The weight management claim is a real breakthrough and was the culmination of 10 years working with dicentra in building a scientific monograph sufficient to earn the marketing authorization.
Newport Beach, CA (PRWEB) August 07, 2014
Pharmachem Laboratories Inc., developer of Phase 2 Carb Controller®, announced it has received a license from the Natural Health Products Directorate, Ottawa, Canada, to market the ingredient with two weight management health claims:
- “At 6 capsules (3,000 mg) per day: Assists in weight management when used with a program of reduced intake of dietary calories and increased physical activity.”
- “At 4 to 6 capsules (2,000 to 3,000 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 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.”
Mitch Skop, Pharmachem’s senior director of new product development, said 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."
dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Located in downtown Toronto, Ontario and in Newport Beach, California, dicentra has over fifteen highly qualified and experienced individuals in house ready to help ready to help with all of regulatory and scientific needs. Contact dicentra at 1-866-647-3279 or visit http://www.dicentra.com.