When introducing a dietary supplement to the market, the introducing entity (manufacturer, distributor) must meet a number of requirements. All this, to avoid problems such as, for example, the investigation in front of the Main Sanitary Inspectorate (GIS), not to mention the danger of the product being withdrawn from the market.
Remember that a dietary supplement:
• is a foodstuff, and therefore a product that is regulated by the food law and not by the pharmaceutical law,
• is to supplement the normal diet, to be a concentrated source of vitamins, minerals or other nutrients, or substances having a nutritional or other physiological effect,
• can take the form of capsules, ampoules, pills or can be contained in dropper bottles.
The composition of dietary supplements can be subject to control of both the field sanitary inspection and the Main Sanitary Inspectorate (GIS), who can, in case of doubt, initiate explanatory proceedings. Each dietary supplement must be labeled in accordance with the Polish and the EU regulations.
For more information on how to introduce dietary supplements to the market in accordance with the law and prevent GIS from starting an investigation, we recommend you will read the compendium of knowledge prepared by our lawyers – experts in the matter. Supplement registration in GIS – what data is required?
The Register of Supplements (actually the Register of Notified Products) kept by GIS operates on the basis of the Act of 25 August 2006 on food and nutrition safety. According to its provisions, adapting Polish provisions to the European regulations, the notification regarding the new dietary supplement should contain:
• the name of the product and its manufacturer,
• the form of the product in which it is marketed,
• the pattern of its marking in Polish,
• the qualification / the type of the foodstuff that has been adopted by the food business operator,
• the qualitative composition, which will include data on all ingredients contained in the product, including active ingredients,
• the quantitative composition of the supplement’s ingredients,
• the details of the subject submitting the supplement.
Preparing the correct notification may create a number of practical difficulties for dietary supplements’ manufacturers (including those related to the precise determination of the quantitative composition of individual ingredients). When GIS has any doubts about the qualification, composition or properties of the notified dietary supplement, the investigation is launched to verify it. Usually, however, if the notification of a dietary supplement, which is then placed in the GIS Register of Supplements, is thoroughly prepared and has been verified by a lawyer - expert in the matter, it is possible to avoid additional verification.
Compendium of supplements law
1. What law regulates the dietary supplements?
Dietary supplements, despite the fact that they often have a form similar to drugs (capsules, pills, syrups) are a special type of food. Therefore, they are regulated by the food law.
Among the legal acts regarding supplements, we can distinguish those concerning all types of food, such as General Food Law (Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ L 031, 1.2.2002, p. 1), as well as those dedicated only to dietary supplements. On the European level, this is primarily the Directive 2002/46 of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, of 12/07/2002, p. 51). In the Polish legal order, the definition of a dietary supplement and the rules for placing a dietary supplement on the market are regulated by the Act of 25 August 2006 on food and nutrition safety (Journal of Laws of 2006, No. 171, item 12250). The Regulation of the Minister of Health of 9 October 2007 regarding the composition and labeling of dietary supplements is also very important (Journal of Laws 2014. 453 consolidated text).
2. What a dietary supplement is?
3. What is the difference between a dietary supplement and a drug?
4. What an investigation during registration (notification) of a dietary supplement is?
5. Do I have to wait for the GIS reply regarding the notification?
6. How to register the dietary supplement?
7. What data is required in order to register a dietary supplement?
8. Does initiating the investigation suspends the product being placed on the market?
9. When will I be notified of the initiation of an investigation and how long will the investigation take?
10. Do I have to provide opinions of scientific institutions during the investigation?
11. What does the obligation to provide the opinion of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products mean?
12. What regulations determine the labeling of dietary supplements?
13. What should a dietary supplement’s label contain?
14. Can I inform about the medicinal properties of a dietary supplement?
15. What is a health claim?
16. What are the types of health claims?
17. What are the health claims about reducing the risk of illness?
18. What are non-specific statements?