Page:United States Statutes at Large Volume 91.djvu/1486

 91 STAT. 1452

Reports to congressional committees.

"Saccharin."

21 USC 348 note.

21 USC 301.

Labeling.

21 USC 343.

PUBLIC LAW 95-203—NOV. 23, 1977 (2) If the Academy declines the Secretary's request to conduct any such study under such an arrangement, then the Secretary shall enter into a similar arrangement with another appropriate public or nonprofit private entity to conduct such study. (3) Any arrangement entered into under paragraph (1) or (2) of this subsection for the conduct of a study shall require that such study be completed and reports thereon be submitted within such period as the Secretary may require to meet the requirements of subsection (c). (c)(1) Within 12 months of the date of the enactment of this Act the Secretary shall report to the Committee on Human Resources of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives (A) the results of the study conducted pursuant to subsection (a)(2) (including supporting data and other materials provided by the entity which conducted the s t u d y), and (B) any action proposed to be taken on the basis of the results of the study. (2) Within 15 months of the date of the enactment of this Act the Secretary shall report to the Committee on Human Resources of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives (A) the results of the studies (including supporting data and other materials provided by the entity which conducted the study) conducted pursuant to subsection (a)(1), (B) the reconunendations, if any, of such entity for legislative and administrative action, and (C) such recommendations for legislative action as the Secretary deems necessary. (d) For purposes of this section and section 3, the term "sacchal i n " includes calcium saccharin, sodium saccharin, and ammonium saccharin. SEC. 3. During the 18-month period beginning on the date of the enactment of this Act, the Secretary— (1) may not amend or revoke the interim food additive regulation of the Food and D r u g Administration of the Department of Health, Education, and Welfare applicable to saccharin and published on March 15, 1977 (section 180.37 of part 180, subchapter B, chapter 1. title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or (2) may, except as provided in section 4 and the amendments made by such section, not take any other action under the Federal Food, Drug, and Cosmetic Act to prohibit or restrict the sale or distribution of saccharin, any food permitted by such interim food additive regulation to contain saccharin, or any d r u g or cosmetic containing saccharin, solely on the basis of the carcinogenic or other toxic effect of saccharin as determined by any study made available to the Secretary before the date of the enactment of this Act which involved human studies or animal testing, or both. SEC. 4. (a)(1) Section 403 of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end thereof the following new paragraph: " (o)(1) If it contains saccharin, unless, except as provided in subparagraph (2), its label and labeling bear the following statement: HEALTH. THIS PRODUCT CONTAINS SACCHARIN W H I C H HAS BEEN DETERMINED TO CAUSE CANCER IN LABORAT O R Y A N I M A L S '. Such statement shall be located in a conspicuous place on such label and labeling as proximate as possible to the name of such food and shall appear in conspicuous and legible type in con-
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