Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA.
Pediatrics. 2012 Aug;130(2):e408-14. doi: 10.1542/peds.2012-0333. Epub 2012 Jul 9.
In this review, we explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified health claim for 100% whey-protein partially hydrolyzed infant formula (W-PHF) and reduced risk of atopic dermatitis (AD). The labeling of health claims, including qualified health claims, on conventional foods and dietary supplements require premarket approval by the FDA. Health claims characterize the relationship between a substance (food or food component) and disease (eg, cancer or cardiovascular disease) or health-related condition (eg, hypertension). To determine whether sufficient evidence exists to support the qualified health claim, the FDA evaluated human intervention studies that evaluated the role of W-PHF in reducing the risk of AD. The FDA concluded there is little to very little evidence, respectively, to support a qualified health claim concerning the relationship between intake of W-PHF and a reduced risk of AD in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. In addition, the FDA required a warning statement be displayed along with the health claim to indicate to consumers that partially hydrolyzed infant formulas are not hypoallergenic and should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.
在这篇综述中，我们解释了美国食品和药物管理局（FDA）如何利用其基于证据的审查系统，评估 100%乳清蛋白部分水解配方（W-PHF）的合格健康声称和降低特应性皮炎（AD）风险的科学证据。传统食品和膳食补充剂的健康声称标签需要 FDA 的预先批准。健康声称描述了一种物质（食物或食物成分）与疾病（例如癌症或心血管疾病）或健康相关状况（例如高血压）之间的关系。为了确定是否有足够的证据支持合格的健康声称，FDA 评估了评估 W-PHF 在降低 AD 风险中的作用的人体干预研究。FDA 的结论是，分别有很少到几乎没有证据支持 W-PHF 的摄入量与部分母乳喂养和完全配方喂养的婴儿在出生后第一年以及 3 岁之前 AD 风险降低之间存在关联的合格健康声称。此外，FDA 要求在健康声称旁边显示警告声明，以向消费者表明部分水解配方奶粉并非低过敏性，不应给对牛奶过敏的婴儿或有现有牛奶过敏症状的婴儿喂食。
