Trumbo Paula R, Ellwood Kathleen C
Division of Nutrition Programs and Labeling, Food and Drug Administration, College Park, MD, USA.
Am J Clin Nutr. 2006 Nov;84(5):971-4. doi: 10.1093/ajcn/84.5.971.
The labeling of health claims that meet the significant scientific agreement standard and of qualified health claims on conventional foods and dietary supplements requires premarket approval by the Food and Drug Administration (FDA). The FDA conducts an evidence-based review to ascertain whether sufficient evidence exists to support a significant scientific agreement standard or a qualified health claim. The FDA recently reviewed intervention and observational studies that evaluated the role of lutein and zeaxanthin in reducing the risk of age-related macular degeneration and cataracts. On the basis of this evidence-based review, the FDA concluded that no credible evidence exists for a health claim about the intake of lutein or zeaxanthin (or both) and the risk of age-related macular degeneration or cataracts.
对于符合重大科学共识标准的健康声明以及常规食品和膳食补充剂上的合格健康声明进行标注，需要获得美国食品药品监督管理局（FDA）的上市前批准。FDA会进行基于证据的审查，以确定是否有足够的证据支持重大科学共识标准或合格健康声明。FDA最近审查了评估叶黄素和玉米黄质在降低年龄相关性黄斑变性和白内障风险中作用的干预性研究和观察性研究。基于这项基于证据的审查，FDA得出结论，没有可靠证据支持关于摄入叶黄素或玉米黄质（或两者）与年龄相关性黄斑变性或白内障风险之间的健康声明。
