Faculty of Medicine, Imperial College London, London, UK.
National Heart and Lung Institute, Imperial College London, London W2 1PG, UK.
BMJ. 2023 Feb 15;380:e071075. doi: 10.1136/bmj-2022-071075.
To review available health and nutrition claims for infant formula products in multiple countries and to evaluate the validity of the evidence used for substantiation of claims.
International cross sectional survey.
Public facing and healthcare professional facing company owned or company managed formula industry websites providing information about products marketed for healthy infants delivered at full term in 15 countries: Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020-22.
Number and type of claims made for each product and ingredient. References cited were reviewed and risk of bias was assessed for registered clinical trials using the Cochrane risk of bias tool, and for systematic reviews using the Risk Of Bias in Systematic reviews tool.
757 infant formula products were identified, each with a median of two claims (range from 1 (Australia) to 4 (US)), and 31 types of claims across all products. Of 608 products with ≥1 claims, the most common claim types were "helps/supports development of brain and/or eyes and/or nervous system" (323 (53%) products, 13 ingredients), "strengthens/supports a healthy immune system" (239 (39%) products, 12 ingredients), and "helps/supports growth and development" (224 (37%) products, 20 ingredients). 41 groups of ingredients were associated with ≥1claims, but many claims were made without reference to a specific ingredient (307 (50%) products). The most common groups of ingredients cited in claims were long chain polyunsaturated fatty acids (278 (46%) products, 9 different claims); prebiotics, probiotics, or synbiotics (225 (37%) products, 19 claims); and hydrolysed protein (120 (20%) products, 9 claims). 161/608 (26%) products with ≥1 claims provided a scientific reference to support the claim-266 unique references were cited for 24 different claim types for 161 products. The reference types most frequently cited were clinical trials (50%, 134/266) and reviews (20%, 52/266). 28% (38/134) of referenced clinical trials were registered, 14% (19/134) prospectively. 58 claims referred to 32 registered clinical trials, of which 51 claims (27 trials) related to a randomised comparison. 46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias.
Most infant formula products had at least one health and nutrition claim. Multiple ingredients were claimed to achieve similar health or nutrition effects, multiple claims were made for the same ingredient type, most products did not provide scientific references to support claims, and referenced claims were not supported by robust clinical trial evidence.
审查多个国家婴儿配方奶粉产品的现有健康和营养声称，并评估用于证实声称的证据的有效性。
国际横断面调查。
在 15 个国家/地区，面向公众和医疗保健专业人员的公司所有或公司管理的配方奶粉行业网站，提供关于在 2020-22 年足月分娩的健康婴儿销售的产品信息：澳大利亚、加拿大、德国、印度、意大利、日本、尼日利亚、挪威、巴基斯坦、俄罗斯、沙特阿拉伯、南非、西班牙、英国和美国。
每个产品和成分的声称数量和类型。审查了引用的参考文献，并使用 Cochrane 偏倚风险工具评估了注册临床试验的偏倚风险，使用 Risk Of Bias in Systematic reviews 工具评估了系统评价的偏倚风险。
确定了 757 种婴儿配方奶粉产品，每种产品的中位数为 2 种声称（范围为 1 种[澳大利亚]至 4 种[美国]），所有产品共有 31 种声称类型。在有≥1 种声称的 608 种产品中，最常见的声称类型是“有助于/支持大脑和/或眼睛和/或神经系统的发育”（323 种[53%]产品，13 种成分）、“增强/支持健康的免疫系统”（239 种[39%]产品，12 种成分）和“有助于/支持生长和发育”（224 种[37%]产品，20 种成分）。41 组成分与≥1 种声称相关，但许多声称没有参考特定成分（307 种[50%]产品）。在声称中最常提到的成分组是长链多不饱和脂肪酸（278 种[46%]产品，9 种不同的声称）；益生元、益生菌或合生菌（225 种[37%]产品，19 种声称）；和水解蛋白（120 种[20%]产品，9 种声称）。在有≥1 种声称的 161 种产品中，有 161/608（26%）种产品提供了支持声称的科学参考-为 161 种产品的 24 种不同声称类型引用了 266 个独特的参考文献。最常引用的参考类型是临床试验（50%，134/266）和综述（20%，52/266）。28%（38/134）的参考临床试验已注册，14%（19/134）为前瞻性。58 项声称涉及 32 项已注册的临床试验，其中 51 项声称（27 项试验）与随机对照有关。51 项声称中的 46 项（90%）参考了高偏倚风险的注册临床试验结果，所有引用的系统评价和汇总分析都存在高偏倚风险。
大多数婴儿配方奶粉产品至少有一种健康和营养声称。多种成分被声称具有相似的健康或营养效果，同一种成分有多种声称，大多数产品没有提供支持声称的科学依据，引用的声称没有得到可靠的临床试验证据的支持。
