomes into the ATMP framework." }, { "instrument": "NMPA classification decision", "citation": "December 2025", "date": "2025-12", "summary": "Exosome-membrane dressings defined as Class III combination products." }, { "instrument": "Safety and Technical Standards for Cosmetics", "citation": "2015 edition", "date": "2015", "summary": "Prohibits human-derived cosmetic ingredients. Reaffirmed September 2024 in response to CPPCC Proposal No. 00971." }, { "instrument": "Administrative Measures for Stem Cell Clinical Research", "citation": "2015, NHC and NMPA dual filing", "date": "2015", "summary": "Hospital-led research track. Research only, no charging." } ], "permitted": [ "Registered clinical trials under NMPA/CDE", "Filed hospital clinical research without charging patients", "The Class III device route for qualifying dressings", "Manufacturing for export" ], "grey": [ "Plant-derived and conditioned-medium cosmetics avoiding the human-derived ban", "Medical-beauty clinics running topical exosome protocols", "Human genetic resources rules on cross-border collaboration" ], "prohibited": [ "Any exosome claim or the term on a cosmetic", "Injectable human exosomes via medical-beauty and daigou channels", "Unregistered cross-border import for clinical use" ], "cell_sources": { "uc_msc": "restricted", "adipose": "restricted", "bone_marrow": "restricted", "placental": "restricted", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "high", "recent_actions": [ { "date": "2024-09", "body": "NMPA", "target": "CPPCC Proposal No. 00971", "note": "Reaffirmed prohibition on human-derived cosmetic ingredients including exosomes." } ] }, "route_in": "No shortcut. A registered NMPA pathway with a local partner, or stay out. A five-year market, not an entry market.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [], "priority": 11 }, { "id": "th", "name": "Thailand", "region": "Asia", "verdict": "grey", "classification": { "product_status": "A medicinal product under Thai FDA; an ATMP under the 2026 royal decree. No registration in practice for aesthetic vials.", "clinical_status": "Only under a registered ATMP or authorised research protocol. Everything else runs on enforcement discretion.", "cosmetic_status": "Widely used through the aesthetics and wellness channel with no product registration." }, "legal_basis": [ { "instrument": "ATMP royal decree and regulatory sandbox", "citation": "2026", "date": "2026", "summary": "Establishes an ATMP pathway with a sandbox. MOPH roadmap positions Thailand as fastest in ASEAN." }, { "instrument": "MOPH standards on stem cell treatment", "citation": "2022, restated 31 October 2024", "date": "2024-10-31", "summary": "Outside haematology and corneal/limbal transplants, stem cell treatment is not approved routine care." }, { "instrument": "Thai FDA cell product requirements", "citation": "2024", "date": "2024", "summary": "GMP laboratory requirements, donor screening for 50+ pathogens, maximum passage number four." }, { "instrument": "Medical Council ethics rules", "citation": "", "date": "", "summary": "Uses outside recognised standards require a research and ethics framework. Guaranteeing results prohibited." } ], "permitted": [ "A registered ATMP under the new decree", "Treatment inside an authorised research protocol with ethics approval", "The regulatory sandbox", "Licensed facilities operating within scope" ], "grey": [ "Exosomes as an aesthetic and wellness add-on with no product registration", "Clinics with facility and physician licences but no product authorisation", "'GMP laboratory' claims with no third-party verification" ], "prohibited": [ "Presenting an investigational treatment as proven", "Exaggerated claims, over 400 cases prosecuted annually", "Selling unregistered cell products as routine care" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "allowed", "dental_pulp": "allowed", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "moderate", "recent_actions": [ { "date": "2024-10-31", "body": "MOPH", "target": "Providers", "note": "Restated that stem cell treatment outside haematology and corneal transplant is not approved routine care." } ] }, "route_in": "The sandbox is the most interesting door in the region. One of few structured routes to a legitimate first commercial footing for an unapproved EV product.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Sandbox application criteria and whether a foreign sponsor can apply directly", "Whether acellular EVs are in scope of the ATMP decree" ], "priority": 5 }, { "id": "ae", "name": "United Arab Emirates", "region": "Middle East", "verdict": "grey", "classification": { "product_status": "No emirate-level exosome standard. Abu Dhabi requires approval from an internationally recognised regulator, which no exosome product holds anywhere.", "clinical_status": "Clinics are licensed and openly market it. The product has no clean registration route.", "cosmetic_status": "Topical products circulate freely." }, "legal_basis": [ { "instrument": "Abu Dhabi DoH Standard on Stem Cell Therapies, Products and Regenerative Medicine", "citation": "2019", "date": "2019", "summary": "HCT/Ps and stem cell products used in Abu Dhabi must hold product approval from an international regulator recognised by MOHAP." }, { "instrument": "DHA Standard on autologous adipose SVF/ADSC therapy", "citation": "2020", "date": "2020", "summary": "Published standard for autologous adipose procedures. No exosome-specific standard exists." }, { "instrument": "DHA PRP guidelines", "citation": "2014", "date": "2014", "summary": "Governs platelet-rich plasma procedures." } ], "permitted": [ "Operating a licensed clinic with licensed physicians", "Autologous adipose SVF and PRP under the DHA standards", "Importing a product holding approval from a recognised foreign regulator" ], "grey": [ "Exosome IV drips advertised at 100-200 billion particles", "'DHA and MOH approved' language referring to a facility licence, not product approval", "Import under a cosmetic, supplement or device classification then clinical administration" ], "prohibited": [ "Marketing a product as approved when only the facility is licensed", "Administering an unregistered biologic where recognised foreign approval is required", "Disease-treatment claims on a wellness product" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "allowed", "dental_pulp": "allowed", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "low", "recent_actions": [] }, "route_in": "Fastest legitimate footing of any market here: a DoH or DHA-licensed clinic partner, a written protocol, full provenance documentation, honest consent.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Whether exosomes fall under semi-controlled medical materials decrees", "Whether DHCC free zone rules differ from mainland Dubai" ], "priority": 8 }, { "id": "de", "name": "Germany (EU baseline)", "region": "Europe", "verdict": "restrictive", "classification": { "product_status": "Unmodified EVs are not ATMPs per the 2025 EMA/CAT guideline. Handled as biological medicinal products case by case. Engineered EVs carrying functional transgenic mRNA are gene therapy products.", "clinical_status": "Only with a marketing authorisation or inside an approved trial. The ATMP hospital exemption does not cover naive exosomes.", "cosmetic_status": "Prohibited. Regulation 1223/2009 bans human cells, tissues and products of human origin. Plant-derived permitted." }, "legal_basis": [ { "instrument": "EMA/CAT guideline on extracellular vesicles", "citation": "2025", "date": "2025", "summary": "Not substantially modified EVs fall outside the ATMP definition. Engineered EVs carrying functional transgenic mRNA classified as gene therapy products." }, { "instrument": "Arzneimittelgesetz", "citation": "§13 manufacturing licence, §4b hospital exemption, §20b tissue procurement, §21(2)", "date": "", "summary": "§4b hospital exemption applies to ATMPs only, via the Paul-Ehrlich-Institut." }, { "instrument": "Cosmetics Regulation (EC) 1223/2009", "citation": "Annex II", "date": "2009", "summary": "Prohibits human cells, tissues and products of human origin in cosmetics EU-wide." } ], "permitted": [ "Clinical trials under the EU Clinical Trials Regulation via a single CTA", "A CAT classification request, free, and the correct first step", "Plant-derived exosome cosmetics", "Marketing authorisation for a non-ATMP biological" ], "grey": [ "Individueller Heilversuch framing used to justify repeat commercial use", "Physician-prepared preparations under narrow §21(2) exemptions", "Whether a given engineered product is ATMP or biological" ], "prohibited": [ "Human-derived exosomes in cosmetic products", "Importing Korean cosmetic-grade vials for injection", "Invoking the ATMP hospital exemption for an unmodified exosome product", "Placing an unauthorised medicinal product on the market" ], "cell_sources": { "uc_msc": "restricted", "adipose": "restricted", "bone_marrow": "restricted", "placental": "restricted", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "moderate", "recent_actions": [] }, "route_in": "A CAT classification request first. Inexpensive, and it tells you whether you are running a biologics filing or a gene-therapy filing before spending anything.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [ "Which national competent authority route is fastest for a non-ATMP biological EV product" ], "priority": 7 }, { "id": "ch", "name": "Switzerland", "region": "Europe", "verdict": "restrictive", "classification": { "product_status": "Transplant product or medicinal product. Culture expansion is substantial manipulation by definition, so any cultured-cell-derived product is caught.", "clinical_status": "Not permitted. Cultured-cell products for wellness or aesthetics outside a trial breach Swissmedic rules.", "cosmetic_status": "Products used in aesthetic medicine to regenerate or repair are treated as transplant products, not cosmetics." }, "legal_basis": [ { "instrument": "Therapeutic Products Act (HMG)", "citation": "", "date": "", "summary": "Governs medicinal products including transplant products. Swissmedic ATMP Division is lead regulator." }, { "instrument": "Transplantation Act", "citation": "", "date": "", "summary": "Transplant products are those manufactured from human or animal tissues or cells by a standardised process, substantially manipulated or used non-homologously. Substantial manipulation includes culture expansion, genetic modification, differentiation or activation." }, { "instrument": "Human Research Act", "citation": "", "date": "", "summary": "Governs clinical trials and research involving human subjects." } ], "permitted": [ "Minimally manipulated autologous material for homologous use in a single procedure", "Authorised clinical trials", "Products holding a Swissmedic marketing authorisation" ], "grey": [ "Where SVF and same-day preparations sit, assessed case by case and sometimes cantonally", "Consultation and diagnostics in Switzerland with treatment delivered abroad" ], "prohibited": [ "Expanded or cultured-cell-derived products sold for wellness or aesthetics outside a trial", "Importing cosmetic-grade exosome vials for injection", "Marketing 'Swiss' regenerative therapy that is neither authorised nor trial-based", "Storing UC-MSCs without a Swissmedic licence" ], "cell_sources": { "uc_msc": "banned", "adipose": "restricted", "bone_marrow": "restricted", "placental": "banned", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "moderate", "recent_actions": [] }, "route_in": "Use Switzerland for credibility, manufacturing partners and capital, not for delivering therapy. There is no permissive Swiss lane.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [], "priority": 6 }, { "id": "us", "name": "United States (federal)", "region": "North America", "verdict": "illegal", "classification": { "product_status": "Unapproved new drug and unlicensed biological product. Never eligible for the 361 HCT/P exemption. No approval exists for any indication.", "clinical_status": "Only under an active IND. Nothing else is lawful for a therapeutic purpose.", "cosmetic_status": "Topical cosmetics permitted with no structure/function claims. Dozens of exosome INCI ingredients exist, mostly plant-derived." }, "legal_basis": [ { "instrument": "Federal Food, Drug, and Cosmetic Act", "citation": "21 U.S.C. §§301 et seq.", "date": "", "summary": "Exosome products for therapeutic use are unapproved new drugs." }, { "instrument": "Public Health Service Act", "citation": "42 U.S.C. §262 (Section 351)", "date": "", "summary": "Unlicensed biological products require a BLA or an active IND." }, { "instrument": "21 CFR Part 1271", "citation": "§1271.10, §1271.3(d)", "date": "", "summary": "The 361 exemption requires minimal manipulation and homologous use. The HCT/P definition excludes secreted or extracted human products including cell factors." }, { "instrument": "FDA public safety notifications", "citation": "2019 and 2020; enforcement discretion ended 31 May 2021", "date": "2021-05-31", "summary": "FDA warned consumers and providers about unapproved exosome products." }, { "instrument": "FDA warning letter, Kimera Labs Inc.", "citation": "1 September 2023", "date": "2023-09-01", "summary": "FDA construed the secreted-or-extracted-human-products exclusion in 21 CFR 1271.3(d) as placing such products outside HCT/P status. Directly analogous to the SB 1768 exclusion, which borrows the same language." } ], "permitted": [ "Topical cosmetics with no structure/function claims", "An active IND with a registered clinical trial", "Contract manufacturing for a sponsor holding the regulatory file" ], "grey": [ "Where a cosmetic claim ends and a drug claim begins", "Post-procedure topical application in aesthetic practice" ], "prohibited": [ "Intravenous infusions, joint injections, scalp injections for hair loss", "'Research use only' vials sold to clinics and administered to patients", "Any therapeutic claim without an IND" ], "cell_sources": { "uc_msc": "banned", "adipose": "restricted", "bone_marrow": "restricted", "placental": "banned", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "high", "recent_actions": [ { "date": "2026-03", "body": "FDA", "target": "Consumer warning update", "note": "Violators may face legal action without further notice, including seizure and injunction." }, { "date": "2024-2026", "body": "FDA CBER", "target": "Warning letters", "note": "Evolutionary Biologics, Chara Biologics, Supreme Rejuvenation, New Life Medical Services, Innate Healthcare Institute, Dynamic Stem Cell Therapy." } ] }, "route_in": "Cosmetic lane or IND. There is no third option, and offshore delivery does not insulate US-facing marketing from FTC or DOJ.", "last_verified": "2026-09-05", "confidence": "high", "open_questions": [] }, { "id": "us-fl", "name": "Florida", "region": "North America", "verdict": "grey", "classification": { "product_status": "SB 1768's HCT/P definition excludes secreted and extracted human products and cell factors, and requires viable live cells on post-thaw analysis (Fla. Stat. §458.3245(2)(a)3., §458.3245(3)(b)3.). Federally, FDA treats unapproved exosome products as outside HCT/P status and unlawful when marketed with therapeutic claims — the state pathway does not reach this product, and a state law cannot authorise what federal law prohibits.", "clinical_status": "FL-licensed MD/DO physicians may perform non-FDA-approved stem cell therapy, but only for orthopedics, wound care, and pain management, with informed consent and an advertising notice (Fla. Stat. §458.3245, effective 2025-07-01).", "cosmetic_status": "Same as US federal. The state law changes only what the medical board may discipline." }, "legal_basis": [ { "instrument": "Florida SB 1768 (2025)", "citation": "Fla. Stat. §§458.3245, 459.0127, effective 1 July 2025", "date": "2025-07-01", "summary": "Authorises non-FDA-approved stem cell therapy for orthopedics, wound care and pain management, from an FDA-registered facility accredited by NMDP, WMDA, AABB or AATB, with cGMP compliance, disclaimer and consent." }, { "instrument": "SB 1768 HCT/P definition", "citation": "Fla. Stat. §458.3245(2)(a)3.", "date": "2025-07-01", "summary": "Expressly excludes secreted or extracted human products, such as milk, collagen, and cell factors. Language lifted from 21 CFR 1271.3(d)." }, { "instrument": "SB 1768 material requirements", "citation": "Fla. Stat. §458.3245(3)(b)3", "date": "2025-07-01", "summary": "Material must contain viable or live cells upon post-thaw analysis, with a lot-specific viability report." }, { "instrument": "FDA warning letter, Kimera Labs Inc.", "citation": "1 September 2023", "date": "2023-09-01", "summary": "FDA construed the secreted-or-extracted-human-products exclusion in 21 CFR 1271.3(d) as placing such products outside HCT/P status. Directly analogous to the SB 1768 exclusion, which borrows the same language." } ], "permitted": [ "Stem cell therapy for orthopedics, wound care and pain management meeting all statutory conditions", "Topical cosmetics with no structure/function claims", "An active IND" ], "grey": [ "Whether the legislature intended to exclude secreted products or inherited the federal exclusion list. No Board rule under §(10) and no case testing scope", "A product containing viable cells alongside vesicles, which may qualify where a pure EV vial cannot", "Suppliers marketing exosome products as usable 'in accordance with SB 1768'", "The SB 1768 carve-out is limited to those three indications and to physician-administered stem cell therapy — it does not clearly cover exosome/secretome products or cognitive indications, so a cognitive secretome sits outside it." ], "prohibited": [ "Relying on SB 1768 as a safe harbour for an acellular exosome product", "Any therapeutic exosome claim without an IND", "Indications outside orthopedics, wound care and pain management" ], "cell_sources": { "uc_msc": "restricted", "adipose": "restricted", "bone_marrow": "restricted", "placental": "restricted", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "high", "recent_actions": [ { "date": "2026", "body": "Florida DOH", "target": "Implementing rules", "note": "Rules under §(10) still in development as of early 2026. Scope questions unresolved." } ] }, "route_in": "Not a route for exosomes. Watch whether Georgia HB 1275 and Tennessee HB 2246, both signed May 2026, use definitions including cell-derived products.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Whether Florida DOH rules address acellular products", "How Georgia and Tennessee 2026 statutes define the category" ], "frontier": true, "headline": "Florida is the fault line where the federal prohibition on unapproved exosome products and the state's new permissive stem-cell-therapy model are actively colliding.", "momentum": "SB 1768 (Fla. Stat. §458.3245, Ch. 2025-185, effective 2025-07-01) is a real, affirmative state law authorizing FL-licensed MD/DO physicians to perform non-FDA-approved stem cell therapy for orthopedics, wound care, and pain management, with informed consent and a mandated advertising notice. On the strength of that law and the surrounding publicity, a large, openly-operating clinic market has grown up selling exosome therapy under its banner — real, active patient demand and real commercial scale, not a fringe activity.", "tension": "That market rests on a reading of SB 1768 the statute's own text doesn't support: its HCT/P definition (Fla. Stat. §458.3245(2)(a)3.) excludes secreted or extracted human products, and its material requirements (§458.3245(3)(b)3.) demand viable live cells on post-thaw analysis — an acellular exosome product fits neither. No FDA-approved exosome product exists for any indication; an active IND is the only clean federal therapeutic pathway. Enforcement is escalating, not static: FDA warning letters have continued through 2024-2026, the Department of Justice established a Health & Safety Unit in December 2025, and FDA's March 2026 consumer notice states violators may face legal action without further notice, including seizure and injunction.", "through_line": "This is the shape the category's near future may take elsewhere: a state creates a real, permissive pathway for a cellular therapy, a commercial market reads it as covering more than it does, and federal enforcement escalates against that gap. Florida is where that pattern is furthest along and most visible right now.", "sources": [ { "label": "Florida SB 1768, Chapter 2025-185", "url": "https://www.flsenate.gov/Session/Bill/2025/1768" }, { "label": "FDA Public Safety Notification on Exosome Products", "url": "https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products" } ], "priority": 1 }, { "id": "pa", "name": "Panama", "region": "Latin America", "verdict": "legal", "classification": { "product_status": "No product registration category in practical use. Lawfulness sits in the protocol, the facility licence and the consent, not the vial.", "clinical_status": "Permitted under a MINSA-licensed facility with National Bioethics Committee approval and documented consent.", "cosmetic_status": "Not the primary channel. Providers typically market secretome or trophic factors rather than exosomes." }, "legal_basis": [ { "instrument": "Health Act and MINSA licensing", "citation": "", "date": "", "summary": "MINSA licenses facilities. Cell therapy delivered under approved research and treatment protocols rather than product registration." }, { "instrument": "National Bioethics Committee approval", "citation": "", "date": "", "summary": "Protocols require committee approval. Charging patients within an approved protocol is permitted." } ], "permitted": [ "MINSA-licensed facility with bioethics-approved protocol and documented consent", "In-house manufacture under the treating institution's laboratory", "Charging patients within an approved protocol" ], "grey": [ "Protocols framed as research but operated as a commercial business at scale", "No independent product registration or lot release oversight", "Marketing to US patients, which brings FTC and DOJ exposure home" ], "prohibited": [ "Cure claims and guaranteed outcomes", "Administering unregistered imported vials outside an approved protocol" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "allowed", "dental_pulp": "allowed", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "low", "recent_actions": [] }, "route_in": "Partnership with an existing MINSA-licensed institution that already holds bioethics approval. Building from zero is slow; buying in is not.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Whether MINSA requires product-level registration for imported biologics used in approved protocols" ], "priority": 10 }, { "id": "co", "name": "Colombia", "region": "Latin America", "verdict": "grey", "classification": { "product_status": "Decree 2493/2004 governs tissue and cell handling. INVIMA licenses banks and supervises trials. No registration category in practical use for exosomes.", "clinical_status": "Formally only in INVIMA-supervised research. In practice sold commercially to medical tourists.", "cosmetic_status": "Bundled into IV longevity packages alongside MSCs and hyperbaric oxygen." }, "legal_basis": [ { "instrument": "Decree 2493 of 2004", "citation": "", "date": "2004", "summary": "Governs handling of tissues and cells. Haematopoietic transplants only at authorised institutions using INVIMA-licensed banks." }, { "instrument": "INVIMA oversight", "citation": "", "date": "", "summary": "Licenses tissue and marrow banks, registers products, supervises trials. Cultured or expanded MSC not approved for routine clinical use." } ], "permitted": [ "Haematopoietic transplants at authorised institutions", "Same-day autologous minimally manipulated procedures", "INVIMA-supervised clinical trials" ], "grey": [ "Expanded MSC and exosome infusions sold commercially outside a trial", "'GMP-certified' and 'ISO' laboratory claims with no verification", "Bundled longevity packages" ], "prohibited": [ "Advertising unproven uses", "Advertising stem cells and delivering exosomes", "Routine commercial use of expanded MSC products" ], "cell_sources": { "uc_msc": "restricted", "adipose": "allowed", "bone_marrow": "allowed", "placental": "restricted", "dental_pulp": "restricted", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "low", "recent_actions": [] }, "route_in": "Viable for volume, poor for asset-building. Nothing done here generates evidence or standing that travels to a stricter market.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Whether INVIMA has issued any exosome-specific position" ], "priority": 9 }, { "id": "mx", "name": "Mexico", "region": "Latin America", "verdict": "grey", "classification": { "product_status": "No product-specific classification for exosomes or secretome exists. A cell-free biologic would most plausibly need COFEPRIS sanitary registration as a 'medicamento biotecnológico' (Art. 222 Bis, Ley General de Salud), but Mexico's dedicated regenerative-medicine framework (Art. 315 licensing; the January 2026 LGS reform's definitions, consent, and anti-commerce rules) is built entirely around 'células troncales' (living stem cells) — exosomes, extracellular vesicles, and secretome are not mentioned anywhere in that reform's text, fetched and searched in full this run.", "clinical_status": "COFEPRIS-authorized regenerative-medicine establishments and stem cell banks/collection centers may administer stem cell therapy under Art. 315 licensing and the 2026 reform's committee and consent requirements. Whether an acellular exosome/secretome product is administered under that same authorization in practice, or falls outside it, is unresolved — clinic-marketing sources describe exosome therapy being offered under the same facility authorization as stem cell therapy, with no regulatory differentiation found.", "cosmetic_status": "No exosome- or secretome-specific cosmetic framework found. General cosmetic product rules (Art. 271 Bis, Ley General de Salud) govern cosmetics generally; whether a topical exosome/secretome product is marketed as a cosmetic or a medical treatment in practice was not resolved this run." }, "legal_basis": [ { "instrument": "Ley General de Salud, decreto de reforma (stem cell provisions)", "citation": "DOF 15 January 2026, in force 16 January 2026 — Art. 3 fracc. XXIX-XXXI, 316, 316 Bis 1, 319, 321 Bis, 327, 332", "date": "2026-01-16", "summary": "Fetched and searched in full (83,206 characters, 26 pages) directly from dof.gob.mx. Adds statutory definitions for 'banco de células troncales', 'centro de colecta de células troncales', and 'establecimiento de medicina regenerativa' (defined by therapeutic purpose — repair, replacement, or regeneration of cells, tissues or organs — not by product type); requires internal committees for establishments that transplant or infuse stem cells; requires informed consent for placental/umbilical cord stem cell donation (Art. 321 Bis); prohibits commerce in stem cells outside a specific statutory exception (Art. 327); permits minor stem cell/bone marrow donation with legal-representative consent (Art. 332). The word 'mesenquimal' does not appear anywhere in the decree text, despite being widely attributed to this reform by secondary press coverage — see open_questions." }, { "instrument": "Ley General de Salud, Artículo 315", "citation": "Amended 2015 (exact DOF date not independently re-verified this run)", "date": "2015", "summary": "Requires COFEPRIS authorization for any establishment engaged in the collection, conservation, analysis, preparation, supply, or disposal of organs, tissues, or cells — the base licensing requirement the 2026 reform's stem-cell-specific rules sit on top of." }, { "instrument": "Ley General de Salud, Artículo 222 Bis", "citation": "Added by decree, DOF 11 June 2009", "date": "2009-06-11", "summary": "Defines 'medicamento biotecnológico' — any substance produced by molecular biotechnology with therapeutic, preventive, or rehabilitative effect, presented in pharmaceutical form — and requires COFEPRIS sanitary registration (registro sanitario) demonstrating quality, safety and efficacy. The pathway a cell-free exosome/secretome product would most plausibly fall under, distinct from the stem-cell-bank framework above." } ], "permitted": [ "COFEPRIS-authorized stem cell banks, collection centers, and regenerative-medicine establishments handling células troncales, per Art. 315 licensing and the 2026 reform's definitions", "A COFEPRIS-registered biotechnological medicine (registro sanitario under Art. 222 Bis) — the formal drug pathway for a cell-free biologic, though not the one clinic-marketing sources describe clinics actually using", "Minimally-regulated cosmetic products under the general cosmetics rules (Art. 271 Bis), to the extent a topical product avoids therapeutic claims" ], "grey": [ "Whether 'establecimiento de medicina regenerativa' and the stem-cell-specific rules (banks, consent, anti-commerce) reach an acellular exosome/secretome product at all — the entire 2026 reform is built around 'células troncales'; exosomes, extracellular vesicles, and secretome are not mentioned anywhere in the decree text", "Whether private clinics selling exosome/secretome therapy hold a product-level registro sanitario (Art. 222 Bis) or only the facility-level Aviso de Funcionamiento and Aviso de Publicidad — clinic-operator sources describe only the latter, not independently confirmed against a COFEPRIS registry this run", "Scale and destination of the medical-tourism market (clinics in Cancún and elsewhere marketing to US/Canadian patients) — described by clinic-operator sources, not independently verified against COFEPRIS's own establishment registry" ], "prohibited": [ "Commerce (sale for profit) in stem cells or donated tissue — donation must be altruistic and free of charge, subject to a narrow statutory exception (Art. 327)", "Operating a regenerative-medicine establishment, stem cell bank, or collection center without the required COFEPRIS authorization", "Advertising a therapy without the required Aviso de Publicidad, or making claims the authorized advertisement doesn't cover" ], "cell_sources": { "uc_msc": "allowed", "adipose": "allowed", "bone_marrow": "allowed", "placental": "allowed", "dental_pulp": "allowed", "ipsc": "restricted", "immortalised": "restricted", "plant": "allowed" }, "enforcement": { "level": "low", "recent_actions": [] }, "route_in": "Mexico already has an active, internationally-marketed private clinic sector for stem cell and exosome therapy, operating on facility-level COFEPRIS authorization (Aviso de Funcionamiento, Aviso de Publicidad) rather than product-level drug registration, per clinic-operator sources. The fast route mirrors that practice; the durable route is COFEPRIS product registration as a medicamento biotecnológico (Art. 222 Bis) — or asking COFEPRIS directly whether the 2026 stem-cell-establishment framework reaches an acellular product.", "last_verified": "2026-09-05", "confidence": "medium", "open_questions": [ "Whether COFEPRIS or a court has ever addressed whether the 2026 stem-cell reform's definitions extend to an acellular exosome/secretome product — no primary source found either way", "Whether Mexican private clinics selling exosome/secretome therapy in practice hold a registro sanitario under Art. 222 Bis, or operate solely under facility/advertising notices — described one way by clinic-operator sources, not independently confirmed against a COFEPRIS registry", "Whether the widely-repeated media claim that the 2026 reform specifically names adipose tissue, placental tissue, dental pulp, and umbilical cord as 'mesenchymal progenitor cell' sources is accurate — the full decree text (fetched and searched in full this run) does not contain the word 'mesenquimal' anywhere, only the generic term 'células troncales'; this discrepancy between secondary reporting and the primary text is unresolved", "No specific COFEPRIS enforcement action against an exosome or regenerative-medicine clinic was found this run — a negative search result, not evidence of absence" ], "priority": 3 } ] }