Guidelines for Participation in ADA Seal Program
The Guidelines for Participation in the ADA’s Seal of Acceptance Program are provided for informational purposes only and may be modified at any time. These Guidelines provide a general overview of the ADA Seal of Acceptance Program; they do not govern a company’s rights to use the ADA Seal. The ADA Seal of Acceptance is a registered certification mark of the American Dental Association. All rights to use the ADA Seal are governed solely by a separate license agreement between the ADA and the manufacturer or distributor of an Accepted product. The ADA Seal of Acceptance may not be used on or in connection with a product until after it has been granted the Seal of Acceptance by the Council on Scientific Affairs and only after a license agreement has been signed. Upon termination or expiration of the ADA license agreement, regardless of cause, all rights of a company to use the ADA Seal immediately cease.
Types of Products Considered for Acceptance
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, regardless of whether the company elects to market the products over-the-counter or exclusively through oral health care professionals. 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, including official ADA guidelines, as well as ANSI/ADA and ISO specifications.
Products for which ADA Guidelines
or technical standards do not exist may also be evaluated if sufficient acceptable data demonstrating safety and efficacy are submitted. ADA Guidelines and technical standards may be modified at any time. ADA will notify companies of any changes applicable to their products.
Product Submission and Acceptance
Commercial products are evaluated upon the request of a distributor or manufacturer, or upon the initiative of the Council. Any company may submit appropriate products to the Council for consideration for Acceptance. Products which meet the ADA Seal Program’s Acceptance general criteria 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.
Termination of Professional Product Component of ADA Acceptance Program
Notwithstanding any other provision of these Guidelines, the ADA stopped accepting professional products for evaluation and inclusion in the Acceptance Program on December 31, 2004 and focus instead on a product evaluation newsletter for ADA member dentists covering an entire category of professional products in one article. We launched the newsletter—the Professional Product Review
—in July 2006. Phase-out of the Seal on professional products was completed on December 31, 2007.