Cosmetic, Medical Device or Drug? Choosing the Regulatory Route for a Nail Product
The same jar of cream can be a cosmetic, a medical device or an unapproved drug depending on one thing: what the label says it does. Before a brand owner picks a supplier, they are picking a route, and each route has its own claims, evidence, paperwork, factory and timeline. This page compares the three.
The three routes side by side
| Cosmetic | Medical device (EU) | Drug (US OTC or prescription) | |
|---|---|---|---|
| What the label may say | Care, appearance and condition: softens, smooths, conditions, improves the look of thickened or discoloured nails | A medical purpose backed by its evidence, e.g. acting on the nail environment in onychomycosis | Treats, cures or prevents a disease, within what the monograph or approval allows |
| Typical examples on shelf | Nail renewal and conditioning creams, herbal foot and nail creams | Pens and lacquers that lower nail pH or form a film, CE-marked with a notified body number | US: tolnaftate and undecylenic acid products for skin (not nails); prescription efinaconazole, tavaborole, ciclopirox for nails |
| Evidence needed | Safety assessment; substantiation for any performance claim | Clinical evaluation, risk management, technical documentation reviewed by a notified body | OTC: conformity to the monograph. New claims or nail indications: clinical trials and an approval |
| Who files | Responsible person: CPNP (EU), SCPN (GB); US product listing under MoCRA | Manufacturer, through a notified body; EU authorised representative if outside the EU | Drug sponsor; drug establishment registration and listing |
| Who can make it | A cosmetics manufacturer; ISO 22716 GMP is the reference standard | A manufacturer with an ISO 13485 quality system covering the device | A drug manufacturer working to drug GMP |
| Time to market | Weeks, once the formula and dossier exist | Commonly more than a year | OTC: months. Prescription: years |
| Cost to enter | Lowest | High: notified body fees, clinical evidence | Highest for anything beyond an existing monograph |
Timelines are typical ranges, not quotes. A device or drug programme depends heavily on the evidence you already hold.
The rule that decides it: intended purpose
Regulators in the EU, the UK and the US classify a product by what it is presented as doing. The formula does not decide the category. A cream that “helps soften and smooth thickened nails” is a cosmetic. Put the same cream in a box that says “kills nail fungus” and it becomes, in the US, an unapproved drug, and in Europe, a product that is neither a lawful cosmetic nor a certified device.
Claims include more than the front of the box. Product listings, website copy, social posts, the brand name and the images all count, and so does selective quoting of scientific papers. Herbal brands are exposed to the last one, because every botanical in the category has laboratory literature on antimicrobial activity. Our ingredient dossiers on Sophora, Pseudolarix and Impatiens each explain why that literature stays off the pack.
Each route in more detail
The cosmetic route
In the EU, a cosmetic needs a responsible person established in the EU, a product information file with a cosmetic product safety report signed by a qualified assessor, and a notification on the CPNP portal before it goes on sale. Great Britain runs the same structure with its own notification service. In the US, MoCRA added facility registration, product listing, serious adverse event reporting and a duty to hold safety substantiation. None of these is a pre-market approval. The work takes weeks.
What the route costs you is claim latitude. You can talk about the nail’s appearance and condition. You cannot talk about infection. For a salicylic acid cream, the salicylic acid guide adds a concentration ceiling of 2.0% in the EU and UK.
The medical device route
Several European nail fungus products are CE-marked medical devices rather than medicines. They claim a physical or chemical action, such as lowering the pH of the nail or forming a protective film, rather than killing the fungus pharmacologically. Under the Medical Device Regulation, substances applied to the skin fall under a specific classification rule, and that brings a notified body into the process, along with clinical evaluation, risk management and an ISO 13485 quality system at the manufacturer.
The route takes longer than the cosmetic route, and it cannot be added to a cosmetic formula after launch.
The drug route
In the US, the over-the-counter antifungal rules allow claims for athlete’s foot, jock itch and ringworm on the skin, and products made under them carry a statement that they are not effective on the scalp or nails. The topical nail-fungus treatments approved in the US are prescription drugs. So a US brand that wants a nail-fungus claim is looking at a drug approval, not an OTC listing. In Europe, medicines such as amorolfine nail lacquer are authorised products with their own marketing authorisations.
How brands usually decide
Choose cosmetic if
You want to launch this year, you have no clinical data, and your brand can sell on care, ritual and ingredient story rather than on a cure claim.
Choose device if
Your channel is pharmacy-led, you can fund a notified body and clinical evaluation, and you have more than a year before launch.
Choose drug if
You are a pharmaceutical company with a development budget, or you are licensing an approved product into a new territory.
Common questions
What decides whether a nail product is a cosmetic or a medical device?
Its intended purpose, which regulators read from the claims. A product presented as caring for the appearance and condition of the nail is a cosmetic. A product presented as treating or preventing a nail infection is not, even with an identical formula. In the EU, borderline cases are decided by national authorities.
Why are some European nail fungus products medical devices rather than medicines?
Because they claim a physical or chemical action on the nail environment, such as lowering pH or forming a film, rather than a pharmacological one on the fungus. Products of that kind can be CE-marked as substance-based medical devices under Regulation 2017/745, which requires a notified body and clinical evaluation.
Can I sell a nail fungus treatment over the counter in the US?
Not under the OTC antifungal rules. Those cover athlete's foot, jock itch and ringworm on the skin, and products made under them state that they are not effective on the nails. The topical nail-fungus products approved in the US are prescription drugs.
Which route is fastest to market?
The cosmetic route, by a wide margin. It needs a safety assessment, a responsible person and a notification or listing, with no pre-market approval. The trade-off is that you cannot claim to treat or prevent infection.
Can your factory make a device or drug version?
No. We manufacture the botanical cosmetic. If your programme needs a CE-marked device or a registered drug, you need a manufacturer with the matching quality system and approvals.
Building a cosmetic nail brand?
Tell us your market and channel. We will send the formula breakdown your assessor needs and a stock unit to evaluate, from a minimum of one piece.
More sourcing guides
Sources and where to check
- Regulation (EC) No 1223/2009 on cosmetic products — definition of a cosmetic, responsible person, notification
- Regulation (EU) 2017/745 on medical devices — Annex VIII classification rules, including the rule for substance-based devices
- US FDA — Is it a cosmetic, a drug, or both?
- US FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Sourcing this product for your brand?
We are the factory. The pages below cover manufacturing terms rather than consumer advice — minimum quantities, customisation, formulation and distribution.
Looking for a herbal toenail fungus cream?
Our herbal nail care formula is available for sample orders, wholesale supply, OEM packaging and distributor cooperation. Contact us to get started.