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In June, the Dietary Supplements Team at the Sanitary-Epidemic Council of the GIS issued resolutions on the maximum amount of certain vitamins and minerals in dietary supplements. According to the opinion of Chalas i Wspolnicy law firm, such resolutions are not binding for manufacturers. However, they may have a real impact on the decisions made by GIS in the course of explanatory proceedings.
GIS: Excess vitamin D3 can be harmful to health
According to the opinion of the GIS Dietary Supplements Team, the safe dose of vitamin D3 is 2 000 IU (50 µg)/day. As underlined by the GIS, the 2018 guidelines specified that obese people and seniors should supplement D3 with 4 000 IU/day (100 µg/day). However, the latest scientific data indicate that vitamin D supplementation at doses above 10 µg/day in individuals with no vitamin D deficiency may be associated with increased mortality from cancer and other diseases. In addition, currently more and more products are enriched with D3, which is why the overall intake of this vitamin increases along with the diet. Therefore, a dose of 2,000 IU/day was considered safe for all groups.
Folic acid in a higher dosage for pregnant women
For vitamin C, the maximum dose for adults was set at 1000 mg/day. At the same time, GIS recommends to use, in the labelling of of dietary supplements that contain high levels of vitamin C, warning that these products should not be used in people predisposed to kidney stones or those suffering from kidney stones.
For folic acid, the maximum dose is 600 µg/day and 800 µg/day for pregnant women. At the same time, the GIS recomments to use in the labelling of dietary supplements containing 800 µg of folic acid the warning, that pregnant women should use this product after consultation with their physician.
For vitamin A, the maximum dose is 800 µg in retinol equivalent (retinol and retinyl esters)/day and 7 mg in β-carotene/day. For niacin, GIS recommends 830 mg/day in the form of an amide of nicotinic acid and 16 mg/day in the form of nicotinic acid. For manganese and zinc the doses are 1.8 mg and 15 mg/day, respectively.
The GIS may invoke resolutions during its investigations
According to the opinion presented on the website of Chalas i Wspolnicy Law Firm, resolutions of the Dietary Supplements Team should not be classified as a source of common law. They are internal documents and do not have universally binding force. However, as the law Ffrm emphasises, the opinions of the Team may have an impact on specific explanatory proceedings conducted by GIS.
– It is very probable that many entities may meet at the stage of administrative proceedings with reference to the latest GIS resolutions – says dr Joanna Uchanska, partner in the law firm. As Dr. Uchanska emphasizes, further resolutions of the Team concerning other vitamins and minerals should be expected in the autumn. Therefore, in her opinion, manufacturers should pay attention to the content of these resolutions when creating their products.