Guidance and Regulatory Information
Down to the specifics. Here is a list of links and a description of what you will find when the link is selected.
- The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) has program responsibility for --------infant formula.
- The Office of Food Additive Safety (OFAS) has program responsibility for food ingredients and how infant --------------formula is packaged, including the Generally Recognized as Safe (GRAS) List, Food and Color Additives etc.
Specific parts of the regulations are found at the links below:
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- Electronic Code of Federal Regulation (e-CFR)- 21 CFR 107- Infant Formula is the complete set of regulations that manufacturers comply to in the manufacture of infant formula. From testing ingredients before production, to reducing bacterial contamination in the spray drying processes used to produce infant formula powder, it is covered here. I found having a infant formula label available as I was reading the labeling requirements interesting. There is hardly a word on the label that is not required by the regulation.
- The Center for Food Safety and Applied Nutrition is responsible for overseeing infant formula. However, two agencies under this agency are tasked with handling specific areas of responsibility.
- The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) has program responsibility for --------infant formula.
- The Office of Food Additive Safety (OFAS) has program responsibility for food ingredients and how infant --------------formula is packaged, including the Generally Recognized as Safe (GRAS) List, Food and Color Additives etc.
Specific parts of the regulations are found at the links below:
- 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 Formulas1985 (cited in the Federal Food, Drug, and Cosmetic Act 412(c)(2))
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