There shall be no reference to Council acceptance in labeling, package inserts, advertising and other promotional material for any nonprescription product which requires a professional diagnosis for appropriate dental use. Changes in Provisions for Acceptance Any amendment to these Provisions for Acceptance which may be made after acceptance of a product shall not apply to such product until the current period of acceptance has terminated. At the end of this period, a product must comply with the amended Provisions for Acceptance if acceptance is to be renewed. This provision shall not apply to termination of acceptance of a product on the basis of new evidence regarding lack of safety or efficacy. A combination having components added to enhance the safety or efficacy of the principal active component, or to minimize the potential for abuse is also eligible for acceptance.
Separate consideration is required for any single active component.
Labeling of an accepted fixed combination drug shall indicate the amount of each therapeutically active component in a stated quantity of product. The amounts of active components in the product shall be stated in all advertisements and other promotional material to the dental profession. B. Advertisements and other promotional material to the public shall not include misleading or unwarranted statements relating to dental use. C. Labeling, package inserts, advertisements and other promotional materials to the public shall not include the Seal of Acceptance. The Council may on occasion find it necessary to review the status of a product's acceptance.