Comparative Analysis of Regulations on Health Food and FSMPs in China

1. Definition

Health food in China refers to food products which claim to have specific health functions or supplement one’s vitamins or minerals. Health food is suitable for the consumption by specific groups of people and has the effect of regulating human body functions, but is not used for the purpose of treating diseases.

FSMP refers to a category of foods specially processed or formulated to meet the special nutritional demands of consumers with a limited, impaired or disturbed capacity to intake, digest, absorb or metabolize conventional foods, or consumers with a particular disease or condition.

2. Targeted consumption groups

From the definitions of health food and FSMPs, we can see that the targeted consumption groups are quite different. The targeted consumption group of health food is the group of people determined based on the specific function claims of the product, which is generally indicated on product label. FSMPs are also called enteral nutrition preparations, which are targeted for patients needing nutrient support or specific nutrient intakes.

3. Raw materials

There is strict restriction on the raw materials used in FSMPs. The substances used as both food and traditional Chinese medicine and raw materials used for health food and drugs are not permitted to be used in FSMPs. The use of new food raw materials should be provided with its safety evaluation materials for targeted consumption groups. Only raw materials used for conventional foods can be used in FSMPs, and there should be no unknown ingredients in the raw materials.

The scope of applicable raw materials for health food is much wider compared to that of FSMPs, including:

• Conventional food (including China food composition list, the food composition for conventional use or has the traditional application history)

• Raw materials permitted in MOH No. 51 Document (including the list of substances Used as Both Food and Chinese Medicine, the list of substances that can be used in health food, and the list of substances prohibited to be used in health food)

• Approved new food raw materials

• Food additives listed in GB 2760 and GB14880, as well as new varieties of food additives listed in NHFPC Announcement

• Fungi and probiotics that can be used in health food

4. Product formula design

FSMPs can be divided into three types, i.e. nutritionally complete foods, nutritionally complete foods with a specific formulation, and nutritionally incomplete foods. All the nutrients required by human body should be covered in nutritionally complete foods, including energy, protein, fat, carbohydrate, as well as all varieties of vitamins and mineral substances with strict requirements on the concentration.

• The nutrients covered in nutritionally complete foods with a specific formulation should be adjusted according to the pathological and physiological situation of specific diseases and patients.

• The nutrients contained in nutritionally incomplete foods are limited, and cannot be taken as a complete nutrient source for patients.

The product formula of health food should be designed in accordance with the functional claims, safety requirements, market demand, etc., which are aimed to regulate human body functions rather than providing comprehensive nutrient support and energy.

5. Product form

FSMPs are generally produced in the form of conventional food, such as gelatinous food, soupy food, porous food, etc., while health food is generally made in the forms of tablet, capsule, oral liquid, granule, etc.

6. Consumption approach and dosage

FSMPs should be consumed under the guidance of doctors or clinical dieticians, which can be taken orally or by tube feeding to meet the demand of patients who have specific requirements.

Health food can only be taken through digestive tract, and should not be taken through skin, mucosa, injection, stomach tube, etc. The limit on dosage is generally strict, and the recommended daily intake for specific groups of people should be identified.  Excessive consumption or misuse of health food may result toxicities.

7. Function claims

FSMPs should not indicate any medical or health functions in any form explicitly or implicitly, while there are 27 functions that have been listed into the health food function directory at the current stage, including: