Yunnan Baiyao Toothpaste is a household name in China. For decades, the brand has been advertised for its secret formula of traditional Chinese herbal medicine. However, in October, consumers began accusing the brand of containing tranexamic acid, a prescription drug that
prevents gum bleeding, a common symptom of gingivitis.
Parent company Yunnan Baiyao Group was quick to respond with a statement on October 22 saying that all ingredients used in its products comply with national standards and they did not contain any illegal ingredients. “Tranexamic acid is widely used in functional toothpastes both inside and outside China,” the statement read.
During a follow-up investigation, NewsChina found that at least five other brands of toothpaste contain tranexamic acid, a fact often overlooked by domestic consumers.
Tranexamic acid was developed in 1962 to effectively prevent excessive gum bleeding. It has been more than half a century since its first clinical use in 1968. “It is a widely adopted bleeding control drug,” Ji Lianmei, a Beijing-based pharmacist told NewsChina. “It is used during and after clinical surgery, but there are differences on allowed doses between countries.”
According to Ji, in Japan, tranexamic acid is non-prescription medicine. With a daily maximum dose of 750 milligrams, it is approved for use in painkillers and cold medicines. The US approved production of tranexamic acid sustained release tablets in 2009 at a dose of 650 milligrams. The UK has listed it as an over-the-couter medication since 2011.
It was Japan who took the lead in using tranexamic acid as a toothpaste additive to treat gum bleeding. Lion Cooperation, a Japanese manufacturer, applied for a US patent on an oral hygiene product containing tranexamic acid in 1980. Approved in August 1984, the patent clearly states that tranexamic acid accounts for 0.01 to five percent of the total quantity of the toothpaste.
In China, toothpaste manufacturing is supervised and approved by the China Food and Drug Administration. According to national standards released in 2008, tranexamic acid is not listed as a prohibited ingredient. Gao Yuanqin, Secretary General of China Oral Care Industry Association (COCIA), said publicly that “according to existing Chinese law, use of tranexamic acid is not illegal.”
“The quantity of tranexamic acid in toothpaste is not significant,” said Xu Chunsheng, COCIA science and technology committee member, to our reporter during a recent interview. According to Xu, the amount of tranexamic acid swallowed during an average brushing is around 0.068 milligrams.
That means it would take 26 years to ingest 650 milligrams, or just one tablet of the
US-approved tranexamic acid drug. The amounts of tranexamic acid in toothpaste vary by manufacturer and, as Xu explained, there are no industry guidelines to date.
However, whether tranexamic acid or any other toothpaste ingredient can effectively prevent bleeding gums remains unclear. According to Dr. Liu Xi from Peking University Hospital of Stomatology, the main cause of bleeding gums is periodontitis, while the effectiveness of brushing lies in repeated action rather than any specific ingredient. “So far no evidence has shown that any single ingredient can play an effective role in controlling gum bleed,” Liu told NewsChina.
“Anti-inflammation and bleeding control are what we in the cosmetic chemical industry call the ‘cooperative effect’ of tranexamic acid and herbal medicine,” said Xia Leng, managing director of the Guangdong Institute of Cosmetic Science and Technology.
Humans have used forms of toothpaste for thousands of years. Ancient Egyptians used tooth powder as early as 5,000 BCE. Liu explains that the earliest formula on record (4 CE) includes rock salt as an abrasive and flavorants such as peppermint, dried iris and pepper. “Using this kind of tooth powder would be more like preparing meat to be barbecued [than cleaning teeth]. The sad part is it would unavoidably cause the gums to bleed,” added Liu. In China, mixtures of herbs, salt and other ingredients were in widespread use during the Tang Dynasty (618-907). There is evidence that during the 18th-century, Europeans used burned bread to brush their teeth. Chalk, charcoal and brick dust were all used. The first modern toothpaste was produced in the late 1800s.
The first toothpaste in China was produced in 1922 by the then China Chemistry Industry Association in Shanghai. It quickly replaced tooth powder as the most popular dental care product.
Today, ingredients in toothpaste are quite similar. The main difference between Chinese toothpaste and major brands in other countries is the widespread use of herbal medications. In the 1950s, the Shanghai Toothpaste Factory made China’s first ever modern herbal toothpaste and branded it as “spearmint chlorophyl toothpaste.”
“Chinese herbal toothpaste suits Chinese healthcare traditions. Culturally, Chinese consumers accept herbal toothpaste more readily than Western ingredients such as fluorides, triclosan and nitrates,” wrote Xu Chunsheng in an article titled Retrospect and Prospects of Chinese Herbal Toothpaste Research.
Yunnan Baiyao Toothpaste went public in 2005 and within one year, it saw sales worth more than 100 million yuan (US$14.4m). More domestic toothpaste companies, including Dihon Pharmaceutical and Zhangzhou Pien Tze Huang Pharmaceutical, joined to promote their own herbal toothpastes. Foreign companies also noticed the market potential. In 2000, Colgate began marketing herbal toothpastes containing honeysuckle, Chinese ginseng and other herbal ingredients. Unilever followed in 2005, then Proctor & Gamble in 2008.
In 2016, Xu Xiaoming, director of the Shanghai Dental Disease Prevention and Treatment Center, conducted a study of 34 kinds of toothpastes from 19 different brands. He found all but one claimed to have active ingredients. A total of 24 claimed to prevent cavities. Other popular purported functions include whitening, anti-bacteria, anti-inflammatory or reduced sensitivity. Furthermore, 11 out of the 34 kinds contain herbal ingredients.
“Researchers in this industry have struggled to make technological and functional breakthroughs for toothpastes. However, added ingredients are also heavily influenced by the market,” said Xia Leng, who also said that in recent years toothpaste ads have been increasingly exaggerating their effects. “I feel they are cheating consumers,” Xia said.
Packaging and flavors have diversified in a bid to attract more consumers. This summer, a toothpaste hit the shelves in China boasting such exotic ingredients as Australian orange extract, fir tree oil and even caviar. It sells for 108 yuan (US$15.5) a tube, five to 10 times higher than the average toothpaste.
“Generally speaking, if a toothpaste claims to be functional, it will be certified. If it does not receive certification, it is common toothpaste,” said Chen Jianfen from the China National Institute of Standardization’s committee on oral cavity nursing materials.
According to Xu Chunsheng’s study, the estimated total global toothpaste market is worth US$17.4 billion, with China accounting for 27.6 percent. Statistics released by the China Oral Care Industry Association indicate that annual production of toothpaste in China is around 10 billion tubes.
The significant potential market for functional toothpastes is partly owing to increases in the number of cases of gingivitis and other dental health issues in China. In September 2017, the Chinese Stomatological Association released a document that raised issues with the marketing of functional toothpaste: “In 2014, the market share of functional toothpaste in China amounted up to 94 percent, in which many companies made exaggerated claims in ads and some ingredients were not tested for safety.” The document also pointed out that currently there are no set standards for functional toothpastes or which organization should evaluate them.
“Presently, many of the claims are just false advertising. There are no clinical trials because they are time consuming and costly,” said Chen Jianfen, adding that trials can cost up to 600,000 yuan (US$86,000).
Chen believes significant progress has been made. “Regulations for the toothpaste industry have been implemented, and I believe that toothpastes that are certifed are safe to use,” Chen said. “When it comes to market supervision, those responsibilities lie with national-level government institutions.”
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