Saccharin Study and Labeling Act of 1977 explained

Shorttitle:Saccharin Study and Labeling Act of 1977
Longtitle: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.
Colloquialacronym:SSLA, SSLAA
Nickname:Saccharin Study, Labeling and Advertising Act
Enacted By:95th
Effective Date:November 23, 1977
Public Law Url:http://www.gpo.gov/fdsys/pkg/STATUTE-91/pdf/STATUTE-91-Pg1451.pdf
Cite Public Law:95-203
Title Amended:21 U.S.C.: Food and Drugs
Leghisturl:http://thomas.loc.gov/cgi-bin/bdquery/z?d095:SN01750:@@@R
Introducedin:Senate
Introducedby:Ted Kennedy (DMA)
Introduceddate:June 23, 1977
Committees:Senate Human Resources, Senate Commerce, Science, and Transportation, House Interstate and Foreign Commerce
Passedbody1:Senate
Passeddate1:September 15, 1977
Passedvote1:87-7
Passedbody2:House
Passeddate2:October 17, 1977
Passedvote2:375-23, in lieu of
Conferencedate:November 3, 1977
Passedbody3:House
Passeddate3:November 3, 1977
Passedvote3:agreed
Passedbody4:Senate
Passeddate4:November 4, 1977
Passedvote4:agreed
Signedpresident:Jimmy Carter
Signeddate:November 23, 1977

Saccharin Study and Labeling Act of 1977 or Saccharin Study, Labeling and Advertising Act was a United States federal statute endorsing 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 39th President of the United States Jimmy Carter on November 23, 1977.

Research Perspective

In 1948 to 1949, U.S. Food and Drug Administration pathologists conducted laboratory analyses on Osborne-Mendel rat specimens concluding lymphosarcoma after a two-year laboratory analysis.[1] In 1951, scientists collaboratively suggested the white crystalline sweetening agent could be a possible carcinogen. In 1958, saccharin was registered Generally Recognized As Safe (GRAS) by decree of the food additives amendment retaining the non-nutritive sweetener as a marketable product for human consumption.

In 1972 to 1973 after much growing concern among the United States population, the U.S. Food and Drug Administration and Wisconsin Alumni Research Foundation (WARF) led carcinogenic studies concluding the incidence of bladder tumors in Charles River Sprague-Dawley rat specimens. As a result of the laboratory analyses, the U.S. Food and Drug Administration revoked the Generally Recognized As Safe (GRAS) classification and imposed regulatory procedures restricting the use of saccharin in food products.[2] In 1974, the National Academy of Sciences published a scientific review emphasizing saccharin could not be identified as the carcinogenic agent of benign tumors and malignant tumors due to equivocal analysis procedures, inadequate scientific experimental design, and potential impurities.[3] [4]

In 1977, the Canadian Health Protection Branch Study was completed on Charles River Sprague-Dawley rat specimens concluding lymphoma in the blood cells.[5] [6] [7] The Canadian carcinogenic study encouraged Canada to remove saccharin as a marketable product for human consumption in 1977.[8]

Provisions of the Act

The Act established criteria for the scientific study of saccharin with key elements regarding the display, notification, and labeling of the non-nutritive sweetener.

Saccharin and sweetening agent variants

'Saccharin' includes calcium saccharin, sodium saccharin, and ammonium saccharin.

Saccharin and conduct of study

(A) The Secretary of Health, Education, and Welfare shall arrange an analytical study to be conducted and based on available information of;

(B) The Secretary shall arrange a study to be conducted and to determine to the extent feasible of;

Entity to conduct study

National Academy of Sciences is to conduct the studies whereby the actual expenses incurred by the Academy directly related to the non-nutritive sweeteners studies will be incurred by the Department of Health, Education, and Welfare. If the National Academy of Sciences declines the 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 the non-nutritive sweeteners study.

Reports to congressional committees

Within twelve months of the date of the enactment of the Act a report is to be submitted to the Senate Committee on Human Resources and the House Committee on Interstate and Foreign Commerce;

Within fifteen months of the date of the enactment of the Act a report is to be submitted to the Senate Committee on Human Resources and the House Committee on Interstate and Foreign Commerce;

Labeling requirement

If product contains saccharin, a label or labeling shall bear the following statement:

The statement is to 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 contrast by typography, layout, and color with other printed matter on such label and labeling.

Labeling requirement for retail establishments, notice, and display

Vending machines and health risk statement requirements

Regulation requires 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. Regulation requires such statement to be located in a conspicuous place on such vending machine and as proximate 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 the labeling requirement is to be considered a misbranded food.

Information availability and distribution

Amendments to 1977 Act

U.S. Congressional amendments to the Saccharin Study and Labeling Act of 1977.

Date of EnactmentPublic Law NumberU.S. Statute CitationU.S. Legislative BillU.S. Presidential Administration
June 17, 1980P.L. 96-273Jimmy E. Carter
August 14, 1981P.L. 97-42Ronald W. Reagan
April 22, 1983P.L. 98-22Ronald W. Reagan
May 24, 1985P.L. 99-46Ronald W. Reagan
April 1, 1996P.L. 104-124William J. Clinton

Repeal of Saccharin Clause

See also: National Toxicology Program. The saccharin health risks clause, 21 U.S.C. § 343a, was repealed by the United States 106th Congressional session enactment of the Consolidated Appropriations Act of 2001.[9] [10] [11] The 2001 Appropriations Act was confirmed as a federal law by the 42nd President of the United States Bill Clinton on December 21, 2000.[12] [13]

External links

Notes and References

  1. Carcinogenicity of Saccharin . Reuber . Melvin Dwaine . August 1978 . 174–175, 187 . 1637197 . 363408 . 25 . Environ. Health Perspect. . 10.1289/ehp.7825173.
  2. Web site: F.D.A. Removes Saccharin From List of Safe Foods . Harold M. Schmeck Jr. . January 29, 1972 . The New York Times.
  3. Carcinogenicity of Saccharin . Reuber . Melvin Dwaine . August 1978 . 197 . National Institutes of Health . National Institute of Environmental Health Science . 1637197 . 363408 . 25 . 10.1289/ehp.7825173.
  4. Web site: Dissent on Saccharin Report; Dozen on Science Academy Panel Express Serious Doubts About Federal Approval of Additive Use News Analysis Delaney Clause Endorsed Many Studies in Decade . Richard D. Lyons . March 5, 1979 . The New York Times.
  5. Web site: New Canadian Study Connects Sweeteners With Cancer in Men . June 18, 1977 . The New York Times.
  6. Web site: F.D.A. Says New Canadian Study Reinforces Its Ban of Saccharin . June 19, 1977 . The New York Times.
  7. Carcinogenicity of Saccharin . Reuber . Melvin Dwaine . August 1978 . 181, 183, 193 . National Institutes of Health . National Institute of Environmental Health Science . 1637197 . 363408 . 25 . 10.1289/ehp.7825173.
  8. Web site: Canada's Saccharin Ban Leaves a Bitter Taste . Robert Trumbull . May 14, 1978 . The New York Times.
  9. Web site: Consolidated Appropriations Act of 2001 ~ P.L. 106-554 . December 21, 2000 . 114 Stat. 2763 (2763A–73) ~ House Bill 4577 . U.S. Government Printing Office.
  10. Web site: H.R. 4577 ~ Consolidated Appropriations Act of 2001 . June 1, 2000 . P.L. 106-554 ~ 114 Stat. 2763 (2763A–73) . Congress.gov.
  11. Web site: S. 2553 ~ Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act of 2001 . May 12, 2000 . P.L. 106-554 ~ 114 Stat. 2763 (2763A–73) . Congress.gov.
  12. Web site: Remarks on Signing the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2001 - December 21, 2000 . Clinton . William J. . December 21, 2000 . Internet Archive . Washington, D.C. . National Archives and Records Service . 2762–2766.
  13. Web site: Statement on Signing the Consolidated Appropriations Act, FY 2001 - December 21, 2000 . Clinton . William J. . December 21, 2000 . Internet Archive . Washington, D.C. . National Archives and Records Service . 2770–2777.