26 November 2024 – In its decision of 26 September 2024, the Federal Administrative Court affirmed Swissmedic’s actions regarding the product C. and related products E. and F., all marketed as oral hygiene products, confirming their classification as medicinal products under the Therapeutic Products Act (TPA) due to their health risks and intended medical purposes. The court dismissed the appeal filed by the licensor and principal for the contract manufacturing, which challenged both the classification of its products as medicinal, and the restrictions imposed by Swissmedic.

Swissmedic intervened in March 2022 after discovering that product C. was being sold in Switzerland without the necessary approval and contained the potentially harmful substance D., which posed significant health risks. The appellant argued that product C. was never sold and that relabeling had occurred without its knowledge. Additionally, Swissmedic identified that the other two products, E. and F., marketed by the appellant, potentially contained the same dangerous substance. As a result, Swissmedic issued a prohibition in April 2022, suspending the sale, production, and distribution of products C., E., and F., and requiring the destruction of existing stock.

The court assessed whether the three products qualified as medicinal under the TPA. It stated that the classification of a product depends on its intended medical use, composition, and associated health risks. The court determined that the packaging and marketing of these products indicated their intended use for medicinal purposes, including the treatment of viral infections and other conditions, despite the appellant’s contrary assertions.

The court also addressed the health risks posed by substance D., which is hazardous when ingested and could lead to severe health effects. Despite the appellant’s presentation of alternative evidence, including blood tests and altered labeling, the court concluded that the risks associated with these products could not be overlooked. It upheld Swissmedic’s determination that the products should be regulated as medicinal products to protect public health.

The appellant contended that the products had been successfully licensed and marketed in other countries. However, the court stated that it was irrelevant whether the products have been authorized in other countries. Furthermore, it found that public health considerations took precedence over the appellant’s economic interests. It emphasized that the classification of these products as medicinal products was essential to mitigate health risks and ensure their use in appropriate, medically supervised contexts. The court concluded that the restrictions were justified and did not infringe upon the company’s economic rights under the law.

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