Investigation of chaotic images of online sales of "San Fu Tie": Difficult to distinguish true from false, chaotic classification, and hidden risks
During the hot summer months, many hospitals’ TCM departments are crowded with people lining up to apply the sanfu paste.
On the e-commerce platform, the "San Fu stickers" have been packaged by some merchants as "universal stickers" that can cure all diseases, claiming that they can treat digestive, respiratory, and immune system diseases. effect.
Many merchants call themselves "Ancestral Formula", "Hospital Same Model", and "Factory Direct Sales". They sell a dazzling array of product styles and diverse brands, and the monthly sales shown are tens of thousands or even hundreds of thousands.
A survey by The Paper (www.thepaper.cn) found that there are many suspected fakes of "Sanfu Tie" sold online.
In addition, most of the "three-volt stickers" purchased online are not the same as those used by hospitals.
As early as July 2013, the State Administration of Traditional Chinese Medicine issued a notice: The institution that provides the "San Fu Tie" service should be a department of Chinese medicine, a department of integrated traditional Chinese and western medicine, or a department of ethnic medicine that has been approved and registered by the health administration department and the Chinese medicine management department. The medical institution of the subject, and has carried out corresponding Chinese medicine or ethnic medicine service work.
A staff member of a Chinese medicine hospital in Shanghai told The Paper that the "San Fu Tie" project carried out by the hospital is a medical technology, and the raw materials used are all prescription drugs.
During the specific operation, the medical staff will scientifically observe and judge the skin reaction process during the treatment based on the actual condition of the patient, and intervene if necessary or terminate it in due course.
Deng Yong, associate professor of the Law Department of Beijing University of Chinese Medicine and associate researcher of the National Academy of Chinese Medicine Development and Strategy of Beijing University of Chinese Medicine, pointed out that many businesses deliberately claim that products have certain curative effects to confuse consumers. It's completely different from the "three-volt stickers" in the hospital."
Relevant national departments have strict classifications of food and drug products to standardize production and use, but what the "three-volt stickers" sold on the market belong to is very confusing-there are daily necessities, health care products, and medical products that have not clearly labeled ingredients. Mechanical products.
Some online merchants even sell products with a registered number that has been cancelled.
Chen Yunfei, vice chairman of the Committee of Acupuncture and Medicine Integrative Medicine of the Chinese Acupuncture Society, and director of the Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, said bluntly that the State Administration of Traditional Chinese Medicine and other departments need to further clarify the technical requirements and operating specifications of the "San Fu Paste" to maximize Protect the interests of consumers.
Many products are suspected to be counterfeit, and some of them use deregistered registration numbers.
The Paper found that some individual sellers sold "San Fu Tie" products on the second-hand commodity trading platform "Xianyu", most of which were called daily necessities, and many sellers claimed that their micro-shops were closed and sold at low prices for clearance.
The reporter noticed that a product named "Nanjing Tongrentang Green Gold Home Sanfu Paste" was marked on the back of the package as "daily necessities, not a substitute for medicines or medical devices", and there are related information such as usage methods, precautions, specifications and so on.
The Paper called "Nanjing Tongrentang Lvjinjiayuan Health Products Co., Ltd." (hereinafter referred to as Lvjinjiayuan Company). After confirming the packaging, specifications and anti-counterfeiting codes of the product, relevant personnel and reporters said that this is an unauthorized fake product. .
She said that patch products such as "Sanfu Paste" are often fake, and her company is also defending their rights.
Lvjinjiayuan has no direct relationship with "Nanjing Tongrentang".
The company stated that it was authorized by "Nanjing Tongrentang Pharmaceutical Co., Ltd." to use the name "Nanjing Tongrentang" within the operating period, and both parties are independent market operators.
On platforms such as 1688 Wholesale and Taobao, the reporter found that there are at least 6 other three-volt stickers under the banner of "Nanjing Tongrentang Green Gold Home", with different packaging, and all of them are produced in Henan.
"Original products from the manufacturer, please rest assured to buy." A number of online store customer service assured that, but the above-mentioned Lvjinjiayuan staff issued a lawyer's letter and two official seal appraisal reports to The Paper and pointed out that 4 of them are from " The products sold by "Nanjing Qicaotang Health Industry Co., Ltd." are counterfeit and use the brands and names of "Nanjing Tongrentang" and "Nanjing Tongrentang Lvjinjiayuan" without authorization. The lawsuit has been sued and the judgment is awaited.
As of press time, the phone number of Nanjing Qicaotang Health Industry Co., Ltd. has not been opened.
In addition, The Paper also discovered that the cancellation number was misappropriated.
The "San Fu Tie" sold by a Tmall store named "Haowanzhong Pharmacy Flagship Store". The manufacturer in the product attribute column is "Nanyang Aihe Shanai Products Co., Ltd.", and the registration number is "Jinlin Machinery Prepared No. 20150012"-here "San Fu paste" has become a medical device product.
However, the reporter found after inquiring that the registration number had already been cancelled.
Prior to this, at least 5 OEM "children's cough plasters" on the market had used this registration number.
According to the packaging information of these "Children's Cough Patches", the reporter called the relevant companies separately.
Among them, the relevant staff of Lufeng Fengrentang Biotechnology Co., Ltd. stated that the registration of this document number was "Children's Cough Paste", which was once produced by the company and another medical company. Other companies are all OEM sales.
She said that in 2018, according to relevant regulations, the first-category medical device "pediatric cough patch" must be cancelled and upgraded to the second-category, and the above-mentioned registration certificate number will also be cancelled.
When The Paper reported to the Tmall consumer platform about the above-mentioned expired certificate number "Zhang Guan Li Dai", the customer service responded, "The platform will increase management."
Mr. Ye, who has been responsible for procurement in hospital pharmacies for many years, told Peng Mei News that the medical device product registration certificate is valid for 5 years.
If the period of validity expires and the registration needs to be renewed, an application for renewal of the registration shall be submitted to the original registration department 6 months before the expiration of the period of validity and relevant documents shall be obtained. Otherwise, a fine will be imposed upon detection.
The cancelled registration number can no longer be used. If the cancellation number is illegally misappropriated, the relevant manufacturers will also be held accountable.
Health products with "alternative" symbol
The Paper noticed that, like some of the "San Fu stickers" products of Lvjinjiayuan, there are many "San Fu stickers" under the banner of health products, using the "Yujian Standard" issued by the Henan Health Products Industry Chamber of Commerce. , "Yu Jian Tuan Biao Zheng Zi" such an alternative symbol.
According to the Tianyan Check, the Henan Health Products Industry Chamber of Commerce is a social organization established and registered on November 21, 2014. Its business scope is "technical exchanges, business training, consulting services, coordination and cooperation and other activities."
A statement published on the official website of the chamber of commerce stated that health care products currently do not require administrative approval. Except for local regulations in Guizhou, Shaanxi, and Jilin, administrative approval is not required in other regions.
Henan Province has industry self-discipline third-party group standard evaluation (consultation)-that is to say, the "Yujian Zhunzi" and other symbol of the Chamber of Commerce's method are the "assessment symbol" issued by the third-party industry chamber of commerce.
According to an article "Market Economy Status of Health Products" published on the website of the Chamber of Commerce, health products refer to external products that have health functions and promote health on the body. Products, etc., "emphasis on health and sub-health in terms of literal expression, rather than treating diseases as the goal."
A staff member of the Chamber of Commerce told The Paper that the Chamber of Commerce currently issues "Yujian Group Standard Characters" and "Yujian Group Standard Certificates" and other certificate numbers to eligible participating companies to evaluate the manufacturer's production conditions and correspondence. Whether the product is standard or not, both must be clearly stated on the back of the product package, "If one is missing, it may be illegal abuse or embezzlement by the participating company."
The Paper found that the above-mentioned "Sanfu Tie" products with the symbol of "Yujian Tuan Biaozheng" contained wormwood, Yuanhu, asarum, white mustard seeds, kansui and other traditional Chinese medicine ingredients.
Regarding how to ensure the safety of products containing Chinese medicine ingredients, the staff of the above-mentioned chamber of commerce said that the expert team of the chamber of commerce assesses the risks, and it is impossible to produce a single effective test document.
In fact, since 1997, Henan Province has issued the name "Yuweijianyong" to support the development of traditional Chinese medicine.
In February 2010, the Henan Provincial Department of Health issued the "Notice on Abolishing the Approval Number of Health Products".
Zhao Lianzhou, then director of the Food Safety and Hygiene Supervision Division of the Provincial Department of Health, once stated that the health care product approval number approved by the unit has expired and will not be reissued or renewed in the future, and enterprises are prohibited from marking "Yuweijian" for approval. Symbol.
Deng Yong, an associate researcher at the National Academy of Chinese Medicine Development and Strategy, Beijing University of Chinese Medicine, told The Paper that health care products generally refer to products with health care effects, and internationally, they mainly refer to health foods.
The former Ministry of Health and the Food and Drug Administration have repeatedly requested the relevant regions to revoke the approval documents for non-compliant application products, but alternative document number application health products are emerging one after another, mainly due to the local understanding and grasp of relevant national policies and laws To varying degrees, the industry is quite chaotic.
The reporter called the Henan Provincial Drug Administration, but the relevant personnel said that the health care products need to complain to the Market Supervision Bureau.
A related person from the Henan Provincial Market Supervision Administration confirmed to The Paper that such document numbers were approved and issued by the local health department in the past, but currently Henan Province has not issued relevant legislation for health care products, and there is no clear department to supervise it. If consumers want to complain about product problems, they can call the 12315 hotline to report and feedback."
my country has always encouraged the development of traditional Chinese medicine and ethnic minority medicine. In order to support local enterprises, strengthen the local economy, and encourage the development of local associations in some regions.
However, Deng Yong pointed out that the self-discipline of the association alone is far from being able to strictly regulate the market order of health products.
Once the words "have curative effect" appear in the publicity of health care products, it means that the business is suspected of false publicity, and the public should carefully consider consuming its products.
Medical equipment? "The ingredients of the standard Chinese medicine cannot be approved"
"Look carefully at the'three-volt stickers' sold on the Internet. The actual packaging does not have the name, they are all used to wipe the edges." A salesperson from a Shandong medical equipment Co., Ltd. that provides the "three-volt stickers" OEM service told Peng Mei News (www. thepaper.cn) revealed that products such as "acupoint application therapy patch", "cold application for shoulder and neck", and "cold application for pain relief", whether they belong to a class of medical devices for home health care, or require further filing or registration For the second-class medical devices in China, no Chinese medicine ingredients are clearly marked on the outer packaging.
The Paper found that in a Tmall enterprise store named "Medical Medical Equipment Store", there are 5 products sharing the same "Qing Xia Bei" brand, including three-volt medicine powder, three-volt patch, cervical vertebra and waist patch, etc., all of which are called "Old Chinese medicine inherits ancient prescriptions and cooks them by hand." The manufacturer is a Qinghai Medical Device Co., Ltd.
One of the canned "San Fu Tie" Chinese medicinal powder products shows monthly sales of more than 300 pieces. Only a white note is posted on the package, and the black letters indicate the ingredients, usage methods, precautions, net content and expiration date. , And did not specify important information such as the manufacturer.
The first comment was that the buyer complained about it-"I got burned after I posted it. It didn't heal for half a month, blisters and pain."
The reporter asked why the seller did not clearly indicate the manufacturer's information on the jar. Is it illegal to use the same serial number for multiple products?
The other party only replied that the products are all made of pure Chinese medicine powder, without any additions, and there is no need to worry about safety issues. "Use with confidence."
According to the information registered by the merchant, The Paper Journalist did not inquire about the relevant "medical device enterprise production/operation enterprise (licensing)" information on the official website of the State Drug Administration.
The product name corresponding to the "Qingxiebei" brand name is the second-class medical device product "pain-relieving cold compress".
In accordance with the approval of the State Drug Administration, this "pain-relieving cold compress" is composed of non-woven fabric, adhesive layer, anti-adhesive layer (polyethylene film or anti-adhesive paper) and other parts.
The glue layer is mainly composed of polymer resin, menthol, p-hydroxybenzoic acid, etc., and does not mention the white mustard seeds, asarum, astragalus and other traditional Chinese medicine ingredients contained in the above-mentioned "save powder".
On July 23, 2021, the State Food and Drug Administration issued the "Notice on Matters Concerning the Registration of Combination Products of Medicines and Devices", which clarified that: Combination products of drugs and devices refer to the combination of drugs and medical devices and produced as a single entity product.
The external application of traditional Chinese medicine is a combination product of medicine and equipment with the main function of medicine, which shall be registered and managed in accordance with "drugs".
The aforementioned salesperson of a Shandong Medical Device Co., Ltd. claimed that the current supervision is not strict, and will only spot check whether the product is officially approved based on the information on the product packaging, and will not deliberately check whether there are pharmaceutical ingredients in it. "The above-mentioned Mr. Ye, who is responsible for purchasing in the hospital pharmacy, also told The Paper that such products cannot enter hospitals and regular pharmacies, so most of them are circulated and sold online. The so-called "hospital same money" is just a cover for drainage.
Yang Min, a lawyer at the Shanghai Huiye Law Firm, told The Paper (www.thepaper.cn) that adding medicated cakes to the acupoint application treatment patch that was originally a "class II medical device" would violate the relevant drug-device combination products. The relevant regulations for registration management belong to the "high-class low-batch" and should be corrected.
At the same time, if the perpetrator fails to explain the legal source of the drugs he added, and fails to provide the "Medical Institution Preparation License" and the preparation approval number, the relevant provisions of the "Drug Administration Law" are violated.
The first paragraph of Article 74 of the "Drug Administration Law" stipulates that "medical institutions preparing preparations shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and obtain a preparation license for medical institutions. There is no preparation license for medical institutions. No preparations are allowed.” At present, major medical institutions across the country mainly process dressings on their own in accordance with regulations, or companies provide raw materials for preparations, and then perform dressing operations in accordance with standards in hospitals.
The sales staff of the aforementioned medical device company also revealed that in order to look genuine, many manufacturers would also apply for trademarks containing the related words "San Fu Tie" to confuse consumers.
Take a medical cold compress of "Wan Moxibustion Hall" as an example. The package is printed with the huge words "Fire Mud Sanfu Paste", and the small mark "TM" in the upper right corner is easily overlooked-this means that the trademark is still It has not become a registered trademark and does not have legal protection.
The Paper Journalists searched on the "China Trademark Network" and found that many companies tried to apply for trademarks containing the word "San Fu", but they were basically rejected.
Zhan Guang, a partner of Shanghai Zhengce Law Firm, told lawyer Peng Mei News that even if the registered trademark is not authorized, the "TM" logo can be printed on the trademarks of daily necessities, health care products, and medical equipment. The law does not restrict this. .
Deng Yong told The Paper that the "Sanfu Paste" itself has health effects, is highly accepted by the public, and is relatively less dangerous. In addition, the cost of such application products is low and the marketing speed is fast, so the grassroots regulatory authorities pay attention. It is difficult to focus on the whole or focus on supervision.
For the pharmaceutical companies or enterprises involved, even if they are investigated, the cost of violations is not very high, and it is difficult to meet the criteria for filing a case.
"Policy is one part, and implementation is another part." Deng Yong believes that it is necessary to continue to expand the law enforcement team, strengthen supervision, and at the same time, on the basis of formulating principles and requirements, give more specific implementation methods and strategies.
Allow all parties to be supervised and supervised, especially the Internet platform, to have sufficient space for operation, "using their own advantages to solve problems reasonably is part of the current policy that needs to be implemented."
Experts in Chinese medicine: hidden risks in online sales of "San Fu Tie"
Consumers are most concerned about whether the product is undoubtedly effective. However, in the opinion of Chen Yunfei, director of the Department of Acupuncture and Moxibustion at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, online shopping for "San Fu Tie" is convenient, but it is "a mess." The hidden dangers are not small.
After Chen Yunfei read the 3 formulas of the sun-fed paste that the reporter randomly saw on Taobao, they all said that they were "inappropriate".
He pointed out that in the formula composed of Chinese medicines such as wormwood, fritillaria, bezoar, ginkgo, licorice and camphor, bezoar is cool in nature, while fritillaria and ginkgo are high in fat, which tends to promote dampness and heat, which is counterproductive to symptoms of asthenia and cold. .
In another formula table composed of wormwood, frankincense, myrrh, Yuanhu, spatholobi, spatholobus, papaya, etc., the two medicinal materials, "Spatholobus spatholobi" and "papaya", are mainly rhizomes. It is mainly used for nourishing yin and nourishing blood, and should not be used as an applicator.
When the Paper reporter communicated with several Taobao sellers, they all suggested buying multiple boxes according to the course of treatment. They said they could not finish the stickers during the dog days, and they could continue to be used at ordinary times, but the effect was not so good.
On most product pages, the shelf life of the product is 2-3 years.
Chen Yunfei pointed out that traditional Chinese medicine pays attention to the coordination with nature, and sweat should be appropriate in summer, but it should not be too damaging to yang.
The seller claims that it can be applied casually for a long time. On the one hand, it means that the dosage has not been reached and there is no effect. On the other hand, there may be no obvious response in the short term. "This point requires more vigilance."
He explained that some Chinese medicines (such as gypsum, tuckahoe, rehmannia, Ophiopogon japonicus, dendrobium, etc.) are cold in nature and do not contain aromatic substances. They are not suitable for application drugs because the amount of application that penetrates the skin is too small. May have obvious pharmacological effects.
The shelf life of aromatic drugs routinely used in hospitals is generally very short. For example, musk can only be stored for 2 hours at room temperature. After 2 hours, the power of the medicine will disappear on its own, and it will not reach the shelf life set on the market.
At the same time, the sources and ingredients of traditional Chinese medicines used by some manufacturers on the market are unknown. Some may be medicines that chronically damage liver and kidney functions. They are overused due to their low prices. "Like our hospital (Yueyang Integrated Traditional Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine) ) Some of the dressings used can only be used externally, and there is a risk if accidentally swallowed."
Chen Yunfei stated from past case descriptions that some patients with yin deficiency and fire are not suitable for applying "Sanfu Paste", but these people will still buy it and try.
After a while, without knowing it, I started to fall asleep at night.
"This is caused by the virtual fire in his body. Many patients will have similar adverse reactions, but it is not obvious, and everyone is not concerned."
In addition, he pointed out that the acupuncture point maps included with many online shopping products are not accurate.
If consumers place the wrong place on some large blood vessels or areas with less subcutaneous fat, such as the Baliao acupoint, once it is ulcerated, it is difficult to heal, and it may also cause a series of problems such as inflammation.
For another example, among the acupoints for immune problems, the acupoints at the joints are not suitable for application. The "Jiexi" acupoint is located at the ankle joint. If it blisters and ulcerates, it will easily affect joint movement.
The Paper reporters also found that there are many three-volt stickers aimed at children, and some sellers bluntly said, "The sales volume is better than those used by adults."
Public reports show that in 2019, a number of children in Nanchang were burned after sticking "San Fu stickers" at Jiangxi Children's Hospital, and 92 children developed pruritus, burning sensation, blisters and other adverse reaction symptoms, which caused heated discussions in the outside world.
Chen Yunfei emphasized that children’s skin is very thin and tender, and the dosage may be less than one-tenth that of adults. If the foaming time is slightly wrong, it is easy to burn and purify.
At present, regular medical institutions are also constantly exploring and adjusting the application site, length of time, application interval, and total application times. If parents use the powder at home, serious consequences are more likely to occur.
Chen Yunfei bluntly said that in Chinese medicine, children are regarded as pure yang bodies. The biggest feature is sufficient yang, and most children do not need to apply "Sanfu Paste".
Some advertisements claim that "Sanfu Tie" has obvious effects on children with asthma, and it is only limited to patients with Yang deficiency.
"The structure of the human body is complex, and it needs to be judged by experienced doctors. It is not possible to achieve a "one-stick general purpose"."
[Extended reading]
"Sanfu Paste" is the abbreviation of "Acupoint Application for Winter Diseases and Xiazhi", also known as "drug foaming" or "applied foaming". It is a kind of traditional Chinese medicine scar moxibustion therapy, the principle is to put medicines The applicator covers the corresponding acupoints on the human body and stimulates the acupoints to achieve the corresponding effect in conjunction with the "Dog Day", the most yang season.
The “Notice on Strengthening the Application and Management of Acupoint Application Technology for Winter Diseases and Summer Treatments” issued by the State Administration of Traditional Chinese Medicine in July 2013 pointed out that the “Sanfu Paste” is mainly suitable for recurrent chronic respiratory diseases, and can also be used for recurrent chronic respiratory diseases. Onset and aggravation in winter are clinical features, and TCM syndromes are other diseases of cold syndrome.
In fact, "Sanfu Tie" is considered to have no clear historical origin and case records in the Chinese medical field.
There is a view that "Sanfu Tie" evolved from the concept of "Tianfu".
Tian moxibustion mainly uses skin-irritating drugs to apply to acupoints or affected areas.
Sun Si of the Tang Dynasty took the lead in proposing this term in "Gan Jin Yi Fang".
Song Dynasty Wang Zhizhong further used Eclipta prostrata to treat malaria in "Acupuncture and Moxibustion Zisheng Jing", which was regarded as the prototype of "Sanfu Paste".
Chen Yunfei told The Paper that the concept of "Treatment of Winter Diseases in Summer" behind "San Fu Tie" can be traced back to the "Huang Di Nei Jing".
The "Fifty-two Prescriptions for Diseases" unearthed from the Mawangdui Han Tomb contains many externally applied alchemy prescriptions, which can be regarded as the prototype of Sanfu Tie.
Tian moxibustion is another form developed on the basis of sticking application. "In the Qing Dynasty, there were great masters."
During the Kangxi period of the Qing Dynasty, the physician Zhang Lu recorded in the "Zhang Shiyitong" in the "Summer Moon Sanfuzhong", using mustard, corydalis, asarum, and kansui as the last, adding musk, and applying it to Feishu, Bailao and other acupuncture points to treat cold asthma-this is regarded as a sign of the formation of "three-volt stickers".
At present, major hospitals still choose medicinal materials with foaming and warming yang effects, such as ginger, white mustard seeds, kansui, asarum, etc.
There is no standard and uniform formula and ratio for "Sanfu Paste". As with a medical institution, different departments have different medicines and ratios.
Chen Yunfei explained that the State Administration of Traditional Chinese Medicine has a range of drugs for "Sanfu Tie", but does not specify the specific medication and ratio. "For example, some hospitals will replace ginger with garlic, which has similar characteristics. This is traditional Chinese medicine and Western medicine. The biggest difference".
Beginning in the late 1970s, the type of disease corresponding to this therapy developed from cold asthma to the entire lung system, adapting to more pathologies of yang deficiency, and gradually being promoted.
The Paper News reporter Feng Yinlun and intern Yan Huihuan