Transcript Gains and losses in Health Claims Arena – Janice Harland

GAINS & LOSSES
in the
HEALTH CLAIM ARENA
Dr Janice Harland
ASSOCIATES, UK
OUTLINE

Health Claims






Energy – just what can be claimed now?
Digestive health – a marketing success story, but who
are the winners for claims?
What’s on the horizon for weight loss claims?
Movement – muscle, bone and joint health EFSA
update
Other gains & losses
Other considerations
2
© HarlandHall Associates
INTRODUCTION

Health Claims – health warning!





Await wording from EC on approved claims
Await confirmation that EC will adopt all of EFSA
opinions
Await final assessments from EFSA
Await nutrient profiles
The views expressed are personal,
every attempt is made to be accurate,
but please take advice, as interpretation
of the Regulation is not finalised
3
© HarlandHall Associates
ENERGY: JUST WHAT CAN BE CLAIMED
NOW?
EFSA - cause & effect relationship has been
established between:

thiamine/niacin/riboflavin/pantothenic acid/ vitamin B6,
vitamin B12, vitamin C, biotin, Ca, P, Mg, Cu, I, Mn and
normal energy-yielding metabolism

the consumption of glycaemic carbohydrates and
maintenance of normal brain function

the consumption of creatine and an increase in physical
performance during short-term, high intensity, repeated
exercise bouts
4
© HarlandHall Associates
ENERGY: JUST WHAT CAN BE CLAIMED
NOW?
EFSA - cause & effect relationship has been
established between:
carbohydrate electrolyte solutions that
 contribute to the maintenance of endurance
performance during prolonged endurance exercise

enhance the absorption of water during physical
exercise
Conditions of use:

80-350 kcal/L from carbohydrates, and at least 75 % of the energy should be derived from
carbohydrates which induce a high glycaemic response, such as glucose, glucose polymers and
sucrose. In addition, these beverages should contain between 20 mmol/L (460 mg/L) and 50 mmol/L
(1,150 mg/L) of sodium, and have an osmolality between 200-330 mOsm/kg water..
5
© HarlandHall Associates
ENERGY: JUST WHAT CAN BE CLAIMED
NOW?
EFSA - cause & effect relationship has been
established between the consumption of:

caffeine and increase in endurance performance
/endurance capacity reduction in the rated perceived
exertion during exercise

caffeine and increased alertness

caffeine and increased attention
In order to bear the claim, a product should contain at least
75 mg caffeine per serving

For children, consumption of a dose of 5 mg/kg body weight could result in transient behavioural changes, such
as increased arousal, irritability, nervousness or anxiety. In relation to pregnancy and lactation, moderation of
caffeine intake, from whatever source, is advisable.
6
© HarlandHall Associates
ENERGY: NEW OPPORTUNITIES

the consumption of fructose in place of sucrose or glucose in foods
or beverages

xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, Dtagatose, isomaltulose, sucralose or polydextrose instead of sugar

pectins, beta-glucans from oats and barley, arabinoxylan produced
from wheat endosperm, resistant starch, slowly digestible starch,
Hydroxypropyl Methylcellulose (HPMC)
....and reduction of post-prandial glycaemic responses
lower blood glucose rise after a meal
BUT NOT

and the long-term maintenance or achievement of normal blood
glucose concentrations

glycaemic carbohydrates and energy metabolism
7
© HarlandHall Associates
ENERGY: NOT ESTABLISHED

the consumption of caffeine
and an increased fat oxidation leading to a reduction in
body fat mass
 and increased energy expenditure leading to the reduction
of body weight
... the consumption of carnitine, Coenzyme Q10, folate,
taurine and normal energy metabolism


BUT
 a cause and effect relationship has been established between
the dietary intake of folate and the reduction of tiredness
and fatigue.
8
© HarlandHall Associates
ENERGY: TAKE CARE
9
© HarlandHall Associates
ENERGY: TAKE CARE

Wording from EC critical

Await confirmation that EC will adopt all of EFSA opinions
10
© HarlandHall Associates
DIGESTIVE HEALTH – A MARKETING
SUCCESS STORY

UK sales of pre and probiotic yogurts are expected
to show strong growth from £12.63 to £15.78 per
head by 2016

Claims related to digestive health are key to
consumers

Everyone knows about
friendly bacteria
11
© HarlandHall Associates
DIGESTIVE HEALTH – SCIENTIFIC
UNCERTAINTY

Probiotics - no positive opinions from EFSA (276 rejections)

Prebiotics – no positive opinion for galacto oligosaccharides,
resistant starch, polydextrose, gums

Insufficient characterisation of bacteria

Studies conducted on inappropriate subjects (not healthy)

...EFSA Panel considers that the evidence provided does not
establish that increasing numbers of intestinal microorganisms
is a beneficial physiological effect. The Panel considers that
decreasing potentially pathogenic gastro-intestinal
microorganisms might be a beneficial physiological effect....

Studies and claim not perfect match

12
Inconsistent results
© HarlandHall Associates
DIGESTIVE HEALTH – FUTURE

Yakult says its rejected EU health claim for upper
respiratory tract infection (URTI) benefits won’t alter
its core sell in Europe

Feb 2012 Danone formed the Global Alliance for
Probiotics (GAP) with other sector businesses: Yakult,
DuPont-Danisco and Chr Hansen as industry seeks to
win first EU health claim

Mar 2012 GAP state a complete rethink of probiotic
health claim rules is required in EU, and Industry
should be part of the process

In the meantime...
13
© HarlandHall Associates
DIGESTIVE HEALTH – FUTURE

Italian Ministry of Health revised probiotic
characterisation, labelling & claim guidelines –
opportunity to open claim-making around the idea of
microflora balance.
....EFSA has said increasing healthy gut flora is not of
itself a health benefit, the Italian ministry indicates
“supports balance of the internal microflora” is a
condition of use ...

...therefore this indication is not considered as a health
claim in the sense of the Regulation (Barbara Klaus,
legal firm Meyer Meistererns, Italy)

Nutrition labelling options?
14
© HarlandHall Associates
DIGESTIVE HEALTH – FUTURE

Potential loopholes that could fall under nutritional
labelling or “nutrition claim” rules; where the probiotic
bacterial strain was used as a “generic descriptor”

Probiotic strain forms part of the name of a product, (i.e.
part of trade mark or brand name of product) which had
been traditionally used prior to 1/1/2005 may be marketed
until 19/1/2022 .
15
© HarlandHall Associates
DIGESTIVE HEALTH – FUTURE

Probiotic claims still awaiting evaluation

EFSA committed £4500 to produce characterisation
document for probiotic

Opinions on re-assessed dossiers expected by June 2012

Once EU has a list of approved health claims, products not
complying will have to be removed from supermarket
shelves 6 mo after the law comes into effect

By 2013 many products currently labelled as probiotics will
have to be removed from the market, but ....
EFSA on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health
claims related to gut and immune function. EFSA Journal 2011;9(4):1984. [12 pp.]
© HarlandHall Associates
16
DIGESTIVE HEALTH – FUTURE

Permitted claims – digestive health







“Wheat bran fibre contributes to a reduction in intestinal transit
time”
“the consumption of lactulose and a reduction in intestinal
transit time”
“Wheat bran fibre contributes to an increase in faecal bulk”
“Barley grain fibre contributes to an increase in faecal bulk”
“Oat grain fibre contributes to an increase in faecal bulk”
“Rye fibre and changes in bowel function”
Watch this space

...evidence provided is insufficient to establish a cause and effect
relationship between the consumption of dried plums of ‘prune’
cultivars (Prunus domestica L.) and maintenance of normal bowel
function
© HarlandHall Associates
17
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
18
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
EFSA -
ESTABLISHED HEALTH RELATIONSHIPS1:

Reduction in body weight

Body weight maintenance after weight loss

Reduction in waist circumference, if accompanied by
improvement in adverse health effects of an excess
abdominal fat, is a beneficial physiological effect

Sustained reduction in body fat, and particularly abdominal
fat, is a beneficial physiological effect for overweight and
obese subjects in the general population

Changes in “body shape”
19
1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Draft guidance on the scientific requirements
for health claims related to appetite ratings, weight management, and blood glucose concentrations released
for public consultation. EFSA Journal 20xx;x(x):xxxx.
© HarlandHall Associates
WEIGHT LOSS CLAIMS?
Health relationships:
INCREASED SATIETY AND/OR REDUCED SENSE OF HUNGER/APPETITE
 The health benefit of changing appetite ratings is to decrease
subsequent energy intake, subsequent energy intake should
be measured using appropriate methods, and the effect
should be sustained over time, taking into account possible
compensatory effects

The reduction of energy intake during or after consumption of
a food/constituent will be considered on a case-by-case basis
after chronic consumption of the food (1 month). If the
health benefit of changing energy intake is to decrease body
weight, body weight changes should be measured (3 month).
20
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Draft guidance on the scientific requirements
for health claims related to appetite ratings, weight management, and blood glucose concentrations released
for public consultation. EFSA Journal 20xx;x(x):xxxx.
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
INCREASED SATIETY AND/OR
REDUCED SENSE OF HUNGER/APPETITE
- not a claim in its own right
21
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
PERMITTED CLAIMS:

...a cause and effect relationship has been established
between the consumption of a very low calorie diet and
reduction in body weight.
VLCDs are diets which contain:
•
Energy levels between 450 and 800 kcal per day,
•
100 % of the recommended daily intakes for vitamins &
minerals.
•
Not less than 50 g high-quality protein (PDCAAS of 1)
•
Not less than 3 g linoleic acid and not less than 0.5 g alphalinolenic acid with a linoleic acid/alpha-linolenic acid ratio
between 5 and 15
•
Should provide not less than 50 g available carbohydrates
© HarlandHall Associates
22
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
PERMITTED CLAIMS:

...a cause and effect relationship has been established
between the consumption of meal replacements in
substitution of regular meals in the context of energy
restricted diets ...
and reduction in body weight
and the maintenance of body weight after weight loss
Meal replacements contain:
• A maximum of 250 kcal/serving and comply with specifications laid
down in Directive 96/8/EC
• In order to achieve the claimed effect, one or two meals should be
substituted with meal replacements daily.
The target population is overweight subjects in the general population who
wish to maintain their body weight after significant weight loss.
© HarlandHall Associates
23
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
PERMITTED CLAIMS:
...a cause and effect relationship has been established
between Glucomannan in the context of an energy restricted
diet contributes to weight loss
Conditions of use:
• 1 g of glucomannan per quantified portion
•
daily intake of 3 g of glucomannan in three doses of 1 g each,
together with 1-2 glasses of water, before meals and in the
context of an energy-restricted diet
24
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?
PERMITTED APPETITE/WEIGHT MANAGEMENT HEALTH


CLAIMS:
Few left
New strategies required:
 Opportunity to make greater use of nutrition claims?
 If you believe you have strong proposition conduct
research for your product, with the view of making
Article 13.5 Application
 Position product demonstrating
it meets healthy eating objectives
25
© HarlandHall Associates
PERMITTED NUTRITION CLAIMS
LOW ENERGY


A claim that a food is low in energy - the product does not contain more than 40 kcal
(170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids.
For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g of
sucrose applies.
ENERGY-REDUCED

A claim that a food is energy-reduced - the energy value is reduced by at least 30%
with an indication of the characteristic(s) which make(s) the food reduced in its total
energy value.
ENERGY-FREE


A claim that a food is energy-free - the product does not contain more than 4 kcal
(17 kJ)/100 ml.
For table-top sweeteners the limit of 0.4 kcal (1.7kJ)/portion, with equivalent sweetening properties to 6 g of
sucrose applies.
LIGHT/LITE

A claim stating that a product is ‘light’ or ‘lite - same conditions as those set for the
term ‘reduced’; the claim shall also be accompanied by an indication of
the characteristic(s) which make(s) the food ‘light’ or ‘lite’.
26
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?

WHO cited the following about European people:

30–80% adults are overweight in the countries of the WHO European
Region

About 20% children & adolescents are overweight, and 1/3 are obese

Prevalence of obesity is rising rapidly by 2010 likely to be 150 million
adults & 15 million children

The trend in obesity is especially alarming in children & adolescents.
Annual rate of increase in childhood obesity is growing steadily –
the current rate is 10 X that in the 1970s
27
WHO, The challenge of obesity in the WHO European Region and the strategies for response ed. F. Branca, H.
Nikogosian, and T. Lobstein. 2007, Copenhagen, Denmark: WHO Europe.
© HarlandHall Associates
WHAT’S ON THE HORIZON FOR WEIGHT
LOSS CLAIMS?

WHO recommendations:

Promote the inclusion of low energy density
in the diet
For example:
 Eating more fruit, vegetables, legumes,
whole grains, nuts and seeds and reducing
the amount of energy-rich foods, is a
simple and easy way to help manage
weight

Promote foods on basis of nutrition
content not using health claims
28
WHO, 5.2 Recommendations for preventing excess weight gain and obesity, p61-71. 2003, www.who.org.
© HarlandHall Associates
OTHER GAINS & LOSSES

Movement – muscle, bone and joint health EFSA
update1

Article 14 claims: Ca, Vit D, Ca +Vit D, bone health
Ca(+Vit D) and reducing the loss of BMD, which may
contribute to a reduction in the risk of bone fracture

Article 13 claims:
Ca, Vit D, Ca +Vit D & bone health
protein & growth
or maintenance of muscle mass
or bone
1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA);
Draft guidance on the scientific requirements for health claims related to bone,
joints, and oral health released for public consultation. EFSA Journal
20xx;x(x):xxxx. [11 pp.]. doi:10.2903/j.efsa.20NN.NNNN
29
© HarlandHall Associates
OTHER GAINS & LOSSES

Claims not established in respect of muscle, bone
and joint health






chondroitin or chondroitin sulphate
methylsulfonylmethane, either alone or in combination
with glucosamine hydrochloride
glucosamine hydrochloride or as glucosamine sulphate,
either alone or in combination with chondroitin
sulphate
Gamma-linolenic
Boron
EPA, DHA and bone/joint maintenance
30
© HarlandHall Associates
OTHER GAINS & LOSSES

Claims not established in respect of whole grains,
soy protein, soy isoflavones, prunes, fruits & tea
and antioxidant, cranberries etc
31
© HarlandHall Associates
GAINS AND LOSSES HEALTH CLAIMS
 Target
audience
B2B
 Health Professionals/influencers communication
programme backed by good science (not
overstated or “too medical”)
 Claims that meet public nutrition health policy
 Simple consumer messaging with few claims
 Claim and brand image should be comfortable
partners

32
© HarlandHall Associates
OTHER GAINS – LABELLING REQUIREMENTS

Health/Nutrition claims prompt full 8 Nutrition
Label + nutrient subject of claim

All claims subject to profiles

Trigger the following additional information:
Statement indicating the importance of a varied and balanced
diet and a healthy lifestyle
 Quantity and pattern of food to be consumed to achieve
benefit
 If appropriate, statement addressed to those who should
avoid food
 Appropriate warning for foods likely to be consumed to excess

33
© HarlandHall Associates
HEALTH CLAIMS - GAINS & LOSSES CONCLUSIONS

More losses than gains!

Consider using health claims already assessed (largely nutrients)

Can nutrition claims be used to good effect?

Wording of EFSA assessed claims to be finalised by EC

Take care to ensure wording you use gives same impression as
authorised claim

Ensure all labelling requirements are met

All claims subject to profiles (when finalised)
34
© HarlandHall Associates
Thank you for your attention
ASSOCIATES
[email protected]
tel: + 44 1285 850661
Every attempt is made to be accurate, but please take advice,
as interpretation of the Regulation is not finalised.
© HarlandHall Associates
35