China Oral Care Products Industry Association: tranexamic acid is not a prohibited substance

In response, the China Oral Cleaning Products Industry Association issued a statement on its official website, saying that tranexamic acid is not a prohibited substance for toothpaste raw materials, and that Japan began producing toothpaste containing tranexamic acid in 1962. In order to ensure the safety of raw materials used, the Association requires companies to assess the safety risks of products in the product development stage, taking into account the exposure, site of action, intake pathways and other aspects, and allow products to be marketed only after passing the safety assessment.

China Oral Cleaning Products Industry Association said that tranexamic acid (also known as clotting acid, tranexamic acid) is commonly used to stop bleeding, with anti-fibrinolytic effect. When used as a drug in China, there are two forms of oral tablets and injections, the tablets are 500mg each, and the injections are 1g each, the recommended dose in China is 1-2g per day, there is no maximum safe dose limit for adults abroad, but the maximum recommended dose can sometimes be used up to 6g, and the maximum dose limit for children is 3g. Research results show that the toothpaste has an auxiliary effect on gum bleeding. This ingredient is currently used in a variety of effective toothpastes both domestically and internationally. The same chemical may be used as both a cosmetic ingredient and a pharmaceutical ingredient, but the purpose of use and the amount used will vary.

Tranexamic acid is not a prohibited substance in toothpaste as listed in the national standard "Specification of raw materials for toothpaste" (GB22115). In order to ensure the safety of raw materials used, the Association requires companies to evaluate the safety risk of products in the product development stage, taking into account the exposure, site of action, intake pathways and other aspects, and to allow products to be marketed only after passing the safety assessment.

The Association hopes that consumers will understand the clinical efficacy and safety of tranexamic acid scientifically and rationally, and choose toothpaste products according to their actual needs.

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