Infant Formulas What’s for What and What’s for Whom???

1. Infant FormulasWhat’s for What and What’s for Whom??? Kathryn Camp, MS, RD, CSP Pediatric Nutritionist Walter Reed Army Medical Center

3. Today’s Presentation • History and regulation of infant formulas • Categorize formulas by composition and intended use • Alternate products sometimes given to infants

4. Infant Formula • Product intended for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk

5. Historical Perspective • Early attempts at artificial feeding of infants employed the milk of other mammals • Infant survival during the 1st few weeks of life approached 0% • Wet nurses were employed but their availability declined with the onset of the Industrial Revolution

6. Pewter Ceramic Examples of Early Infant Feeding Vessels

7. Banana feeder Commercial Formula Development • In 1867, Henri Nestlé created the first commercially sold formula.

8. At the end of the 19th century the gross composition of human milk was determined. • Recognition of low concentration of protein in BM lead to the use of diluted cow milk • Less mortality among infants • But poor growth • To increase caloric density of diluted cow milk, sugar or cereals were added • Infants lived and grew • Pediatrics became a medical specialty • Mortality still remained high

10. Early 20th century • Electric refrigeration and pasteurization • Significant decrease in mortality • Increased popularity of formula feeding • Improved sanitation and milk handling • Modifications in cow protein improved digestibility • Direct advertising to physicians influenced use of formulas

11. Good rubber nipples made feeding easier

12. 1911-- Dextri-Maltose introduced by Mead Johnson • 1915 -- a formula called synthetic milk adapted (forerunner of Wyeth’s SMA) required only the addition of water • 67 kcal/dL • Non-fat cow milk • Lactose • Oleo and vegetable fat

13. The importance of vitamins was recognized • Infant formulas became suitable vehicles • Previously common vitamin-deficiency diseases such as scurvy and rickets became less prevalent

14. Highlights in Formula History • 1929--the first soy flour formula was developed • milk–free, lactose–free • designed as an alternative to the home prepared milk–based formulas of the time • soy flour caused significant abd discomfort • 1942--protein hydrolysate formula • 1959—iron-fortified formula appeared • 1960—appreciation of renal solute load • 1965--soy protein isolate formula

15. 1966—1st premmie formula designed to meet the special nutritional needs of rapidly growing low–birth–weight infants. • 1971--first nutritionally complete protein hydrolysate formula containing MCT oil. • 1990’s • lactose free cow milk-based formulas appeared • Nucleotides were added to some formulas • Early 2000’s • DHA and ARA were added to both cow milk and soy formulas

16. Regulation of Infant Formulas • The US was one of the last major industrialized nation to implement federal regulations concerning safety of infant formulas • The first FDA reference to safety of infant formulas was in 1938 • 1941 first requirement for specific information to be included on an infant formula label • No new revisions until 1971 when the results of AAP recommendations and public hearings included minimum requirements for protein, fat, linoleic acid and 17 vitamins and minerals.

17. Infant Formula Act Passed by Congress in 1980 • Following reports in 1979 that over 100 infants became seriously ill because of the lack of chloride in two soy-based formulas • The new law authorized the FDA to adjust nutritional standards for infant foods to conform with the best available scientific knowledge. • Manufacturers are required to test their products periodically and report to the FDA when they do not meet the official specs.

18. Furthermore….Formula Manufacturers are required to • Verify composition before a new product goes to market • specifying that it meets minimum (29 nutrients) and does not exceed maximum (9 nutrients) requirements • Meet “good manufacturing practices” • Maintain records for annual inspection • The FDA has the authority to recall products that are adulterated or misbranded

19. Categories of Infant formulas • Standard • Similac, Enfamil, Carnation, Store brands • Soy • Isomil, Prosobee, Alsoy, • Protein hydrolysates • Pregestimil, Nutramigen, Alimentum • Elemental • Neocate, Elecare • Premature • Enfacare, NeoSure • “Next Step”—older infants and toddlers • Specialized • Modified for specific medical indication • Metabolic, renal, GI disorders

20. Standard Formulas • Cow milk altered by • Removing the butter fat • Adding vegetable oils and carbohydrate • Decreasing the protein • 34 g/L to 15 g/L • Adding vitamins, minerals, and other nutrients such as amino acids, fatty acids, nucleotides • Whey to casein ratio varies • Major whey protein is β-lactoglobulin • Major casein protein is bovine -casein • Amino acid profile varies • Taurine and carnitine are added to some

22. Whey to Casein Ratio

23. Breast milk 20cal/oz Human milk fat Lactose whey:casein 70:30 9 g/L Iron 0.3mg/L Vitamin D 21 IU/L 260 mOsm/kg H20 Contains DHA and AA Enfamil/Similac/Good Start 20cal/oz Soy, coconut, sunflower, palm Lactose 60:40, 18:82  15 g/L Iron 12mg/L Vitamin D 405 IU/L 265-300 mOsm/kg H20 DHA and AA added Formulas still made without Standard FormulaFeatures

24. Breast milk 20cal/oz Human milk fat Lactose whey:casein 70:30 9 g/L Iron 0.3mg/L Vitamin D 21 IU/L 260 mOsm/kg H20 Contains DHA and AA Enfamil/Similac/Good Start 20cal/oz Soy, coconut, sunflower, palm Lactose 60:40, 18:82  15 g/L Iron 12mg/L Vitamin D 405 IU/L 300 mOsm/kg H20 DHA and AA added Formulas still made without Standard FormulaFeatures

25. Low Iron Formula PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123 AMERICAN ACADEMY OF PEDIATRICS:Iron Fortification of Infant Formulas Position Statement “The manufacture of formulas with iron concentrations less than 4.0 mg/L should be discontinued. If these formulas continue to be made, low-iron formulas should be prominently labeled as potentially nutritionally inadequate with a warning specifying the risk of iron deficiency. These formulas should not be used to treat colic, constipation, cramps, or gastroesophageal reflux.”

26. Soy Formulas • Indications for use • Milk protein intolerance (IGE mediated) • Lactose intolerance (rare) • Galactosemia • Vegetarian diet • Not appropriate for • preterm infants < 1800 grams d/t risk of osteopenia and growth concerns • Hereditary fructose intolerance (contains sucrose)

27. Breast milk 20cal/oz Human milk fat Lactose whey:casein 70:30 9 g/L Iron 0.3mg/L Vitamin D 21IU/L 260 mOsm/kg H20 Contains DHA and AA Isomil/Prosobee 20cal/oz palm olein, soy,coconut,sunflower Corn syrup/sucrose Protein, 17 g/Lsoy isolate and L-MET Iron 12mg/L Vitamin D 405 IU/L 200 mOsm/kg H20 DHA and AA added Soy Formulas

28. Protein Hydrolysates • Hydrolyzed casein or whey protein • Various fat blends • All are lactose free

29. Breast milk 20cal/oz Human milk fat Lactose 70%whey 30%casein 9 g/L Iron 0.3mg/L Vit D 21 IU/L 260 mOsm/kg H20 Contains DHA and AA Pregestimil 20cal/oz MCT (55%), safflower, soy corn syrup solids, corn starch Casein Hydrolysate-nonantigenic peptides 19 g/L Iron 12mg/L Vitamin D 405 IU/L 330 mOms/kg H20 Does not have DHA and AA Protein Hydrolysates

30. Other Hydrolysates • Alimentum Advance • For infants and children with severe food allergies, sensitivity to intact protein (including colic symptoms due to protein sensitivity), protein maldigestion or fat malabsorption • Hydrolyzed casein + free amino acids • 33% of fat is MCT • 370 mOms/kg H20 • Contains DHA and ARA • Lactose free (contains sucrose) • Nutramigen LIPIL • hypoallergenic • for infants who are sensitive to intact protein in milk and soy-based formulas • 270 mOms/kg H20 • Lactose and sucrose free

31. New Kid on the Block!

32. Enfamil Gentlease LIPIL • Launched in July 05 • “is a nutritionally balanced, milk-based infant formula designed as a first switch formula for babies who have fussiness or gas.” • Partially broken down proteins • 6-9% hydrolyzed • Reduced lactose • 1/4 of typical • Whey:casein ratio of 60:40 • Contains DHA and ARA, “nutrients also found in breast milk that promote brain and eye development.” • No studies to document efficacy in the intended population

33. Elemental Formulas • Indications: For infants and children who need an amino acid-based medical food or who cannot tolerate intact protein • protein maldigestion or malabsorption • Short bowel syndrome • severe or multiple food allergies • GI tract impairment • eosinophilic esophagitis or gastroenteritis • Lactose, sucrose, fructose, and galactose-free • Galactosemia and hereditary fructose intolerance

34. Breast milk 20cal/oz Human milk fat Lactose 70%whey 30%casein 9 g/L Iron 0.3mg/L Vit D 21 IU/L 260 mOsm/kg H20 Contains DHA and AA Neocate/Elecare 20cal/oz MCT, safflower, soy Corn syrup solids 100% free amino acids, 21 g/L Iron 12mg/L Vitamin D 500 IU/L 335 mOsm/kg H20 Do not contain DHA and AA Elemental 5% MCT 33% MCT

35. Premature Formulas • NICU • Similac Special Care Enfamil Premature Lipil • 20 and 24 kcal/oz • Available only for inpatients • Cow milk based • 40% of fat is MCT • Products are not appropriate for larger babies (2.5-3 kg) because of higher amounts of vitamins (esp A and D) and minerals

36. Premature Infants • Hospital discharge • NeoSure • EnfaCare • 22 kcal/oz •  Pro, calcium, phosphorus, MCT (20%) • Cow milk based • Improved growth • Wheeler, RE. Journal of Perinatology, 16:111-116, 1996.

37. Others • Enfamil AR • Milk-based standard formula • added rice starch that thickens in the acid environment of the stomach • For babies who spit up frequently or need a thickened formula • Reduced reflux symptoms • Vanderhoof , Clin Pediatr. 2003;42:483-495. • Isomil DF • Soy protein, soy fiber • For firming loose, watery stools in infants older than 6 months and toddlers. •  duration of antibiotic-induced diarrhea • Burks, J Pediatr. 2001;139(4):578

38. Others • Enfamil LactoFree • Milk-based • Lactose and sucrose-free formula for infants with fussiness, gas or diarrhea due to lactose sensitivity. • Calcium absorption was less than with lactose containing formula but total calcium absorption was adequate (Abrams, AJCN;2002) • Studies on efficacy have been mixed

39. Generic Formulas • Must meet requirements set under the infant formula act • Minimums and maximums • Less expensive

40. Specialized • Portagen (Mead Johnson) • 86% MCT oil fat malabsorption, intestinal lymphatic obstruction, or chylothorax • 2002 recall after the death of a premature infant from Enterbacter sakazakii contaminated formula. • Manufacturer no longer recommends for infants • RCF (Ross) Ross Carbohydrate Free • Infants with CHO intolerance • Must add CHO • Modified for the ketogenic diet

41. Specialized, cont: • Similac PM 60/40 • For infants with hypocalcemia due to hyperphosphatemia or impaired renal function. • Metabolic Formulas • PKU, MSUD, tyrosinemia, homocystinuria, glutaric aciduria, PPA/MMA, urea cycle • Ross, Mead Johnson, Scientific Hospital Supplies

42. ToddlerFormulas • Milk and soy based products • for infants and toddlers • 9-24 months • who are eating solid foods • Contain DHA and ARA • Has > twice the calcium of regular infant formulas (300 mg vs 125 mg)

44. Alternatives to Infant Formulas • Evaporated Milk Formula • AAP does not support its use • Poorly digested fat • Low iron and vitamin C • Excessive sodium, protein, PO4 • Preferable to unmodified cow milk • Recipe • 13 oz can • 19.5 oz water • 3 Tablespoons sugar or corn syrup • Requires supplementation with vitamins A, D, calcium, and iron

46. Case • 10.5 mo old female with hx of poor growth • 26.5 weeks gestation • 3 mo NICU course complicated by poor feeding, BPD, hernia repair, seizures • Discharged on Elecare and O2 • 7.5 mo corrected age • Meds—synthroid, zantac, Poly-vi-sol, flovent, calcium gluconate

47. Weight--5 kg • Length-- 61.6 cm • IBW--6.5 kg • 77% of IBW

48. Dietary data • Family had switched to goat milk 1 mo prior on the advice of “someone” who said it would provide more nutrition • She was drinking more volume • 1 pound weight loss in 1 month • 24-hr dietary intake • 20 oz of goat milk (rice cereal added at 1T per 4 oz) • 3 T baby solids

49. Dietary Analysis

50. Formulas vs Goat Milk *Added