ADA Seal of Acceptance
ADA Seal
For more than 125 years, the American Dental Association (ADA)
has sought to ensure the safety and effectiveness of dental products.
As early as 1866, an ADA committee prepared a statement on dentifrices
(toothpaste).
By 1930, the ADA established rigorous guidelines for testing and
advertising of dental products. 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 it is strictly voluntary, about 350 companies participate
in the Seal program. Participating manufacturers commit significant
resources to evaluate, test and market products in the Seal program.
Some 1,300 dental products carry the Seal of Acceptance. Of these,
about 30 percent are products sold to consumers, such as toothpaste,
dental floss, manual and electric toothbrushes and mouthrinses.
The rest are products prescribed or used by dentists, such as antibiotics
or dental restorative materials.
Qualifying for the ADA Seal
Not every dental product qualifies for the Seal. There are certain
requirements that must be met. For example, a manufacturer who applies
for the Seal must:
- 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 advertising, promotional claims and patient education
materials for review and approval by the ADA, and be in compliance
with the ADA's standards for accuracy and truthfulness in advertising.
- Submit ingredient lists and other pertinent product information
for review and approval.
- The ADA Seal generally is awarded for a three-year period. Manufacturers
must reapply to continue using the Seal. Whenever the composition
of an accepted product changes, the manufacturer must resubmit
the product for review and approval before it is marketed with
the Seal. As long as a product bears the Seal, it must continue
to meet these requirements.
How Products Are Evaluated
More than 100 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 request
additional product testing. Only after a product has demonstrated
its safety and effectiveness will the ADA Council on Scientific
Affairs award the Seal.
Advertising and Packaging
The ADA reviews all advertising claims for any product bearing
the Seal. Only those claims that can be supported by appropriate
clinical and/or laboratory studies and scientific data are allowed.
The Seal on a product is an assurance for consumers and dentists
against misleading or untrue statements concerning a product, its
use, safety and effectiveness. The labels of products awarded the
Seal must present true and accurate information of the product's
intended use. All label claims must be supported by appropriate
clinical and/or laboratory studies and scientific data.
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