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Presentation to FDA Advisory Committee March 2011

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Food Dyes & Behavior: 

Food Dyes & Behavior A Different View

Challenge studies : 

2 Challenge studies % Levy(a) Sarantinos Pollock Adams Swanson Goyette Swanson Rowe Wilson Rowe Weiss Harley Levy(b) Spring(a) Spring(b) 1978 1990 1990 1981 1980 1978 1980 1988 1989 1994 1980 1978 1978 1981 1981

Diet studies: 

3 Diet studies

Step 1 - Recruit children: 

4 Step 1 - Recruit children

Step 2 - Remove additives: 

5 Step 2 - Remove additives

About 70% respond favorably: 

6 About 70% respond favorably

Step 3 – Give them some dye: 

7 Step 3 – Give them some dye

How much to use?: 

8 How much to use?

How much to use?: 

9 How much to use?

How much to use?: 

10 How much to use?

Challenge studies : 

11 Challenge studies % Levy(a) Sarantinos Pollock Adams Swanson Goyette Swanson Rowe Wilson Rowe Weiss Harley Levy(b) Spring(a) Spring(b) 1978 1990 1990 1981 1980 1978 1980 1988 1989 1994 1980 1978 1978 1981 1981

Challenge studies : 

12 Challenge studies % mg

Challenge studies : 

13 Challenge studies % mg

In the Real World, however . . .: 

14 In the Real World, however . . .

How much is in there?: 

15 How much is in there? 13 mg

Sent for analysis: 

16 Sent for analysis

Report of lab analysis: 

17 Report of lab analysis 3 Tb frosting for 1 cupcake = 58 mg Red 40 1072.3 mg/kg = 1.072 mg/g 3 Tb = 54 g 54 g x 1.072 mg/g = 57.8 mg

Nutrition Foundation recommended 27 mg per child : 

18 Nutrition Foundation recommended 27 mg per child

Where are the studies using realistic amounts of food dyes?: 

19 Where are the studies using realistic amounts of food dyes?

Where are the studies using realistic amounts of food dyes?: 

20 Where are the studies using realistic amounts of food dyes?

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Well there’s a pill for that …: 

41 Well there’s a pill for that …

Warning labels on ADHD drugs: 

42 Warning labels on ADHD drugs Blood pressure  Heart problems Strokes Aggression Mania Hallucinations Seizures Vision problems Stunted growth Sudden death

Some problems are fixable: 

43 Some problems are fixable Vision problem Hearing problem Sensory integration problem Thyroid dysfunction Excess of heavy metals Deficiency of “good fats” Excess manganese from soy infant formula Zinc or Iron deficiency Lack of sleep Family stress Loss of a pet or loved one Food allergies Synthetic food dyes Other food additives Natural salicylates, aspirin Fluoride sensitivity Environmental chemicals Wood burning stoves, kerosene heaters Gas or oil heat with inadequate filters Fragrances – plug-ins, cologne, scented candles, etc .

Some problems are fixable: 

44 Some problems are fixable Vision problem Hearing problem Sensory integration problem Thyroid dysfunction Excess of heavy metals Deficiency of “good fats” Excess manganese from soy infant formula Zinc or Iron deficiency Lack of sleep Family stress Loss of a pet or loved one Food allergies Synthetic food dyes Other food additives Natural salicylates, aspirin Fluoride sensitivity Environmental chemicals Wood burning stoves, kerosene heaters Gas or oil heat with inadequate filters Fragrances – plug-ins, cologne, scented candles, etc .

New York City Public Schools 1979-1983: 

45 New York City Public Schools 1979-1983 803 schools … 1,000,000 children Banned synthetic food dyes Banned synthetic flavorings Banned petrochemical preservatives Schoenthaler et al, 1986 International Journal of Biosocial Research, 8(2); 185-195

803 New York City Public Schools National California Achievement Test Scores: 

46 803 New York City Public Schools National California Achievement Test Scores 1978-79 Before diet change 1982-83 After diet change 50% = national average

12 prison studies: 

47 12 prison studies 8,076 juvenile delinquents Improved diet Average of all antisocial behavior went down 47%

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www.diet-studies.com

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This is our third generation: 

57 This is our third generation

Use at least this much: 245 mg: 

58 Use at least this much: 245 mg Amount Item Mg/Unit Mg Total 2 cans Code Red Soda 10.5 21.0 4 oz cup Yoplait Trix Green/Red Yogurt 2.5 each 2.5 4 oz cup Mott’s Apple Sauce–Mixed Berry 3.7 each 3.7 1 cup Jello (black cherry) .367 /g 83.0 2 Cupcakes with red frosting 1.07 /g 115.8 38g (1/3 box) Handful of red Skittles .224 / g 8.5 5-oz bag Twizzlers … munching at movie .066 / g 10.0 TOTAL _______ 244.5 mg

More Dye = More Reactions : 

59 % mg More Dye = More Reactions

Here is our future. Protect her. : 

60 Here is our future. Protect her.

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Or here?: 

62 Or here?

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Presented at FDA Hearing on Food Dyes March 30, 2011 by: 

64 Presented at FDA Hearing on Food Dyes March 30, 2011 by The Feingold Association of the United States The dietary connection to better behavior, learning & health www.feingold.org Shula Edelkind Research Information Director Feingold Association 800-321-3287