Transcript EU Claims

ARE WELLNESS CLAIMS LEGAL?
Neville Craddock, MA (Cantab.), CSci, FIFST
Neville Craddock Associates
Food Law Consultants
United Kingdom
Overview
 Where does the concept of Wellness sit within the EU Nutrition and
Health Regulations?
 Update on stumbling blocks and opportunities as the EU regulations
unfold.
 Some examples of Wellness products on the market and their claims.
 Informal opinion on whether Wellness foods and drinks could be legal or
illegal in future.
 A few tips on how to market Wellness while staying within the law.
FDIN Wellness Seminar October, 2008
2
What do we mean by “wellness”?
 Wellbeing products encompass “healthy eating”, a bit of “functional” and
some “provenance” claims
 They might include … “quoted a wide range of well-known brands and
individual products … household names and ‘in’ products ”
 Claims can be ‘good for you’, slimming, wholesome, natural, specific
functional claims.
 Wellbeing products are those which try to go beyond simple functional
or nutraceutical claims to encompass holistic health, mood, feeling good
about oneself.
Seems to encompass just about everything – and a legal minefield
FDIN Wellness Seminar October, 2008
3
Wellness – a definition?
“An interactive process of becoming aware of and practicing healthy
choices to create a more successful and balanced lifestyle”
“The condition of good physical and mental health, especially when
maintained by proper diet, exercise, and habits”
“A condition obtained when a person achieves a level of health that
minimizes the chances of becoming ill”
10 types: Social Occupational Spiritual Physical Intellectual
Emotional Environmental Financial Mental Medical
FDIN Wellness Seminar October, 2008
4
“Wellness” – salvation at last?! …
 Merriam-Webster (1653)
 “the quality or state of being in good health especially as an actively
sought goal”
 “lifestyles that promote wellness”
 OED
 “The state of being well or in good health”
… So now we know!!
FDIN Wellness Seminar October, 2008
5
So … what do we want to do?
… what do we want to say?
…and what will we be able to say?
Let’s start with a quick reminder …
EU Health Claims Regulation 1924/2006
(and other related legislation)
FDIN Wellness Seminar October, 2008
6
Wellness? - A Raft of Regulation
 Nutrition and Health Claims
 scientific assessment; formal authorisations
 Novel Foods
 exotic traditional foods; prior use criteria
 Food Supplements
 Fortified Foods (“Addition of Nutrients and Other Substances”)
 botanicals
 General Food Labelling
 “prevention, treatment and cure”; “misleading” presentation
 Medicines
 when is a food a medicine?
 Unfair Commercial Practices
 European Court Judgments
 ……
FDIN Wellness Seminar October, 2008
7
EU Claims - Key Definitions
“Claim”: any non-mandatory message or representation (including
pictorial, graphic or symbolic) that states, suggests or implies a food has
particular characteristics.
“Health Claim”: any ‘claim’ that states, suggests or implies relationship
between a food category, a food or one of its constituents and health.
“Reduction of disease risk claim”: any ‘health claim’ that …
consumption of a food category, a food or one of its constituents
significantly reduces a risk factor in the development of a human disease.
“Claims referring to children’s development”: no definition
 case by case basis
FDIN Wellness Seminar October, 2008
8
EU Claims Regulation - Key Definitions (2)
“Nutrition claim”: … any ‘claim’ that a food has particular beneficial
nutrition properties due to
 energy it does / does not provide (including reduced / increased)
 nutrients or “other substances” it contains / contains in reduced or
increased proportions / does not contain.
“Nutrient”: protein, carbohydrate, fat, fibre, sodium, vitamins and minerals
in Annex to Directive 90/496 and their components.
“Other substance”: substance other than a “nutrient” that has a nutritional
or physiological effect.
FDIN Wellness Seminar October, 2008
9
Directive 2000 / 13 - Article 2.1(b)
 The labelling, presentation and advertising of a food “must not
attribute … the property of preventing, treating or curing a human
disease, or refer to such properties.”
 Labelling: “… words, particulars, trade marks, brand name, pictorial
matter or symbol placed on any packaging, document, notice, label, ring
or collar accompanying or referring to the food.”
 Presentation: “…shape, appearance or packaging, packaging materials
used, way in which they are arranged and setting in which they are
displayed.”
 Applies equally to explicit and implied claims (e.g. pictures)
Arguably does not prevent “health maintenance” claims
But “disease risk reduction” had always been a very grey area!
FDIN Wellness Seminar October, 2008
10
EU Health Claims Regulation 1924/2006
 Retains ban on “prevention, treatment and cure” claims
 Distinguishes “reduction of disease risk factor” concept
 Restriction on “children’s development and health” claims
 Restriction on non-specific and psychological / behavioural claims
 Absolute ban on alcoholic drink health claims (>1.2% alc.)
 List of “generally-recognised” health claims
 A priori approval for novel / specific claims
 Claims must be scientifically verifiable
 Wording to be taken into account by EFSA
 Public “Register” of approved (and rejected) claims
 Plus … Quantitative criteria for wide range of “nutrition claims”
FDIN Wellness Seminar October, 2008
11
EU Claims – General Principles
 Only claims that comply with the Regulation will be permitted - must be:
 supported by “generally-accepted” scientific evidence
 capable of justification by operator
 Product must contain ‘significant’ quantity of ‘beneficial’ substance, or
reduction of ‘harmful’ substance, and able to deliver claimed effect
 in quantity of food “reasonably expected to be consumed”
 substance must be biologically available
 Refers to food “ready for consumption”
 Claims must be understood by “average consumer”
N.B. Cannot include other foods in claim’s justification
FDIN Wellness Seminar October, 2008
12
“Health” Claims
 All subject to EFSA assessment and EC authorisation
 either generic or specific
 Label (presentation / advertising) must include statements / advice
 importance of ‘varied and balanced diet and healthy lifestyle’
 quantity of food and pattern of consumption to achieve effect
 if appropriate, persons who should avoid the food
 appropriate warning, for products likely to present a health risk if
consumed to excess
Guidelines may be adopted “where appropriate”
FDIN Wellness Seminar October, 2008
13
Prohibited Health Claims
The following claims are NOT permitted:
 suggesting health could be affected by not consuming the food
 reference to RATE or AMOUNT of weight loss
 recommendations of individual doctors / health professionals
 but national rules may apply to national associations, e.g.
 medical, nutrition or dietetic professionals
 health-related charities
FDIN Wellness Seminar October, 2008
14
“Generally-accepted” Health Claims
Specific prior authorisation will not be required for claims describing
 role of nutrient etc in growth, development or normal functions
 psychological and behavioural functions
 slimming, weight control
 reduction in sense of hunger or increase in satiety
 reduction in available energy from the diet
PROVIDED they are
 based on generally-accepted scientific evidence
 well-understood by an “average consumer”
 included on ‘Community list’
 EFSA currently evaluating science
 31st January 2010 - Community list permitted claims
Complex transitional provisions apply
FDIN Wellness Seminar October, 2008
15
“Disease Risk Reduction” Claims
New Category
 Will be permitted following formal authorisation
 already very diverse MS opinions – “medicinal claims”
 EFSA seeking “cause and effect” relationship
 Label must also state that
 the disease to which claim refers has multiple risk factors
 altering one of these may / may not have a beneficial effect
 Will appear on the public “Register”
FDIN Wellness Seminar October, 2008
16
Consumer Understanding
Consumer understanding is a key aspect
 If favourable Scientific Opinion, EFSA will evaluate wording
 to ensure that it reflects the scientific evidence
 is understandable in terms of relevance for human health
 may recommend changes based on the scientific assessment
Claims considered from a scientific viewpoint to be vague, confusing
or misleading will not receive a favourable opinion
But … what is “well-understood” by an “average consumer”?
FDIN Wellness Seminar October, 2008
17
What is an “Average Consumer”?
ECJ rulings consistently describe “average consumer” as:
 “reasonably well-informed, reasonably observant and circumspect”
Claims Regulation: "It is appropriate to protect all consumers from misleading
claims. […] In line with … proportionality, and to enable the effective application of
the protective measures contained in it, this Regulation takes as a benchmark the
average consumer as interpreted by the ECJ, taking into account social, cultural
and linguistic factors but makes provision to prevent the exploitation of consumers
whose characteristics make them particularly vulnerable to misleading claims".
Labelling Directive: “… could mislead the purchaser to a material degree”
FDIN Wellness Seminar October, 2008
18
“Nutrition” and “Comparative” Claims
NUTRITION CLAIMS (e.g. “rich” “reduced” “low” “free”)
 Only permitted if listed in, and comply with, detailed conditions in Annex
 … but … recent ASA adjudications!! (interpreting “implication”)
COMPARATIVE CLAIMS (e.g. “chalk versus cheese”)
 Comparison only between foods of same category, and must
 take into account a range of foods in category
 compare against range whose composition does not allow a claim
 include other brands
N.B. Categories not defined
 Difference in quantity of nutrient and / or energy must be stated
 Comparison must relate to same quantity of food
FDIN Wellness Seminar October, 2008
19
So … how do we get a claim approved?
FDIN Wellness Seminar October, 2008
20
EFSA Scientific Substantiation of Claims
FDIN Wellness Seminar October, 2008
21
Application contents (1)
Characteristics of the food / constituent
 Composition, physical and chemical characteristics
 Manufacturing process, stability, and bioavailability
 Competent laboratory that can certify the data
 Quality system for control / documentation should be indicated
 e.g. GMP, GLP, applicable ISO standard
FDIN Wellness Seminar October, 2008
22
Application contents (2)
Proposal for wording of claim
 specific conditions of use
 target population for the intended health claim
 quantity of the food / constituent and pattern of consumption to obtain
claimed effect
 whether this quantity could reasonably be consumed as part of a balanced
diet
 where appropriate
• statement for persons who should avoid the food
• warning if excess consumption may present risk
 any other restrictions of use
 directions for preparation and / or use
FDIN Wellness Seminar October, 2008
23
Application contents (3)
All pertinent scientific data, published / unpublished, favourable / not
 human studies addressing relationship between consumption of food /
constituent and claimed effect
 comprehensive, systematic and transparent review of data
 intervention and observational studies data organised in a hierarchy
to reflect relative strength of evidence
 quality expected from peer-reviewed journal
 quality system e.g. GLP, GCP to be indicated
 studies in animals or other model systems may be included only as
supporting evidence
 e.g. to explain the mechanism underlying the claimed effect
FDIN Wellness Seminar October, 2008
24
Application contents (4)
Evidence must demonstrate:
 claimed effect of food / constituent is relevant for human health
 cause and effect relationship is established, e.g.
• strength, consistency, specificity, dose-response and biological
plausibility
 quantity of the food / constituent and pattern of consumption needed
could reasonably be achieved as part of a balanced diet
 specific study group(s) used for evidence are representative of
target population for claim
FDIN Wellness Seminar October, 2008
25
NUTRIENT PROFILES
EU EFSA and UK FSA
FDIN Wellness Seminar October, 2008
26
EU Claims Regulation – Nutrient Profiles
Products making claims must respect “nutrient profiles” (*)
 To be established (EC 19.01.2009, with EFSA advice) taking account of
 nutrients and other substances “such as” fat, saturated fat, trans fats,
sugars, salt / sodium
 role and importance of the food / category in diet
 in general, or
 “as appropriate” certain risk groups, including children
 overall nutritional composition and presence of nutrients with
scientifically-recognised (good and / or bad?) effects on health
 exemptions may be defined (e.g. olive oil, cheese etc)
 Single nutrient may exceed profile – “High X content” labelling
(*) – except reduction of fat, saturated fat, trans fats, sugars, salt / sodium
FDIN Wellness Seminar October, 2008
27
Nutrient Profiles – UK FSA Advertising Model
 “Scoring” of foods high in fat, salt or sugar, balanced against positive
nutrients in certain foods e.g. dairy, meat, fish, fruit, nuts, vegetables:
 'group A' nutrients (energy, saturated fat, total ‘sugar’ and sodium)
 'group C' nutrients (nuts, fruit and vegetables, protein and NSP fibre*)
 points awarded for each nutrient content per 100g of the food
 score for 'group C' nutrients is subtracted from 'group A' nutrients
 Net score 4 or more (1 for drinks): broadcasting controls
 Absolute threshold for “A” score – not redeemable by protein
* AOAC may be used, subject to conversion factor
“NOT suitable for other purposes, including labelling” (?? …!!)
FDIN Wellness Seminar October, 2008
28
FSA Nutrient Profile Points – Groups “A” and “C”
Total ‘A’ points = energy + saturated fat + sugars + sodium
Total ‘C’ points = (FVN) + fibre (NSP or AOAC) + protein
(Why no recognition of 20% FV content – 5-a-day?)
FDIN Wellness Seminar October, 2008
29
FSA Nutrient Profile Points – Groups “A” and “C”
Overall score calculation:
 If a product scores <11 ‘A’ points
 Overall score = (total ‘A’) minus (total ‘C’)
 If a product scores >11 ‘A’ points but 5 for FVN
 Overall score = (total ‘A’) minus (total ‘C’)
 If a food scores >11 ‘A’ points but <5 for FVN
 Overall score = (total ‘A’ points) minus (fibre points + FVN points only) [i.e.
no points scored for protein]
 i.e. if product scores >11 ‘A’ points, it cannot currently score for protein
unless it also scores 5 points for FVN (but ongoing consultation)
A food is classified as “less healthy” where it scores 4 points or more
A drink is classified as “less healthy” where it scores 1 point or more
FDIN Wellness Seminar October, 2008
30
EU Nutrient Profiles – EC Paper June 2008
Nutrient profiles will be set (by Jan 2009):
 counter promotional effects of claims; help consumers make choices to
influence their diet in a way beneficial to health
 provide an incentive for product reformulation
Will be “based on” EFSA Opinion (adopted 31.01.08), taking into account
 non-scientific aspects
 e.g. ease of use by businesses and authorities
 while protecting interests of consumers
 reformulation incentive effect
 cost effectiveness
Possible exemptions (for discussion)
 supplements and low energy foods, chewing gum, herbs etc
 PARNUTS foods, possibly “sports drinks” (but not ‘notified’ products)
 fruits and vegetables
FDIN Wellness Seminar October, 2008
31
EU Nutrient Profiles – EC Paper June 2008
Simplified model: 100g basis
Sodium: 100mg/100g; Saturated fat: 10%; Sugar: 10%; No exemption
FDIN Wellness Seminar October, 2008
32
EU Nutrient Profiles – EC Paper June 2008
Simplified model: 100 kcal basis
Sodium: 100mg/100kcal; Saturated fat: 10% energy; Sugar: 10% energy; No exemption
FDIN Wellness Seminar October, 2008
33
and, the next hurdle …
a brief summary of Regulation 258/97
FDIN Wellness Seminar October, 2008
34
EU Novel Foods Regulation 258/97 - Scope
Food not used to a significant degree within EC (pre-15.5 97) and which
 has new or intentionally modified primary molecular structure
 consists of, or isolated from
 micro-organisms, fungi or algae
 plants and ingredients isolated from animals, except for foods obtained by
traditional propagating or breeding practices and having a history of safe
food use
 to which has been applied a (novel) production process … that gives rise to
significant changes in composition or structure which affect nutritional value,
metabolism or level of undesirable substances
FDIN Wellness Seminar October, 2008
35
Supplements and Additives - Prior Use
 Dietary supplement use prior to 15th May 1997 is NOT indicative of
“significant” use as a food ingredient
 This view was ‘formalised’ by MS at SCFCAH* in February 2005
 Similar view applies if history of prior use only as a food additive
 Number of examples
 Phosphated distarch phosphate
 Glucosamine
* Standing Committee on the Food Chain and Animal Health
FDIN Wellness Seminar October, 2008
36
A few quick words …
How is safety assessed?
and
How does the process operate?
FDIN Wellness Seminar October, 2008
37
Recommendation 97/618 (based on SCF, 1997)
FDIN Wellness Seminar October, 2008
38
Full Safety Assessment Procedure
Recommendation 97 / 618 (Guidelines based on SCF, 1997)
 Formal application to MS of 1st marketing, plus copy to EC
 evidence of safety (studies, dossier); labelling proposals
 Assessment
 composition, nutritional value, metabolism, intended use
 microbiological and chemical contaminants
 normally includes studies on toxicology and allergenicity
 details of the production process
Complex authorisation process – frequently time-consuming
FDIN Wellness Seminar October, 2008
39
EU Novel Foods – Structured Scheme
1. Pure chemicals or simple mixtures: non-GM sources
2. Complex NF: non-GM source
6. Derived from novel process
FDIN Wellness Seminar October, 2008
a – EC history of use
b – no EC history of use
40
Novel Foods – full assessment overview
3 broad categories of NF – sub-divided by origins and history of exposure
 8 - 10 “types” of information – prescribed data requirements
 Composition
 specification
 effect of production process
 Intake
 quantitative (normal and maximum) levels; any related history of use
 experience from prior use e.g. safe preparation and handling
 Nutrition
 role in diet, anti-nutritional factors, human trials (good practice GLs)
 Toxicology
 Allergenic potential
 Post-market monitoring
FDIN Wellness Seminar October, 2008
41
Novel Foods – toxicological assessment
Appropriate nutritional-toxicological testing program
 possible toxicity of individual chemical components
 toxicity studies in vitro and in vivo including mutagenicity, reproduction and
teratogenicity; long term feeding studies
 a tiered approach on a case-by-case basis
 if warranted by structural or exposure considerations, additional studies
 usual toxicological endpoints including metabolism, toxico-kinetics, chronic
toxicity / carcinogenicity, reproductive function, teratogenicity, and possibly
neurotoxicity and immunotoxicity
 90-day feeding trials or longer
FDIN Wellness Seminar October, 2008
42
Foods and Medicinal Claims
Where do we (they) draw the line?
FDIN Wellness Seminar October, 2008
43
Directive 2001/83 – “medicinal product” definition
 (a) “any substance or combination of substances presented for treating
or preventing disease in human beings or animals”, or
 (b) “… which may be used in or administered to human beings … with a
view to restoring, correcting or modifying physiological functions by
exerting a pharmacological, immunological or metabolic action, …”.
 “substance”: “any matter … may be human…animal…vegetable …chemical”
 In cases of doubt, where, taking into account all its characteristics, a
product may fall within the definition of a ‘medicinal product’ and within
the definition of a product covered by other Community legislation the
provisions of this Directive shall apply.
FDIN Wellness Seminar October, 2008
44
European Court of Justice
 “The Directive therefore gives two parts to the definition of a medicinal
product, by virtue of its “presentation” and by virtue of its “functions”.
Consequently, a product is legally a “medicinal product” if it falls within
either or both of these parts”.
Monteil and Samanni C - 60/89
FDIN Wellness Seminar October, 2008
45
European Court of Justice
 “A product which is recommended or described as having prophylactic or
therapeutic (‘preventative or curative’) properties is a medicinal product “by
virtue of its presentation” [within the meaning of Article 1(2)] even if it is
generally regarded as a food and even if it has no known therapeutic effects
in the present state of scientific knowledge”.
Ter Voort C- 219/91
 ...implicit medicinal status may arise from impression gained by “average
consumer”
 “reasonably well-informed, reasonably observant and circumspect”
FDIN Wellness Seminar October, 2008
46
Medicinal Products – the problems
 “Medicinal Product” interpreted very broadly and differently between MS
 Labelling, presentation, advertising of a food “must not attribute … the property
of preventing, treating or curing a human disease, or refer to such properties.”
 No definitions of “prevention” and “disease”
 MS free to interpret the prohibition on basis of a long, national tradition
 Semantics and literal interpretations of legal texts prevail in some MS, in others,
an approach based on perceived “spirit” of legislation is applied
 legal uncertainty, inconsistent and arbitrary interpretation
FDIN Wellness Seminar October, 2008
47
Herbal Medicines - HMPs
 HMP: Any medicinal product, exclusively containing as active ingredients
one or more “herbal substances” / “herbal preparations” or combinations
 Herbal substances: whole, fragmented or cut plants, plant parts, algae
etc in unprocessed form e.g. fresh / dried; certain exudates;
 precisely defined by plant part and botanical name (genus, species,
variety and author)
 Herbal preparations: … subjecting herbal substances to such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation, e.g. chopped / powdered HS, tinctures, extracts, essential
oils, expressed juices and processed exudates
 Traditional HMP: HMP with >30 years prior use, >15 years within EU
FDIN Wellness Seminar October, 2008
48
Herbals and Botanicals – Safety Assessment
FDIN Wellness Seminar October, 2008
49
… and finally, a few words on what else might
be coming over the horizon from Brussels …
FDIN Wellness Seminar October, 2008
50
Possible Future European Commission Actions
Paula Testori Coggi, June 2008
FDIN Wellness Seminar October, 2008
51
So … let’s see what linguistic and practical
expertise the FSA has recently demonstrated …
FDIN Wellness Seminar October, 2008
52
UK FSA “Fresh” “Natural” “Pure” etc
 voluntary best practice advice
 common terms … of interest to
consumers but not defined in law
 encourage use of terms that convey
clear meaning - not misleading
 use should be considered in context of
• label as a whole
• presentation of product
• on case by case basis
 should not be taken as authoritative statement nor
interpretation of the law (only courts)
 responsibility of individual business to ensure
compliance with law
 compliance with advice on best practice is not
required by law
… BUT used by Advertising Standards Authority to publicly condemn companies
FDIN Wellness Seminar October, 2008
53
UK FSA “Fresh” “Natural” “Pure” etc
 Original GLs (2002) based on Food Advisory Committee Report
 Revisions (2008):
 Original, Traditional, Authentic, Real, Homemade,
 Fresh*, Pure*, Natural*, Farmhouse*:
 * existing advice not identified as requiring consumer research but
revised in light of “recent enquiries and issues” that have arisen
 New advice on Farmhouse Pâté
 General advice on Handmade, Quality, Selected, Premium, Finest,
Best, Seasonal, Wild, Style and Type
FDIN Wellness Seminar October, 2008
54
FSA amendments to “Natural”
 … processes such as non-traditional enzymatic treatment, immobilised
micro-organisms, non-traditional fermentation, solvent extraction, carbon
filtration and ion exchange, or acid or alkali treatment (except traditional
pickling) or non-traditional distillation are now excluded from “natural”
 “Natural” may be used to describe
 permitted additives obtained from natural sources (e.g. food or plant) by
appropriate physical processing (including distillation and solvent extraction)
or traditional food preparation processes
 but NOT for food ingredients!!
 flavourings when in conformity with legal provisions
 but excludes those made with the use of immobilised microorganisms
or non-traditional fermentations or non-traditional enzyme treatments
FDIN Wellness Seminar October, 2008
55
FSA “Natural” “Fresh” etc Guidelines - 2008
 NATURAL:
 Compound foods should not be described directly or by implication as
“natural”, but may be “made from natural ingredients” if all ingredients
(including additives and flavourings in ingredients) meet the criteria
 TRADITIONAL:
 to describe recipe, fundamental formulation or processing method that has
existed for “significant period”
 ingredients and process available, substantially unchanged, for same period
 within consumer expectations that product has been made in a factory
 ~ 1 generation / 25 years, (Reg 509/2006 on Traditional Specialities for
production / recipe for a registered traditional food)
FDIN Wellness Seminar October, 2008
56
Wellness? - A Nightmare of Enforcement!!
 Beware scope of “implication”
 examine ambiguities
 think about the “average consumer”
 Scientific validity and ability to deliver
 Remember the Novel Foods Regulation
 Beware the Medicines and Foods borderlines
 … but, in particular …
BEWARE THE ASA (and MHRA)
“Be Very, Very Careful !!!”
FDIN Wellness Seminar October, 2008
57
Thank you for your attention,
ladies and gentlemen.
Any comments or questions?
FDIN Wellness Seminar October, 2008
58
Neville Craddock Associates
Tun House
28 High Street
Bletchingley
Surrey UK
[email protected]
Tel: +44 (0) 1883 740 553
Mob: +44 (0) 7802 641 081
FDIN Wellness Seminar October, 2008
59