The formula and production processes surronding Yunnan Baiyao
The formula of, and production processes surronding Yunnan Baiyao are trade secrets. The company website mentions that the steroid progesterone is in the formula, in addition to several saponins, alkaloids and calcium phosphate. The separate herbal ingredients are reportedly compounded by thirteen separate teams, none of whom have any knowledge of the ingredients the other teams are mixing. The prepared mixed components are then combined by a further team, who have no knowledge of what constitutes them but knows the proportions in which they are combined. Protopanaxadiol and panaxatriol, sapogenins found in ginseng (Panax ginseng) and notoginseng (Panax pseudoginseng), have been detected in Yunnan Baiyao powder formulations through capillary supercritical fluid chromatography. Yunnan Baiyao should not be used with alcohol or when pregnant.
In December 2010, purported lists of ingredients were published on the websites of Amazon.com and the Food and Drug Administration (FDA). The list supposedly containing eight active ingredients of a liquid form of the drug were found in a document published on the FDA website that contains correspondence between the FDA and a distributor of the drug. Ingredient lists were also present in the product information sections for the powdered and capsule forms of the drug on Amazon.com. The proportions and exact manufacturing processes are still unknown.
The 2010 FDA document listed notoginseng (Panax pseudoginseng) root, borneol (Dryobalanops aromatica) crystal, Boea Clarkean (Boea clarkeana) entire plant, Inula Copp (Inula coppa) root, Complanatum (Lycopodium complanatum) rhizome, Chinese Yam (Dioscorea opposita) rhizome, galanga (Alpina offcinarum), cranebill(Erodium stephanianum) aerial parts, camphor (Cinnamonmum camphora) crystal extracts, and peppermint (Menta haplocalyx) leaves as active ingredients in Yunnan Baiyao products.
Under the “Law on Guarding State Secrets”, the formula as well as the production processes regarding Yunnan Baiyao are considered secret and possess the longest period of product proprietary secrecy protection of four levels of secrecy under Chinese trade law. As a result, Yunnan Baiyao’s exact ingredients are not printed on its packaging in China, and its production process was not disclosed to workers in the factory. Some of the Yunnan Baiyao’s products are sold in the US as diet supplements. According to FDA regulations, all diet supplements sold in the US market must list their ingredients on the package and report them to relevant authorities. Officials from the Yunnan Baiyao Group, the exclusive producer of Yunnan Baiyao, denied to Xinhua News Agency Thursday that there is a double standard in Yunnan Baiyao’s secret-protection policy, and that ingredients are only reported to drug authorities. “Whoever disclosed the ingredients should be held legally liable,” Huang Wushuang, an expert on intellectual property rights at East China University of Political Sciences, said.
In early 2013, officials in Sichuan province banned the sale of Baiyao powders and pills over faulty and defective wrappers that led to water contamination in addition to finding products contaminated with mold. In February 2013, the Department of Health of Hong Kong found potentially toxic undeclared aconitum alkaloids in samples of Yunnan Baiyao products, leading to a mandatory recall of products and a temporary ban on the sale of Yunnan Baiyao in the administrative regions of Hong Kong and Macau.