Overview
Alerts, Safety Information & Reporting Problems
General Information & Other Resources
Regulatory / Guidance Documents & Advisory Meetings
Frequently Asked Questions
Exempt Infant Formulas
Laws, Regulations, and Guidance
FDA Regulations And Critical Information on the Manufacture And Distribution of Infant Formula March 2002
Federal Food Drug and Cosmetic Act, Section 412 - Requirements for Infant Formula
61 FR 36153 1996 Proposed Rule for Infant Formula: Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors
Current Manufacturing Regulations and Guidelines
Infant Formula Products for Export Only
Federal Food, Drug, and Cosmetic Act, Section801(e)(1) - Imports and Exports
Clinical Studies of Infant Formulas
Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants June 1988
Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance April 1996 (available in PDF, 262 Kb)
Guidance for Industry. E11. Clinical Investigation of Medicinal Products in the Pediatric Population. December 2000 (available in PDF)
21 CFR 50 Human Subjects Protection Informed Consent
66 FR 20589 - Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products (Interim Rule) April 24, 2001
21 CFR 56 Institutional Review Boards
Advisory Meetings
CFSAN Public Meetings, Advisory Committees, and Dockets Management - Includes FDA Advisory Committees
Food Advisory Committee Meeting (Infant Formula) - Notice of meeting for November 18-19, 2002
Agenda, Questions, Briefing Materials, and Transcript
Food Advisory Committee (Infant Formula), Notice of Meeting for April 4, 2002
Agenda, Questions, Briefing Materials, and Transcript (see April 4, 2002)
Inspections, Compliance, Enforcements and Recalls (general FDA information)
FDA Inspection References (Manuals and other documents that provide procedures and guidance to FDA personnel for conducting their inspectional and investigational activities)
FDA Compliance References (Compliance Policy Guides and Regulatory Procedure Manual)
Imports and Exports (Procedures, Compliance Programs, Import Alerts, Detentions)
FDA Recalls and Safety Alerts (Policies, Enforcement Reports, Alerts)
Information Materials for the Food and Cosmetic Industries: Food Labeling Publications (includes guidance documents, methods book, guidelines for household measures)
Certificates of Free Sale