Allegations relating to the use of tranexamic acid in China’s extremely popular Yunnan Baiyao toothpaste have garnered considerable attention amongst Chinese netizens and have highlighted the need for more stringent regulation of Chinese traditional medicine. Controversy revolves around use of label claims which attribute the functional efficacy of the toothpaste i.e. reduced gum bleeding to the Chinese medical ingredients rather than the pharmaceutical agent tranexamic acid.
Yunnan Baiyao is an extremely popular Chinese traditional medicine product used to treat minor muscle trauma and other soft tissue injuries. A spinoff toothpaste product made by the same company has recently gained widespread public notoriety after allegations were made by a prominent hematologist claiming that Yunnan Baiyao toothpaste contains tranexamic acid.
Question 1: Is it legal to use tranexamic acid in toothpaste?
The short answer to this question is yes. It is perfectly legal to use tranexamic acid in toothpaste, an ingredient which is mainly used as a hemostatic agent in hospitals in an inpatient setting. According to the official statement of Yunnan Baiyao Group, the ingredients used in Yunnan Baiyao toothpaste meet the national standard (GB22115 General Requirements on Raw Materials of Toothpaste) and international relevant general regulations. There are no illegal additions and no prohibited ingredients in the toothpaste.
Yunnan FDA also said that there is no list of permitted ingredients for use in toothpaste, only a list of prohibited ingredients, and tranexamic acid is not a prohibited ingredient. According to Chinese regulations tranexamic acid can be added to cosmetics and toothpaste, but the usage limitations in toothpaste have not been determined. Tranexamic acid is also included in the IECIC usually as a topical agent to inhibit melanin production and whiten the skin.
In China’s draft standard of Determination of Tranexamic Acid in Cosmetics, the limit of detection of tranexamic acid is 3.0 mg/kg and the limit of quantitation is 10.0 mg/kg. Another reference is that the former CFDA released the first batch of permitted cosmetic ingredients in 2013. The limitation of tranexamic acid in that inventory is 2%. The limitation of tranexamic acid in cosmetics is 2%-3% in Taiwan. Cosmetics containing it are regulated as general cosmetics and do not need pre-market registration.
Question 2: Is there any false or misleading claim?
The real controversy surrounding this case is not the addition of tranexamic acid but rather attributing the functional efficacy of the toothpaste to the Chinese medicine ingredients and not to the tranexamic acid. Yunnan Baiyao toothpaste’s outer package claims to contain active ingredients of Yunnan Baiyao (a Class-1 protected traditional medicine in China) to help reduce bleeding gums. The claims suggest that Chinese herbal medicine is playing the key role in alleviating oral problems. This problem is compounded as Yunnan Baiyao products have a secret proprietary formulation which makes it impossible for any 3rd party agency to adequately analyze the product, a fact which would appear to infringe on consumer rights.
Current regulations and standards for toothpaste
In 2006, China implemented production license management on toothpastes. At present toothpaste occupies a regulatory grey area and is categorized as neither a cosmetic nor a drug. The production license for toothpaste is the same as that of cosmetics, but it has its own standard system.
In the first draft of Regulation concerning Supervision and Administration over Cosmetics, toothpaste was classified as cosmetics. In fact, the former CFDA (now SAMR) considered regulating functional toothpaste as drugs, however drug production requires drug GMP certification, which is not feasible for the toothpaste industry.
In the second draft of Regulation concerning Supervision and Administration over Cosmetics, oral hygiene cosmetics only require compliance with national or industrial standards such as GB 8372-2017 Toothpaste, GB 22115-2008 and GB 29337-2012 instead of registration or filing. Efficacy claims (such as “anti-caries”, “inhibit plaque” and “anti-dental sensitivity”) of these products are permitted to be used provided adequate standard-based evaluation data supports the claims.
However, efficacies (improve gum problems, repair mucosal damage, nourish gums and improve periodontal health) claimed by Yunnan Baiyao and other functional toothpastes sold in the market are not included in the scope of permitted efficacy claims stipulated by the competent authority (anti-caries, inhibit plaque, anti-dental sensitivity, etc.).
It is expected that Yunnan Baiyao Toothpaste incident will prompt SAMR and NHC to formulate stricter and more detailed regulations on toothpaste, which should include a list of permitted ingredient of toothpaste and clearly define their limitations and establish negative list for oral care products claims.
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