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

Tuesday, November 2nd, 2010

2:00 pm to 4:00 pm ET

Attendees

Committee Members

  • Cheryl Yuill (Chair)
  • Guy Chamberland (Co-chair)
  • William (Bill) Bookout
  • Paul Dick
  • Pierre Gadbois
  • Vincent Girard (new member)
  • Steve Marsden
  • Pauline Nadlersmith
  • Gerrit Rietveld
  • Gregory Tilford

Veterinary Drugs Directorate (VDD)

  • Marie S. Lemaire, Manager, Veterinary Natural Health Product (vNHP) team
  • Simon Adam, vNHP team
  • Mario Simard, consultant
  • Femma Van As, vNHP team
  • Emmanuelle Verrette, Clinical Evaluation Division

Observers

  • Paul Loeven & Raymond Perron, Animal Feed Division, Canadian Food Inspection Agency (CFIA)
  • Paul Enwerekowe, Pest Management Regulatory Agency (PMRA), Health Canada
  • Benjamin Mahon, Natural Health Products Directorate (NHPD), Health Canada
  • Oksana Yarosh, Veterinary biologics Section, CFIA
  • Nicholas Shipley, Health Products & Food Branch Inspectorate (HPFBI), Health Canada

Absent

  • Rob Tremblay (Committee Member)

1. Welcome & Opening Remarks

2:05 pm

C. Yuill welcomed and thanked all participants for taking the time to participate to the tele/web conference.

2. Introduction of our new Committee member: Dr. Vincent Girard

2:07 pm

  • C. Yuill announced that a new member had recently joined the vNHP Expert Advisory Committee (EAC). She invited him to introduce himself to the other member of the Committee. His name is Dr. Vincent Girard and he is a professor at the Faculté de Médecine Vétérinaire (FMV) of Université de Montréal. He recently received a substantial grant from the Federal government to build a research facility at the FMV, in order to develop new approaches for animal production which would reduce the use of antibiotics in livestock species.
  • C. Yuill welcomed Dr. Girard in the Committee and proposed a general roundtable to allow each of the Committee members, VDD attendees and observers to introduce themselves (name and short description of background). This was carried out.

3. Conduct of the conference

2:10 pm

C. Yuill reminded that for the teleconference to be efficient and respectful of everyone, a few rules of conduct need to be followed:

  • Keep comments as short (few minutes) and concise as possible;
  • Use the "Raised Hand" function if you are logged in the webconference with Lotus Sametime (the chair will open the floor from time to time to those who are on the telephone line only);
  • Mention your name before speaking.

4. Confirmation of affiliations and interests

2:15 pm

S. Adam indicated that we could skip this agenda item as the members did confirm or update their affiliations and interest during the roundtable introductions.

5. Return on the last meeting (teleconference March 30, 2010)

2:20 pm

  • Minutes approval:
    • W. Bookout clarified a statement in the previous meeting minutes (under item 5: Discussion on the Presumed Safe Products document /Manufacturing) related to the sales figure of NASC member companies. "The NASC has 110 member companies with a sales figure of 1.4 billions USD."
    • C. Yuill asked the Committee for other comments on the previous meeting minutes. No question or comment was put forward by the members. A motion was made by W. Bookout to approve the rest of the minutes and it was seconded by P. Dick. All Committee members were in favor. The minutes were approved unanimously.
  • Update on current action items:

    All Committee Action Items indicated in the March 30 meeting minutes have been completed except for Item 1 (i.e., Review of VDD's presumed safe substances list), which is to be discussed today.

6. Discussion on the List of Presumed Safe Substances

2:30 pm

  • C. Yuill opened the discussion by asking the Committee for comments or questions on the list of presumed safe substances prepared by F. Van As.
  • A member asked if the list contains all the ingredients presently listed in the NHPD Ingredient Database. VDD answered that not all ingredients from this database are present on the list, as some ingredients for human use are not suitable or applicable to animal use. Also, the NHPD Ingredient Database's purpose and design is to facilitate the preparation and submission of applications for approval of Natural Health Products (NHPs). The information in this database refers to product/ingredient monographs supported by scientific evidence originating from human use. Moreover, the NHPD database ingredient has not been developed based on the risk to health of these ingredients; not all ingredients on this database can be presumed safe, particularly for other species.
  • A member needed clarification as what are VDD's expectations from the Committee regarding this list. VDD indicated that it wishes the Committee members provide comments and suggestions regarding the format and presentation, and tap into their varied expertise to advice on the acceptability on the substances listed. VDD is open to accept the suggestion of a few substances the Committee believe should be added to the list (comments and suggestions from members can be sent to F. Van As, if preferred). Comments on the other documents included in the e-mail invitation would also be welcome. It was also clarified that the evaluation process of these proposed substances would take time and VDD would like the Committee to focus on the list as it is currently.
  • It was asked if the statement and warning listed under the "Restrictions" column would appear on the product labels. Depending on the individual products, some may need to be on the label while some may not. A clarification should then be added in the list as which statement have to be present on the label. The NASC list of substances contains 1431 ingredients and there are approximatively 1000 to 5000 more ingredients currently on the market. Committee members indicated that the review of all these ingredients will likely be very time-consuming and resource-intensive for VDD and it was suggested that the NASC list be grand-fathered by VDD. VDD indicated that the review will be a long-term process, as ingredients will be added to the list along the way. The NASC list contains a letter-based (A, B, C, D) classification system to determine the risk or acceptability of each substances. VDD believe that the ingredients listed A and B can be presumed safe, but the ingredients listed C and D cannot be considered as "presumed" safe.
  • A member proposed that, considering the limited resources of Health Canada, the review of vNHP ingredients be given to an outside, independent third party group or organization of experts. The issues of the resources available at the regulatory level and the outsourcing of non-regulatory operations were previously discussed during the November 12, 2009 meeting.
  • Another member indicated that, in order to feel comfortable recommending the list, sources and references need to be added, allowing the reader to better understand the decision process and to see that there is scientific evidence for the presence of each ingredient on the list. It would be better for the Committee to accept criteria instead of individual substances. VDD indicated that the criteria used for the development of the list have been already incorporated in the Presumed Safe Substances (PSS) Application Guidance document. A few examples of references and sources (international regulatory bodies, GRAS lists, monographs, etc.) were given. However, some members would like to have more details on certain substances and it was asked if VDD could add the references directly in the document. VDD put the references in a separate background document for the list to be clear, concise and easy to use for industry.
  • Some other members congratulated F. Van As for her thorough work on the list of Presumed Safe Substances list and wanted to confirm that when no information was available on a particular substance, it was not added to the list (or presumed safe). Individual companies that have their own data or information on a substance would have to share it with VDD to support the safety of that substance and have it added to the list.
  • A member asked about the system/program attached with the list. VDD mentioned that it would be a pilot project, run and administered with the involvement of an independent third- party. Such program would not be cost-recovered by Health Canada until a new regulatory framework will be in place, in which a cost-recovery system would be integrated.
  • The chair indicated that the committee needs to come up with very precise recommendations for VDD regarding this project.
  • The PMRA observer indicated that its organization has already conducted reviews of a few natural substances/ingredients used in animals and would be willing to share that information and the decision-making process they used with VDD.
  • Another member mentioned that the Canadian public will want to know and be consulted on what Health Canada is putting forward regarding vNHPs. Ideally, the VDD would need "macro" recommendations and "big picture" approach from the Committee. It should be prescriptive and think "big" in its advice. The Committee should not deal with details (these can be left to VDD). It should focus to move this whole initiative forward and make progress. P. Dick volunteered to try to put down recommendations to share with the Committee and be the point man to help identify and set up a third party body.
  • VDD understood from the discussion that the list is useful but that we need to make it grow quickly. A member added that there are sectors of the production industry, like the organic industry, which significantly depend on access to approved natural products and need a rapid solution to the current situation. However, it should be noted that the List of Admissible Substances contains ingredients that are considered low risk when used in cats, dogs and horses not for food.
  • Because of the lower risk to human health, VDD decided to start with implementing a program limited to companion species first as a pilot, while working on a list of substances presumed safe for food-producing animals. In the event the pilot would be a success, the same program would later be implemented for food-producing species, in the development of a new regulatory framework. This is a step-by-step approach, and the pilot is only the first step.
  • A member indicated that there are likely less substances for food-producing animals than for companion animals and that the Committee and VDD should focus on these instead. According to another member, there are less than 50 substances that are really needed for food-producing animals, especially the organic production. It was then proposed to have the food-producing experts on the Committee do a review of these 50 substances while VDD works on the companion animal substances list and regulatory process. VDD indicated that it consider this proposition and consult internally.
  • A Committee member indicated that from a regulatory point of view, using the companion animals as a pilot makes sense and is good to limit the risk to health. However, it was argued that the focus of the Committee is to start with general principles and work down towards the details.
  • Another member reminded everyone that the goal of the Committee is find the best approach based on their expert opinions and to put it forward to VDD as recommendations. The Committee would need other volunteers to tackle the issues of food-producing animals. It was proposed that to reactivate the food-producing sub-committee made of P. Nadlersmith and S. Marsden to look a species-specific data and work on putting forward Committee recommendations regarding the substances and issues regarding food-producing animals. VDD indicated that some work as already being done on this subject and it currently has a draft list of low-risk substances intended for use in food-producing animals. P. Nadlersmith indicated that she had compiled a list of substances for use in organic production and she has submitted to VDD for review. S. Marsden indicated that he is willing to help define the process for Health Canada's decision-making.
  • C. Yuill motioned that the Committee thinks it is important to start working on guidance for food-producing species and a list of "safe" substances. This motion was seconded by W. Bookout. He made a new motion that the food-producing sub-committee should be tasked with the object of drafting recommendations which will identifying the decision-making process that should go into the list of substances. The sub-committee would then make a complete proposal to the Committee for review and discussion. This additional motion was seconded by G. Chamberland. There was no objection from other Committee members. These two motions were carried.

7. Discussion on the Health Claims Guidance Document

3:10 pm

  • C. Yuill asked the Committee for comments regarding the document on acceptable health claims prepared by VDD.
  • The committee mentioned that it would be important to clarify the meaning of some health claims present in this document. For instances, the claim "normalize the gut flora" may be interpreted differently by various persons.
  • A member indicated that positive references to clinically proven benefits should not be allowed for Notifiable products. If allowed, these references may decrease the incentives for manufacturing companies to conduct supportive research. VDD agreed that the statement "clinically proven" needs to be supported and should not be allowed as VDD would not review these products. In order to accept this type of promotional claim, sponsors will have to submit the clinical data to VDD for review. VDD is planning a completely different stream of regulatory approval for these situations.
  • M. Simard reminded that VDD is planning a new regulatory approach based on the level of health risk presented by types of products. There will be different levels of regulatory approval: a Level 1 approval for lower-risk products and a Level 2 approval for higher-risk products. A Level 2 approval would be an opportunity for sponsors to submit data to support more specific therapeutic claims and be allowed to put them on their product labels.
  • Another Committee member added that this framework (particularly for Level 2 products) should also describe the type of studies needed to substantiate the claims. This type of information is currently missing when scientists try to determine the validity of certain claims made by products. Criteria for conducting sound experimental studies should be put together to help industry obtain solid scientific data.
  • F. Van As indicated that the issue of claims for homeopathic products still needs to be resolved since these products are to be included in this scope of the document on health claims. She asked the Committee for its opinion about allowing health claims or not for homeopathic products, and if yes, for what type of homeopathic (single or multiple ingredient) products? The constitutional use of homeopathic medicines for maintenance of health is controversial. The NHPD does not allow claims on single ingredient remedies, but does accept claims for multiple ingredients products, based on references in various Materia medica. A committee member stated that although homeopathic medicines are intended for a therapeutic purpose, specific claims should not be allowed. The criteria of the claims (or absence thereof) should be applied to all homeopathic products, regardless of their ingredients. Most homeopathics for human use are approved for sale without a label claims.
  • W. Bookout motioned that the Committee members with homeopathic expertise should draft guidelines claims regarding claims acceptability for homeopathic medicines. P. Dick seconded this motion. C. Yuill indicated that she would need additional background information on the NHPD approach to homeopathic approval.

8. Discussion on the Presumed Safe Substance Application Guidance Document and its Application Form

3:40 pm

(Note: These documents were initially discussed during the discussion on the List of Presumed Safe Substances)

  • The Committee was very impressed by the amount of details put into those documents.
  • A member indicated that the definition of Adverse Event (AE) is very important and will determine the level and scope of reporting. He proposed to provide to VDD the NASC material on adverse event reporting.
  • It was mentioned that the AHPA (American Herbal Products Association) documents developed for the NASC includes a wide definition of an adverse event. Another member agreed and mentioned that post-market surveillance should be broad and as much encompassing as possible.  The NASC database could be used as a post-market tool by VDD.
  • W. Bookout was agreeable to VDD having access to the database of the NASC Adverse Event Reporting System. The NASC is currently in the process of interfacing with the CVM – FDA ADR (Adverse Drug Reactions) Database. He indicated that a permission of the board members would need to be obtained first.
  • In addition to the comments above, some committee members noted a few contradictions and discrepancies between the form and the guidance document.
  • C. Yuill confirmed with VDD that the Committee had given all the necessary feedback. W. Bookout congratulated C. Yuill for successfully facilitating this meeting.

9. Next Steps/Actions items

3:50 pm

Next Steps

  • Committee members to send additional comments to the chairs or to VDD in writing.
  • Sub-committees to send their work and/or recommendations to all Committee members via e-mails.
  • Next meeting/teleconference date and time to be determined by VDD.
  • M. Simard mentioned that VDD received a proposal from the Canadian Animal Health Institute (CAHI) to put forward a voluntary notification system for veterinary natural products. It would be an interim measure while the implementation of a new regulatory framework for veterinary product is pending. This system will be the subject of an upcoming consultation with veterinary stakeholders and the EAC will be invited to participate.
  • A face-to-face meeting was suggested. However, this may not be feasible due to VDD short timelines and limited resources for the consultation.

Committee Actions Items

  1. Prepare draft recommendations to focus/direct committee discussions - P. Dick
  2. Search and identification of a suitable third-party body - P. Dick
  3. Prepare draft recommendations regarding the list of substances and decision-making criteria regarding food-producing animals - P. Nadlersmith and S. Marsden
  4. Prepare draft guidelines regarding claims acceptability for homeopathic medicines. - C. Yuill and S. Marsden
  5. Provide NASC material on adverse event reporting and access to NASC ADR Database to VDD, upon consent form NASC Board members. - W. Bookout

VDD Action Items

  1. Update March 30, 2010 meeting minutes - vNHP team
  2. Write November 2, 2010 meeting minutes - vNHP team
  3. Provide information on the NHPD homeopathic review process to Committee members - F. Van As (Completed)
  4. Contact PMRA to obtain their scientific safety evaluations already conducted on certain natural substances. - vNHP team (PMRA has been contacted, waiting response)
  5. Feedback on Committee recommendations when received - All VDD
  6. Provide draft list of presumed safe substances for food producing animals - F. Van As (Completed)

10. Adjournment of the meeting

4:00 pm

C. Yuill thanked everyone for their continued participation and adjourned the meeting.

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