What exactly is special medical food? This article takes you to understand the special medicine food industry.

Guide: Special medical food refers to the special needs of people with limited eating, digestive and absorption disorders, metabolic disorders or specific disease status of the special needs of nutrients or diet, specially processed formulated foods.
, when it comes to special medical-purpose formula foods, maybe some friends will feel strange, special medical food? It's not going to be health food like Quan Jian that preaches the effects of his treatment, is it? If we have this idea it is very wrong, special medical food in fact at home and abroad are very standardized management mechanism, and it is of great benefit to the treatment and rehabilitation of patients.
let me have a deep chat with my friends about this topic today.
1. Special Medical Food Introduction 1.1 Concept and Definition of Special Medical Use Formula referred to as Special Medical Food means a specially processed formula formulated to meet the special needs of people with restricted eating, digestive and absorption disorders, metabolic disorders or specific disease status, including special medical use infant formula from 0 months to 12 months of age and special medical use formula for over 1 year of age.
In addition, such foods can only improve the nutritional status of patients and provide a good basis for the treatment and rehabilitation of diseases, but they are not a substitute for the use of drugs for disease treatment, nor can they claim the prevention and treatment function of such products.
1.2 The concept of special medical food originated in Europe, in the 1970s and 1980s nutrition began to rise, people's concept of intestinal health has just taken shape, when the emergence of the intestinal nutrition technology with food as a carrier to assist in the treatment of intestinal diseases, Europe called this kind of technical products special medical purpose food.
special medical food into our country is due to special clinical needs, so it is named as medicine, and then classified into the category of health food.
the world's first truly specialty medical food was produced in 1957, when it was approved by the FDA as an orphan drug for dietary treatment of phenylatonuria.
, with a series of related regulations introduced in the United States medical food gradually on the right track, began to enter a high-speed stage of development.
1.3 classification standards are currently divided into three main categories of special medical foods in China: whole-nutrition formula food is suitable for people who need to fully supplement their nutrients and do not have special requirements for specific nutrients.
category II: Specific whole-nutrition formula foods are suitable for people who need to be fully supplemented with nutrients in a particular disease or medical condition, and meet the requirements of the population for some nutrients.
category III: Non-full nutritional formula refers to special medical-purpose formulas that meet some of the nutritional needs of the target population and are suitable for people who need to be supplemented with single or partial nutrients.
1.4 The relevant registration regulation of special medical foods in different countries around the world, the United States referred to special medical use formula food as medical food (Medical Food), and the United States special medical food before the market does not require any registration approval, but there are certain provisions for food additives and nutrients.
The EU has made clear provisions on the quality, standards and ingredients of special medical foods, but different member states are different and need to conduct a separate analysis according to the expected region of the product, such as Spain and other countries need to go to the relevant departments before listing for the record.
years, China's relevant regulations and regulations are becoming more and more perfect, market supervision began to move towards the standardization stage.
Since 2013, special medical food products have now been relatively independent standards and registration methods, on July 1, 2016, China implemented the "Special Medical Uses Formula Food Registration Management Measures" so that special medical foods from the scope of drugs and health food separate planning.
This is an independent registration management method of the document, but also the corresponding Yantai product standard GB29922-2013 "National Standards for Food Safety Special Medical Use Formula Food General Principles" and G-29923-2013 "Special Medical Use Formula Food Enterprise Good Production Practice" so that the production and sale of such food should be distinguished from health food, medicine and general food, is required to be eaten under the guidance of a doctor or clinical nutritionist.
2. As of now, there are 49 formulated foods approved by the registration and approval of special medical-purpose formulated foods in China.
Of these, 29 were suitable for children between 0 months and 12 months of age, including 6 lactose-free formulations, 5 partial hydrolytic formulas for lactose proteins, 3 deep hydrolytic or amino acid formulations for lactose proteins, 11 formulas for premature/low birth weight infants, 3 infant nutritional supplements, 1 formulation for amino acid metabolic disorders, and 19 formulations for people over 1 year of age, including 16 full nutritional formulations and 4 non-nutritional formulations.
Table 1 Full Nutrition Formula Food Listing Catalog (China) (Data Source: Pharmaceutical Intelligence Consulting) 3. Although the prospects of the domestic special medical food market are very few consumers in China, and whether it is well-known or market share, are far below the developed countries, but can foresee The future market potential of China's special medical food is huge.
statistics, the average inpatient malnutrition in China is about 12%, the nutritional risk is about 36%.
57 per cent of patients with severe malnutrition, about 70 per cent of whom did not receive the necessary nutritional support.
In addition, with the further aggravation of the aging of Chinese mouths, will lead to a series of medical problems, promote the further development of clinical treatment, nutritional supplements and other industries, and with the improvement of the overall quality of Chinese, the importance of health problems, as well as the concept of disease prevention, enhanced exercise, supplementation of comprehensive nutrition, the national demand for special medical use formula food products is growing.
believe that China's special medical food market will be a wide blue sea in the future, and is expected to become a new growth point of the national economy.
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