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June 2009 | dentalproductsreport.com
part 2: endorsements 101

ADA evaluates products,
but does not endorse them

Popular ADA Seal program recognizes consumer
dental products’ safety, effectiveness

By Stan Goff, Executive Editor

For more than a century, the American Dental Association’s Seal program has been a highly recognized symbol of a dental product’s safety and effectiveness.

The program was testing dental products and sharing information with its members and consumers long before the Food & Drug Adminstratrion got involved with medical and dental products and materials. But that’s not to say the ADA endorses products.

In fact, Dr. Dan Meyer, Senior Vice President ADA’s Science/Professional Affairs, wants to make this point very clear. “We don’t endorse products. We’ll evaluate them; we’ll report out on them but we will not endorse them,” he said. “Because we don’t think that is fair. It’s not fair to products that are not endorsed and it’s not the way we feel a scientifically based association should be assessing those products.”

What the ADA does do is evaluate all consumer dental products whose manufacturers apply for the Seal program—it’s strictly a volunteer program—and it also provides professional product evaluations to its members in its quarterly ADA Professional Product Review (ada.org/prof/resources/pubs/ppr/index.asp). The publication mails out along with the regular issues of JADA four times each year and Dr. Meyer describes it as a source of unbiased, scientifically sound comparisons of professional dental products.

Early days
According to the ADA, as early as 1866 an ADA committee prepared a statement on dentifrices (toothpaste) to look into 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.”

Dr. Meyer, noting that the Seal program came long before there was an FDA and before there were such research groups as the National Institute of Health and the National Institute of Dental and Craniofacial Research, said the Seal program was created to provide guidance to the profession on professional products. It was actually a joint measure with the American Medical Association in its earlier years.

How it works today
More than 300 dental products sold to consumers carry the ADA Seal of Acceptance today, including toothpaste, dental floss, manual and electric toothbrushes and mouthrinse.

“The Food & Drug Administration when it was first formed was looking at food, not medicinals and not therapeutics, and so the ADA and the American Medical Association got together and started this to assess products,” Dr. Meyer said. “Well since that time the FDA and has come along and certainly set its own criteria.”

It was in part because of the FDA’s arrival and the fact that some manufacturers of professional products chose to skip the Seal process that the ADA stopped including professional products in its Seal program at the end of 2006. Some manufacturers wanted to introduce new products without having these products and advertisements scrutinized, and in some cases without having to conduct clinical studies, Dr. Meyer said.

“It was a volunteer program and as a result of that I think some of the manufacturers thought they could get products to the market without ever having to do a clinical study, or a clinical trial. We phased out the Seal Program because it was a voluntary program and one thing that our members were asking for in all of our surveys was more factual information, more credible information, especially about products. But they also realized there were a lot of evaluations out there, some of which were underwritten by the manufacturers,” he said.

Consumer products
The current Seal program for consumer dental products is a voluntary program and the ADA evaluates products in its own laboratories. All of the products submitted are reviewed by consultants and ADA officials. There are 200 such consultants and the ADA’s Council on Scientific Affairs—consisting of 17 experts from throughout the country—also is involved in the process.
“We actually evaluate the products for not only safety and effectiveness but also that the products do what they claim to do,” Dr. Meyer said. “So if there’s a product claim, the manufacturers have to support that with the scientific validation.”

Before a product gets the ADA Seal of Acceptance, it has to pass the laboratory tests and other evaluations. But after that, the ADA also keeps an eye out for inaccurate advertising. “We do have an advertising review where we make sure to validate the companies’ claims and some products don’t meet our criteria,” Dr. Meyer said.

He used the example of fluoride toothpastes. Some products may include fluoride, but may not be formulated in such a way to have the fluoride be effective while the toothpaste is in use. This is where the Seal can really help a consumer.

“Not all fluoride toothpastes are created equally. You can have fluoride in the toothpaste but if it’s bound and it’s not released within a few minutes of when you’re brushing your teeth it will all be washed down the sink. The chemistry in binding fluoride and then making sure that it’s released in saliva is very complex chemistry. As a result of that, you want to make sure the fluoride is from the toothpaste released in the mouth when it’s being used, not long after it’s been put down the sink,” he said.

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