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.
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 are partnering on this project to further corroborate the need for scientifically-based information on how much is too much and to disseminate that science.
This publication proposes a new framework for recommended intake, enabling the incorporation of aspects of basic, pre-clinical and clinical research – including the Evidence Based Medicine approach of Randomized Controlled Trials (RCT) – but allowing for decision-making based not primarily on RCT but on the totality of the evidence. It suggests the need for human intervention studies of a smaller scale than those used to evaluate drug efficacy and safety, arguing that RCT used to establish the safety and efficacy of drugs is, alone, not an appropriate method for establishing recommended intakes for nutrients and other bioactive substances.