FDA Fortifies Quality and Manufacturing Regulations for Infant Formula

Beginning July 10, 2014, infant formula manufacturers will be required to adhere to new FDA regulations establishing quality control procedures and good manufacturing practices for infant formulas. The new regulations will “prevent the manufacture of adulterated infant formula and ensure that the nutrients in the infant formula are present in a form that is bioavailable and safe,” stated the FDA in its interim final rule, set to be published in the Federal Register on February 10, 2014.    

“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” noted FDA deputy commissioner Michael R. Taylor in an FDA press announcement. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”

Current Good Manufacturing Requirements (CGMRs)

The interim final rule established CGMRs for producing nonexempt infant formula. Manufacturers are required to develop a production system and “in-process controls” to handle all stages of infant formula processing. Such systems must include a written plan and procedures that establishes “specifications and corrective action plans, documented reviews and material disposition decisions for articles not meeting a specification, and the quarantine of any article that fails to meet a specification pending completion of a documented review and material disposition decision.” In addition, manufacturers must follow specific controls to avoid the adulteration of infant formula by workers, facilities, equipment or utensils, as well as ingredients, containers, and closures.

Quality Factors

The interim final rule also clarifies validation of manufacturing systems requirements and creates manufacturing specifications for infant formula. The quality factors that an eligible infant formula must meet are: (1) normal physical growth and (2) sufficient biological quality of the protein component. A monitoring study to measure the physical growth of infants will be implemented in order to ensure infant formula meets the normal physical growth quality factor. However, manufacturers may be able to present other scientific evidence to demonstrate normal growth. In addition, regularly scheduled audits are required in order to ensure that manufacturers are meeting the nutritional requirements to meet the biological quality factor.


New records and recordkeeping requirements were also developed. According to the interim final rule, manufacturers are “required to establish and maintain various records that help demonstrate compliance with the quality factors, CGMP, quality control procedure, registration, submission, and notification requirements.” For example, microbiological testing of infant formula records is required to prove compliance with the sufficient biological quality factor.

According to FDA estimates, the implementation of the interim final rule will yield an annual $10 million benefit to public health. Although the cost of placing the interim final rule in effect is $7.29 million for the first year and $4.06 million in subsequent years, the FDA estimates the total net benefits to be $2.71 million for the first year and an annual $5.94 million net profit thereafter.

Two draft guidances, “Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for ‘Eligible’ Infant Formulas” and “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports,”  were issued along with the interim final rule. The latter noting that, “More stringent controls are necessary for the production of infant formulas than for processing food generally because of the vulnerable nature of the infant population and the status of infant formula as the sole source of nutrition for a segment of this population.”