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  1. Heaney, Robert P. MD
  2. Weaver, Connie M. PhD
  3. Blumberg, Jeffrey PhD


The criteria used in evidence-based medicine provide a poor fit for decisions concerning nutrient intake recommendations. For many nutrient-disease relationships, level 1 evidence cannot be ethically obtained. The challenge is to design an approach that will allow responsible development of national policy in the absence of randomized clinical trials. A decision strategy based not on proving benefit but on estimating harm is proposed. We note that not changing a recommendation is itself a recommendation