Medicines only for health risks
Herbal products can be sold in moderate doses without a drug approval as food supplements, provided that the intake is not associated with health risks. This also applies if a low medicinal effect is possible, ruled on Thursday, November 7, 2019, the Federal Administrative Court in Leipzig (Az .: 3 C 19.18).
Dry extract from Ginkgo biloba leaves
The dispute concerns capsules with 100 milligrams of dry extract from Ginkgo biloba leaves. The manufacturer recommends taking one capsule a day. In Austria the capsules are approved as food supplements.
In Germany, the Federal Office of Consumer Protection and Food Safety opposed this. From a dose of 100 milligrams per day, a pharmacological effect may be assumed. Therefore, it is a drug and requires a corresponding authorization.
The lower courts had followed. The Federal Administrative Court now overturned these judgments and referred the dispute back to the Higher Administrative Court (OVG) in Lüneburg for further review.
Dosage is in the limit of a possible effect
As justification, the Leipzig judges explained that the recommended dosage here lies in the border area of a possible effect and therefore "in the border area between food supplements and pharmaceuticals". Therefore, the "usage risks" are essential for classification.
According to the findings of the OVG, the ginkgo is said to have the property of improving the blood fluid. This would also improve blood flow to certain brain regions.
The OVG viewed these effects as positive, but did not deal with any possible negative effects, the Federal Administrative Court complained. However, a classification as a medicinal product is only justified "if this is necessary to protect human health". The OVG should now check this again.
Proof of medicinal effects is not required
However, the Leipzig judges confirmed that classification as a medicinal product does not initially require a medicinal effect to be demonstrated. It only depends on the admission.
Author and source information
This text corresponds to the specifications of the medical literature, medical guidelines and current studies and has been checked by medical doctors.
- Federal Administrative Court: Consideration of possible health risks when delimiting nutritional supplements and pharmaceuticals (published November 7th, 2019), bverwg.de