Home
Human milk is the ideal food for human infants, but in many instances mother's own milk is not available for infants. Infant formula is a human milk substitute. It is a unique food; the only food an infant ingests during the first 4-6 months of life. Infants have tremendous growth at this time and the burden of producing a safe and efficacious food is great. Producing infant formula is a complex process. (short video).
A nice (free) overview of evaluating the safety of new ingredients for infant formula was published by the Institute of Medicine, Committee on the Evaluation of the Addition of Ingredients New to Infant Formula, Food and Nutrition Board. (2004).
Infant formula manufacturing was not regulated by law until 1980. Prior to 1980 it was regulated under the Good Manufacturing Process Regulations, as all food production is regulated. This set of web pages explains what happened in 1978-1979, the ensuing law and its revisions. The work of the Federal agencies responsible for creating systems to enforce the law is detailed as well.
The top toolbar has six tabs.
All information is up to date as of July 15, 2011.
Next
A nice (free) overview of evaluating the safety of new ingredients for infant formula was published by the Institute of Medicine, Committee on the Evaluation of the Addition of Ingredients New to Infant Formula, Food and Nutrition Board. (2004).
Infant formula manufacturing was not regulated by law until 1980. Prior to 1980 it was regulated under the Good Manufacturing Process Regulations, as all food production is regulated. This set of web pages explains what happened in 1978-1979, the ensuing law and its revisions. The work of the Federal agencies responsible for creating systems to enforce the law is detailed as well.
The top toolbar has six tabs.
- You are currently on the home page, the first tab.
- The second tab is a summary of the law (Infant Formula Act, 21 U.S.C. § 350a ) as it reads today. Included in this tab is the history, or story of the law and the exemption that is made in the law for metabolic foods. In the case of infant formula, this important exemption allows formula for children with inborn errors of metabolism (IEM) to be produced.
- The third tab contains pages that explain the role of the FDA. Infant formula is the only food that is regulated by law. The production and distribution of infant formula is regulated under the auspices of the FDA. The function of the sub-agencies that have program responsibility for assuring safe processing are explained.
- The fourth tab, labeled USDA explains the role of the USDA in WIC, the Women, Infants, and Children Program. The WIC program has a profound effect on the infant formula market.
- The fifth tab describes how the Bio-terrorism Law of 2002 effects infant formula manufacturing.
- Finally, the sixth tab highlights International regulation and the role it plays in the manufacture of infant formula. From the export of infant formula to other countries, to importing formula, keeping infant formula safe is paramount. However, you will see how it is difficult to come to agreement on many issues.
All information is up to date as of July 15, 2011.
Next
