On 4 April 2025, Thailand’s Food and Drug Administration (Thai FDA) issued a draft notification proposing significant amendments to the labelling requirements for fluoride-containing cosmetics, including toothpaste and mouthwash. The proposed regulation will take effect the day after its publication in the Royal Gazette. These changes aim to strengthen consumer protection, particularly for young children, by enhancing product safety and information.
Revocations: Previous Warning Statements Repealed
Under the new draft notification, Thailand will revoke several previous labelling requirements related to fluoride compounds used in cosmetic products. Specifically, entries 23–40, 44, and 52 of the 2018 Notification on Cosmetic Labelling will be repealed. These entries previously mandated specific warnings for various fluoride-containing substances, such as ammonium monofluorophosphate, sodium fluoride, and calcium fluoride. The revocation of these entries paves the way for new, standardized warning statements to ensure consistency across product categories.
Revised Warning Requirements for Fluoride-Containing Products
The new regulation introduces standardized labelling requirements for products containing fluoride substances. Key updates include:
For children under the age of three: The recommended amount of toothpaste should be the size of a grain of rice.
For children aged three to under six years: An amount the size of a pea or corn kernel should be used.
Supervision by adults: Children in both age groups should be supervised while brushing their teeth.
Additional medical advice: If children are exposed to fluoride from other sources, parents or guardians should consult a doctor or dentist.
Furthermore, mouthwash products containing fluoride should not be used by children under the age of six, and appropriate warnings must be displayed on the product label.
Transition Period for Industry Compliance
Manufacturers, importers, and contractors producing fluoride-containing cosmetics will be required to update their product labelling in accordance with the new regulation within one year from the effective date. This transition period will provide businesses with sufficient time to adapt their processes and ensure full compliance.
Implications for Global Cosmetic Industry Stakeholders
The revised labelling requirements will have significant implications for the global cosmetic industry. Companies that manufacture, import, or distribute fluoride-containing products in Thailand will need to review and update their product labels to align with the new standards. Failure to comply within the specified timeline may result in regulatory penalties. Businesses are encouraged to take immediate steps to ensure that their products meet the new labelling guidelines and to consult the full draft text for detailed requirements.