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Products containing 500 mg of Epicor can now bear this claim in the Canadian market: “Helps reduce incidence of cold and flu symptoms.”
Health Canada has approved for sale in the Canadian market a natural health product containing immune-health ingredient EpiCor. Before natural health products can be sold in Canada, they must first undergo premarket approval for safety, efficacy, and quality. Approved products are given a Natural Product Number (NPN) or a Homeophatic Medicine Number (DIN-HM).
Embria Health Sciences (Ankeny, IA), EpiCor’s maker, says Health Canada’s decision was based on a number of scientific studies showing that EpiCor provides benefits, without safety concerns. The company points out that the Canadian approval is especially notable considering that EpiCor’s research was reviewed using pharmaceutical guidelines-and the fact that no disclaimers are being required to limit benefits to certain populations.
Additionally, EpiCor was given an approved health claim. Products containing 500 mg of Epicor can now bear this claim in the Canadian market: “Helps reduce incidence of cold and flu symptoms.”
Embria says EpciCor offers clear benefits without safety concerns caused by other ingredients currently available. “We believe that the cold and flu market in Canada needed something new and innovative, and EpiCor delivers that with very few warnings and cautions that are found on other products,” says Alex Azoulay, president of contract manufacturer Praxis Nutri-Pharma (Chateauguay, QC, Canada), which made the announcement together with Embria. Praxis Nutri-Pharma produces the EpiCor product that was approved. “Now we can offer EpiCor to new or existing customers.”
“This is a significant accomplishment for EpiCor since Health Canada’s process for confirming health claims is perhaps one of the most comprehensive in the world,” adds Paul Faganel, Embria’s president. “Recently, we’ve seen other immune products have issues with U.S. regulators, and we are very pleased Health Canada confirmed EpiCor’s research is second to none by allowing the Praxis product to use such strong claims.”
EpiCor also has a new dietary supplements (NDI) on file with FDA in the United States.