FDA OK with Phase 2 Weight Loss Claims

KEARNY, N.J.—Pharmachem Laboratories received a letter of non-objection from the Food and Drug Administration (FDA) regarding two structure/function claims for its Phase 2 Starch Neutralizer® dietary ingredient and finished dietary supplements containing the ingredient. After reviewing Pharmachem’s submission about proposed claims, FDA stated it has no objection to the claims:

Pharmachem has been working with FDA since 2004, when the agency raised concerns about the ingredient, a proprietary extract of the white kidney bean, and related claims. “We have worked closely with the FDA to provide them with the results of our clinical studies to substantiate Phase 2’s efficacy,” said Mitch Skop, director of new product development. “We appreciate the agency’s cooperation, and are extremely pleased with the FDA’s letter. These important claims demonstrate the value of sound science in the dietary supplement category.”

Phase 2 (www.phase2info.com) was originally introduced in the United States in 2001; in early 2006, Pharmachem launched a food version of the ingredient, StarchLite™, with applications in a variety of food and beverage products. Both Phase 2 and StarchLite have been affirmed GRAS (generally recognized as safe). “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, Pharmachem’s founder and chief executive officer (CEO). “The implications for both our Phase 2 ingredient in weight control supplements and StarchLite for food applications are tremendous.”