This document provides information on neutraceuticals and the regulatory framework for neutraceuticals in India. It defines neutraceuticals as food or food components that provide health or medical benefits. The key regulatory body is the Food Safety and Standards Authority of India (FSSAI), which establishes standards for neutraceutical products and licensing. The document outlines labeling requirements, restrictions, and documents needed to apply for a license to manufacture or sell neutraceuticals in India.

1. Neutraceutical:
Let Food be Your
Medicine
Prersented by: Shrikant Deshmukh

2. Neutraceutical : The Neutraceutical term was coined by
Stephen Defelice. .
“A NEUTRACEUTICAL is any substance that is a food or part of food
and provides medical or health benefits, including prevention and
treatment of disetase.” The term Neutraceutical combines the
word “nutrient” (a nourishing food or food component
with “pharmaceutical ” (a medical drug).
The word Neutraceutical has been used to describe broad
list of products sold under the premise of bing dietary suppliments
(i.e. a food) for trement and prevention of disease.

3. Neutraceutical mainly consist of
1. Nutrients: Substances which have established Nutritional
functions e.g. Vitamins, Minerals, Amino Acids, Fatty acids, etc.
2. Herbals/ Phytochemicals: Herbs or Botanical products.
3. Dietary Supplements: Probiotics, Prebiotics, Antioxidents,
Enzymes.

4. Nutraceutical can be classified as
1. Potential Nutraceuticals - One which has promising approach
towards particular health or medicinal benefit.
2. Established Nutraceuticals – A Potential Nutraceutical becomes
established nutraceutical only after there are sufficient clinical use
to demonstrate a benefit.

5. The food safety and standards act 2016 is act to consolidate the law
relating to food and to establish the food safety and standards
authority of india for laying down science based standards for
articles of food.FSSAI is a main regulatory body to regulate
manufacturing, storage,distribution, sale and import of nutritional
products.
Functions of Fssai
1. To specify standards and guidelines for food articles.
2. Limits of Food additives, contaminants, veterinary drugs, heavy
metals, mycotoxins, irradiation of food, processing aids.
3. Guidelines for accreditation of certification bodies engaged in
FSMS Cerification.

6. 4. Quality control of imported foods.
5. Specify food labeling standards including claims on health,nutrition
Special dietary uses and food category system.
6. Scientific advice and technical support to state or central government
Governing Bodies of FSSAI
1. Food Safety Commissioner
2. Food Safety Officer
3. Food designated Officer

7. ROLE AND RESPONSIBILITIES OF FOOD SAFETY COMMISSIONER
1.Prohibition of manufacturing,storage,distribution or sale of any
article of food in the interest of public health.
2. Carry out survey/inspection of food processing unit in the state
to find out compliance of prescribed standards.
3.Conduct training programmes for personnels engaged in food
safety.
4.Ensure efficient and uniform implementation of standards and
other requirements of food safety.

8. ROLE AND RESPONSIBILITIES OF FOOD SAFETY OFFICER
1. Taking sample of food intended for sale.
2. Seize any article of food which appears to be in contravention of
this act.
3.Enter and inspect any place where food is manufactured, or stored
for Sale.
4. Seize any adulterant found in possession of a manufacturer or
distributor.
5.Can be penalising/punished to Complainant for false complaint.

9. ROLE AND RESPONSIBILITIES OF FOOD DESIGNATED OFFICER
1.Issue or Cancel licence of food business operator.
2. Prohibition of sale in contravention of this act.
3. Receive report and samples of article of food from Food Safety
Officer and get them analysed.
4. Maintain records of all investigations made by Food Safety Officer
5. Investigation of Complaints in respect of any contravention of
provision of this act.

10. Label requirement as per FSSAI
1.The word “NUTRACEUTICAL”.
2. Brand name of Drug products
3. The list of ingredients shall contain an appropriate title, such as the
term “Ingredients”(Ingredients specified in Schedule I to VI as per
FSSAI must be used ).
4. The name of Ingredients used in the product shall be listed in
descending order of their composition by weight or volume .
5. A specific name shall be used for ingredients in the list of
Ingredients.

11. 6. An advisory warning for ‘recommended usage’ ;
7. An advisory warning ‘NOT FOR MEDICINAL USE’ prominently
written;
8. A statement that the health supplement is not to be used as a
substitute for a varied diet;.
9. A warning or any other precautions to be taken while consuming,
known side effects, if any, contraindications, and published product or
drug interactions, as applicable; and
10. A statement for storage condition : Store in an air tight container
;to be stored out of reach of children.

12. 11.Nutritional information – Nutritional Information or nutritional
facts per 100 gm or 100ml or per serving of the product shall be given
on the label containing the following:— i) energy value in kcal;
ii) the amounts of protein, carbohydrate (specify quantity of sugar)
and fat in gram (g) ;
12. Manufactured by or Marketed by with complete address with
FSSAI Logo and licence no.format used for logo as follows
FSSL 10000000000000

13. 13. If any food formulation contains non vegetarian ingredient
then it should be displayed as brown colour logo as follows
Brown colour
14. If any food formulation contains vegetarian ingredient then it
should be disaplayed as green colour logo as follows
Green colour
15. FSSAI Approved colours, flavours should be used with their INS
No.
e.g.- Sunset Yellow - INS NO: 110
Erythritol - INS NO: 968

15. Specific restrictions on Product labels
1. The label shall not contain any reference to the Act or any of these
regulations or any comment on, or reference to, or explanation of
any particulars or declaration required by the Act.
2. Labels not to use words implying recommendations by medical
profession ( e.g.- the food is recommended, prescribed, or approved
by medical practitioners or approved for medical purpose).
3. Unauthorized use of words showing imitation prohibited .
4. The word "pure" or any word or words of the same significance shall
not be included in the label of a package that contains an imitation
of any food.
5. Do not use of any logo of certified agency .if you have to use logo
then you have to take permission for same one.if they permitted
then and then only you can use same logo on product label.(e.g. ISO
Certified,GMP Certified).

16. Documents required for new application for license to State/Central
Licensing Authority
1.Form-B (Application for License / Renewal of license under Food
Safety and Standards Act, 2016) duly completed and signed (in
duplicate) by the proprietor/ partner or the authorised signatory.
2. Blueprint/layout plan of the processing unit showing the dimensions
in metres/square metres and operation-wise area allocation.
3. List of Directors with full address and contact details.
4. Name and List of Equipments and Machinery along with their ID
which actually used for formulation of product.
5. Photo I.D and address proof issued by Government authority of
Proprietor/Partner/Director(s)/Authorised Signatory.

17. Documents required for new application for license to State/Central
Licensing Authority
6. List of food products desired to be manufactured. ( In case of
manufacturers).
7. Authority letter with name and address of responsible person
nominated by the manufacturer along with alternative responsible
person indicating the powers vested with them viz assisting the officers
in inspections, collection of samples, packing & dispatch.
8. Analysis report (Chemical & Bacteriological) of water to be used as
ingredient in food from a recognized/ public health laboratory to
confirm the portability .
9. Proof of possession of premises. (Sale deed/ Rent agreement/
Electricity bill, etc.)

18. Documents required for new application for license to State/Central
Licensing Authority
10. Partnership Deed/ Affidavit/ Memorandum & Articles of Association
towards the constitution of the firm.
11. Food Safety Management System plan or certificate if any,
12. Recall plan wherever applicable, with details on whom the product is
distributed.
13. List of workers with their medical fitness certificates.
14. Name, qualification and details of technical personnel in charge of
operation.
15. Nominee certificate /acceptance certificate/Application letter

19. Issuance of Licence
1.Submission of all documents by FBO,Concerned designated officers
checks same document. If there is any document still remain then
he intimates to FBO for fulfill the required documents.
2. Designated officer will give him unique application number and fix
the date of inspection of manufacturing premises.
3. Either grant or reject the license within 60 days of receipt of
completed application or within 30 days of inspection.
4.The applicant may start his food business if a licence is not issued
within two months from the date of application or his application is
not rejected.
5. If the articles of food are manufactured, stored, sold or exhibited for
sale at different premises situated in more than one area, separate
applications shall be made and separate licence shall be issued for
such premises not falling within the same area.

20. Conditions of License
All Food Business Operators shall ensure that the following conditions
are complied with at all times during the course of its food business.
Food Business Operators shall:
1.Display a true copy of the license granted in Form C shall at all times at
a prominent place in the premises.
2. Give necessary access to Licensing Authorities or their authorised
personnel to the premises .
3. Inform Authorities about any change or modifications in activities
/content of license.

21. Conditions of License
4. Employ at least one technical person to supervise the production
process. The person supervising the production process shall possess at
least a degree in Science with Chemistry/Bio Chemistry/Food and
Nutrition/ Microbiology or a degree or diploma in food technology.
5. Ensure that no product other than the product indicated in the
license/ registration is produced in the unit.
6. Maintain daily records of production, raw materials utilization and
sales separately.
7. Maintain factory's sanitary and hygienic standards and worker's
Hygiene.
8. Ensure that the source and standards of raw material used are of
optimum quality.

22. Conditions of License
9. Ensure Clean-In-Place systems (wherever necessary) for regular
cleaning of the machine & equipments.
10. Ensure that as much as possible the required temperature shall be
maintained throughout the supply chain from the place of procurement
or sourcing till it reaches the end consumer including chilling,
transportation, storage etc.
11. Nutritional parameter and pesticides residue analysis of food
products should be done from NABL accredited /FSSA notified labs.
12. The manufacturer/importer/distributor shall buy and sell food
products only from, or to, licensed/registered vendors and maintain
record thereof.