Mannitol
Also known as: E421
Mannitol is recognized by EFSA and FDA as safe with no Acceptable Daily Intake numerical limit ("not specified" / no toxicological concerns). Like other polyols, excessive intake can cause laxative effects; FDA requires a label statement of 'Excess consumption may have a laxative effect' when foods could provide ≥20 g/day.
What it is
Mannitol (E421), a sugar alcohol (polyol) sweetener occurring naturally in some plants and produced commercially by hydrogenation of fructose.
Sweetener, bulking agent, anti-caking, and humectant control; provides ~50-60% the sweetness of sucrose with reduced calories.
Why it's flagged
- laxative effect at high intakes (>20 g)
What regulators actually say
"Mannitol is a polyhydric alcohol prepared as a white, crystalline powder, granules, or free-flowing powder. It is GRAS as a multipurpose food ingredient."
Regulatory status
United States — FDA
GRAS (21 CFR 184.1801); laxative-effect label warning required under 21 CFR 184.1801(c)(1).
European Union — EFSA
Authorized as Polyol sweetener under Regulation (EC) No 1333/2008; ADI 'not specified'.
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