Successful Health Claims: Challenges for Natural (Whole Foods)

Transcription

1 Successful Health Claims: Challenges for Natural (Whole Foods) Nigel Baldwin, B.Sc., MIFST, CSci Director, Scientific & Regulatory Consulting, Europe Intertek 1

2 Natural Botanical Food Herbal The situation is still not clear what will happen to these (800+) claims related mainly to their background of traditional use Both EFSA and the Commission have to decide and regulation is at member state level on case by case basis Natural Generally refers to foods from primary production, i.e. whole foods and their basic preparation Regulation (EC) No 1924/2006 applies to these products 2

3 Key Points for a Successful Health Claims Submission 10) Other causality criteria 1) Clarity in claim Wording* 2) Food/ constituent is characterised* * Especially challenging for natural/whole foods 9) Statistical significance 3) Transparent, comprehensive literature search* Healthy Claim Application 8) Consistency 4) High quality human studies* 7) Biologically relevant magnitude of effect 6) Valid outcome measures* 5) Study population relevant* 3

4 1) Clarity in Claim Wording An apple a day keeps the doctor away? (not specific enough) versus Apple juice contains vitamin C. Vitamin C contributes to maintain the normal function of the immune system. (Article 13) 4

5 2) Food Constituent is Characterised Characterising whole foods/botanical foods give rise to tremendous variation Walnuts are seeds from the walnut tree (genus Juglans) of which about 20 different species are known in different parts of the world. Walnuts are drupes, rather than nuts. One of the most popular varieties of walnut is the Persian or English walnut, which has a large seed and a thinner shell, yielding more edible walnut meat by weight than other species. Black walnuts are another commonly sold walnut species, as are white walnuts, also called butternuts. The nut kernels contain about % fat, of which about 3-6 % are saturated fatty acids (SFAs), 9-15 % are monounsaturated fatty acids (MUFAs), and % are polyunsaturated fatty acids (PUFAs) (33-38 % linoleic acid (LA), and 2-9 % alphalinolenic acid (ALA)). The nut kernels also contain about 5-7 % fibre, of which about 25 % is soluble fibre, % protein, and small amounts of plant sterols and other phytochemicals. The Panel notes the variation in terms of macronutrient composition between different types of walnuts. 5

6 Example: Cranberry Extract Standardisation of bioactives is easier for extracts Example of how cranberry extract is standardised: to PAC content: The food that is the subject of the health claim is the cranberry extract and D-mannose containing food supplement Uroval According to a conformity declaration for Uroval manosa, one tablet, coated with a polymer film agent, a hydroxyl-propylmethylcelullose, contains 300 mg of D(+)-mannose and 100 mg of cranberry extract with 10% proanthocyanidins, and the additives talc (5 mg), microcrystalline cellulose (90 mg) and magnesium stearate (5 mg). According to a certificate of analysis issued by the Chinese company Dalian Hongjiu Biotech Co Ltd., the botanical source of the ethanol/water- extracted cranberry powder is Vaccinum macrocarpon L. 6

7 3) Transparent, Comprehensive Literature Search Literature search must be systematic, comprehensive, transparent, reproducible, and properly documented. For natural/whole foods, how do you conduct a meaningful literature search on such wide criteria? Characterisation of the food defines what you search for. A search on Milk and Bone reveals initial individual publications. 7

8 4) High Quality Human Studies High quality double blind placebo-controlled studies are more often focussed on single components and/or well characterised/defined ones within more complex foods Whilst there may be many studies for whole foods and botanicals that are traditionally consumed there are usually very few high quality studies What is an appropriate control for a whole food? What is the expectation for blinding in whole food studies? Although single-blinding is achievable, many whole food studies are not blinded. 8

9 4) High Quality Human Studies Walnuts endothelium-mediated vasodilation In weighing the evidence, the Panel took into account that one intervention study in healthy subjects, adequately powered and controlled, showed a sustained effect of the consumption of walnuts on endothelium-dependent vasodilation, that the results of one additional intervention study in type 2 diabetic subjects on blood pressure-lowering, cholesterol-lowering, and/or oral antidiabetic medication are consistent with these findings, and that an acute intervention study also showed a positive effect of the consumption of walnuts on endothelium-mediated vasodilation. 9

10 5) Study Population Relevant Target populations can be extremely wide in some cases (e.g., apple) or geographically narrow in others (e.g., baobab, monkfruit), in particular for traditional use claims. Estimations of population exposure for risk reduction claims based on epidemiological data will vary considerably. Populations studied must be relevant to target populations. Caution should be exercised in relying on studies in subjects with disease. EFSA reviews these on a case-by-case basis. 10

11 6) Valid Outcome Measures There may be several valid outcome measures depending on the nutritional complexity of the product and claimed effect: Keeps the doctor away (traditional use) Versus Results in a significant decrease in risk of incidence of the common cold (scientifically validated ) Applicants should consult EFSA s guidance documents to gain perspective on the outcome measures and methods used to assess the outcome measures that are considered acceptable by EFSA. 11

12 Other Causality Criteria Magnitude of effect statistically and clinically significant Consistency Dose response Biological plausibility/mechanism Specificity Temporality These causality criteria can be difficult to establish given the complexity of test article as a natural/whole food. 12

13 There is hope! 13

14 Examples of Authorised Natural Claims Whole Foods (n=8): Dried plums/prunes Walnuts Meat or fish Olive oil polyphenols (recommended intake in terms of olive oil) Foods low in saturated fat Foods low in sodium Meal replacements for weight control (n=2) Dietary Fibre (n=6): Sugar beet fibre Barley grain fibre Oat grain fibre Rye fibre Wheat bran fibre (n=2) Macronutrients (n=5): Carbohydrates Protein (n=4) 14

15 Authorised Claims for Whole Foods Article Food Claimed Effect Conditions for Use 13(3) Dried plums/prunes 15 Contribute to normal bowel function 13(3) Meat or fish Meat or fish contributes to the improvement of iron absorption when eaten with other foods containing iron 13(3) Olive oil polyphenols Olive oil polyphenols contribute to the protection of blood lipids from oxidative stress 13(3) Walnuts Contribute to the improvement of the elasticity of blood vessels Only for food which provides a daily intake of 100 g of dried plums (prunes) Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 g of dried plums (prunes) The claim may be used only for food which contains at least 50 g of meat or fish in a single quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained by consuming 50 g of meat or fish together with food(s) containing non-haem iron. The claim may be used only for olive oil which contains at least 5 mg of hydroxytyrosol and its derivatives (e.g. oleuropein complex and tyrosol) per 20 g of olive oil. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20 g of olive oil. Only for food which provides a daily intake of 30 g of walnuts Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 30 g of walnuts

16 Authorised Claims for Foods Low in Saturated Fat or Sodium Article Food Claimed Effect Conditions for Use 13(3) Foods with a low or reduced content of saturated fatty acids 13(3) Foods with a low or reduced content of sodium Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels Reducing consumption of sodium contributes to the maintenance of normal blood pressure Only for food which is at least low in saturated fatty acids, as referred to in the claim LOW SATURATED FAT or reduced in saturated fatty acids as referred to in the claim REDUCED [NAME OF NUTRIENT] as per Reg (EC) No 1924/2006 Only for food which is at least low in sodium/salt as referred to in the claim LOW SODIUM/SALT or reduced in sodium/salt as referred to in the claim REDUCED [NAME OF NUTRIENT] as per Reg (EC) No 1924/

17 Authorised Claims for Dietary Fibres Article Food Claimed Effect 13(5) Sugar beet fibre 13(3) Barley grain fibre 13(3) Oat grain fibre Increases faecal bulk Contributes to an increase in faecal bulk Contributes to an increase in faecal bulk 13(3) Rye fibre Rye fibre contributes to normal bowel function 13(3) Wheat bran fibre 13(3) Wheat bran fibre Contributes to an acceleration of intestinal transit Contributes to an increase in faecal bulk Conditions for Use Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/2006 Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/2006 Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/2006 Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/2006 Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/2006 Information shall be given to the consumer that the claimed effect is obtained with a daily intake of at least 10 g of wheat bran fibre Only for food which is high in that fibre as referred to in the claim HIGH FIBRE as per Reg (EC) No 1924/

18 Authorised Claims for Macronutrients Article Food Claimed Effect Conditions for Use 13(3) Carbohydrates Contributes to the maintenance of normal brain function 13(3) Protein Contributes to a growth in muscle mass 13(3) Protein Contributes to the maintenance of muscle mass 13(3) Protein Contributes to the maintenance of normal bones 14(1)(b) Protein Needed for normal growth and development of bone in children Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 130 g of carbohydrates from all sources. May be used for food which contains at least 20 g carbohydrates which are metabolised by humans, excluding polyols, per quantified portion and complies with the nutrition claim LOW SUGARS or WITH NO ADDED SUGARS as per Annex to Regulation (EC) No 1924/2006. Shall not be used on food which is 100% sugars. Only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as per the Annex to Regulation (EC) No 1924/2006. Only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as per the Annex to Regulation (EC) No 1924/2006. Only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as per the Annex to Regulation (EC) No 1924/2006. The claim can be used only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation 1924/

19 Disease Risk Reduction (Article 14) To date there are no approved disease risk (factor) reduction claims for whole or natural foods themselves 19

20 Do we Need Claims on These Foods? Is there a need to make specific health claims for all whole, natural or super" foods themselves? Whole foods can in a number of cases make more indirect nutrient claims based on their composition than would be shown for the whole food in many expensive placebo-controlled studies 20

21 Claims Related to Nutrients NATURALLY Present TOGETHER in Walnuts Poon T, Baldwin N (2014). Authorised EU health claim for walnuts (chapter 16). In: Sadler MJ, editor. Foods, Nutrients and Food Ingredients with Authorised EU Health Claims: Volume 1. (Woodhead Publishing Series in Food Science, Technology and Nutrition, number 263). Amsterdam, The Netherlands: Elsevier / Cambridge, UK: Woodhead Publishing Limited, pp

22 Claims Related to Nutrients NATURALLY Present TOGETHER in Walnuts 22

23 Claims Related to Nutrients NATURALLY Present TOGETHER in Walnuts 23

24 Claims Related to Nutrients NATURALLY Present TOGETHER in Walnuts 24

25 Example: Walnuts are a Natural Superfood? 92 Article 13(3) claims related to nutrients NATURALLY present TOGETHER in walnuts 4 related to MUFAs/PUFAs 34 related to vitamins 54 related to minerals Versus 1 Article 13(3) claim for walnuts and the improvement of the elasticity of blood vessels 25

26 Thank you! Website: /food/consulting NOTE: "Intertek Cantox" is now "Intertek Scientific & Regulatory Consultancy". 26

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