VETERINARY ORAL HEALTH COUNCIL SEAL OF ACCEPTANCE VOHC

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The VOHC website is http://www.vet.upenn.edu/~vetdent/vohc/




If Therapeutic claims are being made, the product becomes a drug, and these claims must be approved by the FDA.

THE VETERINARY ORAL HEALTH COUNCIL SEAL OF ACCEPTANCE
Is A System for Recognition of Effectiveness of Veterinary Dental Products

General Information on Product Submission and the Review Process

This information is designed to ensure that packages submitted for consideration of awarding of the VOHC® Seal can be dealt with efficiently by the VOHC office and Council. It is in everybody’s interest to minimize the time and expense required to put together and review each package. We recommend that you carefully review this information and the relevant VOHC protocol(s) before assembling your package. If you have questions, please call, fax or e-mail us for clarification or additional information.

The VOHC awards its Seal in two claim categories – Helps Control Plaque, and Helps Control Tartar. A separate submission (and submission fee) is required for each claim. In addition, if a Product is available in more than one size or shape etc., the VOHC will require a separate submission (and fee) for each form of the Product if there is a significant difference in the Product or in the population for which the Product is marketed. For example:
A Product that is available in two sizes labeled for, and marketed to, medium-large dogs for one size and small dogs for the other size will require separate submissions because of the documented differences in the dental anatomical features and periodontal disease prevalence data between small and medium-large dogs.

A Product that is available in two slightly different shapes or sizes and is labeled for, and marketed to, the same size range of dogs will not require two separate submissions, provided that there are no changes in the consistency, flavoring or manufacturing methods etc., that may cause differences in the effectiveness of the two forms of the Product.

VOHC will determine whether a separate submission is required for different sizes, etc. Please note that the Seal is awarded for use in connection with the specific Product that was tested – if a developmental Product was tested, and substantial changes were subsequently made in the shape, flavoring, manufacturing methods etc., for the Product as marketed, the submitted data may be inappropriate for consideration. Please contact the VOHC office prior to submission if you have specific questions on these issues.

A submission will be successful if it demonstrates that the Product meets the requirements as stated in the VOHC protocol(s). Note that in some instances the requirements are very specific - the statistical hurdle required for demonstrating efficacy, for example. In other areas, the requirements are less specific – for example, a minimum trial duration period is stated, but not a maximum; the indices to be used must measure plaque or calculus specifically, but there is no required index; there is no minimum number of animals required for each group. We recognize that there is some need for flexibility, particularly when considering studies conducted before the VOHC protocol was instituted. Alternate but credible methods of demonstrating efficacy are permitted under the VOHC system, provided that justification is provided for methods that are not in general use.

Data sets from two populations of animals are required. For studies conducted after January 1, 1998, in addition to requiring that the animals enrolled in the two studies must be different, at least one of the following three items must be different to meet the "two populations" requirement:
location of trial;
dates of trials;
principal investigator/scorer.
We recommend that two or more of these items are different.

We strongly recommend stratification prior to randomization into test groups, and recommend that randomization by blocking on stratification of the substrate under study is based on blocks equal to the number of arms in the study. Statistical significance is to be determined using a two-tailed test rather than a one-tailed test.
The submission must include all original data, such that an independent statistical analysis could be run by VOHC. The data may be provided in the form of a spreadsheet or database file on disk in a standard software package format, plus printed tables summarizing the whole-mouth mean scores (+/- SD) for each group.
The written materials submitted are to include:
The protocol(s) as adopted prior to conducting the trials, including details of the randomization process between groups, indices used, pre-trial and during-trial management (diet, housing etc.), and between periods management for cross-over trials.

A brief description of the site(s) of the trials, personnel involved (with details of the training and experience of the scorers and identification of the statistician), dates of the trials, source and identification of individual animals, certification of animal care procedures (IACUC, AALAC etc.).

An affadavit signed by the senior investigator and by a representative of the sponsoring company that the information submitted is complete and correct.

Indication of any areas in which the submission does not meet specific VOHC requirements, with reasons why the VOHC should consider such departures from its stated requirements. This could be anything from a notation that one animal was missing one of the recommended teeth, to use of an entirely new method of scoring plaque or calculus.

Submit one copy of the disk with the original data and 12 copies of the written submission.
Include the Submission Fee, as a check made out to the "American Veterinary Dental College." If the fee is not included, the company will be invoiced for the fee before the review process will be commenced. The fees are:
For Products marketed to the general public, whether through specialty pet stores only or through supermarkets and other points-of-sale: $5,000.

For Products marketed only through veterinarians or available only by prescription: $3,000

The Submission Fee is not refundable if the Product is not awarded the VOHC Seal.

If the Council recommends awarding of the VOHC Seal, a detailed Agreement must be signed by both the Company and the VOHC before the Company is permitted to use the VOHC Seal. A copy of the Agreement may be requested from the VOHC office for review prior to submission. The VOHC Seal is awarded initially for a 3-year period; an annual maintenance fee of $1,000 for mass-market products and $500 for veterinarian-only products will be billed prior to the anniversary of the awarding of the Seal. Annual renewal will ordinarily be continued beyond the initial 3-year period if the Product has not been changed in any significant way and if the VOHC Protocols have not changed in any significant way.
The VOHC Seal will be provided to the Company as camera-ready copy. The VOHC Seal Agreement contains specific language regarding advertising, packaging, etc., for materials that use the VOHC Seal. Draft designs showing proposed uses of the VOHC Seal may be submitted to the VOHC office for review during the Product Submission Review process.

Further information should be obtained from the VOHC prior to initiation of studies!

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Hill's Advertising Claims
pet age 1 JUNE 2004
NEWSBeat


Hill's Pet Nutrition proves advertising claims for some of its pet food products, but not others.


The National Advertising Division of die Council of Better Business Bureaus Inc. (New York), the advertising industry's self-regulatory forum, in April determined that Hill's Pet Nutrition Inc. (Topeka, Kan.) had provided sufficient evidence to support advertising claims for some of the products in its Prescription Diet line, but recommended that the company discontinue claims for other products in the line.
The truth and accuracy of Hill's claims were brought to the attention of NAD by The lams Co. (Dayton, Ohio).
NAD concluded that Hill's provided sufficient evidence to support the claim that its Prescription Diet t/d Oral Care and Science Diet Oral Care Adult foods for dogs and cats reduce tartar more effectively than lams' Eukanuba Adult Maintenance Formula with Eukanuba Dental
Defense System. However, NAD found that Hill's claims of superior plaque removal were unsupported and recommended that they be discontinued.
NAD also concluded that Hill's provided sufficient evidence to support the "Clinical Nutrition Proven to Help Extend Life" claim for its Prescription Diet k/d, g/d and n/d foods for canines. However, NAD said Hill's failed to provide sufficient evidence to support the claim for its Prescription Diet r/d, w/d, 1/d, i/d, h/d, p/d, z/d, d/d, c/d, s/d, t/d, a/d, b/d, p/d, u/d, x/d and g/d foods. NAD recommended that the claim be discontinued for these products.
In a statement to NAD, Hill's said it was pleased with the findings and would take NAD's concerns into account for future advertisements.