Expert Advisory Committee -Veterniary Natural Health Products Teleconference Minutes

Wednesday, March 28, 2012

Ottawa, Ontario
2:00 PM to 4:00 PM EST

Attendees

Committee Members

• Guy Chamberland (Acting Chair)
• Bill Bookout
• Paul Dick
• Pierre Gadbois
• Vincent Girard
• Gerrit Rietveld

Veterinary Drugs Directorate (VDD)

• Marie S. Lemaire, Manager, vNHP team
• Simon Adam, vNHP team
• Mario Simard, consultant
• Femma Van As, vNHP team

Observers

• Benjamin Mahon, Natural Health Products Directorate (NHPD), Health Canada
• Eian Elliott, Health Products & Food Branch Inspectorate (HPFBI), Health Canada

Absent committee members

• Cheryl Yuill, Pauline Nadlersmith , Rob Tremblay, Steve Marsden.

Welcome & Opening Remarks

Around 2 PM, Marie Lemaire welcomed and thanked all participants for their presence. She announced that Greg Tilford will no longer be a committee member due to other commitments.

Guy Chamberland reminded everyone of their confidentiality agreements and asked the members to disclose any changes in their affiliations.

Bill Bookout informed the group about his new position (now on the Board of Directors of NASC instead of President, and working for Kemin, having sold his company Genesis to Kemin) but everyone agreed this would not change his status as EAC member.

Update on the Interim Notification Program (INP)

Marie Lemaire provided an update of the INP and discussed the feedback received from Notifiers. She highlighted some challenges encountered.

There was positive feedback from committee members with regards to a proposal for dealing with proprietary blends and label requirements. It was acknowledged that this was an issue for Notifiers to protect the details about certain formulations. The proposed concept to disclose minimum quantities per dosage unit rather than exact quantities of ingredients to prevent manufacturers from "fairy-dusting" as well as copying formulations was well received. Bill Bookout offered to get feedback from the board of directors of the National Supplement Council and report back to the group April 2^nd (Action Item #1).

The committee members acknowledged the challenge for Notifiers having to display the name and address of the Canadian representative on the label. Some felt there is no need for this. Other suggested that the third party administrator (North American Compendiums) could deal with questions as well as adverse event reporting. This would provide clarity for end users. Contact information for product question could be dealt with outside of Canada, as long as this service was available in one of the official languages and within reasonable Canadian business hours. The issue will be addressed in a timely manner.

Review of Action Items from May 24, 2011 meeting

All action items had been completed

Follow up Report Sub-committee (Recommendations to Potential Classification Approach to Presumed Safe Substances List- Sep 29, 2011)

Femma Van As pointed out that most recommendations had been adopted for the INP, and pointed out slight variations. The changes were done for functionality reasons, but the end result was similar to the recommendations. Bill Bookout mentioned that the Sub-committee's proposal for a "Restricted Use" category was intended for products that should only be sold and used by veterinarians. Femma Van As responded that this concept had not been understood in this way by VDD, as all products are intended for "over the counter use" and the INP does not differentiate between the types of end users (prescription by veterinarians -vs- OTC). Companies can choose to sell to veterinarians only, but this is irrelevant to the INP. If the product would not be considered safe as an OTC product, (i.e. it qualifies for prescription status) it would be automatically excluded from the INP.

Mario Simard presented a proposal for adding substances to the list of the INP. The proposal included the creation of an expert committee who would make recommendations for substances where a decision would not be straightforward. In general the proposal was well received by the committee members, but most pointed out that members of such a proposed expert committee could/would not be expected to give their expert opinion without compensation. Experts would then not consider this a priority and this may not result in an efficient decision making process. Some suggested that the Program Administrator could provide this service, but this may result in conflict of interest issues. Paul Dick, Bill Bookout, Pierre Gadbois and Gerrit Rietveld offered to form a subcommittee to develop a business plan/process for an independent expert committee that could offer this service for a fee, or be funded by other (government) agencies. Everyone agreed that HC would oversee such a process and make the final decision.

Food-producing animals

Mario Simard presented the proposed approach for low risk products intended for food-producing animals that would be coming into effect when the regulations are amended. Horses would be considered a food-producing animal. He discussed the oversight appropriate for these products. The committee members were generally supportive of the proposal. Femma Van As discussed requirement for probiotics and the possibility of default withdrawal times for all LRVHPs. A default withdrawal period (e.g. 48 hrs) was not found to be useful if not science-based by some, while others felt it was beneficial as an extra safety precaution although not applicable to all substances.

Other companion animals

This item was not discussed because of limited time.

Next meeting

Everyone agreed that the next meeting should be a face to face meeting if financially possible. The best time would be in the fall of 2012. Suggested topics were the creation of the expert committee for adding substances, issues with LRVHP added to livestock feed and implications with the CFIA, assessment of claims for nutritional substances (drug -vs- feed).

Meeting adjournment

The meeting was adjourned around 4PM.