Mueller C, Nestle M
Nutr Clin Pract. 1995 Feb;10(1):8-15. doi: 10.1177/011542659501000108.
Medical foods are enterally administered formulas used as complete or supplemental nutrition support in the treatment of diseases and clinical disorders of hospitalized or incapacitated adult patients. Because clinical trials have failed to demonstrate a consistent benefit of these products on morbidity and mortality rates, it has been difficult to reach consensus on their primary role. Are medical foods components of supportive care or should they be considered pharmacologic treatment? To date, the US Congress has defined medical foods, but the Food and Drug Administration has not developed regulatory statutes for them beyond those designed to ensure the sanitary manufacture of all processed foods. Before effective regulations can be developed, medical foods need to be defined further in order to distinguish them from each other and from other classes of nutritional products such as parenteral nutrients or infant formulas. Because we believe that the role of medical foods is in supportive care rather than pharmacologic therapy, we argue that these products should be subject to regulations similar to those that apply to conventional foods.
医用食品是经肠道给药的配方产品，用于为住院或失能成年患者的疾病和临床病症提供完全或补充营养支持。由于临床试验未能证明这些产品对发病率和死亡率有持续益处，因此很难就其主要作用达成共识。医用食品是支持性护理的组成部分，还是应被视为药物治疗？迄今为止，美国国会已对医用食品进行了定义，但美国食品药品监督管理局尚未针对它们制定超出确保所有加工食品卫生生产的监管法规。在制定有效的法规之前，需要对医用食品进行进一步定义，以便将它们彼此区分开来，并与其他类别的营养产品（如肠外营养剂或婴儿配方奶粉）区分开来。因为我们认为医用食品的作用在于支持性护理而非药物治疗，所以我们主张这些产品应遵循与适用于传统食品的法规类似的法规。
