Practice for classification of products containing lactic acid bacteria
Products for oral use containing lactic acid bacteria will not generally be classified as medicinal products unless they are presented as products that can prevent or treat disease.
So far, the Danish Medicines Agency has regarded tablets, capsules, vaginal tablets and similar products containing lactic acid bacteria as medicinal products based on the effect of the lactic acid bacteria in the human body.
In December 2005, the new Danish Medicines Act entered into force, and this entailed a change of the definition of medicinal products. In continuation of this, the Danish Medicines Agency has reassessed the classification of products containing lactic acid bacteria.
A medicinal product is defined as follows in section 2 of the Danish Medicines Act
2. For the purpose of this Act, the following definitions shall apply:
(i) Medicinal product: Any product:
(a) presented as having properties for treating or preventing disease in human beings or animals, or
(b) which may be used in or administered in human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
A product is a medicinal product if it is covered by merely one of the definitions.
After reassessing the classification of products with lactic acid bacteria, the Danish Medicines Agency has estimated that the main effect of lactic acid bacteria is not pharmacological, immunological or metabolic.
Products containing lactic acid bacteria will still be considered medicinal products if they are presented as products suitable for preventing or treating disease, cf. section 2(i)(a).
If a product for oral use containing lactic acid bacteria is not presented as a product that can prevent or treat disease, it may therefore be marketed as a dietary supplement in future.
If a product containing lactic acid bacteria is to be used vaginally, it is the Danish Medicines Agency’s assessment that certain health and safety risks may be involved. Therefore, products containing lactic acid bacteria for vaginal use will continue to be medicinal products regulated by the legislation on medicinal products.
For more information about the marketing of products containing lactic acid bacteria as dietary supplements, please contact the Danish Veterinary and Food Administration