5,000 ppm fluoride toothpaste needs expert guidance, FDA says
Thailand has classified 5,000 ppm fluoride toothpaste as a dangerous drug requiring professional advice, while ordinary toothpaste remains unaffected
- Thailand's FDA has classified toothpaste with 5,000 ppm of fluoride as a "dangerous drug," a legal category to control its sale and ensure proper use.
- This classification does not mean the toothpaste is poisonous or banned; it signifies that it requires professional guidance from a dentist or pharmacist for use.
- The high-strength toothpaste is intended for specific high-risk groups, such as oral cancer patients, and is not for the general public or children under 12.
- Regular toothpaste containing up to 1,500 ppm of fluoride is unaffected by this rule and remains classified as a cosmetic for everyday use.
Thailand’s Food and Drug Administration (FDA) has reassured consumers that ordinary fluoride toothpaste remains unaffected by a new regulation classifying products containing 5,000 parts per million (ppm) of fluoride as a “dangerous drug”.
The classification is a legal category intended to control sales and promote appropriate use. It does not mean the product is poisonous, prohibited or unsafe when used correctly, according to FDA Secretary-General Supattra Boonserm.
The Ministry of Public Health notification, dated August 6, took effect on August 19 after its publication in the Royal Gazette.
Ordinary fluoride toothpaste remains unaffected
Supattra explained that ordinary toothpaste and high-strength 5,000 ppm fluoride toothpaste have different purposes and are subject to different regulatory controls.
Fluoride helps prevent tooth decay, while correct brushing with fluoride toothpaste remains an important and widely accepted part of dental care.
Toothpaste containing no more than 1,500 ppm fluoride remains classified as a cosmetic. Consumers may continue buying and using these products normally for everyday protection against tooth decay.
The new notification does not change the regulation of ordinary fluoride toothpaste, which the FDA maintains is safe and effective when used properly.
High-strength toothpaste intended for at-risk patients
Toothpaste containing 5,000 ppm fluoride has a substantially higher concentration and is intended as an additional preventive option for people at high risk of tooth decay.
The FDA identified oral cancer patients receiving radiotherapy as one example of a group that may benefit from the product.
Because of its strength, the toothpaste should be used only when necessary and under the guidance of a dentist or pharmacist.
It should not be used by children under 12 because they may be more likely to swallow toothpaste.
The FDA stressed that the classification was not intended to encourage the general public to replace their regular toothpaste with a 5,000 ppm product.
‘Dangerous drug’ is a legal classification
Supattra explained that “dangerous drug” is the term used under Thai pharmaceutical law for products requiring tighter controls over their distribution and use.
The designation does not mean that 5,000 ppm toothpaste is a poison or that its use has been banned. Rather, it reflects the need for professional advice because the product contains a much higher fluoride concentration than ordinary toothpaste.
Consumers who are not at particularly high risk of tooth decay can continue using their regular fluoride toothpaste without changing products.
Imported products remain listed online
Post Today reported finding imported 5,000 ppm fluoride toothpaste still listed for sale on online platforms, with some products apparently available for purchase without prior consultation with a dentist or pharmacist.
The report did not identify the sellers or establish whether individual products were registered or imported in compliance with Thai regulations.
The Thai FDA has previously advised consumers to exercise caution when ordering health products from overseas platforms, particularly when products have no Thai-language labels or their ingredients and regulatory status cannot be verified.
