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Regulatory Status in Various Countries

Regulatory Status in Various Countries

Australia: COLD-fX is listed as a medicine with the Therapeutics Goods Administration in Australia (ID # 19884).

Canada: COLD-fX was previously issued a Drug Identification Number (DIN) under the former traditional medicine program of the Therapeutic Products Directorate (drug branch) of Health Canada (DIN 02242024). Like other phytomedicinal products, the DIN status of COLD-fX was changed according to the new Canadian Natural Health Product (NHP) regulations. In accordance with these regulations, the Natural Health Products Directorate (NHPD) evaluates NHPs for quality control, safety, and efficacy. If appropriate standards are met, NHP manufacturers can make drug claims and obtain licenses (Natural Product Number or NPN). In February 2007, the NHPD issued NPN 80002849 for CVT-E002 (COLD-fX) and approved the following claim: “helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.”13

United States of America: CVT-E002/COLD-fX meets the legal definition of a dietary supplement pursuant to Section 201 (ff) (1) (C) and (F) of the FDC Act. The Food and Drug Administration (FDA) accepted CVT-E002 as a New Dietary Ingredient (NDI) based on a review of extensive safety and quality manufacturing evidence (FDA Docket # 95S-0316). The FDA has previously approved CVT-E002/COLD-fX for its Phase II clinical trial.