Is the WHO Creating Unnecessary Confusion Over Breast Milk Substitutes?

A recent statement by WHO that "breast milk substitutes should be understood to include any milks …that are specifically marketed for feeding infants and young children up to the age of 3 years" differs significantly from the definition in the International Code which states "a breast milk substitute is any food being marketed or otherwise presented as a partial or total replacement for breast milk, whether or not suitable for that purpose." The new interpretation, which lacks consultation and endorsement, is also ambiguous, with the boundaries between breast milk substitutes and complementary foods being blurred during the first 3 years of life. The logical definitions of breast milk substitutes and complementary foods contained within the Code should be maintained and inappropriate promotion of foods and fluids for infants and young children should be addressed through effective regulation of composition and labelling standards.

Media audit reveals inappropriate promotion of products under the scope of the International Code of Marketing of Breast-milk Substitutes in South-East Asia.

OBJECTIVE: To review regulations and to perform a media audit of promotion of products under the scope of the International Code of Marketing of Breast-milk Substitutes ('the Code') in South-East Asia. DESIGN: We reviewed national regulations relating to the Code and 800 clips of editorial content, 387 advertisements and 217 Facebook posts from January 2015 to January 2016. We explored the ecological association between regulations and market size, and between the number of advertisements and market size and growth of milk formula. SETTING: Cambodia, Indonesia, Myanmar, Thailand and Vietnam. RESULTS: Regulations on the child's age for inappropriate marketing of products are all below the Code's updated recommendation of 36 months (i.e. 12 months in Thailand and Indonesia; 24 months in the other three countries) and are voluntary in Thailand. Although the advertisements complied with the national regulations on the age limit, they had content (e.g. stages of milk formula; messages about the benefit; pictures of a child) that confused audiences. Market size and growth of milk formula were positively associated with the number of newborns and the number of advertisements, and were not affected by the current level of implementation of breast-milk substitute laws and regulations. CONCLUSIONS: The present media audit reveals inappropriate promotion and insufficient national regulation of products under the scope of the Code in South-East Asia. Strengthened implementation of regulations aligned with the Code's updated recommendation should be part of comprehensive strategies to minimize the harmful effects of advertisements of breast-milk substitutes on maternal and child nutrition and health.

Violations of the International Code of Marketing of Breast-milk Substitutes: Indonesia context.

OBJECTIVES: To measure compliance with the International Code of Marketing of Breast-milk Substitutes ('the Code') in Indonesia. DESIGN: The study was a cross-sectional survey using the Interagency Group on Breastfeeding Monitoring protocol. SETTING: Public and private health facilities in six provinces on Java island in Indonesia. SUBJECTS: A total of 874 women (382 pregnant women and 492 breast-feeding mothers of infants below 6 months) and seventy-seven health workers were recruited from eighteen participating health facilities. The study also analysed a total of forty-four labels of breast-milk substitute products, twenty-seven television commercials for growing-up milk (for children >12 months) of nine brands and thirty-four print advertisements of fourteen brands. RESULTS: The study found that 20 % of the women had received advice and information on the use of breast-milk substitutes and 72 % had seen promotional materials for breast-milk substitutes. About 15 % reported receiving free samples and 16 % received gifts. Nearly a quarter of the health workers confirmed receiving visits from representatives of breast-milk substitute companies. Two health workers reported having received gifts from the companies. The most common labelling violations found were statements or visuals that discouraged breast-feeding and the absence of mention about the consideration of local climate in the expiration date. CONCLUSIONS: Violations of the Code by health workers, breast-milk substitute companies and their representatives were found in all provinces studied. A regular monitoring system should be in place to ensure improved compliance with and enforcement of the Code.

The Impact of Toddler Milk Claims on Beliefs and Misperceptions: A Randomized Experiment with Parents of Young Children.

BACKGROUND: Toddler milk (ie, a nutrient-fortified milk-based drink marketed for children aged 12 to 36 months) has been marketed increasingly in the United States with structure/function claims on product packaging that are potentially misleading. OBJECTIVE: This study examined how structure/function claims impact parents' beliefs and perceptions about a toddler milk product. DESIGN: This was a 3-arm between-subjects randomized experiment. PARTICIPANTS: A diverse sample of 2,190 US parents of children aged 1 to 5 years were chosen to take an online survey. INTERVENTION: Participants were randomly assigned to view a toddler milk package with either an unrelated claim ("new and improved," ie, control condition), a "brain development" claim (ie, "brain" claim), or an "immunity-related" claim (ie, "immunity" claim). MAIN OUTCOME MEASURES: Outcomes included perceptions, intentions, and beliefs about the toddler milk product. STATISTICAL ANALYSES PERFORMED: Linear regression for continuous outcomes and logistic regression for dichotomous outcomes. RESULTS: Parents who were exposed to the "brain" claim or the "immunity" claim were more likely to incorrectly believe that the toddler milk was as healthy or healthier than cow's milk compared with those who saw the control claim (89% for brain claim, 87% for immunity claim, and 79% for control; P < .001 for both comparisons). Parents exposed to either the brain or immunity claim had higher intentions to give the toddler milk to their child, higher perceived product healthfulness, and stronger beliefs that pediatricians would recommend the product compared with parents exposed to the control (all, P < .001). CONCLUSIONS: These findings suggest that structure/function claims on toddler milk packaging may mislead parents and increase the appeal of toddler milk. Our findings support calls for public health policies to regulate marketing on toddler milk packaging.

Advocacy, Strategy and Tactics Used to Confront Corporate Power: The Nestlé Boycott and International Code of Marketing of Breast-milk Substitutes.

Douglas A. Johnson began his career as a human rights activist while earning his undergraduate degree in philosophy (1975) at Macalester College in the United States. He lived at Gandhi's ashram in India to study nonviolent organizing (1969 to 1970). He served as the director of the Third World Institute in Minneapolis, MN, USA (1973-1979), which functioned as the international social justice program of the Archdiocese of Minneapolis and St. Paul. Johnson's work included creating and running a political collective; leading development study tours into villages in Guatemala and Honduras; and investigating how transnational companies (e.g., Nestlé) were penetrating the developing world. He was the co-founder of the Infant Formula Action Coalition (INFACT), elected national chairperson (1977-1985), and appointed as Executive Director (1978-1984). His role included representing INFACT before national and international organizations, the human milk substitute industry, the US Congress and Executive Branch, and the press. He initiated and coordinated the first international grass-roots consumer boycott (against Nestlé) in ten nations. He was also a co-founder of the International Nestlé Boycott Committee and the International Baby Food Action Network (IBFAN). He earned a Master's in Public and Private Management at Yale University (1988). Then he became the first Executive Director of the Center for Victims of Torture, in Minneapolis (1988-2012), the first treatment center for torture victims in the US. Since 2013, he has been teaching human rights theory and practice, and sharing lessons he has learned, as a Lecturer in Public Policy at the Harvard Kennedy School, Harvard University (US). (This interview was conducted via Zoom and transcribed verbatim. It has been edited for ease of readability. DJ refers to Doug Johnson and LD refers to Laura Duckett.).

David Clark: Defender of Human Rights and Breastfeeding.

On September 10, I had the pleasure of interviewing my friend and colleague David Lawson Clark, the legal advisor for infant and young child nutrition and expert on the International Code of Marketing of Breast-milk Substitutes at UNICEF. A native of Scotland, David began his career as an attorney with the Scottish Development Agency and subsequently worked for the United Nations Interregional Crime and Justice Research Institute in Rome, Italy. Since 1995, David has assisted more than 60 countries in drafting legislation to implement the International Code of Marketing of Breastmilk Substitutes and has been instrumental in bringing a human rights-based approach to the protection, promotion, and support of breastfeeding. He has contributed to the development of international policy guidelines in the area of HIV and infant feeding and infant feeding in emergencies, and has provided guidance on issues around international trade agreements and intellectual property rights. David has written and contributed to many articles and publications on health and nutrition policy, developed courses and training materials on the implementation of the International Code and maternity protection, and has facilitated numerous workshops on the issue. (LGS refers to Dr. Laurence Grummer-Strawn and DC are the verbatim responses of David Clark).

Effects of milk replacer formulation on measures of mammary growth and composition in Holstein heifers.

Overfeeding prepubertal heifers may impair mammary parenchymal growth and reduce milk production, but evidence suggests that increased intake of a high-protein milk replacer before weaning may be beneficial. This study was designed to evaluate effects of milk replacer (MR) composition on mass and composition of mammary parenchyma and fat pad, growth hormone (GH)/insulin-like growth factor-I (IGF-I) axis gene expression, and putative mammary epithelial stem cells. Specifically, we hypothesized that positive effects of faster rates of gain during the preweaning period alter the development, persistence, or activity of populations of putative mammary epithelial stem cells, possibly through involvement of GH/IGF-I axis molecules. Twenty-four newborn heifers were fed 1 of 4 MR diets (n = 6/diet): control [20% crude protein (CP), 21% fat MR fed at 441 g of dry matter (DM)/d], high protein, low fat (28% CP, 20% fat MR fed at 951 g of DM/d), high protein, high fat (27% CP, 28% fat MR fed at 951 g of DM/d), and high protein, high fat+ (27% CP, 28% fat MR fed at 1,431 g of DM/d). Water and starter (20% CP, 1.43% fat) were offered ad libitum. Animals were killed on d 65 and mammary tissue was subjected to biochemical, molecular, and histological examination. No differences in mammary parenchymal mass or composition, with or without adjusting for empty body weight, were detected. Mass was increased and composition of the mammary fat pad was altered by nutrient intake. No diet differences in putative mammary epithelial stem cell abundance or abundance of transcripts for genes of the GH/IGF-I axis were detected. In this study, growth of the mammary epithelium, size of the mammary epithelial stem cell population, and components of the GH/IGF-I axis did not depend on diet. However, an underlying positive correlation between telomerase, a marker of mammary stem cells, and growth of the mammary parenchyma was detected. Implications of diet-induced effects on mammary fat pad and possible effects on subsequent development and function remain to be determined.

Evaluation of the Use of Microtracers™ in a Proficiency Testing Program.

Background: An effective proficiency testing program must utilize accurate splitting procedures to ensure that customers receive equivalent (by some measure) test items. When test items are not equivalent, it becomes impossible to separate variation among laboratories from variation among test items, and the program cannot achieve its objectives. Therefore, there is a critical need to validate the splitting process used to manufacture test items. Objective: The incorporation of MicrotracersTM was investigated for validating the splitting process used in the Association of American Feed Control Officials Proficiency Testing Program and as a potential quality control event for a production run. Methods: Microtracers were incorporated into six production runs. From each run, 12 test items were randomly selected for evaluation. Proficiency test materials were prepared from commercially available feedstuffs using base animal feeds and feed additives. The tracers were incorporated into base feed with other additives, recovered, and counted from the randomly selected test items. Results: Uniformity of test items was evaluated with the following two statistical methods: (1) relative standard deviation (RSD) of particle counts according to a Poisson distribution and (2) a Pearson's Chi-square test. RSDs for counts (per mass basis) ranged from 2.49 to 4.13%, and Chi-square P values ranged from 0.0097 to 0.3740 over the six sets. Conclusions: Microtracers were determined to be a potential tool for validating the splitting process used to manufacture proficiency test items and a tool for incorporating quality control events into the manufacture of proficiency test items. Highlights: The authors offer suggestions for proficiency testing programs.

Manganese levels in infant formula and young child nutritional beverages in the United States and France: Comparison to breast milk and regulations.

Exposure to high levels of manganese (Mn) in children has recently been associated with adverse neurodevelopmental effects. Current infant formula regulations for Mn content were set between 1981 (United States), 2006 (European Union, France), and 2007 (Codex Alimentarius) prior to the publication of much of the growing body of research on the developmental neurotoxicity of Mn. In this study, we sought to measure the concentrations of Mn in some infant formulas and young child nutritional beverages available on the United States (US) and French markets using ion beam analysis by particle induced X-ray emission (PIXE) spectrometry and then compare the analytical results to concentrations reported in the literature for breast milk and applicable infant formula regulations and guidelines. We were particularly interested in measuring Mn concentrations in product types for which there is very little data from previous surveys, especially soy-based, rice-based, goat-milk based, chocolate-flavored, and nutritional beverages for young children that are not regulated as infant or follow-on formulas (e.g. "toddler formulas" and "toddler powders"). We purchased 44 infant formulas and young child nutritional beverage products in the US and France with varying protein sources (cow-milk, goat-milk, soy, rice) labelled for birth to 3 years. We selected these samples using maximum variation sampling to explore market extremes to facilitate comparisons to regulatory limits. Since this sampling method is non-probabilistic, other inferences cannot be made beyond this set of samples to the overall markets. We used ion beam analysis to measure the concentrations of Mn in each product. The range of measured Mn concentrations in the products is 160-2,800 µg/L, substantially higher than the 3-6 µg/L mean Mn concentration reported in human breast milk. All products satisfied national and Codex Alimentarius Commission (CAC) international standards for minimum Mn content in infant formulas; however, 7/25 of the products purchased in the US exceeded the CAC Guidance Upper Level of 100 µg Mn/kcal for infant formula.

Recommendations for Adopting the International Code of Marketing of Breast-milk Substitutes Into U.S. Policy.

In 1981, the World Health Organization adopted the International Code of Marketing of Breast-milk Substitutes ( International Code), with subsequent resolutions adopted since then. The International Code contributes to the safe and adequate provision of nutrition for infants by protecting and promoting breastfeeding and ensuring that human milk substitutes, when necessary, are used properly through adequate information and appropriate marketing and distribution. Despite the World Health Organization recommendations for all member nations to implement the International Code in its entirety, the United States has yet to take action to translate it into any national measures. In 2012, only 22.3% of infants in the United States met the American Academy of Pediatrics recommendation of at least 6 months of exclusive breastfeeding. Countries adopting legislation reflecting the provisions of the International Code have seen increases in breastfeeding rates. This article discusses recommendations for translating the International Code into U.S. policy. Adopting legislation that implements, monitors, and enforces the International Code in its entirety has the potential to contribute to increased rates of breastfeeding in the United States, which can lead to improved health outcomes in both infants and breastfeeding mothers.

Inorganic arsenic levels in rice milk exceed EU and US drinking water standards.

Under EU legislation, total arsenic levels in drinking water should not exceed 10 microg l(-1), while in the US this figure is set at 10 microg l(-1) inorganic arsenic. All rice milk samples analysed in a supermarket survey (n = 19) would fail the EU limit with up to 3 times this concentration recorded, while out of the subset that had arsenic species determined (n = 15), 80% had inorganic arsenic levels above 10 microg l(-1), with the remaining 3 samples approaching this value. It is a point for discussion whether rice milk is seen as a water substitute or as a food, there are no EU or US food standards highlighting the disparity between water and food regulations in this respect.

Analysis of fluoride concentration in mother's milk substitutes.

The aim of the present study was to determine the fluoride concentration in some brands of mother's milk substitutes and evaluate the possibility of developing dental fluorosis by consuming these products. The products, all powdered, were divided into 3 groups: infant formulae (group I, n = 7), milk-based (group M, n = 8) and soy-based (group S, n = 3). Samples from 3 cans of different batches of each brand were reconstituted in deionized water and analyzed using the specific electrode method, after hexamethyldisiloxane (HMDS) facilitated diffusion. The fluoride content (mg F/L) of the products ranged from 0.044 to 0.326 (I), 0.014 to 0.045 (M) and 0.253 to 0.702 (S). There was significant difference in the fluoride content of cans from distinct batches (p < 0.05) in most of the brands. The reconstitution of all products in water with optimal fluoride concentration for consumption during the mineralization phase of the primary teeth could result in daily fluoride intake above 0.07 mg F/kg body weight/day. Therefore, the consumption of these products, especially when reconstituted with optimally fluoridated water, could increase the risk of developing dental fluorosis.

Analysis of fluoride concentration in mother's milk substitutes / Análise da concentração de flúor em substitutos do leite materno

The aim of the present study was to determine the fluoride concentration in some brands of mother's milk substitutes and evaluate the possibility of developing dental fluorosis by consuming these products. The products, all powdered, were divided into 3 groups: infant formulae (group I, n = 7), milk-based (group M, n = 8) and soy-based (group S, n = 3). Samples from 3 cans of different batches of each brand were reconstituted in deionized water and analyzed using the specific electrode method, after hexamethyldisiloxane (HMDS) facilitated diffusion. The fluoride content (mg F/L) of the products ranged from 0.044 to 0.326 (I), 0.014 to 0.045 (M) and 0.253 to 0.702 (S). There was significant difference in the fluoride content of cans from distinct batches (p < 0.05) in most of the brands. The reconstitution of all products in water with optimal fluoride concentration for consumption during the mineralization phase of the primary teeth could result in daily fluoride intake above 0.07 mg F/kg body weight/day. Therefore, the consumption of these products, especially when reconstituted with optimally fluoridated water, could increase the risk of developing dental fluorosis.

Este estudo teve como objetivos determinar os teores de flúor de algumas marcas comerciais de substitutos do leite materno e avaliar a possibilidade de desenvolvimento de fluorose dentária com o consumo destes produtos. Os produtos, todos em pó, foram divididos em três grupos: fórmulas infantis (grupo F, n = 7), leite (grupo L, n = 8) e leite de soja (grupo S, n = 3). As amostras de pó de três latas de lotes diferentes de cada marca comercial foram reconstituídas em água deionizada e analisadas pelo método eletrodo específico, após difusão facilitada por hexametildisiloxane (HMDS). O conteúdo de flúor (mg F/L) dos produtos variou de 0,044 a 0,326 (F), 0,014 a 0,045 (L) e 0,253 a 0,702 (S). Houve diferença significativa (p < 0,05) entre o conteúdo de flúor de latas de lotes diferentes do mesmo produto na maioria das marcas comerciais analisadas. A reconstituição de todos os produtos em água com concentração ótima de flúor, para o consumo de crianças na faixa etária de formação dos dentes decíduos, pode resultar em quantidades diárias de ingestão de flúor superiores a 0,07 mg F/kg peso/dia. Portanto, o consumo desses produtos, principalmente quando reconstituídos em água fluoretada poderia aumentar o risco de desenvolvimento de fluorose dentária.

Programa nacional de incentivo ao aleitamento materno: revisão e avaliação das ações nacionais para a implementação dos princípios e objetivos do Código Internacional de comercialização dos substitutos do leite materno / Brazilian breastfeeding promotion programme: revision and evaluation of implementing national actions for the principles and objectives of milk substitutes commercialization International Code

Avalia e revisa os objetivos e princípios das"Normas para a Comercialização de Alimentos para Lactentes", com o objetivo de torná-las mais atuais e eficazes. Aborda também os instrumentos legais de apoio ao aleitamento materno, histórico da sua disseminação e as interfaces das normas com as demais áreas do Programa Nacional de Aleitamento Materno