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ARE WELLNESS CLAIMS LEGAL?

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?

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ARE WELLNESS CLAIMS LEGAL?

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

  2. 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. 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. “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 2010 - 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 systemsmay 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 PROFILESEU 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 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 reductionof 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 • 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

  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 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

  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-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

  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. A few quick words … How is safety assessed? andHow 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 • 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

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

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