History And Development Of “One Root Of Medicine And Food Ⅲ

Feb 18, 2025

4. The Current State, Issues, and Countermeasures of the "Unity of Medicine and Food"

Throughout history, dual-purpose substances for both medicine and food have primarily been applied in food therapy and nutritional maintenance, with the latter reflecting modern health preservation concepts. With the increasing focus on health today, functional foods with benefits for nourishment and disease prevention have gained popularity, further promoting the development of the health food industry. Many traditional dual-purpose substances possess health benefits. Moreover, the concept of "dual-purpose for medicine and food" has historically been highly valued, and regulatory authorities have issued lists of "items classified as both food and medicine" to standardize this category.

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4.1 Modern Definitions of Dual-Purpose Substances for Medicine and Food

Ancient understandings of the "unity of medicine and food" reflect four primary characteristics and functions of food: safety, nutrition, health benefits, and therapeutic effects. These characteristics represent both the commonalities and distinctions between food and medicine. While there is a traditional overlap between food and medicine, for safety and health considerations, clear definitions are necessary. Modern legal standards have explicitly delineated the boundaries between food and medicine. Due to the health benefits of certain substances, a new category of health foods has emerged. "Dual-purpose substances for medicine and food" are widely used in history and folk traditions, and regulatory authorities have defined these substances as "dual-purpose substances traditionally classified as both food and medicine" (hereinafter referred to as "dual-purpose substances").

The revised Drug Administration Law of the People's Republic of China (2009) defines drugs as substances intended for the prevention, treatment, or diagnosis of human diseases, or for the purposeful regulation of physiological functions. Drugs must have indications or therapeutic claims, along with specified usage and dosage. The law encompasses categories such as Chinese medicinal materials, Chinese herbal decoctions, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radiopharmaceuticals, serums, vaccines, blood products, and diagnostic drugs. This definition emphasizes that the primary purposes of drugs are disease prevention and treatment, including traditional Chinese medicinal categories.

The Food Safety Law of the People's Republic of China (2009) defines food as all finished products and raw materials intended for human consumption or drinking, including traditional dual-purpose substances classified as both food and medicine. However, items intended solely for therapeutic purposes are excluded. This definition encompasses two aspects:

Ordinary food, which is suitable for consumption.

Dual-purpose substances for medicine and food, which lie at the intersection of food and medicine.

In 2014, the National Health and Family Planning Commission (NHFPC) issued the Management Measures for Substances Traditionally Classified as Both Food and Medicinal Materials (Draft for Comments). This document renamed "dual-purpose substances traditionally classified as food and medicine" to "substances traditionally classified as both food and Chinese medicinal materials." It defined them as substances with a traditional history of consumption that are listed in national standards for Chinese medicinal materials, such as the Pharmacopoeia of the People's Republic of China and related standards. These substances include edible parts of animals and plants, such as food ingredients, spices, and seasonings.

The Ministry of Health issued the "List of Substances Classified as Both Food and Medicine" in 2002, identifying 87 items, all derived from traditional Chinese medicinal materials and widely applied in traditional practices.


The "List of Substances Classified as Both Food and Medicine" reflects the food therapy concept within the traditional "unity of medicine and food" approach. In contrast, health foods represent the nutritional maintenance aspect of this concept. In 2002, the Ministry of Health issued the Notice on Further Standardizing the Management of Ingredients for Health Foods, which included a List of Substances Permitted for Use in Health Foods. Most of the items on this list were derived from Chinese medicinal materials.

In 2005, the Administrative Measures for the Registration of Health Foods (Trial) defined health foods as foods that claim to have specific health benefits or aim to supplement vitamins and minerals. These foods are suitable for specific groups of people, regulate bodily functions, are not intended for disease treatment, and do not cause acute, subacute, or chronic harm to the human body. The regulation emphasizes that health foods must be safe and targeted toward specific populations.

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4.2 The Issuance of the "List of Dual-Purpose Substances for Medicine and Food" and Existing Issues

The latest version of the "List of Substances Traditionally Classified as Both Food and Medicine" was issued in 2002, over a decade ago. Since then, a series of issues have arisen. The following analysis of the background and current state of the list aims to provide a reference for future revisions.

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4.2.1 Issuance Background and Context

The original Ministry of Health issued the "List of Substances Traditionally Classified as Both Food and Medicine" to regulate the safety of food and health food. In recent years, with improving living standards, chronic diseases and suboptimal health conditions have become major concerns for public health. People's growing interest in health preservation and wellness has driven the development of the health food industry, but it has also led to some problems.

For example, some food companies arbitrarily add Chinese medicinal materials to their products and claim health benefits. To address this, the Ministry of Health issued the "Administrative Measures on Prohibiting the Addition of Drugs to Food" in 1987, which stipulated that drugs must not be added to food. However, substances traditionally classified as both food and medicine, when used as raw materials or seasonings, were exceptions to this rule. At the same time, the Ministry of Health published the first batch of "Substances Traditionally Classified as Both Food and Medicine", which included 33 substances.

This decision was based on traditional Chinese practices, recognizing that some medicinal substances are also foods. When such substances are added to food, they should not be classified as drugs but as food ingredients.

With the development of the health food industry, the Ministry of Health issued the "Administrative Measures for Health Food" in 1996, which legally defined the raw materials that could be used in health foods. In 2002, the Ministry of Health issued the "Notice on Further Regulating the Management of Health Food Raw Materials" (Document No. 51 of 2002), also known as "Document 51." This document included updated versions of:

The "List of Substances Traditionally Classified as Both Food and Medicine,"

The "List of Substances Permitted for Use in Health Foods," and

The "List of Prohibited Substances in Health Foods."

 

4.2.2 Issues with the "List of Dual-Purpose Substances for Medicine and Food"

The Document 51 list included 87 substances, but it provided only a list of substances without specific guidelines or limitations, which has led to several issues.

(1) Source Issues

The original list did not specify the sources or Latin names of the substances, which has caused confusion due to the common phenomenon of "same name, different substances" in Chinese medicine.

For example, the list includes "Dan Zhu Ye" (淡竹叶). However, in practice, there are two interpretations:

The "Dan Zhu Ye" recorded in the Pharmacopoeia of the People's Republic of China, which refers to the dried stems and leaves of the plant Lophatherum gracile Brongn. (family Poaceae) [20].

Alternatively, it could refer to the leaves of Phyllostachys glauca McClure (family Poaceae), which are historically also considered a source of Dan Zhu Ye.

These two interpretations represent different plant sources, both of which have historically been referred to as Dan Zhu Ye.

(2) Multiple Sources

Certain substances on the list, such as almonds (Xing Ren) and jujubes (Zao), have multiple sources:

Almonds include both bitter almonds and sweet almonds.

Jujubes include red dates (Da Zao), wild jujubes (Suan Zao), and black dates (Hei Zao).

As medicinal substances, their sources are clearly defined in the Pharmacopoeia of the People's Republic of China. However, when these substances are classified as foods, what standard should their sources follow?

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For example:

Almonds have bitter and sweet varieties. The 2010 edition of the Pharmacopoeia of the People's Republic of China only includes bitter almonds, sourced from the dried mature seeds of plants such as Prunus armeniaca L. var. ansu Maxim., P. sibirica L., P. mandshurica (Maxim.) Koehne, or P. armeniaca L. [20].

According to the Comprehensive Dictionary of Chinese Medicine, sweet almonds are derived from the sweet-tasting seeds of cultivated varieties of Prunus armeniaca L. or P. armeniaca L. var. ansu Maxim. [21].

While bitter almonds and sweet almonds share overlapping sources, sweet almonds, being a sweet-tasting cultivated variety, are not included in the Pharmacopoeia.

From a historical perspective, bitter almonds have long been used medicinally, and they are considered toxic. For instance:

The Prescriptions Worth a Thousand Gold mentions that bitter almonds are toxic and should not be consumed long-term, as they can cause blindness [12].

The Proper and Essential Diet Principles states that bitter almonds are toxic and primarily used to treat cough and asthma [14].

The Dietary Manual of Sui Xi Ju notes that bitter almonds should not be consumed as food due to their toxicity [22].

Modern pharmacological research has shown that the toxic component of almonds is amygdalin, which can release highly toxic hydrocyanic acid under enzymatic or acidic conditions. Bitter almonds have a higher amygdalin content, while sweet almonds contain relatively little. This may explain why bitter almonds have traditionally been considered toxic and unsuitable for long-term consumption.

Thus, the classification of bitter almonds as a "dual-purpose substance" is controversial. Sweet almonds, on the other hand, have a history of culinary use but still require further safety studies to support their use.

 

(3) Issues with Parts Used

For some substances, the medicinal parts and edible parts may not be consistent. For example, the list includes Zhijuzi (枳椇子), which is recorded in the Chinese Materia Medica as the seeds of Hovenia dulcis Thunb., H. acerba L., and H. trichocarpa Chun et Tsiang, all species in the family Rhamnaceae [25]. However, historical research indicates that the edible parts of Hovenia are primarily the fleshy, swollen fruit peduncles (commonly called "gai jiao" or "Chinese raisins"), as well as the leaves and stems, but not the seeds. This makes it particularly important to clarify the edible parts of substances.


(4) Issues with Varieties

As with drugs, the cultivation of food crops can lead to the development of different genotypes, which may influence the distinction between edible and medicinal uses. For instance, the Pharmacopoeia of the People's Republic of China specifies that chrysanthemum (菊花) refers to the dried flower heads of Chrysanthemum morifolium Ramat., a species of the Asteraceae family [20]. However, in practice, chrysanthemum is further classified based on production areas and processing methods into types such as Hangju, Boju, Chuju, and Gongju.

These varieties can, in turn, be categorized into three groups:

Chrysanthemum primarily used for medicinal purposes (e.g., Boju, Chuju),

Chrysanthemum primarily used for tea beverages (e.g., Gongju),

Chrysanthemum that is both medicinal and edible (e.g., Hangbaiju).

Although these all belong to the same species, differences in cultivated strains lead to significant variations in their actual uses. This raises the question of whether the edible varieties of chrysanthemum need to be specified in the list and whether the Latin names should be restricted to cultivated variants.


(5) Issues with Usage Restrictions

Throughout history, materia medica, particularly food-related materia medica, has imposed strict restrictions on the use of dual-purpose medicinal materials, including timing, origin, preparation methods, dosage, and pregnancy contraindications. Since even ordinary foods require attention to healthy consumption, the limitations on the consumption of dual-purpose substances, such as contraindications, usage methods, and the need for related safety studies, are particularly critical.


(6) Issues with Updating Standards

Standards such as the Pharmacopoeia of the People's Republic of China are updated periodically, resulting in changes to the descriptions of certain substances. However, the "List of Dual-Purpose Substances for Medicine and Food" has not been updated to reflect these changes, creating a disconnect. To address this, it is necessary to revise the list.

For example:

Shanyinhua (Mountain Honeysuckle)
The 2002 list of dual-purpose substances was based on the 2000 edition of the Pharmacopoeia of the People's Republic of China, which listed honeysuckle (金银花) as derived from Lonicera japonica Thunb., L. hypoglauca Miq., L. confuse DC., and L. dasystyla Rehd. [26]. At the time, honeysuckle and mountain honeysuckle (山银花) were not differentiated. However, the 2005 edition of the Pharmacopoeia listed mountain honeysuckle as a separate entry [27]. Based on the current pharmacopoeia standards, the inclusion of mountain honeysuckle as a dual-purpose substance may need to be reconsidered.

Pueraria (Kudzu Root)
Similarly, the 2000 edition of the Pharmacopoeia of the People's Republic of China listed kudzu root (Ge Gen) as derived from Pueraria lobata (Willd.) Ohwi and P. thomsonii Benth. [26]. However, the 2005 edition of the Pharmacopoeia separated P. thomsonii Benth. as the source of Fen Ge (粉葛), treating it as a distinct variety [27]. Based on the current pharmacopoeia standards, Fen Ge should be considered for inclusion as a separate item in the list of dual-purpose substances.

 

4.3 Issues with the Revision of Dual-Purpose Substances for Medicine and Food

China's materia medica records a significant number of dual-purpose medicinal and edible Chinese herbal materials, but the officially approved list includes fewer than 100 items. This reflects respect for traditional applications while prioritizing safety and health considerations. As research advances and health needs evolve, it is reasonable to gradually include new varieties, which also highlights the openness of the dual-purpose substance category. However, the issuance of the original list has also brought about a series of problems, making revisions necessary. For this reason, the Food Safety Comprehensive Coordination and Health Supervision Bureau of the former Ministry of Health began conducting related revision work in 2011.

The National Health and Family Planning Commission (NHFPC) has addressed connectivity issues in its publication of the "List of Dual-Purpose Substances for Medicine and Food," such as its connection with "Novel Food Ingredients."


Novel Food Ingredients and Their Relationship with Dual-Purpose Substances

The concept of "Novel Food Ingredients" emerged in China in the 1990s, but it was not until 2007 that the Ministry of Health implemented the Administrative Measures for Novel Food Ingredients to define this category. In 2013, the Administrative Measures for the Safety Review of Novel Food Ingredients replaced the term "Novel Food Ingredients" with "New Food Raw Materials" and defined it as follows:

Animals, plants, and microorganisms not traditionally consumed in China.

Components extracted from animals, plants, and microorganisms.

Food components with significantly altered original structures.

Other newly developed food raw materials.

In 2014, the NHFPC emphasized in the Draft Management Measures for Substances Traditionally Classified as Both Food and Chinese Medicinal Materials that substances not included in the list must undergo safety evaluations and approval in accordance with the Administrative Measures for the Safety Review of New Food Raw Materials before being developed as food ingredients.

Additionally, in 2014, the NHFPC issued an explanation titled "Clarification on Issues Related to New Food Raw Materials, Ordinary Foods, and Health Foods", which stated that items listed in the 2002 "List of Substances Permitted for Use in Health Foods" cannot be used as raw materials for ordinary food production and sales. If an item in the health food list is to be developed for ordinary food production, it must first be approved through the procedures outlined in the Administrative Measures for the Safety Review of New Food Raw Materials.


Implications for the Revision of Dual-Purpose Substances

The above regulations demonstrate that the NHFPC has established "New Food Raw Materials" as a gateway for Chinese medicinal materials to enter the food sector. For example, many items in the "List of Substances Permitted for Use in Health Foods" are medicinal materials recorded in the Pharmacopoeia, and some have been historically classified as dual-purpose substances. However, to include them in the "List of Dual-Purpose Substances for Medicine and Food," they must first undergo safety evaluations and approvals according to the Administrative Measures for the Safety Review of New Food Raw Materials. If deemed safe, they may be selectively added to the list.

Since 2008, several Chinese medicinal materials have been approved as new food raw materials, such as Prunella vulgaris (self-heal), artificially cultivated ginseng, and Clerodendrum cyrtophyllum leaves.

Case Study: Ginseng

Ginseng was included in the 2002 "List of Substances Permitted for Use in Health Foods".

In 2012, it was approved as a new food raw material, with specifications that it must be artificially cultivated, grown for no more than five years, and meet strict safety requirements [28].

Ginseng, which is recorded in the Pharmacopoeia as a medicinal material and is also used in health foods, was classified as a new food raw material because it fulfilled the criteria for dual-purpose substances.

In 2014, the NHFPC considered including ginseng as a new variety in the draft Management Measures for Substances Traditionally Classified as Both Food and Chinese Medicinal Materials.


Safety as the Basis for Inclusion

The incorporation of new items into the list of dual-purpose substances for medicine and food must prioritize safety, requiring the establishment of comprehensive principles and criteria. The NHFPC's use of the "New Food Raw Materials" process as a transitional gateway reflects its adherence to safety-first principles. However, caution must be exercised to prevent the misuse of this process for commercial interests, such as the arbitrary inclusion of medicinal materials in the "New Food Raw Materials" category, which could eventually lead to their entry into the dual-purpose substances list.

For medicinal materials classified as "New Food Raw Materials" and intended for inclusion in the dual-purpose substances list, it is recommended to establish a safety monitoring period to ensure their suitability and safety for consumption.

 

5. Summary

The concept of "unity of medicine and food" reflects the wisdom of ancient people in their discovery of food and medicine. Like medicine, food has certain properties, such as the four natures and five flavors. Thus, in addition to providing basic nutrition, food also possesses therapeutic functions similar to medicine. As early as the Zhou Dynasty, the specialization of "food physicians" emerged, and later, materia medica focusing on food therapy was developed. Modern research on the third function of food-regulating bodily functions- suggests that the secondary metabolites of plants, which help regulate bodily functions, may provide the scientific foundation for the therapeutic effects of plant-based foods.

Although food and medicine share the same origin, they are distinct. Food primarily provides nutrition and is non-toxic, while medicine is mainly used to treat diseases. Food is mild in nature, whereas medicine tends to have stronger and more intense properties. Therefore, the therapeutic effects of food are primarily reflected in nutrition-based health maintenance (food nourishment) and dietary therapy (food therapy). Substances that are both food and medicine often have restorative functions and are particularly suited for promoting health and preventing disease. Based on the ancient understanding of the four main characteristics of dual-purpose substances-safety, nutrition, health benefits, and therapeutic effects- modern regulations have defined related concepts, categorizing substances into medicine, food, health food, and substances traditionally classified as both food and medicine.

Ancient materia medica, especially food-related ones, not only recorded a large number of medicinal foods but also provided detailed discussions on consumption methods and contraindications. This reflects the emphasis ancient people placed on the safety and functionality of dual-purpose substances, offering valuable references for modern research on dietary therapy and health maintenance.

The "List of Substances Traditionally Classified as Both Food and Medicine" issued by the National Health and Family Planning Commission (NHFPC) is a modern manifestation of the concept of the unity of medicine and food. However, the list only provides a catalog without detailed specifications, leading to a series of issues such as source identification, edible parts, multi-source problems, variety distinctions, and consumption methods and contraindications. Therefore, revisions to the list must adhere to the principle of "safety first" and consider both traditional and modern applications, providing relevant explanations and limitations.

The "List of Substances Traditionally Classified as Both Food and Medicine" should remain open, but the inclusion of new items must follow strict standards and principles. The NHFPC has established the "New Food Raw Materials" category as a transitional gateway for new substances, which reflects the priority given to safety. However, for Chinese medicinal materials in the "New Food Raw Materials" category to be included in the "List of Substances Traditionally Classified as Both Food and Medicine," it is recommended to set a fixed safety monitoring period before full inclusion.

 

 

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