EU medical devices route tempts article 13 health claim losers

By Shane Starling

- Last updated on GMT

EU medical devices legislation is opening doors slammed shut by the NHCR
EU medical devices legislation is opening doors slammed shut by the NHCR

Related tags Medical devices Nutrition

European Union medicines agencies are reporting increasing numbers of ‘medical device’ applications for food supplement products rejected under strict EU health claim laws.

These include fibre, cranberry, chitosan and other supplements featuring nutrients on the now enforceable EU nutrition and health claims regulation (NHCR) list of 1500+ non-authorised health associations that accompanies the approved vitamins and minerals dominated, 222-claim approved register​.

“The French authorities told us there has been a sharp increase in applications for medical device status from rejected food supplements,” ​said Gunter Haessaerts, the owner of French cranberry supplements brand, Pharmatoka.

The situation is being mirrored across some of the EU’s 70+ offices that are able to process such applications.

Trade groups like the European Federation of Associations of Health Product Manufacturers (EHPM) have been advising members affected by the NHCR to consider applying for medical device registrations.

“This hurts everybody’s business”

However Haessaerts and his firm are lobbying against this for business and ideological reasons.

“This hurts everybody’s business,” ​he told us. “We have had to remove our claims as have others in the industry due to the NHCR article 13.1 rulings. We are using the strength of our brand and science to stay in the market.”

“Then these products come along that allegedly show a mechanical action as the medical device laws demand, and they are able to make medicinal claims which should never be allowed on such products.”

“These products contain only 8mg of PACs [proanthocyanidins​] and will not treat urinary tract disease [compared to the 32mg the French Food Agency (ANSES) had previously approved as being beneficial to women with the condition.]”

One cranberry product that has achieved a medical device authorisation – Medical Brands' I-Say – claims it can treat and prevent UTI.

See Medical Brands CEO Maikel Hendriks talking about medical devices here.

Arkopharma has applied for a medical device registration in Luxembourg for its product Cys-control
Arkopharma has applied for a medical device registration in Luxembourg for its product Cys-control

There are about 60 cranberry supplement brands on the market in France, with the biggest owned by Arkopharma (Cys-control). Arkopharma has also applied for a medical devices registration via Luxembourg.

Haessaerts said Pharmatoka intended to go even further and achieve a prophylactic medicine approval, but first needed to complete clinical trials that were underway using high dose products in combination with antibiotics.


Another company making medical devices claims is Belgian firm Kitozyme which is authorised to state its plant-sourced chitosan fat-binding ingredient called KiOnutrime-Cs can:

  • Support a weight reduction diet in cases of excess weight through reduced fat absorption from food.
  • Treat excess weight.
  • Deliver weight control within the scope of a fat conscious diet.
  • Reduce fat absorption from food.
  • Reduce cholesterol absorption from foods.

KitoZyme's Alexia Louchet told us its dossier contained some studies rejected by the European Food Safety Authority (EFSA) under the NHCR, as well as others demonstrating the 'mechanical action' of chitosan as a medical devices authorisation demands.


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1 comment

opportunity not an escape route

Posted by Maikel Hendriks,

Self-Care Medical Devices could be an opportunity for only a small selection of the Health Claim products.

This means that such a product needs to be re-developed according to Medical Device QMS procedures ISO-13485. In addition a technical file needs to be created according the conformity assessment route including clinical data, biocompatibility data, validation, production records, risk analysis, audit reports, etc. All above needs to be audited by an recognized Notified Body.

Also be aware that Simethicone Medical Devices are on the market since early 2000, including isotonic nasal sprays that are still marketed as food supplement today in several european countries.

As a result a self-care medical device can use the medical claim (not medicinal claim, that is a pharmaceutical).

Conclusion: Could be an opportunity, but for sure not an escape route....

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