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Title: Alternative Sweeteners

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250 Embuscado and Patil<br />

V. SAFETY AND DIGESTIVE TOLERANCE<br />

On the basis of numerous safety studies following FDA’s Redbook guidelines,<br />

the safety of erythritol has been established. These include in vitro tests for mutagenicity<br />

and clastogenicity; subchronic toxicity tests in mice, rats, and dogs;<br />

chronic toxicity/carcinogenicity studies in rats and dogs; a multigeneration study<br />

in rats, and two teratogenicity studies in rats and rabbits (27, 31, 32). Table 7<br />

contains a summary of recent toxicity studies, which overwhelmingly support<br />

the safety of erythritol as a food ingredient. On the basis of the entire safety data<br />

package on erythritol, it is concluded that erythritol is safe for its intended use<br />

in foods (27).<br />

The digestive tolerance of erythritol compared with other polyols is given<br />

in Table 8. Erythritol is highly tolerated by humans and by animals because it<br />

is such a small molecule that it is immediately absorbed by the body and excreted<br />

within 24 hr (80%). This rapid absorption at high concentration prevents the<br />

accumulation of unabsorbed products in the large intestine, which may cause side<br />

effects such as diarrhea, abdominal pain, and flatulence. Erythritol exhibits high<br />

digestive tolerance even at high dosage levels.<br />

Table 8 Digestive Tolerance Doses of Undigestible Sugars<br />

Condition of testing<br />

Undigestible Throughout Chronic<br />

sugar Single load the day exposure Dose (g)<br />

Erythritol — a 30–55<br />

Xylitol — b 60–80<br />

Sorbitol 10<br />

30–40<br />

Maltitol 20<br />

60<br />

Isomalt 20–30<br />

(Palatinit) 50<br />

Lactitol 50<br />

a Single oral dosage did not alter plasma or urine osmolarity or electrolyte balance. Erythritol is well<br />

tolerated by the digestive tract (42).<br />

b Seven-day high-dosage ingestion using a double-blind, two-way crossover study in 12 healthy male<br />

volunteers; sucrose used as a control. Erythritol was well tolerated and without any side effects<br />

(32).<br />

Source: Ref. 12 with modification.

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