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China NMPA Prohibits “Facial Mask” as Product Name for Medical Dressing

  •   14 Jan 2020
  •    Hedy He
  •  287
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    • Products with certificates for medical devices shall not use “facial mask” as their names.
    • Facial masks with filing or registration certificates for cosmetics shall not claim "medical skincare products."

    On Jan 2, 2020, China National Medical Products Administration (NMPA) released an announcement [1] stating that products certified as medical devices shall not use “facial mask” as their names and facial masks certified as cosmetics shall not claim medical efficacy.

    Main Contents of NMPA Announcement

    1. Products with certificates for medical devices shall not use cosmetic claims

    Products claimed as “facial masks with certificates for medical devices (in Chinese 械字号面膜)" on the market are medical dressings and are categorized as medical devices. Medical dressings can be in direct or indirect contact with wounds and have the medical effects of absorbing wound exudate, supporting organs, preventing adhesions, or providing a suitable environment for wound healing.

    The naming of medical dressings shall comply with the Naming Rules for the Generic Names of Medical Devices. Medical device names shall not use claims such as "beauty," "health care," etc., and shall not exaggerate the scope of application or contain other misleading or deceptive content. Therefore, the claim “facial masks with certificates for medical devices (械字号面膜)” is illegal. Medical devices shall not use the term facial mask in their product names.

    2. Facial masks with filing or registration certificate for cosmetics shall not claim medical efficacy or use medical terminology in the product name or advertising

    Facial masks with certificate for cosmetics (in Chinese 妆字号面膜) refer to cosmetics that are smeared or applied to the surface of human skin, peeled off after some time, scrubbed or retained for care or cleaning. Facial mask cosmetics include facial masks, eye masks, nasal masks, lip masks, hand masks, foot masks, and neck masks.

    According to the pre-market requirements, facial mask cosmetics are divided into two categories. The first are special-use cosmetics which require registration with NMPA. They are facial masks with effects such as freckle removing, skin whitening, etc. The second is non-special use cosmetics, which require filing with NMPA or provincial MPA. They are facial masks with effects such as moisturizing, cleaning, etc.

    According to Regulations concerning the Hygiene Supervision over Cosmetics 1989, cosmetics shall not claim to have a medical effect, and the labeling shall not be exaggerated or false. On Jan 10, 2019, NMPA banned cosmetics from claiming “medical skincare products” or “medicated cosmetics” [2].

    Current Conditions in E-commerce Platforms

    After the announcement was issued, searches for the keyword of “facial masks with certificates for medical devices (械字号面膜)” on e-commerce platforms such as Taobao, Suning, Red, etc., and related products have been blocked.

    Screenshots from Taobao, Suning, and Red

    However, searches for the keyword of “certificates for medical devices (械字号)”, medical dressings appeared still use “facial masks with certificates for medical devices (械字号面膜)” as product description.

    Screenshots from JD and Tmall

    Reasons for Illegal Claims

    1. Catering to consumers' emphasis on safety

    Claims such as “facial mask with certificate for medical device (械字号面膜)," "medical facial mask (医用面膜)," "medical beauty facial mask (医美面膜)” become popular in recent years. Brands advertise products using these claims to show that the product is safer, thus catering to consumers’ emphasis on safety.

    The awareness of medical dressings at the consumer level is not as high as that of facial masks. Enterprises use a facial mask to promote medical dressing to maximize sales. According to an expert on the new retail of fast-moving consumer goods [3], Bao Yuezhong, once the product is taken off the shelf because of illegal claims, brand image will be damaged, and the brand will face the risk of being banned from the market.

    2. Low cost of violation

    Lai Yang, executive vice president of the Beijing Business Economics Association, said in an interview with the Beijing Business Today that the fines are not worth mentioning compared to the benefits obtained from violations.

    This situation is expected to improve. On Jan 3, 2020, China State Council finally passed the Cosmetic Supervision and Administration Regulation [4]. The new regulation clarifies the responsibilities of cosmetics manufacturers and operators and increases punishments for illegal acts. Enterprises and individuals may be prohibited from entering the cosmetic industry for between 5 to 10 years if they seriously violate the regulations. The maximum fines may reach 5-20 times the value of products, much greater than the past.

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    ChemLinked Editor

    Tracking regulatory change news in Asia Pacific area and focusing on cosmetic ingredient requirements, registration/filing/notification procedures of China and South Korea.

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