07.25.14
Pharmachem Laboratories, Inc., Kearny, NJ, developer of Phase 2 Carb Controller, has received a license from the Natural Health Products Directorate, Ottawa, Canada, to market the ingredient with two health claims:
· “At 6 capsules (3000 mg) per day: 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: Provides support for healthy glucose metabolism following a carbohydrate rich meal.”
The application for the claim was made on behalf of Pharmachem by Dicentra, Toronto, Canada, and according to Ryan Ramdeo, regulatory affairs associate, 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.”
“The weight management claim is a real breakthrough,” said Mr. Ramdeo, “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.”
· “At 6 capsules (3000 mg) per day: 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: Provides support for healthy glucose metabolism following a carbohydrate rich meal.”
The application for the claim was made on behalf of Pharmachem by Dicentra, Toronto, Canada, and according to Ryan Ramdeo, regulatory affairs associate, 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.”
“The weight management claim is a real breakthrough,” said Mr. Ramdeo, “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.”
