With the rapid economic and social development and the increasing improvement of people’s living standards, people have a scientific knowledge of the subhealthy state of the body, in order to supplement dietary nutrients, maintain or improve the health of the body and reduce the risk of disease, a large number of food products with functional claims have emerged in the market.

At the same time, the “Healthy China 2030” program and other national policies and regulations to support the development of the health industry have been introduced one after another, and the objective need for food claiming functionality is also becoming increasingly apparent. However, China’s current laws and regulations have not yet clarified the concept and requirements of functional foods, which makes the scientific research, production and sales, market awareness and market supervision of functional foods unclear, especially not distinguishable from health foods with legal definitions, which will not only fail to promote the scientific and technological innovation of ordinary foods, but also impede the healthy development of the health food industry in the long run.

This study collects and organizes the relevant definitions and requirements of functional foods through official government documents, websites, academic journals and other authoritative media, compares the focuses of domestic and international research on functional foods using high-frequency keywords in visual analysis, differentiates them from the relevant requirements of health foods, refines the categories of functional foods in the market from the top-level design, and puts forward suggestions to better connect each category with the existing system. Suggestions.

In 2017, the Guiding Opinions on Promoting the Healthy Development of the Food Industry, jointly issued by the National Development and Reform Commission (NDRC) and the Ministry of Industry and Information Technology (MIIT), pointed out that it is necessary to carry out the evaluation of the health efficacy of food products, accelerate the development of infant formula food, food for the elderly, and functional food that meets the needs of specific populations, and support the development of health food products for the maintenance of health and the research and development of health and wellness products such as functional proteins, functional dietary fibers, functional glycogen, functional fats and oils, probiotics, and bioactive peptides. , bioactive peptides and other health and wellness foods, and carry out application demonstrations [1].

Since then, functional food research has entered a period of rapid development, universities and research institutions and other subjects have increased research efforts, greatly promoting the domestic nutritional functional food production technology and development and research level. Data show that in 2020, China’s functional food consumption market value of more than 270 billion yuan, from 2018 to 2020, the industry growth rate of more than 15% [2], and then attracted by the news media and the capital market is a greater concern, a large number of functional food startups flooded the market between 2020 and 2021, which shows that China’s functional food industry has a broad prospect for development.

In China, functional food is often mentioned together with health food, and the quiet rise of the functional food industry is often interpreted as the rapid development of the health food industry, but in fact, according to the existing domestic laws and regulations, health food has a clear legal status, and as a special food in the function claim, product promotion [3] and product marketing [4] before the efficacy of the review and so on, there are clear rules and regulations, and functional food in the domestic market has not yet been a major problem. Functional foods have not yet had a clear legal definition in China, and their regulation is still categorized as ordinary foods. The main purpose of this paper is to comprehensively organize and summarize the concept of functional food at home and abroad from the transmutation process of the concept of functional food, to explore the chaos of the definition of functional food in our country as well as to learn from the successful experience of foreign countries, to analyze the similarities and differences with health food, to understand functional food more thoroughly and to connect functional food with the existing regulations and systems, to help the functional and nutritional food industry and to promote the healthy development of the market.

Functional Foods at Home and Abroad
Definition and Legal Positioning

Concept is a rational understanding of the essential attributes of things, no concept means no thinking, using the concept of reasoning and judgment to achieve a rational determination and objective understanding of a thing [5].

1.Definition of Functional Food in China
By reviewing and combing the functional food literature and webpage word definitions, this study organizes the domestic definition of functional food as in Table 1.

From Table 1, it can be found that the domestic references to the definition of functional food are mainly categorized into four major groups.

In addition, from the perspective of academic research, Functional Foods and Chinese Medicinal Diets, edited by Lu Weihong, makes it clear that functional foods are a class of foods with special health care functions, which, in addition to providing sufficient nutrition, can have beneficial effects on the human body, and have a function that is not present in general foods or is not emphasized, i.e., the function of regulating the physiological activities of the human body. Functional foods are suitable for both specific groups of people and healthy people. Functional food has the function of regulating the organism and does not cause any acute, sub-acute or chronic harm to the human body, and is not intended for therapeutic purposes. It covers a number of food categories such as health food, infant formula milk powder, formula food for special medical purposes, other special dietary foods, and ordinary food with certain functionality such as (enhancement of human physique, prevention of diseases, regulation of body rhythms, restoration of health, and delay of aging) [18].

Functional Food Design and Evaluation, edited by Bai Xinpeng, makes it clear that functional foods have the following characteristics: First, there is no clear legal definition, no functional claims, no health effects expressed or implied, and no registration or filing is required before the product is put on the market. Secondly, it is suitable for people without diseases (except minors, pregnant women and lactating women) to supplement certain nutrients scientifically based on their own needs. Third, functional food is essentially food, not a tablet, capsule or any other form of dietary supplements. Fourth, in addition to providing adequate nutrients, they also produce beneficial effects on body functions, as evidenced by an improved state of health and well-being, or a reduced risk of disease. Fifth, as part of daily food consumption, functional food forms are more snackable and conveniently ready-to-eat, which are both efficacious while satisfying consumers’ palate and conveniently ready-to-eat [19].

It can be seen that functional foods currently have no clear official definition and legal status in China, and its positioning has not yet reached a consensus. Some researchers believe that functional foods are ordinary foods, which are regulated according to ordinary foods and do not need to be registered or filed before the products are marketed, and they are not allowed to make functional claims.

Some researchers believe that functional foods include special foods and some ordinary foods specified in the Food Safety Law of the People’s Republic of China (hereinafter referred to as “Food Safety Law”). After reviewing the literature, the author summarizes that the concept of functional food has the following characteristics: specially designed and specially processed for the purpose of nutrition and health, with the content or activity of functional factors significantly higher than that of ordinary food, and there is scientific evidence proving that it has the efficacy of benefiting health, does not aim at treating diseases, and does not produce any acute, subacute or chronic hazards to the human body.

2. Definition of Functional Foods in Foreign Countries

Glenn R. Gibson and Christine M. Williams, editors of “Functional Foods” clearly pointed out that functional food is a concept rather than a clear definition of food, is an important way to improve physical fitness and nutritional intervention for chronic diseases [20].

In the 1970s, the concept of “functional food” was first proposed by Japanese officials and gradually introduced to Europe [21,22], which is defined as food with functional factors related to biological defense, adjustment of biological rhythms, prevention and treatment of diseases, and restoration of health, etc., and is designed and processed to have a significant adjustment of the function of the organism, and the brand-new concept has provided a new opportunity for the Japanese food industry and related laws and regulations to improve health. The new concept brought a lot of development opportunities for the Japanese food industry and related laws and regulations.

Influenced by Japan, New Zealand issued the Dietary Supplement Regulation in 1985, which stipulates that functional foods in the country include three kinds of dietary supplements, complementary foods, and some ordinary foods with health claims [23].

In 1998, the European Union established the Functional Food Science Association (FUFOSE), which provides a good institutional support for the development of functional foods [24,25]. In 2009, the American Dietetic Association described functional foods as “foods with potential health benefits that are part of a consumer’s daily diet, including whole foods and foods fortified, enriched, or enhanced with biologically active ingredients”. foods that contain fortified, enriched, or enhanced bioactive ingredients” [26].

Comparison shows that different countries do not have the same perception of functional foods, and the main differences between functional foods and ordinary foods and pharmaceuticals in the “general sense” are, firstly, whether the products are designed and processed in a special way to enhance their functionality, secondly, whether they are able to prevent, diagnose, or treat diseases, thirdly, the different groups of people who are suitable for them, fourthly, the differences in presentation and morphology, and fifthly, how to carry out the functionality of the foods. The fifth is how the functionality claims are made. There are also some differences in the relevant regulatory legislation of different countries.

Similarities and Differences in Domestic and International Research on Functional Foods

The keywords extracted by summarizing and condensing the articles can fully reflect the content and value of the study, and at the same time, high-frequency keywords are usually regarded as pointers to the hot issues of research in a certain field [27].

In order to explore the similarities and differences of the research status and hotspots of functional foods at home and abroad, this study uses cite space software to visualize and analyze the keywords of the literature. Web of science database was selected for foreign studies, and “Functional food” and “Nutraceutical” were used as the keywords to search for all the review articles, and a total of 1769 valid articles were included after selection and deletion.

In the domestic research, China Knowledge Network database was selected as the platform, and “functional food” was used as the keyword to search, and the core journals of Beida were selected, and a total of 385 effective documents were obtained after screening.

The results of analyzing the number of publications show that the number of publications at home and abroad, although fluctuating, is on the rise, and the field of functional foods is attracting more and more teams to conduct research.

Analyzing the results of high-frequency keywords, the top ten keywords that appear in the domestic and foreign functional food literature are shown in Table 2.

It can be seen that foreign research on functional foods mainly focuses on oxidative stress [28], biological activity [29], chemical composition [30], and experimental methods, while domestic research mainly focuses on the processing technology, raw materials, mechanism of action, and active ingredients of functional foods [31].

In general, the domestic functional food research focuses on the specific functions of food or its ingredients, and the research results can be easily demonstrated through the nutritional labels in food labels, which can achieve the purpose of enhancing the added value of products. Compared with domestic research, foreign research is more macroscopic [32], and has more mature and advanced experience in the cognitive attitude and management of functional foods.

Requirements of health food and
Differences with Functional Foods

1. Definition of health food

Health food refers to food that claims and has specific health care functions or aims to supplement vitamins and minerals, i.e., food that is suitable for consumption by a specific group of people, has the ability to regulate the functions of the organism, does not aim at treating diseases, and does not produce any acute, subacute or chronic hazards to the human body [33].

Chapter IV, Section 4 of the Food Safety Law categorizes health food, food formulated for special medical purposes and infant formula as special food and implements strict supervision and management [34].

Article 38 of the Regulations for the Implementation of the Food Safety Law stipulates that food other than health food shall not be claimed to have health functions [35].

In order to better meet the development of the health food industry with strong momentum, the health food regulatory authorities have issued the Measures for the Administration of Registration and Filing of Health Food, which makes strict provisions on the production registration of health food, functional claims, raw material management, etc., so as to make the positioning of health food clearer [36].

2. Regulatory Requirements of Health Food

From the product access point of view, China’s health food to take the registration and record “dual-track” management approach [37], that is, the use of raw materials other than health food raw material catalog of health food and health food imported for the first time (belonging to the supplementation of vitamins, minerals and other nutrients other than health food) using registration management. Health food products whose raw materials have been listed in the catalog of health food raw materials and health food products imported for the first time that are supplemental vitamins, minerals and other nutrients only need to be filed for the record before they can be listed on the market.

From the raw materials of the products, on the one hand, China’s health food has established a health food raw material catalog, raw material directory is actually a bridge for product access, the use of raw materials within the directory of raw materials of the products in the access link can reduce the procedure; on the other hand, health food can use the raw materials and ordinary food can use the raw material range is not the same, in addition to ordinary food can use the raw materials, the former Ministry of Health in 2002 issued the “Ministry of Health on the Notice on Further Standardizing the Management of Health Food Raw Materials”[38] , which contains the “List of Items that can be Used for Health Food” and the “List of Items Prohibited for Health Food”, especially the “List of Items that can be Used for Health Food” can only be used for health food.

In terms of product claims, health food claims health functions, while other food products may not claim health functions. At this stage, China has accepted and approved a total of 27 kinds of health care functions, and at the same time, the Implementing Rules for Technical Evaluation of New Functions of Health Food Products (Trial) (Draft for Public Comments) has been issued for public consultation, of which Article 6 specifies that the new functions are clearly categorized into three types: supplementing dietary nutrients, maintaining or improving the health of the organism, and lowering the risk factors for the occurrence of diseases. From this, it can be speculated that health food may subsequently achieve the purpose of product classification and supervision through the claimed classification and management.

3. Consumers’ Concerns and Perceptions of Functional Foods and Health Foods

Through Baidu index search “functional food” and “health food”, the time span is from January 1, 2011 to September 9, 2022, and the results are shown in Figure 1, from which it can be seen that the fluctuation amplitude of the search volume of functional food and health food shows the same trend. The results are shown in Figure 1. Among them, after the release of the Measures for the Administration of Health Food Registration and Filing in 2016, there was an obvious surge in the web search index of “health food”.

It can be seen that consumers pay the same attention to “functional food” and “health food”, which further indicates that consumers are interested in “functional food” and “health food”. This further suggests that consumers may not be aware of the similarities and differences between “functional food” and “health food”.

The General Standard for Health (Functional) Foods, released in 1997, was the first standard in China to regulate health (functional) foods, and its provisions are deeply embedded in the public’s cognition. It is not difficult to see from the standard that health foods and functional foods are equivalent to each other and interchangeable, which may be one of the reasons why the concepts of the two remain confusing to this day. Subsequently, the name of the standard was modified in the 2014 edition of the National Standard for Food Safety Health Food [39], which excluded functional foods and retained only health foods. From this, it can be seen that “functional food” and “health food” are not the same concepts in the national documents, and the public gradually realized the difference between the two, but the general cognition has not been formed, and the phenomenon of confusing the concepts of the two still exists.

By sorting out the requirements related to health food, it can be seen that ordinary food, functional food and health food have the following differences (Table 3): analyzed from the regulatory perspective, the positioning, production and sales of health food and the regulatory requirements are clear, while functional food is still an ordinary food in nature, regulated according to ordinary food, and does not need to be registered or filed prior to the market launch of the product, and is not allowed to carry out the product’s functional claims. From the perspective of scientific research, health food focuses on standardized research on safe and controllable health food ingredients based on existing mature science and technology to ensure the safety and efficacy of the final product. Functional food focuses on the development of new products, discovery of new substances and research on new functions based on advanced science and technology, with emphasis on the landing of scientific and technological innovation technology.

Policy Suggestions for Promoting the Orderly Development of Functional Food Industry

Through the above analysis and research, it can be seen that the market demand for functional foods is increasing day by day, but the definition, legal status and market positioning of related products have not yet been clarified, resulting in the industry’s development goals being unclear and paths being impassable. Based on the fact that functional food is a concept and not a class of specific products, it would be beneficial for the quality development of the food industry to connect functional food with the categories in the current food classification, and at the same time, to make clear the path of scientific claims of various types of food.

1. Clarify the positioning of functional foods and ensure that scientific and technological research and development can help safety supervision.

According to the “Guiding Opinions on Promoting the Healthy Development of the Food Industry” jointly issued by the National Development and Reform Commission and the Ministry of Industry and Information Technology on the relevant provisions of functional foods, functional foods are foods with health care and health functions, in which the health care function focuses on the legal attributes (i.e., the legal terminology), and the Food Safety Law and its Implementing Regulations make it clear that, “health food claiming health care functions shall have a scientific basis and shall not produce any health effects on the human body. The Food Safety Law and its implementing regulations make it clear that “health food claiming health function shall have scientific basis and shall not cause acute, subacute or chronic harm to human body” and “food other than health food shall not be claimed to have health function”, and food with health function belongs to the category of health food in special food.

Health function focuses on scientific attributes (i.e. scientific terminology), i.e. the function of supporting health through scientific confirmation, and its scope is wider than that of health function. Foods with health function have a wide range, and according to the “General Rules for the Labeling of Prepackaged Foods” (GB7718-2011), China’s pre-packaged foods can make nutritional claims and nutritional function claims on the ingredients of the products. Therefore, according to the provisions of the current regulatory system, functional foods can theoretically be divided into two categories: health foods that can make claims on products and ordinary foods that can make claims on product ingredients [40,41]. It is suggested that according to the conclusions of scientific research, the object of functional expression (ingredients or the product itself) should be determined, and different directions of product research and development should be selected to ensure that scientific research and technological innovations are landed at the same time technologies are developed to guarantee the high-quality development of the functional food industry.

2. Improve the claim of nutritional properties of food and distinguish between ordinary food and special food.
In order to ensure that the functional claims of functional foods can be accurate and scientific, it is recommended that the administrative departments involved in food claims do a good job in top-level design, uniformly promote the formulation and revision of systems and standards related to food claims, form a synergy and reach a consensus, smooth, supplement and update the channels of nutrient function claims, standardize the terminology of nutrient function claims, and guarantee that ordinary foods can make standardized nutrient function claims under the support of scientific evidence. The standardization of the terms used in the functional claims of nutritional ingredients should be realized, so as to ensure that ordinary foods can make standardized functional claims of nutritional ingredients under the support of scientific evidence.

At the same time, utilizing the opportunity of unimpeded access to new functions of health foods, health foods are managed in a hierarchical manner, with health functions classified into three categories, namely, supplementing dietary nutrients, maintaining or improving the health status of the organism, and reducing the risk of occurrence of diseases, and the threshold of entry for products claiming to supplement dietary nutrients and maintain or improve the health status of the organism is also simplified. Therefore, functional foods involving the above three categories enter the market by applying for health food, while other functional claims achieve the effect of scientific and technological innovation through the smooth functional claims of nutrients [42].

In addition, for some of the substances that can be directly sold as products and can be used as functional raw materials (such as jujube, buckwheat, etc.), in order to avoid the problem of claiming difficulties after the entry of relevant products into the market, it is recommended that, on the basis of optimizing the formulation and revision of the catalog of health food ingredients, we should increase the study of the quantitative and qualitative effect relationship between the relevant raw materials, and actively promote the incorporation of the relevant substances into the catalog of health food ingredients, so as to break through the institutional barriers to the scientific claims for the relevant products in the following period. Open up the institutional barriers for the subsequent scientific claims of related products.

3. Conduct scientific research to improve the scientificity of functional potency.
Functional food is a comprehensive field covering food science, medicine and biochemistry [43]. Functional foods are generally categorized into foods that naturally contain bioactive ingredients and foods that contain enhanced, enriched or purified bioactive ingredients.

The core of functional foods is functional factors such as bioactive ingredients and their effects. The content and efficacy of functional factors vary significantly depending on the individual, batch, geography, environment, genetics, etc. [44], and the stability and structure of different functional factors are different, and the mechanism of action also varies [45].

It is necessary to strengthen the research on the quantity-effect relationship of efficacy factors, and study the correlation between beneficial functional factors and active nutrients in functional foods and human health. Improve the functional evaluation indexes and evaluation standards, and endeavor to construct a quantitative-effect relationship covering functional factors-functions-population through scientific literature, animal experiments and human trial food.

4. Compacting the main responsibility of enterprises and promoting the standardized development of the food industry
In addition to the quality and safety of functional foods, nutritional safety is also a key concern. At this stage, there are bad operators false propaganda, exaggerated propaganda phenomenon, misleading consumers to buy products, and ultimately unbalanced nutritional intake affects health.

First of all, enterprises should be clear about their responsibilities, the production of food enterprises should be the health of the general public as the primary criterion [46], to have a sense of corporate responsibility to the community and the public, and to establish a good and upward corporate philosophy. Enterprises should actively and consciously assume the legal responsibility for their own product positioning, product publicity in strict compliance with the relevant provisions, to avoid the phenomenon of exaggerated publicity. At the same time need to implement the responsibility of production safety, strengthen the prevention and control of risk, the establishment of a precise traceability system, so that there is a source to be found, there is a responsibility to be traced.

Secondly, internal personnel training should be strengthened, so that the production, quality control, sales and other aspects of the product accurate positioning. Among them, the sales staff directly contact with consumers, has a guiding role in consumer intentions, and most sales staff do not have a relatively rich knowledge base or good academic qualifications, the cognition of functional food mainly comes from the information conveyed by the enterprise, so the professional training of the sales link is particularly important.

Finally, when the enterprise goods and publicity content does not match the situation, should actively respond to the rectification, to the public to clarify the reasons for the problem and the measures to solve it, to achieve transparency of information, to reduce the barriers to communication with consumers, and timely modification of publicity errors and loopholes. Only by being honest and seeking truth in their product publicity, enterprises can continue to improve their competitiveness, and the industry can ultimately develop in an orderly and healthy manner.

5. Enhance the publicity of food safety science, improve consumer awareness level
As the direct audience of the product, consumers should have a scientific and objective understanding of the goods they buy. The government can increase the efforts to promote functional food safety publicity, such as organizing regular food safety campaigns in grassroots communities or villages and towns [47], using new media publicity channels, producing functional foods, popular science articles, videos, etc., and striving to achieve universal popularization and universal participation, so as to enhance the general public’s cognition of functional foods, in particular, to make clear the positioning of functional foods as well as their differences with health foods. In particular, the positioning of functional foods and their difference from health foods should be clarified.

Social organizations, such as consumer associations, should also increase the popularization of knowledge on consumer rights protection, so that consumers can strengthen the protection of their rights and interests. Enterprise publicity can learn from the advanced experience of Japan [48], Japan has outstanding achievements in publicizing health knowledge, and many Japanese magazines focus on proposing that daily good behavioral habits have a non-negligible role in health [49], China can adapt to the current situation, and under the background of the rapid development of new media, functional food enterprises can combine the successful experience of Japan in popularization of science and make innovations, and launch accurate advertisements on the Internet and social software as platforms. Social software as a platform for the launch of accurate advertising, but also focus on popularizing and disseminating health concepts to the public, so that the concept of “prevention of disease is far more effective than treatment” in-depth consumer awareness, so that the consumer groups have a correct knowledge of functional food at the same time, to spontaneously and actively rationally choose functional products [ 50]. 50].

The development of functional foods in China is later than that of Japan and other countries, and the communication cost with consumers is also greater [51], but it is believed that through the joint efforts of the above subjects and channels, the ability of Chinese consumers to identify functional foods will be gradually improved.

In this paper, by combing the definition of functional food at home and abroad and comparing the current status of functional food research at home and abroad, we discuss the suggestions for the chaos that occurs in China due to the ambiguity of the definition and draw on the successful experience of foreign countries. The concepts and theories of functional foods still need to be continuously improved, and the professional development and in-depth research of the functional food industry need to be guided by legally clear and accurate concepts. Therefore, more scholars are expected to develop and enrich the concept of functional foods in the future research in this field, so as to finally form a complete definition of the connotation as well as precise research boundaries.