From what aspects will the Measures for the Supervision and Administration of Toothpaste protect consumers’ rights and interests？ Interpretation of a text

First, why should we formulate the Measures for the Supervision and Administration of Toothpaste?

Toothpaste is not only a daily consumer product, but also a product closely related to people’s health. From the early days of the founding of New China to the 1990s, toothpaste was managed by the former Ministry of Light Industry. In 2005, the former General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) implemented production license management for toothpaste manufacturers and issued cosmetics production licenses in accordance with the Regulations of the People’s Republic of China on the Administration of Production Licenses for Industrial Products. In 2007, the former General Administration of Quality Supervision, Inspection and Quarantine issued the Regulations on the Management of Cosmetic Labeling (Order No.100), which included products used for teeth in cosmetics. After the institutional reform in 2013, the former Food and Drug Administration assumed the function of cosmetics supervision, and continued to issue cosmetics production licenses to toothpaste manufacturers, but toothpaste products were not included in cosmetics management.

On June 16th, 2020, the State Council issued the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations), which stipulated that toothpaste should be managed with reference to the regulations on ordinary cosmetics. After evaluating the efficacy of toothpaste according to national standards and industry standards, the filer can claim that toothpaste has the efficacy of preventing caries, inhibiting dental plaque, resisting dentin sensitivity and alleviating gum problems. The specific measures for the administration of toothpaste shall be formulated by the drug supervision and administration department of the State Council, and submitted to the market supervision and administration department of the State Council for review and release. In order to implement the Regulations, standardize the production and operation activities of toothpaste, strengthen the supervision and management of toothpaste, ensure the quality and safety of toothpaste, protect the health of consumers, and promote the healthy development of toothpaste industry, National Medical Products Administration organized the drafting of the Measures for the Supervision and Management of Toothpaste (hereinafter referred to as the Measures), and submitted it to the State Administration of Market Supervision for review and release according to procedures.

2. What are the main contents of the Measures?

The "Measures" consists of 25 articles, the main contents of which include: First, the definition of toothpaste and the regulatory authorities are clarified. Toothpaste is defined as a paste product that is applied to the surface of human teeth in a rubbing way with the main purpose of cleaning. It is clear that the departments responsible for drug supervision and administration in National Medical Products Administration and above the county level are responsible for toothpaste supervision. The second is to clarify the management requirements of toothpaste and toothpaste raw materials. It is stipulated that toothpaste should be put on record management, and new toothpaste raw materials should be registered or put on record management according to the degree of risk. Third, continue to use the current toothpaste production license system and issue cosmetics production licenses for toothpaste production. The fourth is to clarify the efficacy management and labeling requirements of toothpaste. It is required that the efficacy claim of toothpaste should have sufficient scientific basis, and the contents that toothpaste should be labeled and prohibited should be clearly defined.

3. What are the principles and ideas for drafting the Measures?

The drafting process of the Measures mainly follows the following principles and ideas:

First, strictly implement the "four strictest" requirements. According to the relevant provisions of the Regulations, "Toothpaste shall be managed according to the provisions of these Regulations on ordinary cosmetics", the Measures set up a series of supervision systems from the aspects of new raw material management, product filing, label declaration, efficacy evaluation, etc. of toothpaste, so as to clarify legal responsibilities and effectively safeguard consumers’ health rights and interests.

The second is the principle of highlighting key points. Judging from the product characteristics and international supervision experience, toothpaste and cosmetics have much in common in management. In order to improve the supervision efficiency and highlight the key points of toothpaste supervision, the Measures mainly specify the specific requirements of toothpaste reference management, and make special management provisions on toothpaste filing management, toothpaste new raw material registration and filing, toothpaste production license, safety assessment, efficacy declaration, etc. For the contents consistent with cosmetics management, the Measures do not make repeated provisions.

The third is to highlight the principle of problem orientation. The main problem in the current toothpaste market is the confusion of efficacy claims. The "Measures" clearly define the boundaries of toothpaste, and at the same time strictly restrict the claims of efficacy of toothpaste products, such as preventing caries, inhibiting dental plaque, resisting dentin sensitivity and alleviating gum problems, in order to curb the occurrence of illegal claims of toothpaste.

The fourth is to adhere to the working principle of striving for progress while maintaining stability. Considering that the filing management of toothpaste is the new requirement of the Regulations and Measures, the Measures intend to reduce the impact and impact on the industry by setting a reasonable transition period and following the existing national standards and industry standards.

4. What is the definition of toothpaste in the Measures?

The "Measures" stipulate that toothpaste refers to a paste-like product that is applied to the surface of human teeth by friction, with cleaning as the main purpose. This definition reaffirms that the action mode of toothpaste is auxiliary friction, the action site is the tooth surface, and the main purpose of use is cleaning, which is basically consistent with people’s daily understanding of toothpaste products. It can be seen from this definition that the material properties of toothpaste products are limited in the Measures, which must be "paste", which means that tooth powder, mouthwash and other oral care products are excluded.

Considering that oral cleaning and nursing products include a wide range of products, besides tooth powder and mouthwash, there are also products such as oral bacteriostatic cream with the name of Xiao (sanitary disinfection), tooth desensitizing gel with the name of Machinery (medical devices) and butyl boron cream with the name of Medicine (medicines). Among these products, those with relatively high safety risks need to be strictly supervised according to drugs and medical devices, while those with relatively low safety risks can be managed according to general industrial products. It is obviously not scientific and reasonable to refer to cosmetics for record management in general. Therefore, according to the system design of the Regulations, the Measures make the above provisions on the definition of toothpaste.

5. What is the management idea of the "Measures" on the efficacy claim of toothpaste?

Relatively speaking, the efficacy claims in China’s toothpaste market are confusing, and there are endless cases of claiming "anti-inflammatory, analgesic, hemostasis", "promoting children’s teething", "repairing tooth cavities", "stabilizing teeth loosening" and "regenerating teeth". Some claims are blurred with drugs and medical devices, which seriously mislead consumers and bring great security risks to their health. In order to solve the problems of false and exaggerated claims, the Measures learn from the management experience of other countries (regions), and strengthen the management of efficacy claims by implementing the main responsibility of enterprises and strengthening social co-governance. The "Measures" stipulate that the efficacy claims of toothpaste should have sufficient scientific basis. Toothpaste filers shall, at the time of filing, publish the abstracts of documents, research data or product efficacy evaluation data on which efficacy claims are based, and accept social supervision. The efficacy claim evaluation of toothpaste shall conform to the relevant requirements of laws, regulations, mandatory national standards, technical specifications and quality, safety and efficacy claim evaluation stipulated by National Medical Products Administration, so as to ensure the scientificity, accuracy and reliability of efficacy claim evaluation results.

(Headquarters CCTV reporter Yu Jingying)