The measure is particularly relevant to manufacturers and importers of high-fluoride toothpaste and other oral-use products. It does not, however, mean that fluoride toothpaste in general has been reclassified as a hazardous drug.
What the New Notification Covers
Notification No. 37 adds the following category to the existing list of hazardous drugs:
Drugs containing fluoride at 5,000 ppm for oral use.
The provision was issued under Thailand’s Drug Act and follows a recommendation from the Drug Committee. The notification was signed by the Minister of Public Health on August 6, 2026, and became effective on August 19 following publication in the Government Gazette.
The wording of the notification is important. It refers to drugs containing fluoride at 5,000 ppm for oral use, rather than creating a blanket classification for all toothpaste products containing fluoride.
How 5,000 ppm Fluoride Toothpaste Is Regulated
Thailand’s FDA has subsequently clarified that toothpaste containing 5,000 ppm fluoride is classified as a hazardous drug, reflecting its higher fluoride concentration and intended use for people at high risk of dental caries. The agency notes that such products may be used, where appropriate, under the advice of a dentist or pharmacist.
The classification of a product as a “hazardous drug” is a regulatory category under Thailand’s pharmaceutical legislation. It does not mean that the product is prohibited or inherently poisonous. Instead, the designation provides a higher level of control over its distribution and use.
For companies marketing these products in Thailand, the classification therefore needs to be considered when determining the applicable drug registration, licensing, distribution and other pharmaceutical compliance requirements. The specific regulatory pathway should be assessed based on the product and its intended market status rather than assuming that the new notification applies to all oral-care products.
Ordinary Fluoride Toothpaste Remains Regulated as Cosmetics
Thailand’s FDA has expressly stated that toothpaste containing no more than 1,500 ppm fluoride remains classified as a cosmetic and that the new notification does not change the regulatory status of these conventional products.
This distinction is important for companies selling everyday oral-care products in Thailand. The country’s FDA identifies toothpaste as a cosmetic when it falls within the applicable cosmetic definition, which covers products used on the teeth and oral mucous membranes for purposes such as cleaning and maintaining them in good condition.
Accordingly, the new notification should be understood primarily as a measure concerning high-concentration fluoride products, rather than as a general change to the regulation of fluoride toothpaste.
Implications for Manufacturers and Importers
Companies supplying oral-care products to Thailand should review their product portfolios in light of the new classification. In particular, manufacturers and importers should verify the actual fluoride concentration of relevant formulations and determine whether any products contain fluoride at the 5,000 ppm level.
Products falling within the newly designated category should be assessed under Thailand’s drug regulatory framework, while conventional toothpaste containing up to 1,500 ppm fluoride continues to follow the applicable cosmetic requirements.
Companies should also avoid interpreting the term “hazardous drug” as a prohibition on 5,000 ppm fluoride toothpaste. Thailand’s FDA has emphasized that these products remain available for appropriate use, particularly for individuals with a high risk of dental caries. The new classification is intended to ensure that their use and distribution are appropriately controlled.
Key takeaway: Thailand’s Notification No. 37 creates a clear regulatory distinction between conventional fluoride toothpaste and 5,000 ppm fluoride oral products. Companies exporting high-fluoride oral-care products to Thailand should reassess their regulatory pathway and compliance obligations following the notification’s entry into force.
