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PDRN and exosomes in skincare: what they are, what is allowed, and what you can claim

The two biggest K-beauty trend actives of 2025 and 2026, explained for brand founders: sources and INCI names, what the studies really show, where the line sits between cosmetic, drug and medical device, and the rules on human-derived ingredients in the EU, US, Korea, Japan, China and Canada.

Not legal adviceThis guide summarizes published rules and studies as of October 2026. Rules on biological ingredients change quickly; your safety assessor, importer or the regulator has the final word for your product and market.

Short answer

PDRN is purified DNA fragments, usually from salmon, listed on cosmetic labels as Sodium DNA; it is a legal cosmetic skin-conditioning ingredient, while the same family of molecules is sold as injectable medical products and, in Korea, as an over-the-counter wound cream. Most PDRN evidence comes from injections and wounds, so cosmetic claims should stay on hydration and smoother-looking skin. Exosomes are tiny vesicles released by cells: plant-derived "exosomes" can be used as ordinary plant ingredients, but the EU bans cells, tissues or products of human origin (Annex II entry 416), China treats human-origin materials as prohibited, Korea allows only human cell culture fluid that meets its strict safety standard, and the FDA says exosomes used to treat diseases are drugs and biological products with no FDA-approved product.

PDRN: what it is and its INCI names

PDRN (polydeoxyribonucleotide) is a mixture of DNA fragments. The classic material is purified from the sperm cells of salmon trout or chum salmon in a process designed to remove proteins and peptides, giving fragments of roughly 50 to 1,500 kDa (Squadrito 2017). PN (polynucleotides) is the same family with longer chains; a 2025 review proposed calling fragments under 1,500 kDa PDRN and longer ones PN (Marques 2025).

Material	Typical INCI name	Note
Salmon PDRN	Sodium DNA	EU CosIng lists Sodium DNA as the sodium salts of DNA, with a skin conditioning function
Plant-derived PDRN	Hydrolyzed DNA or a plant-named ingredient	The INCI name does not reveal the source; ask for a statement of origin
"PDRN complex" raw materials	Several INCI names (sodium DNA plus carriers)	Often sold as a solution, so the DNA itself is a fraction of the input

Our article on private label PDRN serum covers the basics of making a PDRN product, what "10,000 ppm" means (it is 1%) and the questions to ask before you approve a sample. This guide goes deeper on categories, evidence, exosomes and the rules.

PDRN as a cosmetic, drug or medical device

The same molecule family sits in three regulatory worlds. What decides the category is the product's intended use, route and claims, not the molecule.

Product	Category	Example of the rule
PDRN serum, cream or mask on intact skin with appearance claims	Cosmetic	Sodium DNA as a skin conditioning ingredient
Injectable PDRN or PN "skin boosters" used by clinicians	Medicinal product or medical device, depending on the country and product	Korean trade press reports PN injectables approved as medical devices in Korea
PDRN cream for wounds and ulcers	Drug	Korean trade press reported in 2025 that MFDS approved an over-the-counter cream with polydeoxyribonucleotide sodium for nutrition of skin prone to wounds and ulcers

So a cosmetic PDRN serum is not a needle-free version of a clinic treatment. Saying it is (for example "salmon injection in a bottle") can move it toward drug territory in the US and Canada and mislead customers who expect clinic results. See our cosmetic vs drug guide.

PDRN evidence

Mechanism: lab and animal studies link PDRN to adenosine A2A receptors and to supplying building blocks for DNA recycling (Squadrito 2017).
Human trials: a 2026 systematic review found only seven randomized trials of PN or PDRN for skin rejuvenation, scars and wounds, 183 participants in total; benefits were most consistent in wound healing, and the authors called the evidence limited by small samples and mixed protocols. In those trials the material was injected, used after procedures or applied to wounds.
Cosmetic on intact skin: a 2026 randomized, double-blind, split-face study compared a 0.1% PDRN eye cream with a 0.1% retinol eye cream for 28 days and reported larger improvements in eye-area wrinkles on the PDRN side. It is one small study of one formula.
Evidence level: limited for topical cosmetics; moderate for injected and wound uses, which a cosmetic cannot borrow.

Typical use levels are not well documented in independent literature; supplier materials and product claims vary widely, and the one topical trial above used 0.1%. Agree the real DNA level with your manufacturer in writing.

Plant PDRN and vegan claims

Plant PDRN is DNA purified from plants or plant cell cultures (for example ginseng), and there are versions from microalgae and bacteria. A 2026 review of plant-derived PN and PDRN says most data are preclinical, that receptor effects seen with salmon PDRN have not been directly shown for most plant preparations, and that head-to-head studies are limited. If you print "vegan PDRN":

Get a statement of origin
The botanical or microbial source, from the raw material supplier.
Get proof it is DNA
A specification showing DNA content, not only a plant extract with a PDRN trade name.
Confirm no animal inputs
For the material and the whole formula, if the product is marketed as vegan. See our vegan and cruelty-free guide.

Exosomes: what they are and where they come from

Exosomes are nanoscale membrane vesicles that cells release to carry proteins, lipids and RNA to other cells. Research uses them from many sources; a 2026 review lists mesenchymal stem cells, other cells, plants, milk and plasma (Zhang 2026). In cosmetics the source decides almost everything.

Source	Typical cosmetic use	Regulatory risk
Plant (fruit, callus or cell culture "exosome-like nanovesicles")	Most exosome ingredients reported in the INCI dictionary, according to a CIRS analysis	Lowest: treated as a plant ingredient; claims are the main risk
Microbial or yeast ferments	Ferment-derived vesicle ingredients	Low to moderate: treated like other ferment ingredients
Animal (for example milk)	Rare	Moderate: animal by-product and disease-transmission rules apply
Human cells (stem cell conditioned media)	Used in some Korean and clinic products	Highest: banned in the EU and China, tightly controlled in Korea, drug or biologic territory in the US when used to treat conditions

Exosome evidence

A 2026 review of exosome therapies for skin aging describes effects on oxidative damage, collagen and matrix enzymes in preclinical work, and names the limits: different preparations behave differently, there are no standard isolation and production methods, delivery is inefficient, and long-term clinical safety and efficacy data are insufficient (Zhang 2026). A 2026 review of plant-derived exosomes in aesthetic medicine presents them as a promising, scalable platform, again mostly on preclinical evidence (Chen 2026). Evidence level for cosmetic exosome products on intact skin: limited.

For a supplier's "exosome" ingredient, ask for characterization data: particle size distribution (for example by nanoparticle tracking), particle count per mL, the source, the isolation method, and whether vesicles survive in your formula. Without that, the word "exosome" on your box may not be supportable.

Rules per market

Market	PDRN (sodium DNA)	Exosomes and human-derived materials
EU and UK	Allowed as a cosmetic ingredient (CosIng: Sodium DNA); safety assessed in the CPSR	Annex II entry 416 prohibits "cells, tissues or products of human origin", so human stem cell media and human-derived exosomes cannot be used. Animal materials must also respect the Annex II ban on certain animal by-products (entry 419). Ask your safety assessor whether a nanoscale vesicle triggers the EU nanomaterial notification
United States	Cosmetic if claims are about appearance	FDA (2019): "exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products", subject to premarket approval, and "there are currently no FDA-approved exosome products". FDA has warned about serious adverse events from unapproved exosome products in clinics. Topical cosmetics with appearance claims are outside that statement, but regeneration or healing claims are not
Korea	Allowed as a cosmetic ingredient	Human cells, tissues and their culture fluid are on the banned list, except culture fluid that meets Annex 3 of the Cosmetic Safety Standards: healthy adult donors screened for HBV, HCV, HIV, HTLV, parvovirus B19, CMV, EBV and other infections; collection only at medical institutions; culture in a clean area of class 1B (Class 10,000) or better; treatment to inactivate or remove bacteria, fungi and viruses; full records; no payment for cells and no ads naming a donor. Human placenta-derived materials are banned
Japan	Allowed as a cosmetic ingredient	Human stem cell culture supernatant is reported as usable under the health ministry's 2003 guidelines for biological-origin materials, with special requirements for human-derived inputs; human placenta extract is reported as prohibited
China	Check the inventory of existing cosmetic ingredients with your filing partner	Human cells, tissues and human-origin products are prohibited under the 2015 safety standards; consultancy analyses report that no exosome ingredient has been approved and that using the word "exosome" on cosmetics is treated as non-compliant
Canada	Allowed; cosmetic claims only	Substances of human origin are on the Hotlist restricted list: the maker must give Health Canada the source, production method, quality control data (including microbial limits and viruses) and labeling

Rules on biological ingredients are moving: China moved extracellular vesicles into its advanced therapy framework in 2025, and Taiwan changed its approach in 2026, according to trade reports. Check before every new market. See our guides to EU, Korea, China, Japan and Canada rules.

Formulation, stability and packaging

PDRN: water soluble, used in serums, ampoules, essences, mists, creams and masks. DNA can be broken down by nuclease enzymes from microbes, so a strong preservative system and clean filling matter; run a challenge test.
Exosome ingredients: vesicles can be damaged by heat, strong surfactants, solvents and freezing; add them in the cool-down phase and follow the supplier's limits.
Stability: track appearance, pH, viscosity and microbial results in the final pack. Measuring DNA or vesicle content in a finished cosmetic is hard; keep batch records of the input amount.
Packaging: airless pumps, droppers with tight closures or single-dose ampoules and sachets limit contamination. See airless vs dropper and minis and sachets.

Claims you can and cannot make

Usually fine as a cosmetic	Avoid
"Hydrated, bouncy, smoother-looking skin"	"Repairs DNA", "regenerates cells", "heals"
"With salmon-derived PDRN (Sodium DNA)"	"Salmon injection in a bottle", "works like a skin booster"
"With plant-derived vesicles from [plant]" (with supplier data)	"Stem cell therapy", "regenerative", "with human stem cell exosomes" (banned in the EU and China)
"10,000 ppm PDRN raw material" only if you explain it and can document it	"10,000 ppm PDRN" when the DNA itself is far below 1%

EU rules add a test for ingredient claims: a claim that carries an ingredient's benefit over to the product needs evidence, such as presence at an effective level (Regulation (EU) No 655/2013). More in our claims guide.

Common mistakes

Buying a "human stem cell exosome" raw material for an EU, UK or China launch, where human-origin ingredients are banned.
Selling a Korean human culture fluid ingredient without the supplier's documents showing it meets Korea's Annex 3 safety standard.
Marketing a PDRN serum as an injection replacement or with "repairs DNA" claims.
Printing "vegan PDRN" without a statement of origin and proof that the material is DNA.
Calling a plant extract "exosomes" without particle data from the supplier.
Printing a ppm figure that describes the raw material solution, not the DNA in the product.
Assuming one formula is legal everywhere; the source of a biological ingredient changes the answer per market.

Checklist for a PDRN or exosome product

Source confirmed in writing: salmon, plant, microbial, animal or human.
INCI name confirmed and checked in CosIng for EU markets.
Target markets checked against human-origin rules (EU entry 416, China, Korea Annex 3, Canada Hotlist).
Supplier certificate of analysis, specification and, for exosomes, particle characterization data.
Real input level of DNA or vesicles agreed and recorded in batch documents.
Vegan or fish-free statements backed by supplier documents.
Preservative challenge test passed; stability tested in the final pack.
Claims limited to appearance and feel; no healing, DNA repair or injection comparisons.
Any ppm or "concentration" claim explained and documented.
Nanomaterial question asked to the EU safety assessor for exosome ingredients.

How KoreanOEM helps

KoreanOEM is a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea. PDRN is one of the most requested actives in our formula library:

Ready PDRN formulas: PDRN serum, PDRN cream, PDRN eye cream, neck cream, mist, sheet mask, eye patches, sachets, a PDRN and collagen balm stick and a PDRN scalp serum.
A serum starts from about USD 3.40 per unit at 500 units and a cream from about USD 3.41 at 500 units, with a stock container and a one-color label included. A higher PDRN level or a plant-derived source is an adjusted library formula (USD 399 per SKU, credited against your first order).
Our library has no ready exosome formula. If you want a plant-derived vesicle ingredient, tell us the source and markets; our team checks the material and the rules with the lab before anything is promised.
We prepare the INCI list after the NDA, the COA and supplier documents for your importer, and our label proof check reviews PDRN and exosome claims for your market.

Get a free quote Order a sample box

Frequently asked questions

What is PDRN in skincare?

PDRN (polydeoxyribonucleotide) is purified DNA fragments, usually from salmon, used as a skin-conditioning ingredient. On the label it normally appears as Sodium DNA.

Does topical PDRN work?

Most human evidence comes from injections, procedures and wounds; a 2026 review found only seven randomized trials with 183 people. One small 2026 split-face study of a 0.1% PDRN eye cream reported wrinkle improvements, so keep cosmetic claims to hydration and smoother-looking skin.

Is PDRN a drug or a cosmetic?

It depends on the product. A PDRN serum on intact skin with appearance claims is a cosmetic, while injectable PDRN or PN products are medicines or medical devices, and Korea has approved an over-the-counter PDRN cream for wound care as a drug.

Are exosomes allowed in cosmetics?

Plant-derived exosome ingredients can generally be used as plant ingredients with appearance claims. Human-derived exosomes and stem cell media are banned in the EU (Annex II entry 416) and China, allowed in Korea only as culture fluid that meets a strict safety standard, and FDA says exosomes used to treat conditions are drugs and biological products with none approved.

Can I sell a human stem cell culture serum in the EU?

No. The EU Cosmetics Regulation prohibits cells, tissues or products of human origin in cosmetics, which covers human stem cell conditioned media and human-derived exosomes.

What is plant PDRN?

DNA purified from plants, plant cell cultures, microalgae or bacteria, used as a salmon-free alternative. A 2026 review found the evidence mostly preclinical, so ask the supplier for proof of source and DNA content before printing vegan PDRN claims.

What does 10,000 ppm PDRN mean?

10,000 ppm is 1%. It can mean 1% pure DNA or 1% of a diluted raw material solution, so ask which, and print only what your batch records support.

Can I call my product an exosome serum in China?

It is risky. China prohibits human-origin materials, no exosome ingredient is reported as approved, and consultancy analyses say using the word "exosome" on cosmetics is treated as non-compliant; check with your filing partner first.

Sources

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.