saccharin molecule

Regulatory History of Saccharin

home button
general information button
fda button
proposition 65 button
tox research button
authors opinion button

1879 - Saccharin, a synthetic compound derived from coal tar, is discovered by a student researcher at Johns Hopkins University.

– A top food safety official tried to ban saccharin from use as a sweetener, but the idea was adamantly opposed by President Theodore Roosevelt.

1911 – A board of federal scientists called saccharin “an adulterant” that should not be used in foods and limited its use to products intended for invalids. The restriction was lifted during World Wars I & II due to shortages of sugar.

– The Delaney Clause was enacted into law prohibiting the use of any food additive shown to cause cancer in animals or humans.

1958 – Congress passed the Food Additives Amendment to the Food, Drug and Cosmetic Act requiring pre-market approval from the U.S. Food and Drub Administration (FDA) for food additives developed after 1958. This did not apply to saccharin, which was classified by the FDA as “generally recognized as safe” (GRAS).

1969 – An FDA Ban on cyclamates, a sweetener similar to saccharin, led to investigations of saccharin carcinogenicity

1970 – The FDA started to review GRAS substances to ensure that current scientific information backed the safety claims

1972/73 – Toxicological rat studies indicated the possibility that bladder cancer could be caused by saccharin. The data, however, suggested that impurities in saccharin were actually causing the cancer.

1972 – The FDA removed saccharin from the list of GRAS substances and issued an interim food additive regulation limiting use of saccharin in foods.

1974 – The National Academy of Science reviewed available data and stated that saccharin itself could not be identified as the cause of tumors due to impurities and problems with research. FDA interim regulations remained in effect.

1977 – Canadian rat studies by Arnold D.L., et al., showed that saccharin itself was causing bladder cancer in rats (primarily male); Based on these studies, the FDA proposed to ban all uses of Saccharin except for over-the-counter (OTC) drugs for use by diabetics and/or those who would benefit from an artificial sweetener.

1977 – Congress passes two year moratorium preventing the proposed FDA ban on saccharin.. Congress asks for additional research and institutes product labeling requirements.

– The National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC) listed saccharin and its salts as “anticipated human carcinogen” based on Canadian rat studies.

1988 – Saccharin and its salt, sodium saccharin were added to the State of California’s Proposition 65 list as chemicals known to cause cancer.

1991 – The FDA formally withdraws its 1977 proposal to ban the use of saccharin.

1998 – The International Agency for Research on Cancer (IARC) downgraded rating of saccharin and its salts from “possibly carcinogenic to humans” to “not classifiable as to its carcinogenicity to humans”.

2000 – The NTP removed saccharin from its 9th Edition of the Report on Carcinogens.

2000 – President Clinton signed a bill to remove the warning label from saccharin products.

2001 – The Carcinogen Identification Committee of the State of California issued a request for data and comments from professionals and the public regarding new information on sodium saccharin. Currently, sodium saccharin products still carry the warning label.

Return to top of page

Page last updated: 2/23/05