Seal Program Overview

Under the ADA Bylaws, the Council on Scientific Affairs has subject matter responsibility for the ADA Seal of Acceptance Program. This involves the evaluation and dissemination of information regarding the safety and efficacy of over-the-counter dental therapeutic agents.  

Additionally, the Council maintains liaison with related regulatory, research and professional organizations.  The Council also encourages research in the field of over-the-counter dental therapeutics and devices.  Furthermore, the Council encourages coordinated efforts for development and improvement of over-the-counter dental devices by national and international standardization programs.

Products eligible to apply for the ADA Seal are those that have been cleared by the U.S. Food and Drug Administration for market directly to consumers. The Council on Scientific Affairs evaluates consumer dental products such as therapeutic agents, drugs, chemicals, materials, instruments, and equipment that are employed in the treatment or prevention of dental disease. In addition, cosmetic agents may also be eligible for the Seal. When evaluating these products the Council utilizes published technical standards, ADA Requirements, as well as ANSI/ADA and ISO specifications. Products for which ADA Requirements or technical standards do not exist may also be evaluated if sufficient acceptable data demonstrating safety and efficacy are submitted. ADA requirements and technical standards may be modified at any time. ADA will notify companies of any changes applicable to their products.

Participation in the ADA Seal program is voluntary.  Commercial products are evaluated upon the request of a distributor or manufacturer. Any company may submit appropriate products to the Council for consideration for Acceptance.

Companies pay a submission fee when they apply for the Seal to help offset the cost of evaluation. Submission fees are a one-time, non-refundable fee required with the application. Annual maintenance fees are billed to the company every January. Participation fees as of January 2017 are:

Submission:  $15,000    Maintenance:  $4,000

Products which meet the ADA Seal Program’s general criteria for Acceptance with respect to safety, efficacy, composition, labeling, package inserts, advertising and other promotional material will be granted the ADA Seal of Acceptance. Notification of a product’s Acceptance into the ADA’s Seal Program will be made in writing by the Council. A company may not begin use of the ADA Seal of Acceptance unless and until it has executed the ADA’s standard ADA Seal license agreement and complied with the ADA’s advertising requirements. The Council may require a company to use an authorized statement in conjunction with its use of the ADA Seal. Acceptance is renewable and may be reconsidered at any time. If there is a change in the manufacturer or distributor of a product, the Seal of Acceptance is withdrawn automatically and the license agreement expires simultaneously.

Products that are obsolete, substantially inferior, ineffective or dangerous to the health of the user will be declared unaccepted. When it is in the best interest of the public or the profession, the Council may submit reports on unaccepted products to the Editor for publication in The Journal of the American Dental Association or in another Association medium.