In this response, hang time refers to the total time the prepared formula is unrefrigerated. In other words, the amount of time the prepared formula is unrefrigerated before tube-feeding administration actually begins should be included as part of the hang time.
Continuous Tube-Feeding in Patients in the NICU or Premature or Immunocompromised Patients
Since powdered formulas are not sterile, it is recommended that they not be fed to infants in neonatal intensive care settings nor to premature or immunocompromised patients unless no alternative is available.1 If powdered formula must be used for continuous tube-feeding, we recommend a maximum of 4 hours hang time.2 Commercially sterile liquid infant formulas (concentrated liquid and ready-to-use) administered by continuous tube-feeding may be hung for up to 4 hours. If a powder product is added to a liquid formulation for continuous tube-feeding, the feeding should be limited to a maximum 4 hours hang time.
Continuous Tube-Feeding in Other Patients
For prepared (powdered or concentrated liquid) formula that is administered by continuous tube-feeding, we recommend a maximum of 4 hours hang time. Unmodified commercially sterile ready-to-use liquid infant formulas administered by continuous tube-feeding may be hung for up to 8 hours. If a powder product is added to a liquid formulation for continuous tube-feeding, the feeding should be limited to a maximum 4 hours hang time.
Enfamil® Human Milk Fortifier Powder
An in vitro study of bacterial growth rates performed by Mead Johnson reflects low bacterial growth rates in prepared Enfamil Human Milk Fortifier Powder for up to six hours at room temperature.3 As a result, Mead Johnson recommends a maximum of 4 hours hang-time for human milk fortified with Enfamil Human Milk Fortifier Powder.
1. US Department of Health and Human Services; US Food and Drug Administration; Center for Food Safety and Applied Nutrition. Health Professionals Letter on Enterobacter sakazakii Infections Associated With Use of Powdered (Dry) Infant Formulas in Neonatal Intensive Care Units. Office of Nutritional Products, Labeling and Dietary Supplements. April 11, 2002; Revised October 10, 2002. Available from: http://www.cfsan.fda.gov/~dms/inf-ltr3.html. Accessed August 29, 2005.
2. Pediatric Nutrition Practice Group, American Dietetic Association. Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities, Second Edition. Robbins ST and Myers R, eds. Chicago, IL: American Dietetic Association; 2011.
3. Telang S, Berseth CL, Ferguson PW, et al. Fortifying fresh human milk with commercial powdered human milk fortifiers does not affect bacterial growth during 6 hours at room temperature. J Am Diet Assoc. 2005;105:1567-1572.
For our unopened liquid and powdered products, the best general recommendation we can make regarding storage temperatures is that the product be maintained at "normal" room temperature, e.g., 68-80° F. The rationale is that the shelf life of the product is based on the best estimate of the time when certain changes may occur at normal temperatures.
In most circumstances, short-term storage at higher temperatures (e.g., 85-100° F), or storage in a non-air-conditioned facility that cools due to night temperatures, would not be harmful to either our unopened liquid or powder formulas. However, many of the normal chemical and physical changes that occur over time at room temperature will be accelerated at constantly elevated temperatures, such as near a furnace or water heater.
If our liquid product has been stored for an extended period at excessively hot temperatures (e.g., above 100° F), the fat in the product may tend to separate, and it may also darken significantly; however, these changes are not apparent in all samples exposed to extreme elevated temperatures. Since the length of exposure is an important factor, it is impossible for us to provide specific limits to fit all situations.
We recommend that our products packaged in clear glass or plastic containers not be stored in direct sunlight, due to vitamin loss associated with light exposure.
For our liquid products, storage at cool temperatures (above freezing) does not affect the nutrition, functionality, or appearance of our unopened products. However, if the unopened product is held or stored in a cold area or refrigerator, we recommend that it be allowed to warm to room temperature and shaken well before use. Freezing of our products may cause loss of desirable appearance and functionality (though not nutrition), and is not recommended.
As long as there is no damage to the seal or container, our unopened liquid products that have been exposed to extreme temperatures or light should remain commercially sterile. As always, the formula should be well shaken and carefully examined for appearance and odor before use.
Temperature of storage and preparation of Nutramigen® with Enflora™ LGG® infant formula powder is of particular importance to provide the benefits of live cells to babies consuming the formula. Temperatures over 100 degrees F will likely reduce the level of viable LGG below the desired level. For this reason, the product should not be exposed to temperatures above 100 degrees F for prolonged periods of time. In addition, water used to prepare Nutramigen with Enflora LGG should be less than 100 degrees F, and the prepared formula should not be warmed over 100 degrees F.
We conducted distribution stability studies throughout the USA, including Phoenix, Arizona in the summer, and found that no shipping controls beyond our current requirements were needed to maintain viability of cells upon reconstitution. Stability studies confirmed that the probiotic is provided at an appropriate concentration.
Our other powdered products withstand exposure to extreme temperatures relatively well. Long-term exposure to extreme heat can occasionally cause the powder to darken slightly and the odor to change. As mentioned above, we recommend all our infant formulas be carefully examined prior to use. Any formula that looks or smells unusual should not be used.
None of the ingredients in our products are known sources of gluten.
We distribute two items that contain latex and are labeled to indicate that they contain latex: the NUK® Newborn Orthodontic Nipple (order #2105-02), the NUK Newborn Orthodontic Pacifier-Exerciser (order #2107-02).
The nipples we distribute under the Enfamil® name (Standard-Flow Soft, Slow-Flow Soft, Cross-Cut, and Neonatal) are not made of latex materials. The Cleft Lip/Palate Nurser with nipple unit is also not made of latex .
In summary, our infant formulas, pediatric formulas, pediatric vitamin products, and packaging do not have latex; the only two products containing latex are the items mentioned above.
It is important that we use the same definitions for terms. Labeling of water as sterile requires that it meet the requirements of the United States Pharmacopeia (USP) and that it be manufactured to render it not only sterile but also pyrogen-free. The USP provides specifications for various intended uses, such as water for injection, water for inhalation, water for irrigation, etc.
Our Enfamil® Water for oral use is manufactured to render it commercially sterile, which means that heat is applied that renders it free of viable microorganisms (including spores) of public health significance, as well as microorganisms of non-health significance that are capable of reproducing in the water under normal non-refrigerated conditions of storage and distribution. It is intended for oral consumption only.
Our Enfamil® Water for oral use undergoes extensive purification procedures prior to bottling. These processes include aeration, carbon filtration, and reverse osmosis. Our Enfamil® Water for oral use meets federal standards for "potable water" and is tested to ensure this.
Although we could accurately label this water as "commercially sterile," we have deliberately chosen not to do so in order to minimize inappropriate use. We have no reservations or qualifications, however, in supporting the product as safe and appropriate for its intended oral use.
No, two published studies support the equal tolerance of low iron and iron-fortified formulas.1,2 The first study demonstrated no difference in the incidence of constipation or other gastrointestinal symptoms when an infant was given iron-fortified vs. a low-iron formula. The second study compared infant behavior and stool characteristics reported by parents in a crossover study. Characteristics studied included fussiness, cramps, regurgitation, flatus, colic, stool frequency, consistency, and color. Only stool color was different (darker) when infants received an iron-fortified formula. There is no evidence that iron, at the levels found in infant formulas, causes formula intolerance.
Iron is very important in infant formulas because it is the nutrient most likely to be at low levels in an infant's diet. Iron-fortified formulas have been very important in decreasing the occurrence of iron deficiency in infancy. The American Academy of Pediatrics recommends that infants who are not breastfed or are partially breastfed receive an iron-fortified formula (containing between 4.0-12 mg iron/liter or 3.8-11.4 mg iron47;quart) from birth to 12 months of age.3 Therefore, doctors generally recommend an iron-fortified formula during the first year of life. Enfamil® formulas have 12.2 mg iron/liter. Mead Johnson Nutrition discontinued Enfamil LIPIL Low Iron (4.7 mg iron/liter) in 2007.
1. Oski FA. Iron-fortified formulas and gastrointestinal symptoms in infants: A controlled study. Pediatrics. 1980;66:168-170.
2. Nelson SE, Ziegler EE, Copeland AM, Edwards BB, and Fomon SJ. Lack of adverse reactions to iron-fortified formula. Pediatrics. 1988;81:360-364.
3. American Academy of Pediatrics Committee on Nutrition. Iron fortification of infant formulas. Pediatrics. 1999;104:119-123.
Ready-to-use and concentrated liquid formulas appear darker and thicker than formula prepared from powder. This may be due to the heat sterilization process the liquids undergo and the emulsifier ingredients in our liquid formulas. When powder or liquids are prepared according to directions, they are nutritionally equivalent. We would expect a baby to accept and tolerate all forms equally. However, each baby is different and must be individually evaluated.
The processing of our liquid formulas results in a commercially sterile product. This means the formula is free of illness-causing or spoilage-causing organisms. As long as the seal on the container is intact, the formula is commercially sterile. Powdered infant formulas are not sterile, and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by the baby's doctor.
In 2002, the US Centers for Disease Control (CDC) stated that powdered infant formulas are not recommended for use by infants in neonatal intensive care settings unless no alternative is available.1 Mead Johnson & Company supports this recommendation. According to the American Academy of Pediatrics, the warning does not apply to healthy full-term infants at home.2
Powdered Formula Quality
Our infant formulas are manufactured under strict adherence to regulatory Good Manufacturing Practices and are routinely inspected by the Food and Drug Administration. The processing of powdered and liquid infant formulas differs, however. Liquid formulas are subjected to and can withstand high temperatures for sufficient time to make them commercially sterile. Powdered formulas are heat-treated during processing but cannot be made commercially sterile. Therefore, powdered infant formulas, like tap water and many foods commonly consumed, may contain low levels of bacteria. Even bacteria that are generally nonpathogenic can cause disease in patients with weakened immune systems. For this reason, powdered formulas are not recommended for feeding to infants in neonatal intensive care settings or to hospitalized premature or immunocompromised infants unless no alternative is available or unless directed and supervised by a doctor.
The microbiological purity of powdered formulas manufactured by Mead Johnson & Company is high, and the quality of each batch is assured with validated testing methods. Testing is conducted for total aerobic plate count, coliform organisms, fecal coliforms, Enterobacteriaceae, yeasts, molds, Staphylococcus aureus, Enterobacter sakazakii, and Salmonella species. Our microbiological quality specifications are consistent with those established by the World Health Organization and the Codex Alimentarius Commission. We only release formula that meets our stringent criteria. This helps assure that powdered formulas are appropriate for feeding healthy full-term infants.
Powdered Formula Preparation and Storage at Home
Mead Johnson includes detailed mixing and storage instructions for home use on powdered infant formula package labels. Following the specific label instructions helps further assure that infants receive feedings of high microbiological quality.
Hospital Formula Preparation
For hospital and institutional formula preparation, the American Dietetic Association (ADA) published Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities.3 This book can be ordered from the Academy of Nutrition and Dietetics at www.eatright.org. It provides specific guidelines for the preparation, storage, and bedside handling of infant formula in healthcare facilities. The guidelines recommend that staff trained in aseptic techniques prepare formulas in a specifically designated room that is appropriately maintained and has a clean air supply.
1. Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula - Tennessee, 2001. Morbidity and Mortality Weekly Report. April 12, 2002;51(14):298-300.
2. American Academy of Pediatrics. CDC, FDA advise against powdered formula in NICUs. AAP News. 2002;20(May):219.
3. Pediatric Nutrition Practice Group, American Dietetic Association. Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. Robbins ST and Meyer R, eds. Chicago, IL: American Dietetic Association; 2011.
Studies show that most soy-allergic individuals may safely eat soybean oil (not cold pressed, expeller pressed, or extruded oil). Patients should ask their doctors whether or not to avoid this ingredient.
Food allergies are associated with the protein component of foods. We are aware of only two notable exceptions described to date.1,2 Corn protein is a significant component of less refined corn products such as corn meal, corn flour, and grits. Such products have often been associated with food protein allergy. Unfortunately, this association has sometimes been erroneously extended to corn syrup solids as well.
Corn syrup solids and corn starch, as used in Mead Johnson infant formulas, are carbohydrate ingredients produced with filtration and purification processes that remove all but the most minute traces of residual corn protein, the potentially allergenic component of corn. Ultra-sensitive laboratory methods are required to detect the residual corn protein.3
The presence of minute amounts of protein from corn does not necessarily mean that people with corn allergies will react to a product containing corn syrup solids. A previous study identifying these trace amounts of protein clearly indicated that they were not involved in any allergic reactions.4 And even though corn allergy is quite rare, Mead Johnson scientists studied the corn-derived products used in Nutramigen® and Nutramigen® with EnfloraTM LGG® infant formulas* using the FDA Bureau of Biologics method of RAST-inhibition analysis.5 This test used serum from corn allergic persons; it detected no allergens in corn syrup solids similar to those used in our formulas.
* Studied before the addition of ARA, DHA, and LGG.
1. Nagpai S, Metacalfe DD, and Roa PVS. Identification of a shrimp-derived allergen as RNA. J Immunol. 1987;138:4169-4174.
2. Fötisch K, Altmann F, Haustein D, Vieths S. Involvement of carbohydrate epitopes in the IgE response of celery-allergy patients. Int Arch Allergy Immunol. 1999;120:30-42.
3. Frisner H, Rosendal A, Barkholt V. Identification of immunogenicmaize proteins in a casein hydrolysate formula. Pediatr Allergy Immunol. 2000;11:106-110.
4. Hoffman KM, Sampson HA. Serum specific IgE antibodies to peptides detected in a casein hydrolysate formula. Pediatr Allergy Immunol. 1997;8:185-189.
5. Richardson GG, Leary HL, and Halsey, JF. Allergenicity of Corn-Derived Carbohydrate Ingredients for Use in Infant Formulas. Abstract. "Adverse Reactions to Foods and Chemicals." 5th International Food Allergy Symposium. American College of Allergists. October 15-18, 1984. Atlanta, GA.
According to Montgomery et al,1 lactose does not appear to induce lactase in humans. Lactase activity can be detected in the brush border of the fetal small intestine as early as the 10th to 12th week and reaches the level of the full term infant by about 36 weeks' gestation.2
A review article3 concluded that all evidence suggests that the level of lactase activity is genetically determined and that no regulation is exerted by lactose. These publications support a conclusion that infants will produce lactase even though they are not fed lactose-containing formulas.
1. Montgomery RK, et al. Lactose intolerance and regulation of small intestinal lactase activity. In: Berdanier CD and Hargrove JL, eds. Nutrition and Gene Expression. Boca Raton, FL: CRC Press;1993:23-53.
2. Parimi P, Kalhan S. Carbohydrates including oligosaccharides and inositol. In: Tsang RC, Uauy RD, Koletzko B, Zlotkin SH, eds. Nutrition of the Preterm Infant: Scientific Basis and Practical Guidelines. 2nd ed. Cincinnati, Ohio: Digital Educational Publishing Inc; 2005;84.
3. Rings EHHM, et al. Lactase; origin, gene expression, localization, and function. Nutr Res. 1994;14(5):775-797.