Guidance & Regulatory Information

Regulatory / Guidance Documents & Advisory Meetings

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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, Section 801(e)(1) - Imports and Exports
• Clinical Studies of Infant Formulas
  • 21 CFR 50 Human Subjects Protection Informed Consent
  • 21 CFR 56 Institutional Review Boards
  • Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants June 1988

Advisory Meetings

• Contaminants and Natural Toxicants Subcommittee of the Food Advisory Committee - Notice of Meeting for March 18-19, 2003
  • Meeting Agenda, Briefing Materials and Transcript
• Food Advisory Committee Meeting (Infant Formula) - Notice of meeting for November 18-19, 2002
  • Agenda, Questions, Briefing Materials, and Transcript (see November 18-19, 2002)
• Food Advisory Committee (Infant Formula), Notice of Meeting for April 4, 2002
  • Agenda, Questions, Briefing Materials, and Transcript (see April 4, 2002)

General FDA Information

• Imports and Exports (Procedures, Compliance Programs, Import Alerts, Detentions)
• Information Materials for the Food and Cosmetic Industries: Food Labeling Publications (includes guidance documents, methods book, guidelines for household measures)