An Act to require studies concerning carcinogenic and other toxic substances in food, the regulation of such food, the impurities in and toxicity of saccharin, and 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 saccharin; and for other purposes.
PL 95-203 (S.1750), enacted 11/23/1977

PUBLIC LAW 95-203—NOV. 23, 1977 
91 STAT. 1451 
Public Law 95-203 
95th Congress 
An Act 
To require studies concerning carcinogenic and other toxic .sul)stauces in food, 
the regulation of such food, the Impurities in and toxicity of saccharin, and 
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^ 
SECTION 1. This Act may be cited as the "Saccharin Study and 
Labeling Act". 
SEC. 2. (a)(1) The Secretary of Health, Education, and Welfare 
(hereinafter in this Act referred to as the "Secretary") shall arrange, 
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 part 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 
Sciences (hereinafter in this section referred to as the "Academy"), 
acting through appropriate units, to conduct the studies, required by 
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, 
the Secretary shall enter into such an agreement with the Academy. 
Nov. 23, 1977 
[S. 1750] 
Saccharin Study 
and Labeling Act. 
21 u s e 301 note. 
Study. 
21 u s e 343 note. 
National 
Academy of 
Sciences, conduct 
of studies. 
Agreement. 
91 STAT. 1452 
PUBLIC LAW 95-203—NOV. 23, 1977 
Reports to 
congressional 
committees. 
"Saccharin." 
21 u s e 348 note. 
21 u s e 301. 
Labeling. 
21 use 343. 
(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 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 study), 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 (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. 
(d) For purposes of this section and section 3, the term "saccha-
lin" 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 regula-
tion of the Food and Drug 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 
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 drug 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 sub-
paragraph (2), its label and labeling bear the following statement: 
*USE OF T H I S PRODUCT MAY BE HAZARDOUS TO YOUR 
H E A L T H . T H I S PRODUCT CONTAINS SACCHARIN W H I C H 
H A S B E E N D E T E R M I N E D TO CAUSE CANCER IN LABORA-
T O R Y ANIMALS'. 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 
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 
respect to food introduced or delivered for introduction in interstate 
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 
Resources of the Senate and the Committee on Interstate and Foreign 
Commerce of the House of Representatives any action taken under 
section 403 (o) (2) of the Federal Food, Drug, and Cosmetic Act. 
(b) (1) Section 403 of the Federal Food, Drug, and Cosmetic Act 
is amended by adding after paragraph (o) the following new 
paragraph: 
"(p) (1) If it contains saccharin and is offered for sale, but not for 
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 
the requirement of subparagraph (1) if he determines such action is 
necessary to reflect the current state of knowledge concerning 
saccharin. 
"(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-
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. 
In any action brought for judicial review of any such regulation, the 
reviewing court may not postpone the effective date of such 
regulation.". 
(2) The amendment made by paragraph (1) shall apply with 
respect to food which is sold in retail establishments on or after the 
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. 
(3) Section 201 of the Federal Food, Drug, and Cosmetic Act is 
amended by adding at the end thereof the following: 
"(z) The term 'saccharin' includes calcium saccharin, sodium sac-
charin, and ammonium saccharin.". 
(c) The Secretary may by regulation require vending machines 
through which food containing saccharin is sold to bear a statement of 
the risks to health which may be presented by the use of saccharin. A 
regulation under this subsection shall require such statement to be 
located in a conspicuous place on such vending machine and as proxi-
Regulation. 
Effective date. 
21 u s e 343 note. 
Report to 
congressional 
committees. 
21 u s e 343 note. 
Supra. 
Retail 
establishments, 
notice, display. 
21 u s e 343. 
Notice 
requirement, 
review, revision 
or removal. 
Hearing. 
42 u s e 4321 
note. 
5 u s e 500 et seq. 
Judicial review. 
Effective date. 
21 u s e 343 note. 
Supra. 
"Saccharin." 
21 use 321. 
Vending 
machines, health 
risk statement, 
requirements. 
21 u s e 343a. 
91 STAT. 1454 
PUBLIC LAW 95-203—NOV. 23, 1977 
21 u s e 301. 
Information, 
availability and 
distribution. 
42 u s e 289Z-1 
note. 
42 u s e 218 note. 
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-
eral Food, Drug, and Cosmetic Act, be considered a misbranded food. 
(d) The Secretary shall (1) prepare information respecting the 
nature of the controversy surrounding the use of food containing 
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 
Law 93-348) is amended by striking out ''36-month period" each place 
it appears and inserting in lieu thereof "42-month period". 
(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.