Teething Issues: The Borderline Between Cosmetic, Medicinal, and Medical Device Products in Oral Care

6 Sept

Introduction

The oral care sector is undergoing a quiet renaissance. From eco-friendly toothpastes to tablets and powders, the category is brimming with innovation. Consumers are eager for products that promise brighter smiles, fresher breath, and healthier mouths. But in this fast-moving market, there’s one challenge that keeps catching brands off guard: the regulatory borderline.

Oral care products often blur the lines between cosmetics, medicinal products, and medical devices. Understanding these distinctions isn’t just a legal requirement, it’s the difference between a smooth launch and a costly fine.

Why the Borderline Matters

The UK and EU regulatory landscape draws sharp boundaries between product categories:

Cosmetic products (under the UK/EU Cosmetics Regulation) are intended to clean, perfume, change appearance, correct body odours, or protect/keep in good condition, without treating or preventing disease.
Medicinal products (under Directive 2001/83/EC) are substances or combinations that treat or prevent disease, or exert a pharmacological effect.
Medical devices (under the UK Medical Devices Regulations 2002 or EU MDR 2017/745) are articles, instruments or apparatus that achieve their purpose by physical means rather than pharmacological action.

At first glance, this seems straightforward. But in oral care, the boundaries overlap:

A toothpaste removes stains (cosmetic).
A toothpaste treats sensitivity (borderline medicinal).
A light device assists whitening gel (possibly cosmetic or device).
A light device alters tooth structure (likely medical device).

Small differences in claims, composition, or function can completely change a product’s classification with massive consequences for testing, authorisation, market access and cost.

The Top 5 Borderline Pitfalls in Oral Care

1. Whitening Claims That Tip into Medicinal

Whitening is one of the most competitive areas of oral care. But it’s also where brands most often overstep.

Cosmetic: “Helps restore the natural whiteness of teeth.”
Medicinal: “Treats discolouration caused by tetracycline use.”

Why it matters: If your whitening product claims to treat or prevent disease-related staining, regulators may classify it as medicinal. This shifts your product from Cosmetic Regulation into medicinal territory requring a Marketing Authorisation from the MHRA prior to sale.

2. Hydrogen Peroxide and the Fine Line of Ingredients

Hydrogen peroxide is a common whitening ingredient, but it comes with strict concentration limits in cosmetics.

Below 0.1%: Generally permitted in cosmetic products.
0.1–6%: Restricted use, often requiring professional supervision (e.g., in-clinic whitening).
Above 6%: Considered unsafe for cosmetics, and may fall into medicinal territory.

The risk: Even if your product is marketed as cosmetic, exceeding these thresholds can get it classified as medicinal or unsafe. Borderline missteps here often lead to customs seizures, product withdrawals, or retailer rejection.

3. Blue-Light Whitening Kits and Medical Device Confusion

Light-activated whitening kits are a growing trend. But here’s the catch:

If the light assists the action of a whitening gel (cosmetic), regulators will probably consider this to be a cosmetic.
If the light is marketed as changing tooth structure or treating intrinsic stains, it may be considered a medical device.

4. Fluoride Toothpaste: The Classic Borderline Case

Fluoride toothpaste is the textbook example of a borderline product.

Everyday fluoride pastes at cosmetic concentrations: cosmetic.
High-strength fluoride product (e.g., 2800 ppm), prescribed to treat decay: medicinal.

5. Mouthwashes: Fresh Breath or Disease Treatment?

Mouthwashes show how small wording choices can make big regulatory differences:

Cosmetic: “Leaves your breath fresh.”
Borderline: “Helps reduce bacteria.”
Medicinal: “Prevents or treats gum disease.”

The risk: Over-claiming efficacy against bacteria or oral disease risks medicinal classification. Brands often underestimate how tightly regulators interpret these phrases.

Final Thoughts

Borderline challenges can feel like roadblocks, but they can also be opportunities. Brands that invest in the right classification from the outset:

Launch faster, without regulatory pushback.
Gain retailer confidence (buyers hate borderline uncertainty).
Protect themselves from legal challenges by competitors.
Build consumer trust through clear, credible messaging.

Whether your innovation is a toothpaste, mouthwash, or whitening device, we’ll help you find the right classification, make compliant claims, and launch with confidence. Because in oral care, a bright smile starts with a clear regulatory strategy. Yes, we know this is beyond cheesy.

Consider appointing a Responsible Person - this isn’t just a tick box exercise, a good RP will have a wealth of knowledge and experience that you can learn from. Don’t settle for the cheapest option. Invest in a Responsible Person who brings real scientific knowledge to the table. It’s the smartest move you can make for your brand’s success in the UK and EU markets. Whether you’re launching your first product or expanding into new markets, having expert compliance support is key.

Jordon Sandland