KEARNY, NJ, NOV. 29, 2006 – Pharmachem laboratories announced today that the Food and Drug Administration, based on clinical data and information submitted to the agency, does not object to weight control and starch reduction claims for the company’s Phase 2 Starch Neutralizer® dietary ingredient, and finished dietary supplement products containing the ingredient.
The structure/function claims for the ingredient, a proprietary extract of the white bean, are as follows, according to a letter issued by the FDA:
“May assist in weight control when used in conjunction with a sensible diet and exercise program.”
“May reduce the enzymatic digestion of dietary starches.”
“To Pharmachem’s knowledge, Phase 2 Starch Neutralizer is the first nutritional ingredient to receive structure/function claims for both weight control and reduced digestion of dietary starches,” said David Holmes, founder and CEO of Pharmachem. “The implications for both our Phase 2 ingredient in weight control supplements and StarchLite™ for food applications, are tremendous.”
Introduced in 2001, Phase 2 received rapid distribution in the U.S. In 2004, several consumer products were successfully launched in the UK. Last year Phase 2 products were introduced in the European Union, and throughout Asia.
Mitch Skop, director of new product development, said, “We have worked closely with the FDA to provide them with the results of our clinical studies to substantiate Phase 2’s efficacy. We appreciate the agency’s cooperation, and are extremely pleased with the FDA’s letter. These important claims demonstrate the value of sound clinical science in the dietary supplement category,” added Skop.
Earlier this year, Pharmachem introduced StarchLite, a food version of Phase 2, for potential applications in a variety of food and beverage products, including baked goods, cereals, frozen foods, packaged meals, pasta, pizza crust, soups and confectionary.
Both Phase 2 and StarchLite have been affirmed “Generally Recognized As Safe,” (GRAS) for dietary supplements and food products, respectively.
Pharmachem Laboratories, Kearny, NJ, develops, supplies and manufactures a variety of high-quality, efficacious ingredients for the dietary supplement and food industries. Ingredients are manufactured under the strictest quality control in accordance with cGMP standards. For more information, log-on to www.phase2info.com; or call 1-800-526-0609.
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