Statement on FDA Toothpaste Warning Labels
The American Dental Association's (ADA) Council on Scientific Affairs believes that one part of the warning that has been required on fluoride toothpastes by the Food and Drug Administration (FDA) since 1997 could unnecessarily frighten parents and children, and that the label greatly overstates any demonstrated or potential danger posed by fluoride toothpastes.
The FDA warning states, "If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately". But the ADA, in a letter sent to the FDA when the FDA was first considering whether or not to require this warning, pointed out that a child could not absorb enough fluoride from toothpaste to cause a serious problem. It also stated that the excellent safety record on fluoride toothpaste argues against any unnecessary regulation. The ADA had already limited the amount of fluoride allowed in ADA-Accepted toothpaste years ago for this reason.
Since 1991, the ADA has required that toothpaste manufacturers include the following language on all ADA-Accepted toothpastes: "Do not swallow. Use only a smear or rice-sized amount for children under three. 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 over a prolonged period.
Through its ADA Seal of Acceptance program, the toothpaste manufacturers must submit clinical and laboratory 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 packaging and promotional claims for review and approval so that consumers and dentists have assurance that the claims the product makes are supported.
July 19, 1997, June 2002, November 2011
Page Updated: December 07, 2011
