Food For Special Medical Purposes

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Food For Special Medical Purposes

Table of Content

1. What is Food for Special Medical Purposes?

The Food for Special Medical Purposes is defined by the FSSAI as food designed for specific medical needs:

1. A particular dietary use and is carefully prepared or processed.
2. Individuals should be aware of their dietary restrictions and should use this food under a physician’s supervision.
3. Feeding people exclusively or in part if they have a limited, impaired, or
4. Disturbed capacity to consume, digest, absorb, metabolise, or expel common foodstuffs, specific nutrients they contain, or their metabolites;
5. Other medically determined nutrient requirements where dietary management cannot be achieved solely by modifying a normal diet, using food for specific nutritional use, or combining both.

Reference: FSSAI. (2021). Compendium of Food Category-wise List of Nutraceuticals/Health Supplements/FSMP/Probiotic/Prebiotic Ingredients (Version: September 29, 2021). Page no: 1 of 153 Under (2) definition of (d) Food for Special Medical Purposes

2. What is the need to develop food for special medical purposes?

Food for Special Medical Purposes (FSMP) provides customised nutritional support for individuals with specific health conditions to ensure essential nutrient intake. FSMP must meet certain requirements given below:

Special Needs: For conditions like cancer or gastrointestinal disorders that affect nutrient absorption.
Nutritional Support: Provides complete or partial nutrition, including carbohydrates, fats, proteins, vitamins, and minerals.
Customised Formulations: Made to meet the nutritional needs of specific people.
Medical Supervision: Should be used under healthcare professional guidance.
Health Outcomes: Aims to maintain nutritional status and reduce malnutrition risks.

Reference: FSSAI. (2024). Compendium of Food for Infant Nutrition – Infant Formula Regulations (Version II, January 4, 2024). Page no: 37 of 53 Under (3) Labelling (a) Food for Special Medical Purposes

3. Who are the targeted population for the Food for Special Medical Purposes?

Food for Special Medical Purposes is designed for individuals with specific diseases or medical conditions that affect their ability to digest or absorb normal food. It is used when dietary management can’t be achieved through regular diet modifications alone. This food can be administ

Reference: FSSAI. (2020). Guidance Note on Food for Special Medical Purpose (FSMP) – August 28, 2020. Page no: 3 of 7 Under (4) Distinguish categories of products (5) Food for Special Medical Purposes (Target Population)

4. How are Food for Special Medical Purposes classified?

FSMP are categorised into three groups:

i) Nutritionally complete food with a standard formulation: This type of food can serve as the sole source of nutrition when used according to the manufacturer’s instructions.

ii) Nutritionally complete food with a disease-specific formulation: This food is tailored for a disease, disorder, or medical condition. It can also serve as the sole source of nutrition if used as directed by the manufacturer.

iii)Nutritionally incomplete food: This category may have either a standard or disease-specific formulation, but it cannot be used as the sole source of nutrition.

Reference: FSSAI. (2021). Compendium of Food Category-wise List of Nutraceuticals/Health Supplements/FSMP/Probiotic/Prebiotic Ingredients (Version: September 29, 2021). Page no: 20 of 153 Under (9) Food for Special Medical Purposes

5. Which FDA regulations apply to medical foods?

Medical food manufacturers must follow all relevant FDA food rules, including these key requirements:

a) Good Manufacturing Practices
b) Food facility registration
c) Low-acid foods in sealed containers
d) Acidic or Sour foods
e) Emergency permit control

These were taken from different parts of the 21st Code of Federal Regulations.

Reference: FDA. (2016). Draft Guidance for Industry: Frequently Asked Questions About Medical Foods – Second Edition. Page no: 5 Under (5) what labelling Requirements apply to medical foods?

6) What is the role of EFSA (European Food Safety Authority) in Food for Special Medical Purposes?

The EU Regulation No 609/2013 assigns EFSA to provide scientific advice on FSMP.
Regulation (EU) No 609/2013 addresses food for infants, young children, those with medical needs, and weight control especially among the vulnerable consumers.
FSMP should be used only under physician supervision, and its usage must be clearly labelled.
EFSA operates based on the laws of the EU and takes specific requests from the European Commission.
Thorough, impartial scientific evaluations serve as the foundation for EFSA’s risk management strategies.
Applications to authorise novel chemicals and new uses in food, including FSMP, are evaluated by EFSA.
EU Regulation: To improve legal clarity for businesses and make it easier for the laws to be correctly applied, this regulation went into effect on July 20, 2016.
Labelling: The FICR and EFSA ensure that all food packages in the EU provide ingredient lists, names, allergy information, nutritional data, and other details.

Reference: Freyr Solutions. (n.d.). What is Food for Special Medical Purposes (FSMP)?

FSMP Examples by Category and Use Case

Q. No.	Question	Example Product	Brand/Manufacturer	Purpose / Medical Use
1	What is FSMP?	Peptamen®	Nestlé Health Science	For patients with malabsorption or GI disorders; hydrolyzed protein for easier digestion
2	Why is there a need to develop FSMP?	Glucerna® SR	Abbott Nutrition	For diabetic patients; provides slow-release carbs to manage blood glucose
3	Who is the target population for FSMP?	PKU Lophlex®	Nutricia (Danone)	For individuals with phenylketonuria (PKU); low-phenylalanine formula
4(i)	Nutritionally complete food (standard formulation)	Isosource® Standard	Nestlé Health Science	Tube-feeding formula that meets full daily nutritional requirements
4(ii)	Nutritionally complete food (disease-specific formulation)	Neocate® LCP	Nutricia	For infants with cow’s milk protein allergy; used as the sole source of nutrition
4(iii)	Nutritionally incomplete food (standard or disease-specific)	MSUD Express®	Vitaflo (Nestlé)	For Maple Syrup Urine Disease; provides specific amino acids but needs additional nutrients
5	What FDA regulations apply to FSMP?	EleCare®	Abbott Nutrition	Follows 21 CFR Part 105; designed for protein allergies; requires GMP and FDA food safety compliance
6	What is EFSA’s role in FSMP?	L-Carnitine for FSMP	Multiple EU Submissions	EFSA reviewed L-Carnitine use in renal patient FSMPs under EU Regulation 609/2013

Conclusion

Food for Special Medical Purposes (FSMP) is specially formulated to meet the dietary needs of individuals with specific medical conditions that standard foods can’t address. These nutritional products provide essential nutrients and caloric requirements vital for health and well-being. FSMP is important for managing conditions like metabolic disorders, malnutrition, and gastrointestinal diseases, ensuring optimal nutrition while supporting medical treatment and improving quality of life.

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Food For Special Medical Purposes

Food For Special Medical Purposes

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