KEARNY, NJ, JUNE 1, 2006—Pharmachem Laboratories, Inc., today announced that its branded white bean extract, Phase 2 Starch Neutralizer®, has been designated “generally recognized as safe,” (GRAS). Pharmachem received the notification from research firm, Cantox U.S., Inc., who organized the expert panel and scientific review.
“The panel unanimously agrees that, anticipating final publication of the 28-day rat safety study, Phase 2 is GRAS for use in supplements and food products (that are not restricted by standard of identity) yielding consumption of up to 6.0 grams Phase 2 per day,” said David H. Bechtel, Ph.D., DABT, Managing Director and Senior Scientific Consultant, Cantox U.S., Inc. According to an expert opinion statement, the “experts unanimously agreed that the long-time presence of Phaseolus vulgaris in the human diet and its digestion by normal physiological pathways is supporting evidence of the safety of Phase 2. Also supportive is its current widespread use in dietary supplements, with no known adverse events.”
To supplement this evidence, “Pharmachem conducted a series of studies, and was confident in the safety of its ingredient,” said Mitch Skop, Director of new product development. “While all our studies concluded Phase 2 was safe, it is gratifying to receive the GRAS designation for the assurance of our customers, particularly as we move into many new, exciting food applications.”
The expert opinion statement said, “The results of pivotal nonclinical safety studies indicate that Phase 2 and dietary supplements containing Phase 2 is of low toxicological concern. Supportive evidence of safety was also presented in clinical studies, conducted in both the U.S. and Europe, designed to primarily examine the effects of Phase 2 or dietary supplements containing Phase 2 on glucose response and body weight loss. However, at least two studies included tests for hematology, clinical chemistry, and/or unrinalysis. During these studies, Phase 2 was administered to healthy subjects with meals for periods from 30 days to 24 weeks. No effects of toxicological concern were observed.”
“GRAS status will accelerate the launch of Phase 2 into the food and beverage industries as our StarchLite® line of ingredients rolls out worldwide,” added Skop.
Pharmachem Laboratories, Kearny, NJ, is the supplier of Phase 2 starch neutralizer. The company develops, supplies and manufactures a variety of high-quality, efficacious food ingredients under the strictest quality control. For more information, log-on to www.phase2info.com; or call 1-800-526-0609.
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