FDA Issues Interim Final Rule on Infant Formula Standards, Seeks Comments
The U.S. Food and Drug Administration (FDA) today released an interim final rule that sets standards for manufacturers to produce safe infant formula that supports healthy growth.
While breastfeeding is strongly recommended and many mothers hope to breastfeed, most U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.
The interim final rule amends FDA's quality control procedures, requirements about how and when manufacturers must notify the agency about new formulas and changes to formulas, and requirements concerning what manufacturing and related records and reports must be established and maintained. It establishes current good manufacturing practices specifically designed for infant formula, including required testing for contamination from harmful bacteria such as Salmonella. In addition, the interim final rule will help ensure that infant formula contains all federally required nutrients, such as protein, fat, and certain vitamins and minerals, and that the formula supports healthy growth.
Companies currently manufacturing infant formula in the U.S. have been producing safe infant formula in compliance with requirements of the Infant Formula Act, and these firms voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, FDA will accept and review comments on issues or information not previously considered.
FDA is also publishing two draft guidance documents (see links below) to provide industry with additional information related to the interim final rule. One draft guidance document addresses the manufacture of infant formula products made for infants with unusual medical or dietary problems, such as infants who are born extremely premature and have special dietary needs; this type of formula is not the subject of the interim final rule. The other draft guidance document explains how manufacturers of currently and previously marketed infant formulas can demonstrate that their products meet the quality factor requirements of the interim final rule.
Comments from the public are being accepted on the interim final rule for 45 days at Regulations.gov (Docket Number FDA-1995-N-0036).
Use the links below to access the two draft guidance documents and the text of the interim final rule:
- Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports
- Draft Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for “Eligible” Infant Formulas
- Interim Final Rule: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
Additional FDA guidance documents and regulatory information regarding infant formula are available here.