High vitamin D products are medicines not food supplements: German government
BVL’s recommendation was based on a January report from 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).
The joint committee was set up in 2013 in response to the increasing food use of substances once primarily or exclusively found in drugs.
Under the BVL’s latest recommendations, products regulated as Foods for Special Medical Purposes may still contain dosages above 20 micrograms (µg) per day when this can be justified for the target population.
Discussing the development, food law consultancy firm Food Compliance International said: “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.”
Shaky legal ground?
The firm highlighted the EU’s directive on medicinal products, which stated products should be defined as medicinal based on their presentation or the pharmacological, immunological or metabolic action claimed.
“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,” Food Compliance International wrote in its blog.
“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.”
The firm said previous EU Court of Justice rulings had suggested an absence of a nutritional need for a substance was not a valid justification for a ban.
Based on this precedent Germany would have to justify its plans by demonstrating that exceeding this intake would exert a pharmacological, immunological or metabolic action or else a potential risk to public health.
Doses up to 100 µg per day are considered toxicologically safe, however last year the Norwegian Food Safety Authority said it was monitoring vitamin D products that contained six times the 20 µg per day limit laid out by Norwegian legislation.
At the time it said taking such high quantities of fat-soluble vitamins like vitamin D could be dangerous and lead to conditions like hypercalcemia, a condition in which the calcium level in your blood is above normal, which may lead to bone health issues and kidney stones.
