Prof. Shubini A Saraf Govind
Yadav
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Contents:
 Introduction
 Function of labels
 Objective of labels
 Contents in labels
 Regulation of nutraceutical labeling in
India
 Labeling system in Japan
 Different labels
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Introduction
Label :- ( As per IP)
Any printed packing material,
including package inserts that provide
information on the article
The oxford dictionary defines a label as
“a slip of paper, card, liner, metal for
attaching to an object and indicating its
nature, owner, name,etc
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Function of labels
 To identify the product
 Provide ingredients
 Purpose /use of the product
 Decoration as evidence
 Child safety
 Other information like maximum retail
price(MRP), Batch NO, Shelf-life,etc
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Objective of labeling
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Who uses product labeling
 Pharmaceutical Food Personal
care
 Bio-tech Beverages Cosmetics
 Medical devices
 Nutraceuticals
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 To Summarize - Which Information Is Mandatory?
Labeling of packaged food products shall include
the following information:
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Contents in a Nutraceutical
label
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Regulation of Nutraceuticals in
India
 No clear regulatory framework exists:
◦ The Prevention Of Food Adulteration Act, 1954
◦ Food Products Order
◦ Drugs and Cosmetics Act
(Ayurvedic, Unani & Siddha Drugs Technical Advisory Board)
◦ The Drugs And Magic Remedies (Objectionable
Advertisements) Act, 1954
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Food Safety and Standards
Authority of India 2011
General Requirements:
 Every pre-packaged food shall carry a
label containing information
 Label in pre-packaged food shall be
applied in such a manner that they will
not become separated from the
container
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Food Safety and Standards
Authority of India 2011
 The particulars of declaration required
under these regulations to be
specified on the label shall be in
English or Hindi
 Pre-packed food shall not be
described or presented on any label or
in any label manner that is false,
misleading 20

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Labeling in Japan
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Labeling in India
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New FDA Labeling
Requirements
 On May 20, 2016, the U.S. Food and
Drug
Administration (FDA) finalized significant
changes to food, beverage, and
supplement
labeling, including updates to daily values,
serving sizes, the Nutrition Facts chart, and
more. The new rules become effective on
July
26, 2016 and require most food 32

A COMPARATIVE STUDY OF
REGULATORY
REGISTRATION
PROCEDURE OF
NUTRACEUTICALS
IN INDIA, CANADA AND
AUSTRALIA 33

Definition
 INDIA: Food Safety and Standards authority (FSSA) defines
Nutraceuticals as “Foods for special dietary uses” in India.
 CANADA: In Canada Nutraceuticals are known as Natural
health Products. Under the Natural Health Product
Regulations.
 AUSTRALIA: In Australia, traditional, herbal, natural and
alternative medicines and remedies are referred to as
‘complementary medicines’. 34

Regulatory Act(s) and Issues of India, Canada
and Australia
Country Regulatory act Regulatory issues
India The Food Safety and Standard Act
(FSSA), 2006
The Food Safety and Standard
Authority of India (FSSAI), 2008
Manufacture, sell or import of
novel foods, GMF, functional
food, nutraceuticals and health
supplements
Canada Canadian Food and Drugs Act,2001
Natural Health Product Directorate
(NHPD), 2003
Describe foods with health
benefits
Define nutraceutical
Australia Therapeutic Goods Act 1989
FSANZ 1991
Regulation of CMs
Develops food standards
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REGULATORY REGISTRATION PROCEDURE
OF NUTRACEUTICALS IN
INDIA, CANADA AND AUSTRALIA
1. Regulatory Registration Requirements in India
A. Product Evaluation : Examination of each active
ingredient & additive.
B. Licenses: To get Product registered in India, number of
licenses (almost 4 - 5) might be required, depending on the
actual product status.
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C. Health and label Claims: “Health claims” means
any representation that states, suggests or implies that a
relationship exists between a food or a constituent of
that food and health .
Health claims can further be grouped into:
1. Nutrient function claims
2. Other function claims and
3. Reduction of disease risk claims.
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2. Regulatory Registration requirements in
Canada
Natural Health Products Regulations for Traditional
medicines, Herbal remedies, homeopathic
medicines, vitamins, minerals, probiotics, amino
acids and essential fatty acids.
A. Product licensing: A product licensing system
requires that all licensed products display a Product
identification
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Number prefixed by NPN/NPN-HM The number is issued once
a product is authorized for sale in Canada by Natural Health
Product Directorate.
B. Evidence requirements for Safety & efficacy: The
safety and efficacy of NHPs and their health claims must be
supported by proper evidence
C. Labelling: All NHPs must meet specific labelling
requirements, to help us make safe and informed choices
about the NHPs which are choosen to use.
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D. Site Licensing: A Site licence issued by the
NHPD (Natural Health Products Directorate) gives
the licensee authorization to manufacture, package,
label and/or import NHPs.
E. Good Manufacturing Practices: The site to
meet GMPs as per Natural products Regulations.
GMPs are to be employed to ensure product safety
and quality.
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F. Adverse Reaction Reporting: The Natural
Health Products Regulations require product
licence holders to monitor all adverse reactions
related to their product. License
holders must report serious adverse reactions to
Health Canada.
G. Clinical Trials: A clinical trial is when natural
health products are tested using human subjects.
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Health Claims: a health claim for food is considered to be
“any representation in labeling and advertising that states,
suggests, or implies that a relation exists between the
consumption of foods or food constituents and health”.
Types:
1. Specific health claims: are claims about the effects of
a food, or food constituent, on a specific organ, disease,
biomarker, or health condition.
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There are 2 types of specific health
claims:
A. Disease risk-reduction claims.
B. Function claims.
2. General health claims: are claims that do
not refer to a specific health effect, disease or
health condition .
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3. Regulatory Registration requirements in
Australia
CMs in Australia are regulated under the following
legislation:
 Therapeutic Goods Act 1989
 Therapeutic Goods Regulations 1990 (as amended)
1) Product licensing: All CMs must be entered (on
application to the TGA) in the ARTG. Regulation is on the
basis of risk. Products can be either listed (low risk) or
registered (higher risk).
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2) Good manufacturing practice: All products must be
manufactured in compliance with GMP.
3) Site licensing: The TGA licenses manufacturers and
audits GMP compliance.
4) Labelling requirements: Registered medicines (higher
risk) are identified on the label by AUST R followed by a
unique number. Listed medicines (low risk) are identified on
the label by AUST L followed by a unique number.
5) Post-market regulatory activity: The TGA takes a
risk-based approach to post-market surveillance.
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Health Claims: Types
1. General level claims: General level claims are claims
where the manufacturer has to make an assessment of the
evidence supporting the claim prior to the product going to
market, and to hold the evidence
2. High level claims:-
 High level claims are those claims which make reference to a
serious disease, including:
 Claims that refer to the potential for a food or component to
assist in controlling a serious disease or condition.
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COMPARATIVE STUDY OF REGULATORY REGISTRATION OF
NUTRACEUTICLAS IN INDIA, CANADA AND AUSTRALIA
S. No. India Canada Australia
Definition FSSA define
Nutraceutical as
“Foods for Special
dietary use”
NHPD define
Nutraceutical as
“Natural Health
Products”
TGA define
Nutraceutical as
“Complementary
Medicines”
Rules/Regulations
for licensing and
registration
The Food Safety
and Standards
Regulations
Natural Health
Products
Regulations
Therapeutic Goods
Regulations.
Regulations came
into force in year
2011 2004 1989
Responsible
Regulatory
authorities for
Registration of
Nutraceuticals
Food Safety and
Standard
Authority of India
(FSSAI)
Natural Health
Product
directorate
(NHPD),
Health Canada
Therapeutic Good
Administration
(TGA)
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Continued…
Regulatory
Requirements for
Registration
A. Product
evaluation
B. Licenses
C. Health & label
claim
A. Product
licensing
B. Evidence
requirements for
Safety & efficacy
C. Libeling
D. Site Licensing
E. GMP
F. Adverse
Reaction
reporting
G. Clinical Trials
A. Product
Application
B. GMP
C. Labeling
D. Post-market
Surveillance
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Continued…
Fees for
registration
Rs. 100 Currently No
fees required
$AUS 720
Authorities for
approval of
claims
FSSA Health Canada FSANZ
Health Claims 1) Nutrient
function claim,
2) Other function
claims,
3) Reduction of
disease risk
claims
General Health
Claims
Specific Health
claims
General Level
Health Claim
High Level
Health claim
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THANK
YOU
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