The Food And Drink Innovation NetworkOmega-3 Seminar, Northamptonshire, 19th Oct 2005

Melanie Ruffell, Executive DirectorUK Joint Health Claims Initiative

Food Industry

Enforcement Consumers

Healthy Claims

• JHCI background

• General principles for making healthy claims

• Substantiation requirements overview

• JHCI approved claim for LC omega-3 PUFA

Overview

• A unique joint venture between consumer organisations, enforcement authorities and industry trade associations

• To establish a voluntary Code of Practice for the use of health claims on food, beverages and supplements

• To provide case by case advice and an independent scientific opinion about the validity of health claims

• To help ensure claims do not mislead consumers or contravene food law

What is the JHCI?

Council - 3 Enforcement authority reps - 3 Food industry reps

- 3 Consumer interest reps - Independent Chairman

Secretariat - Executive Director

- Administration Assistant

Expert Committee - 7 independent scientists

Observers - FSA, ITC, CAP/ASA, BACC

Who is the JHCI

• to protect and promote public health

• to help companies to provide accurate & responsible information relating to food to enable consumers to make informed choices

• to promote fair trade & innovation in the food industry

• to promote consistency in the use of health claims across different media

• to promote consistency in the regulation of health claims in the UK, Europe and internationally.

JHCI Objectives

How JHCI can help

The Code is not part of food legislation and does not replace or compete with the current UK systems of regulation and self-regulation

IN THE SHORT TERM: • Compliance with the Code assists companies to establish a defence

of all due diligence in the event of prosecution over the truthfulness of claims

IN THE LONG TERM: • Lack of high profile cases helps restore consumer faith in products

carrying health claims• Help prepare for the new legal environment and help ensure

suitable claims stay on the market under new legislation

Types of claims

Lc n

-3 P

UFA

hel

ps m

aint

ain

a he

alth

y he

art

(hea

lth m

aint

enan

ce)

LC

n-3

PU

FA im

prov

es

vasc

ular

end

othe

lial f

unct

ion

(enh

ance

d fu

nctio

n) L

C n

-3 P

UFA

con

trib

utes

to n

orm

al v

ascu

lar

endo

thel

ial f

unct

ion

(nut

rien

t fun

ctio

n)

LC n

-3 P

UFA

hel

ps r

educ

e th

e

risk

of C

VD

(dis

ease

ris

k re

duct

ion)

MEDICINE FOOD

LC

n-3

PU

FA h

elps

prev

ent h

eart

att

acks

(med

icin

al)

Borderline Area

Stated claims

• Wording

Implied claims

• Brand name

• Pictures

• Images

• Endorsement

NB: Has not been considered by JHCI

Consumer perception

• Consumer perception is paramount

• Not just one interpretation, but all likely interpretations of a health claim must comply with the Code

• A range of factors which can determine consumer perception, e.g. use of pictures and logos on the packaging

HOW WILL THE CONSUMER INTERPRET THE STATED OR IMPLIED CLAIM?

Legal and Nutrition Principles

Claims should, e.g.:

• not exaggerate the effect or claim benefits beyond the scope of evidence

• be communicated in a way to assist consumer understanding of the basis of the health claim

• include quantification of the active ingredient

• be supported by instructions for recommended consumption patterns and amounts

Using pre-approved generic claims

• Claims freely available from JHCI website

• Approval includes claim-specific conditions for use and points to note

• Companies strongly advised to discuss use of claims with JHCI to ensure products and marketing complies with the JHCI Code

Working with the Evidence:Substantiation of Health Claims

Approval process requirements

Dossier must include:

1. Proposed health claim

2. Systematic Review of Evidence

3. Supplementary information:

• Relevance to UK public health context

• Potential implications

• Typical products likely to carry the claim

• Sample labels

• Statement of intended use; level and frequency of consumption

• Other documentation (see JHCI Code)

Approved claims based on systematic review of evidence

What is a systematic review of the evidence?

• Evidence directly linked to the claim• Searched, reviewed and presented in an objective and

unbiased manner• Using a pre-defined and reproducible methodology.

Why?

Reassures the JHCI Expert Committee that all relevant papers have been included, so it can make an informed decision based on the totality of evidence.

Filtering the Evidence

YEAR

SEARCHED ARTICLES

FOUND ABSTRACTS

READ FULL

ARTICLES RETRIEVED

INCLUDED AS

EVIDENCE 2001 31 7 2 1 2000 39 15 3 1 1999 36 11 3 2 1998 19 2 2 1 1997 21 1 1 0 1996 8 0 0 0 1995 20 0 0 0 1994 18 1 1 0 1993 7 0 0 0 1992 16 0 0 0 1991 5 0 0 0 1990 9 0 0 0

Statistical summary of data (forest plot)

Demonstrates overall consistency of results

Dossier requirements put simply…

Unbiased, transparent systematic approach

Evidence reflects application

Set in (UK) public health context

Anticipated use of claims

Complies with legal

and nutrition principles

in Code

LC n-3 PUFA JHCI Claim

Eating 3g weekly, or 0.45g daily, long chain omega-3 polyunsaturated fatty acids, as part of a healthy lifestyle, helps maintain heart health. (11/02/05)

POINTS TO NOTE: A. The claim relates only to very long chain

polyunsaturated fatty acids (of chain length 20 carbons or above) including EPA, DPA and DHA (i.e. 20:3n-3, 20:4n-3, 20:5n-3, 22:5n-3 and 22:6n-3), and not all long chain polyunsaturated fatty acids, such as alpha-linolenic acid (i.e. 18:3n-3 and 18:4n-3). The ratio of EPA and DHA should reflect that which occurs naturally in oily fish.

LC n-3 PUFA JHCI Claim

1. Include the statement: ‘The Government advises that at least 2 servings of fish, one of which should be oily, containing approximately 3g LC n-3 PUFA, is consumed each week’.

2. For fortified foods and supplements, inform consumers that oil-rich fish is an alternative source of LC n-3 PUFA.

3. When a product is presented as a stand alone serving, then each serving must contain no less than 0.2g LC n-3 PUFA.

4. Not personalise the claim to the individual, e.g. “provides half your daily needs”.

B. Products carrying the claim should:

LC n-3 PUFA JHCI Claim

B. Products carrying the claim should (cont’d):

5. When a product carries a recommendation for a number of portions per day or week then:

• the total LC n-3 PUFA content of the daily recommendation (daily serving) must be greater than 0.2g.

• the total LC n-3 PUFA content of the weekly recommendation (weekly serving) must be greater than 0.5g.

6. State the proportion (i.e. a ‘quarter’, ‘third’, ‘half’ etc) of the 0.45g daily intake, or 3g weekly intake, in each serving or portion.

LC n-3 PUFA JHCI Claim

7. Clarify the distinction between servings of a product and portions of oily fish.

8. Clarify to consumers when products have been fortified with LC n-3 PUFA and make clear to consumers the origin of the oil.

9. Products containing significant amounts of contaminants (identified by the SACN/COT Inter-Committee Subgroup to be marlin, swordfish, shark and, to a lesser extent, tuna) carrying the claim should also carry a warning for pregnant women and children.

B. Products carrying the claim should (cont’d):

LC n-3 PUFA JHCI Claim

POINTS TO NOTE (cont’d):

C. The JHCI Code states that health claims that could encourage high levels of consumption must not be made for any substances where there is evidence that high intakes of the food or substance could be harmful or unlikely to contribute to a healthy diet (refer section 6.2.16).

JHCI advises that products carrying the claim should make a positive contribution to healthy eating. Products high in saturated fatty acids, salt, sugar etc should therefore not be promoted on this basis.

LC n-3 PUFA JHCI Claim

POINTS TO NOTE (cont’d):

D. The JHCI strongly recommends that companies seek advice from the Secretariat before using this claim to help ensure that the food product is consistent with good nutrition principles and complies with the JHCI Code of Practice for Health Claims on Food.

E. The wording of the claim has been carefully formulated to reflect the evidence on which the claim has been approved. Wording may be altered, in consultation with the JHCI, as long as the claim does not imply health benefits beyond the scope of the evidence change the meaning of the claim; or, confuse consumers.

LC n-3 PUFA JHCI Claim

Approval of the use of nutrient content claims on food labels is beyond the remit of JHCI, therefore appropriate legal advice must be sought by those wishing to use such claims.

However, the JHCI Expert Committee considered, from a scientific basis, that nutrient content claims could be substantiated as follows and recommended that it be made clear to consumers when these claims were in relation to the daily amount or weekly amount.

NUTRIENT CONTENT CLAIMS

LC n-3 PUFA JHCI Claim

Based on a WEEKLY intake amount:

• ‘A good source of the weekly intake’ = at least 1/6th of 3g LC n-3 PUFA per week

• ‘A rich source of the weekly intake’ = at least ½ of 3g LC n-3 PUFA per week

Based on a DAILY intake amount:

• ‘A rich source of the daily intake’ = at least ½ of 0.45g LC n-3 PUFA per day

Quantification of nutrient content claims should be reported to the nearest 0.1g/100g, so not to imply a higher level of precision than exists.

NUTRIENT CONTENT CLAIMS (cont’d)

• Don’t dilute the claim – ensure all salient points are included in any revised wordings.

• The claim is about long chain n-3 PUFA – this should not abbreviated to ‘omega-3’.

• Ensure nutrition composition panel also is expressed in ‘g’ not ‘mg’ (to be consistent with claim).

LC n-3 PUFA JHCI Claim

General advice:

JHCI Contact Details

P.O. Box 43Leatherhead, Surrey

KT22 7ZWUnited Kingdom

Ph: 0044 (0)1372 822 378Fax: 0044 (0)1372 822 288

melanieruffell@jhci.org.uk

www.jhci.org.uk