What is the ADA, how does it help you, and what is required to receive the ADA Seal of Acceptance? For over 125 years, the American Dental Association has been helping consumers have access to products and technologies that work. As a non-profit entity, the ADA sets standards for safety and effectiveness in dental products ranging from toothbrushes, to denture products, and mouth rinses. It was founded back in 1859, and today has more than 157,000 members who are dentists. The ADA also has standards for dentists who seek membership, which includes the Principles of Ethics, the Code of Professional Conduct and the Advisory Opinions.
While the ADA sets strict industry standards for safety and effectiveness in products and technologies, they do not receive payment for their endorsement. Products must meet rigorous testing and advertise truthfully. All marketing claims must be accurate; no unsubstantiated claims are allowed on product advertising. The ADA has even required higher standards from companies requesting the Seal than the law actually requires. Even so, today there are more than 300 dental products which carry its Seal of Acceptance.
For companies applying for the Seal of Acceptance, the following criteria must be met:
— Must provide a list of ingredients and other relevant information about the product to be reviewed and approved.
— Must provide data from clinical and/or laboratory studies backing up claims for product safety, effectiveness, and any claims the company will make promoting the product.
— Must conduct clinical trials in strict compliance with the guidelines and procedures provided by the ADA.
— Must supply evidence of proper supervision of the manufacturing and laboratory space used to provide purity and uniformity of the product. It also has to show that the product is manufactured in compliance with GMP (Good Manufacturing Practices).
— Must give the ADA all product packaging and labeling for review and approval. The product must also comply with ADA standards for accuracy and truthfulness in advertising.
A company who passes the Seal test not only gets to display the seal, but must also have a provide a Seal Statement on the product label and on any accompanying advertising. This Seal Statement explains why the product was accepted by the ADA. For example, the Seal Statement found on the Save-A-Tooth product, an emergency tooth preserving system says:
“The ADA Council on Scientific Affairs’ Acceptance of Save-A-Tooth is based on its finding that the solution in Save-A-Tooth has been shown to increase the survival rate of a knocked-out-tooth, when used as directed. Although data show that the solution is effective up to 24 hours, the survival rate is highest if the knocked-out-tooth is implanted by a dentist within one hour.”
Once the ADA grants a company the Seal of Acceptance, it is valid for five years. After that, the company must reapply and requalify again to ensure that sure the product is still in compliance with ADA standards. It is a privilege to carry the Seal of Acceptance and nothing less than accuracy in quality and advertising accuracy is allowed to carry the Seal. Every time your dentist recommends a product that carries the Seal, you can be assured that the product meets the highest standards.
If you have any questions please contact our staff at 415.737.0430 today. At Presidio Dental, we are happy to help you with all your oral health needs!