OF HEALTH AND HUMAN SERVICES Food and Drug

that indicates the researchers found an association of high tofu intake with low cognitive test scores and with Alzheimer’s disease, rather than vascular dementia. FDA finds that this abstract does not provide a sufficient basis to evaluate the merits and weaknesses of this study. As such, it is not useful in evaluating the safety concerns at issue. Moreover, the report does not provide information on total soy intake or what variables were controlled in the analysis. If tofu or soy were implicated in Alzheimer’s disease, its prevalence would be expected to be higher in Japan than in Hawaii, but White et al. (Ref. 115) found the prevalence of Alzheimer’s disease was higher in Hawaii than in Japan. Therefore, FDA is not persuaded by the comment raising concerns about potential adverse effects of soy protein in dementia and brain atrophy in older