Infant Formula Safety: What Parents Need to Know

Breastfeeding is encouraged as the sole source of nutrition for babies until complementary foods are introduced, between the first 4 to 6 months of life. However, infant formula is a complete source of nutrition for babies when breastfeeding is not an option or when parents choose not to breastfeed.

The following information can help caregivers put safety first when selecting and preparing formula.

Infant Formula Safety

Because infants are a vulnerable population, it is essential that infant formulas always be safe. The U.S. Food and Drug Administration (FDA) oversees its safety. The FDA sets specific requirements for nutrients in infant formula and also requires testing for two types of bacteria: Salmonella and Cronobacter sakazakii. Water used in formula manufacturing must meet EPA standards for safety. Additionally, the FDA lays out requirements for companies on Good Manufacturing Practices. If there are problems, the FDA can require a product recall.

Imported formula sold in the U.S. must meet these same standards. However, if these products are sold online, there’s no guarantee they meet FDA requirements. In addition, buying formula from online sources can be risky because they may be unsafe or expired.

Safe Formula Preparation and Handling

Good Manufacturing Practices help keep infant formula safe during manufacturing, but it’s equally important for caregivers to prepare and store formula safely.

Before preparing infant formula, always wash your hands with soap and water for at least 20 seconds. Bottles, including nipples, should be boiled in clean water for five minutes to sanitize before the first use. Alternatively, a bottle sterilizer can be used. This should be repeated at least once daily for babies younger than 2 months old or who have weakened immune systems. Bottles should be washed in a dishwasher or with hot water and allowed to dry thoroughly before each use.

Infant formula should be stored in a cool, dry location in a sealed container. Once opened, follow the manufacturer’s instructions for storage and use within one month. Formula that has been prepared in advance should be stored in the refrigerator and used within 24 hours. After a bottle has been used, discard any remaining formula within an hour after feeding.

Parents and caregivers should never make their own infant formula at home. Infant formula is carefully formulated to meet the needs of infants.

Infant Formula Nutrition

The FDA sets requirements for nutrients in infant formula, including a minimum and maximum amount for several nutrients. Labels must disclose this information for consumers, including amounts of protein, fat and carbohydrate, plus the amounts of specific vitamins and minerals. Labels also must disclose ingredients. Types of formulas vary, so ingredients will too. The most common is standard cow’s milk, but soy and goat milk formulas also are available.

Specialty formulas may be needed for infants with specific health conditions, including formulas with proteins that have been hydrolyzed, meaning they are partially or completely broken down to improve digestion. Formulas may include ingredients such as inositol (a nutrient that supports healthy lungs), docosahexaenoic acid, or DHA, (a specific kind of omega-3 fatty acid that supports brain development), and probiotics (live microorganisms, such as yeast or bacteria, that may support healthy digestion).

Formulas that need to be mixed with water, either from liquid or powdered form, should be done exactly as instructed on the label or by a baby’s health care provider to maintain adequate nutrition. If you’re concerned about the safety of your tap water, boil and allow it to cool before mixing with formula — or use bottled water instead.

Some people are concerned with processed ingredients, like seed oils or corn solids, but these are not unsafe or unhealthy. In fact, they are easy to digest sources of important nutrition for babies who are unable to consume breast milk.

Ask an Expert

Infant formula is a safe, complete source of nutrition for infants younger than 12 months old. If you have questions about how to feed your baby, consult with your pediatrician and a pediatric dietitian for personalized recommendations.