While not a regulatory body, the American Dental Association (ADA) takes a vested interest in informing the public on the safety and effectiveness of oral care products. They do this primarily through their Seal of Acceptance program, which began in 1930. The ADA Seal of Acceptance program is entirely voluntary, whereby manufacturers may submit safety and efficacy data for a product to the ADA Council on Scientific Affairs. Through a standardized, scientific review process, the Council decides whether to award its Seal of Acceptance to the product.5
The ADA Seal of Acceptance can be a powerful product endorsement in both professionals’ and consumers’ minds, as both of these groups have come to trust the ADA for providing guidance on the safety and efficacy of products. In order to obtain the ADA Seal, manufacturers are required to submit data in accordance with published ADA guidelines for confirmation of each benefit for which the Seal of Acceptance is desired. For some benefits, these requirements include the submission of at least two well controlled clinical studies confirming efficacy, with the clinical trials run according to established ADA protocols. For benefits where clinical studies are not required, the ADA has established a series of specific laboratory tests that must be followed in order to confirm product effectiveness. For a product that wishes to claim multiple benefits, each benefit must be confirmed according to the required guidelines; thus, the overall investment (both clinical and laboratory) to obtain the ADA Seal is considerably higher for a product that is able to claim multiple benefits, compared to a product that claims a single benefit. The ADA Seal is usually awarded for a 5-year period, after which the company must seek renewal. If a dentifrice formulation changes, the manufacturer must submit a new application for the modified product.5,6
Click here for more information about the “ADA Seal of Acceptance Program & Products” requirements and products that carry the ADA Seal.