1. ARE WELLNESS CLAIMS LEGAL?
Neville Craddock, MA (Cantab.), CSci, FIFST
Neville Craddock Associates
Food Law Consultants
United Kingdom

2. FDIN Wellness Seminar October, 2008
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

3. 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

4. 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

5. “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

6. FDIN Wellness Seminar October, 2008
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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. FDIN Wellness Seminar October, 2008
“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

14. 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

15. “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 Community list permitted claims
Complex transitional provisions apply
FDIN Wellness Seminar October, 2008

16. “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

17. 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

18. 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

19. “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

20. So … how do we get a claim approved?
FDIN Wellness Seminar October, 2008

21. EFSA Scientific Substantiation of Claims
FDIN Wellness Seminar October, 2008

22. 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

23. 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

24. 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

25. 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

26. NUTRIENT PROFILES EU EFSA and UK FSA
FDIN Wellness Seminar October, 2008

27. EU Claims Regulation – Nutrient Profiles
Products making claims must respect “nutrient profiles” (*)
To be established (EC , 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

28. 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

29. 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

30. 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
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

31. 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 ), 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

32. 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

33. 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

34. and, the next hurdle … a brief summary of Regulation 258/97
FDIN Wellness Seminar October, 2008

35. EU Novel Foods Regulation 258/97 - Scope
Food not used to a significant degree within EC (pre ) 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

36. 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

37. FDIN Wellness Seminar October, 2008
A few quick words … How is safety assessed? and How does the process operate?
FDIN Wellness Seminar October, 2008

38. Recommendation 97/618 (based on SCF, 1997)
FDIN Wellness Seminar October, 2008

39. 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

40. EU Novel Foods – Structured Scheme
1. Pure chemicals or simple mixtures: non-GM sources a – EC history of use
2. Complex NF: non-GM source b – no EC history of use
6. Derived from novel process
FDIN Wellness Seminar October, 2008

41. Novel Foods – full assessment overview
3 broad categories of NF – sub-divided by origins and history of exposure
“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

42. 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

43. Foods and Medicinal Claims Where do we (they) draw the line?
FDIN Wellness Seminar October, 2008

44. 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

45. 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

46. 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

47. 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

48. 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

49. Herbals and Botanicals – Safety Assessment
FDIN Wellness Seminar October, 2008

50. FDIN Wellness Seminar October, 2008
… and finally, a few words on what else might be coming over the horizon from Brussels …
FDIN Wellness Seminar October, 2008

51. Possible Future European Commission Actions
Paula Testori Coggi, June 2008
FDIN Wellness Seminar October, 2008

52. FDIN Wellness Seminar October, 2008
So … let’s see what linguistic and practical expertise the FSA has recently demonstrated …
FDIN Wellness Seminar October, 2008

53. 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

54. 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

55. 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

56. FSA “Natural” “Fresh” etc Guidelines - 2008
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

57. 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

58. FDIN Wellness Seminar October, 2008
Thank you for your attention, ladies and gentlemen. Any comments or questions?
FDIN Wellness Seminar October, 2008

59. FDIN Wellness Seminar October, 2008
Neville Craddock Associates Tun House 28 High Street Bletchingley Surrey UK Tel: +44 (0) Mob: +44 (0)
FDIN Wellness Seminar October, 2008