Page:United States Statutes at Large Volume 94 Part 1.djvu/1240

 94 STAT. 1190

PUBLIC LAW 96-359—SEPT. 26, 1980

Public Law 96-359 96th Congress An Act Sept. 26, 1980 [H.R. 6940]

Infant Formula Act of 1980. 21 USC 301 note.

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Infant Formula Act of 1980". SEC. 2. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding after section 411 the following new section: REQUIREMENTS FOR INFANT FORMULAS

Adulterated formulas. 21 USC 350a.

Quality control procedures.

Testing.

Notification to Secretary.

"SEC. 412. (a)(1) An infant formula shall be deemed to be adulterated if— "(A) such infant formula does not provide nutrients as required by subsection (g); "(B) such infant formula does not meet the quality factor requirements prescribed by the Secretary under this section; or "(C) the processing of such infant formula is not in compliance with the quality control requirements prescribed by the Secretary under this section. "(2) The Secretary may by regulation— "(A) revise the list of nutrients in the table in subsection (g); "(B) revise the required level for any nutrient required by subsection (g); "(C) establish requirements for quality factors for such nutrients; and "(D) establish such quality control procedures as the Secretary determines necessary to assure that an infant formula provides nutrients in accordance with this section and establish requirements respecting the retention of records of procedures required under this clause (including maintaining necessary nutrient testing records). Quality control procedures prescribed by the Secretary shall include the periodic testing of infant formulas to determine whether they are in compliance with this section. "(b)(1) On the 90th day after the date of the enactment of this section, and on each 90th day thereafter, a manufacturer of infant formula shall notify the Secretary that each infant formula manufactured by such manufacturer provides the nutrients required under subsection (g). Such notification requirement shall expire upon the effective date of regulations relating to quality control procedures prescribed by the Secretary under subsection (a)(2)(D). "(2) Not later than the 90th day before the first processing of any infant formula for commercial or charitable distribution for human consumption, the manufacturer shall notify the Secretary whether— "(A) such infant formula provides nutrients in accordance with subsection (g) and meets the quality factor requirements prescribed by the Secretary; and "(B) the processing of such infant formula meets the quality control procedure requirements prescribed by the Secretary.

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