Regulatory / Guidance Documents
& Advisory Meetings

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

  • 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