These Infant Formula web pages contain information about infant formula that may be helpful to industry,
consumers, government agencies, and other interested parties. They include the following:
- information about FDA's regulation of commercial infant formulas,
- commonly asked questions about infant formulas,
- links to other relevant resources, and
- how to report problems.
Requirements for infant formula are found in the Federal Food, Drug, and Cosmetic Act (the Act). All
manufacturers of infant formula must begin with safe food ingredients, which are either generally
recognized as safe (GRAS) or approved as food additives for use in infant formula.
Once an infant formula product is formulated, current laws require that the manufacturer must provide
FDA assurance of the nutritional quality of that particular formulation before marketing the infant
formula. FDA has provisions that include requirements for certain labeling, nutrient content,
manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as
company records and reports. FDA is also working to finalize a proposed rule for good manufacturing
practice, quality control procedures, quality factors, notification requirements, and reports and
records, for the production of infant formulas.
September 12, 2008