FDA grants Pharmachem's Phase 2 Carb Controller GRAS

The company's Phase 2 Carb Controller white kidney bean extract receives GRAS status from the FDA, the first natural carb control ingredient for weight loss to do so.

Phase 2 Carb Controller white kidney bean extract has achieved GRAS status based on a notification from the Food and Drug Administration (FDA), according to an announcement by Pharmachem Laboratories, supplier of the ingredient, at the IFT Annual Meeting and Food Expo.

The FDA notice stated: "Based on the information provided by Pharmachem, as well as other information available to FDA, the agency has no questions at this time regarding Pharmachem's conclusion that white kidney bean extract is GRAS under the intended conditions of use."

“Phase 2 is the first, natural carb control ingredient for weight loss to receive GRAS status,” said Mitch Skop, Senior Director, New Product Development, Pharmachem. “While it was self-affirmed GRAS prior to this notification, the “no questions” letter will have an extremely beneficial impact for the use of Phase 2 in foods and beverages domestically, and around the world. Phase 2 has been shown to be extremely effective in our studies, and this further recognition of its safety will make it even more attractive to manufacturers developing food for weight conscious consumers."

The notification resulted from a dossier of information submitted by Pharmachem regarding the composition, safety and clinical human evidence demonstrating that Phase 2 is a safe addition to foods and beverages aimed at the healthy weight loss market.

Within the dossier, Pharmachem showcased an exposure assessment based on multiple food examples of the intended use of Phase 2 Carb Controller. The diversity of foods included: baked goods and baking mixes (breads, rolls, pizzas, muffins, frozen waffles and pancakes, tortillas, pre-mixed baking products, bagels, crackers, and cookies) and toppings (Parmesan cheese, butter-flavored topping, spice topping, and sugar sprinkles).

A copy of the text of the FDA letter responding to GRAS Notice No. GRN 000480 is available for public review and copying at www.fda.gov/grasnoticeinventory.

Phase 2 Carb Controller was developed by Pharmachem Laboratories, Inc., Kearny, New Jersey, a family of companies specializing in the manufacture and supply of a wide variety of custom and specialty nutritional ingredients, as well as process services. The company is a NOP-Certified organic handler and processor, operating 16 manufacturing facilities in the U.S. It is also (c)GMP compliant, producing a variety of ingredients and ingredient systems under strict quality control.

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