The VOHC® Seal of Acceptance

Multiple

Products in a

‘Product Line’

 

A ‘product line’ is two or more products manufactured or marketed by one company that incorporate the same plaque and/or tartar (calculus) retardant formulation, ingredients or technology.

VOHC recognizes that the VOHC two-trial protocol requirement may not be necessary for every product in a product line. The primary considerations for VOHC are whether the products in the product line:

• Have different dental effectiveness, and if so, whether each product meets the minimum VOHC standard.
• Are marketed for different 'body-size classes' of dogs. (Not applicable to cats).

Although it is not possible to state a definitive policy that will apply to all product lines because of the range of possible product lines, a general policy is described below. Contact VOHC to determine how this general policy may apply to a specific product line.

Available on this page:

 

Minor Difference Between Products in a Product Line

Difference in Flavorings, No Other Differences Between Products


For example, a treat product is marketed in one size, but in two or more different flavors. A company submits data from two trials that meet the VOHC requirements, and the two trials are conducted using one product, as required by VOHC. Thus there are no data presented to VOHC from trials for the product coated with the other flavors.
VOHC would permit the Seal to be used on the product with the un-tested flavors if the company offered a satisfactory explanation of why the difference in the flavorings would not affect the rate of dental plaque and/or calculus deposition compared with the tested product.

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Major Differences Between Products in a Product Line

Differences in Size of Product and in Body Size Classes of Dogs


A significant difference in size of a chewed product (and thus likely chewing time) would be reason for VOHC not permitting use of the Seal on more than one size of the product even when a product of one size has satisfactorily completed the VOHC review system. Conducting the two required trials using one size of product in one trial and another size in the second trial would not be accepted, because VOHC’s basic statistical hurdle includes conducting two trials of the same product, in both of which the product performs significantly better than in the control group.

Differences in size of product are compounded by the fact that products of different sizes are often marketed for use in dogs of specific body-sizes (e.g. the ‘Jumbo’ product package may state ‘For Giant-sized Dogs’).

Based on epidemiological evidence (references 2,3), toy and small-breed dogs are prone to develop more severe periodontal disease than are larger dogs; with increasing body weight, there was a significant decrease in gingival index, mobility index, attachment loss and presence of a complete furcation defect (3). The decrease was most obvious when comparing small dogs to medium-large sized dogs, as opposed to comparing medium-sized dogs with large-sized dogs (3). In addition to having smaller jaws in absolute terms, small dogs have teeth that are proportionately larger relative to jaw size than those of larger dogs (1).

Based on this evidence of increased severity of disease and anatomical pre-disposition in small dogs, VOHC requires separate submissions for products marketed for small dogs and for products marketed for medium-sized and larger dogs. Given that there are insufficient data on which to define body-weight groups, VOHC is willing to review body-weight grouping prior to commencing the trials, and will take into consideration the availability of dogs of different body sizes for clinical trials. Use of laboratory-housed beagles for trials of products marketed for small-medium dogs and laboratory-housed mixed breed pointer-retriever sized dogs for trials of products marketed for large dogs is acceptable. Use of client-owned dogs is acceptable provided that randomization, blindedness of the scorer and compliance with the instructions for the assigned group can be assured.

When two sizes of a product are marketed:
Testing the small-sized product in small dogs using the VOHC two-trial criterion, and testing the large-sized product in large dogs in one VOHC trial (or vice-versa) will be acceptable. If results in all three trials exceed the VOHC statistical criteria, the VOHC Seal will be awarded for use on both products.

When more than two sizes of a product are marketed:
Testing the small-sized product in small dogs using the VOHC two-trial criterion, and testing the large-sized product in large dogs in one VOHC trial (or vice-versa) is recommended. If results in all three trials exceed the VOHC statistical criteria, other sizes of product will be permitted to use the Seal without further testing.

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Differences in Shape of Product


Many dog and cat treat product lines are marketed in a variety of shapes. These different shapes may have widely different abilities to retard plaque and calculus deposition, based on the interest of the dog or cat in chewing the product and on the mechanical effect the treat has on the teeth. In the absence of results of testing for each shape, this is a frustrating situation for VOHC and industry. Testing of each different shape may be prohibitively expensive. The general policy outlined above may be applicable. Assuming that there is prior agreement with VOHC on what constitutes the "ends of the range of shapes" and what constitutes "intermediate shapes", testing products at either end of a spectrum of shapes (using VOHC criteria and with results that meet VOHC standards) will permit use of the Seal on those two products and on any intermediate shapes. VOHC strongly recommends pre-trial discussion between the company and VOHC about what constitutes the "ends of the range of shapes" and what constitutes "intermediate shapes". The body-size(s) of the dogs for which the products are marketed are to be taken into consideration.

 

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Other Differences, e.g. Nutritional Formulation


When a line of products incorporating the same dental formulation or technology is marketed in a number of different nutritional profiles (e.g. for different life-stages, or for obesity control and as a maintenance formula), and general physical characteristics of the diet such as kibble size are very similar in each product, VOHC will consider a submission to award the Seal to all of the products in that line based on: A two-trial study as per VOHC protocol using one of the products (“primary product”), and a single trial of each of the other products in the same product line for which the Seal is requested, provided that the single trial of each additional product demonstrated that each additional product is statistically “at least as good as” the product subjected to the standard two-trial protocol, and that the company provides appropriate information about the differences in the formulations. If one of the additional products was not statistically “at least as good as” the primary product, this additional product may still be eligible for the VOHC Seal if results of a second trial of that specific product, in combination with the first trial of that specific product, met the VOHC criteria for an original submission.

This policy is subject to the provision regarding body size noted above, and possibly additional considerations. For example, consider a dental diet line that includes a diet marketed for diabetic dogs and another for non-diabetic obese dogs, both of which incorporate the same dental technology as the maintenance diet that has been awarded the VOHC Seal. The diabetic diet may have a higher fiber content than the maintenance diet as part of its diabetic control mechanism (and thus may have potentially higher dental abrasive action), and the glucose content of saliva may be higher in the diabetic dogs (which may have a stimulatory effect on oral bacterial growth). The obesity diet may have a higher fiber content than the maintenance diet, as well as lower carbohydrate/fat/protein content. Separate two-trial submissions would be required for each additional diet in the absence of explanations satisfactory to VOHC that the differences in dental effectiveness of the products are not significant.

Other differences in products in a product line will be considered on request, and the VOHC decision will be based on the general policies described above.

 

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References

1. Gioso MA et al: Mandible and mandibular first molar tooth measurements in dogs: relationship of radiographic height to body weight. J Vet Dent 18; 65-68, 2001

2. Hamp SE et al: Macroscopic and radiologic investigation of dental diseases of the dog. Vet Radiol; 25, 86-92, 1984.

3. Harvey CE et al: Association of age and body weight with periodontal disease in North American dogs. J Vet Dent 11; 94-105, 1994.

 

 

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