The two sections
Section 361 covers human cells and tissues that are regulated only to prevent disease transmission. No FDA premarket approval is needed. To qualify, a product must meet all of a set of criteria, the two important ones being minimal manipulation and homologous use.
Section 351 covers biological drugs. Anything that fails the 361 criteria is a 351 product and needs an approved Biologics License Application, the same pathway as a new vaccine or monoclonal antibody, with clinical trials proving safety and efficacy. No stem cell product for orthopedics, neurology, autoimmune disease or anti-aging has that approval.
Test one: minimal manipulation
For structural tissue (fat, bone) minimal manipulation means the processing does not alter the tissue's original characteristics relating to its utility for reconstruction or repair. For cells and non-structural tissue (bone marrow, cord blood) it means processing does not alter the relevant biological characteristics.
- Bone marrow aspirate spun in a centrifuge: generally minimal manipulation
- Fat broken down with enzymes to isolate the stromal vascular fraction: the FDA considers this more than minimal manipulation, and courts agreed in the 2024 Ninth Circuit ruling
- Cells grown in culture for days or weeks to increase numbers: not minimal; this is where nearly all Colombian and Mexican expanded-cell products sit
Test two: homologous use
The cells must perform the same basic function in the recipient that they performed in the donor. Bone marrow cells used to support blood formation is homologous. Bone marrow or fat cells injected into a knee to regenerate cartilage, or infused intravenously for anti-aging, is not, in the FDA's view. This single test knocks out most clinic indications regardless of how the cells were processed.
Why clinics say "FDA registered"
Facilities that handle 361 tissue must register their establishment with the FDA. Registration is a listing, not a review. A clinic can be truthfully "FDA registered" while selling a product the FDA considers an unapproved drug. See what FDA registered really means.
Quick decoder
| Claim | What it usually means |
|---|---|
| "FDA approved stem cells" | False for any joint, neuro, or anti-aging use. Ask for the BLA number; there is none. |
| "FDA registered lab" | Establishment listing only |
| "Same-day, your own cells, no expansion" | Positioned as 361; still fails homologous use for most indications |
| "Culture-expanded, 100 million cells" | Unambiguously a 351 drug; illegal to market in the US without a trial; legal status abroad depends on local law |
Where the 2024-2026 enforcement landscape landed
The 2024 appellate decision in the California Stem Cell Treatment Center case confirmed the FDA's authority over stromal vascular fraction products. Since then the agency has continued warning letters against clinics marketing expanded cells, exosomes and umbilical products. In parallel, Florida enacted a 2025 law permitting certain stem cell treatments under state licensing for orthopedic, wound and pain indications; see Florida's law explained. Federal law still governs the product; state law governs the practice of medicine. Both apply.
What this means when you look at Colombia
Colombia does not use the 351/361 framework. INVIMA regulates advanced-therapy products under its own rules, and legally offered expanded-cell products exist there under authorization or research protocols. Knowing the US framework helps you ask the right question of a Colombian clinic: not "is this FDA approved" (nothing is) but "under which INVIMA authorization or protocol is this product supplied, and can I see it?" Our INVIMA guide covers that side.
Regulatory status: FDA vs INVIMA
United States (FDA): No stem cell product is FDA-approved for orthopedic, neurologic, or systemic use. Minimally manipulated same-day autologous procedures are marketed under a narrow exemption; culture-expanded cells and most umbilical products are unapproved biologics and the FDA's authority over them was reaffirmed in federal court in 2024. Florida's 2025 law permits certain treatments under state rules but does not create FDA approval.
Colombia (INVIMA): Cell therapies are regulated as advanced-therapy products. Clinics require INVIMA habilitation for the facility and, for laboratory-processed products, product-level authorization or an approved research protocol. Ask to see the INVIMA registration number and verify the treating physician on ReTHUS. "INVIMA registered" for the clinic is not the same as an authorized product.
Frequently asked questions
Is any stem cell therapy FDA approved?
Only hematopoietic stem cell products for blood cancers and certain immune disorders. Nothing for joints, spine, neurologic disease, autoimmunity or aging.
Can a same-day bone marrow injection be legal in the US?
It can be marketed under Section 361 if it is minimally manipulated, but the FDA's position is that injecting marrow cells into a joint is non-homologous use. Enforcement has focused on expanded and fat-derived products.
Does Florida's law make stem cells FDA approved?
No. It changes state practice rules; federal product law is unchanged.
Want a clinic that can show its authorization?
We ask Colombian clinics for INVIMA documentation before we refer anyone. Tell us your condition and we will tell you who can produce it.
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