Human stem cell cosmetics are not regenerative medicine | The legal boundary

Our shop carries several cosmetics formulated with human stem cell conditioned culture medium.

That is exactly why, we will first make clear something that is often confused.

Cosmetics formulated with human stem cell culture medium are not regenerative medicine.
The applicable laws and procedures are completely different.

Regenerative medicine has its own dedicated law

Act on the Safety of Regenerative Medicine (Act No. 85 of November 27, 2013). It is commonly known as the Regenerative Medicine Safety Act.

This law classifies regenerative medicine technologies into 3 categories according to risk and sets different procedures for each.

• Class I regenerative medicine technology
• Class II regenerative medicine technology
• Class III regenerative medicine technology

Before providing it, medical institutions a regenerative medicine provision plan must submit.

The committees that review them are also certified by the national government

The provision plan Certified Committee for Regenerative Medicine must obtain the opinion of.

This refers to a committee system made up of experts such as specialists in regenerative medicine technologies and law, that has received certification from the Minister of Health, Labour and Welfare through prescribed procedures this is what it means.

Furthermore, among them, those with particularly advanced review capabilities and third-party independence are called “Special Certified Committees for Regenerative Medicine.”

The certification is valid for 3 years. To continue, an application for renewal is required between 90 days and 60 days before the expiration date.

Currently, “ e-Regenerative Medicine ” is the online procedure site used for various applications.

Cosmetics are outside this law

As you can see if you have read this far, regenerative medicine is a “medical practice.” It is something conducted by medical institutions after submitting a plan, following review by a committee certified by the national government.

On the other hand, cosmetics formulated with human stem cell conditioned culture medium are “cosmetics” under the Pharmaceuticals and Medical Devices Act.

Because the names are similar, they are often confused, but when organized, the picture looks like this.

	Regenerative medicine	Cosmetics containing stem cell culture medium
Governing law	Regenerative Medicine Safety Act	Pharmaceuticals and Medical Devices Act
Entity that performs it	Medical institution	Cosmetics company
Procedures	Submission of provision plan and committee review	Marketing notification and full ingredient labeling
What is used	Cells themselves are processed and administered	No cells are included. The liquid after culture is used

The term “conditioned culture medium”

What appears in the full ingredient list is a name such as “human umbilical cord blood cell conditioned medium.”

This the liquid after cells have been cultured refers to. It is not the cells themselves.

That is why it can be blended into cosmetics, and that is also why it cannot claim effects like regenerative medicine.

Why we are writing this article

For the seller, it may be more convenient to leave the boundary vague.

But Speaking of medicine and cosmetics as if they were mixed together is problematic under the Pharmaceuticals and Medical Devices Act, and above all, it is disrespectful to the person buying.

Human stem cell culture medium is sufficiently interesting when seen as a cosmetic ingredient. There is no need to dress it up in medical language.

References: Ministry of Health, Labour and Welfare “About the Act on the Safety of Regenerative Medicine,” “About Certified Committees for Regenerative Medicine,” “About Submission of Regenerative Medicine Provision Plans, etc. (Overview),” Ministry of Health, Labour and Welfare “e-Regenerative Medicine,” PMDA “Overview of the Act on the Safety of Regenerative Medicine”
※This article explains the system and is not intended for the diagnosis, treatment, or prevention of disease. What our shop carries are cosmetics, and we do not provide regenerative medicine.

—The Value Village Editorial Team