Protocols and Submissions
This web page contains general information on VOHC Protocol and Submission Requirements and related information. VOHC recommends careful review of this information before drawing up a plan for trials designed to meet VOHC requirements.
Dental Claims Recognized
VOHC awards the Seal in two claim categories: Helps Control Plaque, and Helps Control Tartar. If a submission requests review for both claims, separate data sets and analysis summaries are required for each claim, though data for both claims can be collected during the same trial.
Plaque: The soft, bacteria-rich layer that rapidly forms on the surface of the teeth as a result of poor dental hygiene. The bacteria in mature plaque are the cause of gingival inflammation that starts the periodontal disease process. Specific information on scoring plaque is available.
Tartar: Calcium salts secreted in saliva that are deposited on the surface of the teeth as a hard substance (calculus or tartar) that is resistant to removal by chewing or brushing. Tartar provides a rough surface that enhances development of plaque, and is thus is an exacerbating factor in development of periodontal disease. Because good oral health of dogs and cats depends on a collaboration of the owner, the veterinarian and the pet, VOHC uses the publicly-recognized term ‘tartar’ rather than the medical term ‘calculus’. Specific information on scoring tartar is available.
Definitions of Terms Used by VOHC
Product Sponsor: The company that manufactures or markets the product, provides the product and funding for the trials, and submits the fee and package for review by VOHC.
Trial Site Owner or Official: The responsible official of the company that owns the laboratory animal facility or the veterinary hospital or clinic that provides the animals and at which the scaling and scoring is conducted.
In some cases, the Product Sponsor and the Trial Site Owner are the same company.
Seal: The ‘VOHC Accepted’ Seal®, which is a US-PTO registered mark that must not be used in association with specific products without prior approval of VOHC.
Plaque and Tartar: See Claims section.
VOHC Chemical Agent Policy
The general principle is that VOHC must be satisfied that introducing a chemical agent into the mouth must both not create harm (as evidenced by there being no increase in gingivitis following use of the active agent compared with an appropriate control) and must reduce accumulation of plaque and/or calculus at or above the minimum VOHC standard compared with an appropriate control.
If the product contains a chemical anti-plaque or anti-calculus agent, the submission is to provide confirmation that either:
- The chemical agent is on the Generally Regarded As Safe (GRAS) list as an ingredient in a pet food, treat or device at the concentration used in the product submitted for VOHC review, OR
- If the chemical agent is a novel agent (not previously used as an ingredient in a pet food, treat or device), it has been reviewed and accepted as safe by US-FDA (or equivalent regulatory agency if the product is to be marketed only in a non-North American country) at the concentration used in the product, and known safety history to date is to be included in the submission.
If a product has both chemical and mechanical dental effects, three groups (negative control, positive control and test groups) may be necessary. See Required Groups for details.
Use of the Seal
Upon approval of a submission by VOHC and the AVDC Board of Directors, the sponsor and AVDC sign a formal Agreement governing use of the VOHC Accepted Seal. The blank Agreement is available.
‘VOHC’ or ‘VOHC Seal’ may not be used in relationship to a specific product if the VOHC Seal has not been awarded to the product and the VOHC-Sponsor Agreement has not been signed by both parties.
To ensure that the VOHC Seal is not misused, the product sponsor is to include the following text in its affidavit accompanying the VOHC submission for that product:
I acknowledge being aware of VOHC policy that the company and its representatives are not to make any mention of VOHC relative to the product until such time as the review process has been successfully completed and the VOHC – Sponsor Agreement has been signed by both parties. I acknowledge that I am aware that VOHC can elect not to continue with the submission review process if the sponsor is not in compliance with this requirement.
The letter notifying the company that the submission meets VOHC standards will include two copies of an Agreement, which are to be signed by the company and VOHC before use of the VOHC Seal on the product can commence. The VOHC Seal Agreement contains specific language regarding advertising, packaging, etc., for materials that include the Seal. A review copy of the Agreement will be sent on request; please contact the VOHC Office.
Draft materials showing proposed layout and text of packaging and advertisements incorporating the VOHC Seal may be submitted to the VOHC office for review at any time following receipt of the submission by VOHC.
The VOHC Seal will be provided to the Company as an electronic image. The specific claim(s) for which the Seal was awarded (plaque and/or calculus) are to be included as part of the Seal on product packaging. Inclusion of the VOHC web site URL (www.VOHC.org) below or close to the Seal on product packaging and advertisements is encouraged, and will be required in Agreements from 2004 onwards.
Use of foreign languages as part of the Seal is permitted, provided that the core of the Seal [Veterinary Oral Health Council, VOHC, Accepted] is included in English as the world-wide common logo of VOHC and the VOHC Seal system.
Inclusion of a comment on the need for/value of professional care in association with the Seal or elsewhere on packaging and advertisements is recommended.
Two Trials Requirement
Two trials are required, to ensure repeatability of results. The dogs or cats included in one trial cannot be included in the second trial.
For products in a “Product Line”, such as the same product in different sizes or shapes, or dietary products with a common anti-plaque or anti-calculus mechanism but with different nutrient profiles, see Product Line policy and requirements.
Types of Trials
Parallel group or cross-over trial designs are permitted. For cross-over trials, minimum duration is 28 days per leg of the trial, with a minimum between-leg rest period of 7 days in trials of a chemically-active product.
Because each subject acts as its own control, a cross-over trial design may be able to demonstrate a significant difference from control with fewer animals per group. However, see the comment in the Statistics section regarding the risk of a sequence effect in cross-over designs.
Safety and Regulatory Issues
Please read the ‘Meaning of the VOHC Seal’ on the VOHC web Home page.
VOHC trials include two methods designed to assess safety of the product: Gingivitis scores, and observation for non-gingival inflammation or oral ulceration or laceration, at the beginning and end of the trial.
VOHC also requires that the sponsor of a product that is the subject of a submission to VOHC certifies via affidavit from the responsible official at the time of submission that it has complied with all safety and regulatory requirements in the jurisdictions where the product is marketed, that there is no information at the time of the VOHC submission that the product is unsafe, and that it will promptly inform VOHC of any reports or regulatory actions concerning the safety of the product.
‘Safety ‘ in the VOHC context includes:
A. Major extra-oral or body-wide issues such as toxicity, esophageal or gastro-intestinal obstruction or perforation, or gross nutritional imbalance;
B. Trauma to oral tissues, such as fracture of teeth or laceration or penetration of oral mucosa.
Complaints from consumers that relate to any of the product safety issues mentioned above are to be promptly copied to VOHC, and confirmation of continuation of use of the VOHC Accepted Seal is contingent on affirmation in the Annual Report that no
safety complaints that have not already been brought to VOHC’s attention have been received by the product sponsor in the past year.
Policy on Revision of VOHC Seal Requirements
VOHC will consider submissions containing results of trials conducted according to VOHC requirements that were in place at the time the trial was commenced, provided that a pre-trial protocol review was provided by VOHC, even if a change in VOHC protocol requirements was made subsequent to the commencement date of the trial.