Injection Action: Norwegian Authorities Sanction Illegal Practices Related to Cosmetic Treatments

We provide an overview of the findings revealed in the action, the consequences for the industry, and the key rules for marketing medicinal products and medical devices.

Findings from the Injection Action

Nearly 50 clinics received reactions following the Injection Action: 40 clinics received letters pointing out violations of the law and providing guidance on the applicable regulations, whilst four clinics were notified about administrative fines. Additionally, the authorities have reported that they are working on three further notices that may lead to such fines. Among the most serious findings were the marketing of medicinal products outside their approved use (off-label use), use of value-laden words and expressions in advertisements, illegal and misleading marketing of medical devices, and marketing of filler treatments appealing to children and youth.

A similar supervisory action has been conducted previously (as reported on the NoMA's website here). In the previous action, fines of up to NOK 800,000 were imposed, underscoring the seriousness of the violations. Despite increased awareness in the industry, the findings of the recent action show that several actors continue to operate in contravention of the regulations, even after warnings from the authorities.

Providers of Cosmetic Treatments Must Familiarise Themselves with Regulations for Medicinal Products and Medical Devices

It is crucial that actors marketing medicinal products and medical devices are well-acquainted with and ensure compliance with applicable regulations, including in communication on social media and other digital platforms. When marketing medicinal products and medical devices, actors must comply with specific rules for these product categories, in addition to following general marketing rules. The special rules for medicinal products and medical devices include, among other things, clear restrictions on the marketing of prescription-only medicinal products, requirements for compliance with approved summaries of product characteristics, and prohibitions against misleading or exaggerated claims about medical devices. In the following, we provide an overview of the most important rules that apply to the marketing of medicinal products and medical devices.

Rules for Marketing of Medicinal Products

Marketing of medicinal products in Norway is subject to strict regulations, primarily through Chapter 7 of the Medicinal Products Act and Chapter 13 of the Medicinal Products Regulation. The rules cover all forms of proactive information activities, campaigns, advocacy, and other measures intended to promote the prescription, dispensing, sale, or use of medicinal products. The purpose of the rules is to ensure the proper use of medicinal products and safeguard public health.

Here is an overview of some of the key rules that actors engaged in marketing in this area must adhere to:

• Prohibition on advertising medicinal products without marketing authorisation: It is only permitted to advertise medicinal products that have marketing authorisation (MA) in Norway. This means that the medicinal product must be approved by the NoMA for sale on the Norwegian market.
• Prohibition on advertising off-label use: All medicinal product advertising must comply with the information in the summary of product characteristics approved by the NoMA. This means, for example, that advertising Botox in cosmetic treatment is prohibited, as Botox for cosmetic use is outside the medicinal product's approved indication in Norway.
• Prohibition on advertising prescription-only medicinal products to the general public: It is not permitted to market prescription-only medicinal products to the general public. Such advertising may only be directed at healthcare professionals. In this context, advertising for Botox is a practical example of what may constitute illegal marketing: Botox is a prescription-only medicine, and it is therefore illegal to advertise Botox treatment to the general public.
• Limitations on disease types: In addition to only being able to advertise over-the-counter medicinal products to the general public, it is required that the medicinal products are exclusively recommended for diseases or disease symptoms that do not require examination or treatment by a doctor or dentist. Further, it is not permitted to mention serious diseases in advertising to the general public, such as cancer, diabetes, chronic insomnia, or sexually transmitted diseases.
• Additional requirements for advertising to the general public: Advertisements to the general public must be designed in such a way that it is clear that it is advertising, and that the medicinal product being advertised is clearly identified as a medicinal product. Section 13-6 of the Medicinal Products Regulation sets out further requirements for the content of advertising to the general public and contains a list of material that medicinal product advertising cannot legally contain. For example, it is not permitted to include advertising that refers to recommendations from healthcare professionals or researchers, or that suggests that a person's health can be improved through the use of the medicinal product.

In case of violations of the rules on medicinal product advertising, the NoMA may impose administrative fines.

Rules for Marketing of Medical Devices

It is generally permitted to advertise medical devices in Norway, and there is no distinction between healthcare professionals and the general public, as is the case for medicinal product advertising.

Nevertheless, requirements apply to the content of such marketing. These requirements are set out in Article 7 of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), and can be summarised as follows:

Marketing of medical devices is illegal if it misleads about the device's intended purpose, safety, and performance. In labelling, instructions for use, and advertising of medical devices, it is not permitted to use text, names, trademarks, pictures, and figurative or other signs that may mislead the consumer or patient. It is prohibited to:

• Give the impression that the device has functions and properties that it does not have.
• Create a false impression of the treatment or diagnostic ability or of properties that the device does not have.
• Fail to inform the user or patient of a likely risk associated with the use of the device.
• Suggest a use for the device other than the intended purpose that formed the basis for the product's conformity assessment.

Under the Injection Action, several instances of marketing were uncovered that, according to the NoMA, violate these rules. One example is surgical threads, originally developed for reconstructive surgery, that were marketed for cosmetic purposes such as creating "foxy eyes" or reducing signs of ageing. The NoMA warns that such marketing can lead to misuse of the products, with unknown risks and lack of documentation on long-term effects.

• The supervisory action Injection Action is described on the NoMA's website here