"Medical masks" flooded with e-commerce platform regulators one after another to rectify
Be wary of consumption traps of facial mask cosmetics
·The so-called "Machine Brand Mask" is actually a medical dressing, which belongs to the category of medical devices. Medical dressings should be used within the scope allowed by their "applicable scope" or "intended use", guided by a qualified doctor and used in the correct usage and dosage, and cannot be used as a daily skin care product for a long time
· Cosmetics must not claim to have medical effects, and their logos must not be marked with exaggerated functions, false propaganda, etc. Some facial mask cosmetics, which declare products as "medical skin care products", "drug cosmetics" products, etc., are express or implied products that have medical effects, and are all illegal claims
·Ensuring the safety of use is the bottom line of cosmetic raw material management. While implementing classification management of new cosmetic raw materials and simplifying the use of common new raw materials, new raw material registrants and recorders must pay close attention to the safety of their use after the new raw materials are on the market. Main responsibility of related enterprises
Our reporter Wan Jing
On July 21, in order to promote the implementation of the "Regulations on the Supervision and Administration of Cosmetics" and further standardize the management issues of cosmetics registration and production licenses, quality and other management issues, the State Drug Administration drafted and issued the "Administrative Measures for Cosmetics Registration (Draft for Comments)" and "Cosmetics Measures for the Supervision and Administration of Production and Operation (Draft for Soliciting Opinions)", and soliciting opinions from the public.
Online shopping of various beauty and skin care products has become a popular way of consumption among young people. Among them, the purchase of facial masks is huge. There are many types of facial masks sold on major e-commerce platforms, but they are mixed. Some e-commerce companies claim that whitening, anti-wrinkle, anti-acne...just a piece of "medical beauty mask" or "medical mask" can be done. In particular, the "Machine Font Mask" has been regarded by many young women as the star product of the "Savior of Bad Face".
However, the National Medical Products Administration released the "Science Popularization of Cosmetics: Beware of Facial Mask Consumption Trap" as early as January 2, and clearly stated that there is no so-called "mechanical face mask" concept. It is actually a medical dressing and belongs to the type of medical device. Therefore, safe use of makeup is very important, and all kinds of "medical facial masks" must be guarded against consumption traps.
"Machine font mask" does not exist
"Makeup font face mask" carefully declared
The State Drug Administration pointed out in the article that the so-called "Machine Brand Mask" is actually a medical dressing and belongs to the category of medical devices. Medical dressings can be in direct or indirect contact with the wound surface, and have medical effects such as absorbing wound exudate, supporting organs, preventing adhesion, or providing a suitable environment for wound healing.
Medical dressings managed by medical devices can be divided into three categories: surgical dressings (divided into absorbable and non-absorbable dressings), contact wound dressings (divided into acute wound dressings and chronic wound dressings), and bandaging fixed dressings.
According to the "Regulations on the Supervision and Administration of Medical Devices", medical dressing products are classified according to the degree of risk from low to high, and are managed according to the first, second and third types of medical devices. For medical dressings that are claimed to be sterile, their management category is the lowest category II medical device; if they come into contact with wounds damaged in the deep layer of the dermis or below, or are used on chronic wounds, or can be fully or partially absorbed by the human body, their management The category is the third category of medical devices. Domestic second-class medical device products need to be registered with the provincial drug regulatory authority before being marketed; third-class medical devices and imported second-class medical devices need to be registered with the State Drug Administration before they are marketed.
The State Drug Administration pointed out that the naming of medical dressings under the management of medical devices should comply with the requirements of the "General Naming Rules for Medical Devices", and must not contain words such as "beauty" or "health", and must not include exaggerated scope of application or other misleading or deceptive Sexual content. Therefore, there is no concept of "Mask", and medical device products cannot use "Mask" as its name.
In addition, the State Drug Administration also reminded that medical dressings should be used within the scope permitted by their "applicable scope" or "intended use", guided by a qualified doctor, and used in accordance with the correct usage and dosage, and cannot be used as a daily skin care product for a long time. .
In addition to the "Machine Brand Mask", the National Medical Products Administration in the article "Cosmetics Science: Beware of Facial Mask Consumption Trap", also disclosed the popular "makeup brand mask".
According to the article, the so-called "makeup face mask" refers to a facial mask product that is managed in accordance with cosmetics. It refers to a cosmetic that is applied or applied to the surface of the human skin and removed, scrubbed or retained after a period of time to provide care or cleansing.
According to the classification of pre-marketing supervision methods, facial mask cosmetics are divided into two categories: the first category, special-purpose cosmetic facial masks that need to be registered with the State Drug Administration before marketing are mainly products that claim to have special effects such as freckle removal and whitening; The second category, non-special use cosmetic masks that need to be filed with the State Drug Administration or the provincial drug regulatory authority before being marketed, are mainly products that claim to have moisturizing, cleansing, and moisturizing effects.
According to the "Regulations on Cosmetics Hygiene Supervision" and other laws and regulations, cosmetics must not claim to have medical effects, and their logos must not be marked with exaggerated functions, false propaganda, etc. For some facial mask cosmetics, declaring the products as “medical skin care products” or “drug cosmetics” products, etc., are either expressly or impliedly that the products have medical effects and are illegal claims.
In addition, Article 22 of the Regulations on the Supervision and Administration of Cosmetics, which was announced in June this year and will be officially implemented on January 1, 2021, stipulates that the claims of cosmetics' efficacy should have sufficient scientific basis. Cosmetic registrants and record holders shall publish the summary of the literature materials, research data or product efficacy evaluation materials on which the efficacy claims are based on the special website specified by the drug regulatory department of the State Council, and accept social supervision.
Article 43 of the "Regulations on Cosmetics Supervision and Administration" stipulates that the content of cosmetics advertisements should be true and legal. Cosmetics advertisements must not explicitly or imply that the products have medical effects, must not contain false or misleading content, and must not deceive or mislead consumers.
The medical mask is good at playing the "edge ball"
Most of the low cost "sell concept"
A reporter from "Legal Daily" searched on some e-commerce platforms and found that many merchants selling "medical masks" marked "products registered with the State Drug Administration" or advertised that they have a registration certificate number in a prominent position on the front page of the store.
Enlarging these product descriptions, the reporter of "Legal Daily" found that although the back of the package will clearly indicate the registration certificate number: ×mechanical injection standard×××××××××××, but the front of the package does not mark "mask "Two words. And, on the official website of the State Drug Administration, enter the registration certificate number to query this product, and it shows that it is a registered medical device.
In other words, these merchants have played a "margin ball". These so-called "medical masks" are actually medical cold compresses, medical sodium hyaluronate repair patches, and human-like collagen dressings.
According to a specialist doctor from a well-known dermatology hospital in Beijing, "XiaZiHao" medical dressings are mainly targeted at postoperative populations. The ingredients are very simple, generally only collagen (hyaluronic acid) and some simple hyaluronic acid ingredients, but no whitening or anti-wrinkle , Acne and other effects.
Due to the low threshold for mask production, short development cycle, and low investment, many investors have poured in, leading to the homogenization of the mask market.
"The most popular facial mask products on the Internet now are the ones that are popular in the offline market. For example, Japanese and Korean facial masks are popular in the past few years, and Thai facial masks are popular recently." said the owner of a beauty shop in Beijing.
According to the owner of the beauty shop, the cost of making sheet masks is actually very low. Nowadays, the mask market is selling packaging and concepts. With gimmicks such as red wine, collagen, and bird’s nest, the ingredients are roughly the same. Some unscrupulous manufacturers even use one. Various kinds of original liquids are formulated into various masks with different effects for diversified sales. As a result, various "medical beauty masks" and "mechanical font masks" have appeared, and the cost of these masks can be as low as 2 yuan per sheet. Driven by huge economic benefits, some businesses are playing the "edge ball" of medical cosmetology, riding on the "medical cosmetology" to confuse the public, causing many beauty lovers to spend a lot of money but use cheap skin care products.
Implement classified management of new raw materials
Implement the main responsibility of relevant enterprises
The "Regulations on the Supervision and Administration of Cosmetics" puts forward a targeted treatment plan for the above-mentioned "medical facial masks", implements classified management of cosmetic raw materials, especially new raw materials, and sets a monitoring period for new raw materials.
Many contents of this regulation involve raw material management, dividing cosmetic raw materials into new raw materials and used raw materials, including clearly classifying and managing cosmetic raw materials according to the degree of risk, and implementing registration or filing management of new raw materials according to the degree of risk. The drug regulatory authority formulates a list of prohibited raw materials.
The regulations clearly stated that new cosmetic raw materials with antiseptic, sunscreen, coloring, hair dyeing, spot removal and whitening functions can only be used after being registered by the State Council's drug regulatory authority; other new cosmetic materials should be filed with the State Council's drug regulatory authority before use. The recorder of new cosmetic raw materials shall complete the record after submitting the record materials stipulated in these Regulations through the online government service platform of the drug regulatory department of the State Council.
Xu Liang, a member of the Cosmetic Standards Expert Committee of the State Food and Drug Administration and an expert in cosmetic technology review, believes that the regulations will refine new cosmetic raw materials based on risk differences and implement classified management, that is, preservatives, sunscreens, colorants, hair dyes, High-risk raw materials such as freckle and whitening agents are subject to registration management. Other common new raw materials with relatively low risks no longer require administrative approval but are changed to filing management. The filing person can use it after completing the filing online.
The regulations do not leave the record management of ordinary new raw materials all alone. In addition to clearly stipulating the information requirements for applying for registration or filing of new cosmetic raw materials in Article 12, it also specifically stipulates in Article 14. Within 3 years of the new raw materials of cosmetics that have been registered and filed, the registrant and filer of the new raw materials shall report the use and safety of the new raw materials to the drug regulatory department of the State Council every year. For new cosmetic raw materials that have safety problems, the drug regulatory department under the State Council shall deregister or cancel the record. New cosmetic raw materials that have not had any safety problems after the three-year period have expired will be included in the used cosmetic raw materials catalog formulated by the State Council's drug regulatory department.
Xu Liang believes that ensuring the safety of use is the bottom line of the management of cosmetic raw materials (including new raw materials). The establishment of a new raw material monitoring period can be understood as implementing the classification management of new cosmetic raw materials and simplifying the procedures for the use of common new raw materials. At the same time, the new raw material registrant and recorder must pay close attention to the safety of the new raw materials after they are put on the market, and implement relevant The main responsibility of the enterprise is to ensure the safe use of new raw materials. In fact, to ensure the safe use of new raw materials is to ensure the self-interest of related companies and promote their long-term development.
Fake and inferior medical devices are rampant
Regulatory crackdowns must be stepped up
A reporter from "Legal Daily" found that there are not many e-commerce companies that use ordinary masks to pretend to be "Machine Brand Masks". The reason is that in addition to catering to consumer needs and bringing more profits to businesses under the banner of medical beauty, there are also An important reason is that as a type of medical device, the registration of "Machine Brand Mask" only needs to be filed.
According to the current "Regulations on the Supervision and Administration of Medical Devices", the state implements classified management of medical devices according to the degree of risk. The first category is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness; the second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness; the third category is medical devices with relatively high levels of risk. High risk, special measures need to be taken to strictly control and manage to ensure its safe and effective medical devices.
The first category of medical devices is subject to product registration management; the second category of medical devices is subject to the provincial food and drug regulatory authorities, and the third category of medical devices is subject to product registration management by the State Food and Drug Administration. Liberalize the operation of first-class medical devices, implement record management for the second-class medical devices, and implement licensing management for the third-class medical devices.
According to the reporter of "Legal Daily", most of the "medical masks" and "machine brand masks" currently on the market are registered in accordance with the first category of medical devices. This kind of registration and filing conditions is not difficult for most manufacturers, and the cost is low, so some businesses have exploited loopholes. In fact, many businesses do not understand the laws, regulations and regulatory policies of medical devices, so they rush to produce and sell. These enterprises have also become the focus of the next step of supervision by the Food and Drug Administration.
It is reported that the drug regulatory authorities in many places have begun to increase the intensity of unannounced inspections for these cosmetic manufacturers that have obtained medical device qualifications, and cancel their qualifications for companies that do not meet the requirements for medical device production.
In addition, the relevant state departments have also accelerated the pace of the standardization of medical devices. Recently, the State Drug Administration issued a document to further strengthen the management of mandatory industry standards for medical devices.
On July 8, the State Drug Administration held a video and telephone conference on national drug regulatory policies and regulations for 2020, and proposed to speed up the revision of the "Regulations on the Supervision and Administration of Medical Devices."
The "Regulations" began in 2000, a comprehensive revision was carried out in 2014, partial revisions were made in May 2017, and again in 2018, and finally the "Regulations on Medical Device Supervision and Administration Amendments (Draft for Review) ".
The highlight of the draft submitted for review is the addition of the concept of "counterfeit medical devices". In response to the current raging phenomenon of counterfeit and inferior medical devices on the market, an amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review) has been added to "prohibit the production, operation and use of counterfeit medical devices." At the same time, the specific circumstances of counterfeit medical devices are clarified: "Production or import without a medical device registration certificate or filing certificate; non-medical devices pretending to be medical devices, or other types of medical devices pretending to be such medical devices; deception Manufacturing or importing of medical device registration certificates or filing certificates by means; forging or fraudulent use of others’ medical device registration certificates or filing certificates, business names, production addresses, etc."