Infant Formula Act of 1980

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Infant Formula Act of 1980

The Infant Formula Act of 1980 (Public Law 96-359) is a United States federal law that was enacted on September 26, 1980. The law established minimum nutritional requirements for infant formula in the United States and required manufacturers to register with the U.S. Food and Drug Administration (FDA) and adhere to specific quality control procedures. This legislation was a response to concerns over the safety and nutritional adequacy of infant formula products available in the market at the time.

Background[edit | edit source]

Prior to the enactment of the Infant Formula Act, the regulation of infant formula was less stringent, leading to instances where formulas were found to be nutritionally inadequate or harmful to infant health. Notably, in the late 1970s, issues with certain formulas led to severe malnutrition and health problems among infants, prompting public outcry and a call for stricter regulatory oversight.

Provisions[edit | edit source]

The Infant Formula Act of 1980 set forth several key provisions to ensure the safety and nutritional value of infant formulas:

  • Nutritional Standards: The act requires that all infant formulas meet specific nutritional standards that are based on recommendations by the American Academy of Pediatrics. These standards cover essential nutrients necessary for infant growth and development.
  • Quality Control: Manufacturers are required to maintain strict quality control processes to ensure the consistency and safety of their infant formula products. This includes testing for nutrient content and screening for contaminants.
  • Labeling Requirements: The act mandates clear labeling of infant formula products, including nutritional information and ingredients, to help caregivers make informed decisions.
  • FDA Oversight: The FDA is given the authority to inspect manufacturing facilities, review formula recipes for nutritional adequacy, and enforce the act through recalls and penalties for non-compliance.

Impact[edit | edit source]

The Infant Formula Act of 1980 significantly improved the safety and quality of infant formula in the United States. By establishing rigorous standards and oversight, the act has helped prevent nutritional deficiencies and health issues among infants fed formula. It also provided a framework for the ongoing regulation and monitoring of infant formula products.

Amendments and Updates[edit | edit source]

The act has been amended and updated several times since its original passage to incorporate new scientific findings and address emerging issues. Notably, the Infant Formula Act Amendments of 1986 further strengthened the FDA's authority to regulate infant formula and introduced additional requirements for formula composition and quality control.

See Also[edit | edit source]

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Contributors: Prab R. Tumpati, MD