ADA POSITIONS & STATEMENTS
ADA STATEMENT ON FDA TOOTHPASTE WARNING LABELS
The American Dental Association’s (ADA) Council on Scientific Affairs believes that one part of the warning now required on fluoride toothpastes by the Food and Drug Administration (FDA) could unnecessarily frighten parents and children, and that the label greatly overstates any demonstrated or potential danger posed by fluoride toothpastes.
The label language, “If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately” is now required on all fluoride toothpastes. But the ADA, in a letter sent to the FDA last year, pointed out that a child could not absorb enough fluoride from toothpaste to cause a serious problem and that the excellent safety record on fluoride toothpaste argues against any unnecessary regulation.
Recent media coverage has focused attention on the safety of fluoride toothpastes, but the coverage has not revealed that the ADA limited the amount of fluoride allowed in ADA-Accepted toothpaste years ago for this reason.
In addition, back in 1991, the ADA began requiring that toothpaste manufacturers include the following language on all ADA-Accepted toothpastes: “Do not swallow. Use only a pea-sized amount for children under six. To prevent swallowing, children under six years of age should be supervised in the use of toothpaste.” The new FDA labels are consistent with the ADA statements, with the exception of the poison control warning.
The ADA warning labels were required to help reduce the risk of mild fluorosis, which is a cosmetic defect noticeable as very light spots on permanent teeth and develops only while the teeth are still forming. Fluorosis only occurs when more than the optimal daily amount of fluoride is ingested.
Through its ADA Seal of Acceptance program, the toothpaste manufacturers must submit clinical data to the ADA in order to meet its guidelines on safety and effectiveness. Additionally, all products with the ADA Seal must submit the product’s advertising and packaging for review so that consumers and dentists have assurance that the claims the product makes are supported by the clinical data.