Title
Infant Formula Open-Date Marking Guidelines
Law
Bfad Fda Regulation No. 001-c S. 1982
Decision Date
Oct 1, 1982
Guidelines mandate that all powdered infant formula must display a "Best before" date to ensure nutritional quality, specifying limits for moisture content, vitamin C, and solubility, effective January 1983.
A

Definitions

  • Infant Formula: A product derived from milk of cows, other animals (including fish), or plants, proven suitable for infant feeding.
  • Infant: A person not older than 12 months.

Labeling and Quality Requirements

  • All infant formula products must prominently display a "Best before" date on their label or packaging.
  • The "Best before" date indicates when any of the following limits are expected to be reached:
    • Maximum moisture content: 3.5%
    • Minimum Vitamin C content: 90% of the label claim, but not less than 30 mg per 100 mg sample.
    • Minimum percent solubility: 80%

Effective Date

  • Full compliance with the open-date marking guidelines is required from January 1983 for all covered products.

Issuance and Re-issuance

  • Originally adopted on October 1, 1982, and re-issued on October 7, 1991.
  • Signed by the Acting Administrator and the Minister of Health in 1982 and later by the Director and Assistant Secretary for Standards and Regulation in 1991.

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