PUBLIC LAW 96-359—SEPT. 26, 1980
94 STAT. 1193
SEC. 3. Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: "Infant "(aa) The term 'infant formula' means a food which purports to be formula." or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.". SEC. 4. Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended— (1) in the first sentence, by inserting "(1)" before "For purposes" and by redesignating clauses (1) and (2) as clauses (A) and (B), respectively; (2) in the third sentence, by inserting "or by paragraph (3)" after "preceding sentence"; (3) in the sixth sentence, (A) by striking out "The provisions of the second sentence of this subsection" and inserting in lieu thereof the following: "(2) The provisions of the second sentence of paragraph (1)", and (B) by redesignating paragraphs (1) through (4) as subparagraphs (A) through (D), respectively; and (4) by adding at the end the following: "(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of section 412 applica- Ante, p. 1190. ble to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records— "(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 412, or "(B) required to be maintained under section 412.". SEC. 5. (a) Section 301 of the Federal Food, Drug, and Cosmetic Act 21 USC 331. is amended by adding at the end the following new paragraph: "(s) The failure to provide the notice required by section 412(b) or 412(c), the failure to make the reports required by section 412(d)(1)(B), or the failure to meet the requirements prescribed under section 412(d)(2).". Ob) Section 301(e) of such Act is amended (1) by striking out "section 703" and inserting in lieu thereof "section 412 or 703", and (2) by striking out "section 505" and inserting in lieu thereof "section 412, 505". (c) Section 301(j) of such Act is amended by inserting "412," before "505". SEC. 6. Section 412 of the Federal Food, Drug, and Cosmetic Act Effective date. (added by section 2) shall apply with respect to infant formulas 21 USC 350a manufactured on or after the 90th day after the date of the enact- note. ment of this Act. SEC. 7. (a) The Secretary of Health and Human Services shall Health study. conduct a study to determine the long-term effect on infants of hypochloremic metabolic alkalosis resulting from infant formulas deficient in chloride. The Secretary shall report the results of such Report to Congress. study to the Congress. (b) The Secretary of Health and Human Services shall conduct a Federal labeling review of existing Federal requirements for the labeling of infant requirements, formula to determine the effect of such requirements on infant review. Submittal to nutrition and proper use of infant formula. Not later than the 180th congressional day after the date of the enactment of this Act, the Secretary shall committees.
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