Foods for Special Medical Purposes (FSMP) | FSSAI Update | Food Safety
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Nutrition is the most essential aspect of a healthy human being. Improper nutrition opens the gate for various problems in healthy living. Malnutrition is a major health problem in the present times and also exists in various forms in India. Malnutrition refers to “deficiencies, excesses, or imbalances in a person’s intake of energy and/or nutrients” and besides undernutrition also includes overweight obesity or micronutrient malnutrition. To meet the particular nutritional requirement for persons suffering from malnutrition because of specific diseases disorders or medical conditions, companies have started making dietary food for special medical purposes. This food specially made for medical purposes has emerged as a boon to a lot of the population and in lieu of that government, authorities have been receiving an immense amount of applications for registering the production of these products. These foods must be used under medical supervision, maybe with the assistance of other health professionals. As these food are either supplement or replacement for the nutrition intake, they must be used with proper caution and to avoid any confusion, the Indian government has even made guidelines directing companies engaged in the business of producing this dietary food to use proper caution and measures and taking appropriate licenses before introducing any product in the market.
Duty of the Food Business Operator
All of these dietary foods must be produced according to the prescribed guidelines. The food prepared for weight reduction with the intention of replacing it with the normal diet shall be included in food for special medical purposes. It is the duty of the Food Business Operator to formulate these foods for special medical purposes in the format specifically meant for feeding through enteral tubes or oral feeding. This food for special medical purposes shall never be used for parental use. Foods for special medical purpose, not including the foods intended for infants, either can be nutritionally complete foods if being taken in accordance to the manufacturer’s instructions, can constitute as the sole source of nourishment for the intended persons or not nutritionally complete food formulated specifically for a medical condition, disorder or disease but can never be taken as a sole source of nourishment. To understand briefly as per these regulations, food for special medical purposes are classified further into three categories,
- Foods having complete nutrition and a standard nutrient formulation, when taken as per the instruction of the manufacturer, may be taken as the sole source of nourishment to the persons they are intended for.
- Foods having complete nutrition and a nutrient-adopted formulation specifically for disease, medical condition, or disorder, taken as per the manufacturer’s instructions, may be taken as the sole source of nourishment for the person they are intended for.
- Foods having incomplete nutrition and a standard formulated or a nutrient-adopted formulated specifically for a medical condition, disorder, or disease that is not suitable to be taken as a sole source of nutrition.
That is, foods mentioned in the above clauses (b) and (c) can be taken as a supplement or partial replacement in a diet of a person. This food for the special medical purpose may affect differently on different persons depending on various factors like metabolism, kind of disease or medical condition a person is suffering from, other medications or form of diet a person usually has. That is why it is absolutely necessary for any person to consume these foods or products explicitly on the instruction of a medical supervisor or assistance of health professionals.
Nowadays, 1 in 3 persons is already taking or are desiring to use these foods to supplement their daily need for nutrition. Therefore, it is the duty of the government to keep these companies, producing such foods, on a leash by implementing the rules and regulations in regards of these foods for special medical purposes. These rules state that these foods shall contain only among the ingredients mentioned in Schedule I, Schedule II, Schedule III, Schedule IV, Schedule V, Schedule VII or Schedule VIII and only the enzymes specified in Schedule VI provided by the Food Safety and Standard Authority of India. It is the utmost responsibility of the food business operator to use only those ingredients mentioned in the schedule provided by the government in the manufacture of foods for special medical purpose, must be without any prejudice to a modification to the nutrients rendered necessary for the intended use of the product. If any food business operator wants to use any new nutrient in the manufacture of the products which has no history of use in the country of India, or any such nutrient that does not have any proof establishing that the said nutrient would result in physiological or nutritional benefit with justification for approval must apply to the Food Authority and then the Food Authority, after extensive scientific evaluation may specify from time to time about the nutrients approved by the authority. Manufacturers of this food for special medical purposes must ensure that they abide by this rule and can never use any nutrient apart from mentioned in the schedule without prior permission of the Food Authority.
Weight reduction foods intended as a total replacement of diet shall comply with the schedule III of Food Safety and Standard Authority of India and also with the conditions that:
- If a very low energy diet formulated food are prepared, it must be as per the instructions with 450-800 kcal daily energy intake as the only source of energy.
- Protein digestibility corrected amino acid score 1 having not less than 50 g protein shall be present in the recommended daily intake of energy and if essential amino acids are added to improve the quality of protein, must be only in the amount necessary. Those are L-forms of amino acids except methionine for which DL form is also permitted.
- Very low energy diet includes more than 3 g of linoleic acid, 0.5 g α-linoleic acid in recommended daily intake and a ratio of 1:5 and 1:15 between α-linoleic acid and linoleic acid.
- Carbohydrates are not less than 50 g in recommended daily intake of very low energy diet.
- Adequate dietary fiber in the formulated food for special medical purposes.
- Nutrients can be added higher than that of recommended daily allowance but shall not exceed the limits of vitamins and minerals as mentioned in schedule III.
Packaging & Labeling
Packaging of food for special medical purposes must have the information on the label. Information like
- Words ‘FOODS FOR SPECIAL MEDICAL PURPOSE’ printed in the immediate proximity of the name or maybe the brand name of the product.
- ‘RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY’ advisory warning shall appear in bold letters in the separated area from another graphic, written, or printed information.
- ‘For the dietary management of _______’, specific disease, disorder or medical condition for which the product is intended for or for which it has proven to be effective must be filed in this blank and this statement shall support appropriate scientific, clinical, or epidemiological data only after its approval by the Food Authority.
- If the food is intended to be used as a nutritionally complete food, then a statement of ‘NUTRITIONALLY COMPLETE’.
- Description of the properties or characteristics that make it useful and a statement on the rationale mentioned only for the use of the product by its target consumers.
- A statement, only in case when the product is being formulated for a specific age group.
- A statement specifying if any nutrients have been reduced, increased, deleted, or otherwise modified in regards to normal requirements and the rationale of such reduction, deletion, or modification.
- Nutrients expressed in percentage of daily recommended allowances, where it is appropriate.
- If applicable, all the information on osmolality or osmolality, Renal Solute Load, Potential Renal Solute Load, or acid-base balance.
- All the information and instructions regarding feeding, preparation, storage, and use of the product after opening the container.
- Warning regarding the parental use of the product.
- A statement mentioning that the product must be stored out of the reach of children.
Additives if used for the food for the special medical purposes shall be specified in Schedule VC or Schedule VD or Schedule VE or Schedule VF. It is the responsibility of the food business operator to not use any other additives than those specified
No Advertising on the food for special medical purpose that it can be used by the general public, and be consumed explicitly without the instructions of any health professional.
Food for special medical purposes is emerging day by day in the present times and extensive care is an absolute necessity that shall not be ignored by the manufacturer and the government. The government has realized the consequence if any product is made public without proper vigilance and in lieu of that, Food Safety and Standard Authority implemented these rules and also have made it mandatory for the manufacturer to procure a license from Government Authority for a manufacturer pursuing the production of any such food for special medical purpose. License from FSSAI is such license mandatory prior to production of the products. And the government have made sure that no manufacturer gets this easily and the authority scrutinizes each document and demand deposit of long list of documents along with the application and obtaining such license is an extensive process and to procure this license is a difficult one as the health of public would be at risk.