China Foods for Special Medical Purpose: A Regulatory Overview

In China, foods for special medical purpose (FSMP) are regulated as foods for special dietary uses. Before 2013 there was no national standard for FSMPs in China. In the past this kind of food could only be imported to China by being registered as a drug or health food.

Under the new Food Safety Law, FSMP is categorized as one kind of special food together with infant formula foods and health foods and subject to specialized management requiring registration with CFDA prior to sale in China’s market. This change is a milestone in the development of China’s FSMP industry and the new policy will greatly facilitate overseas FSMP enterprises entering China’s markets.

1. Definition

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. This category of foods is intended for the exclusive or partial feeding of these consumers under the guidance of doctors or clinical dieticians.

2. Basic regulatory status

2.1 Relevant laws and regulations in China

• Food Safety Law of the People’s Republic of China

• GB 29922-2013 General Rules for Foods for Special Medical Purposes

• GB 25596-2010 General Standard for Infant Formula for Special Medical Purposes

• GB 13432-2013 Labeling of Prepackaged Foods for Special Dietary Uses

• GB 29923-2013 Good Manufacturing Practice for Foods for Special Medical Purposes

2.2 Detailed information

3. Classification

FSMPs can be divided into FSMPs for infants (≤ 1 year old), nutritionally complete foods, nutritionally complete foods with a specific formulation, and nutritionally incomplete foods.

3.1 FSMPs for infants (≤ 1 year old)

• Main product categories of FSMPs for infants:

• Free or low lactose formula

• Partially hydrolyzed milk protein formula

• Deeply hydrolyzed milk protein formula or amino acid formula

• Formula for premature delivery/low birth weight infants

• Breast milk nutritional supplements

• Formula for amino acid metabolism disorder

3.2 Nutritionally complete foods

It refers to FSMPs that are intended for the nutritional demands of a target population as the sole nutritional supply. Nutritionally complete foods are suitable for the patients who have these demands without restrictions or limitations on certain nutrients, and their nutritional demand can be met by exclusive feeding of this kind of food.

3.3 Nutritionally complete foods with a specific formulation

It refers to nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition.

13 major categories of nutritionally complete foods with a specific formulation:

• Nutritionally complete foods for patients with diabetes

• Nutritionally complete foods for patients with respiratory disease

• Nutritionally complete foods for patients with kidney disease

• Nutritionally complete foods for patients with malignant tumor

• Nutritionally complete foods for patients with liver disease

• Nutritionally complete foods for patients with muscle attenuation syndrome

• Nutritionally complete foods for patients with trauma, infection, surgery and other stress states

• Nutritionally complete foods for patients with inflammatory bowel disease

• Nutritionally complete foods for patients who are allergic to food protein

• Nutritionally complete foods for patients with intractable epilepsy

• Nutritionally complete foods for patients with gastrointestinal malabsorption and pancreatitis

• Nutritionally complete foods for patients with fatty acid metabolic disturbance

• Nutritionally complete foods for patients for bariatric surgery

3.4 Nutritionally incomplete foods

It refers to the FSMPs that can partially meet the nutritional demands of target population, which is not suitable to be taken as the sole nutrient supply.

It should be consumed together with other kinds of FSMPs or conventional foods according to the specific medical status of the consumer.

4. Age grouping

FSMP consumption groups are categorized based on consumer age as follow: ≤ 1 year old, 1-10 years old, and ≥10 years old. The suitable age range can be redesigned during the product development to meet specific target group consumption requirements.

5. Labeling requirements

5.1 Basic requirements

The labeling of FSMPs should be in accordance with GB13432-2013 Labeling of Prepackaged Foods for Special Dietary Uses.

The product formula or nutritional information should be described in the label. The product category, suitable consumer group, as well indications of unsuitable consumer groups should be labeled.

There should be obvious indications of “use under the guidance of doctors or clinic dieticians” and “this product is prohibited for parenteral nutritional support”.

5.2 Claims

FSMP is regulated as a specific category of food rather than a medicine, which is aimed to improve the nutritional status of patients and should not be used therapeutically in the treatment of a disease. Any claims relating to disease prevention and/or indications of curative functions are prohibited.