No! Businesses do not need to be concerned about using terms such as dose or dosage on dietary supplement packaging, as these terms are not reserved exclusively for medicinal products. This has been confirmed in a recent judgment made by the Supreme Administrative Court (Naczelny Sąd Administracyjny).

The nature of the dispute
The Chief Sanitary Inspector (Główny Inspektor Sanitarny, GIS) held that the use by a business of the term dosage on dietary supplement packaging was unlawful. In the GIS’s view, this could suggest that the supplements were medicinal products and could result in  properties being attributed that they do not possess. However, both the Voivodship Administrative Court and the Supreme Administrative Court took a different view. The Supreme Administrative Court ruled that the mere use of such a term does not determine that a product is a medicinal product and does not mislead consumers as to the nature or effects of a dietary supplement.

According to the definition of a dietary supplement contained in Article 3(3)(39) of the Act on Food and Nutrition Safety, a dietary supplement is a foodstuff placed on the market in a form enabling dosing. A similar approach is taken in Article 2(a) of Directive 2002/46/EC, where dietary supplements are defined as foodstuffs sold in dose form. There are therefore no grounds for considering the concepts of dose and dosage to be associated exclusively with medicinal products, given that use of both product categories involves the concept of a dose. Of course, the function of the normal (recommended) dose differs between these products. In the case of a dietary supplement, the purpose is to supplement the diet and achieve a nutritional or physiological effect, whereas in the case of a medicinal product it is to restore, correct, or modify physiological functions through a pharmacological, immunological, or metabolic action, or to make a medical diagnosis.

At the same time, the court agreed with the GIS that the terms dosage and dose are customarily associated with the use of medicinal products and that, in this context, a consumer seeing such labelling on a product may assume that they are dealing with a medicinal product. However, the applicable regulations on dietary supplements also use these terms in relation to the use and function of these foodstuffs, which cannot be disregarded.

This is an important signal for the industry. Terminology that we intuitively or customarily associate with one category of products cannot automatically be considered misleading when used in relation to other products, if the regulations also employ that terminology with respect to those products.

Judgment of the Supreme Administrative Court of 6 May 2025, II GSK 1813/24.