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1
PRESENTATION ON LABELING OF NUTRACEUTICALS
PRESENTED TO PRESENTED BY
Prof. Shubini A Saraf Govind Yadav
(Department of pharmaceutical science) Babasaheb Bhimrao Ambedkar University Lucknow
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Contents:IntroductionFunction of labelsObjective of labelsContents in labelsRegulation of nutraceutical
labeling in IndiaLabeling system in JapanDifferent labels
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IntroductionLabel :- ( 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 labelsTo identify the productProvide ingredientsPurpose /use of the productDecoration as evidenceChild safetyOther 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 devicesNutraceuticals
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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 IndiaNo 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
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Labeling in Japan
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Labeling in India
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New FDA Labeling RequirementsOn 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 manufacturers to comply by July 26,
2018.
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A COMPARATIVE STUDY OF
REGULATORY REGISTRATION
PROCEDURE OF NUTRACEUTICALS
IN INDIA, CANADA AND AUSTRALIA
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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’.
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Regulatory Act(s) and Issues of India, Canada and AustraliaCountry 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 1989FSANZ 1991
Regulation of CMsDevelops 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 AustraliaDefinition 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 ClaimHigh Level Health claim
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THANK YOU