Saccharin and Cancer Risk
Saccharin is not associated with cancer in humans and does not cause inflammation at typical consumption levels. The evidence consistently demonstrates that while high-dose saccharin causes bladder tumors in male rats through a species-specific mechanism involving bladder stone formation, this mechanism does not occur in humans, and extensive epidemiological studies have found no increased cancer risk in people who consume saccharin 1.
Cancer Risk Evidence
Removal from Carcinogen List
- Saccharin was officially removed from the U.S. National Toxicology Program's list of potential carcinogens in 2001, reflecting the scientific consensus that it does not pose a cancer risk to humans 1.
- The FDA has approved saccharin as safe for consumption by the general public after rigorous scrutiny 1.
Animal Studies vs. Human Evidence
- High doses of sodium saccharin (5-7.5% of total diet) cause bladder stones in male rats, which can lead to bladder tumors through a mechanism specific to rodents 1.
- This rat-specific mechanism involves bladder stone formation that does not occur in humans who consume saccharin 1.
- The form used in animal studies (sodium-saccharin at extremely high doses) represents a large group of sodium salts known to act as tumor promoters specifically in the male rat urinary bladder, making these findings irrelevant to human consumption 1.
Human Epidemiological Studies
- A total of 30 human studies conducted to date have found no association between saccharin use and cancer of any type 1.
- A large case-control study of 3,010 people with bladder cancer and 5,783 controls found no association between self-reported past saccharin use and bladder cancer 1.
- Multiple case-control studies of adults with incident neoplasia (stomach, pancreas, endometrium) versus unaffected controls did not find greater odds of cancer among those exposed to saccharin 1.
Inflammation Evidence
There is no evidence in the provided guidelines or research that saccharin causes inflammation in humans. The mechanism by which saccharin might theoretically increase cancer risk in humans (if it did at all) would require doses many times greater than amounts typically consumed 1.
Safety Considerations
General Population
- Saccharin is considered safe when consumed within FDA-established acceptable daily intake levels 1, 2.
- The FDA determined saccharin safe for consumption by the public, including people with diabetes, after rigorous pre-market scrutiny 1.
Special Populations
- Pregnant women should avoid saccharin because it can cross the placenta and remain in fetal tissues due to slow fetal clearance, though there is no definitive evidence of harmful effects 2.
- Other FDA-approved sweeteners like aspartame, sucralose, and acesulfame-K can be consumed in moderation during pregnancy 2.
- People with diabetes can safely use saccharin as it does not need to be restricted due to concerns about aggravating hyperglycemia 1.
Clinical Bottom Line
The concern about saccharin causing cancer stems from outdated animal studies using extremely high doses that produced a rodent-specific mechanism not applicable to humans. The weight of evidence from three decades of human epidemiological research, combined with the official removal from carcinogen lists and FDA approval, firmly establishes that saccharin does not increase cancer risk in humans at typical consumption levels 1. There is no evidence linking saccharin to inflammation in humans.