Guidelines for Earning the Seal
The Guidelines for Participation in the ADA’s Seal of Acceptance Program (“Guidelines”) 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.
Purpose of the Council
Under the Bylaws of the American Dental Association, the Council on Scientific Affairs studies, evaluates and disseminates information with regard to: the safety, efficacy, promotional claims, and proper use of dental therapeutic agents, their adjuncts and dental cosmetic agents used by the public or profession. The Council also determines the safety and effectiveness of and disseminates information on, materials, instruments and equipment that are offered to the public or the profession and further critically evaluates statements of efficacy and advertising claims.
Additionally, the Council maintains liaison with related regulatory, research and professional organizations, and encourages, establishes and supports research in the field of dental therapeutics and dental materials, instruments and equipment. Furthermore, the Council encourages development and improvement in materials, instruments and equipment by coordination of national and international standardization programs.
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 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.
General Criteria for Acceptance
A. Established or Generic Names: The selection and use of established or generic names must conform to the requirements of the Federal Food, Drug and Cosmetic Act.
B. Trade Names: Proprietary names will be acceptable to the Council provided the names meet certain professional standards:
Misleading Names: Names which are misleading or which suggest diseases or symptoms will not be acceptable. This provision may not apply to certain biological products such as serums or vaccines.
Unacceptable product names (as determined by, but not limited to, the above criteria) must be revised before Acceptance.
II. Composition, Nature and Function
A. Product Information: A company is required to provide a quantitative statement of composition, including excipients, to the Council. For therapeutic agents, adequate information on the properties of all ingredients must also be provided. For materials, instruments and equipment, a description of the materials used in the construction and the method of operation must be provided. Any change in the composition, nature or function of an Accepted product must be submitted to the Council for review and approval before a modified product is marketed. A modified product is prohibited from using the ADA Seal unless and until it is approved by the Council.
B. Manufacturing Standards: The company must provide evidence that manufacturing and laboratory control facilities are under the supervision of qualified personnel, are adequate to assure purity and uniformity of products, and are in compliance with Good Manufacturing Practices. The company must agree to permit representatives of the Council to visit laboratories and factories upon request. For products whose guidelines include an official American National Standard Institute/American Dental Association Specification (ANSI/ADA Specification), the manufacturer is required to conduct testing on a regular basis to determine continued compliance with the specification. Upon request of Council, the company must make these test records available to the Council. In addition the manufacturer must make available to the Council on request test records and data for any batch of an Accepted product.
C. Complying with Guidelines and/or Specifications:
i. The company must provide evidence that a product demonstrates compliance with its relevant guideline and/or specification.
ii. The Council at any time and without notice to the company, may authorize the testing of such products.
iii. For Products which fall under the scope of official ANSI/ADA Specifications the following information must be submitted: (1) the serial or lot number; (2) the physical properties as obtained by standard test methods; and (3) data covering every provision of the official specification. Responsibility for guaranteeing that product complies with an official specification lies solely with the manufacturer and not with the American Dental Association.
iv. Test samples will be procured at the expense of the manufacturer as indicated in Section III. In the event that an Accepted product fails to comply with the appropriate specification, the ADA Seal of Acceptance will be withdrawn from the product, the license agreement will terminate immediately, and all rights of the company to use the ADA Seal will cease. All products that do not comply with the specification must be removed from the market. If the ADA Seal of Acceptance is withdrawn from a product, the product may be resubmitted at any time, provided adequate evidence of safety and effectiveness is submitted for Council review.
III. Evidence of Safety and Efficacy
A. Submission of Evidence: Evidence must be submitted pertaining to: actions, safety and efficacy; and where applicable, mechanical and physical properties. Information on acceptable standard test methods for physical properties may be obtained from the Council on Scientific Affairs. In general, the data required on physical tests will include: methods, results, names of the observers, and dates of testing.
B. Nature of Evidence: The company must provide objective data from clinical and laboratory studies demonstrating safety and effectiveness. Evaluation of a product may also be based on similarity to a previously Accepted product. Products that fall under the scope of an official ANSI/ADA Specification will be tested for compliance with the specification by the ADA laboratory. Test samples, unless otherwise indicated in the appropriate specification, will be procured on the open market at the expense of the manufacturer.
C. Supplemental Evidence: All proprietary studies for the product as well as a list of all other studies conducted using the final product must be submitted. Additionally, the ADA may, through use of its own laboratory facilities or use of other facilities, conduct any additional evaluation deemed necessary by the Council.
D. Post Marketing Surveillance: Any new information regarding safety and efficacy must be submitted as it becomes available. This evidence may be in the form of new clinical studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.
E. Renewal of Acceptance: The company may be required to submit evidence demonstrating continued acceptable clinical performance of the product. This evidence may be in the form of new clinical and/or laboratory studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.
F. Disclosure: The company must disclose any past, present or anticipated financial arrangements between the investigators and the company, its affiliates or subsidiaries, including, but not limited to, consulting agreements, speakers’ fees, grants or contracts to conduct research, or membership on the company’s advisory committees including remuneration policies, or in the product that is the subject of the investigation. If the Council determines that the financial interests raise a question about the integrity of the data, the Council may take any action it deems necessary to ensure the reliability of the data, including but not limited to:
- requesting that the company submit further analyses of the data;
- requesting that the company conduct additional independent studies; and
- rejecting the data as a basis for council action.
IV. Governmental Regulations
A product must conform to all applicable laws and governmental regulations.
V. Use of Biodegradable and Recyclable Materials
The American Dental Association is concerned about the environment and about the negative impact that the widespread use of non-biodegradable materials for the manufacture and packaging of disposable products can have on the environment. Therefore, the ADA encourages all dental manufacturers, especially those with Accepted products, to use, whenever possible, materials that are biodegradable and/or recyclable.
VI. Labeling, Package Inserts, Advertising and Other Promotional Material
A. Name: The established or generic name of a product must be displayed in a prominent manner in all material directed to the dental profession.
B. Claims: Claims of significance to dentistry for a product must be clear and accurate.
C. Packaging/Labeling: All packaging/labeling must be submitted to the Council for review and approval prior to use.
D. Advertising: Advertising must conform to the ADA’s advertising standards and certification mark usage guidelines. The ADA’s name and the ADA Seal and Seal Statement may appear in advertising and promotional materials, to include point-of-purchase advertising if it is presented in good taste and professional dignity and is only part of the commercial message. The Seal statement sets forth the basis for acceptance by the Council and must be used whenever the Seal is used, unless otherwise authorized by the Council.
E. Disparagement of Other Products: Advertising of an Accepted product must not result in the disparagement of other products.
F. Implied Acceptance: An Accepted product must not be advertised or displayed with unaccepted products in a manner that implies Acceptance of the unaccepted product. This provision does not apply to conventional price lists or catalogs.
G. Responsibility: The responsibility of providing substantiation of claims for safety and efficacy or claims of compliance with an official standard must reside with the manufacturer and not with the American Dental Association.
VII. Reference to Council Acceptance
A. Any reference to the Council in labeling, package inserts, advertising and other promotional material for an Accepted product is permitted solely to indicate to the profession or public that the claims for product effectiveness in treating or preventing oral disease are valid.
B. The Seal of Acceptance may only be used after notification of Acceptance in writing by the Council and execution of the ADA’s standard ADA Seal license agreement. The ADA Seal must not appear in conjunction with the seal or certification mark of any other investigative group unless approval for such display has been obtained from the Council. The ADA Seal is to be used without comment on its significance unless the Council has previously approved such comment. The Seal must be legible and must not be used in any manner that detracts from its dignity.
C. The same principles established for the use of the ADA Seal must apply to the Seal Statement.
VIII. Changes to the ADA Seal of Acceptance Program
The ADA reserves the right to make changes to the ADA Seal of Acceptance Program at any time at its sole discretion. Such changes may include, by way of example only and without limitation, changes to the guidelines or specifications, testing criteria, license agreement or advertising standards. Note that in some instances, changes to the Program may result in the permanent withdrawal of the ADA Seal from a product or product category. If the foregoing circumstance occurs, ADA will determine the date by which the license agreement will terminate and will notify affected companies accordingly. All rights of a company to use the ADA Seal will cease upon termination of the license agreement.
IX. Withdrawal of Acceptance
The Council may on occasion find it necessary to permanently withdraw the ADA Seal of Acceptance from a product or product category. Such decisions may be made at any time at the sole discretion of the Council.
Any violation of the ADA Seal license agreement is grounds for Council’s withdrawal of the ADA Seal of Acceptance from the Product.
X. Confidentiality of Submission Material
It is the policy of the American Dental Association to treat the material submitted for Council review as confidential. Any confidential information submitted by a company should be marked as “confidential,” “proprietary” or with a similar legend indicating its confidential nature.
Although ADA utilizes outside consultants in its review of products, ADA Seal Program consultants are required to sign the ADA’s Code of Conduct. The Code of Conduct requires the consultants to refrain from disclosing confidential product submission materials to anyone outside the ADA. Except as required to evaluate a product submission or otherwise implement the ADA’s Seal of Acceptance Program or as may be required by law, ADA refrains from voluntarily disclosing properly marked product submission materials to any third party without the prior consent of the manufacturer. ADA also takes commercially reasonable steps to ensure that such materials are not disclosed or distributed by its employees, consultants or other agents. However, ADA will not be liable for any damages resulting from the acts or omissions of ADA consultants, including but not limited to their failure to abide by the Code of Conduct.
ADA does not treat as confidential any information that (i) is or becomes a part of the public domain through no act or omission of ADA; (ii) was in ADA’s lawful possession prior to the disclosure; (iii) is lawfully disclosed to ADA by a third party without restriction on disclosure; or (iv) is independently developed by ADA without use of or reference to the company’s Confidential Information.
XI. 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. No ADA Seal license agreement shall have a term that extends beyond December 31, 2007.