1. Why is it necessary to formulate the "Toothpaste Supervision and Management Measures"?

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 under industry management by the former Ministry of Light Industry. In 2005, the former General Administration of Quality Supervision, Inspection and Quarantine 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 Industrial Product Production Licenses". In 2007, the "Cosmetics Labeling Management Regulations" (Order No. 100) issued by the former General Administration of Quality Supervision, Inspection and Quarantine included products for teeth into cosmetics. After the institutional reform in 2013, the former Food and Drug Administration unified the supervision functions of cosmetics and continued to issue cosmetics production licenses to toothpaste manufacturers, but did not include toothpaste products in cosmetics management.

On June 16, 2020, the State Council issued the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), which stipulates that toothpaste shall be managed with reference to the regulations on general cosmetics. After toothpaste filers conduct efficacy evaluations in accordance with national standards and industry standards, they can claim that toothpaste has the effects of preventing caries, inhibiting dental plaque, fighting dentin sensitivity, and alleviating gum problems. Specific management measures for toothpaste shall be formulated by NMPA and submitted to the Market Supervision and Administration Department of the State Council for review and release. In order to implement the provisions of the "Regulations", standardize toothpaste production and operation activities, strengthen toothpaste supervision and management, ensure toothpaste quality and safety, protect consumer health, and promote the healthy development of the toothpaste industry, the NMPA organized the completion of the "Toothpaste Supervision and Management Measures" (hereinafter referred to as the "Measures for the Supervision and Administration of Toothpaste"). "Measures") drafting work and submit it to the State Administration for Market Regulation for review and release according to procedures.

2. What are the main contents of the Measures?

25 articles in the "Measures" . The main contents include: First, clarify the definition of toothpaste and the regulatory authorities. Define toothpaste as a paste-like product that is applied to the surface of human teeth by friction, with the main purpose of cleaning ; clarify that the NMPA and the departments responsible for drug supervision and management at or above the county level are responsible for the supervision of toothpaste. The second is to clarify the management requirements for toothpaste and toothpaste raw materials. It stipulates that toothpaste should be subject to filing management, and new toothpaste raw materials should be registered or filed according to the degree of risk. The third is to continue to use the current toothpaste production licensing system and issue a cosmetics production license for toothpaste production. The fourth is to clarify toothpaste efficacy management and labeling requirements. It is required that the efficacy claims of toothpaste should have sufficient scientific basis, and the content that toothpaste should be labeled and prohibited from being labeled should be clarified.

3. What are the principles and ideas behind the drafting of the Measures?

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

First, strictly implement the “four most stringent” requirements. According to the relevant provisions of the "Regulations", "Toothpaste shall be managed with reference to the provisions of these Regulations on general cosmetics", the "Measures" set up a series of regulatory systems from the management of new raw materials of toothpaste, product filing, label claims, efficacy evaluation, etc., clarifying the law Responsibility and effectively safeguard consumers’ health rights and interests.

The second is the principle of highlighting key points. Judging from product characteristics and international regulatory experience, toothpaste and cosmetics have many commonalities in management. In order to improve the efficiency of supervision and highlight the key points of toothpaste supervision, the "Measures" mainly clarify the specific requirements for reference management of toothpaste, and make special management provisions for toothpaste filing management, registration and filing of new toothpaste raw materials, toothpaste production licenses, safety assessments, efficacy claims, etc. The "Measures" do not make repeated provisions regarding the consistent content of cosmetics management.

The third is to highlight the principle of problem orientation. The main problem currently existing in the toothpaste market is confusing efficacy claims. The "Measures" clearly define the boundaries of toothpaste, and at the same time strictly limit the terms used to claim the efficacy of toothpaste products such as preventing caries, inhibiting dental plaque, fighting dentin sensitivity, and reducing gum problems, in order to curb the occurrence of illegal toothpaste claims.

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

4. How does the Measures define toothpaste?

The "Measures" stipulate that toothpaste refers to a paste-like product that is applied to the surface of human teeth in a frictional manner with the main purpose of cleaning . This definition reiterates that the mode of action 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 "Measures" limit the material properties of toothpaste products, which must be "paste", which means that tooth powder, mouthwash and other oral care products are excluded.

Considering that oral hygiene and care products include a wide variety of products, in addition to tooth powder and mouthwash, there are also products such as oral antibacterial pastes with the " disinfection " brand (hygiene and disinfection category), and tooth removal products with the "mechanical" brand (medical device category). Sensitive gel and other products, "medicine" brand (pharmaceutical) butyl boron cream and other products. Among these products, those with relatively high safety risks need to be strictly supervised as drugs and medical devices, while those with relatively low safety risks can be managed as general industrial products. If the registration management is generally based on cosmetics, it is obviously not scientific and reasonable enough. Therefore, in accordance with 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" regarding toothpaste efficacy claims?

Relatively speaking, the efficacy claims on my country's toothpaste market are relatively confusing, with random claims such as "anti-inflammatory, analgesic, and hemostasis," "promoting teething in young children," "repairing cavities," "closing gaps between teeth," "stabilizing loose teeth," "regenerating teeth," and "treating Helicobacter pylori" cases are emerging one after another, and some claims have blurred boundaries with drugs and medical devices, seriously misleading consumers and causing great safety risks to consumers' health. In response to problems such as false and exaggerated claims, the Measures draw on the management experience of other countries (regions) and strengthen the management of efficacy claims by implementing the main responsibilities of enterprises and strengthening social co-governance. The "Measures" stipulate that the efficacy claims of toothpaste should have sufficient scientific basis. Toothpaste filers shall publish a summary of the literature, research data or product efficacy evaluation data on which the efficacy claims are based when filing, and accept social supervision. The efficacy claim evaluation of toothpaste should comply with laws, regulations, mandatory national standards, technical specifications and the quality, safety and efficacy claim evaluation stipulated by the NMPA.