25 Jun 2014

Pharmachem Carb Controller Receives GRAS Status

FDA issued a generally recognized as safe (GRAS) notice to Pharmachem Laboratories, LLC for its Phase 2 Carb Controller® white kidney bean extract.

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.”

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).

Phase 2 Carb Controller