‘Regulatory grey area’: Chinese herbal toothpaste controversy highlights licensing and standards anomalies

The ingredients was highlighted by a pair of medical practitioners, who took to Weibo​ to question if the efficacy of the product was due to tranexamic acid, which is used to treat excessive blood loss, rather than the herbal components.

Acid in the hotseat

The incident has put tranexamic acid under the glare of the spotlight.

Yunnan Baiyo released an official statement defending its use of tranexamic acid, stating that its toothpaste meets the national standard and relevant international general regulations.

The company went onto reassure consumers by adding that the product does not contain illegal additions or prohibited ingredients.

Hedy He of Chemlinked​ confirmed that tranexamic acid is legal to use adding that it is widely used as a hemostatic agent in hospitals.

She added that according Chinese regulations, tranexamic acid can be used in cosmetics products and is included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) as “topical agent to inhibit melanin production and whiten the skin.”​

Cosmetics containing it are regulated as general cosmetics and do not need pre-market registration, said He.

According to China’s draft of Determination of Tranexamic Acid in Cosmetics​, tranexamic acid is limited to 3.0mg/kg and its limit of quantitation is 10.0mg/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%,”​ said He.

Infringing on consumer rights

He stressed that the true controversy surrounding Yunnan Baiyao is not the inclusion of tranexamic acid, but the misleading claims that attribute the efficacy of the toothpaste to the Chinese medicine ingredients.

“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,” ​said He.

He added that the problem is further compounded as Yunnan Baiyao products have a secret proprietary formulation which makes it impossible for any third-party agency to adequately analyse the product.

Current standards

Currently, toothpaste occupies a “regulatory grey area”, explained He. It is not categorised as a drug nor a cosmetic.

However, the production license for toothpaste is the same as cosmetics, even though it has its own standard system.

The State Administration for Market Regulation (SAMR) has in the past considered regulating functional toothpaste as drugs, said He. However the plan was scraped as it was not feasible.

He further explained that in the second draft of Regulation concerning Supervision and Administration over Cosmetics, oral hygiene cosmetics are only required to comply with national or industrial standards instead of registration or filing.

Claims said to inhibit plaque or aid dental sensitivity are permitted, provided that adequate standard-based evaluation data supports the claims.

However the claims made by Yunnan Baiyao, which included improving gum problems, repairing mucosal damage, improving periodontal health, are not permitted.

He said, “It is expected the 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.”​