white kidney bean extract
effects in humans and other animals. These would be the substance of greatest toxicological concern. However, routine tests of production lots show that these substances are present at very low levels in Phase 2® white kidney bean (Phaseolus vulgaris) extract; •Phase 2® white kidney bean (Phaseolus vulgaris) extract administered to rats in various oral (gavage) toxicity studies. No mortality or signs of toxicity were noted following administration of a single dose of the extract at up to 5000 mg/kg bw or multiple doses up to 2500 mg/kg bw/day for 28 days or up to 1112 mg/kg bw/day for 90 days. •The effects of the enzyme a-amylase are comparable across species, reducing the uncertainty regarding interspecies variability; •The results of multiple clinical investigations in which hundreds of healthy subjects receiving Phase 2® white kidney bean (Phaseolus vulgaris) extract (as is or as an ingredient in dietary supplements) at levels ranging from 500 to 3000 mg/day for periods from 30 days to 24 weeks showed no treatment-related adverse effects. While the primary objective of these studies was to assess the effects on glucose response and body weight loss, a subset of the studies included some measures of safety, such as hematology, clinical chemistry, and/or urinalysis; and •Phase e white kidney bean (Phaseolus vulgaris) extract is currently used in various forms (e.g., tablets, capsules, chewables, powdered drinks, chewing gums, baking mixes) in products marketed worldwide under approximately 200 brand names. These products provide up to 4500 mg/day (4.5 g/day) Phase 2® white kidney bean (Phaseolus vulgaris) extract. To date, Pharmachem Laboratories, Inc. has had no reports of adverse events despite cumulative sale of 500,000 kg Phase 2 white kidney bean (Phaseolus vulgaris) extract.