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.

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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