Original source
อย. ชี้แจง ยาสีฟันฟลูออไรด์ 1,500 ppm เป็นเครื่องสำอาง
- Official date
- 2026-08-19
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Instrument: Announcement of the Ministry of Public Health on Dangerous Drugs (dated 6 August 2569 BE). Scope: Reclassifies toothpaste containing 5,000 ppm fluoride as a dangerous drug. Impact: Toothpaste with fluoride ≤1,500 ppm remains a cosmetic; no change in regulation. Effective date: The announcement is in effect; clarification issued 19 August 2569 BE. Note: 5,000 ppm toothpaste not for children under 12 years.
Thai FDA clarifies that toothpaste with fluoride up to 1,500 ppm remains regulated as a cosmetic and can be used normally. Toothpaste with fluoride 5,000 ppm is classified as a dangerous drug, intended only for high-risk groups under professional guidance. No change in regulatory status for standard toothpaste.
Official text
English translation — the official-language text prevails
The Food and Drug Administration (FDA) clarifies that after the announcement of the Ministry of Public Health on Dangerous Drugs, toothpaste containing fluoride 5,000 ppm is classified as a dangerous drug due to its high concentration, intended for individuals at high risk of tooth decay, such as oral cancer patients receiving radiation therapy. Therefore, it should be used under the advice of a dentist or pharmacist. Meanwhile, regular toothpaste with fluoride not exceeding 1,500 ppm remains classified as a cosmetic and can be used safely and effectively for daily oral care.