The term “botanical” stands for dried plants and plant extracts, but also for purified botanical constituents. The absence of an unequivocal definition can lead to legal ambiguities. Especially highly purified plant extracts often struggle with the demarcation between drug and food. Two crucial points have to be considered to determine wether an extract is suitable as a food ingredient: The recommended dosage, which should not exhibit a pharmacological effect, and the novel food question.
A current example emphasizes the relevance of this distinction. A manufacturer of a food supplement containing a ginkgo extract was sued by a competitor who suspected the supplement to have a pharmacological effect or, alternatively, the extract to be a novel food. The court did not confirm the pharmacological effect, but it did question the non-novel food status of the extract. Since the manufacturer could not provide data to verify the regulatory status, the court ruled that the product is not marketable. This case illustrates that the true nature of an extract is an important criterion for determining whether a plant extract falls under the Novel Food Regulation. Even if the employed process is typical for food processing, changing the nutritional properties or the safety profile of a botanical extract in comparison to the established source may render the extract a novel food. Food business operators should be aware that neither the safety profile nor the regulatory status of the established botanical source can automatically be transferred to the final product. If you need support in verifying the legal compliance of your botanical extract, please feel free to contact us.