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

Tuesday, May 24, 2011

8:30 AM to 4:00 PM ET

Attendees

Committee Members

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

Veterinary Drugs Directorate (VDD)

• Marie S. Lemaire, Manager, vNHP team
• Simon Adam, vNHP team
• Mario Simard, consultant
• Femma Van As, vNHP team
• Daniel Chaput, Director General VDD
• Mary Jane Ireland, Director, CED

Observers

• 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

Regrets

• Rob Tremblay (Committee Member), Gerrit Rietveld (Committee Member)

1. Welcome & Opening Remarks

8:30 AM

C. Yuill welcomed and thanked all participants for their presence. D. Chaput expressed his appreciation for the committee member's excellent input over the last few years as we explore moving to a more risk -based approach to regulating low risk products. He noted that the approach would need to be formalized through an amendment to the drug regulations.

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).

2. Update on the Interim Notification Program

8:45 AM

M. Lemaire briefly summarized the concept of the Interim Notification Program and reported that the majority of the comments received after the consultation were positive and supportive of the Program. A summary of the comments will be posted on VDD web site in the near future. A committee member asked about the process on how to add a substance to the List of Admissible Substances (LAS). F. Van As advised that draft criteria, SOPs, application forms were developed last fall, which were then shared with committee members and she committed to resending these documents to all committee members. She would include an example of a submission for Black Currant.

One committee member felt that the idea of "HC will not prioritize compliance enforcement for LRVHPs who have been issued a Notification Number" (as written in the concept paper), was not a "big carrot on a stick" for sponsors considering participating in the Program. It was also pointed out that it was not clear what was meant by "credible and objective evidence" of efficacy. F. Van As pointed out that, as an example, the opinion of one person would not be considered adequate evidence and advised that a list of examples of useful resources had been created in the Guidance documents which she will resend with the above.

F. Van As reported on the progress of the LAS (expanded from 420 to 688 substances). Copies of the draft Notification form and Guidance were shared with the group for their review and comments. One member indicated that it is important to develop a program by which the List of Admissible substances is easily amended.

M. Simard summarized the similarities and differences between the EAC Recommendation report and the concept of the Interim Notification Report. The committee members agreed that almost all their recommendations would be implemented if the INP would come into force. Questions were asked about the health claims allowed under the INP. F. Van As will send the participants a list of acceptable claims under the program along with a Guidance document. The renewal period of "notification numbers" were discussed; some organizations, such as the NASC, USFDA and Health Canada require annual renewal of their authorization numbers, when CFIA's renewal period is 3 years for feed ingredients. Further discussion will be needed on this topic.

3. Issues re: Low Risk Veterinary Health Products Part 1 (F. Van As)

10:30 AM

F. Van As discussed Microbial products, Organic Mineral Complexes and Glandulars and their risk assessment from the committee members assessment. The committee members felt that there are risks involved with these substances and recommended the following:

• Microbial products:
  • Only those microorganisms with QPS (Qualified Perception of Safety by EFSA) in EU, as well as those considered not presenting a safety concern by FDA in the US should be added to the LAS. This would be acceptable for products for companion animals but needs to be revisited for products used for food producing animals. It was mentioned that an expert could be asked for an opinion with regards to the safety of probiotics.
  • Add specific requirements in the GMP guidance document
  • The Chair recommended that an external ad-hoc expert (Committee if needed) on probiotics be delegated if needed.
  • A member mentioned that the problem associated with anti-microbial resistance is mostly present with food-producing animals and not companion animals.
• Mineral complexes
  • could be added to the LAS with qualifiers, such as dose limits. It was suggested to use AAFCO recommendations.
  • VDD should start evaluating the minerals that are less toxic, and then review the more toxic ones, such as copper and selenium. One participant suggested that an approach similar to the NHPD be adopted.
  • Add specific requirements in the GMP guidance document
• Glandulars:
  • Even if some glandulars could be acceptable, they have to be treated on a case-by-case basis. Therefore, it was recommended not to add glandulars to the LAS because of their potential risk of BSE contamination (They are considered Specified Risk Material )
  • Insufficient information is available at this time to be make a decision at this point.

B. Bookout generously committed to providing VDD with access to the NASC Adverse Event Reporting System database (NAERS database)

4. Lunch Break

12:00 PM

5. Issues re: Low Risk Veterinary Health Products Part 2 (F. Van As)

1:00 PM

F. Van As discussed Traditional Chinese Herbal Substances and their risk assessment.

The Committee members made the following recommendations:

• Any toxic herb should never be added on the LAS, even if safe in small amounts in formulations.
• Chinese herbs should be treated the same as any herb.
• F. Van As shared with the group the difficulties she has encountered with the identification of the herbs as often the Chinese names are used and not the Latin binomial name, and the fact that in some cases the Latin binomial names are not consistently used for the same herb. S. Marsden offered to help with the identification and also offered to send a list of 100 most commonly used Chinese herbs together with their Latin binomial names. F. Van As will send a list of Chinese herbs she was unable to identify to all Committee members.
• It was also suggested that an applicant would have the option of opting out of the general health claim requirement for products used in certain healing paradigms, such as TCM or homeopathy.
• In terms of quality requirements, some felt that an attestation only would not be sufficient and could present an unacceptable health risk.

There was a discussion on routes of administration for LRVHPs. Committee members had different opinions on whether or not intra-mammary and intra-uterine routs of administration should be considered acceptable for LRVHPs. Everyone then unanimously agreed to exclude these for LRVHPs, as had been decided previously.

F. Van As discussed the process of adding substances to the LAS and presented options. She explained that the decision of whether a substances is added to the LAS will be made by HC, however the "information gathering" part could be done by the sponsor, consultant, contractor, third party, a special admissibility committee, VDD drug evaluator or a combination of all of the above.

A participant mentioned that it would be important to look at the issue of raw material contamination, and consider the possibility of developing a database of preferred raw material supplier.

6. Modernization Veterinary Drug Regulations (M. Simard)

2:45 PM

Members of the Committee compared their previous recommendations with the proposed Interim Notification Program and concluded that there is no significant discrepancy, except that it only applies to products used on cats, dogs and horses not intended for food.

They recommended that the Interim Notification Program be extended to product used in food-producing animals.

Members of the Committee then proceeded to discuss the regulatory requirements that should apply to low-risk veterinary health products used in companion animals and in food-producing animals, should new regulations be adopted. The attached table reflects their discussions.

7. Closing Remarks & Meeting Adjournment

4:00 PM

It was anticipated that the next meeting would take place in September 2011