About
What it is and where it shows up.
Mannitol is a naturally occurring sugar alcohol (polyol) found in plants, algae, fungi, and bacteria, and is also endogenous in humans. It is used in food as a sweetener, bulking agent, humectant, and texturizer — most commonly in sugar-free confectionery, chewing gum, and low-calorie products.
Safety summary
The regulatory and scientific consensus.
Mannitol is GRAS in the US at intakes up to 20 g/day and broadly approved across major jurisdictions with no IARC carcinogenicity classification. At high doses it can exert a laxative/osmotic diarrhea effect common to all polyols; EU rules require a laxative warning on products with more than 10% added polyols. It is the only sweetener permitted in EU foods for infants and young children, though elevated intakes warrant caution in sensitive populations such as those with IBS or renal impairment.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| FDA (Food and Drug Administration) (United States) | Restricted | Regulated as an interim food additive under 21 CFR 180.25 — interim status has persisted for over two decades without permanent restrictions or outright prohibition. GRAS at food-use intakes up to 20 g/day without additional labeling; products exceeding 20 g/day must carry a laxative-effect statement. Permitted as a sugar alcohol sweetener alongside sorbitol, xylitol, lactitol, erythritol, and maltitol.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Permitted quantum satis (no numerical maximum) under Regulation (EC) No 1333/2008. E421 comprises two sub-forms: E421(i) mannitol by hydrogenation and E421(ii) mannitol by fermentation. Subject to ongoing EFSA re-evaluation under the sweetener re-evaluation programme. E421 is the only sweetener specifically authorised in foods for infants and young children in the EU. Products containing >10% added polyols must carry a laxative warning label.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as a caloric/polyol sweetener under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, alongside other polyols such as sorbitol, xylitol, maltitol syrup, and lactitol.source |
Who should approach with care
Whose guidance would steer them away.
Ibs — As a poorly absorbed polyol, mannitol can cause osmotic diarrhea, bloating, and gastrointestinal discomfort in individuals with irritable bowel syndrome, particularly at or above the 20 g/day threshold referenced by FDA.
Ibd — Incompletely absorbed sugar alcohols like mannitol may worsen gastrointestinal symptoms in individuals with inflammatory bowel disease due to colonic fermentation and osmotic effects.
Infants — Although Mannitol (E 421) is the only sweetener specifically permitted in EU infant and young children foods, unsupervised or high-dose intake may cause osmotic diarrhea; use should strictly comply with regulatory-specified conditions.
Kidney Disease — Mannitol is a well-known osmotic agent; at elevated dietary doses it may impose additional osmotic burden on the kidneys, warranting caution in individuals with pre-existing renal impairment.
Diabetes — While sugar alcohols do not cause a sudden rise in blood glucose, mannitol still provides approximately 1.6 kcal/g and contributes to total carbohydrate load; diabetics should account for it in carbohydrate calculations.
Research citations
The sources behind this verdict.
- 1FDA. 21 CFR 180.25 – Mannitol (Interim Food Additive Regulation). accessdata.fda.gov
- 2FDA. Aspartame and Other Sweeteners in Food – FDA. fda.gov
- 3other. Legal Aspects of the Food Additive Approval Process – Enhancing the Regulatory Decision-Making Approval Process (NCBI Bookshelf). ncbi.nlm.nih.gov
- 4EFSA. Protocol on Hazard Identification and Characterisation of Sweeteners authorised as food additives in the EU, 2019. efsa.europa.eu
- 5WHO. JECFA Food Additives Database: Mannitol (INS 421, CAS 69-65-8), 1996. apps.who.int
Independently researched5 citations