Pharachem Laboratories (Kearny, NJ) announced their new licensure for Phase 2 Carb Controller by Canada’s Natural Health Products Directorate out of Ottawa.
Pharmachem by Dicentra (Toronto, Canada) made the application stating “claims are unique to Phase 2 as the particular wording for the weight management claim is a rare phenomenon for licensed NHPs in Canada,” according to Ryan Ramdeo, regulatory affairs associate, Pharmachem.
“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,” said Ramdeo.
Mitch Skop, Pharmachem’s senior director, New Product Development, said the approval was indeed positive, noting 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.”
Ramdeo said 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.”
Phase 2 Carb Controller was developed by Pharmachem Laboratories, Inc., and is a NOP-Certified organic handler and processor, operating 16 manufacturing facilities in the U.S.
For more information, visit www.phase2info.com.