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Health Claims in the US: Health Claims in the US: Public Health Boon or Public Health Boon or Tower of Babel? Tower of Babel? Clare M. Hasler, Ph.D., M.B.A. Clare M. Hasler, Ph.D., M.B.A. May 15, 2008 May 15, 2008 [email protected] [email protected] www.rmi.ucdavis.edu www.rmi.ucdavis.edu
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Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

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Page 1: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Health Claims in the US: Health Claims in the US: Public Health Boon or Public Health Boon or

Tower of Babel?Tower of Babel?

Clare M. Hasler, Ph.D., M.B.A.Clare M. Hasler, Ph.D., M.B.A.May 15, 2008May 15, 2008

[email protected]@ucdavis.eduwww.rmi.ucdavis.eduwww.rmi.ucdavis.edu

Page 2: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 3: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Critical Need for Facilities

Cruess Hall (FS&T) Pilot Plant Wickson Hall (V&E) Cellar Cruess Hall (FS&T) Pilot Plant Wickson Hall (V&E) Cellar

Page 4: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

$25 million from $25 million from Robert Mondavi Robert Mondavi

in 2001…in 2001…

The Gift

…turned the vision …turned the vision into realityinto reality

Page 5: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Robert MondaviRobert Mondavi

“Enhancing the quality of life through “Enhancing the quality of life through wine and food sciences”wine and food sciences”

Page 6: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

New Gateway to Campus

■■■■■■■■ Graduate School of Management & Conference CenterGraduate School of Management & Conference Center■■ 7575--Room Hyatt Place HotelRoom Hyatt Place Hotel■■ UC DavisUC Davis Museum of ArtMuseum of Art

(W)(W) San Francisco SacramentoSan Francisco Sacramento((E)E)

Page 7: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

RMI Academic Complex

Sensory Laboratories Sensory Laboratories and RMI Officesand RMI Offices

Viticulture & EnologyViticulture & Enology

Food Science & TechnologyFood Science & Technology

Future site:Future site:AnheuserAnheuser--Busch BrewingBusch Brewingand Food Science Laboratoryand Food Science Laboratory

Future site:Future site:Research/Teaching WineryResearch/Teaching Winery

Page 8: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 9: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 10: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Grand Opening in October!

Page 11: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

1984 Kellogg1984 Kellogg-- National Cancer National Cancer Institute partnership on AllInstitute partnership on All--Bran cereal: “…may reduce Bran cereal: “…may reduce the risk of certain cancers.”the risk of certain cancers.”

First time “cancer” used First time “cancer” used on a food packageon a food package

FDA took no actionFDA took no actionFDA took no actionFDA took no action

Flurry of unsubstantiated Flurry of unsubstantiated health claims resultedhealth claims resulted

Congress passed the NLEA Congress passed the NLEA in 1990in 1990

Page 12: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Claims Allowed on Conventional Foods or Dietary Supplements in the U.S.

1. Health ClaimsNLEA authorized health claimsNLEA authorized health claims

Claims based on authoritative statementsClaims based on authoritative statements

2. Structure/Function Claims3. Nutrient Content Claims

Claims based on authoritative statementsClaims based on authoritative statements

Qualified health claimsQualified health claims

Page 13: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

TwentyTwenty--five five gramsgrams of soy of soy protein a day, as protein a day, as part of a diet low part of a diet low in saturated fat in saturated fat and cholesterol, and cholesterol, may reduce the may reduce the

Health Claim

may reduce the may reduce the risk of heart risk of heart disease. One disease. One serving of Sun serving of Sun SoySoyTMTM contains contains 6.25 grams of 6.25 grams of soy proteinsoy protein

Page 14: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 15: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

"Scientific evidence "Scientific evidence suggests suggests but does not provebut does not provethat that eating 1.5 ounces per day of eating 1.5 ounces per day of most nuts, such as most nuts, such as

“Qualified” Health Claim

most nuts, such as most nuts, such as almonds, as part of a almonds, as part of a diet low in saturated diet low in saturated fat and cholesterol may fat and cholesterol may reduce the risk of heart reduce the risk of heart disease.”disease.”

http://www.cfsan.fda.gov/~dms/qhcnuts2.htmlhttp://www.cfsan.fda.gov/~dms/qhcnuts2.html ..

Page 16: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 17: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Consumer Awareness of Health Benefits of Including Nuts in Daily Diet

Page 18: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 19: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 20: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Authorized under the Dietary Supplement Health Authorized under the Dietary Supplement Health Authorized under the Dietary Supplement Health Authorized under the Dietary Supplement Health and Education Act of 1994 (DSHEA)and Education Act of 1994 (DSHEA)

Statements describing the effect of a dietary Statements describing the effect of a dietary supplement on the structure/function of the bodysupplement on the structure/function of the body

“This statement has not been evaluated by the FDA. “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cu re, or This product is not intended to diagnose, treat, cu re, or

prevent any disease” prevent any disease”

Page 21: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Percent of Daily Percent of Daily ValueValue

Good source: Good source: 10% 10% Good source: Good source: 10% 10%

Excellent source: Excellent source: 20%20%

Page 22: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 23: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 24: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Eat a plantEat a plant--based dietbased diet

Page 25: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Consumption of Fruit & Vegetables and Relative Risk of Cancer

Page 26: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

2 cups of fruit and 2.5 cups 2 cups of fruit and 2.5 cups of vegetables each day for a of vegetables each day for a 2,0002,000--calorie diet calorie diet

Choose a variety of fruits Choose a variety of fruits and vegetables each day. and vegetables each day. In particular, select fromIn particular, select fromIn particular, select fromIn particular, select fromall five vegetable subgroups all five vegetable subgroups (dark green, orange, (dark green, orange, legumes, starchy vegetables, legumes, starchy vegetables, and other vegetables) and other vegetables) several times a week. several times a week.

Page 27: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

BlanckBlanck et al., Prev. Chronic et al., Prev. Chronic DisDis 5(2):15(2):1--10, 200810, 2008

Page 28: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

E. Sloan. Food Technology, April 2008E. Sloan. Food Technology, April 2008

##2 Trend: Natural End Benefits. “…a new, 2 Trend: Natural End Benefits. “…a new, unstoppable trend to unstoppable trend to whole food nutritionwhole food nutrition .” .”

Page 29: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

U.S. Supplement Sales Growth, 1995U.S. Supplement Sales Growth, 1995--20062006

12.0%

14.0%

16.0%

18.0%

20.0%

Nutrition Business Journal, www.nutritionbusiness.c omNutrition Business Journal, www.nutritionbusiness.c om NBJ’s Overview Seminar 2007NBJ’s Overview Seminar 2007

5.4%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Page 30: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

1.1. Digestive healthDigestive health2.2. Fruit & Fruit & superfruitsuperfruit3.3. The marketing The marketing

power of “naturally power of “naturally healthy”healthy”

4.4. Beauty foodsBeauty foods5.5. Weight management Weight management 5.5. Weight management Weight management 6.6. Mood foodMood food7.7. PremiumizationPremiumization of of

healthhealth8.8. Healthy snackingHealthy snacking9.9. Kids’ nutritionKids’ nutrition10.10.Are antioxidants the Are antioxidants the

new probioticsnew probiotics

Page 31: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

1.1. Digestive healthDigestive health2.2. Fruit & Fruit & superfruitsuperfruit3.3. The marketing The marketing

power of “naturally power of “naturally healthy”healthy”

4.4. Beauty foodsBeauty foods5.5. Weight management Weight management 5.5. Weight management Weight management 6.6. Mood foodMood food7.7. PremiumizationPremiumization of of

healthhealth8.8. Healthy snackingHealthy snacking9.9. Kids’ nutritionKids’ nutrition10.10.Are antioxidants the Are antioxidants the

new probioticsnew probiotics

Page 32: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

100

120

140

160

180

“The wonderfruit of the American “The wonderfruit of the American juice market” juice market” (Julian Mellentin)(Julian Mellentin)

0

20

40

60

80

100

1999 2000 2001 2002 2003 2004 2005

Retail sales increased 175% ($60 million) in the Retail sales increased 175% ($60 million) in the first 6 months of 2005first 6 months of 2005

Page 33: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Launches of Beverages Containing Blueberry, Europe (1995-2005)

120

140

160

0

20

40

60

80

100

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Page 34: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

1.1. Digestive healthDigestive health2.2. Fruit & Fruit & superfruitsuperfruit3.3. The marketing The marketing

power of “naturally power of “naturally healthy”healthy”

4.4. Beauty foodsBeauty foods5.5. Weight management Weight management 5.5. Weight management Weight management 6.6. Mood foodMood food7.7. PremiumizationPremiumization of of

healthhealth8.8. Healthy snackingHealthy snacking9.9. Kids’ nutritionKids’ nutrition10.10.Are antioxidants the Are antioxidants the

new probioticsnew probiotics

Page 35: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Immunity Boost Immunity Boost -- Naturally rich in Naturally rich in antioxidants vitamins A & C to help support antioxidants vitamins A & C to help support a healthy immune system.a healthy immune system.

Healthy Weight Healthy Weight -- Diets rich in foods naturally Diets rich in foods naturally containing fiber can help you maintain a containing fiber can help you maintain a healthier body weight. healthier body weight. Sliced carrots, sugar snap peas, black beans Sliced carrots, sugar snap peas, black beans and and edamameedamame lightly tossed with butter saucelightly tossed with butter sauce ..

a healthy immune system.a healthy immune system.Broccoli florets, julienne carrots and red and Broccoli florets, julienne carrots and red and yellow sweet pepper strips in a garlicyellow sweet pepper strips in a garlic--herb herb infused extra virgin olive oil seasoninginfused extra virgin olive oil seasoning ..

Healthy Vision Healthy Vision -- with natural antioxidants with natural antioxidants lutein & vitamin A to help support eye healthlutein & vitamin A to help support eye health . . Sliced carrots, zucchini quarters, and sliced Sliced carrots, zucchini quarters, and sliced green beans lightly tossed with rosemary green beans lightly tossed with rosemary butter sauce.butter sauce.

Page 36: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Consumers are relying

less on health and nutrition nutrition

information on package labels for purchase decisions

Page 37: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per
Page 38: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

“We are close to the time when health “We are close to the time when health claims don’t mean anything to claims don’t mean anything to

consumers. I have not done a health consumers. I have not done a health claim petition in 18 months. I am claim petition in 18 months. I am

moving all of my clients to moving all of my clients to structure/function claims structure/function claims

and…looking at publicity as a way to and…looking at publicity as a way to promote products”promote products”

U.S. regulatory consultant and former food industry VP, spring 2007U.S. regulatory consultant and former food industry VP, spring 2007

Page 39: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Foods Meeting Specific Foods Meeting Specific “Better“Better--forfor--you Criteria”you Criteria”

Limits on total, saturated, Limits on total, saturated, transtrans--fats, cholesterol, fats, cholesterol, sodium, and sugarsodium, and sugarsodium, and sugarsodium, and sugar

Foods qualify if they Foods qualify if they provide beneficial nutrients provide beneficial nutrients

(calcium, fiber) or deliver (calcium, fiber) or deliver a functional benefita functional benefit

Page 40: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

One Star Two Stars Three StarsOne Star Two Stars Three StarsGood Nutritional Value Better nutritional Val ue Best nutritional valueGood Nutritional Value Better nutritional Val ue Best nutritional value

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Page 42: Health Claims in the US: Public Health Boon or Tower of Babel?Soy TTMM contains 6.25 grams of soy protein "Scientific evidence suggests but does not prove that eating 1.5 ounces per

Robert Mondavi Institute for Wine and Food ScienceRobert Mondavi Institute for Wine and Food ScienceUniversity of California, DavisUniversity of California, Davis

“Enhancing the quality of life through wine and foo d sciences”“Enhancing the quality of life through wine and foo d sciences”