legislation: 96-hr-6940
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| 96-hr-6940 | 96 | hr | 6940 | 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. | Health | 1980-03-26 | 1980-09-26 | Public Law 96-359. | House | Rep. Waxman, Henry A. [D-CA-24] | CA | D | W000215 | 23 | (Measure passed Senate, amended, in lieu of S. 2490) 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 to revise such requirements, establish quality control procedures and establish requirements respecting the retention of records of required 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 manufacturer who has knowledge which reasonably supports the conclusion that an infant formula leaving his or her control may be adulterated or misbranded so as to present a risk to human health 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 reasonable times. Makes the failure to submit required reports or to provide required notice prohibited acts under the Federal Food, Drug, and Cosmetic Act. Directs the Secretary to report to Congress on the long-term effect on infants of hypochloremic metabolic alkalosis resulting from infant formulas deficient in chloride. Directs the Secretary to study and report to the appropriate committees of Congress on: (1) existing Federal requirements for the labeling of such formula to determine the effects of such requirements on infant nutrition and the proper use of such formula; and (2) the issues concerning the export of infant formula which does not meet the requirements of this Act. Amends the Controlled Substances Act to direct the Attorney General to select annually the controlled substances determined to have the highest rate of abuse and prepare and make available to specified agencies of State descriptive and actual distribution patterns in such States of each such substance. Amends the Psychotropic Substances Act of 1978 to reinstate criminal penalties for violations relating to the possession, use, distribution, sale, or reporting requirements for piperidine. Amends the Controlled Substances Act to establish criminal penalties for a violation of such Act involving in excess of 1,000 pounds of marihuana. Establishes increased criminal penalties for a person committing multiple violations. | 2025-04-21T12:24:17Z |