INCA Comments to DGAC Topics and Questions

March 30, 2018

Kristin Koegel, MBA, RD
USDA Food and Nutrition Service
Center for Nutrition Policy and Promotion
3101 Park Center Drive
Suite 1034
Alexandria, VA 22302

RE: Request for public comments on topics and supporting scientific questions to inform our development of the 2020-2025 Dietary Guidelines for Americans

Dear Ms. Koegel,

The Infant Nutrition Council of America (INCA) is an association representing companies that research, develop, and market formulated nutrition products for infants, children and adults. INCA members produce over 95% of the infant formula consumed in the US, and we take our responsibility of providing optimal nutrition to infants very seriously. INCA supports the American Academy of Pediatrics’ (AAP) position that breastfeeding is the preferred infant feeding method. We also agree with AAP and other leading nutrition, health, and regulatory bodies that infant formula is the only safe, nutritious and recommended alternative for infants who do not receive human milk.

Infant formula is a highly regulated food in the U.S. and the recommended nourishment if human milk is not available. INCA infant formula manufacturers have robust food safety and quality programs in place to ensure every product they make meets or exceeds expectations of consumers, health care providers and regulatory bodies. We believe it is critical to provide parents with accurate information on appropriate infant feeding methods. Developing high quality products is a priority to help ensure a parent’s infant is provided optimal nutrition.

Expanding the Dietary Guidelines for Americans to include recommendations for pregnant women as well as infants and young children 0 to 24 months old presents a significant opportunity to enhance nutrition and feeding experiences of all infants and young children. Accordingly, INCA appreciates the opportunity to provide feedback on topics and questions to be examined in the review of scientific evidence supporting the development of the 2020-2025 Dietary Guidelines. Please see our enclosed feedback to topics and questions in the life-stage specific to infants and toddlers from birth to 24 months, and please do not hesitate to contact me if you have any questions.

Mardi Mountford, MPH
Infant Nutrition Council of America

Infants and toddlers from birth to 24 months (healthy, full-term infants)

Topic: Recommended duration of exclusive human milk or infant formula feeding
INCA supports USDA and HHS in including this topic on duration of exclusive human milk and/or infant formula feeding and its impact on selected endpoints. INCA and its members support the American Academy of Pediatrics’ (AAP) position that breastfeeding is the preferred infant feeding method. We also agree with AAP that infant formula is the only safe and recommended choice for infants who do not receive breast milk. INCA aligns with the AAP1 by recommending exclusive breastfeeding for approximately the first 6 months of life followed by continued breastfeeding and the appropriate introduction of complementary foods for at least 12 months.1 AAP also recommends that in the absence of human milk, iron fortified infant formulas are the most appropriate substitutes for feeding healthy, full term infants during the first year of life.

Questions: What is the relationship between the duration of exclusive human milk or infant formula consumption and 1) growth, size, and body composition; 2) food allergies and other atopic allergic diseases; and 3) long-term health outcomes?

It is important to note that many US mothers do not exclusively use one method of infant feeding during their infant’s first year, but instead practice mixed feeding, such as supplementing human milk with infant formula. According to the U.S. Centers for Disease Control and Prevention (CDC), 28% of mothers supplement breast milk with infant formula within the first 3 months of their infant’s life, and 34% of mothers do so before six months. A mother’s reason for supplementing vary, from going back to work/school, to medical reasons, to personal choice. Beyond aligning with the AAP position, an exhausted review of outcomes pertaining to duration of exclusive human milk can lead to conflicting findings and confusion, regarding duration of exclusive breastfeeding, and would vary depending on the outcome of focus as well as be impacted by confounding factors and the challenge of conducting prospective randomized trials on this topic.

1) Growth, Size and Body Composition

Regarding growth, it should be noted that the Quality Factors set by the U.S. Food and Drug Administration (FDA) serve to ensure that infant formulas are effective in promoting proper growth and development in infants. The Quality Growth Factors require infant formulas satisfy two factors: 1) That the formula supports normal physical growth in infants when fed as a sole source of nutrition and 2) demonstrate that the formula has sufficient biological quality of the protein component of the formula. These requirements are applicable to all infant formulas marketed in the U.S.

We note that it has been suggested that becoming overweight or obese later in life is associated with formula feeding, but such studies have failed to consider significant confounding variables. There are many factors, such as genetics, family environment, and limited physical activity, which can contribute to obesity, and need to be explored further. There is also some literature on the impact of bottle feeding on infant growth. For example, compared with breastfed infant, infants fed by bottle gained significantly more weight per month, yet those who were provided breastmilk in the bottle gained more weight than those provided formula (Li, 2012)2. Additionally, frequent encouragement by mothers for their infant to empty a bottle during early infancy was significantly associated with the child’s frequency of eating all the food on their plate 6 years later (Li, 2014)3. Thus, bottle feeding practices and behaviors may have a stronger influence on infant weight gain and subsequent childhood eating patterns than previously considered. Focusing solely on differences between human milk and infant formula without considering feeding methods and other factors such as gender4-6, will not provide enough information to understand implications for growth, size, and body composition.

2) Food Allergies and Other Atopic Allergic Diseases

Food allergies should be examined within the scope of the newest and most reliable science. Recommendations about when to introduce infants to the most common allergenic foods should be based on sound scientific studies and examined as part of the review of the evidence surrounding complementary feeding. For example, a follow-up study7 reported that socioeconomic and atopic factors were the main predictors of food allergy at 6 years of age, while exclusive breastfeeding (as compared to not exclusively breastfeeding) for the duration of ≥4 months was only marginally associated with lower odds of food allergy at 6 years. Given the lack of credible scientific data about the association of exclusive breastfeeding and food allergies, INCA would recommend deprioritizing food allergies and atopic disease in this breastfeeding/formula section accordingly.

3) Long-term Health Outcomes

There are limited studies addressing the potential relationship of early infant feeding methods and long-term health risk, including cardiovascular disease, diabetes, cancer and obesity (see attached studies). Given limited available data, it is not scientifically correct to conclude that lack of breastfeeding and different early infant feeding methods play a causative role in the development of chronic diseases. Additionally, studies on the effect of formula protein concentration on obesity risk have misrepresented actual protein concentrations in the market8.

Topic: Frequency and volume of human milk and/or infant formula feeding

INCA supports USDA and HHS in including this topic on frequency and volume of human milk and/or infant formula feeding. Infant formula is the only safe and recommended choice for parents who cannot, or choose not to breastfeed and parents should be supported in their decision, thus evaluation of these feeding practices is justified.

Questions: What is the relationship between frequency and volume of human milk and/or infant formula consumption and 1) micronutrient status; and 2) growth, size, and body composition?

For infants who do not exclusively receive human milk, iron-fortified infant formula is the only alternative that provides the nutrients babies need to grow and develop. It is recommended that all formula-fed infants receive iron-fortified formula to prevent iron deficiency anemia. With regard to micronutrient status, several factors can affect the nutrient content of breast milk. For instance, vitamins A, B1, B2, B6, B12, D, and iodine are dependent on maternal diet and body stores9. For this reason, AAP recommends that exclusively or partially breastfed infants receive daily supplementation for overall health and development, for example, vitamin D supplementation10.

When looking at the impact of the frequency and volume of human milk and/or infant formula consumption on the infant’s growth, size and body composition, USDA should consider the various factors that contribute to one’s future health starting at infancy. There is no credible evidence to support claims that infant formula is a major contributing factor to obesity. The possible correlation of infant feeding practices on obesity later in life remains an active area of research where there is still much uncertainty about the relative importance of various factors. There is a gap in literature looking at how bottle feeding impacts the growth, size and body composition of infants. Moreover, there is a need to understand how bottle feeding impacts human development, irrespective of whether the bottle contains human milk or infant formula. INCA encourages USDA to examine only credible research on these topics i.e., studies that follow basic scientific principles, and control for confounding factors and account for the many other dietary and non-dietary factors. When these potential cofounders are controlled for in statistical models, the relationship between breastfeeding and obesity has so far been shown to be substantially diminished and often found non-significant.

When considering the frequency and volume question, it is important to account for feeding practices. Parents who breastfeed and/or bottle feed (with breastmilk and/or formula) need education on responsive infant feeding practices. This will allow parents to respond appropriately to infants’ hunger and fullness cues and will help avoid over or under feeding 11-13.

INCA therefore recommends the following modification to the question to address the comments above:

What is the relationship between frequency and volume of human milk and/or infant formula consumption and 1) micronutrient status; and 2) growth, size, and body composition? Does controlling for feeding practices, including bottle feeding and responsive feeding, modify this relationship?

Topic: Complementary foods and beverages*: Timing of introduction, types, and amounts *Beverages (cow’s milk, water, 100% fruit juice, sugar-sweetened beverages, milk alternatives)

INCA supports the inclusion of this topic on complementary foods and beverages for infants and toddlers from age of introduction to 24 months. INCA, along with a number of public health and healthcare organizations, recommend that appropriate complementary foods should be introduced based on the infant’s state of development, typically between the ages of 4 and 6 months.

Questions: What is the relationship between complementary feeding and 1) micronutrient status; 2) growth, size, and body composition; 3) developmental milestones; 4) food allergies and other atopic allergic disease; and 5) bone health? What is the relationship between complementary feeding, including foods and beverages, and achieving nutrient and food group recommendations of infants and toddlers?

Consumption of breast milk and/or iron-fortified infant formula, along with age-appropriate solid foods, during the first 12 months of life allows for more balanced nutrition and development of feeding skills. Research indicates that a diverse complementary food diet may improve long-term dietary habits as well as diet quality.14 INCA supports the inclusion of the questions listed under the topic but would like to note the following points:

  • Micronutrient status: Complementary foods play an important role in assuring adequate intake of calories and key nutrients, especially for the breastfed baby, starting around the middle of the first year. Certain fortified infant foods– such as infant cereal– are key to ensuring that essential vitamin and mineral needs, particularly iron, are met.
  • Developmental milestones: Other traditional complementary foods, such as pureed fruits and vegetables, support feeding skill development and acceptance of these healthy foods. Research supports that infant acceptance of new foods often takes 8 to 10 tries. Increased exposure to flavor and texture variety in infancy and toddlerhood may help increase acceptance in older childhood.
  • Food allergies: Scientific evidence indicating that there is no need to delay the introduction of certain allergenic foods (peanuts, eggs) has continued to emerge, and now suggests that delayed introduction of these foods may increase the risk of allergic disease.

Infant formula manufacturers provide large subsets of information to FDA to ensure formula includes specific nutrients as outlined by the Infant Formula Act of 1980. Utilizing the information within the current laws and regulations surrounding infant formula could be a beneficial start for USDA as they create recommendations based on the newest nutrition science that will eventually impact infant nutrition policy. INCA commends USDA and HHS for evaluating the Dietary Guidelines for Americans, and specifically for examining nutrition among an important and vulnerable population: infants and toddlers from birth to 24 months. We thank the Department for allowing us to submit comments and provide input to this process that has implications for everyone in the United States.

1. American Academy of Pediatrics. Breastfeeding and the use of Human Milk. Pediatrics. 2012;129(3):e827-e841.
2. Li R, et al. Arch Pediatr Adolesc Med. 2012 May; 166(5):431-6. doi: 10.1001/archpediatrics.2011.1665.
3. Li R, et al. Pediatrics. 2014 Sep;134 Suppl 1:S70-7. doi: 10.1542/peds.2014-0646L.
4. Nelson SE, et al. Gain in weight and length during early infancy. Early Hum Dev. 1989 Jul;19(4):223-39.
5. Dewey KG, et al. Growth of breast-fed and formula-fed infants from 0 to 18 months: the DARLING Study. Pediatrics. 1992 Jun;89(6 Pt 1):1035-41.
6. Rzehak P, et al. Period-specific growth, overweight and modification by breastfeeding in the GINI and LISA birth cohorts up to age 6 years. Eur J Epidemiol. 2009;24(8):449-67. doi: 10.1007/s10654-009-9356-5.
7. Luccioli et al. Pediatrics. Vol. 134 No. Supplement 1, 2014 doi: 10.1542/peds.2014-0646E
8. Weber M, et al. Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial. Am J Clin Nutr. 2014 May;99(5):1041-51. doi: 10.3945/ajcn.113.064071
9. Ballard O. and. Morrow A L. “Human milk composition: nutrients and bioactive factors.” Pediatr Clin North Am 2013.60(1): 49-74. doi: 10.1016/j.pcl.2012.10.002.
10. American Academy of Pediatrics
11. Behrman RE, et al. Nelson Textbook of Pediatrics. 16th ed. Philadelphia, PA: WB Saunders Co; 2000; 165.
12. Samour PQ, et al. Handbook of Pediatric Nutrition. 3rd ed. Sudbury, MA: Jones and Bartlett Publishers; 2005; 90.
13. Fomon SJ. Infant Nutrition. 2nd ed. Philadelphia, PA: WB Saunders Co; 1974; 24. 14. Bégin F, Aguayo VM. First foods: Why improving young children’s diets matter Matern Child Nutr. 2017;13(S2):e12528.