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Presentation On NUTRACEUTICAL LABELING

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PRESENTATION ON LABELING OF NUTRACEUTICALS PRESENTED TO PRESENTED BY Prof. Shubini A Saraf Govind Yadav (Department of pharmaceutical science) Babasaheb Bhimrao Ambedkar University Lucknow 1
Transcript
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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


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