The ADA Seal of Acceptance: Higher Standards for Your Patients
KOL Forum Sponsored by the American Dental Association Seal of Approval.
As a dental hygienist, I helped patients find safe, effective, and scientifically proven products that best fit their needs. I’ve since moved from patient checkups to product checkups. Now I help companies design and manage clinical research programs and substantiate product claims for over-the-counter drugs, devices, and cosmetics. I also work with the American Dental Association (ADA) Seal of Acceptance program as a consultant on clinical research standards. I know the importance of making sure the products your patients find on the shelves work the way they say they will. One way to ensure this is to look for products that carry the ADA Seal.
Earning the ADA Seal for a product is no easy feat. I’ve worked with several manufacturers over the years, guiding them through the application process to demonstrate the product is safe and effective. This is not a short or simple task, and I can tell you the ADA is as demanding of evidence as the United States Food and Drug Administration (FDA) and other global regulatory bodies. An application for the Seal must include evidence that the product is FDA-approved; a full description of the product, including its chemical composition or components; and evidence to show it complies with established testing standards, including two clinical studies funded by the manufacturer but conducted at an independent, unbiased laboratory.
Now, the program is taking the process one step deeper to ensure data are sound, no matter who commissions it. The ADA Seal team asked me to help develop a voluntary qualification program for the testing labs that companies use to complete studies required for ADA Seal applications. The team inspects the facilities, reviews the accuracy of data collection procedures, and looks at the experience and training of the directors and staff. Research facilities can now apply for the program.
If the research facility meets this strict criteria, it earns the ADA’s Independent Research Testing Site Qualification. By ensuring the research sites are fully independent, follow all the necessary protocols, and produce accurate, valid, and reliable data, we’re giving the ADA Seal program the best nonbiased data with which to evaluate product submissions. When the lab is reliable, the data are too.
The next time you recommend a product with the ADA Seal to your patients, you can be confident it is safe and effective and held to rigorous standards. The Seal has done the research for you. We’ve got the science to back it up—from the testing site to the shelf.
Visit ADA.org/SealTeam for free in-office resources or to contact the ADA Seal of Acceptance.
From Dimensions of Dental Hygiene. October 2019;17(9):24.