Germany: products with more than 20 mcg of vitamin D may be considered medicinal products / by Lara Skoblikov

The German Federal Office of Consumer Protection and Food Safety has issued a Recommendation on the demarcation between food supplements containing vitamin D and medicinal products, concluding that a product with a level of vitamin D up to 20 µg per daily dose can still be considered a food supplement. The recommendation is based on a report of the Joint Expert Committee of the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM).

Higher dosages, according to the report, would go beyond completely or partially covering the daily needs of the nutrient and would be considered medicinal products, even though dosages up to 100 µg/day are considered toxicologically safe.

Foods for Special Medical Purposes falling under Regulation 609/2013 may contain dosages higher than 20 µg/day, when this can be justified for the intended target group.

In order to avoid any risks, it is recommended to follow the recommendation when marketing food supplements in Germany.

We should however note that the legal validity of the Recommendation is somewhat questionable.

Under Directive 2001/83, products are medicinal either by virtue of presentation or by virtue of their action if they are used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. The reasoning of the German authorities that a daily dosage of 20 µg/day of vitamin D would be sufficient to cover the average nutritional needs does not automatically mean that a higher dosage indeed exerts a pharmacological, immunological or metabolic action. If this were true, it could be argued that any product with vitamins or minerals in dosages above their reference intakes should be classified as medicinal products, which is not the case in practice. 

It is also interesting to note that the Court of Justice of the EU has repeatedly ruled that the absence of a nutritional need for a substance is not a valid justification for banning a product. See for example Case C-192/01, Commission v. Denmark. 

Can Germany set an upper level for vitamin D in foods? Certainly they can. But they would have to justify this either by demonstrating that an exceeded vitamin D level would actually exert a pharmacological, immunological or metabolic action (in which case the product would be a medicine), or by demonstrating on the basis of the latest scientific data that there is a potential risk to public health associated with higher vitamin D levels.