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Title: Alternative Sweeteners

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162 Pearson<br />

In 1997, a special International Agency for Research on Cancer (IARC)<br />

panel determined the bladder tumors in male rats resulting from the ingestion of<br />

high doses of sodium saccharin are not relevant to man. In 1998, IARC downgraded<br />

saccharin from a Group 2B substance, possibly carcinogenic to humans,<br />

to Group 3. Substances may be placed in Group 3 when there is strong evidence<br />

that the mechanism of carcinogenicity in experimental animals does not operate<br />

in humans. This was the first time IARC had considered mechanistic data (72).<br />

In 1996, the Calorie Control Council submitted a petition to the U.S. National<br />

Toxicology Program (NTP) requesting that, under the program’s new criteria<br />

allowing for the consideration of mechanistic data, saccharin be delisted from<br />

the NTP’s Ninth Report on Carcinogens. In May 2000, the NTP released the 9th<br />

edition and announced that saccharin had been delisted (73).<br />

X. REGULATORY<br />

Saccharin is a widely used noncaloric sweetener available for use in more than<br />

100 countries. In the United States, it is approved for use under an interim food<br />

additive regulation, permitting use for special dietary and certain technological<br />

purposes (74). In 1977, the U.S. Food and Drug Administration proposed a ban<br />

on saccharin as a result of studies reporting bladder tumors in some male rats<br />

fed high doses of sodium saccharin. The U.S. Congress passed a moratorium<br />

preventing the proposed ban. The moratorium has been extended seven times.<br />

The current moratorium is in effect until May 1, 2002. In 1991, the FDA formally<br />

withdrew its 1977 proposed ban on saccharin. On December 21, 2000,<br />

U.S. President Bill Clinton signed legislation removing the saccharin warning<br />

label that had been required on saccharin-sweetened foods and beverages since<br />

1977 (75).<br />

In 1993, the Joint Food and Agriculture/World Health Organization Expert<br />

Committee on Food Additives reviewed saccharin and doubled its acceptable<br />

daily intake. The Committee noted that the animal data which earlier raised questions<br />

about saccharin are not considered relevant to man (76). Saccharin also has<br />

been evaluated and determined safe by the European Union’s Scientific Committee<br />

for Food (77).<br />

XI. CONCLUSION<br />

Saccharin has been used to sweeten foods and beverages for more than a century<br />

and remains an important sweetener. It is one of the most researched food ingredients<br />

available, having been studied in rats, mice, hamsters, monkeys, and humans<br />

and determined to be safe for human consumption.

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