Performance Improvement 2006. Infant Formula Program (CP 7321.006)


This project provides a means to ensure the safety and nutrition of all infant formula, and to provide for annual surveillance of all infant formula manufacturers (including exempt infant formula manufacturers) to determine compliance with the provisions of Section 412 of the Act, and Title 21 Code of Federal Regulations Parts 106 and 107 and to take corrective action as appropriate. The methodology used to conduct the Infant Formula Program Evaluation included a review of FY 2004 Establishment Inspection Reports, FACTS sample and consumer complaint data, and CFSAN Program Monitor’s data. Major findings of the report include: registered domestic manufacturers of infant formula are in substantial compliance with all applicable regulations; based on sample analysis alone, it appears that infant formulas manufactured by foreign firms that are registered as infant formula manufacturers, are in compliance  with all applicable regulations; and infant formulas marketed by firms that are not registered infant formula manufacturers may not provide adequate nutrition for infants. The report makes a number of recommendations: (1) That inspection of all foreign infant formula manufacturers be conducted in FY05. In the event that the inspections of foreign infant formula manufacturers could not be accomplished, that representative domestic import samples of infant formula be collected from each active foreign manufacturer; (2) Continue to conduct annual inspections of all domestic infant formula manufacturers;(3) Revise the Infant Formula Compliance Program to include sampling of all imported infant formula products that are imported from firms that are not registered as infant formula manufacturers. Update the program to reflect current procedures and priorities (e.g., E. sakazakii, allergens, bioterrorism concerns); (4) Conduct surveys in ethnic markets to determine if infant formulas that are not registered with FDA are being marketed domestically; (5) Work with the Atlanta Center for Nutrient Analysis (ACNA) to develop a testing protocol for analyzing imported products for specific nutrients; (6) Schedule high priority inspections if it is found that infant formula manufactured by firms that are not registered are being imported to the U.S.; (7) Publish Good Manufacturing Practice regulations for infant formula; (8) Develop industry guidance to ensure that powdered infant formula is not contaminated with E. sakazakii; (9) Issue an Import Bulletin to address the issue of American Goods Returned for infant formulas; (10) Ensure that infant formula recalls are classified in a timely manner; (11) Conduct bi-annual evaluations of the Infant Formula Program due to the high rate of compliance; (12) Provide training on how to use databases (e.g., Field Accomplishment Compliance Tracking System [FACTS], Operational and Administrative System for Import Support [OASIS], etc.,) to help facilitate evaluation of program accomplishments.

PIC ID: 8244; Agency Sponsor: FDA-CFSAN, Center for Food Safety and Applied Nutrition; Federal Contact: Greenberg, Beatrice, 301-436-1690; Performer: FDA, Center for Food Safety and Applied Nutrition, Washington, DC

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