KEARNY, N.J.—Pharmachem Laboratories Inc., developer of the Phase 2 Carb Controller, has received a license from the Natural Health Products Directorate of Ottawa, Canada, to market their products using weight and glucose management claims.
Specifically, the company can make the following two claims:
· At 6 capsules (3000 mg) per day, the product assists in weight management when used with a program of reduced intake of dietary calories and increased physical activity.
· At 4-6 capsules (2000-3000 mg) per day, it provides support for healthy glucose metabolism following a carbohydrate-rich meal.
The claim was made on behalf of Pharmachem by Dicentra of Toronto, Canada.
“The weight management claim is a real breakthrough because the requirements for the clinical trials required to gain the claim are quite stringent," said Ryan Ramdeo, regulatory affairs associate. “However, it was our belief that Phase 2 had the studies, the potency and safety to meet those requirements."
In June, the Phase 2 Carb Controller received generally recognized as safe (GRAS) status in the United States.