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Which is better, breastfeeding or formula-feeding? What is in an infant formula, and how do I choose the right one? Can I make my own infant formula? So, what types of formula should parents give to their babies? Find a local Pediatrician in your town What are the main types of infant formula? What infant formula preparations are available? What is an Infant Formula? How do parents know what formula to feed to their infant? Do infants fed infant formulas need to take additional vitamins and minerals? Do "house brand" or generic infant formulas differ nutritionally from name brand formulas? What does the "use by" date mean on infant formula product labels? What are counterfeit infant formulas? How can I avoid buying such products? I have seen bottled water marked for use in preparing infant formula. What does this mean? Are there approved recipes for homemade infant formulas? How do I report a problem or illness caused by an infant formula? Which is better, breastfeeding or formula-feeding? Human milk is the preferred feeding for all infants. This includes premature and sick newborns, with rare exceptions. Pediatricians generally advise that full-term, healthy infants exclusively breastfeed when possible for the first 12 months of life and, thereafter, for as long as mutually desired. Advantages of breastfeeding include: (1) breast milk is nutritionally sound and easy to digest; (2) breastfeeding is believed to enhance a close mother-child relationship; and (3) breast milk contains infection-fighting antibodies (immunoglobulins) that may reduce the frequency of diarrhea, gastroenteritis, otitis media (ear infections), and other respiratory infections in the infant. Please see the Breast Feeding article for more information. Some parents choose formula-feeding either because of personal preference or because medical conditions of either the mother or the infant make breastfeeding ill-advised. Parents need not feel guilty for choosing formula-feeding. Infant formulas are a time-tested, perfectly acceptable alternative to breastfeeding. Even though formula-fed babies do not receive infection-fighting antibodies from the breast milk, they still will have received a four- to six-month supply of these antibodies through the maternal bloodstream prior to delivery. Remember also that the majority of breastfeeding infants end up on a combination of breast- and formula-feedings before their first birthday. Some common reasons for choosing formula-feeding include: * There is an inadequate supply of maternal breast milk. * The baby is sucking inefficiently. * Parents are unable to quantify the amount of breast milk received by the baby. Some parents want to know exactly how much their baby is receiving at each feeding, and formula/bottle-feeding allows exact measurement. * A significant reason for not breastfeeding is concern about transferring certain drugs the mother is taking due to a medical problem through the breast milk to the infant. Examples of medications that are considered unsafe for the baby include cimetidine (Tagamet), cyclophosphamide (Cytoxan), lithium (Lithobid), gold salts, methotrexate (Rheumatrex, Trexall), metronidazole (Flagyl), cyclosporine, and bromocriptine (Parlodel). Numerous other medications have not yet been adequately studied in the context of breastfeeding and the possible effects on the baby. Mothers may choose bottle-feeding rather than risk any potential effect on the baby. * An increasing number of mothers must return to work shortly after their baby's delivery. Formula-feeding offers a practical alternative for mothers who may not be able to breastfeed due to work schedules. Formula-fed babies often need to eat less frequently than do breastfed babies because breast milk moves through the digestive system more quickly. Thus, breastfed babies may become hungry more frequently. * A benefit of bottle-feeding is that the entire family can immediately become intimately involved in all aspects of the baby's care, including feedings. The mother can therefore get more rest, which can be critically important, especially if the pregnancy and/or delivery were especially difficult. What is in an infant formula, and how do I choose the right one? o Breastfeeding and Formula Feeding + It's important to know whether you will breastfeed or bottle-feed your baby prior to delivery, as the breasts' ability to produce milk diminishes soon after childbirth without the stimulation of breastfeeding. Breast milk is easily digested by babies and contains infection-fighting antibodies and cholesterol, which promotes brain growth. Formula-fed babies actually need to eat somewhat less often since formula is less readily digested by the baby than human milk. This article explores the advantages and disadvantages of both forms of feeding. More o Iron Deficiency + Iron is a mineral our bodies need. Iron deficiency is a condition resulting from not enough iron in the body. It is the most common nutritional deficiency and the leading cause in the US. Iron deficiency is caused due to increased iron deficiency from diseases, nutritional deficiency, or blood loss and the body's inability to intake or absorb iron. Children, teen girls, pregnant women, and babies are at most risk for developing iron deficiency. Symptoms of iron deficiency include feeling weak and tired, decreased work or school performance, slow social development, difficulty maintaining body temperature, decreased immune function, and an inflamed tongue. Blood tests can confirm an iron deficiency in an individual. Treatment depends on the cause of the deficiency. Proper diet that includes recommended daily allowances of iron may prevent some cases of iron deficiency. Parenting and Newborn Resources * What You Should Never Put in a Baby's Bottle Infant Formulas * Iron deficiency is the most common nutritional deficiency and the leading cause of anemia in the United States. * Iron deficiency is due either to increased need for iron by the body or a decreased absorption or amount of iron taken in. * Signs of iron deficiency include fatigue, decreased work and school performance, slow cognitive and social development during childhood, difficulty maintaining body temperature, decreased immune function, and glossitis (an inflamed tongue). * Blood tests establish the diagnosis of iron deficiency. * Dietary changes or iron supplements are possible treatments for iron deficiency. What is iron and why do we need it? Iron is a mineral needed by our bodies. Iron is a part of all cells and does many things in our bodie... What is in an infant formula, and how do I choose the right one? This information can help "demystify" the myriad of choices available to a parent when considering options at the pharmacy or grocery store. A small percentage of newborn infants will require a specialized formula (for example, premature infants, infants with metabolic diseases, or infants with intestinal malformations). These children's unique dietary requirements should be an item of individual discussion between the parents and the infant's pediatrician and will not be addressed here. In order to achieve appropriate growth and maintain good health, infant formulas must include proper amounts of water, carbohydrate, protein, fat, vitamins, and minerals. Each of these components is discussed below. The three major classes of infant formulas are 1. milk-based formulas, which are prepared from cow milk with added vegetable oils, vitamins, minerals, and iron. These formulas are suitable for most healthy full-term infants and should be the feeding of choice when breastfeeding is not used, or is stopped before 1 year of age. 2. soy-based formulas, which are made from soy protein with added vegetable oils (for fat calories) and corn syrup and/or sucrose (for carbohydrate). These formulas are suitable for infants who cannot tolerate the lactose (lactose intolerant, see below) in most milk-based formulas or who are allergic to the whole protein in cow milk and milk-based formulas. The American Academy of Pediatrics recommends the use of soy formulas for the above infants as well as for infants of parents seeking a vegetarian-based diet for a term infant. These formulas are not recommended for low-birth-weight or preterm infants or for the prevention of colic or allergies. 3. special formulas for low-birth-weight (LBW) infants, low-sodium formulas for infants that need to restrict salt intake, and "predigested" protein formulas for infants who cannot tolerate or are allergic to the whole proteins (casein and whey) in cow milk and milk-based formulas Water Water is an important part of a baby's diet because water makes up a large proportion of the baby's body. When properly prepared, all infant formulas are approximately 85% water. Infant formulas are available in three forms: liquid ready-to-use, liquid concentrate, and powder concentrate. Liquid ready-to-use formulas do not require the addition of water, while the liquid and powder concentrates require the addition of water. It is of prime importance for parents to read, understand, and follow the manufacturer's directions when adding water to liquid and powder concentrates. Adding too much water to these concentrates or adding water to ready-to-use formulas can lead to water intoxication in the baby. In severe cases, water intoxication can cause low blood sodium levels, irritability, coma, and even permanent brain damage. Conversely, failing to adequately dilute the concentrates with water causes the formulas to be too concentrated, or "hypertonic." Hypertonic formulas can induce diarrhea and dehydration. In extreme cases, ingestion of overly hypertonic formulas can lead to kidney failure, gangrene of the legs, and coma. Therefore, parents should not adjust the amount of water that is added to concentrates to either "fatten the baby up" or "put the baby on a diet." Instead, parents should discuss their concerns regarding the baby's calorie intake with his/her pediatrician. Carbohydrates Carbohydrates (glucose, lactose, sucrose, galactose, etc.) are sugars or several sugars linked together. Carbohydrates provide energy (calories) for the brain tissues, muscles, and other organs. Lactose is a carbohydrate consisting of glucose linked to galactose. Lactose is the major carbohydrate in human breast milk, cow milk, and in most milk-based infant formulas. While most infants will thrive on a formula that contains lactose, some infants are lactose intolerant. Lactose intolerance is due to a lactase enzyme deficiency (low levels of enzyme activity) in the small intestine. Lactase enzymes are necessary for "digesting" lactose by breaking the link between glucose and galactose. The intestines can then absorb the smaller glucose and galactose molecules. In infants who are lactase deficient, the undigested lactose cannot be absorbed. This, in turn, can cause diarrhea, cramps, bloating, vomiting, and gas. Lactase deficiency is more common in premature infants than in full-term babies. Lactase deficiency can also develop temporarily during recovery from viral gastroenteritis (commonly referred to as the "stomach flu"). Finally, lactase deficiency can be inherited (rarely). For infants with lactose intolerance, formulas that contain no lactose can be used. Lactofree is an example of a milk-based formula that contains corn-syrup solids rather than lactose as its carbohydrate calorie source. Many soy-protein formulas also do not contain lactose and are suitable for lactose intolerant infants. In addition to corn-syrup solids, other examples of carbohydrates contained in lactose-free formulas include sucrose (table sugar), tapioca starch, modified cornstarch, and glucose polymers (short chains of glucose molecules). Proteins Proteins contain different amino acids that are linked together. Proteins provide both calories and the amino-acid building blocks that are necessary for proper growth. The protein in human milk provides between 10%-15% of an infant's daily caloric need. Casein and whey are the two major proteins of human milk and most milk-based formulas. (Immunoglobulins, a type of protein unique to breast milk, provide infection-fighting immunity and are not considered as a nutritional source and are not efficiently metabolized.) While formulas from different manufacturers may vary slightly in the relative proportion of these two proteins, healthy babies generally thrive on any milk-based formula brand. Some 0.5%-7.5% of infants have a true allergy to the cow proteins that are in milk-based formulas. Infants with true cow milk allergy can develop abdominal pain, diarrhea, rectal bleeding, skin rash, and wheezing when given milk-based formulas. These symptoms will disappear as soon milk-based formula is removed from the diet. Allergy to cow-milk protein is different from lactose intolerance. Treatment of cow-milk-protein allergy involves using formulas that contain no cow milk or using formulas that contain "predigested" casein and whey proteins. The predigesting process breaks the whole proteins into smaller pieces or into amino acids. The amino acids and smaller protein pieces are hypoallergenic (do not cause allergy). Soy-protein formulas contain no cow milk and are reasonable alternatives for infants with true cow-milk allergy. Since most soy-protein formulas also contain no lactose, they are also suitable for infants with lactose intolerance. The carbohydrates in soy-protein formulas are sucrose, corn-syrup solids, and cornstarch or glucose polymers. Certain infants have allergy to both cow-milk proteins and soy proteins. These infants require a formula in which the cow-milk protein (casein) has been "predigested" and specific amino acids added to provide a formula that can provide proper nutrition. The decision to utilize one of these specialized formulas should be made in consultation with the infant's pediatrician. Fat Fat in human milk and formula provides a significant percentage of the total daily caloric needs for a growing infant. Formula manufacturers utilize many different vegetable oils for fat, including corn, soy, safflower, and coconut oils. Some formulas contain "predigested" fats known as medium chain triglycerides (MCT). These are analogous to the "predigested proteins" discussed above. Because of their unique application, formulas containing MCT are not routinely recommended for healthy infants and children. There is a significant amount of research into determining the ideal concentration and ratios of fatty acids such as arachidonic acid (ARA) and docosahexanoic acid (DHA) for infant nutrition. Some studies have suggested that these may have a positive effect on short-term cognitive function. More research is needed to clarify this issue, and you should discuss this with your infant's pediatrician before supplementing. Vitamins Vitamins are organic substances that are essential in minute quantities for the proper growth, maintenance, and functioning of the baby. Vitamins must be obtained from food because the body cannot produce them. The exception is vitamin D, which can be produced by the skin when it is exposed to the sun. There are four fat-soluble vitamins (A, D, E, and K) and several water-soluble vitamins. These include the B vitamins, B1 (thiamine), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), and B12 (cobalamin), as well as folate and vitamin C and pantothenic acid, and biotin. These vitamins have been added to infant formulas to ensure proper nutrition. Unless otherwise directed by their pediatricians, routine vitamin supplementation is not necessary for healthy full-term infants taking formulas. High doses of certain vitamins can have adverse effects. For example, high doses of vitamin A can cause headaches, vomiting, liver damage, brain swelling, and bone abnormalities. High doses of vitamin D can lead to high levels of calcium in the blood and kidney and heart damage. Therefore, high doses of vitamins should not be given to infants and young children without supervision by their pediatricians. Minerals Minerals (calcium, phosphorus, magnesium, iron, iodine, copper, and zinc) and trace elements (manganese, chromium, selenium, and molybdenum) are included in most formulas. Therefore, there is no evidence that mineral supplementation is necessary for healthy formula-fed, full-term infants. Several years ago, it was recommended that infants from birth to 4 months of age receive a lower quantity of iron compared with those from 4 to 12 months of age. As such, several milk-based formulas such as Similac (Abbot Nutrition—formerly Ross) and Enfamil (Mead Johnson Pharmaceuticals) were marketed under two varieties—"low iron" and "high iron." Multiple studies on iron requirements for all infants have since been performed, and in 1999, the American Academy of Pediatrics (AAP) recommended against the use of any "low iron" formula for infants, due to the fact that these formulas are nutritionally deficient. Pediatricians currently recommend that all children receive the standard iron content found in most formulas. Both the FDA and the AAP have encouraged the infant-formula makers to discontinue production of "low iron" products, without success. This is due to the fact that many parents still purchase these because of a belief that iron in formula causes gastrointestinal side effects, including increased gas and constipation. Many studies have conclusively shown this not to be the case. * Which is better, breastfeeding or formula-feeding? * What is in an infant formula, and how do I choose the right one? * Can I make my own infant formula? * So, what types of formula should parents give to their babies? * Infant Formulas Glossary * Infant Formulas Index * Find a local Pediatrician in your town Can I make my own infant formula? The FDA and AAP recommend against homemade infant formulas. This is due to the fact that these formulas do not meet all of an infant's nutritional needs. In addition, cow-milk protein that has not been cooked or processed appropriately is difficult for an infant to digest and may damage an infant's immature kidneys. Today's infant formula is a very controlled, state-of-the-art product that cannot be duplicated at home. So, what types of formula should parents give to their babies? * Most infants and children will thrive on a cow-milk-based, lactose-containing formula such as Similac (Abbott Nutrition), Enfamil (Mead Johnson Pharmaceuticals), or Good Start (Nestle). * Some infants may be lactose intolerant (not allergic) and will better tolerate a lactose-free milk-based formula such as Enfamil Lactofree (Mead Johnson Pharmaceuticals) or Similac Lactose-Free (Abbott Nutrition). For children who are recovering from infectious diarrhea and gastroenteritis, the short-term use of lactose-free formulas may help decrease cramps and diarrhea. This should only be a temporary change, and reintroduction to standard formulas is recommended. * Some parents of lactose-intolerant infants may prefer to use soy-protein-based formulas such as Isomil (Abbott Nutrition), Prosobee (Mead Johnson Pharmaceuticals), and Allsoy (Nestle). Infants who are allergic to cow-milk protein can also use soy-based formulas. * For infants who are allergic to cow-milk protein and soy protein (approximately 35% of infants allergic to cow-milk protein are also allergic to soy proteins), the "predigested" protein formulas including Pregestimil (Mead Johnson), Nutramigen (Mead Johnson), and Alimentum (Abbott Nutrition) can be used. * Unique medical conditions may require a specific formula recommendation by the pediatrician. This applies to children with some common genetic deficiencies such as PKU, and for premature and low-birth-weight infants. * Generic infant formulas are also available and are often made by the same manufacturers that produce the brand name products. Whether you are considering brand name or generic products, check the expiration dates on the packages, and compare ingredient lists to be sure you are purchasing products with the same ingredients. * Homemade infant __________. * Equipment you'll need * How to sterilise equipment * Making up the formula * General safety tips * Giving the bottle * Getting the formula to flow * How much formula? Equipment you’ll need * 4-6 large bottles, rings, caps and several teats. Teats are either made from latex (brown) or silicone (clear) and either is fine. Choose any bottle or teat you like, as none is better than another. Teats are graded according to the age of the baby, but this is not based on anything scientific. Try teats with bigger or smaller holes until you find the one that you and your baby are happy with. * A bottle brush to clean the bottles and teats. * Sterilising equipment. Until your baby is six months old, her immune system isn’t strong enough to fight off some infections, so disinfecting her bottle equipment will reduce the chance of her getting sick. If you have trouble getting clean water or access to a refrigerator, keep sterilising even when your baby is older than six months. How to sterilise equipment When you’ve finished feeding, dismantle bottles, teats and rings and rinse everything in cold water straight away. Then before you sterilise for the next feed, wash it all in hot, soapy water and rinse thoroughly. Squirt water through the teat to clear the little hole. There are several ways you can sterilise your bottle equipment. Boiling * Put all the utensils in a large pot. * Fill the pot with water until the utensils are covered. * Put the pot on the stove, bring it to the boil and boil for five minutes. * Store equipment you are not going to use straight away in a clean container in the fridge. * Boil cleaning implements such as bottle brushes every 24 hours. Safety when boiling water If you have older children, you might want to use this method when they’re asleep or out of the house to reduce the risk of scalding them. To avoid scalding yourself, let the equipment cool in the pot until you can touch it. Using chemicals * You can also sterilise your bottles with an antibacterial solution that comes in liquid or tablet form. This is a type of bleach that is diluted with water so it’s safe for your baby but strong enough to kill bacteria. * Follow the manufacturer's instructions carefully when you make up the solution to make sure it’s the right strength. * Wash with warm soapy water and rinse thoroughly. Then completely submerge everything and leave it all in the solution for the recommended time before using. Equipment may be left in the solution for 24 hours when not in use. Safety when using chemicals * Store the concentrate and solution well out of the reach of children. * You can only keep the solution for 24 hours once it’s made up, so after this time throw it away, thoroughly scrub the container and equipment in warm soapy water and make up some new solution. * If you use chemical sterilisers you need plastic or glass equipment (that includes the container you use to mix the solution), rather than metal which will eventually be eaten away by the solution. Steam sterilisers Steam sterilisers are automatic units that ‘cook’ your equipment at a temperature high enough to kill bacteria. Put your clean equipment into the unit, add water according to the manufacturer's instructions and switch on. The unit switches itself off when the job is done. Microwave steam sterilisers These are like steam sterilisers, but you put them in the microwave oven. Making up the formula First, boil some water. Start with water fresh from the tap (not water that has been sitting around in a jug or kettle; it’s more likely to have dirt or insects in it) and bring it to the boil either in an electric jug or on the stove top. You don’t need to keep the water boiling any longer than 30 seconds. Let the water cool down to room temperature before you add the powder or liquid. To prepare the bottle 1. Pour the amount of cooled, boiled water you need into the bottle. 2. Using the scoop from the formula tin, measure the required number of scoops into the bottle. Level off each scoop (you can do this with a knife or other implement). 3. Seal the bottle with a cap and disc. Swirl first so powder doesn’t block the teat, and then shake the bottle gently to mix it. 4. If you are not using the formula right away, store it in the back of the fridge where it is coldest, not in the door where it is warmer. Doctors recommend that you only make up formula when you want to use it rather than making it up ahead of time. 5. Throw out any mixed, refrigerated formula you haven’t used after 24 hours. General safety tips * Wash your hands and work surfaces before preparing formula. * Put formula into the fridge as soon as it is made if you’re not using it right away. * Storing half-empty bottles for future use is risky as they quickly become contaminated once they have been sucked on. Throw away the contents of used but unfinished bottles after about an hour. * Check the expiry date on tins of formula and discard them if they are out of date. Discard any opened tin of formula after one month. * The safest way to transport formula is to take the cooled, boiled water and the powdered formula in separate containers and mix them when needed. * If you need to transport prepared formula or expressed breastmilk it must be icy cold when you leave the house. Carrying it in a thermal baby bottle pack will keep it cold. * It can be bad for your baby to 'prop' a bottle and walk away leaving baby to manage on her own. The milk may flow too quickly and she may breathe it into her lungs – that could cause a lung infection or (much less likely) drowning. Babies who feed a lot on their own are at greater risk of ear infections (milk can flow through to her ear cavity, which can cause ear infections). Holding, cuddling and talking to your baby while she’s feeding will help her develop and grow. To find out more about this, see Connecting and communicating. Giving the bottle * Giving babies cold formula is not harmful but babies seem to prefer formula warmed to room temperature. If she doesn’t mind cold formula, feel free to serve it cold. * Standing the bottle in warm to hot water is the safest way of warming the milk. Bottle warmers are convenient and safe as long as they have a thermostat control. (Leaving the bottle in the warmer more than 10 minutes may cause bacteria to breed in the formula. These bacteria are a common cause of diarrhoea.) * Microwaves aren't the safest way to warm milk, as they don’t warm milk evenly, and ‘hot spots’ in the formula may burn your baby’s mouth. Closed bottles can also explode in the microwave. * Check the temperature of the feed by shaking a little milk from the teat onto the inside of your wrist. * Make yourself comfortable, cuddle your baby close to you, holding her gently but firmly. It’s better for her to be on a slight incline so any air bubbles rise to the top, making burping easier. * Put the teat against her lips. She will open her mouth and start to suck. Keep the neck of the bottle at an angle so it is filled with the milk mixture. When she stops sucking strongly or when she has drunk about half the milk, gently remove the bottle and see if she wants to burp. * If she goes to sleep unwrap her, put her over your shoulder, rub her back and stroke her head, legs and tummy to wake her up. A nappy change is a good way to wake her up if that doesn’t work. Wait until she is properly awake before offering her the rest of the milk. Getting the formula to flow * To test the flow, hold the bottle upside down when it is filled with the milk mixture at room temperature – the milk should drip steadily but not pour out. * If you have to shake it vigorously it is too slow and your baby might go to sleep before she drinks what she needs. * A little leakage at the corners of her mouth while she feeds is nothing to worry about – as she gets older this will stop. * If you have trouble finding the perfect teat, go for a faster teat rather than a slow one. How much formula? All babies drink variable amounts and may have some feeds close together and others further apart. There is no set amount of food or number of feeds a baby should have. The following is only a guide – you can also use the chart on the formula tin: * Commonly, babies have 6-7 feeds every 24 hours – researchers recommend you feed your baby whenever she is hungry. Information about the quantity for age on formula tins is a guide only and may not necessarily suit your baby. Some babies never drink the 'required amount' for their age and size, and others need more. Plenty of wet nappies, consistent weight gains that are not excessive and a thriving, active baby mean all is well. What are the main types of infant formula? * Cow's milk formulas. Most infant formula is made with cow's milk that's been altered to resemble breast milk. This gives the formula the right balance of nutrients — and makes the formula easier to digest. Most babies do well on cow's milk formula. Some babies, however — such as those allergic to the proteins in cow's milk — need other types of infant formula. * Soy-based formulas. Soy-based formulas can be useful if you want to exclude animal proteins from your child's diet. Soy-based infant formulas may also be an option for babies who are intolerant or allergic to cow's milk formula or to lactose, a sugar naturally found in cow's milk. However, babies who are allergic to cow's milk may also be allergic to soy milk. * Protein hydrolysate formulas. These are meant for babies who have a milk or soy allergy. Protein hydrolysate formulas are easier to digest and less likely to cause allergic reactions than are other types of formula. They're also called hypoallergenic formulas. In addition, specialized formulas are available for premature infants and babies who have specific medical conditions. Why use formula instead of regular milk? What infant formula preparations are available? Infant formulas come in three forms. The best choice depends on your budget and desire for convenience: * Powdered formula. Powdered formula is the least expensive. Each scoop of powdered formula must be mixed with water. * Concentrated liquid formula. This type of formula also must be mixed with water. * Ready-to-use formula. Ready-to-use formula is the most convenient type of infant formula. It doesn't need to be mixed with water. It's also the most expensive option. What is an Infant Formula? Infant formulas are liquids or reconstituted powders fed to infants and young children. They serve as substitutes for human milk. Infant formulas have a special role to play in the diets of infants because they are often the only source of nutrients for infants. For this reason, the composition of commercial formulas is carefully controlled and FDA requires that these products meet very strict standards. How does FDA regulate Infant Formulas? The safety and nutritional quality of infant formulas are ensured by requiring that manufacturers follow specific procedures in manufacturing infant formulas. In fact, there is a law -- known as the Infant Formula Act -- which gives FDA special authority to create and enforce standards for commercial infant formulas. Manufacturers must analyze each batch of formula to check nutrient levels and make safety checks. They must then test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas must also have codes on their containers to identify each batch and manufacturers must keep very detailed records of production and analysis. Does FDA have nutrient specifications for infant formulas? FDA regulations list specifications for minimum amounts of 29 nutrients and maximum amounts for 9 of those nutrients. All formulas marketed in the United States must meet these nutrient requirements. As more information becomes available about infants' nutrient needs, FDA's nutrient specifications for infant formulas may be modified to incorporate that information. Does FDA approve infant formulas before they are marketed? The law does not require that FDA approve infant formulas but instead requires companies to provide certain information to FDA before they market new infant formulas. Manufacturers must provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. If such assurances are not provided, FDA will object to the manufacturer's marketing of the formula; however, the manufacturer may market the new infant formula over FDA's objection. How do parents know what formula to feed to their infant? A wide selection of different types of infant formulas is available on the market. Parents should ask their infant's health care provider if they have questions about selecting a formula for their infant. Do infants fed infant formulas need to take additional vitamins and minerals? Infants fed infant formulas do not need additional nutrients unless a low-iron formula is fed. If infants are fed a low-iron formula, a health care professional may recommend a supplemental source of iron, particularly after 4 months of age. FDA's nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, manufacturers set nutrient levels for their label claims that are generally above the FDA minimum specifications and they add nutrients at levels that will ensure that their formulas meet their label claims over the entire shelf-life of the product. Do "house brand" or generic infant formulas differ nutritionally from name brand formulas? All infant formulas marketed in the United States must meet the nutrient specifications listed in FDA regulations. Infant formula manufacturers may have their own proprietary formulations but they must contain at least the minimum levels of all nutrients specified in FDA regulations without going over the maximum levels, when maximum levels are specified. Some ingredient statements on infant formula labels include ingredients in addition to nutrients and familiar components such as milk. Why are those ingredients added? Ready-to-feed and concentrated liquid formulas often contain ingredients such as lecithin, carrageenan, and mono- and diglycerides added to ensure that the formula doesn't separate during shelf-life. What does the "use by" date mean on infant formula product labels? The "use by" date on infant formulas is a date, selected by the manufacturer based on tests and other information, to inform retailers and consumers about the quality of the infant formula. Until that declared date, the infant formula will contain no less than the amount of each nutrient declared on the product label and will otherwise be of acceptable quality. The "use by" date is required by FDA regulations on each container of infant formula. What are counterfeit infant formulas? How can I avoid buying such products? Counterfeit infant formulas are infant formula products that have been diverted from normal distribution channels and relabeled. Diverted products may be relabeled with counterfeit labels to misrepresent the quality or identity of a formula. For example, if an infant formula is past the "use by" date, a counterfeit label may bear a false "use by" date to obscure the fact that the product may no longer contain the amounts of nutrients listed on the label and may otherwise not be of acceptable quality. As a second example, an infant formula may be relabeled to disguise the true content of the product. Infants who are intolerant to certain ingredients and are fed such a counterfeit formula could experience serious adverse health consequences. To protect infants, parents or other caregivers should always look for any changes in formula color, smell, or taste. Parents should make sure the lot numbers and "use by" dates on the containers and boxes are the same (if buying by the case), check containers for damage, and call the manufacturer's toll-free number with any concerns or questions. I have seen bottled water marked for use in preparing infant formula. What does this mean? Are there approved recipes for homemade infant formulas? How do I report a problem or illness caused by an infant formula? |