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    Home > Food News > Food Articles > Special medical use formula food interpretation

    Special medical use formula food interpretation

    • Last Update: 2021-02-18
    • Source: Internet
    • Author: User
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    Special medical-purpose formula means specially processed formulated foods, including special medical-purpose infant formulas for
    -month-olds to 12-month-olds, and special medical-purpose formulas for people over 1 year of age, to meet the special needs of people with restricted eating, digestive and absorption disorders, metabolic disorders, or specific disease conditions.When the target population is unable to eat a regular diet or to meet their nutritional needs with a daily diet, special medical-purpose formula foods can serve as a nutritional supplement and as a nutritional support. Such foods are not medicines and are not a substitute for the therapeutic effects of drugs, nor can products claim to be effective in the prevention and treatment of diseases.special medical
    for people over 1 year of age: including whole-nutrition formulas, specific whole-nutrition formulas, non-whole-nutrition formulations.1. Special medical use formula food whole nutrition formula food. Whole nutrition formula, which can be used as a single nutritional source to meet the nutritional needs of the target population for special medical purposes. Suitable for people who require a comprehensive supplementation of nutrients and do not have special requirements for specific nutrients. Patients should choose to use a whole-nutrition formula under the guidance of a doctor or clinical dietitian. It can be used as a dietary substitute or nutritional supplement for patients who need oral or tube feeding.2. Special medical use formula food specific whole nutrition formula. Specific whole-nutrition formula food is based on the corresponding age-specific whole-nutrition formula, according to the pathophysiological changes of a specific disease and the appropriate adjustment of some nutrients of a class of food, eating alone can meet the nutritional needs of the target population.suitable for populations requiring a comprehensive supplementation of nutrients in a particular disease or medical condition and to meet the special needs of the population for some nutrients. (i.e., under certain disease conditions, whole-nutrition formula foods do not adapt to disease-specific metabolic changes, do not meet the specific nutritional needs of the target population, and some of these nutrients need to be adjusted.) ) 3.
    Special medical use formula food non-whole nutrition formula food. Non-whole-nutrition formulas, special medical-specific formulations that meet some of the nutritional needs of the target population, are suitable for people who need to be supplemented with a single or partial nutrient and are not intended as a single source of nutrients. Such products should be used in conjunction with other special medically used formulated foods or general foods under the guidance of a doctor or clinical dietitian, in accordance with the specific medical conditions of the individual patient.Special medical food between ordinary food and medicine, can meet the special nutritional needs, help small owners improve the nutritional status.Our ingredients are relatively clear, generally to whole protein (or short peptides or amino acids), fats, sugars, etc. mainly, with vitamins and mineralsfood, it must be used under the guidance of a doctor or clinical dietitian.Although for many people in China, still do not know very much about special medical food, when you are still in the stage of supplementary nutrition in Xiaomi porridge
    plus hen soup, special medical food has long been in foreign clinical "big red purple", and has a good reputationfrom
    19 In 1988, the U.S. Food and Drug Administration issued guidelines for the production and regulation of special medical-purpose formulated foods, and by 2007 issued guidelines on medical foods, limiting medical foods to "food for patients with serious illnesses and the need to treat such foods as the primary treatment party", medical food has under developed rapidly. But in 2013, the U.S. Food and Drug Administration issued a new version of the note changing the "treatment method" to "an integral part of the specific dietary management required for a disease or condition."before 2013, China had only one national standard for food safety related to special medical food, namely GB25596-2010 "General Guidelines for Special Medical Uses of Food Safety", and in 2014 China promulgated and implemented GB29922-2013 General Guidelines for Special Medical Use Formula Foods for Food Safety. In 2015, China promulgated and implemented the Good Production Practices for Special Medical Use Formulated Foods, and on March 7, 2016, the Measures for the Registration and Administration of Special MedicalLy Used Formulated Foods (Decree No. 24 of the State Administration of Food and Drug Administration) was promulgated., the relevant regulations for the registration and approval of special medical food products are clarified, and detailed provisions are made for clinical trials, labels and instructions, supervision and inspection, legal liability, etc.
    October 2016, the State Administration of Food and Drug Administration formulated and published the Code of Quality Management (Trial) for Clinical Trials of Special MedicalLy Used Formula Foods (No. 162 of 2016). This specification sets out the conditions for the implementation of clinical trials, the requirements of responsibilities and quality assurance and risk management.malnutrition is a risk factor for patients to become ill or even die in hospitals. From infants to elderly patients, nutrition has become more important than professional diagnosis and medical care. Based on many worldwide studies,
    13%-69% of inpatients suffer from malnutrition and cause prolonged hospital stays, increased fatality rates, impaired respiratory and heart function, decreased immune function, and poor growth in infants and young children.a recent report, 23 per cent of
    the 740 patients in the three Danish hospitals were malnourished. Only 25 per cent of malnourished patients received adequate nutrition during their stay in hospital. Only 59 per cent of patients were monitored for nutrition, 47 per cent had a nutrition programme22 per cent of the
    794 patients at the two Berlin hospitals were malnourished. It is accompanied by old age (over 60 years of age), loneliness, low educational level, and malignant tumors. There are many causes of malnutrition, including physical factors, metabolic disorders, organ dysfunction and disease, psychological factors, anxiety, depression and depression, and the effects of drugs. can affect postoperative complications, length of stay, infection and mortality rates, treatment costs, etc. in hospitalized patients. Therefore, it is very important to improve the nutritional status of patients. In particular, the development of special medical food for patients has an extremely important role. china's special medical food market developed rapidly, but compared with developed countries, the gap is obvious.
    2015, the global market size of specialty medical food market of about 64 billion yuan, and in recent years with a steady growth rate of 6%. In the UNITED States, 65 per cent of malnourished people use special medically used formula, compared with 27 per cent in the UK Chinese mainland 1.6 per cent in the UK. China's special medical food scale accounted for less than 3% of the global market. Although the consumption of special medical food lags far behind that of developed countries in Europe and the United States, China's special medical food has achieved rapid development in recent years
    , and the total output value of the domestic special medical food market has increased from 120 million yuan in 2004 to 2 billion yuan in 2015. In recent years, the average annual growth rate has exceeded 37%. At least 70% of china's special medical use formulation products need to be met urgently. currently more than
    90% of the domestic market is monopolized by several multinational companies, including Newdishia Pharmaceutical Co., Ltd., Huarui Pharmaceutical Co., Ltd., Abbott Pharmaceutical Co., Ltd., Nestle Co., Ltd. Whether from the international market or the domestic market, the demand for special medical food is becoming more and more vigorous, will certainly be the focus of domestic pharmaceutical enterprises, food enterprises, from the environmental point of view, the environment has a good paving, such as environmental awareness, health awareness, consumer rational awareness, the pursuit of a healthy and fashionable food, but also the trend of increasing consumer demand. The extension of the industry will have a positive effect, will also lead the development trend of special medical food.
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