The text of the bill below is as of Nov 23, 1977 (Passed Congress).
Summary of this bill
Saccharin Study and Labeling Act of 1977 or Saccharin Study, Labeling and Advertising Act was a United States federal statute enacting requirements for a scientific observation regarding the impurities in, potential toxicity, and problematic carcinogenicity of a non-nutritive sweetener better known as saccharin. The Act of Congress invoked an immediate eighteen month moratorium prohibiting the Secretary of Health, Education, and Welfare from pursuing regulatory implications by limiting the production and use of saccharin. The Act codified a warning label requirement advocating the non-nutritive sweetener had been discovered to yield carcinogenicity in laboratory animals.
The S. 1750 legislation was passed by the 95th Congressional session and signed into law by the ...
PUBLIC LAW 9 5 - 2 0 3 — N O V . 2 3 , 1977 91 STAT. 1451 Public Law 95-203 95th Congress An Act To require studies concerning carcinogenic and other toxic .sul)stauces in food, Nov. 23, 1977 the regulation of such food, the Impurities in and toxicity of saccharin, and [S. 1750] the health benefits, if any, resulting from the use of nonnutritive sweeteners; to prohibit for 18 months the Secretary of Health, Education, and Welfare from taking certain action restricting the continued use of saccharin as a food, drug, and cosmetic; to require certain labels and notices for foods containing saccha- rin ; and for other purposes. Be It enacted hy the Senate and House of RepresentatireH of the United States of America in Congress assembled^ Saccharin Study SECTION 1. This Act may be cited as the "Saccharin Study and and Labeling Act. Labeling Act". 21 u s e 301 note. SEC. 2. ( a ) ( 1 ) The Secretary of Health, Education, and Welfare Study. (hereinafter in this Act referred to as the "Secretary") shall arrange, 21 u s e 343 note. in accordance with subsection ( b ) , for the conduct of a study, based on available information, of— (A) current technical capabilities to predict the direct or secondary carcinogenicity or other toxicity in humans of sub- stances which are added to, become a p a r t of, or naturally occur in, food and which have been found to cause cancer in animals; ( B ) the direct and indirect health benefits and risks to indi- viduals from foods which contain carcinogenic or other toxic substances; (C) the existing means of evaluating the risks to health from the carcinogenicity or other toxicity of such substances, the exist- ing means of evaluating the health benefits of foods containing such substances, and the existing statutory authority for, and appropriateness of, weighing such risks against such benefits; (D) instances in which requirements to restrict or prohibit the use of such substances do not accord with the relationship between such risks and benefits; and ( E ) the relationship between existing Federal food regulatory policy and existing Federal regulatory policy applicable to car- cinogenic and other toxic substances used as other than foods. (2) The Secretary shall arrange, in accordance with subsection ( b ) , for the conduct of a study to determine, to the extent feasible— (A) the chemical identity of any impurities contained in com- mercially used saccharin, ( B ) the toxicity or potential toxicity of any such impurities, including their carcinogenicity or potential carcinogenicity in humans, and (C) the health benefits, if any, to humans resulting from the use of nonnutritive sweeteners in general and saccharin in particular. (b) (1) The Secretary shall first request the National Academy of National Sciences (hereinafter in this section referred to as the "Academy"), Academy of acting through appropriate units, to conduct the studies, required by Sciences, conduct of studies. subsection ( a ) , under an arrangement whereby the actual expenses incurred by the Academy directly related to the conduct of such studies will be paid by the Secretary. If the Academy agrees to such request, Agreement. the Secretary shall enter into such an agreement with the Academy.
91 STAT. 1452 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 non- profit private entity to conduct such study. (3) Any arrangement entered into under p a r a g r a p h (1) or (2) of this subsection for the conduct of a study shall require t h a t such study be completed and reports thereon be submitted within such period as the Secretary may require to meet the requirements of subsection ( c ) . Reports to (c) (1) Within 12 months of the date of the enactment of this Act congressional the Secretary shall report to the Committee on H u m a n Resources of committees. 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 H u m a n Resources of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives (A) the results of the studies (includ- ing 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. "Saccharin." (d) F o r purposes of this section and section 3, the term "saccha- l i n " includes calcium saccharin, sodium saccharin, and ammonium saccharin. 21 u s e 348 note. SEC. 3. D u r i n g 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 regula- tion of the Food and D r u g Administration of the Department of Health, Education, and Welfare applicable to saccharin and pub- lished 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 21 u s e 301. 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. Labeling. SEC. 4. ( a ) ( 1 ) Section 403 of the Federal Food, Drug, and Cosmetic 21 use 343. Act is amended by adding at the end thereof the following new paragraph: " ( o ) (1) If it contains saccharin, unless, except as provided in sub- paragraph ( 2 ) , its label and labeling bear the following statement: *USE O F T H I S P R O D U C T M A Y B E H A Z A R D O U S T O Y O U R HEALTH. THIS PRODUCT CONTAINS SACCHARIN W H I C H HAS BEEN DETERMINED TO CAUSE CANCER IN LABORA- T 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-
PUBLIC LAW 95-203—NOV. 23, 1977 91 STAT. 1453 trast by typography, layout, and color with other printed matter on such label and labeling. "(2) The Secretary may by regulation review and revise or remove Regulation. the requirement of subparagraph (1) if the Secretary determines such action is necessary to reflect the current state of knowledge concern- ing saccharin.". (2) The amendment made by paragraph (1) shall apply only with Effective date. respect to food introduced or delivered for introduction in interstate 21 u s e 343 note. commerce on and after the 90th day after the date of the enactment of this Act. (3) The Secretary shall report to the Committee on Human Report to Resources of the Senate and the Committee on Interstate and Foreign congressional Commerce of the House of Representatives any action taken under committees. section 403 (o) (2) of the Federal Food, Drug, and Cosmetic Act. 21 u s e 343 note. (b) (1) Section 403 of the Federal Food, Drug, and Cosmetic Act Supra. is amended by adding after paragraph (o) the following new Retail establishments, paragraph: notice, display. "(p) (1) If it contains saccharin and is offered for sale, but not for 21 u s e 343. immediate consumption, at a retail establishment, unless such retail establishment displays prominently, where such food is held for sale, notice (provided by the manufacturer of such food pursuant to sub- paragraph (2)) for consumers respecting the information required by paragraph (o) to be on food labels and labeling. "(2) Each manufacturer of food which contains saccharin and which is offered for sale by retail establishments but not for immedi- ate consumption shall, in accordance with regulations promulgated by the Secretary pursuant to subparagraph (4), take such action as may be necessary to provide such retail establishments with the notice required by subparagraph (1). "(3) The Secretary may by regulation review and revise or remove Notice the requirement of subparagraph (1) if he determines such action is requirement, necessary to reflect the current state of knowledge concerning review, revision saccharin. or removal. "(4) The Secretary shall by regulation prescribe the form, text, and manner of display of the notice required by subparagraph (1) and such other matters as may be required for the implementation of the requirements of that subparagraph and subparagraph (2). Regula- Hearing. tions of the Secretary under this subparagraph shall be promulgated after an oral hearing but without regard to the National Environmen- tal Policy Act of 1969 and chapter 5 of title 5, United States Code. 42 u s e 4321 In any action brought for judicial review of any such regulation, the note. reviewing court may not postpone the effective date of such 5 u s e 500 et seq. regulation.". Judicial review. (2) The amendment made by paragraph (1) shall apply with Effective date. respect to food which is sold in retail establishments on or after the 21 u s e 343 note. 90th day after the effective date of the regulations of the Secretary of Health, Education, and Welfare under paragraph (p) (4) of the Federal Food, Drug, and Cosmetic Act. Supra. (3) Section 201 of the Federal Food, Drug, and Cosmetic Act is "Saccharin." amended by adding at the end thereof the following: 21 use 321. "(z) The term 'saccharin' includes calcium saccharin, sodium sac- charin, and ammonium saccharin.". (c) The Secretary may by regulation require vending machines Vending through which food containing saccharin is sold to bear a statement of machines, health the risks to health which may be presented by the use of saccharin. A risk statement, regulation under this subsection shall require such statement to be requirements. 21 u s e 343a. located in a conspicuous place on such vending machine and as proxi-
91 STAT. 1454 PUBLIC LAW 95-203—NOV. 23, 1977 mate as possible to the name of each food containing saccharin which is sold through such machine. Any food containing saccharin which is sold in a vending machine which does not meet any applicable require- ment promulgated under this subsection shall, for purposes of the Fed- 21 u s e 301. eral Food, Drug, and Cosmetic Act, be considered a misbranded food. Information, (d) The Secretary shall (1) prepare information respecting the availability and nature of the controversy surrounding the use of food containing distribution. saccharin, and (2) provide for the distribution of such information for display by retail establishments where such food is sold but not for immediate consumption. The Secretary may review and revise such information if he determines such action is necessary to reflect the cur- rent state of knowledge concerning the risks to health presented by the use of saccharin. SEC. 5. (a) Section 204(d) of the Xational Research Act (Public 42 u s e 289Z-1 Law 93-348) is amended by striking out ''36-month period" each place note. it appears and inserting in lieu thereof "42-month period". 42 u s e 218 note. (b) Section 211(b) of such Act is amended by striking out "Janu- ary 1, 1978" and inserting in lieu thereof "November 1, 1978". Approved November 23, 1977. LEGISLATIVE HISTORY: HOUSE REPORTS: No. 95-658 accompanying H.R. 8518 (eomm. on Interstate and Foreign Commerce) and No. 95-810 (Comm. of Conference). SENATE REPORTS: No. 95-353 (Comm. on Human Resources) and No. 95-369 (Comm. on Commerce, Science, and Transportation). CONGRESSIONAL RECORD, Vol. 123 (1977): Sept. 14, 15, considered and passed Senate. Oct. 17, considered and passed House, amended, in lieu of H.R. 8518. Nov. 3, House agreed to conference report. Nov. 4, Senate agreed to conference report.