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Health Claims:
Latest Developments
Functional Food and Product Health Claims Seminar
Melton Mowbray, 20th April 2004
Melanie Ruffell, Executive Director
UK Joint Health Claims Initiative
Food Industry
Enforcement
Consumers
Overview
• What is the JHCI
• EC proposed Nutrition and Health Claims Regulation
- Key issues
• Well-established health statements: project overview
• Well-established nutrient function statements
- Examples
- Applications
• JHCI approved generic health claims
What is the JHCI?
• 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
Who is 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
Stated claims
• Wording
Implied claims
• Brand name
• Pictures
• Images
• Endorsement
NB: Has not been considered by JHCI
JHCI Objectives
• 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
in the UK, Europe and internationally.
Scope of the Code
Applies to any claim in promotional material for
food, beverages or dietary supplements:
• direct (whole product)
• indirect (ingredients)
• implied (logos, endorsements, pictures)
• in product labelling
• in advertising, marketing (TV, radio, Internet)
• in scientific literature associated with products
How JHCI can help
• Compliance with the Code assists companies to
establish a defence of all due diligence in the event
of prosecution over the truthfulness of claims
• Lack of high profile cases helps restore consumer
faith in products carrying health claims
The Code is not part of food legislation and does not
replace or compete with the current UK systems of
regulation and self-regulation
Claims approval in UK 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.
Proposed Health Claims Regulation
Health claims may be used on complying food products if:
•
They appear on the Register of claims based on
generally-accepted science
OR
•
They have been authorised for use by the Commission
Some practical considerations …
•
•
•
•
Approval timeframe could be 9 - 12 months
Submission of claims in all Community languages
Centralised assessment of consumer understanding
Centralised assessment of nutrition profiles
Prohibitions
Blanket prohibitions -
in addition to prior approval scheme
•
Weight management, satiety
•
Too non-specific (general well-being)
•
Too specific (e.g. folic acid and homocysteine)
•
Health charity endorsements
•
Alcohol
•
Psychological / behavioural
•
Medicinal
Types of Health Claims
MEDICINE
Borderline Area
FOOD
Timeframe for approval
Approval timeframe 180 days bare minimum
-
Dossier must be prepared to the standard, and the
format, required by the Authority, so not to create
further delays
-
Dossier preparation is time consuming and
expensive; submitter cannot afford costly errors
during preparation
Wording of Claims
Requirement to submit claims in all Community languages
–
Overly burdensome with the variability in local culture,
traditions, tastes and diet?
-
Will appropriate translations of the claim exist for
language-specific terms?
-
Will full re-submission be required if a small change of
wording in one Member State is requested?
Consumer Understanding
Centralised assessment of local consumer understanding
-
How will the Authority verify that the proposed claim
is understandable and meaningful to all consumers
across the EU Member States?
-
‘Average consumer’ vs ‘intended consumer’
Nutrition Profiles
Centralised assessment of nutrition profile of local foods
-
Subject of massive debate
-
Strict criteria for all foods too restrictive - possibility of
exemptions, e.g. oily fish
-
Overly burdensome with the variability in local culture,
traditions, tastes and diet?
-
Development of European nutrition framework
proposed
Community Register
•
Member States to contribute to the Register of
well-established claims (Article 12):
‘…health claims describing the role of a nutrient
or of any other substance in growth,
development and normal physiological functions
of the body, which are based on generally
accepted scientific data and well understood by
the average consumer…’
Types of Health Claims
MEDICINE
Borderline Area
FOOD
JHCI ‘Well-established
Health Statements’ project
• UK government funded project to:
- develop a process to identify and define ‘well-
established’ health statements
- produce a list of ‘well-established’ nutrient function
statements
- help provide a mechanism for continuation of well-
established claims currently in use
• Published on UK Food Standards Agency website:
http://www.food.gov.uk/news/newsarchive/jhcinews170304
JHCI ‘Well-established
Health Statements’ project
KEY AIMS:
1. To help inform the UK position during negotiations
with the E C on its proposed health claims
legislation.
2. To help develop a mechanism for handling existing
health claims during the implementation of the
legislation.
3. To provide a framework for identifying claims that
are based on generally accepted scientific data,
which can be added to the EC Register
4. To help form the UK’s contribution to a Europeanwide positive list of well-established health
statements.
JHCI ‘Well-established
Health Statements’ project
SCOPE OF WORK:
• based on well-established scientific evidence - not
emerging scientific evidence
• based on a normal physiological function - not an
enhanced function; function that reduces the risk of
developing a disease; or, function that that can be
attributed to the prevention, treatment or cure of a
disease
• restricted to the vitamins and minerals listed in
Annex 1 to the Food Supplements Directive (2002)
JHCI ‘Well-established
Health Statements’ project
SCOPE OF WORK, continued:
• are related to quantities of nutrients that can be
obtained from a normal diet - not pharmacological
quantities
• have not been considered in terms of their legal
acceptability or meaningfulness to consumers
• have not been considered in terms of their
application to food products and as such are not
approved health claims for food.
JHCI Well-established
Health Statements project
Process Overview
Step 1.
Clearly define ‘well-established’
Step 2.
Determine priority order
Step 3.
Establish working definitions as necessary
Step 4.
Agree credible source documents to draw up
a list of possible functions
Step 5.
Develop phraseology as necessary
Step 6.
Draw up comprehensive list of health
statements.
Results
Table 1a:
Well-established nutrient function statements
(common to all vitamins and minerals)
‘X’ contributes to normal reproduction
‘X’ contributes to normal conception
‘X’ contributes to normal development
‘X’ contributes to normal growth
‘X’ contributes to normal body maintenance
Results
Table 1b:
Approved well-established nutrient function statements
(specific to certain vitamins and minerals), e.g.:
VA1b:
‘Vitamin A is necessary for normal vision.’
Ni1:
‘Niacin is necessary for the normal release of energy from food.’
VB64:
‘Vitamin B6 contributes to the maintenance of normal blood
homocysteine levels.’
Fo2:
‘Folate is necessary for the normal structure of the neural tube in
developing embryos.’
VC1:
‘Vitamin C is necessary for the normal structure and function of
connective tissue (such as that required for normal gums, skin,
healing processes, bone and cartilage).’
Na1:
‘Sodium is necessary for normal water and electrolyte balance
throughout the body.’
Results
Table 2:
Rejected nutrient function statements, e.g.:
VA3:
Vitamin A contributes to normal embryonic development.
(see Table 1a)
VC4:
Vitamin C is necessary for the normal structure of gums.
(see VC1)
Fe6:
Iron contributes to normal taste function. (data insufficient)
Cr1:
Chromium is necessary for the normal regulation of insulin.
(no plausible mechanism)
P3:
Phosphorus contributes to the normal regulation of pH
levels in the body. (too imprecise)
Ca7:
Calcium contributes to maintaining normal blood pressure.
(data inconsistent)
Project Summary
• not approved for use as health claims on foods
• provide a sound scientific basis for the
development of such claims.
• food manufacturers and businesses wishing to
generate health claims from these statements
they should ensure that, when used in food
labelling or to promote food products, they are
meaningful and not misleading to consumers.
They will also need to satisfy themselves that the
claims comply with all the relevant legislation.
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?
Implied health claim
Source:
ASA Adjudications
www.asa.org.uk/adjudications/
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
• not encourage consumption of foods high in added
salt, sugar, saturated fat
• be supported by instructions for recommended
consumption patterns and amounts
Generic Claims in the UK
JHCI has considered evidence in relation to:

saturates and blood cholesterol
 wholegrain and heart health
 soya protein and heart health
 fruit & lung cancer*
 vegetables and bowel cancer*
 fruit and vegetables and stomach cancer*
* illegal under current food law, but will be permitted
under proposed new rules
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
JHCI Contact Details
P.O. Box 43
Leatherhead, Surrey
KT22 7ZW
United Kingdom
Ph: 0044 (0)1372 822 378
Fax: 0044 (0)1372 822 288
[email protected]
www.jhci.org.uk
The
Food & Drink
Innovation
Network
www.fdin.co.uk