The UK position on exosome products, stated carefully
What can and cannot be said about the regulatory status of exosome products in the UK, which framework applies, and where the position is genuinely unsettled.
There is no single rule stating that exosome products are legal or illegal in the UK. Which framework applies depends on what the product is made of, how it is presented, and how it is used, and those three questions can produce different answers for products that look identical on a shelf.
The two things we can state with confidence are these. First, we are not aware of any exosome product holding a UK marketing authorisation as a medicine for any aesthetic indication, which means none has been assessed for safety and efficacy by the medicines regulator for that use. Second, presentation and function are the tests that determine whether something is a medicinal product, and a product marketed with claims about acting on the body invites that classification regardless of how the supplier labels it.
Why there is no simple answer
People ask whether exosome treatments are legal in the UK and expect a yes or a no. The question is malformed, in the same way that asking whether powders are legal would be. Regulation attaches to products and activities defined by specific tests, and a preparation of this kind can fall into different frameworks depending on its origin, its presentation and its route of use.
Four frameworks are potentially in play.
- Medicines. If a product is a medicinal product by presentation or by function, it requires a marketing authorisation to be placed on the market. The Human Medicines Regulations 2012 are the primary legislation and the MHRA is the regulator.
- Advanced therapy medicinal products. A subset of medicines covering gene therapy, somatic cell therapy and tissue engineered products, with its own requirements.
- Human tissue. Where material of human origin is involved, the Human Tissue Act 2004 and the regulations covering tissues and cells for human application engage, with the Human Tissue Authority as regulator.
- Cosmetics. Products intended for application to the external parts of the body for cleaning, perfuming, changing appearance, protecting or keeping in good condition fall under cosmetics legislation, which carries its own restrictions on permitted substances and on claims.
These are not mutually exclusive in the sense that a supplier may choose one. Classification follows from what the product is and how it is presented, which is the point of the borderline test set out in borderline products and the MHRA.
What absence of an authorisation means
This is widely misunderstood in both directions. It does not mean a product has been tested and found wanting. It generally means no application has been made, which is unsurprising given the cost and the evidence such an application requires.
It does mean something specific and important: no regulator has assessed the quality, safety and efficacy of that product for that use. Every assurance a purchaser receives comes from the supplier or the distributor. That is the actual position, and it is neither a scandal nor a clean bill of health.
Exosome products are approved for use in aesthetic treatments in the UK.
- Proposed mechanism
- Regulatory approval has been granted for these products for this use.
- What has been shown
- We are not aware of any exosome product holding a UK marketing authorisation as a medicine for an aesthetic indication. A product being available for purchase, CE or UKCA marked for some other purpose, or lawfully sold in another country does not constitute approval for aesthetic use in the UK.
- Highest level reached
- Not shown
- Main confounders
- Confusion between a product being on the market and a product being authorised. Confusion between device marking, cosmetic notification and medicines authorisation, which are different regimes with different requirements.
GradeNOT SUPPORTED
What would change thisPublication of a granted marketing authorisation, which would appear in the public register of authorised medicines. That is checkable directly and does not require taking anyone's word for it.
The route question
The most consequential distinction in practice is between applying a preparation to the skin surface and injecting it. They are different acts and they engage the frameworks differently.
A preparation presented as a cosmetic and applied topically is being placed within cosmetics legislation, with its restrictions on permitted ingredients and on claims. A preparation injected into a person is being administered, and a product administered with the intention of acting pharmacologically, immunologically or metabolically on the body is engaging the functional limb of the medicines definition.
We treat that fork in detail in topical after microneedling is a different question, including the harder middle case where a preparation is applied to skin that has just been deliberately breached.
The human origin question
Where material derives from human cells, tissue legislation engages questions of consent, donor screening, traceability and licensed establishments. This is a separate matter from medicines classification and it applies on its own terms.
There is a further point worth knowing. Cosmetics legislation restricts what may be used in cosmetic products by means of prohibited and restricted substance lists, and the prohibited list includes an entry covering cells, tissues and products of human origin. That entry is directly relevant to any product of human origin marketed as a cosmetic, and anyone relying on the point should read the current consolidated text rather than our description of it. We take this up in human tissue considerations.
| Framework | Trigger | Regulator |
|---|---|---|
| Medicines | Presented as, or functioning as, a medicinal product | MHRA |
| Advanced therapy medicinal products | Gene therapy, somatic cell therapy or tissue engineered product | MHRA |
| Human tissue | Material of human origin, its procurement, storage and use | Human Tissue Authority |
| Cosmetics | Applied to external body parts for appearance, cleansing, protection or condition | Office for Product Safety and Standards, with local enforcement |
What is genuinely unsettled
We think three things are open rather than merely unclear to us.
The status of application into deliberately breached skin. Whether that is topical use or administration is a question on which we can find no authoritative UK determination applying specifically to this class of product. We say so rather than guessing.
How non-human-derived preparations are treated. The human tissue framework does not engage for material of animal or plant origin, but the medicines tests still can, on both presentation and function limbs. How that plays out across the range of products on the market is not something we can state generally.
Enforcement practice. What a regulator has power to do and what it has done are different questions. The presence of products on the market is not evidence of a regulatory position; it is evidence about enforcement capacity and priorities.
Why we will not go further than this
It would be easy to write a confident article asserting that these products are unlawful to inject in the UK. That assertion circulates widely and it may well be correct in most real cases. We are not prepared to state it as settled without a primary source stating it, and we have not found one that covers the class as a whole rather than particular products or particular circumstances.
What we will say is that any practitioner injecting a product with no marketing authorisation, into a person, on the basis of supplier assurance, is exposed in a way they should have taken advice about, and any patient is entitled to ask what that product is and under what framework it is being used. Those two statements do not require resolving the classification question.
Questions readers ask
Are exosome treatments legal in the UK?
There is no single rule. Classification depends on what the product is made of, how it is presented and how it is used, and different frameworks can apply. We are not aware of any exosome product holding a UK marketing authorisation for an aesthetic indication.
Does no marketing authorisation mean the product was rejected?
Usually not. It generally means no application was made. What it does mean is that no regulator has assessed the quality, safety and efficacy of that product for that use, so all assurance comes from the supplier.
Does a CE or UKCA mark mean it is approved?
Those marks relate to different regimes with different requirements. A mark obtained for one purpose is not an authorisation for use as a medicine, and confusing the regimes is one of the commonest errors in this area.
Is topical application treated the same as injection?
No. Injection is administration and engages the functional limb of the medicines definition directly. Topical application to intact skin sits more naturally within cosmetics legislation. The status of application into deliberately breached skin is the case we cannot find an authoritative determination for.
How can I check a product's status myself?
Search the public register of authorised medicines, read the MHRA borderline guidance and apply its two limbs to the claims being made, and where human material is involved check the Human Tissue Authority position. All three are public.