Office of Dietary Supplements, National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD, 20892, USA; U.S. Department of Agriculture, Jean Mayer Human Nutrition Research Center on Aging, Tufts University, Boston, MA, 02111, USA.
Mol Aspects Med. 2023 Feb;89:101103. doi: 10.1016/j.mam.2022.101103. Epub 2022 Jul 17.
This article describes why the safety and efficacy assessment of non-nutrient bioactives for reducing chronic disease risk is so complicated, especially for dietary supplements and traditional medicines. Scientists, regulators, and the public have different and sometimes opposing perspectives about bioactives. Drug, food, and traditional medicine models used for bioactive safety assessment are based on different assumptions and use different processes. Efficacy assessment is seldom based on clinical trials of boactives' effects in reducing chronic disease risk. It usually consists of application of quality assurance measures and evaluation of label claims and commercial speech about ingredients or products to ensure conformity to regulations. Harmonization of safety and efficacy assessment on a global basis is difficult because of differences within and between regulatory systems. The recommendations provided may open the way for bioactives to play a larger health role in the future, fill gaps in data needed for crafting authoritative dietary guidance on intakes, and speed harmonization of global standards.
本文介绍了为什么对于减少慢性病风险的非营养生物活性物质的安全性和有效性评估如此复杂，特别是对于膳食补充剂和传统药物。科学家、监管机构和公众对生物活性物质有不同的、有时甚至是对立的观点。用于生物活性安全性评估的药物、食品和传统药物模型基于不同的假设，并使用不同的过程。功效评估很少基于生物活性物质降低慢性病风险的临床试验。它通常包括应用质量保证措施，以及对成分或产品标签声称和商业言论的评估，以确保符合法规。由于监管体系内部和之间存在差异，因此在全球范围内实现安全性和有效性评估的协调具有一定难度。所提供的建议可能为生物活性物质在未来发挥更大的健康作用开辟道路，填补制定有关摄入量的权威性膳食指南所需数据的空白，并加快全球标准的协调。
