Regulatory / Guidance Documents
& Advisory Meetings

• Laws, Regulations, and Guidance
  • Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006
  • 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
    • 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 Requirements
    • 21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food
    • 21 CFR 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
    • Guidelines Concerning Notification and Testing of Infant Formulas 1985
      (cited in the Federal Food, Drug, and Cosmetic Act 412(c)(2))
  • 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
  • Contaminants and Natural Toxicants Subcommitee of the Food Advisory Committee; Notice of Meeting March 18-19, 2003
    • Federal Register Notice February 20, 2003
    • Meeting Agenda, Briefing Materials and Transcript
  • 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