Regional Overview on the Double Burden of Malnutrition and Examples of Program and Policy Responses: African Region.

Sub-Saharan Africa is experiencing the double burden of malnutrition (DBM) with high levels of undernutrition and a growing burden of overweight/obesity and diet-related noncommunicable diseases (NCDs). Undernourishment in sub-Saharan Africa increased between 2010 and 2016. Although the prevalence of chronic undernutrition is decreasing, the number of stunted children under 5 years of age is increasing due to population growth. Meanwhile, overweight/obesity is increasing in all age groups, with girls and women being more affected than boys and men. It is increasingly recognized that the drivers of the DBM originate outside the health sector and operate across national and regional boundaries. Largely unregulated marketing of cheap processed foods and nonalcoholic beverages as well as lifestyle changes are driving consumption of unhealthy diets in the African region. Progress toward the goal of ending hunger and malnutrition by 2030 requires intensified efforts to reduce undernutrition and focused action on the reduction of obesity and diet-related NCDs. The World Health Organization is developing a strategic plan to guide governments and development partners in tackling all forms of malnutrition through strengthened policies, improved service delivery, and better use of data. It is only through coordinated and complementary efforts that strides can be made to reduce the DBM.

Violations of the International Code of Marketing of Breast-milk Substitutes in Mexico.

This study estimated the prevalence of violations of the International Code of Marketing of Breast-milk Substitutes (BMS) and subsequent resolutions of the World Health Assembly (Code) at health facilities, points of sale (POS), and on BMS labelling and media in Mexico. We carried out a cross-sectional survey among 693 mothers with children aged less than 24 months and 48 health providers at public and private health facilities in two states of Mexico. Observational assessment at 20 POS and the health facilities was conducted as well as an analysis of labels on BMS products for sale. Women attending public and private health facilities reported receiving free BMS samples in the previous 6 months (11.1%), and about 80% reported seeing BMS promotion in the mass media. Health providers reported contact with BMS manufacturer representatives in the previous 6 months (15.5%), and only 41.6% of the health providers had knowledge of the Code. BMS promotions were identified at nearly all POS. Analysis of 190 BMS labels showed that 30% included pictures/text idealizing the use of BMS, and all labels incorporated health and nutrition claims. Violations of the Code are prevalent within the health services, POS, and labelling of BMS products. The high percentage of health providers with no knowledge of the Code calls for action at national level to better disseminate and comply with the Code. A transparent, free from commercial influence, and continual monitoring system for Code compliance is needed, including a follow-up component on sanctions for contraventions of the Code.

The World Health Organization Code and exclusive breastfeeding in China, India, and Vietnam.

Promoting exclusive breastfeeding (EBF) is a highly feasible and cost-effective means of improving child health. Regulating the marketing of breastmilk substitutes is critical to protecting EBF. In 1981, the World Health Assembly adopted the World Health Organization International Code of Marketing of Breastmilk Substitutes (the Code), prohibiting the unethical advertising and promotion of breastmilk substitutes. This comparative study aimed to (a) explore the relationships among Code enforcement and legislation, infant formula sales, and EBF in India, Vietnam, and China; (b) identify best practices for Code operationalization; and (c) identify pathways by which Code implementation may influence EBF. We conducted secondary descriptive analysis of available national-level data and seven high level key informant interviews. Findings indicate that the implementation of the Code is a necessary but insufficient step alone to improve breastfeeding outcomes. Other enabling factors, such as adequate maternity leave, training on breastfeeding for health professionals, health systems strengthening through the Baby Friendly Hospital Initiative, and breastfeeding counselling for mothers, are needed. Several infant formula industry strategies with strong conflict of interest were identified as harmful to EBF. Transitioning breastfeeding programmes from donor-led to government-owned is essential for long-term sustainability of Code implementation and enforcement. We conclude that the relationships among the Code, infant formula sales, and EBF in India, Vietnam, and China are dependent on countries' engagement with implementation strategies and the presence of other enabling factors.

Public health risks and benefits associated with breast milk and infant formula consumption.

The safety and quality of infant milk, whether it is breast milk (BM) or infant formula (IF), are a major concern for parents and public health authorities. BM is recommended as the gold standard at WHO level. However, nowadays IF appears as an essential alternative in Western countries, challenging producers to optimize nutritional quality and safety of IF. The aim of the present article is to give an overview on the assessment and comparison of risks and benefits associated with BM and IF consumption. To date, this intensively debated subject has been mainly investigated. It has been shown that both diets could be sources of beneficial health effects in terms of nutrition and also risks in terms of chemical safety. Moreover, microbiologists have demonstrated that IF consumption can cause illness due to product contamination or inappropriate milk preparation. The article concludes on the bottlenecks and gaps that should be investigated to further progress the quantification of the impact of early diet on infant health. Performing a multi-disciplinary risk-benefit assessment with DALY as endpoint might be a future option to help prioritize management options.

Implementation of the International Code of Marketing of Breastmilk Substitutes in the Eastern Mediterranean Region.

BACKGROUND: Optimal breastfeeding practices and appropriate complementary feeding improve child health, survival and development. The countries of the Eastern Mediterranean Region have made significant strides in formulation and implementation of legislation to protect and promote breastfeeding based on The International Code of Marketing of Breast-milk Substitutes (the Code) and subsequent relevant World Health Assembly resolutions. AIM: To assess the implementation of the Code in the Region. METHODS: Assessment was conducted by the World Health Organization (WHO) Regional Office for the Eastern Mediterranean using a WHO standard questionnaire. RESULTS: Seventeen countries in the Region have enacted legislation to protect breastfeeding. Only 6 countries have comprehensive legislation or other legal measures reflecting all or most provisions of the Code; 4 countries have legal measures incorporating many provisions of the Code; 7 countries have legal measures that contain a few provisions of the Code; 4 countries are currently studying the issue; and only 1 country has no measures in place. Further analysis of the legislation found that the text of articles in the laws fully reflected the Code articles in only 6 countries. CONCLUSION: Most countries need to revisit and amend existing national legislation to implement fully the Code and relevant World Health Assembly resolutions, supported by systematic monitoring and reporting.

Human Milk Lipids.

Human milk lipids provide the infant with energy and essential vitamins, polyunsaturated fatty acids, and bioactive components. Adding complex lipids and milk fat globule membranes to vegetable oil-based infant formula has the potential to enhance infant development and reduce infections. Cholesterol provision with breastfeeding modulates infant sterol metabolism and may induce long-term benefits. Some 98-99% of milk lipids are comprised by triacylglycerols, whose properties depend on incorporated fatty acids. Attention has been devoted to the roles of the long-chain polyunsaturated fatty acids docosahexaenoic (DHA) and arachidonic (ARA) acids. Recent studies on gene-diet interaction (Mendelian randomization) show that breastfeeding providing DHA and ARA improves cognitive development and reduces asthma risk at school age particularly in those children with a genetically determined lower activity of DHA and ARA synthesis. It appears prudent to follow the biological model of human milk in the design of infant formula as far as feasible, unless conclusive evidence for the suitability and safety of other choices is available. The recent European Union legislative stipulation of a high formula DHA content without required ARA deviates from this concept, and such a novel formula composition has not been adequately evaluated. Great future opportunities arise with significant methodological progress for example in lipidomic analyses and their bioinformatic evaluation, which should enhance understanding of the biology of human milk lipids. Such knowledge might lead to improved dietary advice to lactating mothers as well as to further opportunities to enhance infant formula composition.

Pervasive promotion of breastmilk substitutes in Phnom Penh, Cambodia, and high usage by mothers for infant and young child feeding.

UNLABELLED: In 2005, Cambodia passed the Sub-Decree on Marketing of Products for Infant and Young Child Feeding (no. 133) to regulate promotion of commercial infant and young child food products, including breastmilk substitutes. Helen Keller International assessed mothers' exposure to commercial promotions for breastmilk substitutes and use of these products through a cross-sectional survey among 294 mothers of children less than 24 months of age. Eighty-six per cent of mothers reported observing commercial promotions for breastmilk substitutes, 19.0% reported observing infant and young child food product brands/logos on health facility equipment and 18.4% reported receiving a recommendation from a health professional to use a breastmilk substitute. Consumption of breastmilk substitutes was high, occurring among 43.1% of children 0-5 months and 29.3% of children 6-23 months of age. Findings also indicated a need to improve breastfeeding practices among Phnom Penh mothers. Only 36.1% of infants 0-5 months of age were exclusively breastfed, and 12.5% of children 20-23 months of age were still breastfed. Children that received a breastmilk substitute as a prelacteal feed were 3.9 times more likely to be currently consuming a breastmilk substitute than those who did not. Despite restriction of commercial promotions for breastmilk substitutes without government approval, occurrence of promotions is high and use is common among Phnom Penh mothers. In a country with high rates of child malnutrition and pervasive promotions in spite of restrictive national law, full implementation of Cambodia's Sub-Decree 133 is necessary, as are policies and interventions to support exclusive and continued breastfeeding. KEY MESSAGES: Despite prohibition without specific approval by the national government, companies are pervasively promoting breast-milk substitutes in Phnom Penh, particularly on television and at points of sale. Strengthened implementation and enforcement of Cambodia's subdecree 133 are needed to better regulate promotion in order to protect breastfeeding for the nutrition and health of infants and young children in Cambodia. Mothers who used a breast-milk substitute as a prelacteal feed were 3.9 times more likely to currently feed this same child a breast-milk substitute, as compared with mothers who did not provide breast-milk substitute as a prelacteal feed. Supporting breastfeeding among mothers after delivery is critical to establish and sustain optimal breastfeeding practices. Use of breast-milk substitutes is also very common among mothers of children under 2 years of age in Phnom Penh. We recommend promoting exclusive and continued breastfeeding as beneficial to children's health and development, and supporting policy and workplace environments that enable breastfeeding up to and beyond 24 months of age.

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

Feeding the preterm infant: opportunities and challenges of bringing science to the bedside.

Designing an optimal feeding program for preterm infants is particularly challenging. These infants require individualized feeding plans and frequent medical interventions, and their health status and physical limitations necessitate specialized products. This review highlights the challenges of translating new understandings into practical application and, specifically, the challenges of translating scientific knowledge into available nutritional products that can be used to meet the special needs of preterm infants. All infant formula products are developed for use in a heavily regulated environment, which is not integrated internationally. The regulatory framework for preterm nutrition products can be particularly complex in the areas of composition and the degree of scientific and clinical support required across countries. Registration and approval of products for preterm infants in most countries must address the complexities for a population for which no well-recognized nonclinical safety or efficacy models exist. Mandatory regulatory review for science-based innovative product improvements may require two or more years. In addition, throughout years of development, industry must justify the financial support of programs that serve a small specialty segment of the market. These industry-specific challenges may be neither visible nor appreciated by the general public or health care professionals, and, yet, they are integral to the development process. Effective collaborations among academic scientists, regulatory authorities, and the industry are essential to bring science to the bedside. Without such collaborations, preterm infants, and particularly very low birth weight infants, in the neonatal intensive care unit will not be able to benefit from innovative nutrition interventions designed to improve short- and long-term clinical outcomes.

The International Code of Marketing of Breast-milk Substitutes: lessons learned and implications for the regulation of marketing of foods and beverages to children.

OBJECTIVE: To identify lessons learned from 30 years of implementing the International Code of Marketing of Breast-milk Substitutes ('the Code') and identify lessons learned for the regulation of marketing foods and beverages to children. DESIGN: Historical analysis of 30 years of implementing the Code. SETTING: Latin America and the Caribbean. SUBJECTS: None. RESULTS: Legislation to restrict marketing of breast-milk substitutes is necessary but not sufficient; equally important are the promulgation of implementing regulations, effective enforcement and public monitoring of compliance. A system of funding for regular monitoring of compliance with legislation should be explicitlyd eveloped and funded from the beginning. Economic sanctions, while important, are likely to be less effective than reports that affect a company's public image negatively. Non-governmental organizations play a critical role in leveraging public opinion and galvanizing consumer pressure to ensure that governments adopt regulations and companies adhere to them. Continual clinical, epidemiological and policy research showing the link between marketing and health outcomes and between policy and better health is essential. CONCLUSIONS: Implementation of the Code has not come easily as it places the interests of underfinanced national governments and international and non-governmental organizations promoting breast-feeding against those of multinational corporations that make hundreds of millions of dollars annually marketing infant formulas. Efforts to protect, promote and support breast-feeding have been successful with indicators of breast-feeding practices increasing globally. The lessons learned can inform current efforts to regulate the marketing of foods and beverages to children.

Three decades of the WHO code and marketing of infant formulas.

PURPOSE OF REVIEW: The International Code of Marketing of Breast Milk Substitutes states that governments, non-governmental organizations, experts, consumers and industry need to cooperate in activities aimed at improving infant nutrition. However, the evidence from the last three decades is that of a series of disputes, legal proceedings and boycotts. The purpose of this review is to assess the overall progress in the implementation of the Code and to examine the problematic areas of monitoring, compliance and governance. RECENT FINDINGS: There are continuing issues of implementation, monitoring and compliance which predominantly reflect weak governance. Many Member States have yet to fully implement the Code recommendations and most States do not have adequate monitoring and reporting mechanisms. Application of the Code in developed countries may be undermined by a lack of consensus on the WHO recommendation of 6 months exclusive breastfeeding. There is evidence of continuing conflict and acrimony, especially between non-government organizations and industry. SUMMARY: Measures need to be taken to encourage the Member States to implement the Code and to establish the governance systems that will not only ensure effective implementation and monitoring of the Code, but also deliver the Code within a spirit of participation, collaboration and trust.

Current safety standards in infant nutrition--a European perspective.

Foods intended specifically for infants and young children are considered under European community law and are defined in specific commission directives. In principal, these directives conclude that such foods must be safe, have a special composition, be distinguishable from normal foods, be suitable for fulfilling particular nutritional requirements, and should, when marketed, indicate such suitability. Since infant formulas are intended as the sole source of nutrition during the first months of life, their nutritional adequacy and safety are particularly strictly regulated. The Scientific Committee on Food report from 2003, on which the current commission directive is based, makes clear recommendations on how benefits, suitability, and safety of modifications beyond established standards should be documented and evaluated. These principles resulted in part from a workshop on characterization of infant food modifications in the EU and two position papers by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). These papers are reviewed below.

Safety standards in infant nutrition: a United States perspective.

In the United States, the general standard for food safety is reasonable certainty of causing no harm under the intended conditions of use. In contrast to food safety policy in some other countries, the United States treats foods for infants and children no differently than foods for adults, other than requiring additional standards for infant formulas. In the United States, food safety falls under the regulatory control of more than a dozen government agencies. The principal responsibility is shared by the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA), but significant additional oversight authority is granted to the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention (CDC), and others. Furthermore, while a large number of legislative statutes provide the basis for regulatory oversight, the principal laws that govern food safety are the Federal Food, Drug and Cosmetic Act, the Federal Meat, Poultry Products and Egg Products Inspection Acts, and the Food Safety Modernization Act. The latter statute, enacted in 2011, has provided for a broad range of new industry responsibilities for the safe manufacture of food products and has significantly expanded federal enforcement authority for violations.

Quality control throughout the production process of infant food.

The manufacture of infant food is a highly complex process and needs an effective quality control beyond classical in-process parameters and a final microbiological analysis. To ensure a safe end -product, various tools, such as the Hazard Analysis Critical Control Points (HACCP), have been developed to facilitate the management of food safety. Every single infant formula ingredient must have an excellent quality and safety approach because even if an ingredient is used in very small quantities in a single product, serious consequences may arise if the quality and product safety are not taken seriously by the ingredient manufacturer. The purpose of this article was twofold: firstly, to briefly describe existing Quality Management Systems and, secondly, to highlight the consequences of non-quality.

A case study of infant health promotion and corporate marketing of milk substitutes.

The mismatch between the demand for, and supply of, health products has led to the increasing involvement of courts worldwide in health promotion and marketing. This study critically examines the implementation of one country's Milk Code within the framework of the International Code of Marketing of Breast-Milk Substitutes, and the efficacy of the judicial process in balancing corporate marketing and state regulatory objectives. Drawing upon the Philippine experience with its own Milk Code, it evaluates the capacities of courts to determine policy costs and risks against the benefits of delineating and containing corporate marketing strategies for milk substitutes and supplements. The study finds that the methodological and information-based challenges faced by courts in resolving multi-dimensional health issues may not be overcome without serious questions concerning the legitimacy of the judicial process itself. Despite the deficiencies of litigation and adjudication, the study notes the catalytic potential of a judicial decision in opening up vital policy space for future renegotiations among rival parties and interests. Third-party intervention is explored relative to this catalytic function.

Latin American Considerations for Infant and Young Child Formulae.

Infant formula is the only acceptable substitute for breastmilk from 0 to 6 months old when human milk cannot be provided in sufficient amounts. Manufacturers have developed options that intend to meet the changing needs of the child aged from six to twelve months (follow-on formulae) and after the age of one year (young child formulae). The international code for marketing breast milk substitute stipulates standards for marketing practices of these products. In Latin America there are local variations of marketing practices. Novel marketing strategies such as advertising through social media and influencers pose new threats for breastfeeding success in Latin America. This review aims to examine variations in local regulations for marketing of infant formulae and to analyze the emerging phenomenon of influencer advertising. We reviewed the local norms for Latin American countries and examined differences and possible gaps. Emerging evidence of influencer marketing was explored. The results indicate that national regulations differ among Latin American countries, particularly with respect to product labelling and the requirement to use a local native language, highlighting the cost of the product, and different regulations prohibiting certain messages and illustrations. Regarding new marketing strategies, there is limited evidence on advertising infant formula through social media influencers, where different categories of marketing strategies can be described. More transparent reporting of social marketing by formula providers and more independent research on novel marketing strategies are needed.

Illegal commercial promotion of products competing with breastfeeding.

OBJECTIVE: To assess if the commercialization of infant formulas, baby bottles, bottle nipples, pacifiers and nipple protectors is performed in compliance with the Norma Brasileira de Comercialização de Alimentos para Lactentes e Crianças de Primeira Infância e de Produtos de Puericultura Correlatos (NBCAL - Brazilian Code of Marketing of Infant and Toddlers Food and Childcare-related products). The commercial promotion of these products is prohibited by the Law 11,265. METHOD: Cross-sectional study conducted in 2017 through a census of all pharmacies, supermarkets and department stores that sold products covered by NBCAL in the South Zone of Rio de Janeiro. Health professionals trained at NBCAL used structured electronic form for direct observation of establishments and for interviews with their managers. We created indicators to evaluate commercial practices and performed descriptive analyses. RESULTS: A total of 352 commercial establishments were evaluated: 240 pharmacies, 88 supermarkets and 24 department stores, of which 88% sold products whose promotion is prohibited by NBCAL. Illegal commercial promotions were found in 20.3% of the establishments that sold the products we investigated: 52 pharmacies (21.9%), four supermarkets (7.5%) and seven department stores (33.3%). The most frequent commercial promotion strategies were discounts (13.2%) and special exposures (9.3%). The products with the highest prevalence of infractions of NBCAL were infant formulas (16.0%). We interviewed 309 managers of commercial establishments; 50.8% reported unfamiliarity with the law. More than three-quarters of the managers reported having been visited at the establishments by commercial representatives of companies that produce infant formulas. CONCLUSION: More than a fifth of commercial establishments promoted infant formulas, baby bottles and nipples, although this practice has been banned in Brazil for thirty years. We think it is necessary to train those managers. Government agencies must monitor commercial establishments in order to inhibit strategies of persuasion and induction to sales of these products, ensuring mothers' autonomy in the decision on the feeding of their children.