Saccharin

Saccharin is a synthetic (non‑nutritive) sweetener (E 954) roughly 200–700 times sweeter than sucrose. It is a calorie‑free sugar substitute used in “diet” sodas, tabletop sweeteners (e.g. Sweet’N Low), and sugar‑free desserts or syrups. Global regulators regard saccharin as safe when consumed within approved limits. For example, the FDA and WHO consider it safe (it has GRAS/food‑additive status) and no warning labels are required. Early high‑dose rat studies linked saccharin to bladder tumors, but experts now agree that mechanism does not apply to humans. Consequently, IARC classifies saccharin (and its salts) as Group 3 (“not classifiable” for human cancer). Typical exposures from diet sodas or foods are far below the acceptable daily intake (ADI) established by regulators.

Saccharin’s chemical name is 1,2-benzisothiazol-3(2H)-one-1,1-dioxide (a benzoic sulfimide) and it carries the E‑number E954 in foods. It is a high‑intensity sweetener (about 300× the sweetness of sugar) but provides no calories. It was one of the first artificial sweeteners (marketed since the early 20th century). In food formulations, saccharin is often blended with other sweeteners to mask bitterness and is stable in acidic or high‑temperature conditions (unlike aspartame). Regulatory status: Saccharin is approved as a food additive by the FDA and many global authorities. The FDA permits saccharin in beverages, desserts, candies, etc., and has set an ADI of 15 mg/kg body weight. In Europe, EFSA’s 2024 re-evaluation confirmed saccharin’s safety and raised the ADI to 9 mg/kg (free saccharin). JECFA (WHO/FAO) maintains a group ADI of 5 mg/kg (as sodium saccharin), and Australia/New Zealand similarly use 0–5 mg/kg. All of these ADIs are well above estimated intakes from foods. In fact, EFSA noted that even the 95th percentile exposure in Europe is below the ADI. In Canada, saccharin was de-listed as a food additive in the 1970s, but Health Canada’s recent review (2017) agrees that saccharin is not carcinogenic to humans and is considering re-approval with an ADI similar to WHO/EU. Use in foods/fast food: Saccharin is common in diet sodas and sugar‑free products. For example, fountain Diet Coke (in many U.S. fast‑food restaurants) contains saccharin in addition to aspartame. It is also found in tabletop sweeteners, chewing gum, gelatin desserts, jams, and sauces. Typical concentrations in diet beverages are on the order of tens of mg per liter – one analysis found ~30 mg/L in a diet cola sample. (By contrast, the FDA ADI of 15 mg/kg would allow a 70 kg adult to safely consume over 600 mg/day.) No fast‑food chain currently bans saccharin in its diet drinks or sugar‑free items. U.S. outlets do not require warning labels, and saccharin has been delisted from California’s Proposition 65 (cancer list) since 2001. Other countries similarly allow saccharin in foods, and new evidence has led many agencies to remove earlier restrictions (e.g. the U.S. National Toxicology Program dropped saccharin from its carcinogen list in 2000). Health evidence: Numerous reviews (FDA, IARC, WHO) agree that human consumption of saccharin poses no known carcinogenic risk at approved levels. Mechanistic studies showed the rat bladder tumor pathway (urine crystallization) is not relevant to humans. Epidemiological studies have not found increased cancer in saccharin consumers. A U.S. cancer institute summary states that saccharin “does not cause cancer… in people”. Current concern centers on metabolic effects: a 2023 WHO guideline noted that non‑nutritive sweeteners (including saccharin) failed to improve long-term weight control and were associated in some studies with higher risk of type 2 diabetes and cardiovascular outcomes. However, WHO judged this evidence inconclusive (confounded by diet/lifestyle factors) and made a conditional recommendation against routine use of any such sweeteners for weight management. In practice, typical fast‑food exposures to saccharin (from a few sodas or sugar-free items per day) are very low relative to ADIs, so well below levels that might pose risk.

We assign the limited tier using published research, regulatory guidance, and PRūF’s additive taxonomy. Restaurant usage is derived from public ingredient disclosures and mapped to menu items where this additive appears.