In short: How polynucleotides are regulated depends heavily on the country. In Europe and Switzerland, they are classified as medical devices and are monitored accordingly. In South Korea, they have been established for years, and „salmon DNA» is considered standard there. In the US, however, polynucleotides as injections for aesthetic purposes are not approved – only external products are sold as cosmetics. In Russia, preparations such as Plinest are registered and very common. (As of 2026.)
Anyone looking into polynucleotides will find conflicting statements: sometimes they are described as „not approved,» and other times they are in widespread use. Both can be true – depending on which country is being discussed. We'll sort this out.
First: What does „approved» mean anyway?
An important point first. Countries regulate such products differently. In many regions, injectable polynucleotides are considered Medical device – then they undergo a conformity assessment and can be used with appropriate marking. In other systems, such as the USA, the hurdle for injectable preparations is a Medicinal product-type authorisation, which these products have not had so far. Therefore, the same preparation may be available in one country and not permitted in another.
Europe and Switzerland: Medical Devices
In the European Union, injectable polynucleotides are considered medical devices and carry a CE mark in accordance with the applicable Medical Device Regulation. As such, they are an integral part of aesthetic medicine.
In Switzerland, medical devices are supervised by Swissmedic. CE-marked products that meet Swiss requirements are used. For practical purposes, this means that polynucleotides are regularly available here and are used in the medical-aesthetic field. The product we use PolyPhil™ is a CE-certified medical device.
Korea: the motherland of „salmon DNA»
South Korea is a leader in polynucleotides. Preparations such as Rejuran have been established, widely used, and extensively researched there for years. The Korean regulatory authority oversees this market, and the „Salmon DNA» treatment is part of routine cosmetic medicine. A significant portion of the international recognition of polynucleotides can be attributed to the Korean market.
USA: Not approved for injection
The situation in the USA is different – and this surprises many. Injectable polynucleotides are not approved for aesthetic use there (as of 2026). What *is* available are topical products: creams and serums with related active ingredients (PDRN) are sold as cosmetics, as cosmetics are not subject to prior approval in the USA.
This leads to a paradoxical situation: a trend originating from Korea and Europe is not available as a treatment in the USA. American women who want polynucleotides therefore often travel abroad. It's a good example that „not approved in the USA» does not mean „ineffective» – it simply reflects a different regulatory system.
Russia: registered and very common
In Russia, polynucleotide preparations such as Plinest are registered and firmly established in the market. The treatment – often referred to there as „biorevitalization with polynucleotides» – is widespread and popular. Consequently, there is a high level of familiarity with the name Plinest, which regularly leads to questions when clients come to Switzerland. We explain why it's PolyPhil instead of Plinest here in the article. Plinest or PolyPhil?.
A look into history: PDRN since 1994
The basic idea is nothing new. The related DNA fraction PDRN was already approved in Italy in 1994 for wound healing – for example, for slow-healing wounds. From this medical application, today's use in skin rejuvenation developed. So, polynucleotides are not a fad product without history, but an active principle with decades of foundation.
The overview
| Region | Status (As of 2026) |
|---|---|
| EU | Medical device with CE marking, established |
| Switzerland | Medical device under Swissmedic supervision, available |
| Korea | Established for years, very widespread |
| United States of America | Not approved for injection; only external products as cosmetics |
| Russia | registered, widely used (incl. Plinest) |
What that means for you in Zurich
In Switzerland, you can obtain polynucleotides within a regulated framework. alestetics® At the clinic near Zurich Main Station, we work with the CE-certified PolyPhil™. Whether the treatment is right for you, we will clarify in advance in the free AURA 3D Skin Analysis.
Read on
- Plinest or PolyPhil? The Mastelli connection
- What are polynucleotides?
- Polynucleotides or hyaluronic acid: what is better for skin quality?
Are polynucleotides approved in Switzerland?
In Switzerland, polynucleotides are regarded as medical devices and are subject to the supervision of Swissmedic. CE-marked products are used. They are regularly available here and are employed in medical-aesthetic contexts.
Are polynucleotides approved by the FDA?
Injectable polynucleotides are not approved for aesthetic use in the USA (as of 2025/2026). Topical products with related active ingredients are sold there as cosmetics, as cosmetics do not require prior approval.
Why are polynucleotides not available in the USA, but are in Europe?
Because the regulatory systems are different. In Europe, they are considered a medical device; in the USA, an injection would require drug-like approval, which is currently lacking. „Not approved» does not mean „ineffective» there.
Since when has this active ingredient existed?
The related PDRN faction was already approved in Italy in 1994 for wound healing. Its use in skin rejuvenation developed from this medical application.
Is Plinest approved in Russia?
Yes, preparations like Plinest are registered and widely used in Russia. In Switzerland, polynucleotides from Mastelli are available through PolyPhil.
