Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.

Most of us assume that our government or some international agency is monitoring the quality of infant formula. Government agencies sometimes raise alarms when a batch of formula is seriously contaminated, but they are not monitoring the product to make sure the product helps to make your children as healthy as possible. Manufacturers keep coming up with newer and more expensive versions of infant formula, but no one really knows how they will affect your children's health. And no one is monitoring this! No one compares the healthcare costs linked to different methods of feeding. No one is providing the information that you or any healthcare worker need to make an informed choice between breastfeeding and feeding with infant formula. More than half the infant formula used in the U.S. is provided by the government, at no cost to the families. The government monitors the economic impact on the manufacturers, but not the impact on the health of children. It has been estimated that more than 900 children in the U.S. die each year because they have been fed with infant formula. The large-scale distribution of free formula could end up being very costly to both governments and families, but that is not monitored. This book covers: The regulatory framework Formula's impact on health The assumption of safety of infant formula Outdated and counterfeit infant formula Additives Nutritional adequacy Distribution by governments Strengthening regulations and future work If you are a parent trying to decide whether to breastfeed or formula feed your baby, or if you are a healthcare provider who educates parents on feeding choices, you need to read this book!

Human Milk Biochemistry and Infant Formula Manufacturing Technology, Second Edition covers the history of bottle feeding, its advantages and disadvantages when compared with breast-feeding, human milk biochemistry, trends and new developments in infant formula formulation and manufacturing, and best practices in infant formula processing technology and quality control. The book also covers human milk proteomics as a new, separate chapter and provides additional information on infant formula clinical trial guidelines. In addition, the book includes information about the formulation and processing of premature and low birth weight infant formula. This book is sure to be a welcome resource for professionals in the food and infant formula industry, academics and graduate students in fields like nutrition, food sciences, or nursing, nutritionists and health professionals, government officials working in relevant departments, and finally, anyone interested in human milk and infant formula. - Reviews both human milk biochemistry and infant formula processing technology for broad coverage - Features a comprehensive review on the human milk protein profile using proteomics technology - Contains information on infant formula processing technology - Provides guidelines on infant formula clinical trials and related topics

Infant formula is a primary or supplementary source of nutrition for many infants in the U.S. Consequently, disruptions to the supply of infant formula can have a severe impact on infants' health and well-being. In late 2021 and early 2022, a recall of specific infant formula products, followed by a pause in production, resulted in a widespread, national shortage. The incident demonstrated that additional risk management planning is needed to protect infants from the consequences of potential future supply chain disruptions. In 2023, the U.S. Food and Drug Administration contracted with the National Academies to convene an expert committee to examine and report on challenges in supply, market competition, and regulation of infant formula. The resulting consensus study report explains policy and marketplace vulnerabilities that were exposed during the shortage, describes the extent to which actions taken by relevant stakeholders addressed these vulnerabilities, identifies remaining gaps in the system, and recommends actions to reduce the risk and lessen the effect of any future disruption to the infant formula supply chain.

This list of frequently asked questions (FAQs) is intended to be a convenient place to find answers to common questions about FDA's regulation of infant formula. This FAQ addresses common questions about the regulatory processes and regulatory considerations regarding infant formula.

Recommendations for feeding infants and young children have changed substantially over time owing to scientific advances, cultural influences, societal trends, and other factors. At the same time, stronger approaches to reviewing and synthesizing scientific evidence have evolved, such that there are now established protocols for developing evidence-based health recommendations. However, not all authoritative bodies have used such approaches for developing infant feeding guidance, and for many feeding questions there is little or no sound evidence available to guide best practices, despite the fact that research on infant and young child feeding has expanded in recent decades. Summarizing the current landscape of feeding recommendations for infants and young children can reveal the level of consistency of existing guidance, shed light on the types of evidence that underpin each recommendation, and provide insight into the feasibility of harmonizing guidelines. Feeding Infants and Children from Birth to 24 Months collects, compares, and summarizes existing recommendations on what and how to feed infants and young children from birth to 24 months of age. This report makes recommendations to stakeholders on strategies for communicating and disseminating feeding recommendations.