Medical device or dietary supplement… here's the question!

The observed situation on the market of products with, according to the assurances of manufacturers, the beneficial effect on human health or well-being is increasingly prompting such a question. The consumer, confronted with a variety of leaflets, TELEVISION advertisements, radio broadcasts, etc. products, it may often be questionable which product should be chosen for certain ailments. h[author]t[author_image timthumb=’on’]tp:// [/author_image]K[author_info]atarzyna Gęsiak – Trainee Solicitor

KONDRAT and Partners

Tel. (22) 831 12 34, e-mail: katarzyna.gos@kondrat.[/author_info]p[/author]l

The answer to this question is very often not obvious. In this group of products designed to have a positive effect on the functioning of individual organs in the human body, we can distinguish several types which, at first glance, do not show significant differences. We are talking, first of all, about medical devices and dietary supplements, as well as about medicinal products. Although medical devices and dietary supplements have separate legal definitions and are subject to two different laws, it is impossible not to notice some of their common features.

Thus, in accordance with the Law of 20 May 2010 on medical devices – a medical device is a tool, instrument, device, software, material or other article intended by the manufacturer for human use for the purpose of (i) diagnosing, preventing, monitoring, treating or alleviating the course of the disease, (ii) diagnosing, monitoring, treating, mitigating or compensating for the effects of injury or impairment, (iii) testing, replacing or modifying the anatomical structure or physiological process, or (iv) regulating conception , the essential intended action of which in the human body or body is not achieved by pharmacological, immunological or metabolic means, but the action of which may be assisted by such means. On the other hand, a dietary supplement, in accordance with the Act of 25 August 2006 on food safety and nutrition (Journal of Laws 2010.136.914 as amended), is a food the purpose of which is to supplement a normal diet, which is a concentrated source of vitamins or minerals or other substances having a nutritional or other physiological effect, marketed in a dosage form. On the other hand, products with the characteristics of a medicinal product, as regulated by the Law of 6 September 2001, are excluded from the concept of dietary supplement. Pharmaceutical law (Journal of Laws 2008.45.271 as late as) as having the characteristics of preventing or treating diseases or administered for the purpose of diagnosis or for the restoration, correction or modification of physiological functions of the body by pharmacological, immunological or metabolic action.

Therefore, taking into account the statutory definitions of a medical device and a dietary supplement (as well as a medicinal product), their common denominator can be seen, namely the effect on the physiological processes of the human body. However, while specific, stricter rules apply to the advertising and sale of medicines, consumers are certainly often not aware of, in particular in the case of audio advertising, which of these products they are dealing with. For example, anti-bloating products are advertised and sold both as dietary supplements (e.g. Digestive Enzymes, FINOCARBIO PLUS) as well as medical devices (e.g. Simetigast products), the distinction between product and supplement in advertising requires a certain degree of public attention.

What can influence manufacturers' choice of such and not different legal classification of the products they offer? One aspect that encourages manufacturers to promote and sell products as medical devices may be the possibility of using the term "medical" in the name of such a product, which is not acceptable for dietary supplements. Dietary supplements, as foodstuffs, do not by their very nature have medicinal properties (and such properties may suggest the term 'medical'), whereas the unlawful attributing of such properties to food may result not only in financial sanctions provided for in the Food safety and nutrition act, but also with the criminal liability referred to in Article 10. 130 Pharmaceutical Law. On the other hand, it appears that the use of the term 'medical' in the product name may have a greater impact on the recipient and, consequently, attract a wider range of potential customers.

Author: Katarzyna Gęsiak– KONDRAT Law Firm and Partners

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