Food provides the energy and nutrients that babies need to be healthy. For a baby, breast milk is best. It has all the necessary vitamins and minerals. Infant formulas are available for babies whose mothers are not able to or decide not to breastfeed.

Infants are usually ready to eat solid foods at about 6 months of age. Check with your health care provider for the best time for your baby to start. If you introduce one new food at a time, you will be able to identify any foods that cause allergies in your baby. Allergic reactions include a a rash, diarrhea, or vomiting.

Many parents are concerned about peanut allergies. When babies can eat foods that contain peanuts depends on their risk of food allergies:

• Most babies can have peanut products when they are about 6 months of age
• Babies who have mild to moderate eczema have a higher risk of food allergies. They usually can eat peanut products at about 6 months of age. If you have concerns about this, check with your baby's health care provider.
• Babies who have severe eczema or egg allergies are at high risk for peanut allergies. If your baby is at high risk, check with your baby's health care provider. Your baby may need allergy testing. Your baby's provider can also recommend when and how to give your baby peanut products.

There are some foods that you should avoid feeding your baby:

• Do not give your baby honey before 1 year of age. Honey may contain bacteria that can cause botulism in babies.
• Avoid cow's milk before age 1, since it does not have all of the nutrients that babies need and babies cannot digest it
• Unpasteurized drinks or foods (such as juices, milks, yogurt, or cheeses) may put your child at risk for an E. coli infection. E coli is a harmful bacteria that can cause severe diarrhea.
• Certain foods that can cause choking, such as hard candy, popcorn, whole nuts, and grapes (unless they are cut into small pieces). Don't give your child these foods before age 3.
• Because it contains a lot of sugar, babies should not drink juice before age 1

No brand of infant formula is best for all babies. You should pick an infant formula that is made especially for babies. The US Food and Drug Administration (FDA) regulates commercial infant formulas to make sure they meet minimum nutritional and safety requirements. Iron-fortified infant formulas are recommended, and most commercial infant formulas sold in the United States contain iron. Commercial infant formulas come in liquid and powdered forms.

When choosing an infant formula:

• Make sure it is not expired.
• Make sure the container is sealed and in good condition. If there are any leaks, puffy ends, or rust spots, do not feed it to your baby.
• Make sure it is not labeled for toddlers.

Talk with your child’s doctor or nurse if you have questions about choosing an infant formula for your baby or if you are thinking of switching infant formula brand or type.

Homemade Infant Formula

FDA and the American Academy of Pediatrics warn against using recipes to make homemade infant formula. Using homemade infant formula can lead to serious health problems for your baby. Your baby’s nutritional needs are very specific, especially in the first year of life. Homemade infant formulas may contain too little or too much of certain components, such as vitamins and minerals (like iron).

Homemade infant formula may also have an increased risk of contamination, which could lead to your baby getting sick or developing an infection. Commercial powdered formulas are also not guaranteed to be sterile. However, FDA regularly inspects these products and the manufacturing facilities where they are made to help make sure these products are safe.

Imported Infant Formulas

There are some public claims that infant formulas sold in other countries and promoted as “natural” or “organic” are better for babies. However, there is no scientific evidence that these infant formulas are better for babies than commercial infant formulas sold in the United States. All infant formulas legally sold in the United States—whether made in the United States or imported from other countries—must be reviewed by FDA. The American Academy of Pediatrics warns against using illegally imported formulas, such as products ordered online from third-party distributors. FDA may not have not reviewed these products. Illegally imported formulas also may not have been shipped and stored properly.

FDA reviews all infant formulas sold legally in the United States to make sure they meet minimum nutritional and safety requirements. FDA also makes sure that the water used to make formulas meets safety standards set by the US Environmental Protection Agency.

Toddler Milks, Drinks, or Formulas

Toddler milks, drinks, or formulas are not needed to meet the nutritional needs of young children. They typically have added sugars. At age 12 months, your child can be introduced to plain whole cow’s milk or fortified unsweetened soy beverage.

Babies younger than age 12 months should be fed infant formulas specifically designed to meet their nutritional needs. They should not be fed toddler milks, drinks, or formulas labeled for toddlers.

Carefully read and follow the instructions on the infant formula container. These steps will help you know how to prepare and store your infant’s formula correctly. Preparing your infant’s formula according to the instructions is important.

Here are additional pointers to keep in mind when preparing and storing your infant’s formula.

Preparation

• Wash your hands well before preparing bottles or feeding your baby. Clean and sanitize the workspace where you will be preparing the infant formula.
• Bottles need to be clean and sanitized. To learn more about how to properly clean your baby’s bottles and other feeding supplies, visit the CDC webpage How to Clean, Sanitize, and Store Infant Feeding Items.
• Baby’s milk or infant formula does not need to be warmed before feeding, but some people like to warm their baby’s bottle.
  • If you do decide to warm the bottle, never use a microwave. Microwaves heat milk and food unevenly, resulting in “hot spots” that can burn your baby’s mouth and throat.
  • To warm a bottle: Place the bottle under running warm water, taking care to keep the water from getting into the bottle or on the nipple. Put a couple drops of infant formula on the back of your hand to see if it is too hot.
• If you use powdered infant formula:
  • Use water from a safe source to mix your infant formula. If you are not sure if your tap water is safe to use for preparing infant formula, contact your local health department.
  • Use the amount of water listed on the instructions of the infant formula container. Always measure the water first and then add the powder.
    • Too much water may not meet the nutritional needs of your baby.
    • Too little water may cause your baby’s kidneys and digestive system to work too hard and may cause your baby to become dehydrated.
  • If your baby is very young (younger than 2 months old), was born prematurely, or has a weakened immune system, you may want to take extra precautions in preparing your infant’s formula to protect against Cronobacter (see box).

Did You Know?

Cronobacter can be caused by germs in infant formula.

Cronobacter is a rare but serious infection that can be caused by germs in powdered infant formula. In most cases, it is safe to mix powdered infant formula following manufacturer’s instructions. But if your baby is very young (younger than 2 months old), was born prematurely, or has a weakened immune system, you may want to take extra precautions to protect against Cronobacter.

Use Quickly or Store Safely

• Prepared infant formula can spoil if it is left out at room temperature.
  • Use prepared infant formula within 2 hours of preparation and within one hour from when feeding begins.
  • If you do not start to use the prepared infant formula within 2 hours, immediately store the bottle in the fridge and use it within 24 hours.
• Throw out any infant formula that is left in the bottle after feeding your baby. The combination of infant formula and your baby’s saliva can cause bacteria to grow. Be sure to clean and sanitize the bottle before its next use.
• Store unopened infant formula containers in a cool, dry, indoor place—not in vehicles, garages, or outdoors.
• Once a container of infant formula is opened, store in a cool, dry place with the lid tightly closed. Do not store it in the refrigerator.
• Most infant formulas need to be used within 1 month of opening the container (check the label). When you first open the container, write the date on the lid to help you remember.
• Never use formula after the “Use By” date on the container.

Every baby is different. How much and how often your baby feeds will depend on your baby’s needs. Here are a few things to know about infant formula feeding during the first days, weeks, and months of your baby’s life.

If you have questions about your baby’s growth or how much infant formula he or she is taking, talk with your child’s doctor or nurse.

First Days

• Your newborn baby’s belly is tiny. He or she does not need a lot of infant formula with each feeding to be full.
• You can start by offering your baby 1 to 2 ounces of infant formula every 2 to 3 hours in the first days of life if your baby is only getting infant formula and no breast milk. Give your baby more if he or she is showing signs of hunger.
• Most infant formula-fed newborns will feed 8 to 12 times in 24 hours. Talk with your child’s doctor or nurse about how much infant formula is right for your baby.
• As your baby grows, his or her belly grows too. Your baby will be able to drink more infant formula at each feeding, and the time between feedings will get longer.

First Weeks and Months

• Over the first few weeks and months, the time between feedings will get longer—about every 3 to 4 hours for most infant formula-fed babies. This means you may need to wake your baby to feed. You can try patting, stroking, undressing, or changing the diaper to help wake your baby to feed.
• Some feeding sessions may be long, and other feedings short. That is okay. Babies will generally take what they need at each feeding and stop eating when they are full.

6 to 12 Months Old

• Continue feeding your baby when he or she shows signs of hunger. Most 6 to 12 month olds will need infant formula or solid foods about 5 to 6 times in 24 hours.
• As your baby gradually starts eating more solid foods, the amount of infant formula he or she needs each day will likely start to decrease.

12 to 24 Months Old

• When your toddler is 12 months old, you can switch from infant formula to fortified cow’s milk. You can do this gradually. You may want to start by replacing one infant formula feeding with fortified cow’s milk to help your child transition.

Babies need additional vitamin D.

Although infant formula has vitamin D, if your baby drinks less than 32 ounces of infant formula a day, he or she will need to get extra vitamin D (beginning at birth) from supplements.

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.

I see formulas on the market that contain ingredients called DHA and ARA. What are these substances?

DHA is docosahexaenoic acid and ARA is arachidonic acid. Both are long-chain polyunsaturated fatty acids. The body can make DHA and ARA from certain other dietary fatty acids, which are found in plant oils and other sources; however, DHA and ARA are also consumed directly in the diet.

What foods contain the fatty acids DHA (docosahexaenoic acid) and ARA (arachidonic acid)?

DHA is contained in varying amounts in fish oils, with oils from cold-water fish containing higher amounts. DHA and ARA are also found in some algae and fungi, eggs, and in human breast milk. Some manufacturers make dietary supplements containing DHA and ARA.

Why is there interest in adding DHA and ARA to infant formulas?

While infants can make these fatty acids from other ("essential") fatty acids in their diet, including the fatty acids in infant formulas, some studies suggest that some infants, such as premature infants, may benefit from direct consumption. Other studies suggest no benefit. It is known that long-chain polyunsaturated fatty acids (DHA in particular) accumulate in brain and eye of the fetus, especially during the last trimester of pregnancy. These fatty acids are also found in the fat of human breast milk. Blood levels of DHA and ARA are typically higher in breast-fed infants than in infants fed formulas not containing these fatty acids. For these reasons, some infant formula manufacturers and consumers are interested in providing DHA and ARA directly to infants. These manufacturers and consumers argue that adding oils containing these fatty acids to the fats and oils already in infant formula will provide an infant with both pre-formed DHA and ARA and the essential fatty acids an infant needs to make its own DHA and ARA.

What is the evidence that addition of DHA and ARA to infant formulas is beneficial?

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.

Soy formula is an infant food made using soy protein and other components. It is fed to infants as a supplement or replacement for human milk or cow milk formula.

Why are people concerned about soy infant formula?

The safety of soy infant formula has been debated because it typically contains a class of compounds called isoflavones. Isoflavones are naturally occurring compounds found primarily in beans and other legumes, including soybeans, peanuts, and chickpeas.

The primary isoflavones found in soy products, including tofu, soy milk and soy formula, are genistein, daidzein, and to a smaller extent, glycitein. These isoflavones are referred to as phytoestrogens because they are found in plants (phyto) and because of their ability to act like the hormone estrogen in the body.

Although there have been no specific health problems documented in human infants receiving soy formula, it is recognized that infants go through developmental stages that are sensitive to estrogens. Therefore, infants are more likely than adults to be vulnerable to the estrogen-like effects of the phytoestrogens in soy. In some cases, the health effects resulting from a soy-based diet may not be apparent until years later.

What are the potential health effects?

Animal studies indicate that health effects of possible concern include early onset of puberty in females and alterations in development of breast tissue.

When comparing infants that were fed soy formula versus infants that were fed cow-milk formula, NIEHS scientists and their collaborators found that soy formula girls displayed larger wombs and vaginal cell changes. The researchers suggest these tissues are sensitive to the estrogen-like compounds found in soy.

Other research by NIEHS scientists suggests that infant girls fed soy formula are more likely to develop severe menstrual pain as young adults.

Are infants affected differently than toddlers or adults who eat soy?

An infant’s diet is virtually 100% milk and/or formula. So for infants that are fed only soy formula, they have much higher soy exposure levels than do toddlers or adults who consume a variety of foods and less soy as a percentage of their diets.

Also, infants go through developmental stages that are sensitive to estrogens. Therefore, infants are more likely than adults to be vulnerable to the estrogen-like effects of the phytoestrogens in soy.

Are there alternatives to soy formula if infants cannot tolerate animal milk?

According to the American Academy of Pediatrics, the alternatives to soy formula are amino acid formulations. Amino acids are the building blocks of pure protein. These formulations contain amino acids and all the other ingredients added to current infant formulas to provide appropriate nutrition. Lactose-free cow milk formulas are also now available. The American Academy of Pediatrics (AAP) promotes the use of human milk as the ideal source of infant nutrition. The 2008 AAP revised clinical report states there are few indications for the use of soy protein-based formula in place of cow milk-based formula in infants. According to AAP, the only real indications for soy formula use are for infants with congenital galactosemia, for use by families who are strict vegans, or infants who are truly lactose intolerant.

What should concerned parents do?

As with all health matters, parents should consult their child's doctor.

I thought soy food was good for me, isn’t it?

The expert panel’s conclusions only apply to infants fed soy formula and not to children and adults who consume soy foods or soy supplements.

Do many people use soy infant formula?

Based on 2009 market data, sales of soy formula in the United States represent about 12 percent of the total dollar sales for infant formula — almost a 50 percent decrease from 1999.

The sale of soy formula varies geographically, ranging from 2 to 7 percent of infant formula sales in the U.K., Italy, and France, to 13 percent in New Zealand, to 31.5 percent in Israel.

Many aspects of infant formula use are unknown, including what percent of infants are exclusively fed formula compared to what percent are fed a mixture of infant formula and breast milk. It is also unknown what proportion of formula-fed infants are exclusively fed soy formula.

What is an Infant Formula?

The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk" (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old (Title 21, Code of Federal Regulations 21 CFR 105.3(e)). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.

How does FDA regulate Infant Formulas?

Because infant formula is a food, the laws and regulations governing foods apply to infant formula. Additional statutory and regulatory requirements apply to infant formula, which is often used as the sole source of nutrition by a vulnerable population during a critical period of growth and development. These additional requirements are found in section 412 of the FFDCA and FDA's implementing regulations in 21 CFR 106 and 107. To view the FFDCA and regulations in 21 CFR.

Does FDA have nutrient specifications for infant formulas?

Yes, FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. If an infant formula does not contain these nutrients at or above the minimum level or within the specified range, it is an adulterated product unless the formula is "exempt" from certain nutrient requirements. An "exempt infant formula" is "any infant formula which is represented and labeled for use by an infant who has an inborn error of metabolism or low birth weight, or who otherwise has an unusual medical or dietary problem" (FFDCA 412(h)(1). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.

Does FDA approve infant formulas before they are marketed?

No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated under Section 412(a)(1) of the FFDCA and FDA has the authority to take compliance action if the new infant formula is marketed. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

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. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

I have seen bottled water marked for use in preparing infant formula. What does this mean?

The manufacturers of infant formula provide directions for mixing their products with water and usually do not specify the source of water other than to indicate that the water should be safe to drink. In most situations, it is safe to mix formula using ordinary cold tap water that is brought to a boil and boiled for one minute or as directed on the label of the infant formula. Some water companies wish to make available bottled waters which are marketed for infants and for use in mixing with infant formula. When manufacturers label their water as intended for infants, the water must meet the same standards established for tap water by the Environmental Protection Agency. The label must also indicate that the bottled water is not sterile. As with tap water, consumers should boil bottled water one minute before mixing with infant formula. Water that is sterilized by the manufacturer and intended for use with infants must meet certain strict FDA standards. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.

Are there approved recipes for homemade infant formulas?

FDA regulates commercially available infant formulas, which are marketed in liquid and powder forms, but does not regulate recipes for homemade formulas. Great care must be given to the decision to make infant formulas at home, and safety should be of prime concern. The potential problems associated with errors in selecting and combining the ingredients for the formula are very serious and range from severe nutritional imbalances to unsafe products that can harm infants. Because of these potentially very serious health concerns, FDA does not recommend that consumers make infant formulas at home. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.

I see formulas on the market that contain ingredients called DHA and ARA. What are these substances?

DHA is docosahexaenoic acid and ARA is arachidonic acid. Both are long-chain polyunsaturated fatty acids. The body can make DHA and ARA from certain other dietary fatty acids, which are found in plant oils and other sources; however, DHA and ARA are also consumed directly in the diet. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

What foods contain the fatty acids DHA (docosahexaenoic acid) and ARA (arachidonic acid)?

DHA is contained in varying amounts in fish oils, with oils from cold-water fish containing higher amounts. DHA and ARA are also found in some algae and fungi, eggs, and in human breast milk. Some manufacturers make dietary supplements containing DHA and ARA. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

Why is there interest in adding DHA and ARA to infant formulas?

While infants can make these fatty acids from other ("essential") fatty acids in their diet, including the fatty acids in infant formulas, some studies suggest that some infants, such as premature infants, may benefit from direct consumption. Other studies suggest no benefit. It is known that long-chain polyunsaturated fatty acids (DHA in particular) accumulate in brain and eye of the fetus, especially during the last trimester of pregnancy. These fatty acids are also found in the fat of human breast milk. Blood levels of DHA and ARA are typically higher in breast-fed infants than in infants fed formulas not containing these fatty acids. For these reasons, some infant formula manufacturers and consumers are interested in providing DHA and ARA directly to infants. These manufacturers and consumers argue that adding oils containing these fatty acids to the fats and oils already in infant formula will provide an infant with both pre-formed DHA and ARA and the essential fatty acids an infant needs to make its own DHA and ARA. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

What is the evidence that addition of DHA and ARA to infant formulas is beneficial?

The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

I understand that oils containing DHA and ARA have been added to infant formulas for several years in other countries. Isn't there information from those countries on any long-term benefits or adverse consequences of formulas containing these fatty acids?

Systematic monitoring efforts are not in place to collect and analyze information on effects of infant formulas containing DHA and ARA in countries where these formulas are in use. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

Why has FDA asked manufacturers to do postmarket surveillance of infants consuming formulas containing ARA or DHA?

These are new ingredients that were not used in infant formulas in this country before early 2002, and infant formulas containing ARASCO (ARA Single Cell Oil) and DHASCO (DHA Single Cell Oil) have been marketed in other countries for only a few years. FDA views any evaluation of the safety of use of new food ingredients such as DHASCO and ARASCO as a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient. Therefore, scientific data that become available after specific products containing a new ingredient enter the market must be considered as a part of the totality of information about the ingredient. Pre-market clinical studies evaluating the effects of infant formulas containing DHASCO and ARASCO on physical growth and some aspects of development are short-term studies, while some studies suggest that feeding of infant formulas with oils containing DHA and ARA to infants may have long-term effects on growth and development. For all these reasons, manufacturers have been asked to closely monitor these new infant formulas in the marketplace. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

How do I report a problem or illness caused by an infant formula?

If a consumer has a general complaint or concern about a food product including an infant formula, FDA is the appropriate agency to contact. These problems, complaints, or injuries can be reported in writing or by telephone, or by the Internet at Report a Problem.

If you think your infant has suffered a serious harmful effect or illness from an infant formula, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or by using Reporting by Health Professionals. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods, dietary supplements, and infant formulas. The identity of the patient is kept confidential. In addition, health care providers should report infectious diseases in infants associated with use of infant formula to CDC's Division of Healthcare Quality Promotion (1-800-893-0485).

Consumers may also report an illness, injury or other problem they believe to be related to the use of an infant formula by calling FDA at 1-800-FDA-1088 or using Reporting by Consumers. FDA would like to know when a product may have caused a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.

Infant formula manufacturers provide toll-free telephone numbers on the labels of their products and should be notified about problems, complaints, or injuries caused by their products. Source: FDA/CFSAN Office of Nutritional Products, Labeling and Dietary Supplements July 2002.

Breastfeeding is ideal for infants. Breast milk is easy to digest and contains antibodies that can protect infants from bacterial and viral infections. If breastfeeding is not possible, formula can be used. Parents should speak with their pediatrician about what type of infant formula is best for their child.

Does using infant formula increase risk for dental fluorosis?

Because most infant formulas contain low levels of fluoride, regularly mixing powdered or liquid infant formula concentrate with fluoridated water may increase the chance of a child developing the faint white markings of mild fluorosis.

Does the type of infant formula I use affect my child’s chance of getting dental fluorosis?

Three types of infant formula are available in the United States: powdered formula, which comes in bulk or single-serve packets, concentrated liquid, and ready-to-feed formula. Ready-to-feed formula contains little fluoride and does not cause dental fluorosis. The kinds of formula that must be mixed with water—powdered or liquid concentrates—may increase the chance of dental fluorosis if they are the child’s main source food and if the water is fluoridated.

Can I use fluoridated tap water to mix infant formula?

Yes, you can use fluoridated water for preparing infant formula. However, if your child is only consuming infant formula mixed with fluoridated water, there may be an increased chance for mild dental fluorosis. To lessen this chance, parents can use low-fluoride bottled water some of the time to mix infant formula; these bottled waters are labeled as de-ionized, purified, demineralized, or distilled, and without any fluoride added after purification treatment. The U.S. Food and Drug Administration (FDA) requires the label to indicate when fluoride is added.

Can I use bottled water to mix infant formula?

Yes, you can use bottled water to reconstitute (mix) powdered or liquid concentrate infant formulas, but be aware that the fluoride content in bottled water varies. If your child is exclusively consuming infant formula reconstituted with water that contains fluoride, there may be an increased chance for mild dental fluorosis (a change in the appearance of tooth enamel creating barely visible lacy white markings). To lessen this chance, parents may choose to use low-fluoride bottled water some of the time to mix infant formula. These bottled waters are labeled as de-ionized, purified, demineralized, or distilled and are without any fluoride added after purification treatment (FDA requires the label to indicate when fluoride is added). Some water companies make available bottled waters marketed for infants and for the purpose of mixing with formula. When water is labeled as intended for infants, the water must meet tap water standards established by the EPA and indicate that the water is not sterile.

For decades, researchers have puzzled over why type 1 diabetes is becoming more common. Type 1 diabetes is a serious disease in which the body destroys the cells that make insulin. Insulin tells cells to take up sugar from your blood. People with type 1 diabetes need to take insulin every day to stay alive.

Researchers have wondered whether infant formula made from cow’s milk might cause children to develop type 1 diabetes. Studies suggested that early exposure to the complex proteins in cow’s milk might lead the body to mistakenly attack the cells that make insulin.

To test this idea, researchers used two formulas. One group of infants received a formula made from cow’s milk. The other received a formula made from cow’s milk that was processed to break complex proteins into small pieces. All the infants enrolled in the study had a genetic makeup that put them at higher risk of developing type 1 diabetes.

The mothers were encouraged to use the assigned formula whenever they didn’t breastfeed. The analysis included infants who were fed formula at least 60 days.

The results showed that the chance of developing type 1 diabetes by age 10 was the same for children in both groups. The complex proteins in cow’s milk did not raise the risk of developing type 1 diabetes.

“This once more shows us that there is no easy way to prevent type 1 diabetes,” says researcher Dr. Dorothy Becker at the University of Pittsburgh.

Getting sick from Cronobacter does not happen often, but infections in infants can be deadly. Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula. If your baby is fed with powdered infant formula, you can take steps to protect your baby from sickness.

Cronobacter sakazakii is a germ found naturally in the environment.

These germs can live in dry foods, such as:

• Powdered infant formula
• Powdered milk
• Herbal teas
• Starches

Rare but Serious Illness in Infants

Cronobacter infections are rare, but they can be deadly in newborns. Infections in infants usually occur in the first days or weeks of life. About two to four cases are reported to CDC every year, but this figure may not reflect the true number of illnesses. That’s because most hospitals and laboratories are not required to report Cronobacter infections to health departments.

Cronobacter germs can cause a dangerous blood infection (sepsis). They can also make the linings surrounding the brain and spinal cord swell (meningitis).

Infants who are more likely to get sick include:

• Infants 2 months and younger. These infants are most likely to develop meningitis if they get sick from Cronobacter.
• Infants born prematurely.
• Infants with weakened immune systems. Babies with this condition can’t fight germs as well because of illness or medical treatment, such as chemotherapy for cancer.

Cronobacter illness in infants will usually start with a fever and poor feeding, excessive crying, or very low energy. Some infants may also have seizures. You should take an infant with these symptoms to a medical provider as soon as possible.

Cronobacter infection can also be serious for:

• People 65 years and older.
• People who have immune systems weakened due to illnesses or conditions, such as HIV, organ transplants, or cancer.

Powdered formula is not sterile and might have germs in it.

Powdered infant formula can be contaminated in homes or in processing facilities that make it.

In the home:

You can accidentally get Cronobacter in powdered formula after you open the container. Cronobacter can live on surfaces in your home, such as a kitchen counter or sinks, and in water. Cronobacter could get into powdered formula if you place formula lids or scoops on contaminated surfaces and later touch the formula. It can also get into formula if you mix the formula with contaminated water or in a contaminated bottle.

In a processing facility:

Cronobacter can also get into powdered infant formula in a processing facility in these ways:

• If the manufacturer uses contaminated ingredients to make the formula.
• If the formula powder touches a contaminated surface.