In October 2022, the highest court in Germany ruled that products containing “monograph compliant” Ginkgo biloba dry extract as the main active ingredient at recommended doses of 100 mg per day should be considered drugs, not dietary supplements.
The decision, issued by Germany’s Federal Administrative Court, settled a longstanding dispute between the country’s food regulator, the Federal Office of Consumer Protection and Food Safety (BVL), and an unnamed company that had applied for registration of such a product.
David Pineda Ereño, managing director of DPE International Consulting, said that this judgment may have an impact on how other Ginkgo biloba extracts and plant extracts in general are regarded in Germany and other EU member states.
“It is worth pointing out that Ginkgo biloba extracts are marketed as food supplements in some countries and as traditional medicines in others. In this sense, for manufacturers looking to market Ginkgo biloba extracts as food supplements in the EU, it is recommended that they check the regulatory status country by country, while keeping doses low to avoid potential legal challenges,” he advised.
Don’t generalise: Not all ginkgo products are medicinal
When considering the broader impact of the ruling, Tallon, managing partner at food law firm Legal Products Group, warned against making the automatic assumption that all ginkgo products would now be considered as medicinal under German law.
“The court has not ruled that all ginkgo products are medicinal. The assessment follows settle case law, which is that the assessment must be on a product-by-product basis, giving due regard to all its characteristics,” he told Vitafoods Insights.
In considering the legality of ginkgo products, Tallon said there were three questions that food operators should consider before placing their products on the market, the first being the safety of the ingredient.
“Is the ingredient safe? It is a basic principle of general food law that foods should be safe and fit for human consumption,” he said.
Secondly, he said companies should consider whether the ginkgo ingredient they were using was novel.
“Was it on the market prior to 15 May 1997? Has the company evidence to demonstrate significant history of consumption before this date?” he asked.
Thirdly, they should assess whether the product is a medicine; the fact there is a traditional herbal registration (THR) of herbal monograph for ginkgo does not automatically make it a medicine, he said.
Medicinal by function or presentation: Learnings from red yeast rice
Rather, a product’s classification as medicinal turns on whether or not it is medicinal by function (effect) and/or presentation (how the product “presents” or is perceived by consumers), Tallon explained.
“In relation to medicinal by function, a court would need to see evidence that the specific extract results in a medicinal rather than a physiological/immunological effect,” he said.
To illustrate the difference between a physiological and a medicinal effect, he cited the example of monacolin K from red yeast rice.
“Depending on dose, this could help maintain a healthy cholesterol level, which would be considered a food effect, or it may decrease cholesterol – a medicinal effect. The same assessment should be considered for ginkgo, as the recent ruling related to its function,” he said.
While the pharmacological effect can be based on a robust scientific analysis, the “medicinal by presentation” assessment must be based on the product as viewed by the average consumer, according to Tallon.
“So, for example, consumers in Germany may have a very different view of specific traditional herbal medicines than consumers in, say, Ireland,” he said. “If German consumers purchase ginkgo for the same reasons and the same effect as they would a registered medicine (THR), then any ginkgo could be viewed as a medicine.”
Defence is ‘only as good as the data’
Ultimately, Tallon said, the defence of any case before the courts relied on robust data and considered legal arguments.
For example, if a food company has evidence that 100 mg of Ginkgo biloba extract only results in physiological effect, then it cannot be medicinal by function.
In terms of demonstrating that a product is not medicinal by presentation, supporting data could include a consumer survey, or data that shows the product is not being confused with other medicines, suggested Tallon.
“The onus is on the company to ensure it has all these tick boxes checked before going to market, especially in member states that enjoy taking firms to court,” he said.
