October 3, 2024 Mrzhao

What is the difference between special medical purpose formulas and protein solid drinks?

When applying for registration of food for special medical purposes, it is necessary to provide product formulations, production processes, product standards, labels and instructions, inspection reports and other declarations indicating safety, nutritional adequacy and clinical effects of special medicine, etc., and it is also necessary to pass on-site verification of the production site and product sampling and testing.
Difference between Formula Food for Special Medical Purposes and Protein Solid Drinks
Formulated Food for Special Medical Purposes (hereinafter referred to as “Special Medical Food”) and Protein Solid Drinks are significantly different in terms of nutritional properties and uses of the products, applicable population, regulatory methods, labeling information, etc. 1.
1 from the definition of different 1.1 protein solid drinks: is to contain a certain amount of animal protein or plant protein (or more than two mixed protein) food raw materials and accessories, food additives, etc. processed into powder, granular or block, for mixing or brewing drinking solid food.
1.2 Special medical food: refers to the formula food specially processed and formulated to meet the special needs for nutrients or diet of people with limited eating, digestive and absorption disorders, metabolic disorders or specific disease states.
1.3 Significant differences between the two: (1) Protein solid beverages are ordinary food for the general population, generally not specifically targeted at the consumption of the population, consumers can choose and consume on their own.

(2) Special medical food is nutritional food for specific groups of people suffering from diseases or special medical conditions, which is special food with strict classification and applicable population. Special attention should be paid to the fact that special medical foods must be consumed alone or in conjunction with other foods under the guidance of a doctor or clinical nutritionist.
2 regulatory approach is different protein solid drinks as ordinary food, its product formulations, labels and instructions, etc., do not need to be registered for approval, only need to obtain a production license to produce and sell. Specialty foods are different, its product formulations, production processes, labels and instructions, etc., need to be strictly registered by the State Administration of Market Supervision and Administration for approval, and should obtain the appropriate production and management license before production and sales.
When applying for registration of special medical food, you need to provide product formulations, production processes, product standards, labels and instructions, inspection reports and other information to show that the safety, nutritional adequacy and special medical clinical effects and other reporting materials, but also need to be verified through the production site, product sampling and testing.
3. Product implementation standards for different protein solid beverages should be in line with the “National Standard for Food Safety Beverages” (GB 7101-2015) and other relevant provisions. Specialty foods with different varieties should comply with the relevant provisions of the National Standard for Food Safety General Principles of Food Formulas for Special Medical Purposes (GB 29922-2013) or the National Standard for Food Safety General Principles of Food Formulas for Special Medical Purposes for Infants (GB 25596-2010) accordingly.
Compared with protein solid beverages, the nutrients required in the standards for special medical foods are richer and more comprehensive, and the applicable population is clear. At the same time, the two are different in the type and content of nutrients, especially in the full nutritional special medical food standards, in addition to the requirements of macronutrients such as proteins, fats, carbohydrates, etc., it must also contain 13 kinds of vitamins and 12 kinds of mineral components, and a variety of optional nutrients can be selected to add. The nutritional composition of protein solid drinks is relatively simple, less variety.
4. Labeling information is different from the protein solid beverage labeling should be consistent with the “National Food Safety Standards General Principles for the Labeling of Prepackaged Foods” (GB 7718) of the provisions of the special medical food labeling should be consistent with the “National Food Safety Standards General Principles for the Labeling of Prepackaged Foods” (GB 7718) of the corresponding provisions of the requirements of the National Food Safety Standards should also be consistent with the “National Food Safety Standards for the Labeling of Prepackaged Food for Special Dietary Uses” (GB 13432) The requirements of the corresponding provisions of the General Principles for the Labeling of Prepackaged Special Dietary Foods (GB 13432) should also be met.
Protein solid beverages, as ordinary food, do not require registration approval, so there is no registration number on the label; special medical food labeling must indicate the product registration number, applicable population, product name, etc., of which the registration number can be queried on the official website of the State Administration for Market Supervision and Administration of the State Food and Drug Administration, and the name of the product should contain the content of “special medical use ×××× formulated food (or special medical use of infant ××× formulated food)” and so on. formula food for special medical use (or infant formula food for special medical use)” and so on.
5. Shopping and consumption of different populations 1. Protein solid drinks do not need to comply with medical advice, consumers can buy their own, there is no specific group of people to eat.
2. Special medical food must be in accordance with the guidance of doctors or clinical dietitians to choose to buy the product, and when buying, pay attention to clearly read the labeling information content. Accurate purchase at the same time, in the consumption of time limits and consumption methods, etc., but also in strict accordance with the guidance of a doctor or clinical dietitian, can not be consumed by themselves indefinitely at will.
6. Protein solid beverages and “protein components” are different in the special medical food, there is a “protein components” products, its main nutrient is protein, suitable for special medical conditions of specific groups of people to supplement protein nutrition. Because protein solid drinks also contain a certain amount of protein, so it is easy to be confused with the special food “protein components”, in fact, the two have significant differences.
1. Protein solid drinks are ordinary food, with no special target consumption group; while “protein” components are nutrient component formulas for special medical purposes (referred to as “protein components”), which are nutritional food for specific groups of people suffering from diseases or special medical conditions, and should be prescribed by a doctor or other healthcare professional. Protein Components are nutritional foods for special medical purposes and should be consumed in combination with other foods under the guidance of a doctor or clinical nutritionist.
2. Since protein components are special medical foods, their difference with protein solid drinks is the same as that of the above mentioned II, III, IV and V. 3.
3. Compared with protein solid beverages, the protein types and characteristics of protein components are more specific, the protein content is relatively higher, and the applicable population is clear.
4. When applying for registration, protein components are required to provide product formulations, production processes, product standards, labels and instructions, inspection reports and other materials indicating product safety, nutritional adequacy and special clinical effects, etc., as well as through the verification of the production site and product sampling and testing. Protein solid beverages do not require registration and approval.
5. Attention should be paid to the importance of allergy when purchasing protein solid drinks or protein components.

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