How to Make Health Food Labels Compliant in China

Label is an indispensable part of health food, and it is also the focus of market supervision. In recent years, the State Administration for Market Regulation (SAMR) increases its efforts to rectify fraud, exaggeration and false propaganda of health foods. Ensuring product labeling compliance has gradually become the focusing matter of enterprises. However, the requirements on health food labeling are concentrated in several standards, thus, it is easy for enterprises to omit important rules when making labels, resulting in labeling irregularities.

What are the regulations related to health food labeling? How to make compliant health food labels? In view of the above problems, CIRS summarized the relevant regulations of health food labeling, and listed the mandatory information and risky claims for enterprises’ reference.

1. Relevant Regulations on Health Food Labeling

Table 1 Regulations on Health Food Labeling

S.N.	Main Regulations
1	Food Safety Law of the People's Republic of China (2015 version)
2	Administrative Measure on Health Food Registration and Filing
3	Health Food Registration Application Service Guideline (2016 version)
4	Health Food Filing Guideline (Trail)
5	GB 7718 General Rules for Prepackaged Food Labeling
6	Labeling Regulations for Health Food
7	SAMR Notice on Standardizing the Claim of Health Food Function (Notice of No.23, 2018)

Note: “Labeling Regulations for Health Food” was implemented in 1996. Since the date of implementation is far from now, some contents of this regulation have been invalidated with the updating of health food laws and regulations. If there is any inconsistency with other regulations (e.g., GB 7718, etc.) in this regulation, the latest published regulations shall prevail.

2. Mandatory Information of Health Food Labeling

The mandatory information of health food labeling includes 2 aspects:

• Information of product instructions in approved health food registration/filing certificates; and
  
• Mandatory information required by GB 7718.

Table 2 Mandatory Information for Health Food Labeling

S.N.	Mandatory Information	Note
1	Blue hat and approval information (including approval number and issuing authority)	Blue hats and health food approval information should be arranged side by side or up and down on the top left of the "Main Display Layout". Approval information is divided into 2 lines, one is approval number of the upper and the other is issuing authority such as “XXXX approval”.
2	Product name Raw materials Excipients Name and content of functional/characteristic components Suitable crowds Unsuitable crowds Health function Intake amount and suggested use Specification Storage condition Expiry date Warning	These contents shall be consistent with approved health food registration/filing certificates. The height of unsuitable crowds shall be slightly larger than that of suitable crowds.
3	Net weight	/
4	Production date	/
5	Name, Address and Contact information of Manufacturer, Distributer	For imported products, the distributer refers to “distributer in China”.
6	Food production license number	Only domestic products should be labeled.
7	Product standard code
8	Country (Region) of origin	Only imported products should be labeled.

3. Risky Claims in Health Food Labeling

Risky claims in health food labeling mainly appear in optional items, which generally manifests as exaggeration and false propaganda. Common exaggeration and false propaganda are as follows:

(1) Common False Claims of Health Food Function

Currently, there are many false claims of health functions related to enhancing immunity, alleviating physical fatigue, assisting blood lipids reduction, increasing bone density and sleep improvement , which are listed be low.

Table 3 Common False Claims of Health Food Function

S.N.	Approved Claims of Health Food Function	Common False Claims
1	Enhancing immunity	Prevent cancer, anticancer; adjuvant to radiotherapy and chemotherapy, etc.
2	Alleviating physical fatigue	Improving memory or concentration, improving sexual function, prevention of physical fatigue caused by disease, improving and alleviating mental fatigue, etc.
3	Assisting blood lipids reduction	Anti-atherosclerosis, protecting cardiomyocytes, preventing blood clotting, reducing blood viscosity, etc.
4	Increasing bone density	Promoting bone growth, treatment of bone injury, increasing physical strength etc.
5	Sleep improvement	Relieving brain aging and neurological damage, falling asleep quickly without sleeping pills, keeping skin glowing, etc.

(2) Other methods and claims regarding exaggeration and false propaganda of health foods

• By using the image or the name of authorities, medical institutions, academic institutions, industrial organizations, experts, medical professionals or consumers to prove the efficacy of the health food.
• Containing expressions such as "scientific or research finding" or "experiment or data proof" that cannot be confirmed; or by comparing with other health foods, medicines, medical devices, etc., and depreciating other products.
• By using superstitions to promote health foods; or claiming the health food formula as ancestral secrets; or containing "get refunds if ineffective", "insured by insurance company" and other contents.
• Containing "safe", "non-toxic", "no side effects" and "no habit-forming" and other commitments.
• Containing "latest technology", "highest scientific level", "the most advanced system" and other absolute terms and expressions.

4. CIRS Comments

The SAMR has taken many actions to rectify health food propaganda, e.g., Health Food Fraud and False Propaganda Action, 100-Day Action to Rectify the "Health" Market, and Establishment of a "Health" Market Long-term Regulatory Mechanism, etc. These actions have severely cracked down on enterprises whose product labels and propagandas are not compliant, and SAMR has imposed punishments on them such as fines, confiscate illegal products and revoke licenses etc.

Recently, the SAMR has repeatedly issued some scientific movies or articles related to health food exaggerated and false propaganda, aiming to improve consumers' ability to distinguish false propaganda. It can be seen that the SAMR attaches great importance to the supervision of the propaganda content of health food.

Health food enterprises should strictly abide relevant laws and regulations to avoid irregular contents in health food labeling. Some suggestions from CIRS for enterprises’ reference:

• For mandatory information in labels, enterprises should label product information in accordance with the requirements of laws and regulations, and all information should not be omitted.
• For optional items, it should not contain exaggeration and false propaganda claims. And the product should not be implied or claimed to have preventive or therapeutic effects.

If you have any needs or questions, please contact us at service@cirs-reach.