The Infant Formula Act
Title 21 U. S. C. § 350a grants authority to the Secretary of Health and Human Services the following responsibilities:
New manufacture. Defined as a product that has not been previously manufactured. Therefore, if the type of fat used in production is changed ( EX. docosahexenoic acid and arachidonic acid) the quantitative formula or change in process must be registered 90 days before marketing the formula.
Notice Requirements. If the manufacturer has reasonable knowledge that a formula may not meet the nutrients required or may be adulterated or mislabeled, the manufacture has to notify the FDA, and a recall will occur.
Recalls. The process of recalling infant formula is outlined. Time lines and mandatory record keeping are described.
Exemptions: See Metabolic Foods page.
Nutrient Requirements: Minimum and/or Maximum levels for 29 nutrients are given.
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- Define Good Manufacturing Processes for the production of infant formula
- Define quality control measures including
- what is tested- specifically Vitamin A, Thiamine (Vit B1), Vitamin C and Vitamin E
- when it is tested- pre-mixing, in process and final stage
- the process controls on testing- all audit records must be kept 1 year after expiration date on the product
- audit requirements to show compliance to testing procedures
New manufacture. Defined as a product that has not been previously manufactured. Therefore, if the type of fat used in production is changed ( EX. docosahexenoic acid and arachidonic acid) the quantitative formula or change in process must be registered 90 days before marketing the formula.
Notice Requirements. If the manufacturer has reasonable knowledge that a formula may not meet the nutrients required or may be adulterated or mislabeled, the manufacture has to notify the FDA, and a recall will occur.
Recalls. The process of recalling infant formula is outlined. Time lines and mandatory record keeping are described.
Exemptions: See Metabolic Foods page.
Nutrient Requirements: Minimum and/or Maximum levels for 29 nutrients are given.
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