Medical product, dietary supplement or new food?  |  King and Spalding

Medical product, dietary supplement or new food? | King and Spalding

In the European Union, we find a lot of provisions regarding the distinction between medicinal products and nutritional supplements at the level of the European Union and Member States. Now a third category – new food – is at the center of court decisions. By ruling on May 5, 2022, the Frankfurt Court of Appeal in Germany has now made it clear that manufacturers must be able to prove that their foodstuffs do not qualify as a new food. In determining whether a plant such as a dry extract of ginkgo is a new food within the meaning of Article 3(2)(a) of Regulation (EU) 2015/2283 Concerning New Foods (New Food Regulations), it is necessary to consider whether this Foods have been used for human consumption in the European Union in significant quantities prior to May 15, 1997.

A product may be placed on the market as a food product as long as the product does not qualify as a medicinal product, which means that the product has no pharmacological effect. In court proceedings, the plaintiff has to prove the pharmacological effect when challenging a product as a medicinal product. In practice, it is not easy to provide such evidence. Since the burden of proof is on the plaintiff, the plaintiff bears significant risks in litigation cases. In the new ruling from the Frankfurt Court of Appeal, the court held that the defendant – the manufacturer of the product – needed to prove that the product did not qualify as a new food. The burden of proof here rests with the defendant.

In these proceedings, a phytopharmaceutical manufacturer objected to distributing a dietary supplement based on ginkgo biloba extract. The drug manufacturer sent a warning letter to its competitor, complaining of violating Novel Food’s food regulations. The food manufacturer was putting the new objectionable food on the market without obtaining the required license from the European Commission. Because the food manufacturer did not make the required cease-and-desist declaration and claimed that the ginkgo biloba foods were not new, the manufacturer of the pharmaceutical product filed a lawsuit with the relevant civil court in Germany.

In fact, the food source in question, Ginkgo biloba leaves, may have been largely consumed in the European Union prior to the aforementioned cut-off date; However, the court noted that the question of the novelty of the food item in question did not depend on the source of the material but on the specific product it was made of. Thus, the manufacturing process of the dry extract of Ginkgo biloba was highlighted.

Did the manufacturing process result in physical, chemical, or biological changes in the structure of the initial ingredient used so that the original, non-new food was no longer present but was new food altered by processing?

Only the manufacturer itself knows the specific manufacturing process for food. Therefore, the court held that despite the fact that the plaintiff generally had to prove his case, the objecting manufacturer had to disclose the specific manufacturing process as part of the secondary burden of proof.

In the current case, the defendant did not follow the advice of the court and did not disclose the specific manufacturing process that was carried out. Accordingly, the court considered the food and its manufacturing process based on Ginkgo biloba extract to be new and held that it should not be marketed without the required approval of the new foods.

The ruling by the Frankfurt Court of Appeal marks a turning point: So far, plaintiffs have been threatened with a burden of proof that would require them to detail the manufacturing process of the disputed product, making it difficult to achieve success in their claim to qualify the foodstuff as a new food. With the Court of Appeals clarification, food entrepreneurs can now apply and have better chances of succeeding in their claims of unfair competition.

#Medical #product #dietary #supplement #food #King #Spalding

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