Vitamins and minerals

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This report is the application of the Tolerable Upper Limits (TULs) established by the Indian Council of Medical Research (ICMR) in 2018 and the use of science-based international approaches to nutrient risk analysis for setting maximum levels of vitamins and minerals in health supplements and nutraceuticals. This publication has been developed for the Indian Resource Centre for Health Supplements and Nutraceuticals (ReCHaN).

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Nutrition scientists and public health policy experts from all parts of the globe are concerned about nutrient deficiencies, but in well-nourished societies there are questions regarding potential harm from over-ingesting nutrients at high and potentially toxic levels. “Vitamin and Mineral Safety” is a highly respected and trusted technical resource for dietary supplement and dietary ingredient manufacturers, as well as scientific bodies and regulatory policy makers worldwide. CRN and IADSA partnered on this project to further corroborate the need for scientifically-based information on how much is too much and to disseminate that science.

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Risk analysis for nutrients differs from that for other substances in foods because vitamins and minerals are essential for life, and consequently adverse effects can result from suboptimal intakes and deficiencies as well as from excessive intakes. The key challenge for risk managers is to balance the risk of deficiency in some individuals with risk of overconsumption in others in the same population. This report explains why RDA-based upper safe levels are not scientific or appropriate to establish maximum levels of vitamins and minerals in food supplements. It sets out the three distinct, but closely related, components of nutritional risk analysis as described by Codex and FAO/WHO, namely nutritional risk assessment, nutritional risk management and nutritional risk communication.

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The evolution of the human dataset relevant to vitamin D safety has been as rapid as that for efficacy. In the past decade, a large number of well-designed human clinical trials have been published involving relatively high doses of vitamin D in a range of populations and subgroups. These data, combined with a general scientific consensus of serum 25(OH)D levels as the marker for vitamin D status, have drastically informed our knowledge regarding the safety of vitamin D. Presented in this publication is a risk assessment of vitamin D based on the most recently published human clinical trials.

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