The Controversy and the Congressional Moratorium (1970s)
In the 1970s, studies on laboratory rats suggested a potential link between high doses of saccharin and bladder cancer. This led the FDA to propose banning it under the Delaney clause, which prohibited food additives found to cause cancer in animals. Public backlash, particularly from dieters and individuals with diabetes, prompted Congress to pass the Saccharin Study and Labeling Act of 1977. This act temporarily stopped the ban and required a warning label on saccharin-containing products.
The Reversal: New Research and Label Removal (2000s)
Further research conducted after 1977 led to a scientific consensus by the late 1990s that the mechanism causing bladder tumors in male rats was not relevant to humans. The rat-specific reaction was linked to a combination of factors unique to their urinary composition and not found in humans.
- In May 2000, the U.S. Department of Health and Human Services’ National Toxicology Program (NTP) removed saccharin from its list of substances “reasonably anticipated to be a human carcinogen”.
- In December 2000, legislation was signed to repeal the warning label requirement.
- By 2001, both the FDA and California declared saccharin safe for human consumption.
Current Status and Usage Restrictions
Currently, saccharin and its salts (sodium, calcium, and ammonium saccharin) are approved as safe food additives by the FDA when used within specific limits. They are used to sweeten various foods and beverages, such as processed items, fruit juice drinks, and as a table sugar substitute.
The FDA sets maximum usage levels based on the food type:
- Beverages, fruit juice drinks, and mixes: Maximum 12 milligrams of saccharin per fluid ounce.
- Processed Foods: Maximum 30 milligrams per serving size.
- Table Sugar Substitutes: Products like Sweet'n Low are approved for cooking or table use within safe consumption guidelines.
Comparison of Common Artificial Sweeteners Approved by the FDA
| Sweetener | Sweetness (vs. Sugar) | Calories | Heat-Stability | Common Uses | Brand Names |
|---|---|---|---|---|---|
| Saccharin | 300–400x | None | Stable | Beverages, table-top sweeteners | Sweet'n Low, Necta Sweet |
| Aspartame | ~200x | Caloric | Not stable | Diet sodas, cereals, dairy | NutraSweet, Equal |
| Sucralose | ~600x | None | Stable | Baked goods, beverages | Splenda |
| Acesulfame-K | ~200x | None | Stable | Frozen desserts, baked goods | Sunett, Sweet One |
Conclusion: A History of Scrutiny Leads to Modern Approval
The question "is saccharin legal in the US?" is definitively answered 'yes.' Saccharin has undergone extensive evaluation, including a period with a warning label due to animal study findings that were later found not applicable to humans. The warning label was repealed in 2000 based on this updated scientific understanding. Today, saccharin is one of six high-intensity artificial sweeteners approved by the FDA for use in foods, found in products like Sweet'n Low, diet drinks, and various processed foods. Its legal status is firm, and it's considered safe when consumed within recommended limits as part of a balanced diet.
