Pharmachem Laboratories, Inc. has received a license from the Natural Health Products Directorate to market its Phase 2 Carb Controller with two new health claims.
These new claims state that six capsules (3,000 mg) per day assists in weight management when paired with a reduced intake of dietary calories and increased physical activity; and that four to six capsules (2,000 to 3,000 mg) per day provides support for a healthy glucose metabolism after a carbohydrate-rich meal.
“The claims are unique to Phase 2 as the particular wording for the weight management claim is a rare phenomenon for licensed NHPs in Canada. Furthermore, the glucose metabolism claim emphasizes a carbohydrate-rich meal which is valuable information to consumers as it reflects the true efficacy of Phase 2 and its intended use,” says Ryan Ramdeo, regulatory affairs associate at Dicentra, in a press release. “The weight management claim is a real breakthrough because the requirements for the clinical trials required to gain the claim are quite stringent. However, it was our belief that Phase 2 had the studies, the potency and safety to meet those requirements.”
According to Mitch Skop, senior director of new product development at Pharmachem, the ruling was “the culmination of 10 years of work with Dicentra in building a scientific monograph sufficient to earn the license. The marketing implications for us in Canada and throughout the world are extremely valuable.”
