In the European Union (EU), we find a lot of judgments concerning the distinction between medicinal products and food supplements on both EU and member state levels. Now a third category — novel food — is in the focus of court decisions. With a judgment on May 5, 2022, the Court of Appeal of Frankfurt in Germany now clarifies that manufacturers must be able to prove that their foodstuff does not qualify as a novel food. In determining whether a botanical such as the dry extract of ginkgo biloba is a novel food within the meaning of Article 3(2)(a) of Regulation (EU) 2015/2283 on novel foods (Novel Food Regulation), it is necessary to consider whether such foods were used for human consumption in the EU in significant quantities before 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, meaning the product has no pharmacological effect. In court proceedings, the plaintiff needs to prove the pharmacological effect when challenging a product as a medicinal product. In practice, this evidence is not easy to provide. Since the burden of proof is on the plaintiff’s side, the plaintiff is carrying the significant risk in litigation cases. In the new judgment of the Court of Appeal of Frankfurt, the court held that the defendant — the manufacturer of the product — needs to prove that the product does not qualify as a novel food. The burden of proof here is on the defendant’s side.

In the proceedings, a manufacturer of phytopharmaceuticals objected to the distribution of a food supplement based on gingko biloba extract. The manufacturer of the drug sent its competitor a warning letter, complaining about the violation of the Novel Food Regulation. The manufacturer of the foodstuff was placing the objected-to novel food on the market without having obtained the required authorization from the European Commission. Since the food manufacturer did not issue the requested cease-and-desist declaration and claimed that gingko biloba foods were not novel, the manufacturer of the pharmaceutical product filed a lawsuit before the competent civil court in Germany.

Indeed, the source material of the foodstuff at issue, the leaves of gingko biloba, may have been consumed to a significant extent in the EU before the above-mentioned cutoff date; however, the court pointed out that the question of the novelty of the foodstuff at question does not depend on the source material but on the specific product made from it. Thus, the manufacturing process of the dry extract of ginkgo biloba was brought to the fore.

Had the manufacturing process led to physical, chemical or biological changes in the structure of the starting ingredient used so that the original non-novel food was no longer present but rather was a novel food that had been altered by processing?

SECONDARY BURDEN OF PROOF

Only the manufacturer itself knows the specific manufacturing process of the foodstuff. Therefore, the court held that despite the fact that generally the claimant has to prove its case, the objected-to manufacturer had to disclose the specific manufacturing process as part of its secondary burden of proof.

In the present case, the defendant did not follow the advice of the court and failed to disclose the specific manufacturing process carried out. Consequently, the court qualified the foodstuff and its manufacturing process based on gingko biloba extract as novel and held that it must not be marketed without the required approval of novel foods.

TURNING POINT FOR LIFE SCIENCES ENTREPRENEURS

The judgment of the Court of Appeal of Frankfurt marks a turning point: Until now, plaintiffs were threatened with the burden of proof requiring them to detail the manufacturing process of the contested product, thus leaving it hardly possible to succeed in their claim qualifying the foodstuff as a novel food. With the clarification of the Court of Appeal, food entrepreneurs now can bring forward and have much better chances of succeeding with their claims of unfair competition.