ADA Seal: Frequently Asked Questions
The ADA Seal of Acceptance—a symbol of confidence for consumers and dentists.
- What is the ADA Seal?
- What determines if a dental product qualifies for the Seal?
- How are products evaluated?
- How is the Seal used in advertising and packaging?
- What is the value of the seal?
- How do I apply for the ADA Seal of Acceptance?
- Does the ADA award the Seal to professional dental products (products used by dentists)?
For more than 125 years, the ADA has promoted safety and effectiveness of dental products as part of its mission to advance oral health. As early as 1866, an ADA committee prepared a statement on dentifrices (toothpaste) that questioned whether the extravagant claims made on behalf of patent tooth powders and other dental nostrums of the time were just “an imposition on the public”. The end result was a simple formula for a tooth powder made from chalk, soap and various herbal ingredients. Of course this was years before anyone knew about the benefits of adding fluoride to toothpaste to prevent cavities.
By 1930, the products were new, but consumers were still confronted by extravagant claims about what they could do. That year the ADA adopted guidelines to evaluate dental products for safety and effectiveness. The first Seal of Acceptance was awarded in 1931. In 1984, President Ronald Reagan gave the Association a certificate of commendation for the outstanding self-regulatory efforts of its Seal program.
Although the program is strictly voluntary, today, more than 300 dental products sold to consumers carry the ADA Seal of Acceptance. These include toothpaste, dental floss, manual and electric toothbrushes and mouth rinse. Participating companies commit significant resources to test and market products in the Seal program.
Not every dental product qualifies for the Seal. There are certain requirements that must be met. For example, a company that applies for the Seal must:
- Submit ingredient lists and other pertinent product information for review and approval.
- Supply objective data from clinical and/or laboratory studies that support the product's safety, effectiveness and promotional claims.
- Conduct clinical trials as needed in strict compliance with ADA guidelines and procedures.
- Provide evidence that manufacturing and laboratory facilities are properly supervised and adequate to assure purity and uniformity of the product, and that the product is manufactured in compliance with Good Manufacturing Practices.
- Submit all product packaging and labeling for review and approval by the ADA, and comply with the ADA's standards for accuracy and truthfulness in advertising.
- The ADA Seal usually is awarded for a five-year period. Companies must reapply to continue using the Seal. Whenever the composition of an Accepted product changes, the company must resubmit the product for review and approval before it is marketed with the Seal. As long as a product bears the ADA Seal, it must continue to meet these requirements.
More than 125 consultants, including members of the ADA's Council on Scientific Affairs and ADA staff scientists, review and declare oral care products safe, effective and worthy of the ADA Seal. The consultants represent all fields relevant to evaluating dental products, including dental materials, microbiology, pharmacology, toxicology and chemistry. In some instances, the ADA may conduct or ask the company to conduct additional testing. Only after a product has demonstrated its safety and effectiveness will the ADA Council on Scientific Affairs award the Seal to that product.
The ADA requires Accepted products to display a Seal Statement on the product label and in advertising. The Seal Statement tells the consumer why the ADA accepted that particular product. For example, the Seal Statement on an Accepted toothpaste with fluoride would read: “The ADA Council on Scientific Affairs’ Acceptance of (product name) is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.” Look for the Seal Statement whenever you see the ADA Seal.
The ADA Seal of Acceptance is designed to help consumers make informed decisions about safe and effective consumer products. Market research has shown that the ADA Seal on a product directly affects the purchase decisions of consumers.
Each year, the ADA receives hundreds of inquiries from companies about new and existing products. The ADA also answers questions from dentists and members of the dental team, the media and the public about the Seal program's evaluation process and Accepted products.
To receive a free submission packet e-mail email@example.com or call 312-440-3528.
In 2005, the ADA decided to phase out the Seal of Acceptance program for professional products 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. Get more information on the Professional Product Review.