Infant formula is intended for children under 12 months. FDA regulatory requirements relate to the safety, nutritional adequacy, packaging, and labeling of these products. The U.S. Food and Drug Administration does not approve infant formula; Infant formula manufacturers, however, must notify the agency before selling new formula. FDA trained staff review these notices to ensure that new formulations meet federal nutrition, labeling and other requirements. If a product does not meet applicable requirements, the formulation may be considered adulterated, faulty, or both, and FDA has the right to take enforcement action at the time it is marketed. Federal law allows the FDA to force a recall if the agency determines that adulterated or misbranded infant formula poses a threat to human health.

In its requirements for infant formula, the FDA specifies 30 nutrients that must be included in infant formula. Minimum content of all 30 nutrients and maximum content of 10 nutrients. In addition, any ingredients used in infant formula must be safe and suitable for such use. The law requires control measures to prevent pollution and other problems. For example, manufacturers must establish a control system to ensure that infant formula is not adulterated due to the presence of microorganisms in the formula or the processing environment. In addition, Food and Drug Administration regulations specify specific testing requirements. Salmonella and H. pylori. The FDA also ensures that the water used by these companies to produce their formulations meets safety standards set by the United States. Environmental Protection Agency.

The Food and Drug Administration has specific labeling requirements for infant formula. The most helpful information for infant caregivers includes: preparation and use guidelines, pictograms showing the main steps in preparing infant formula, use by date, and instructions on whether water should be added.

FDA conducts annual inspections of facilities that produce infant formula and carefully trains its investigators to ensure that each infant formula inspection is robust, thorough, and focuses on the most critical aspects of the infant formula production process. The Forest Development Authority has also taken, and will continue to take, several steps to improve the resiliency of infant formula supply, including enforcement discretion, as part of the Agency's recent National Strategy to improve U.S. resilience. Some of this work includes working with manufacturers, who are now required to develop risk redundancy plans to help ensure a stable and continuous supply of infant formula.

In 2022, a large amount of infant formula produced by the Abbott Nutrition Institute in Sturgis, Michigan, was voluntarily recalled due to safety concerns about infant formula. Since then, the Agency has taken steps to strengthen inspection activities, strengthen engagement with the infant formula industry and take regulatory action, as appropriate, through the development of an H. pylori prevention strategy. In March 2023, the Forestry Development Authority issued a letter to the infant formula industry, sharing current safety information and calling on the industry to take immediate action to improve infant protection procedures and programmes. In addition, in August 2023, n has issued three warning letters to infant formula manufacturers as part of these agencies, enhancing oversight and emphasizing the importance of taking and maintaining appropriate corrective action when pathogens are found, as well as complying with FDA laws and regulations.

Illegally imported formulas can be available online or from third-party distributors. These formulas are sometimes promoted as being better for babies, but there is no scientific evidence that these infant formulas are better than commercial infant formulas legally sold in the United States. All infant formula legally sold in the United States, whether made in the United States or imported from another country, must meet the same nutritional and safety requirements.