Title: Alternative Sweeteners

Maltitol 291
available on certain polyols, including maltitol. A report on the energy available
from these polyols was prepared in 1994. The LSRO report (36), prepared in
consultation with an expert panel, determined that the appropriate energy to be
evaluated was net energy. The panel reviewed both published and unpublished
studies relating to the energy determination of these polyols. They evaluated the
methods used to determine energy values and set forth a set of basic premises
with which net energy values could be evaluated. Last, they determined the best
estimates of the metabolizable and net energy values for these polyols (36). Estimated
net energy value for maltitol in the report was 2.8–3.2 kcal/g (11.7–13.4
kJ/g). But it is also stated in the report that in view of the more recent data of
Tsuji et al (36), the NE available for maltitol might be lower than 2.8–3.2 kcal/g.
LSRO also concluded that additional studies were needed to confirm the lower
range of values.
In 1999, LSRO evaluated again the NE value for maltitol. Summarizing
all the available ADME (absorption/distribution/metabolism/excretion) data:
10% of the energy available from maltitol is used at 4 kcal/g during the first 2
hours after ingestion; 85% of the energy available is used by bacterial fermentation
in the large intestine at 2 kcal/g; and 5% of the energy available is excreted
in the feces.
On the basis of the ADME data, one may estimate the factors in Equation
(1) as A, 0.1; B, 1;C, 0.05; and R e,1.
Ew [(A B) (1 (A C)) 0.5] 16.5 Re kJ/g (1)
Using these terms, Equation (1) leads to an estimate of the net energy value for
maltitol of 8.8 kJ/g (2.1 kcal/g). Previous estimates of the NE value have ranged
from 6.7 to 16.4 kJ/g. The current estimate for the NE value of maltitol is based
on the most recent evidence of the ADME of maltitol in humans. The value of
8.8 kJ/g is in good agreement with the values estimated by Oku (37), Tsuji et
al. (37), and the mid-range of Felber et al. (38) and the Japanese Ministry of
Health and Welfare (34).
The FDA issued a no objection letter on May 28, 1999, in response to a
letter proposing a self-determined energy value for maltitol of 2.1 kcal/g for the
purpose of nutrition labeling.
VII. CARCINOGENICITY AND OTHER TOXICITY
Numerous studies examining the acute, subacute, chronic, and subchronic toxicities,
and carcinogenic, mutagenic, and teratogenic activities of maltitol have
shown no evidence of any adverse effects (23,31). In fact, a recent study has
indicated that dietary maltitol decreases the incidence of cecum and proximal
tumors in rats induced by a hydrazine derivative (40).