Classification of dental care products

On 1 December 2006, executive order no. 1225 of 7 December 2005 on advertisement for dental care products was repealed (see link to the executive order - in Danish - via the box to the right).

In this connection, we have been asked if this means that we in future will classify dental care products as medicinal products pursuant to section 2 of the Danish Medicines Act if they are marketed with the advantages mentioned in the executive order.

The repeal of the executive order on advertisement for dental care products entails no changes to the current practice in the area. 

We estimate that even after 1 December 2006 it will be possible to market dental care products with the advantages mentioned in the executive order, without the advertisement for these advantages in itself leading to the products being regarded as medicinal products.

This means that manufacturers may continue to advertise for toothpaste, mouthwash, chewable tablets, toothbrushes, toothpicks and similar dental care products by claiming that it can prevent

• dental plaque
• caries
• gingivitis
• periodontitis

without the products being regarded as medicinal products.

Generally, the Danish Health and Medicines Authority regards products for dental and oral care as cosmetic products that, under section 4(1) of the Danish Medicines Act, are out of the scope of the Act.