The food supplement-pharma divide

Dutch court rules dosage can't turn a supplement into a drug

By Shane STARLING contact

- Last updated on GMT

NPN: 'This ruling sets a precedent for assessment of other categories of products sold as food supplements...' ©iStock
NPN: 'This ruling sets a precedent for assessment of other categories of products sold as food supplements...' ©iStock

Related tags: Food supplements, European union, Eu

The Dutch supplements industry is celebrating a court ruling that sleep aid melatonin cannot be classed as a medicine if its dosage is above a certain threshold.

The Court of the Hague upheld a previous Arnhem appeal court ruling that EU health claim-backed​ melatonin supplements containing more than 0.3 mg per pill could not automatically be classed as prescription medicines.

“The Dutch ruling learns us once again that authorities need to look further than only the dosage of an ingredient,”​ said Saskia Geurtes, director of Dutch food supplements association, NPN, which brought the original appeal in 2015.

“The manner in which the product is used and familiarity to the consumers are, among others, very important characteristics.” 

Although melatonin classification is not harmonised across the EU, the European Food Safety Authority (EFSA)-approved health claim backed the pineal hormone to redcuce jet lag at 0.5 mg per day and 1mg per day for 'the reduction of the time required to get to sleep'.

The Dutch verdict follows the ‘red rice’ Hecht Pharma​ decision in the European Court of Justice (ECJ) that found the status of a product could only be determined case-by-case with all of its characteristics and its mode of consumption considered.

A similar verdict​was reached by an appeals court recently in regard to glucosamine products in the UK.

“This ruling sets a precedent for assessment of other categories of products sold as food supplements and protects the assortment of food supplements,” ​Geurtes said.

In Italy, where serious conisderation​ is being given to categorising high-dose vitamins and minerals as medicines, sector expert Luca Bucchini, PhD, said the Dutch ruling highlighted the EU common market position, and how member states continued to flout it.

“The ruling shows that, when judges are called to consider these issues, and consider carefully EU law, they have no doubt that food supplements cannot be re-classified as medicines without a very good reason,”​ the Rome-based director of Hylobates Consulting told us.

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©iStock

“In many cases, classification as medicines is a regulatory ‘instictive reflex’ which does not serve the public: authorisation of medicines is a demanding process, and rightly so as it leads to more expensive products, and should be used only when required.”

An absence of EU harmony

He said the Italian motion beginning with vitamin B12 and Germany’s position in regard to vitamin D “show that authorities still choose to ignore EU law”.

“It seems member states do not consider EU law and dare the Commission to bring them to the ECJ. Such behaviours set a bad example, and will end up destroying the single market if not challenged. So the news from the Netherlands is excellent.”

Bert Schwitters, author of Health Claims Censored​ and NPN regulatory adviser, agreed, telling us, “Time and again, EU member states across Europe are trying to go around the Court's instructions.”

“These judgments show that when national authorities deviate from the ECJ’s case law, national Courts will not hesitate to correct such practices.”

“In Hecht-Pharma, the ECJ killed any illusion that national authorities may set pharmacological thresholds for the use of ingredients in or as foods.”

“The Dutch and UK rulings are good news for the food supplements industry. They confirm that companies may and can defend themselves and their products against national authorities that disregard the rule of law.”

Know your product

But he warned that companies that may find themselves in legal battles better check and market their products in accordance with the Hecht criteria.

“This is especially relevant for companies marketing their supplements for therapeutic purposes, i.e. through medical practitioners."

“Patients using supplements hardly see a difference between those supplements and medicines.”

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