Is my product a cosmetic, or a medicinal product requiring authorisation? For manufacturers, this is a critical distinction to make. The Cologne Administrative Court recently had to decide whether a cream for dry skin and neurodermatitis is a cosmetic or a medicinal product (judgment of 13 August 2024 – case no. 7 K 2494/22). The case reveals the aspects that manufacturers have to consider in the marketing and presentation of their products if they want to avoid – or ensure, as the case may be - having a product classified as a medicinal product.
The product presentation
The case concerned a skin cream, with the following and other information provided on the packaging:
- “intensive care for very dry, irritated skin and neurodermatitis”;
- “immediate itch relief/prevents inflammation”;
- “clinically dermatologically tested intensive skincare with micro-silver, panthenol and skincare lipids for very dry, irritated skin and for neurodermatitis skincare”;
- “medical skincare”.
On the product website, the cream manufacturer also included links to informative articles, focusing strongly on the curing and alleviating effect of micro-silver on neurodermatitis.
The Federal Institute for Drugs and Medical Devices categorised the product as a medicinal product requiring authorisation, citing its strong connection to neurodermatitis and the specified ingredients micro-silver and panthenol. The manufacturer lodged an objection to this decision with the Administrative Court, arguing that the cream is a cosmetic skincare product.
Distinction between medicinal products by presentation and cosmetics
The classification as a medicinal product or a cosmetic product is highly relevant, as cosmetics are not required to undergo a complex authorisation procedure. The definitions are mutually exclusive: a product must be categorised either as a medicinal product or as a cosmetic product. Therefore, the Cologne Administrative Court had to determine whether the cream at issue is a medicinal product by presentation within the meaning of Sec. 2(1) No. 1 AMG (German Medicinal Products Act), which requires authorisation, or a cosmetic product as defined in Sec. 2(3) No. 3 AMG.
Sec. 2(1) No. 1 AMG defines medicinal products by presentation as substances intended “for use in or on the human body” and “as remedies with properties for the curing, alleviating or preventing of human disease or disease symptoms”. A product that is expressly identified as a remedy having these properties clearly falls within the category of medicinal products by presentation. However – and this is very clear from the recent case – a product that by its presentation merely gives the well-informed, reasonably observant and reasonably circumspect average consumer the impression of having these properties, qualifies as a medicinal product by presentation as well. By contrast, cosmetic products are excluded from the definition of medicinal products by Sec. 2(3) No. 3 AMG and therefore do not require a marketing authorisation under the AMG; they are defined as substances or mixtures intended to be placed in contact with external parts of the human body such as the skin, with a view exclusively or mainly to protecting it or keeping it in good condition.
To make the distinction, one must consider the overall circumstances of the product’s presentation in their entirety.
The approach taken by the Administrative Court
Having viewed the facts and circumstances as a whole, the Administrative Court concluded that the cream in dispute is not a medicinal product as defined by the AMG, relying mainly on the presentation of the product and the information provided on the packaging in support of its decision. While the express reference to the skin condition “neurodermatitis” and the links to the informative articles establish a distinct connection to the clinical condition, this in itself is not sufficient to classify the cream as a medicinal product.
In the court’s view, patients with neurodermatitis are very much aware that there exist not only medicinal remedies to alleviate their condition but also skincare products that help to make them more comfortable. The skincare function of the cream is emphasised both on the packaging and in the enclosed information leaflet. Furthermore, the product only promises intensive skincare for neurodermatitis, but not any efficacy against neurodermatitis.
In addition, the graphic representation on the packaging also was held to be “rather untypical for a medicinal product”. The ingredients panthenol and micro-silver are used in many cosmetic products and therefore cannot be regarded as exclusively for medicinal use.
To do
The Administrative Court decision is instructive especially for the overall approach adopted by the court: While the court saw many reasons to categorise the cream as a medicinal product, the decisive factors were the visual presentation of the packaging and the language used to describe the product – with the result that the court classified the cream as a cosmetic product (not subject to authorisation) rather than a medicinal product. Where relevant in the particular case, the product design should focus on the skincare properties of the product. The decision of the Administrative Court once again confirms that one should pay particular attention to a product’s packaging to avoid the risk of giving consumers different expectations, which could lead to the product requiring authorisation or approval.
