What FDA Requires of Every Infant Formula Sold in the US

Why “FDA approved” is the wrong question

FDA’s infant formula page states the agency’s role in one sentence: “The FDA does not approve infant formulas.” The sentence after it is the part that matters. “However, infant formula manufacturers must notify FDA before marketing a new formula in the United States by providing FDA with a new infant formula submission. The notification review process ensures that all products meet required nutritional and safety requirements.”

So a formula on a US shelf has been through a review, and the review is against a set of requirements rather than a stamp of approval. FDA keeps the other half of that arrangement too: “If an infant formula product is sold in the U.S. and does not meet all applicable requirements, FDA has the authority to take steps to remove it from the market to protect the health of infant consumers.” The agency describes the staff doing this work as “dietitians, doctors, scientists, and food safety experts” who “review the safety, nutritional adequacy, packaging, and labeling of infant formula products sold in the U.S.”

What has to be in the can

The nutrient rule is specific. “The FDA regulations specify 30 nutrients that must be included in any infant formula sold in the United States. New infant formulas are reviewed to ensure they contain adequate protein and support healthy growth in infants.” Every ingredient has a rule of its own as well: FDA “requires that all ingredients used in infant formula be approved food additives or generally recognized as safe (GRAS) and suitable for such use.” And the list is not fixed forever. “The FDA routinely evaluates individual nutrients to ensure infants receive optimal nutrition based on the most current scientific evidence.”

That is the same shape as the rule behind kids’ toothpaste, which What FDA’s Fluoride Rule Says About Kids’ Toothpaste walks through: one federal standard, and every product on the shelf written to it.

What has to happen at the plant

Three requirements, each stated on FDA’s page.

Sanitary controls. “Infant formula manufacturers must follow sanitary controls that are required by federal law to prevent contamination of infant formula during manufacturing,” and in particular “must establish a system of controls designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula.”

Testing. “FDA regulations require testing in infant formula for the pathogens Salmonella and Cronobacter.” The water is covered too: “FDA regulations require that the water the companies use to manufacture formulas meets safety standards set by the U.S. Environmental Protection Agency.”

Inspections. “The FDA inspects facilities that make infant formulas annually and carefully trains its investigators to ensure that every infant formula inspection is robust, thorough, and focused on the most critical aspects of the infant formula manufacturing process.”

What the label has to say

“The FDA has specific requirements for infant formula labels,” the page says, and it names the ones it considers most useful to a caregiver: “directions for preparation and use, a pictogram showing the major steps for preparing infant formula, and a ‘use by’ date.” Labels “are also required to provide information that is truthful and not misleading.”

FDA’s page for parents and caregivers adds one more line that explains a phrase on every can. “The infant formulas currently available on the U.S. market must be labeled as either ‘Infant Formula with Iron’ or include the statement, ‘Additional Iron May Be Necessary.’” The same page notes that the American Academy of Pediatrics recommends formula-fed infants receive a formula with iron “as a way of preventing iron-deficiency anemia.”

Routine, specialty, and the three forms

FDA’s caregiver page sorts the shelf into two kinds. “Routine formulas are formulas intended for healthy, full-term infants. These formulas may contain cow’s milk, goat’s milk, or soy.” Some routine formulas are made for “specific but common digestive needs,” and the page names three: partially hydrolyzed formula, which “contains cow’s milk proteins that have already been partially hydrolyzed, or broken down”; spit-up formula, which “contains thickeners with the aim of reducing infant reflux”; and lactose-free formula, which “contains no lactose.”

“Specialty formulas are intended for use by an infant who has a unique medical or dietary problem such as an inborn error of metabolism, food allergies, premature birth, or low birth weight.” Some “are not available in retail settings and may be prescribed by a physician,” and the page adds a detail worth knowing: because of what they are for, “specialty formulas may be exempt from certain labeling and nutrient requirements.”

Every formula comes in one of three forms, in FDA’s words. Powder “must be mixed with water before feeding.” Liquid concentrate “must be mixed with water before feeding.” Ready-to-feed “requires no mixing with water before feeding.”

What FDA tells caregivers

The page’s instructions are brief and this post repeats them without adding to them. “The FDA recommends caregivers prepare infant formula according to instructions on the infant formula label to ensure safety and to uphold the nutritional quality of the formula.” It “advises parents and caregivers not to make or feed homemade infant formula to infants,” because homemade recipes “have not been evaluated by FDA and may lack nutrients vital to an infant’s growth and development.”

On switching brands, the page is plainer than most people expect. “Most babies will do just fine with different brands of formula, including store brands, as long as they’re the same type, like cow’s milk-based, goat’s milk-based, soy, hypoallergenic (extensively hydrolyzed), or elemental (amino acid-based),” and “any infant formula substitution should only be done under the recommendation and supervision of your pediatrician or other healthcare provider.”

One product category is called out as not covered by any of this. “Drinks for young children, often marketed as ‘toddler formulas,’ do not undergo premarket review by FDA,” the page says, and “babies younger than 12 months of age should not be fed these products, as they are not designed to meet their nutritional needs.”

Runlow does not yet carry product records for infant formula, so this post names no brand. When it does, the form, the iron labeling, and the routine-or-specialty designation will render from the record, the way every product fact on this site does.

Where this comes from

Every statement above is quoted from two FDA pages, the agency’s infant formula homepage and its page for parents and caregivers, both linked in the text and current as of June 15, 2026 and February 26, 2026 respectively when read. Nothing here is medical advice. FDA’s own page says to “check with your infant’s healthcare provider to determine which infant formula to choose,” and this post repeats that rather than adding to it.