Canadian Regulatory Update, July 2002: Summary of Expert Advisory Committee Meeting of Natural Health

Meeting of May 9 -10, 2002 from notes released July 29, 2002

1. Update by Phil Waddington, Director General, NHPD

  • Frank Chandler was introduced as the new EAC Chair
  • The EAC will assume a more science based focus in the coming year
  • Schedule A status: The NHPD is part of a Health Products and Food Branch committee studying this issue. A plan exists that will be released soon.
  • GMPs: A plan has been generally agreed to. Public consultations will take place across the summer.
  • Gazette II: The Directorate hopes to publish in Part II of the Canada Gazette at year's end.
  • Health Promotion has been added to the NHPD functions.
  • FDA: The Directorate will review a draft FDA safety framework for botanicals.

2. Traditional Claims by Peter Chan, Product Review & Assessment, NHPD

  • Types of claims to be permitted. Discussion of pros and cons of: "The Evidence used to support the claim for a product should all be from the same paradigm as the claim".
  • Merits of "Maintaining or promoting health" label statement discussed. Use of "for therapeutic use only" disapproved.
  • OTC product claims: problem of label claims needing to reflect prior physician diagnosis. Product educational insert considered a possible solution.

3. Listable Herbs: Committee agreed that only those herbs not considered acceptable as foods by the Foods Directorate would be listed as a natural health product.

4. Equivalency and Ratio: The committee discussed the problem of products with numerous herbs having varying ways of being designated. Information will be collected from other authorities for a policy draft to be circulated.

5. Ingredient Nomenclature: The chemical name of an ingredient is to used in its monograph and labels. Minerals are to be included and probiotic strains must be identified. A number of source material requirements were agreed to including natural or synthetic, plant or animal, tissue culture and country of origin, where applicable.

6. Monographs: The committee was given 15 monographs which members will individually comment on.

7. Children's Herbs: After discussion, the committee agreed that a child's weight rather than age should have greater weight in determining dosage. Concerning duration a label phase was agreed to: "If symptoms persisted or worsen within 7 days, consult a health care provider". Committee members will individually review the list of herbs to be approved for use in children's products.

To view the full notes: www.hc-sc.gc.ca/hpb/onhp/eac9notes_e.html

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