Summary of Discussions: Expert Advisory Committee - Veterinary Natural Health Products Webconference

Tuesday, March 30th, 2010

1:00 pm to 4:30 pm ET

Attendees

Committee Members

  • Cheryl Yuill (Chair)
  • Guy Chamberland (Co-chair)
  • William Bookout
  • Paul Dick
  • Pierre Gadbois
  • Steve Marsden
  • Pauline Nadlersmith
  • Gerrit Rietveld
  • Rob Tremblay

Veterinary Drugs Directorate (VDD)

  • Ian Alexander, Director, Clinical Evaluation Division
  • Marie S. Lemaire, Manager, Veterinary Natural Health Products team
  • Simon Adam
  • Mario Simard, consultant
  • Femma Van As
  • Emmanuelle Verrette

Observers

  • Tracey Snow, Natural Health Products Directorate, Health Canada (HC)
  • Paul Loeven, Animal Feed Division, Canadian Food Inspection Agency (CFIA)
  • Raymond Perron, Animal Feed Division, CFIA
  • Oksana Yarosh, Veterinary biologics Section, CFIA
  • Nicholas Shipley, Health Products & Food Branch Inspectorate (HPFBI), HC

Regrets

  • Gregory Tilford (Committee Member)

1. Welcome & Introductions

1:05 pm

M. Lemaire thanked all participants for taking the time to participate to the tele/web conference and suggested a roundtable presentation of Veterinary Drugs Directorate (VDD) attendees and of those present on the phone.

2. Conduct of Webconference

1:10 pm

S. Adam explained that since the Lotus Sametime application does not have audio for now, every member also needs to teleconference in addition to logging in into the web site. R. Tremblay mentioned that he could only connect via phone for the meeting. C. Yuill explained the procedures, functions and options of the web interface participating members can use during the conference.

3. Nov 12 Meeting Minutes Approval

1:20 pm

C. Yuill asked the committee for feedback on the previous meeting minutes. No question or comment on the discussion summary document was put forward by the members. A motion was made by G. Chamberland to approve the minutes and it was seconded by P. Nadlersmith. All committee members were in favor. The minutes were approved unanimously.

4. Current updates

1:25 pm

  1. Veterinary Drugs Directorate update
    • M. Lemaire provided an update of the veterinary natural health product (vNHP) team's activities to the committee. She mentioned the team's recent meeting with the Standard Council of Canada regarding the possibility of a third party certification for the quality of veterinary drugs (including vNHPs). Meeting discussions were very useful. She was very pleased to see a good collaboration between VDD and Natural Health Products Directorate (NHPD). F. Van As had the opportunity to work at the NHPD for a 4-week period. She indicated that she learned about the natural health product (NHP) submission process, the preliminary review process, as well as the NHP safety, quality and efficacy reviews. She saw some useful tools to facilitate reviews: pre-cleared information, monographs, labelling standards, ingredient database (4000 ingredients with proper names and uses). An "evidence" database is being considered for future development. She indicated that claim evaluations are very time-consuming and NHPD is thinking about accepting attestations of efficacy for botanicals with general health claims. Prescription NHPs are causing concerns as they present a higher risk and they are not reviewed, due to their exclusion from the NHP Regulations.
    • Committee members discussed that a prescription category would be needed for vNHPs, while this may restrict access for non-veterinarians.
  2. Presumed Safe Products & registration process

    M. Simard explained that the purpose of his Power Point presentation is to summarize where we are at in VDD, as well as to highlight the issues and considerations raised at the last meeting in November, which need to be addressed.

5. Question/discussion period on the Presumed Safe Products document

1:50 pm

M. Simard quickly summarized each topic presented in this document and the chairs opened the floor for discussion.

Annex A

Homeopathic Pharmacopoeias

  • A committee member commented that new products are not necessarily referenced in pharmacopoeias, and they may have other manufacturing standards.
  • Should experimental homeopathic (not prepared or used according to pharmacopoeias) be prescription? It was proposed the pharmacopoeial references be used as a starting point; when the regulatory framework progresses further, it could be possible to remove/keep or add to this reference.
  • More information should be provided on the "fast-track" process and the "regular" process.

Exclusions (no.17)

  • A member asked how a product would be evaluated/approved when it is known to be used by veterinarians for a serious condition; such a condition would be excluded from the low-risk products category. Only general health claims will be allowed on presumed safe (low risk) products.
  • It was felt that the term "Label claims" should be further defined. VDD clarified that the Food and Drug Act is regulating the sale and the label of the product intended for sale. Any promotional material (advertising and Internet sites) are considered to be part of the retail label.
  • The role of the veterinarian to practice extra-label drug use (ELDU) is regulated by provincial legislation and HC can only provide guidance.
  • Public discussions or endorsement of products by veterinarians may not be allowed by the provinces and should not be mistaken as being part of ELDU.

Pre-market requirements: "Typical presumed safe products" - Canadian Representative

  • A few members wanted to have the roles and responsibilities of the Canadian Representative clearly defined in the document. M. Simard indicated that those responsibilities are similar (sometimes identical) to those of a manufacturer.
  • It was reminded to everyone that veterinarians are not legally allowed to sell drug products without a Drug Identification Number (DIN).
  • A member stated that it would be difficult to identify an importer from a manufacturer without and Establishment License (EL), which informs HC of the activities of a company. M. Simard indicated that this would be covered in another part of the framework related to Good Manufacturing Practice (GMP) requirements.
  • Some members agreed that Canadian Representative should not be held accountable for adulterated products or any manufacturing issues. The responsibilities of the Canadian Representative should be fair and should not disengage the manufacturer of its own responsibilities.

Pre-market requirements - "Atypical presumed safe products"

  • The expression "reasonable expectation of effectiveness" should be clarified.
  • The natural products industry is currently not a mature one and some of the requirements may not be realistic.

User Information Section

  • M. Simard explained that this subject will be covered in a future guidance document developed by HC. VDD will come up with a list of acceptable structure-function claims, and overtime a list of specific therapeutic claims will be added, based on the evidence already available.
  • Members believe that if the evidence is strong, a product should not be atypical category. This category should be abolished. In addition, claims should not be too restrictive to industry, to prevent innovation.

Manufacturing

  • M. Simard asked the members if setting quality requirements on the basis of GMPs alone would be sufficient, and if there was other options to ensure product quality.
  • A member indicated that there are different types of manufactures: those with fully integrated GMP and those with no GMPs,
  • Another member stated that GMPs should be an absolute requirements and industry should be allowed to have flexibility and input into how they implement them
  • M. Simard indicated that the proposed regulations would have basic GMPs requirements, which would be enforced by the inspectorate through spot-check inspection and complaints (phase 1). On top of these, industry could adopt higher standards (adapted to their products) which would be enforced trough a third-party certification process. The emphasis would be more on post-market for safety and efficacy.
  • The National Animal Supplement Council (NASC) already has developed requirements for GMPs and they do seem to be attainable for the majority of companies in the United States. The NASC has 110 member companies with a sales figure of 1.4 billions USD. The NASC quality standards were developed in order to be applicable to all. They were based on the standards set for human dietary supplements in Dietary Supplement Health and Education Act (DSHEA) by the US Food and Drug Administration (FDA).
  • Other members said that we should increase the status (recognition) of quality products. HC could start by educating manufacturers about the importance of quality and let the regulatory requirements "weed out" the ones that do not strive to comply.
  • M. Simard indicated that too low requirements would defeat the purpose to have good quality products on the market.

Post-market surveillance

  • Members suggested that some of the post-market terms (such as "immediately", "serious", and "significant") be further precised.

Traditional medicine

  • M. Simard stated that HC does not regulate the veterinary practice, but strongly believe that a veterinary prescription should be required for high risk products.
  • F. Van As added that Traditional Chinese Medicine (TCM) products specifically intended for animals would fall in the high risk category, since their history of use animals is very recent and quite limited. However, product of good quality and approved by NHPD could be encouraged for use by veterinarians in an off-label manner (ELDU).
  • A member informed that the NASC performed a survey of the market for the most commonly used ingredients and that each ingredient was reviewed individually for safety by a group of experts
  • Another member pointed out that TCM mostly uses combination of multiple ingredients and the impact on safety of such combinations should be addressed (combinations are complex but usually safer).
  • It was proposed that the committee reviews the VDD presumed safe ingredients list and compare it with the one from the NASC database.
  • F. Van As reminded the committee that the NASC list is only for companion animals and safety of these substances in food-producing animals is very important and should be considered in the review of the substances list.

6. Recommendation report to come: what do we need?

3:45 pm

M. Lemaire indicated what VDD would need from the committee members in order to prepare/build upon their recommendations:

  1. Provide an answer to every question in Mario's document. She would appreciate if the committee could be as precise as possible on these topics in the recommendations report.
  2. The vNHP team has prepared a document which pinpoints the important vNHP aspects that still need to be resolved (e.g., definition, inclusions/exclusions, types of claims, etc.). Comments and/or responses to these aspects should also be included in the final recommendations report. (Some are repeats from M. Simard's document).
  3. Anything else that the committee feels important to be included in their recommendations to VDD.

The report could be in any shape or form that the committee desires.

  • C. Yuill asked if members had any comments/clarifications requests. She indicated that the claims topic may be difficult to elaborate on in the report.
  • M. Lemaire clarified that VDD would like to get a summary document from the committee, not from each committee member.

7. Next Steps

4:00 pm

  • M. Simard suggested that committee members answer these questions individually and a committee meeting/teleconference could be held to discuss and comments a draft report. VDD could facilitate the organization of this meeting, if needed (e.g., phone lines and numbers, Sametime application)
  • W. Bookout suggested that each member provide their answers/expert opinions in an individual report and send it via e-mail to the chairs, which will be compiled into a draft report. He also indicated that they should have a specific agenda and time lines (i.e., due dates) for the actions items.
  • After discussion, VDD members informed the committee that June 1st, 2010 would be a realistic deadline for the submission of their recommendation report.
  • C. Yuill indicated that depending on the consensus level after receiving input from all members, a tele/web conference may need to be organized shortly. She asked the members for their availability for such meeting.

8. Actions Items

4:15 pm

Committee Action Items
Item Description Responsibility
1 Review VDD's presumed safe substances list (including a comparison with the NASC's list) All members
(Possibility of using/reactivating sub-committees)
2 Provide comments/responses to the VDD document "What should be in the recommendation report of the EAC-vNHP?" (EAC Recommendation report ideas 2.doc) All members
(G. Chamberland to collect comments and put together)
Due date: April 2nd, 2010
3 Provide a written response to questions present in M. Simard's document "Presume Safe Products" (Low risk products 11.doc) All members
4 Prepare a draft recommendation report, and circulate to members for comments/suggestions Chairs
5 Provide a final recommendations report to VDD Chairs
Due date: June 1st, 2010
Veterinary Drugs Directorate Action Items
Item Description Responsibility
1 Update/revision of the document "Presume Safe Products" M. Simard
2 Definition of a whole herb extract vNHP team
3 Definition of a tranquilizer vNHP team

9. Adjournment of the meeting

4:25 pm

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