On August 18, 2026, the Royal Thai Government Gazette published the "Ministry of Public Health Notification on Hazardous Drugs (No. 37)" (Volume 143, Special Issue 196D, page 8), formally classifying toothpastes containing fluoride at 5000 ppm for oral use as hazardous drugs. The notification was signed by the Minister of Public Health on August 6, 2026, and takes effect the day following its publication in the Gazette, i.e., August 19, 2026.
Key Contents of the Notification and Impact Analysis
High-concentration fluoride products subject to drug regulation: Toothpastes and other oral drugs with a fluoride content of 5000 ppm will fall within the scope of hazardous drug management in Thailand; their manufacture, import and sale must comply with the licensing and regulatory requirements for hazardous drugs under the Drug Act.
Ordinary toothpastes unaffected: Ordinary toothpastes containing no more than 1500 ppm of fluoride remain managed as cosmetics; consumers may continue to use them normally, and relevant companies are not required to apply for drug registration.
Transition and compliance advice: Relevant manufacturers and importers should promptly verify the actual fluoride content in product formulations; for products at the 5000 ppm specification, they should assess whether to apply for drug registration or licensing to avoid compliance risks after the new regulation takes effect.
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Further Information:
Ministry of Public Health Notification on Hazardous Drugs (No. 37)
