Natural Health Product Directorate (NHPD) Stakeholder Bilateral Meeting Program - Meeting with the Canadian Health Food Association (CHFA)

Contact: Office of the Senior Executive Director

Place:

Ottawa, Ontario

Date:

June 15, 2011

Record of Decisions

Item 1: Update on the status of the revised NHPD guidance for standards of evidence

• The Natural Health Products Directorate (NHPD) is proceeding with approval and release of updated guidance, following a focused consultation with the Natural Health Products Program Advisory Committee (NHP-PAC), and will provide the guidance to stakeholders once available by NHPD e-mail message (BEEP), and will make the information available on the Health Canada website.

Item 2: Update on the status of natural health products compliance and enforcement activities

• The Health Products and Food Branch Inspectorate (HPFBI) continues its compliance promotion period within a risk-based approach for natural health products (see POL 0001).  Stakeholders will be advised on the status of compliance implementation as information becomes available.
• The CHFA asked for special compliance and enforcement on abuse of the personal importation policy.  The HPFBI and the NHPD are of the opinion that selective compliance and enforcement is not possible. Reasonable proactive compliance and enforcement would be a more durable means for assessing appropriate personal importation.

Item 3: Update on the status of guidance for product quality and testing

• The NHPD is proceeding with approval and release of updated guidance, following a focused consultation with the NHP-PAC, and will provide the guidance to stakeholders once available, by BEEP, and make the information available on the Health Canada website.

Item 4: Update on the status of NHP-PAC recommendations and NHPD guidance on weight loss natural health products

• The NHPD anticipates receiving NHP-PAC recommendations on Weight Loss/Weight Management NHPs (NHP-PAC Report #4) shortly and proceeding with finalization and release of guidance for these products following a focused consultation with the NHP-PAC. Guidance will be provided to stakeholders, by BEEP, and will be made available on the Health Canada website.  To support a durable/robust solution, the NHPD will process product licence applications for this group of products once guidance is completed.

Item 5: Medicinal and Non-Medicinal Ingredients, Natural Health Products Ingredients Database (NHPID)

• It was identified by the CHFA that there may be confusion in the industry that the NHPID is a statement of safety, efficacy and quality.  The NHPD clarified that this is not the case.
• The NHPD will make additional information available for stakeholders, to clarify use of the NHPID, through BEEP message and on the Health Canada website.

Item 6: International Trade Certificates for products with Exemption Numbers (ENs)

• The NHPD is not planning on issuing International Trade Certificates for products with Exemption Numbers as there are concerns that international partners will deduce that these products have been reviewed for safety, efficacy and quality.
• The CHFA will follow-up with the Director General, NHPD, for further discussion.

Item 7: Update on the transition of food-like natural health products

• Health Canada will inform and consult with stakeholders as information becomes available.
• Short and long term solutions are being discussed within Health Products and Food Branch.

Item 8: Imposing nutrition facts-type information on natural health products

• The NHPD does not impose nutrition type facts information on labels.  However, concerns over certain levels of non-medicinal, such as salts and allergens, have been expressed and the NHPD may ask applicants and product licence holders of food-like NHPs to voluntarily include food, nutritional and allergen information on products.
• The NHPD will provide information through response to the CHFA email inquiry sent prior to the June 15th meeting.

Item 9: Update on the time frame for amendments to Schedule F

• The NHPD has no further update since its May 2011 update via BEEP, where 10 ingredients are intended to be removed from Schedule F in the fall of 2011. The NHPD will continue to inform stakeholders as information becomes available.

Item 10: Update on modernization of the Food & Drugs Act

• The NHPD has no update.

Item 11: Update on the Risk-Based Approach to Site Licensing (RBASL)

• The NHPD is proceeding with approval of an RBASL concept paper and will inform and hold information sessions for stakeholders as information becomes available.

Participants

Canadian Health Food Association

• Mr. Carl Carter, Canadian Health Food Association, Toronto, Ontario
• Mr. Matthew James, SunOpta Inc. /Purity Life, Acton, Ontario
• Ms. Barbra Johnston, Natures Formulae Health Products Ltd., Kelowna, British Columbia
• Mr. Bernd Licht, Puresource Inc., Guelph, Ontario
• Mr. Lionel Pasen, Natural Products Consulting Corporation, Toronto, Ontario
• Dr. Jon-Paul Powers, Body Plus Nutritional Products Inc., Toronto, Ontario
• Mr. Patrick Quaile, New Roots Herbal, Montreal, Quebec
• Ms. Krista Rutherford, Canadian Health Food Association, Toronto, Ontario
• Mr. Franco Salituro, CanPrev Natural Health Products Ltd., Richmond, Ontario
• Ms. Helen Sherrard, Canadian Health Food Association, Toronto, Ontario
• Mr. Michel Sirgent, Bio K+ International Inc., Laval, Quebec
• Mr. Joel Taller, Gowling Lafleur Henderson LLP, Ottawa, Ontario
• Ms. Mackie Vadacchino, Bioforce Canada, Dollard-des-Ormeaux, Quebec
• Mr. Colin Watson, Swiss Herbal Remedies, Richmond, Ontario

Health Canada

• Mr. Matthew Bown, Senior Policy Analyst, Health Products and Food Branch Inspectorate (HPFBI)
• Mr. Don Boyer, Director, Bureau of Product Review and Assessment, Natural Health Products Directorate (NHPD)
• Ms. Diana Dowthwaite, Director General, HPFBI
• Ms. Tracey Dunfield, Project Officer, Stakeholder Engagement and Outreach, Office of the Senior Executive Director, NHPD
• Dr. Alison Ingham, Manager, Product Assessment Division, Bureau of Product Review and Assessment, NHPD
• Ms. Sara O'Connor, Manager, Submission Management Division, Bureau of Product Review and Assessment, NHPD
• Ms. Kyra Paterson, Senior Policy Analyst, Bureau of Policy and Risk Management, NHPD
• Mr. Scott Sawler, Director General, NHPD
• Ms. Serena Siquiera, Director, Food and Drugs Act Liaison Office, Public Affairs, Consultation and Communications Branch
• Ms. Carol Toone, Manager, Stakeholder Engagement and Outreach, Office of the Senior Executive Director, NHPD
• Mr. Michael Wiseman, Regulatory Advisor, Bureau of Product Review and Assessment, NHPD