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NFS284 NHP Review Notes

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Nutritional Science
Tom Wolever

Nutrition: Science and Applications Natural Health Products Compendium Natural Health Products - List of NHP with well-documented traditional use or scientific evidence o NHPID name Natural health products (NHP) o Proper name(s) o Common name(s) - According to Health Canada, a NHP includes: o Vitamins and minerals o Source material o Amino acids o Route of administration o Essential fatty acids o Use(s) or purpose(s) o Herbal remedies o Dosage form(s) o Traditional medicines o Dose(s) o Homeopathic medicines o Duration of use - Administered either oral or topical o Risk information - Between food and drug o Specifications o Selected by the consumer for self-care  E.g., Black Cohosh o Low risk of harm  People were reporting adverse reactions - Have a therapeutic purpose  Not linked to the Black Cohosh itself, but to the o Treatment, mitigation, prevention of a disease, disorder, or plants that were being misidentified as Black abnormal physical state Cohosh o Restoring or correcting organic functions - Manufacturer can market any NHP in the compendium by following the - Regulated by the Natural Health Products Directorate (2004) guidelines of the compendium o To ensure that Canadians have a ready access to NHP that are o Rather than providing scientific evidence for ingredients that are safe, effective, and of high quality while respecting freedom of already known to be safe and efficacious choice and philosophical and cultural diversity - Manufacturer can market a NHP not in the compendium or for a purpose o 50,000 NHP have been approved not listed in the compendium by providing strong scientific evidence (e.g., - Try to achieve a balance between tradition and scientific evidence scientific literature review, intervention trial) o Tradition  NHP can be marketed on the basis of traditional use NHP labeling (similar to drug labeling) (e.g., in use >50 years) - Product name  There may not be strong scientific evidence to support its - License holder use - Natural Product Number (NPN) or Homeopathic Medicine Number (DIN- o Scientific evidence  NHP can be marketed if there is scientific HM) evidence of effectiveness for its stated purpose o If there is no NPN, then product is not authorized for sale in NHP manufacturers Canada - Must demonstrate good manufacturing practices in the making of the o However, exemption number (EN) is issued for very low risk product products (e.g., very safe) o Good manufacturing practices  To be marketed immediately while the review process to  Product is what it says it is issue a proper NPN is underway  Product is not contaminated  To reduce the backlog of products that require approval  Microbial contamination - Medicinal ingredients  Chemical contamination (e.g., lead, mercury, - Non-medicinal ingredients prescription drugs) - Dosage form - Recommended use or purpose (e.g., health claim) - Must be issued a license for the site of manufacture by
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