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Among the requirements for infant formulas, the FDA specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients. In addition, any ingredient used in infant formula must be safe and suitable for such use.

Our customer service standard is 15 days to complete review of your formula application.

The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year's large-scale recall and contributed to the infant formula shortage,? said Donald Prater, acting director of the FDA's Center for Food Safety and Applied Nutrition.

An internal review found several factors contributed to the national baby formula shortage, but no one person or agency was listed as at fault.

With respect to infant formula, section 412 of the Act (21 USC 350a) provides requirements relating to nutrient content, nutrient quantity, nutrient quality control, recordkeeping and reporting, and recall of infant formulas.

FDA regulates commercially available infant formulas, which are marketed in liquid and powder forms, but does not regulate recipes for homemade formulas.

Be sure to clean and sanitize the bottle before its next use. Store unopened infant formula containers in a cool, dry, indoor place?not in vehicles, garages, or outdoors. Once a container of infant formula is opened, store in a cool, dry place with the lid tightly closed. Do not store it in the refrigerator.

The Process The base liquid which may be either milk or water is weighed/metered into the process vessel. ... Powdered ingredients - milk proteins, etc. ... The premix is usually homogenized by passing through a high pressure homogenizer. The product is heat sterilized/pasteurized. The product is spray dried before packing.