Food-Medicine Homology: A “Green Light” for Imported Foods or a Compliance Minefield?
In the business of importing food products, health supplements, and traditional Chinese medicine (TCM)-related products, “food-medicine homology” is a frequently used term—and also a major compliance risk area.
Many products that are marketed overseas as ordinary foods or dietary supplements may face a completely different classification when entering the Chinese market. Whether an ingredient belongs to the “Food and Medicinal Substance List” directly determines whether the product is classified as a general food, health food, or even a pharmaceutical product. This classification further affects the entire import process, labeling requirements, and market positioning.
This article provides an in-depth analysis of the regulatory system and approval mechanism behind the Food-Medicine Homology List, clarifies the fundamental differences between this list, the Chinese Pharmacopoeia, and general food ingredient catalogs, and offers clear guidance for achieving product compliance in China.
1. Who Manages the Food-Medicine Homology List?
“Food-medicine homology” is not merely a concept—it is a legally regulated category managed by China’s competent authorities.
Official Name of the List
The official name is: “List of Substances That Are Traditionally Both Food and Chinese Medicinal Materials”
Regulatory Authorities
The list is jointly formulated, issued, and managed by the:
- National Health Commission of China (NHC)
- State Administration for Market Regulation (SAMR)
- Other relevant government departments
The National Health Commission is responsible for developing national food safety standards, while the State Administration for Market Regulation oversees market access and daily supervision.
Update Frequency
The list does not follow a fixed update schedule. Additions and revisions are made based on:
- Food safety risk assessments
- Traditional consumption history
- Industry development needs
- Scientific research progress
Each update is officially announced by the government.
2. How Does a New Ingredient Enter the Food-Medicine Homology List?
Adding a new substance to the Food-Medicine Homology List is a rigorous and lengthy scientific evaluation and administrative approval process. It is not something that companies can simply request and obtain.
Safety Assessment and Project Initiation
Normally, the National Health Commission initiates safety evaluations for certain traditional medicinal materials based on:
- Scientific research developments
- Industry applications
- Regulatory requirements
Scientific Research and Evaluation
Extensive scientific evidence is required to prove that the substance is safe for human consumption as food.
The evaluation may include:
- Toxicological studies
- Nutritional composition analysis
- Historical consumption research
- Human dietary safety investigations
Public Consultation
After preliminary assessments confirm safety, the National Health Commission may publicly solicit opinions from society and collect feedback from relevant stakeholders.
Official Announcement
After reviewing all opinions and completing the final assessment, the National Health Commission officially announces the inclusion of the substance in the:
“List of Substances That Are Traditionally Both Food and Chinese Medicinal Materials.”
3. The Fundamental Differences Between the Three Lists: A Simple Comparison Table
The key to understanding “food-medicine homology” lies in clarifying its boundaries with the Chinese Pharmacopoeia and the general food ingredient catalog.
These three categories represent completely different product identities and regulatory requirements.
| Category | Core Positioning | Regulatory Logic | Product Identity |
|---|---|---|---|
| Food-Medicine Homology List | Safety first, while considering functional value | Permitted to be added to ordinary foods, but no health benefits or therapeutic claims may be promoted. | General Food |
| Chinese Pharmacopoeia List | Disease treatment | Managed as pharmaceutical products, with strict indications, dosage requirements, and permitted use for disease prevention, treatment, and diagnosis. | Pharmaceutical Product |
| General Food Ingredient List | Provides nutrition and meets dietary needs | Only provides energy and basic nutrients. The addition of any medicinal ingredients is strictly prohibited, and no functional claims may be made. | General Food |
In simple terms:
- Food-medicine homology substances are “edible medicinal materials.” However, once they enter the food category, their medicinal identity must be completely disregarded, and they can only be sold as ordinary food products.
- Medicinal materials listed in the Chinese Pharmacopoeia are “medicines for treating diseases.” They cannot be freely added to ordinary foods.
- General food ingredients are “pure food materials” and have no connection with medicinal use.
4. Compliance Application: Examples of Pueraria Root and Schisandra Fruit
According to our compiled import compliance information, both Pueraria Root (Ge Gen) and Schisandra Fruit (Wu Wei Zi) have been included in China’s Food-Medicine Homology List.
This means:
Compliant Import Pathway
Products containing Pueraria Root or Schisandra Fruit extracts may be imported into China as ordinary prepackaged foods, such as:
- Pueraria root powder
- Schisandra fruit tea
- Functional beverages
provided that they meet relevant food regulations.
Compliance Requirements
1. Pure and Compliant Ingredients
The product formulation must not contain:
- Any unapproved pharmaceutical ingredients
- Traditional Chinese medicinal materials that are not included in the Food-Medicine Homology List
- Other ingredients that are not permitted for use in food products
2. Compliant Labeling
The Chinese label of the product must comply with:
National Food Safety Standard: General Standard for the Labeling of Prepackaged Foods (GB 7718)
In addition:
The product label must not claim or imply any health benefits or medicinal effects, such as:
- “Protects the liver”
- “Improves kidney function”
- “Detoxifies the body”
- Other disease prevention or treatment claims
Conclusion
Food-medicine homology is a unique regulatory concept in China that creates a pathway for traditional Chinese medicinal materials to enter the food industry.
However, this pathway has strict boundaries and compliance requirements.
For companies engaged in importing overseas products into China, accurately identifying the regulatory classification of each ingredient is the first and most critical step to ensure:
- Successful customs clearance
- Avoidance of shipment detention
- Prevention of product returns
- Avoidance of destruction due to non-compliance
Before conducting any import operation, companies should always carry out a professional compliance review of their product formulation.
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