Infant Formula Act of 1980

Summary

Infant Formula Act of 1980 - Amends the Federal Food, Drug, and Cosmetic Act to make the failure to comply with the infant formula standards, testing, notification, and reporting requirements a prohibited act. Makes the failure to comply with the required standards of identity and quality cause to deem such formula adulterated. Makes the failure to comply with the labeling and packaging requirements cause to deem such formula misbranded. Directs the Secretary of Health and Human Services (formerly, the Secretary of Health, Education, and Welfare) to promulgate regulations establishing standards of identity and quality, including the required nutrients at minimum and maximum levels, for infant formula. Permits the Secretary to exempt from such regulations any infant formula intended for use by an infant having unusual medical or dietary problems. Requires each processor of infant formula to submit to the Secretary within a specified period of time the reports or test results showing compliance with the prescribed standards. Requires such processor to submit reports and test results within a specified period upon each reformulation of such formula. Requires processors to either notify the Secretary or institute a recall and then notify the Secretary upon acquiring information indicating that any of its already distributed infant formula may be misbranded or adulterated. Prohibits the use in a proceeding against a processor of any information required by the Secretary to be contained in a notification. Sets forth the recordkeeping requirements for processors of infant formula, including manufacturing and distribution information. Permits the detention of formula by an inspector who has reason to believe such formula is adulterated or misbranded. Sets forth procedures for the confirmation or revocation of such detention. Permits the movement of such detained formula upon release by the Secretary or at the end of a prescribed detention period. Requires that inspectors enforcing the requirements of this Act have access to specified records at all reasonable times. Requires each processor of infant formula to prepare information labeling for users to accompany the product. Sets forth the labeling requirements, including a summary of benefits and risks, directions for use, and storage information. Requires that such information be prominently and conspicuously placed on the labeling. Requires such processors to prepare information labeling for practitioners for the subsequent distribution of such formula. Prohibits the exportation of any infant formula which does not comply with specified requirements of this Act.

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Documents

3 official files

• Indefinitely postponed in Senate

  summary · EN · 8 September 1980

  Open at official source

• Reported to Senate with amendment(s)

  summary · EN · 26 August 1980

  Open at official source

• Introduced in Senate

  summary · EN · 27 March 1980

  Open at official source

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