Thailand Notifies WTO of Two Draft Regulations on Fluoridated Toothpaste

On April 4, 2025, the Thai Food and Drug Administration (Thai FDA) notified two draft regulations concerning fluoridated toothpaste to the World Trade Organization (WTO), inviting comments from trading partners until June 3, 2025. These drafts seek to revise existing warning statements for products containing certain fluoride compounds and to introduce new labeling requirements for fluoride-containing toothpaste. Notably, both drafts were initially released for public consultation by Thailand on February 28, 2025.

The first draft regulation¹ proposes amendments to the warning label requirements for 20 fluoride compounds (Items 23–40, Item 44, and Item 52) listed in the List of Warnings on Labels for Cosmetics Containing Restricted Ingredients. Specifically, it updates the recommended toothpaste usage amounts for children:

For children under 3 years old, toothpaste should be used in an amount equivalent to the size of a rice grain.
For children aged 3 to under 6 years, a pea-sized or corn-sized amount is recommended.
In both cases, adult supervision during brushing is advised.

A detailed comparison of the previous and revised warning statements for the 20 compounds is provided for reference. Once the regulation is adopted, businesses with products that contain these ingredients and comply with current labeling rules will be granted a one-year transition period from the effective date of the final notification to update their product labels.

The second draft regulation² introduces mandatory labeling requirements for fluoride-containing toothpaste intended for sale. The manufacturer, importer, or contracted producer must ensure that the label includes:

The phrase “Fluoridated Toothpaste” or an equivalent statement
The total fluoride concentration, expressed as fluoride ions (Fluorine), with the unit specified in parts per million (ppm) or an equivalent notation

These new requirements are in addition to those stipulated in the existing Notification of the Cosmetics Committee Re: Label of Cosmetic B.E. 2562 (2019).

Following the official enactment, businesses that have obtained notification certificates for fluoride-containing toothpaste and labeled their products before the regulation takes effect will be required to update their labels to meet the new standards. However, they may continue using their existing label stock for up to one year from the regulation’s effective date.