R&D and marketing of functional products Key issues to consider

Transcription

1 R&D and marketing of functional products Key issues to consider Vincent Guyonnet, DVM, Ph.D, Dipl. ACPV IEC Scientific advisor 2013 年 5 月 22 日吉林大学

2 What have we learned over the past 2 weeks about functional foods?

3 We are developing a new functional food what are the key things we must consider?

4 Type of functional ingredient; Type of functional food = vehicle for the functional ingredient; Type of food production system; Regulations; Customers; Key things to consider

5 Type of functional ingredient

6 Type of functional ingredient Safe? Bioavailable? Efficacious? Natural or synthetic ingredient? Searching for new functional ingredients?

7 Ingredient is safe Recommended Daily Allowance Lowest Observed Adverse Effect Level No Observed Adverse Effect Level Source: Wenk, 2008

8 Ingredient is safe GRAS = Generally Recognized As Safe

9 Ingredient is safe 262 pages of data submitted

10 Ingredient is safe Average usual use levels - Average maximum use levels Source: Food Technology, 2005

11 Source: Wenk, 2008 Bioavailability

12 Bioavailability Lutein Designer egg evaluation in a controlled trial. Surai et al. (2000). European Journal of Clinical Nutrition 54: Study design: 44 healthy adult volunteers, control group and experimental group; Consumption of one egg per day (raw or cooked) for a total of 8 weeks; Blood samples before and after 8 weeks; Amount per egg Regular egg Functional egg Enhancement factor Omega 3 DHA (mg) x 6.5 Vitamin A (mg) Vit E (mg) x 26.8 Lutein (mg) x 16 Selenium (μg) x 7.7

13 μg mol/liter Bioavailability Lutein plasma concentrations in humans P<0.001 Week ** Week % Control Experimental Surai et al. (2000). British Journal of Nutrition 101:

14 μg mol/liter Bioavailability α-tocopherol (vit E) plasma concentrations in humans P= Week Week % 0.45* Control Experimental Surai et al. (2000). British Journal of Nutrition 101:

15 Efficacious Strength of efficacy data of ingredient How much data is available about this active ingredient? Is it used only in foods or also in supplements? How much active ingredient do you need to consume to see some health benefits?

16 Efficacious Strength of efficacy data of ingredient Requirements vary from ingredient to ingredient: Conjugated linoleic acid (CLA) ~ 10 g / day; DHA omega 3 ~ 400 mg / day; Vitamins & minerals ~ few µg; Can these levels be easily incorporated into our diet?

17 Efficacious 10 mg DHA per 250 ml Enhancement through nutrition of cows

18 Efficacious 20 mg DHA per 250 ml Use DHA from fish oil for fortification mg EPA + DHA per 250 ml Use DHA from fish oil for fortification omega3_nutition_information.php

19 加拿大 Efficacious 125 mg DHA g total Omega 3 PUFA per 53 g egg

20 Natural vs. synthetic Nature / Origin of ingredient used Customers prefer natural products, ingredients; Fear of additives, colours, on labels;

21 Natural vs. synthetic Enhancement of current nutrients Special diet ingredient vitamin, mineral or other functional ingredient Egg enriched in a specific nutrient days to stabilize the level of nutrient

22 Natural vs. synthetic Egg enrichment in folic acid (μg/ 100 g) μg natural olic acid / 100 g P<0.05 Week 0 Week b b 70 a b c c Added synthetic folic acid (ppm) to basal diet (1 ppm) Hoey et al. (2009). British Journal of Nutrition 101:

23 Increasing CLA concentration in pigs SAF = Safflower oil /Control CLA = Synthetic CLA Longissimus dorsi CLA mg / g Fatty Acid Source: Schmid et al., Meat Science 73: Natural vs. synthetic SAF 1.0% CLA 2.5% CLA 5% CLA

24 Increasing CLA concentration in chickens CTL = Control diet CLA = Synthetic CLA day feeding 1.2 period Natural vs. synthetic CLA mg / g Fatty Acid Thigh meat Breast meat CTL Source: Zanini et al., Arq. Bras. Med. Vet. Zootec 60: Liver Gizzard Heart 10% CLA

25 New ingredients Identifying nutritional gaps and opportunities Identify potential nutrition gaps as an opportunity to develop new functional foods: Review medical publications; Reports from the FAO, WHO and other international organizations; Functional foods may be an opportunity to address growing health issues; Partnering with the medical doctors and nutritionists can be of great value;

26 New ingredients Western diets lacking sufficient intake of vegetables, fruits and fish; Reduced fish consumption has an impact on EPA + DHA intake; Ratio n-6:n-3: changed from 1:1 to 30:1;

27 New ingredients Daily EPA+DHA needs estimated at mg; Deficit of ~100 mg; Nutritional solutions: One egg: +100 mg DHA; 250 ml of milk: +10 mg DHA;

28 New ingredients

29 New ingredients Evolution of obesity in the USA ( ) Source: CDC -

30 New ingredients

31 New ingredients

32 New ingredients

33 New ingredients Selenium (Se) soil status in China Source: Shehong Li et al. (2012). Medical geology of arsenic, selenium and thallium in China. Science of Total Environment : 31-40

34 Return to outline

35 Type of functional food

36 Type of functional foods Bioavailability of functional ingredient in the food selected? Enrichment / fortification quantity relevant? Stability of ingredient in the food considered? Attitudes of customers towards certain foods? Trends in food consumption:

37 Bioavailability Lutein Lutein bioavailability is higher from lutein-enriched eggs than from supplements and spinach in men. Chung et al. (2004). Journal of Nutrition 134: Study design: 10 healthy adult volunteers, in a cross-over design; 2-week washout with low carotenoid consumption before any treatment; 4 different source of lutein tested, all providing 6 mg per day: supplement of lutein, lutein ester, spinach and egg; Volunteers completed all 4 treatments of study in random order; Blood samples at Day -14, Day 1, Day 2, Day 3 and Day 10 All serum lutein concentrations compared vs. value on Day 1;

38 nmol/lx mg dose Bioavailability Serum lutein concentrations in humans Egg Spinach Lutein P<0.001 *** 400 Lutein ester 300 *** *** 200 *** Day -14 Day 1 Day 2 Day 3 Day 10 Chung et al. (2004). Journal of Nutrition 134:

39 Bioavailability

40 Relevance of enrichment 10 mg DHA per 250 ml Or consumption of 3.15 liter = 125 mg DHA = 1 egg consumed = 125 mg DHA

41 Relevance of enrichment 300 mg ALA per 250 ml; ALA is a short chain omega-3 polyunsaturated fatty acid; ALA is not equivalent to DHA in terms of efficacy in humans;

42 75 mg DHA + 15 mg EPA mg ALA per 53 g egg Relevance of enrichment

43 Stability in foods Dairy-based probiotics products Wide variety of commercial products (Yoghurt, drinkable yoghurt, sour and fresh milk, cheeses, ); Why Milk and dairy products? Good carrier; Stored under refrigeration; Protect lactic acid bacteria and bifidobacteria against bile and low ph in the upper digestive tract; But some issues with milk: Poor growth in milk (low proteolytic activity, inability to use lactose); Sub-optimal conditions during the production of fermented dairy products;

44 Fruit-based probiotic products Fruit juices typically low ph (< 4) and high levels of organic acids = not good growth media / carrier for probiotics; Organic acids: at similar ph, better viability in pineapple juice than cranberry juice; Phenolic compounds: Inhibitory effects on bacteria; Stability in foods

45 Stability data over time Need to test and document the stability of the functional (active) ingredient in the food product over the shelf-life of products; Effects of freezing and thawing? Stability in foods Effects of cooking on functional ingredient? Clinical studies for efficacy must be done using finished foods and used under similar usage conditions;

46 Stability in foods LC Omega-3 PUFA profile in Pork Forequarter (% total fatty acids) PorcOmega TM = Stabilized tuna fishmeal product from Australia Source: Howe, Functional foods from fish oil and fishmeal

47 Attitudes towards foods Consumers preference (by species) Consumption pattern compared to 5 years ago 45% 44% 32% 63% Source: ALMA, 2012

48 Attitudes towards foods Consumers preference (by species) Consumption pattern Prediction in 5 years 31% 23% 45% Source: ALMA, 2012

49 Attitudes towards foods Nutritional value - Perceptions Source: ALMA, 2012

50 Negative health image of meat: High fat content; High in saturated fatty acids; Cholesterol content; Attitudes towards foods Consumers and Meat Association with some chronic conditions: Cardiovascular diseases; Some type of cancer; Obesity; Hypertension;

51 Trends in food consumption Per capita consumption of livestock products ( ) Source: FAOSTAT - FAO, 2012

52 Million Tonnes Trends in food consumption Animal products consumption in China Pork Dairy Eggs Beef Poultry

53 Return to outline

54 Types of food production system

55 Type of food production system Simple process of naturally produced functional foods? Addition of a functional ingredient during production of foods?

56 Special diet ingredient vitamin, mineral or other functional ingredient Natural process Enhancement of current nutrients Food products naturally enhanced

57 Manufacturing process Addition of new ingredient / component to foods Vitamin, mineral or other functional ingredient added through manufacturing process

58 Manufacturing process Addition of new ingredient / component to foods Special diet ingredient vitamin, mineral or other functional ingredient added through manufacturing process

59 Return to outline

60 Regulations

61 Regulations Approval process for new ingredient and/or functional foods? Type of claims allowed? Trust of consumers in regulatory process and oversight (monitoring)?

62 Ingredient approval GRAS = Generally Recognized As Safe

63 Functional food approval Novel food regulatory process Novel food: Food with composition different from the original food; Not widely consumed by humans; Difference in composition: New ingredient not currently present lycopene in eggs; Enrichment of a natural nutrient present lutein in eggs; Regulatory process often limit the possibility to develop new functional foods or increase the cost of research & development; But the process is important to ensure safety to consumers;

64 Functional food approval Regulatory environment In some countries, there are concerned with the enrichment of staple foods (base diet foods) with new functional ingredients as it may lead to overconsumption and potential food safety issues; Japan Each nutritional function claim must have a mandatory warning indication for folic acid, the claim reads: aids in the red blood cell formation and contributes the normal growth of the fetus - the warning reads: Increased intake of this product will not result in curing diseases nor promoting health. Please comply with the advisable daily intake. This product helps normal development of fetus, but increased intake of this product will not result in better development of fetus Warning statements make marketing of functional eggs very challenging;

65 Type of claims 3 main types of claims usually recognized Let s first define these 3 terms: Nutritional claims; Functional claims; Health claims;

66 Nutritional claims Type of claims Source, good source, excellent source, high Also referred as nutritional content claims

67 Country / Region Type of claims Nutritional claims Nutritional claim based on % Daily value Nbr. Claims allowed per 100 g USA Good (10-19%); High ( 20%) 9 Canada Source (5-14%); Good (15-24%); High ( 25%) 18 Australia Source (10-24%); Good source ( 25%) 11 Europe Source (15-29%); High ( 30%) 10 Japan Contains; High 10

68 Type of claims Functional claims Also referred as nutrient function or biological role claims

69 VITAMIN A aids normal bone and tooth development aids in the development and maintenance of night vision aids in maintaining the health of the skin and membranes helps build strong bones and teeth supports night vision supports healthy skin Type of claims Functional claims Examples of functional claims approved in Canada: PROTEIN helps build and repair body tissues helps build antibodies helps build strong muscles VITAMIN E a dietary antioxidant a dietary antioxidant that protects the fat in body tissues from oxidation

70 Type of claims Health claims Also referred as diet-related health claims or disease risk reduction claim; These health claims are designed to help consumers make informed choices, thereby reducing their risk of developing chronic diseases. The standards also aim to ensure that these claims: are consistent and not deceptive; are based on recognized health and scientific criteria; describe the characteristics of a diet associated with reduced risk of developing the chronic disease identified in the health claim.

71 Type of claims Health Claims Examples of disease risk reduction claims approved in Canada 1. Disease Risk Reduction Claims with Respect to Sodium and Potassium "A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is sodium-free." 2. Disease Risk Reduction Claims with Respect to Calcium and Vitamin D "A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium." 3. Disease Risk Reduction Claims with Respect to Saturated and Trans Fats "A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is free of saturated and trans fats." 4. Disease Risk Reduction Claims with Respect to Cancer Risk Reduction 1 "A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer."

72 Type of claims Nutritional and other claims allowed for regular eggs in the USA, Canada, Australia, the EU and Japan USA (2) Country Nutritional claim rules Nutritional claims for regular egg per 100 g edible portion (1) good source, contains or provides if 10%-19% DV high, rich in or excellent source of if > 20% DV good source for iron, phosphorus, folate, niacin, pantothenic acid and vitamin D high for selenium, riboflavin and vitamin B12 Other claim(s) allowed Canada (3) source if 5-14% DV good source if 15-24% DV excellent source if >25% source for calcium, iron, magnesium, zinc, copper, niacin, vitamin A, thiamin, vitamin B6, vitamin E good source for phosphorus, folate, pantothenic acid and vitamin D excellent source for selenium, riboflavin, vitamin B12 and biotin Australia (4) source if 10%-24% DV good source if >25% DV source for iron, phosphorus, vitamin A, folate, vitamin D and vitamin E good source for selenium, niacin, pantothenic acid, riboflavin and vitamin B12 Folate health claim which states: a) That increased maternal folate consumption in at least the month before and 3 months following conception may reduce the risk of fetal neural tube defects; and b) The recommendation that women consumer a minimum of 400 micrograms folate per day in at least the month and at least the first 3 months following conception (1) for comparison, all claims are listed based on 100 g edible portion. Canada and the USA have a serving size equaled to one egg and not 100 g;

73 Type of claims Nutritional and other claims allowed for regular eggs in the USA, Canada, Australia, the EU and Japan Country Europe (5) Nutritional claim rules source if >15% RDA high if >30% RDA Nutritional claims for regular egg per 100 g edible portion (1) source for phosphorus, vitamin A, folate, niacin, pantothenic acid and vitamin D high for selenium, riboflavin, vitamin B12 and biotin Other claim(s) allowed Japan (6) contains or enhanced specific amount for each nutrient; High specific amount for each nutrient contains for zinc, iron, copper, pantothenic acid, vitamin D and folate high for biotin, vitamin A, vitamin B2 and vitamin B12 Function claims: Vitamin A helps to maintain vision in the dark, and helps to maintain skin and mucosa healthy / Warning indication: increase intake of this product will not result in curing diseases nor promoting health. Please comply with the advisable daily intake. Women within the third months of pregnancy or women considering to be pregnant should be careful of over consumption Vitamin B2 helps to maintain skin and mucosa healthy / Warning indication: increase intake of this product will not result in curing diseases nor promoting health. Please comply with the advisable daily intake. Folic acid aids in the red blood cell formation, and contributes the normal growth of the fetus / increase intake of this product will not result in curing diseases nor promoting health. Please comply with the advisable daily intake. This product helps normal development of fetus, but increased intake of this product will not result in better development of fetus (1) for comparison, all claims are listed based on 100 g edible portion. Canada and the USA have a serving size equaled to one egg and not 100 g;

74 Type of claims Nutritional and other claims allowed for regular eggs in the USA, Canada, Australia, the EU and Japan (2) based on 21CFR and USDA National nutrient database Available from [Accessed on 18 May 2010] (3) based on CFIA Guide to food labeling and advertising Available from [Accessed on 30 January 2010] and Canadian nutrient file Available from [Accessed on 30 January 2010] (4) based on Australia New Zealand Food Standards Code - Standards 1.1.1, 1.1.A.2, and Available from and NUTTAB 2006 Online version Available from [Accessed on 29 March 2010] (5) based on EU nutrition claims Available from [Accessed on 27 March 2010] and EU directive 2008/100/EC Annex I (28 October 2008) (6) based on Ministry of Health, Labour and Welfare Available from [Accessed on 1 May 2010]

75 Type of claims Role of claims (nutritional, functional and/or health claims) Studies in many countries have shown better acceptance of functional foods when: Strong belief in health benefits of functional foods; Government support of health claims; Absence of regulations for claims in many countries has a negative effect on consumers attitude towards functional foods;

76 Trust in regulations Lack of visual production differentiation for some functional foods Nothing looks more like an egg than other egg! Need to have the trust of consumers; Need to have the trust of regulators;

77 Trust in regulations Truthfulness in labeling

78 Trust in regulations Truthfulness in labeling

79 Trust in regulations Truthfulness in labeling

80 Updated 10/13/2011 1:24 PM Truthfulness in labeling China closes 13 Wal-Mart stores, arrests 2 employees Trust in regulations BEIJING (AP) Wal-Mart is getting another public bludgeoning in China as popular anger over food safety and political infighting make the retail giant a convenient target. Authorities in the city of Chongqing have arrested two employees, closed down 13 Wal-Mart stores for two weeks and fined the company 2.7 million yuan ($421,000). Analysts said the penalties seem harsh in light of the violation: passing off regular pork as higher-priced organic meat.

81 Return to outline

82 Consumers

83 Customers attitudes towards functional foods; Role of Price; Consumers Nutritional information and trust; Consumers education;

84 Consumers attitudes Attitudes towards functional foods Consumer general acceptance of functional foods: Functional foods are not an homogeneous product category different attitudes depending on the type of function foods; Urala et al., Food Quality and Preference 18: 1-12 Acceptance of functional food dependent on the perception of the nutritional qualities of the base product [candy bar vs. yogurt]; Bech-Larsen et al., Appetite 40: 9-14

85 Consumers attitudes Which foods are better candidates as a functional food?

86 Taste Willingness of consumers to compromise on taste for health a) I accept functional foods if they taste good Source: Verbeke, Food Quality and Preference 17:

87 Taste Willingness of consumers to compromise on taste for health b) I accept functional foods if they taste worse than conventional substitute foods Source: Verbeke, Food Quality and Preference 17:

88 Taste Importance of sensory qualities of Omega-3 enhanced meats Overall liking No enhancement No enhancement PorcOmega TM = Stabilized tuna fishmeal product from Australia (15% in ration) Source: Howe, Functional foods from fish oil and fishmeal

89 Attitudes towards functional foods Role of price: US study showed that the price was important for 40% of shoppers who also considered nutrition as important; Bowman, Nutrition Research 25: Role of price Price is an issue even for consumers likely to accept the concept of functional foods and be prepared to try them; Premium price for functional foods (+10-30%) will likely affect the buying decision;

90 Role of price Attitudes towards functional foods Single dose presentation to make the product less expensive!

91 Role of price Product differentiation and segmentation Same functional ingredient but Made just for you! Digestive troubles linked to international traveling Animals Children

92 Trust in information Level of Consumers trust towards information provided Role of knowledge and disbelief of information provided: Many studies have demonstrated that consumers have little knowledge about nutrition and the benefits brought by functional foods; Consumers are very skeptical about the information provided, especially by food manufacturers; In the USA where health claims have been allowed by the FDA, communication of benefits had limited success;

93 Role of Health Professionals: Trust in information Level of trust and confidence in health professionals Health professionals are in a great position to influence the consumption of functional foods by their patients; Study in Sweden showed more skepticism and distrust about functional foods by physicians and nurses than by dieticians; Landstrom et al., : Lack of trust, interest and understanding of functional foods given as main explanations for not recommending functional foods to patients;

94 Consumer education Need for an education process with customers Functional foods are a new concept difficult for consumers to understand as their benefits are often linked to long term consumption; Consumers education will play a critical role in their success as demonstrated by numerous studies; Education programmes are complex and require the interaction between consumers, the food industry, retailers, the health sector and governments;

95 Consumer education Need for an education process with customers Focus on attributes and benefits of eggs; Strong branding efforts;

96 Power of branding Consumer education

97 Consumer education Power of branding

98 Consumer education Gain support from health officials In many countries, health officials have the goal to increase the overall consumption of long chain Omega-3 fatty acids; Egg industry has a viable and proven solution; Role of functional eggs to close the nutritional gap for omega 3, vitamin A, vitamin E and selenium;

99 Consumer education Need the support of the health professionals Complexity of Omega-3 messages to consumers Average consumer lacks understanding of nutrition and needs for Omega 3; Omega-3 complex family of fatty acids (short chain from plants, long chain from animal products); Required intake for EPA and DHA dependent on the Omega 6 consumption as well; Consumers have limited trust for information provided by the industry; Health professionals are reluctant to recommend functional foods, mostly due to a lack of knowledge and confidence in this field; Need to assist health professionals to deliver the messages;

100 Consumers will trust health professionals Consumer education Tools for health professionals

101 Consumer education Tools for health professionals

102 Return to outline

103 Conclusion A number of key criteria concerning the functional ingredient and its vehicle, the functional food, are important for the successful developing of new functional foods; Regulations can help the development of functional foods through approval of claims and better monitoring of claims made; Customers want everything healthy, good for you, tasty and cheap foods, and control the buying decision process;