The development history of "special medical food"
The concept of special medical food originated in Europe. Nutrition began to rise in the 1970s and 1980s, and people’s concept of intestinal health has just taken shape. At that time, the technology of enteral nutrition using food as a carrier for auxiliary treatment emerged. A brand-new concept of intestinal diseases. Europe calls such technical products as foods for special medical purposes.
Special medical foods were introduced into my country due to special clinical needs, so they were dubbed as medicines and then classified as health foods.
The world's first special medical food was born in 1957 and was approved by the US FDA as a dietary treatment for phenylketonuria. In the 1980s, many developed countries began to use "special medical foods" extensively to solve the problem of nutrition absorption of infants and young children, and formulated strict management measures and usage standards for them.
At present, the United States, the European Union, Australia and Japan have all given clear legal status to formula foods for special medical purposes.
"Chen Wei, chief physician of the Department of Clinical Nutrition, Chinese Academy of Medical Sciences and Peking Union Medical College Hospital, said: Formula foods for special medical purposes are referred to as special medical foods. They are mainly used by clinical patients who cannot refuse or do not eat enough. Food. Because it needs a special processing method and has a specific formula, it is collectively called formula food for special medical purposes."
In fact, this kind of food has a history of decades of application in the world, but it has been used as an enteral nutrition preparation in our country for a long time. It is a form of medicine that has entered clinical practice. The complexity of the approval makes it difficult for many patients to obtain this type of product. Of course, there is indeed a vast demand in clinical practice. Patients with tumors, patients with diabetes, and stroke patients often need these special medical foods for clinical applications.
Development of Special Medical Food in China
In my country, the development of special medical food is relatively slow. At the beginning, it was administered according to medicines. In 1974, enteral nutrition preparations were managed according to medicines. Traditional nasal feeding and tube feeding cannot be called enteral nutrition preparations. Food safety legislation was introduced in 2005. Special food.
Before 2013, Chinese companies had no legal basis for special medical food production. The domestic special medical industry has just started. Currently, the registered products are mainly imported, and the market has always been in a situation of low quantity and high price.
"In 2013, my country officially issued the "General Principles of Formulated Foods for Special Medical Purposes (GB 29922-2013)" and "Good Manufacturing Practices for Formulated Foods for Special Medical Purposes (GB 29923-2013)" to guide and standardize my country's "special medical foods" Classification, production and use to ensure the nutritional needs of the applicable population of "special medical food" and to ensure the high quality and safety of "special medical food"."
On July 1, 2016, my country began to implement the "Regulations for the Registration of Formulas for Special Medical Purposes", setting extremely stringent entry thresholds for production and R&D units to further ensure product quality.
As of June 30, 2020, there are only 51 "special medical foods" approved for registration, which can be described as "one in a hundred".
"Special medical food" is divided into special medical use infant formula food (applicable to 0 months to 12 months old) and special medical use formula food (applicable to people over 1 year old).
Among them, infant formula for special medical purposes (applicable to 0 months to 12 months of age) includes lactose-free formula food or low lactose formula food, milk protein partially hydrolyzed formula food, milk protein deep hydrolysis formula food or amino acid formula food, premature birth, Low birth weight infant formula, amino acid metabolism disorder formula and breast milk nutritional supplements, etc.
Formula foods for special medical purposes for people over 1 year old, including full nutritional formula foods, specific full nutritional formula foods, and non-full nutritional formula foods.
Special medical food suitable for people
Having said that, who is the "special medical food" suitable for?
"Category 1: Full nutritional formula food is suitable for people who need to fully supplement nutrients and have no special requirements for specific nutrients. Category 2: Specific full nutritional formula foods are suitable for specific diseases or medical conditions that require comprehensive nutritional supplements The third category: non-full nutrition formula food refers to special medical formula food that can meet part of the target population’s nutritional needs. It is suitable for people who need to supplement single or partial nutrients."
Those who cannot eat normally, or have significantly reduced food intake. For example, people who have a lot of stress during continuous work, have no way to eat on time and on a regular basis for a week, are often hungry, lose weight, and lose energy.
People who have insufficient nutritional intake such as diarrhea and incomplete upper gastrointestinal obstruction during digestion and absorption. People who have insufficient and unbalanced nutritional intake due to illness or severely picky eaters.
People who are suffering from malnutrition or nutritional risk when they are sick. Cancer patients are undergoing surgery or chemotherapy.
Prospects of the domestic special medical food market
Although there are very few domestic consumers of special medical foods, and both their popularity and market share are far lower than those of developed countries, it can be foreseen that the market potential of special medical foods in my country will be huge in the future.
According to statistics, the average malnutrition of hospitalized patients in my country is about 12%, and the nutritional risk is about 36%. The incidence of moderate to severe malnutrition in cancer patients is as high as 57%, of which about 70% do not receive the necessary nutritional support.
In addition, as the aging of the Chinese population further intensifies, a series of medical problems will be triggered, which will promote the further development of clinical treatment, nutritional supplements and other industries. At the same time, as the overall quality of the Chinese people improves, they pay attention to health problems and prevent diseases. With the rise of the concept of enhancing exercise and supplementing comprehensive nutrition, the people's demand for formula food products for special medical purposes is increasing. It is believed that China's special medical food market will be a broad blue ocean in the future, and it is expected to become a new growth point for the national economy.
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