FDA to Enforce New Infant Formula Rules Immediately

By EAS Senior Consultant Allen Sayler

An estimated one million infants (roughly one-third) in the United States are fed infant formula from birth, and by the time they are three months old, about 2.7 million (roughly two-thirds) rely on formula for at least part of their nutrition. US-produced and packaged infant formula is in high demand internationally because of its excellent safety and nutrition record and because of the concerns raised by the melamine scandal in China and the tainted milk powder incident in New Zealand.

Based on a number of unfinished infant formula regulations and the need to update existing regulations, FDA published an interim final rule on February 10, 2014 and announced on June 9, 2014 that it was finalizing this rule, intended to set standards for the manufacture of infant formula either processed in the US or intended to be marketed in the US. The final rule is similar to the interim rule with a few modifications based on comments received by the agency after the February 2014 publication.

While infant formula processors have been applying many of the newly required Good Manufacturing Practices (GMPs) as part of their own internal product safety and quality programs, these finalized GMPs and other parts of the new rule now become federally enforceable. As a result, the industry requested that FDA delay enforcement to allow the industry to become familiar with and implement these new requirements. FDA rejected industry requests, setting a date of September 8, 2014 for manufacturer compliance. It is hoped that for the rest of 2014, FDA will instruct its field inspection/auditing staff to be reserved in their enforcement to allow the industry time to adapt to the vast new regulation, but there is no certainty of this.

Below is a reference table with links to additional information as well as the complete and final GMPs for infant formula processing.

• Short FDA Summary of the New Rule
  • http://www.fda.gov/forconsumers/consumerupdates/ucm048694.htm
• Final Rule: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula June 2014
  • https://www.federalregister.gov/articles/2014/06/10/2014-13384/ current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification
• Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for “Eligible” Infant Formulas June 2014
  • http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/ucm400036.htm
• Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports February 2014
  • http://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/ucm384451.htm

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. Under the final rule, some points addressed include:

• Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
• A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth (of infants).
• A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.
• A few other existing requirements:
• “Use by” date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date to be specified on each container of infant formula.
• Storage. Manufacturers must include instructions on infant formula packaging for its handling before and after the container is opened. They must also include information on the storage and disposal of prepared formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula. Proof of compliance with existing and new requirements will be required when FDA investigators conduct their annual inspections/audits of all infant formula processors selling product in the US market. In addition, FDA also collects and analyzes product samples. Based on the inspections/audits and sampling, if FDA believes that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Additional references regarding the FDA requirements for processing infant formula for the US market include:

• 21 CFR 106 Infant Formula Quality Control Procedures
• 21 CFR 106.100 Records and Reports Regulations
• 21 CFR 107.3 – 107.30 Infant Formula Labeling Requirements
• 21 CFR 107.50 Exempt Infant Formulas
• 21 CFR 107.100 Nutrient Requirements for Infant Formulas
• 21 CFR 107.200 – 107.280 Infant Formula Recall Requirement