An act to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority under that Act to assure the safety and nutrition of infant formulas, and for other purposes.

Summary

Infant Formula Act of 1980 - Amends the Federal Food, Drug, and Cosmetic Act to set forth requirements for infant formulas. States that formulas which do not conform to such requirements shall be deemed to be adulterated. Permits the Secretary of Health and Human Services (formerly, the Secretary of Health, Education, and Welfare) to revise such requirements and establish quality control procedures. Requires each manufacturer of an infant formula to notify the Secretary whether the formula as processed meets such requirements and of any changes in such formula or its processing. Requires a processor who has information that any infant formula leaving his or her control may be adulterated or misbranded to promptly notify the Secretary. Sets forth reporting and recordkeeping requirements respecting the distribution of such formula as may be necessary to effect and monitor recalls. Directs the Secretary to prescribe the scope and extent of such recalls. Exempts infant formulas represented and labelled for use by infants having unusual medical or dietary problems from the specified nutrient requirements of such Act. Permits the Secretary to establish terms and conditions for the exemption of other infant formulas from such requirements. Grants an inspector enforcing the provisions of this Act access to specified records of the manufacturer at all times. Makes the failure to submit required reports or to provide required notice prohibited acts under the Federal Food, Drug, and Cosmetic Act.

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Documents

5 official files

• Public Law (PDF)

  Public Law · EN · 27 September 1980

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• Passed Senate amended

  summary · EN · 8 September 1980

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• Passed House amended

  summary · EN · 20 May 1980

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• Reported to House with amendment(s)

  summary · EN · 12 May 1980

  Open at official source

• Introduced in House

  summary · EN · 26 March 1980

  Open at official source

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